【4565】そーせいG 453 【SOSEI 2018年12月期第1四半期決算:8/9】

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1山師さん@トレード中 (ワッチョイ 6b37-9nzk [ [上級国民]])2018/07/28(土) 21:30:43.17ID:zPNL6Fvq0
【4565】そーせいG 452 【Novartis Q2 2018 Results: 7/18 】
VIPQ2_EXTDAT: checked:vvvvvv:1000:512:----: EXT was configured

2山師さん@トレード中 (ワッチョイ 4b37-9nzk [ [上級国民]])2018/07/28(土) 21:33:13.31ID:zPNL6Fvq0
Granta Park:
※Site 5 Granta Park Cambridge, Design & Access Statement September 2016: Client: Heptares. (2016/9/26)
※Site 5 Granta Park Cambridge, Full Planning: Planning Applications. (Registration Date: 2016/10/19 - Decision Date: 2017/2/7)
※Cambridge Enjoys Strong Office Take-Up: Deals of this nature include Heptares taking 30,000 sq ft at Granta Park. (2016/12/20)
※Aukett Swanke Group Final Results: " The £20m Biomed Realty building at Granta Park pre let to Heptares and a further phase on the iconic Adelphi building off the Strand." (2017/1/12)
※Heptares: Heptares Plans Relocation to Cambridge, UK. Company to create a state-of-art R&D facility on Granta Park to support growth strategy. (2017/6/20)
※Business Weekly Cambridge: Japanese owned biotech joins march into Cambridge cluster. Heptares is creating a state-of-the-art R & D facility at Granta Park to support an international growth strategy. (2017/6/20)
※SOSEI:Heptares、研究施設を英国ケンブリッジへ移転することを発表。更なる成長戦略の推進にむけて、Granta Parkに最先端研究開発施設を開設。The Steinmetz Buildingと呼ばれる予定。2018 年後半をめどに新拠点へ移転します。(2017/6/20)

3山師さん@トレード中 (ワッチョイ 4b37-9nzk [ [上級国民]])2018/07/28(土) 21:34:34.58ID:zPNL6Fvq0
※Heptares: The company is currently based in Welwyn Garden City and will be relocating to the Cambridge area in "July 2018". It has approximately 100 employees. (2017/9/6up)
※"Steinmetz Granta Park Cambridge, Design and Access, Statement October 2017". (Issue Date: 2017/10/21)
・The recent advances in electron microscopy of individual proteins have helped put Heptares at the top position as a world leaders in structure-based drug discovery.
・Therefore, to maintain their position direct access to a state of the art electron microscopy facility is essential.
・Currently they have to transport the crystals of protein to Oxford for testing, however an inhouse facility is vital for Heptares’ future growth and success.
・Due to the size of the electron microscopes, it prevents the facility being housed within the existing Steinmetz building, consequently a new extended facility is required.
・Existing external enclosures to the north is to be re modified and incorporated within the extension.
※Site 5 (Steinmetz Buillding), Granta Park, GREAT ABINGTON, CB21 6GP: Electron Microscope extension to research and development building as approved. (Registration Date: 2017/10/31, Decision Date: 2018/1/15)
※Business Weekly Cambridge: "Rapidly Advance Drug Discovery. Heptares is set to relocate to a new 35,000 sq ft facility at Granta Park, Cambridge in-mid 2018 by which time local headcount should be up to 130." (1/16)
※Heptares: Approximately 100 Employees. →Changed to "Heptares has approximately 130 employees who will all be based in this new research facility". (2/5update)

4山師さん@トレード中 (ワッチョイ 4b37-9nzk [ [上級国民]])2018/07/28(土) 21:35:07.73ID:zPNL6Fvq0
※Aukett Swanke Annual Report: BioMed Realty, Granta Park: Following our initial option studies the client engaged in tenancy negotiations with Heptares improve their laboratory and technical research facilities. will be completed in July 2018. (3/1)
※Business Weekly Cambridge: Granta Park’s owner BioMed Realty: "The next move for Granta Park will be to welcome life science company Heptares in the summer". (3/2)
※Heptares Zurich: By mid-2018, we are seeking for our site in Schlieren/Zurich (Switzerland) an enthusiastic and motivated laboratory technician (70-100%). (3/15up)
※Heptares Zurich: Protein Biochemistry Group, Grow the team from currently 2 FTEs to 5 FTEs by 2020. Close interaction with protein biochemistry group in the UK. (4/3up)
※Labiotech.eu: The 10 Biotech Companies in London to Keep an Eye on in 2018. "Golden Triangle”: London, Oxford and Cambridge. Worth keeping an eye on. "Heptares". (4/16)
※GOV.UK [Notice]: "CB21 6GT, Heptares Therapeutics Limited (Steinmetz Building, Granta Park: Radioactive substances activity) environmental permit application advertisement." (4/5)
※Heptares: We are seeking to appoint "Logistics Assistant", working in our expanding Operations team, with an opportunity to contribute to the setting up of our exciting new facility in Cambridge. (5/20 Closed)
※Heptares: We now seek to recruit a analytical chemist to join the analytical and compound purification team within our medicinal chemistry department. "Analytical/Seperation Scientist". (5/24 Closed)

5山師さん@トレード中 (ワッチョイ 4b37-9nzk [ [上級国民]])2018/07/28(土) 21:35:47.83ID:zPNL6Fvq0
※Heptares: "Senior Scientist - Molecular Pharmacology": Strengthen and expand its capabilities in the immunology/inflammation therapeutic areas, now seek to recruit a laboratory-based in vitro pharmacologist to join our Molecular Pharmacology team. (6/21 Closed)
※Heptares: "Scientist/Research Scientist - Molecular Pharmacology": Strengthen and expand Molecular Pharmacology team and, now seeking to recruit laboratory-based in vitro pharmacologists. (6/21 Closed)
※Heptares: "Receptionists - Jobshare (25 hours per week)": We are now seeking to recruit two highly motivated part-time receptionists to join the Operations team. (7/6 Closed)
※Heptares: "I.T Support Technician": We are now seeking to appoint an enthusiastic and motivated IT Support Technician working in our expanding IT team. (7/9up, 7/30 Closing)

Heptares Therapeutics: The company is currently based in Welwyn Garden City; however, this role will be based at our brand-new research facility at Granta Park (Cambridge) from August 2018.
Heptares has been operating for over ten years and has approximately 130 employees who will all be based in this new research facility.

6山師さん@トレード中 (ワッチョイ 4b37-9nzk [ [上級国民]])2018/07/28(土) 21:40:09.45ID:zPNL6Fvq0


8山師さん@トレード中 (ワッチョイ 4b37-9nzk [ [上級国民]])2018/07/28(土) 22:00:14.69ID:zPNL6Fvq0
※MRC LMB: Richard Henderson shares Wiley Prize in Biomedical Sciences. "Developed cryo-EM to be the most important new tool" (2017/2/23)
※MRC LMB: G-protein coupled receptors as drug targets: Heptares Therapeutics celebrates its tenth anniversary. "Challenges and solutions: G protein-coupled receptors as novel drug targets." (2017/6/19)
・Dr Chris Tate is a Programme Leader at the MRC Laboratory of Molecular Biology, Cambridge, where he researches G protein-coupled receptors.
・He is a co-founder of Heptares Therapeutics, a company that is creating novel medicines targeting G protein-coupled receptors.
・Recently, the lab of Dr Tate has engineered a minimal G protein, mini-Gs, that improves the chances of getting a high-resolution structure of a receptor in the fully active state.
・As proof of principle, the structure of the adenosine A2A receptor was determined coupled to mini-Gs.
・This gave valuable insights into the role of the G protein in binding to the receptor and how it affected the receptor’s structure around the ligand binding pocket.
・Novel minimal G proteins have now been derived from other types of G proteins, such as Gq, Gi and Go, which now permits the structure determination of many more receptors, thus accelerating drug discovery.
・Structure of A2AR in the fully active state bound to the agonist NECA and a mini G protein, mini-Gs.

9山師さん@トレード中 (ワッチョイ dbe3-+HIz [])2018/07/28(土) 22:00:20.32ID:jEgwY4vs0

10山師さん@トレード中 (ワッチョイ 4b37-9nzk [ [上級国民]])2018/07/28(土) 22:00:36.97ID:zPNL6Fvq0
※MRC LMB: In celebration of the 10th Anniversary of the founding of Heptares Therapeutics: "G protein-coupled receptors: structure-based drug discovery from crystals to the clinic". (2017/07/13).
・Speakers: Fiona Marshall, Malcolm Weir, Chris Tate, Richard Henderson, Gebhard Schertler, Andreas Pluckthun, Rob Cooke, Jon Mason, Tim Tasker, Miles Congreve.
※IUCr 2017: Richard Henderson, Receive the EM Crystallography Medal at IUCr 2017. Congratulations! (2017/8/28)
※MRC LMB: Brochure 2017: "Impact: Heptares." (2017/9/19update)
・In 2007 the LMB’s Richard Henderson and Chris Tate co-founded Heptares Therapeutics to exploit pioneering new technology to stabilise G-protein-coupled receptors (GPCRs).
・Heptares StaR (Stabilised Receptor) technology platform allows us to apply contemporary drug discovery approaches to stabilised GPCRs
・improving the chances of finding drugs to previously intractable targets and enabling the development of safer and more selective therapeutic agents.'
・Heptares is using this technology to work on its own and with partners to discover new medicines to target key diseases such as Alzheimer"s, schizophrenia, type 2 diabetes, cancers and HIV.

11山師さん@トレード中 (ワッチョイ 4b37-9nzk [ [上級国民]])2018/07/28(土) 22:01:56.81ID:zPNL6Fvq0
※MRC LMB, PhD Programme: We are now accepting applications for our PhD programme. Applications now open. Projects: The PhD projects available for studies leading to a University of Cambridge PhD degree commencing 1 October 2018 are listed. (2017/9/22up)
[Chris Tate: "Cryo-EM of GPCRs"]: "Structural StudiesStructure of activated states of G protein-coupled receptors by Electron Cryo-Microscopy."
・Recently, we also developed a thermostabilised G protein that has allowed us to determine the structure of the activated state of the adenosine A2A receptor.
・We wish to build on these successes and to utilise the developments in electron cryo-microscopy to determine structures of GPCRs bound to stabilised heterotrimeric G proteins and arrestin by single particle imaging.
・The successful candidate will be expected to learn all the steps involved in the overexpression, purification and preparation of cryo-EM samples of a GPCR
・and to determine one or more structures using the Titan Krios equipped with state of the art detectors.
※Heptares: We're delighted to hear that Heptares co-founder Richard Henderson is a recipient of this year's Nobel Prize in Chemistry. (2017/10/4)
※Fiona Marshall: So delighted that Heptares founder Richard Henderson has won the Nobel Prize. "Uses of Cryo-EM, Just Beginning." (2017/10/4)
※SOSEI:Heptares創設者Richard Hendersonが、生物学的構造を画像として解析することのできるクライオ電子顕微鏡(CRYO-EM)の開発により、2017年ノーベル化学賞を受賞。(2017/10/5)

12山師さん@トレード中 (ワッチョイ 4b37-9nzk [ [上級国民]])2018/07/28(土) 22:02:32.26ID:zPNL6Fvq0
※BioRxiv: New Results: "Cryo-EM structure of the adenosine A2A receptor coupled to an engineered heterotrimeric G protein": Chris Tate. (2/19 up)
・Determine the structure by Cryo-EM of A2AR at pH 7.5 bound to the small molecule agonist NECA and coupled to an engineered heterotrimeric G protein, which contains mini-GS, the bg subunits and nanobody Nb35.
※SOSEI個人投資家説明会:2017年ノーベル化学賞受賞Richard Henderson博士の基調講演。(3/14)
※名古屋大学細胞生理学研究センター/株式会社CeSPIA:『Richard Henderson博士による講演会』:"Electron cryomicroscopy in structural biology: progress and prospects." (3/16)
※米国特許出願(Heptares):Mutant G-Protein Coupled Receptors and Methods for Selecting Them. (Inventors MRC LMB: Chris Tate, Richard Henderson). (3/29公開)
※Structural Biology and Molecular Biophysics: "Cryo-EM structure of the adenosine A2A receptor coupled to an engineered heterotrimeric G protein.": (Chris Tate), Heptares also funded this work. (5/4up)
※The Journal of Biological Chemistry: "Mini G protein probes for active G protein-coupled receptors (GPCRs) in live cells". Heptares Grants MC_U105197215 and EMPSI 339995 (to Chris Tate.). (5/11up)
※RCSB Protein Data Bank: (Structure ID: 6GDG): "Cryo-EM structure of the adenosine A2A receptor bound to a miniGs heterotrimer": (Released: 2018/5/16) (5/16up)
※MRC LMB: The New LMB Building in Cambridge was Officially Opened by Her Majesty The Queen. The Queen spoke at length to LMB group leader, Chris Tate, and was fascinated by the potential for new drug delivery systems. (5/24)

13山師さん@トレード中 (ワッチョイ 4b37-9nzk [ [上級国民]])2018/07/28(土) 22:03:12.79ID:zPNL6Fvq0
※MRC LMB:Congratulations to Richard Henderson from MRC_LMB on being made a Companion of Honour in the Queen’s Birthday Honours. (6/8)
※BBC NEWS: Nobel laureate joins another exclusive club. Dr Richard Henderson has been made a Companion of Honour in the Queen’s Birthday Honours. The order is a special award held by only 65 people at any one time. (6/8)
※HeptaresTL: Congratulations to our founder Richard Henderson, named a Companion of Honour in the Queen's Birthday Honours list. (6/8)
※Varsity Cambridge: Three Cambridge academics recognised in 2018 Queen’s Birthday Honours List. Awarded the Companion of Honour. Dr Henderson said that “it is a great honour to join such a distinguished group of people from all walks of life”. (6/9)
※MRC LMB: Richard Henderson made Companion of Honour. from the LMB’s Structural Studies Division, has been made a Companion of Honour in the Queen’s 2018 Birthday Honours list, for services to electron microscopy of biological molecules. (6/11)
・Founding of the MRC start-up company Heptares in 2007. Heptares now has - 125 employees and is wholly owned by the Japanese company Sosei, developing new drugs for medically important GPCRs.
※Nature: "Cryo-EM structure of the serotonin 5-HT1B receptor coupled to heterotrimeric Go": Christopher G. Tate (MRC Laboratory of Molecular Biology). This work was funded by the Heptares Therapeutics. (6/20up)
※RCSB Protein Data Bank: (Structure ID: 6G79): "Coupling specificity of heterotrimeric Go to the serotonin 5-HT1B receptor": (Released: 2018/6/20) (6/20up)
※MRC LMB: Uncovering the structure of the serotonin receptor. Scientists in Chris’ group purified the serotonin receptor (a GPCR) and combined it with the individual purified components of an engineered Go protein to recreate the signalling complex. (6/21)
※Nature: "PtdIns(4,5)P2 stabilizes active states of GPCRs and enhances selectivity of G-protein coupling" Acknowledgements: Christopher G. Tate acknowledges the MRC, an ERC Advanced Grant EMPSI and funding from Heptares Therapeutics. (7/11)
※Daniel J. Scott(Fiona Marshall, Nathan Robertson, Retweet): Cool use of a StaR, a CHESS-stabilized GPCR and MS to investigate GPCR-lipid interactions. (7/12)

14山師さん@トレード中 (ワッチョイ 4b37-9nzk [ [上級国民]])2018/07/28(土) 22:30:25.68ID:zPNL6Fvq0
※Pluristem 2Q Report: "Our Expectations; Sosei CVC"; "Pluristem is working hard to negotiate the best possible terms for a Japanese JV and will provide an update upon reaching an agreement." (2/7)
※Pluristem 3Q Report: "The proposed joint venture, with Sosei CVC for the clinical development and commercialization in Japan, the plan to enter into definitive agreements and the timing of entering into such agreements." (5/9)
※Pluristem: Announced that the top-line results of the company’s multinational Phase II clinical trial of PLX-PAD cells in the treatment of Intermittent Claudication (IC) will be released on June 12, 2018. (6/4)
※Pluristem Reports: Positive Top-Line Results from Its Multinational Phase II Intermittent Claudication Study: PLX-PAD treatment reduced risk of revascularization and improved patients’ mobility. (6/12)
※Pluristem: "These study results are highly encouraging and suggest that PLX-PAD cells may be the answer for both PAD patients and physicians seeking effective medical solutions". (6/12)
※Reuters: Israel's Pluristem sees positive results from leg pain study: The study’s results also validate the design of Pluralism’s advanced Phase III trial for CLI, the company said. (6/12)
※Pluristem: Pluristem to Open Weekly Market Trading at TASE Following Positive Study Results. (6/14)
※Pluristem: U.S. Department of Defense to Study Pluristem’s PLX-R18 for the Treatment of Mustard Gas Injuries Studies to be funded by the U.S. NIH Marks the second project for DOD with PLX-R18 cell therapy product. (6/19)
※Seeking Alpha: Pluristem's PLX-PAD Cell Therapy Promising As A Non-Invasive Treatment For Peripheral Artery Disease. (6/19)
※Pluristem: and Fukushima University Report Positive Data: PLX-R18 Increases Survival Rates and Mitigates Severe Intestinal Damage after Acute Radiation Exposure. (6/25)
※Pluristem: A Glimpse from the Media: Study shows placenta treatment effective against radiation sickness. Pluristem has been working with researchers in Fukushima, the site of nuclear meltdowns in 2011, to treat acute radiation syndrome. (6/27up)
※World Congress of Basic and Clinical Pharmacology, Kyoto: "PLX-R18- Placenta-derived Mesenchymal-like Stromal Cells are efficacious in reducing lethality in Gastrointestinal Acute Radiation Syndrome (GI-ARS) Mouse Model": Yoshiyuki Soeda, Fukushima Medical University. (7/3 Presented)
※Pluristem: Signs Collaboration Agreement With Thermo Fisher Scientific: Advance fundamental knowledge of cell therapy industrialization and to improve quality control of the end-to-end supply chain. "A potential to advance the industry significantly". (7/9)

15山師さん@トレード中 (ワッチョイ 4b37-9nzk [ [上級国民]])2018/07/28(土) 22:30:54.98ID:zPNL6Fvq0
※Pluristem: Company Presentation July 2018. (7/23update)
・Critical Limb Ischemia (CLI): PLX-PAD: Single pivotal study (Japan: Via PMDA’s Accelerated Regulatory Pathway for Regenerative Therapies).
・Collaboration with Fukushima Medical University: Evaluating PLX-R18 cells as a treatment for radiation damage to the gastrointestinal (GI) tract and bone marrow. 50% Increase in survival rate. Suggesting PLX-R18 potential as a multi-organ therapy for radiation exposure.
※Pluristem: "New patent in Japan- covers PLX-R18’s protection of the gastrointestinal (GI) tract from radiation exposure". (7/26)
※Pluristem: Granted Key Patent in Japan for Treatment of GI Following Acute Radiation Exposure. (7/26)
・Patent covers PLX-R18’s protection of the gastrointestinal (GI) tract from radiation exposure
・Recent data from Fukushima University shows PLX-R18 cells significantly increased survival and enhanced the recovery of the GI tract after radiation exposure.
HAIFA, Israel, July 26, 2018 - Pluristem Therapeutics Inc., announced today that the Japan Patent Office has granted Pluristem a patent for the treatment of Acute Radiation Syndrome (ARS) and its impact on the gastrointestinal tract.
The patent titled “Methods for Treating Radiation or Chemical Injury” relates to intramuscular (IM) administration of adherent stromal cells, cultured under three-dimensional culturing conditions, for mitigating intestinal damage in patients that have been exposed to radiation or chemotherapy.
“The patent is a particularly meaningful asset for our Company in Japan, due to recently published findings from pre-clinical studies conducted at Fukushima Medical University,
showing that following radiation exposure PLX-R18 cells significantly increase survival rates, preserve GI stem cell activity, enhance the recovery of the GI system and prevent severe damage to the intestinal lining,” stated Pluristem Chairman and Co-CEO Zami Aberman.
“We believe PLX-R18 is the optimal therapy available today for acute radiation injury. ARS includes injury to multiple organs, with its lethality stemming from radiation-induced damage mainly to the bone marrow and GI tract.
The Fukushima University studies demonstrate PLX-R18’s potential ability to treat multiple organs affected by ARS,” Aberman added.
Pluristem’s PLX-R18 cells are in late-stage development as a treatment for ARS in a program conducted and funded by the U.S. National Institutes of Health (NIH) and are also being studied by the U.S.
Department of Defense (DOD) and Fukushima University. A PLX-R18 investigational new drug (IND) application for ARS was recently cleared by the U.S. Food and Drug Administration (FDA), allowing Pluristem to treat victims who may have been acutely exposed to high dose radiation due to nuclear attack or accident.
Pluristem’s PLX-R18 ARS program has also received an orphan drug designation by the FDA.

16山師さん@トレード中 (ワッチョイ 4b37-9nzk [ [上級国民]])2018/07/28(土) 22:31:16.23ID:zPNL6Fvq0

17山師さん@トレード中 (ワッチョイ 4b37-9nzk [ [上級国民]])2018/07/28(土) 23:04:50.98ID:zPNL6Fvq0
※Reuters Analysts Forecasts: Ultibro 2017FY(400m: +10.19%), Ultibro 2018FY(466m), Ultibro 2019FY(509m), Seebri 2017FY(149m: 0%), Seebri 2018FY(151m) , Seebri 2019FY(154m). (2017/10/19update)
※中国COPD新薬市場の進展:Ultibro Breezhaler、2017年5月に中国で上市申請を行い、2018年には中国市場に参入予定。来年後半以降、COPD市場全体に新たな変化が起こることが予想されます。(2017/12/8)
※ClinicalTrials: Ultibro(Phase3): "Concept2 Inhaler: Digital Adherence System": Evaluate the Effect of Reminder Notifications and Motivational/Adaptive Messaging: "Study Start: 2018/3/23" (2017/12/20up)
※ClinicalTrials: Phase 3, Study to Compare QVM149 and Free Triple Combination (salmeterol/ fluticasone+ tiotropium): Change, Start Date: "2018/1/15"(11/22update), Participants: 1251→"1500". (2017/12/20update)
※Vectura Presentation: Ultibro Q3 net sales, up 18% in Europe. Strong growth with FLAME data supporting strong, Ultibro evolution. QVM149 First regulatory submissions expected in 2019. (1/4)
※ClinicalTrial: Phase 2, Assess Bronchodilator Effect QVM149 Dosed Either in the Morning or Evening Compared to Placebo in Patients With Asthma: "Add Locations: Germany", "Change, Study Completion: 2018/4/26" (1/15update)

18山師さん@トレード中 (ワッチョイ 4b37-9nzk [ [上級国民]])2018/07/28(土) 23:05:28.97ID:zPNL6Fvq0
※Novartis Q4 & FY 2017 Results: Ultibro(China; Approved in December 2017): Q4 (120million, +26%cc), 2017FY (411million, +12%cc), Seebri: Q4 (42million, +4%cc), 2017FY (151million, +3%cc). (1/24)
※Novartis Annual Report 2017: "Ultibro, A New Version of the Breezhaler Device is being Developed that contains electronics. The First Clinical Study(12/20up) with this Inhaler is due to begin this Year in COPD." (1/24)
※SOSEI:「シーブリおよびウルティブロ」の2017年第4四半期(10月〜12月)の業績について。サノビオン社(10月にSeebri Neohaler販売開始)。「ウルティブロ」中国(12月に製造販売承認を取得)。(1/24)
※Australian Government, TGA Annual Summary 2017: Registrations of Extended Uses of Already-Approved Prescription Medicines: "September 2017, Ultibro Breezhaler" (1/29up)
※ATS(5/21), ITEM Scientists will Present: "CLAIM study: Lung deflation and improvement of cardiac end-diastolic volumes with IND/GLY reduce dyspnea and improve health status in hyperinflated COPD patients". (2/3up)
※ClinicalTrials: Phase 3, Study to Compare QVM149 and Free Triple Combination(sal/ flu+ tio): Change, Study Start: 2018/1/15→"2018/2/5", Primary Completion: 2019/3/29→"2019/6/21". (2/6update)
※ClinicalTrials: Phase 2 (NVA237 Asthma), Bronchodilator Effects and Safety of NVA237 (25 ug and 50 ug o.d.) in Asthma. Status Change: "Completed" (2018/4/16[Anticipated]→"2017/12/29 [Actual])". (2/15update)

19山師さん@トレード中 (ワッチョイ 4b37-9nzk [ [上級国民]])2018/07/28(土) 23:07:03.46ID:zPNL6Fvq0
※Lancet Respiratory Medicine: "Effect of lung deflation with indacaterol plus glycopyrronium on ventricular filling in patients with hyperinflation and COPD (CLAIM)". (2/21)
※ClinicalTrials: Phase 2, Two Doses of QVM149 Compared to a Fixed Dose Combination of Sal/Flu in Patients with Asthma. Status Change: "Recruiting", Actual Start: "2017/5/31", Completion: "2018/8/2". (3/2update)
※ClinicalTrials: Phase 2, Two Doses of QVM149 Compared to a Fixed Dose Combination of Sal/Flu in Patients with Asthma. Patients who have used ICS and LABA combinations for asthma for at least "1 year".→"3 month". (3/6update)
※ClinicalTrials: Phase 3, Study to Compare the Efficacy and Safety of QVM149 With QMF149 in Patients with Asthma. Change: Study Start"2015/2/1"[Actual], Completion "2019/6/3". (3/7update)
※ClinicalTrials: Phase 3, A Multicenter, Open-label, Single Arm, 52-week Treatment Study to Assess the Safety of QVM149 in Japanese Patients with Asthma. Primary Completion: 2018/11/6→"2018/9/18". (3/9update)
※ClinicalTrials: Phase 3, Study to Compare QVM149 and Free Triple Combination of Salmeterol/Fluticasone + Tiotropium. Status Change:"Recruiting", Actual Study Start: "2018/2/9" (3/12update)
※ClinicalTrials: Phase 4, Ultibro vs Spiriva Alone to Reduce Exertional Dyspnea in Patients With Moderate to Severe COPD (RED): Change, Primary Completion: "2018/5/25", Study Completion: "2018/6/16" (3/21update)

20山師さん@トレード中 (ワッチョイ 4b37-9nzk [ [上級国民]])2018/07/28(土) 23:08:04.93ID:zPNL6Fvq0
※Vectura 2017 Preliminary Results: Ultibro and Seebri, 2017 combined net sales of $562 million and Vectura recognised €17.3 million of Total Royalties for sales of these products. (3/21)
※Vectura Earnings Call: "Ultibro growing at almost 21% year-on-year.", "In our 2018 outlook strong growth of revenues driven by Ultibro in particular." (3/21)
※Sunovion: Utibron and Seebri, Savings Card (Savings Program: Valid for up to $250 off; cost may be as little as a $0 Co-Pay; qualify for a 30-Day Trial Offer): Expiration: 2018/3/31→"2019/3/31". (4/1update )
※ClinicalTrial: Phase 3, Study to Compare QVM149 and Free Triple Combination of Salmeterol/Fluticasone + Tiotropium. Actual Study Start: "2018/2/5". Locations Added: "Argentina, Turkey". (4/4update)
※Journal of COPD: "Exacerbation heterogeneity in COPD: Subgroup analyses from the FLAME study". (4/10)
※Journal of COPD: "IND/GLY reduces the risk of clinically important deterioration after direct switch from baseline therapies in patients with moderate COPD: a post hoc analysis of the CRYSTAL Study". (4/16)
※Novartis Q1 2018 Results: "Ultibro (USD 106 million, USD +16%, +4% cc)" continued to grow. "Seebri (USD 38 million, USD +11%, -4% cc)" declined due in part to a focus of resources on Ultibro. (4/19)
※SOSEI:「シーブリおよびウルティブロ」の2018年第1四半期(1月〜3月)の業績について。ウルティブロは、FLAME, FLASH, CLAIM Studyの良好な結果、並びに2018年版GOLDレポートに後押しされ、引き続き進捗。(4/20)
※Sosei Statement:英Vecturaに対して買収提案を実施した可能性に関する報道を受けましたが、当社はVecturaに対して買収提案を実施した事実はございません。本件に関して検討している事実はありません。(4/25)

21山師さん@トレード中 (ワッチョイ 4b37-9nzk [ [上級国民]])2018/07/28(土) 23:09:29.79ID:zPNL6Fvq0
※大日本住友製薬 2018年3月期決算:主要製品の販売状況(北米):COPD治療剤(導入3製品):2017年度通期実績 5億円、2018年度2Q累計予想10億円、2018年度通期予想29億円。(5/11)
※COPD Knowledge Centre: Coming soon: Industry Symposium Highlights from ATS 2018: "New evidence in COPD: is there consensus for clinical practice recommendations?", SUNSET study: Ken Chapman, University Toronto, Canada. (5/14)
※Sunovion: Present eight posters featuring data from treatments for COPD at ATS 2018. New data analyses include three posters reporting effects of Seebri and Utibron on lung function and patient-reported outcomes. (5/16)
※Novartis Investor Presentation: Full pipeline of late-stage assets with blockbuster potential: QVM149 Asthma, "Planned Filings: 2019", "Expected Launches: 2020". Expected launches leverage existing infrastructure. (5/16)
※Vectura AGM (Annual General Meeting) Trading Update: "Growth in revenues continues to be driven by Vectura's key inhaled marketed products including flutiform and Ultibro". (5/17)
※ATS International Conference 2018: (Sunovion, University of Toronto, Novartis Canada, Imperial College London, University of Rome, Fraunhofer ITEM, Novartis Spain). (5/20-5/22 Presented)
※CHEST Conference Coverage (ATS 2018 Report): Switching from Triple Therapy to Indacaterol/Glycopyrronium is Effective in COPD Patients and Avoids Long-Term Exposure to Inhaled Corticosteroids: "SUNSET Study" (5/20)
※Meeting Coverage ATS: "Step-Down Therapy in Severe COPD OK for Some" The SUNSET study was funded by Novartis, and several of the study researchers were employees of the company. (5/22)
※Fraunhofer ITEM: ATS International Conference 2018, Scientists from Fraunhofer ITEM Presented, "Lung deflation and improvement of cardiac end-diastolic volumes with indacaterol/glycopyrronium; CLAIM study" Poster. (5/22up)

22山師さん@トレード中 (ワッチョイ 4b37-9nzk [ [上級国民]])2018/07/28(土) 23:10:25.32ID:zPNL6Fvq0
※MedicalResearch.com Exclusive Interviews with: Dr. Chapman(Professor of Medicine, University of Toronto): "SUNSET Trial Supports Bronchodilators as Foundation of COPD Therapy." (5/29)
※ClinicalTrials: Phase 2, Assess Bronchodilator Effect QVM149 Dosed Either in the Morning or Evening Compared: Change, Study Status: Recruiting→"Completed", Study Completion: 2018/4/26→"2018/2/24 [Actual]" (6/8update)
※COPD Knowledge Centre: on June 28 and 29, 2018 for the exclusive COPD Spotlight interactive live webinars: "Can we avoid ICS in COPD? Time for clarity" to be broadcast. This program is supported by Novartis. (6/13up)
※ClinicalTrials: Ultibro(Phase3): "Concept2 Inhaler: Digital Adherence System": A Randomized Study to Evaluate the Effect of Reminder Notifications and Motivational/Adaptive Messaging. Change Study Start: "2018/7/16" (6/13update)
※Respiratory Research: Indacaterol/glycopyrronium versus salmeterol/fluticasone in the prevention of clinically important deterioration in COPD: results from the FLAME study. Post-Hoc Analysis. (6/20)
※MD Linx: Results from the FLAME Study. Post-Hoc Analysis: IND/GLY reduced the risk of CID and, long-term exacerbation outcomes in these patients with a history of ≥1 exacerbations in the previous year were significantly influenced by CID. (6/22)
※SOSEI:第28回定時株主総会:2018年3月期の事業報告:「Novartis COPDフランチャイズの売上は順調に推移(Ultibroは欧州市場シェア1位、Ultibroの中国での認可、Utibronが米国において販売開始、QVM149申請は2019年の予定)」。(6/22)
※Live Interactive Webinar: "Spotlight on latest evidence for dual bronchodilation and triple therapy in COPD": Wisia Wedzicha - NHLI, Imperial College. "Spotlight on where and when to avoid ICS in clinical practice": Kai Beeh - Germany. (6/28,29)

23山師さん@トレード中 (ワッチョイ 4b37-9nzk [ [上級国民]])2018/07/28(土) 23:11:17.76ID:zPNL6Fvq0
※ClinicalTrials: Phase 3, Study to Compare the Efficacy and Safety of QVM149 With QMF149 in Patients with Asthma. Study Locations: (Research Site update, Research Site Status update). (7/16update)
※Novartis Q2 2018 Results: Continued Strong Growth of Ultibro (USD 116 million, +11% cc). QVM149 Asthma: First planned submissions: "2019", Expected Launches: "2020". News update: "QVM149 IRIDIUM study enrollment completed end of April". (7/18)
※SOSEI:「シーブリおよびウルティブロ」の2018年第2四半期(4月〜6月)の業績。ウルティブロは当四半期において、FLAME, CLAIM studyの良好な結果、2018年版GOLDレポート、さらにSUNSET studyに後押しされ、売上は二桁の伸び。シーブリの売上は、ほぼ横ばい。(7/18)
※ClinicalTrials: Phase 3, A Long-term Safety Study of QVM149 in Japanese Patients With Asthma. Study Start: "2017/4/13 [Actual]", Primary Completion: 2018/9/18, Study Completion: "2019/4/8, Study Enrollment: "94 participants [Actual]". (7/24update)
※大日本住友製薬2019年3月期 第1四半期決算。(7/27)
※Vectura Interim Results 2018: (9/11)

24山師さん@トレード中 (アウアウウー Sa9b-FJh+ [])2018/07/28(土) 23:57:41.10ID:39V47pmxa



27山師さん@トレード中 (ワッチョイ 4b8e-9nzk [ [上級国民]])2018/07/29(日) 06:00:19.48ID:W3QsNmv90
Allergan (M Series):
※Allergan Q1 2017: Pipeline Highlights: "Muscarinic Receptor M1 Agonist: "Entry Ph 1, 2H 2017" (2017/5/9)
※SOSE決算説明会:Wave1のパイプラインが中期臨床開発段階へと進展:"M1受容体作動薬のPh1b(Patient Study)開始、M4受容体作動薬のPh1開始"。(2017/5/12)
※ClinicalTrials: HTL0018318-105: Phase 1, Pharmacokinetics of Oral Capsule in Healthy Japanese vs. Caucasian Subjects. Actual Start: 2017/5/16, Completion: 2017/8/15. "New Trial Record Entry". (2017/6/25up,"New Trial Record")
※Allergan Q2 2017 Presentation: Pipeline Highlights: "Muscarinic Receptor M1 and M4 Agonist: Ph 1, 2H 2017; Entry Ph 1, 2H 2017; Rspectively." (2017/8/3Changed)
※Netherland Trials: HTL0018318-101(NTR5648) "Trial Finished", ※HTL0018318-102(NTR5781) "Trial Finished", ※HTL0018318- CHDR162 (NTR619) "Trial Finished". (2017/8/5:Completed. 2017/8/8update)
※ClinicalTrials: HTL0016878-101: Phase 1, A Two Part Study to Assess Safety, PK, PD, and Food Effect of Oral HTL0016878. Star: 2017/8/7. Study Completion: 2018/9. "New Trial Record Entry". (2017/8/8up,"New Trial Record")
・更に、認知症状及び行動的症状の両方の治療薬候補としてM1/ M4デュアル受容体作動薬を開発するために前臨床試験に取り組んでいます。
※ClinicalTrials: HTL0018318-105: Phase 1, Pharmacokinetics of Oral Capsule in Healthy Japanese vs. Caucasian Subjects. "Actual Study Completion: 2017/8/20." (2017/9/7update, "Completed")
※ClinicalTrials: HTL0016878-101: Phase 1, A Two Part Study to Assess Safety, PK, PD, and Food Effect of Oral HTL0016878. "Recruiting: Actual Study Start: 2017/8/25.", Estimated Study Completion: 2018/9. (2017/9/7update)

28山師さん@トレード中 (ワッチョイ 4b8e-9nzk [ [上級国民]])2018/07/29(日) 06:00:53.91ID:W3QsNmv90
※Heptares: Corporate Overview September 2017. (2017/9/27update)
・M1 Agonist - HTL009936/HTL0018318: First-In-Class Oral Agents in Phase 1 Clinical Studies. "Planning Underway for Studies in AD Patients"
・M4 Agonist - HTL0016878 - Highly Selective for M4, optimised pharmacology: Phase 1 Study Initiated in Healthy Subjects.
・Dual M1/M4 Agonists - Cognitive impairment & neurobehavioural symptoms: In Preclinical Stage.
・Wave 1 Partnered Pipeline: M1, Progression 2017-2019: "Start of Phase 2 POC Trial in AD Patients", "AD PoC Results Emerging"
・Wave 1 Partnered Pipeline: M4, Progression 2017-2019: "Start of Phase 1 Trial", "Phase 1 Results", "Progression to PoC Studies"
・Wave 1 Partnered Pipeline: M1/M4 dual, Progression 2017-2019: "Start of Phase 1 Trial"
※ClinicalTrials(NCT03316898): A FDG-PET Study of AGN-242071 Added to Standard-of-Care (Donepezil±Memantine) for the Treatment of Participants with Mild to Moderate Alzheimer's Disease: Ph1b. (2017/10/21up, "New Trial Record")
・(Protocol ID: 3142-101-001. Sponsors and Collaborators: Allergan), (Study Locations: United States.)
※Allergan Q3 2017: Pipeline Highlights 2017: Muscarinic Receptor M1: Ph 1, 2H 2017 and M4 Agonist: Entry Ph 1, 2H 2017. Rspectively: "Achieved". (2017/11/1)

29山師さん@トレード中 (ワッチョイ 4b8e-9nzk [ [上級国民]])2018/07/29(日) 06:01:45.80ID:W3QsNmv90
※SOSEI:レビー小体型認知症患者を対象とするHTL0018318の日本臨床開発開始。提携契約を主要な認知症を追加承認取得する改定。研究開発協力分野を拡大。2018年にPh2 POC試験開始予定。(2017/11/9)
※SOSEI第2四半期決算説明会(2017/11/9):パイプライン開発進捗状況。説明会(音声): Q&A (HTL009936 他適応を探索)。(2017/11/14up)
・M1 AD:アルツハイマー型認知症患者を対象にした選択的M1受容体作動薬のPh1bを開始。HTL0018318は他の物質候補群に比べて良好なプロファイル。(New)
・M4 SZ:ファースト・イン・クラスの選択的M4受容体作動薬であるHTL0016878のPh1において健康人への初投与を実施。マイルストン収入15百万ドルを受領(9/1)。
・M1 DLB:日本におけるDLB開発・販売権を獲得。2018年中にPh2a POC試験(単剤投与)を開始予定。日本国内における製造販売承認申請並びに上市を目指す。(New)
※ClinicalTrials(NCT03316898): Phase 1b, FDG-PET Study of AGN-242071 Added to Standard-of-Care (Donepezil ± Memantine): Change Start: 2017/11/28→"2018/2/20", Change Completion: 2018/6/4→"2018/11/4". (1/12update)
※SOSEI (English) Presentation Material: (J.P. Morgan Healthcare Conference: 1/8). (1/16up)
・HTL0018318 (AD): Same Compound Being Advanced by Allergan for AD in Our Partnered Pipeline. "Phase 1b"
・HTL0018318 (DLB): Phase 2 POC Monotherapy Study, Expected to Begin in Japan in 2018. "Phase 2 Ready"

30山師さん@トレード中 (ワッチョイ 4b8e-9nzk [ [上級国民]])2018/07/29(日) 06:02:14.18ID:W3QsNmv90
※Allergan Q4 and FY 2017: Pipeline Highlights 2017: Muscarinic Receptor M1: Ph 1, 2H 2017 and M4 Agonist: Entry Ph 1, 2H 2017. Rspectively: "Achieved". FY 2017 R&D Milestones: $15m. (2/6)
※Allergan: Management's and Analysis: Long-term Obligations: Heptares Transaction: (Maximum Milestones: $ 3,224.5m, R&D / Approval: $ 649.5m, Sales Based and Other Milestones: $ 2,575m). (2/16)
※ClinicalTriasls(NCT03456349): A Phase 1b, Multi-center Study to Determine the Safety and Tolerability of HTL0018318 in Subjects with AD. "Actual Start: 2017/11/10". Estimated Completion: 2018/8. (3/7up, "New Trial Record")
・(Protocol ID: HTL0018318-202. Sponsors: Heptares. Collaborators: Allergan.), (Study Locations: Czechia: Recruiting, Poland: Recruiting, Slovakia: Recruiting, Spain: Recruiting.)
※Allergan Fact Sheet: This is Allergan: Our Open Science Pipeline(50→70 mid-to-late stage programs): CNS(10→13 programs): Alzheimer’s disease: (M1 Agonist, M4 Agonist, M1/M4 Agonist). (3/9 update)
・HTL0018318(AD):2つの第1相後期試験(Allergan Phase 1b):欧州:2017年に患者投与開始 (Protocol: HTL0018318-202進行中)。米国:今後数ヵ月内に患者投与開始予定 (NCT03316898: Protocol 3142-101-001)。
・HTL0018318 (DLB):第1相前期試験では、高齢者を含め、安全かつ忍容性が良好であることが示された。2018年中に日本におけるレビー小体型認知症を対等とした第U相臨床試験(PoC)開始を目指す。
・HTL0016878:ADの神経行動学的症状:第1相試験段階(Allergan Phase 1):HTL16878を最初の被験者である健常人に投与したことを公表(2017/9/1)。(結果速報は2018年上期に得られる予定)。
※ClinicalTrials(NCT03316898): Phase 1b, FDG-PET Study of AGN-242071 Added to Standard-of-Care (Donepezil±Memantine) for the Treatment of Participants with Mild to Moderate AD. Change Start: 2/20→"2018/4/13". (3/14update)
※ClinicalTrials(NCT03316898): Phase 1b, FDG-PET Study of AGN-242071 Added to Standard-of-Care (Donepezil±Memantine) for the Treatment of Participants with Mild to Moderate AD. Change Start: 4/13→"2018/5/20". (4/17update)

31山師さん@トレード中 (ワッチョイ 4b8e-9nzk [ [上級国民]])2018/07/29(日) 06:03:31.12ID:W3QsNmv90
※Allergan Q1 2018:As a leader in the field of symptomatic improvement to work. We have the deal with Sosei-Heptares. Symptomatic improvement is one of our core areas of R&D within Allergan. (4/30)
※Allergan Management's Analysis: "Transaction: Heptares". Product: "Neurological disorders". Maximum Milestones: "$ 3,224.5m". R&D/Approval Milestones: "$ 649.5m". Sales Based and Other Milestones: "$ 2,575.0m". (5/3)
※SOSEI 2018年3月期決算:研究開発費4,818百万円(54%増加)97%は英国活動。毎年3つの新薬候補を発見するPresentingことができるプラットフォーム構築。当社独自の化合物関連パイプラインが大幅に進展。自社開発品拡充。(5/10)
・提携パートナーとのパイプライン開発の継続的な進捗: アルツハイマー型認知症患者を対象としたM1 及び M4 受容体作動薬の臨床試験に対するAllergan社からの追加投資。
・強力で生産性の高い自社研究開発プラットフォーム: 2018年下期(Q3 CY18)に日本でDLBを対象としたM1 受容体作動薬の第2相 PoC試験を開始予定。
※SOSEI Presentation: "Sosei Group Corporation, UBS Global Healthcare Conference": Global operations and aspirations - aiming to build Japan’s first global biotech champion: Drive Global Growth Strategy. (5/21Presented, 5/22up)
・M1 Program for Alzheimer’s disease, A novel approach for symptomatic treatment of AD: Selective muscarinic M1 receptor agonism offers a potential first-in-class therapy for AD patients.
・HTL0018318 is a potential first-in-class therapy for Alzheimer’s disease: Receptor subtype selectivity is crucial. HTL0018318 has a differentiated mechanism of action with the potential to optimise symptomatic benefits in AD patients.
・HTL0018318 for DLB in Japan, Summary of Clinical Program: Clinical progress to date encouraging. Advancing preparation to commence Phase 2 PoC study in DLB in Japan in Q3 CY18.
※Heptares: Download Corporate Presentation: "2018.06.08 Corporate Presentation (Sosei Group Corporation Corporate Presentation June 2018)". (6/8up)
※ClinicalTrial: Phase 1b, FDG-PET Study of AGN-242071 Added to Standard-of-Care (Donepezil±Memantine) for the Treatment of Participants with Mild to Moderate AD. Change Start: 5/20→"2018/7/30", Add Research Sites(United States, California). (6/14update)
※SOSEI株主総会事業報告:世界トップレベル企業との複数の共同開発プログラムを保有:提携GPCRパイプライン(伝統的導出型モデル/共同研究プロジェクト):アルツハイマー病 (M1, M4, M1/M4):認知症治療を通じたより良い未来を実現 (提携先:Allergan)。(6/22)
※ClinicalTrials(NCT03456349: HTL0018318-202): Phase 1b, Multi-center Study to Determine the Safety and Tolerability of HTL0018318 in Subjects With Alzheimer's Disease Receiving Standard-of-care. Actual Study Completion: "2018/7/16". (7/20update, "Completed")
※Allergan Q2 2018 Results: (7/26)

32山師さん@トレード中 (スッップ Sd42-3zXB [])2018/07/29(日) 06:28:02.07ID:vRHGYu8Gd

33山師さん@トレード中 (ワッチョイ 4b8e-9nzk [ [上級国民]])2018/07/29(日) 06:33:11.47ID:W3QsNmv90
SOSEI : HTL0018318 (DLB):
※大阪大学:これまで認知症診療や臨床研究の実績のある大阪大学において、認知症に対する高度な専門医療を実践するとともに、認知症医療イニシアチブが始動!医学系研究科と協力して構築。ヘプタレス社 寄附講座(10/1)設置。(2017/10/17)
・記者発表(2017/10/16):安井忠良(株式会社そーせい 代表取締役社長)、森悦朗(大阪大学 学院連合小児発達学研究科 行動神経学・神経精神医学 附講座教授)、池田学(大学院医学系研究科 精神医学 教授)。
・大阪大学は、認知症性疾患を中心とした大脳疾患に対する専門医療およびそれに対する高度な治験を含む臨床研究を推進するために、ヘプタレス社の支援を得て、2017年10月1日に大阪大学大学院連合小児発達学研究科に行動神経学・神経精神医学 寄附講座を設置。
※SOSEI第2四半期決算説明会(2017/11/9):パイプライン開発進捗状況。(New) M1 DLB:日本におけるDLB開発・販売権を獲得。2018年中にPh2a POC試験(単剤投与)を開始予定。日本国内における製造販売承認申請並びに上市を目指す。(2017/11/14up)
※日本認知症学会学術集会:2017年11月24日-26日 第36回日本認知症学会学術集会にて阪大精神医学教室の先生方が発表されました。(2017/11/24)

34山師さん@トレード中 (ワッチョイ 4b8e-9nzk [ [上級国民]])2018/07/29(日) 06:33:44.98ID:W3QsNmv90
※SOSEI (English) Presentation Material: (J.P. Morgan Healthcare Conference: 1/8): HTL0018318 (DLB): Phase 2 POC Monotherapy Study, Expected to Begin in Japan in 2018. "Phase 2 Ready". (1/16up)
※日本商標出願(Sosei):SOSeIHEPTARES (ttps://pbs.twimg.com/media/DXNlWr8UMAAQbNa.jpg) 出願日:2018/2/9、出願人:そーせいグループ株式会社 (2/27公開)
・HTL0018318 (DLB):第1相前期試験では、高齢者を含め、安全かつ忍容性が良好であることが示された。2018年中に日本におけるレビー小体型認知症を対等とした第U相臨床試験(PoC)開始を目指す。
※大阪大学大学院連合小児発達学研究科 行動神経学・神経精神医学(Heptares)寄附講座:2018年4月より新しいスタッフが入られました。鈴木由希子(寄附講座助教:医師)・渡部宏幸(特任研究員:言語聴覚士)。(4/13up)
※感覚器研究イニシアチブ・シンポジウム:「幻視の発現機構」森悦朗:大阪大学大学院連合小児発達学研究科 行動神経学・神経精神医学(Heptares)寄附講座教授。(4/15)
※SOSEI 2018年3月期決算:研究開発費4,818百万円(54%増加)97%は英国活動。毎年3つの新薬候補を発見するPresentingことができるプラットフォーム構築。当社独自の化合物関連パイプラインが大幅に進展。自社開発品拡充。(5/10)
・強力で生産性の高い自社研究開発プラットフォーム: 2018年下期(Q3 CY18)に日本でDLBを対象としたM1 受容体作動薬の第2相 PoC試験を開始予定。

35山師さん@トレード中 (ワッチョイ 4b8e-9nzk [ [上級国民]])2018/07/29(日) 06:35:28.58ID:W3QsNmv90
※SOSEI Presentation: "Sosei Group Corporation, UBS Global Healthcare Conference": Global operations and aspirations - aiming to build Japan’s first global biotech champion: Drive Global Growth Strategy. (5/21Presented, 5/22up)
・HTL0018318 for DLB in Japan, Summary of Clinical Program: Clinical progress to date encouraging. Advancing preparation to commence Phase 2 PoC study in DLB in Japan in Q3 CY18.
※Heptares: Download Corporate Presentation: "2018.06.08 Corporate Presentation (Sosei Group Corporation Corporate Presentation June 2018)". (6/8up)
・試験の内容:疾患名:レビー小体型認知症(DLB) ・試験薬剤名:HTL0018318、用法・用量:HTL0018318の5mg、15mg又は25mgを最終用量として1日1回、経口投与する。対照薬剤名:HTL0018318 プラセボ。
・本治験の副次的な目的:認知障害レベルに対する有効性、精神病様症状(i.e. 幻覚および妄想)に対する有効性をプラセボと比較して評価することである。
※SOSEI 第28回定時株主総会事業報告:日本初の国際的なリーディングバイオ製薬企業へ。自社パイプラインの迅速な拡充。日本から世界へ:新たなグローバルブランドへ統一:2018年内に運用開始。(6/22)
・将来の革新的な医薬品提供のため、速やかに投資する:レビー小体型認知症 (Sosei M1DLB):20%近くの認知症患者がDLBと診断:アンメットメディカルニーズがイノベーションの原動力。
※Trial Profile: A randomized, double-blind, placebo controlled, dose ranging study to assess the safety, tolerability, and efficacy of HTL0018318 in patients with dementia with Lewy bodies: JapicCTI-183989. (6/28update)

36山師さん@トレード中 (ワッチョイ 4b8e-9nzk [ [上級国民]])2018/07/29(日) 06:37:24.97ID:W3QsNmv90
・大阪大学大学院医学系研究科 精神医学教室:「認知症プレシジョン医療開発学」寄付講座に、理化学研究所から永田健一博士が寄付講座講師として、阪大精神医学教室から森原剛史医学部講師が寄付講座教授として着任。
※大阪大学大学院医学系研究科 精神医学教室 スタッフ更新。寄附講座教授:森原剛史(認知症プレシジョン医療開発学)寄附講座講師:永田健一(認知症プレシジョン医療開発学)(7/5update)
※JapicCTI-183989:レビー小体型認知症患者を対象としたHTL0018318の安全性、忍容性及び有効性を評価する無作為化二重盲検プラセボ対照用量範囲探索試験 (予定試験期間:2018/6/1〜2020/7/31、目標症例数172、被験者募集状況:募集前→[参加者募集中]、日本)。(2018/7/19改訂)
※ClinicalTrials(NCT03592862: HTL0018318-203): Phase 2, A Study to Assess Safety, Tolerability, and Efficacy of HTL0018318 in Patients With Dementia With Lewy Bodies (DLB). Study Start: "August 2018". Primary Completion: "July 2020", Study Completion: "January 2021". (7/19up, "New Trial Record".)
※メルトレ:そーせいグループHTL18318の国内フェーズ2試験が8月に開始。「HTL18318 セールスピーク800億円予想」。国内大手証券バイオセクターアナリストは、「重要な進捗でプラスな印象」とコメント。今回の試験期間は2018年8月〜2021年1月の予定、患者数172人、有効性の観察期間は12週間。(7/25)
※Heptares: "All set for our study of HTL0018318 in Patients with Dementia with Lewy Bodies (DLB)". (7/25)
※SOSEI 2018年12月期第1四半期決算発表:(8/9)
※千里ライフサイエンスセミナー「アルツハイマー病研究の最前線」:「アルツハイマー病というcomplex diseaseをどう攻めるか:A mouse-to-human translational research」大阪大学大学院 医学系研究科 医学部講師 (寄附講座教授) 森原剛史 (9/19 11:00)
※千里ライフサイエンスセミナー「アルツハイマー病研究の最前線」:「アルツハイマー病の治療戦略に対する洞察:対症療法や他の認知症性疾患の臨床試験をモデルとして」行動神経学・神経精神医学(Heptares)寄附講座教授 森悦郎 (9/19 14:10)

富士フイルムHD、後発薬縮小 グループ会社を解散へ


38山師さん@トレード中 (ニククエ 4b8e-9nzk [ [上級国民]])2018/07/29(日) 13:00:32.81ID:W3QsNmv90NIKU
※ClinicalTrials(NCT02740985): AZD4635, Phase 1b Expansion Cohorts, Estimated Study Completion Change: 2019/8/13→"2019/8/21". Locations Status Change: New York [Not yet recruiting]→"[Recruiting]". (2/23update)
・第1相後期試験 (欧州:単剤及びデュルマブマブとの併用療法は終了の見込み。1つめの第T相試験は進行中。) ・第1b/2相試験 (米国:2018年第1四半期に患者投与開始。)
※ClinicalTrials(NCT02740985): A Phase 1 Clinical Study of AZD4635 and Durvalumab in Patients With Advanced Solid Malignancies. Ph1b Expansion Cohorts Study Completion Change: 2019/8/21→"2019/12/23"[Anticipated] (3/20update)
※AstraZeneca IMED Biotech Unit, 2017 - A year in review: Early Clinical Development Highlights: "We delivered Phase II Start AZD4635 (Oncology Pipeline: Phase II, A2aR) in Solid Tumours". (4/10up)
※AACR: "Inhibition of A2AR by AZD4635 induces anti-tumor immunity alone and in combination with anti-PD-L1 in preclinical models": A. Borodovsky, AstraZeneca Pharmaceuticals. (4/17)

39山師さん@トレード中 (ニククエ 4b8e-9nzk [ [上級国民]])2018/07/29(日) 13:00:55.05ID:W3QsNmv90NIKU
※ClinicalTrials(NCT03381274): Phase 1b/2, MEDI9447 EGFRm NSCLC Novel Combination Study (MEDI9447 with Osimertinib or AZD4635, AZD4635 with MEDI9447). Study Start Change: 2018/2/9→"2018/5/2" (4/25update)
※Trial Profile: "A Multiarm, Open-label, Multicenter, Phase 1b/2 Study to Evaluate Novel Combination Therapies in Subjects with Previously Treated Advanced EGFRm NSCLC." Study Completion: "2022/1/7". (4/30update)
※SOSEI:2018年3月期決算説明会:「戦略プランを着実に実行し2017年度は著しい進捗を達成」。事業は堅調に進捗。提携GPCRポートフォリオ: AstraZeneca A2a AZD4635 第1b相試験段階 免疫腫瘍学領域。(5/10)
・将来的に受領する可能性のあるマイルストンに先立ち、パイプラインへの投資を継続 (進捗イメージ):提携パイプラインからの収入 (AstraZeneca A2a: 次の開発段階CY2019)。
・StaR/SBDD技術による化合物のクオリティは提携プログラムのFY2017年の進展により実証。(A2a、CGRP、M4、M1、Multiple targets、A2a、A2a)
・AZD4635は次世代がん免疫療法として開発。(次世代がん免疫療法としてより多くの腫瘍系統に対して免疫チェックポイント阻害剤の有効性を高める)、(臨床試験結果は良好、AACR 2018でのハイライト)
※SOSEI:「A2A拮抗薬の将来性」- BioCenturyがAZD4635の記事(3/26)を掲載。新規併用療法の後期第I相/第II相試験(NCT03381274)データは2021年になる見込み。固形がんに対する第I相試験(NCT02740985)を併せて実施中。(5/16)
※ClinicalTrials(NCT03381274): Phase 1b/2, MEDI9447 EGFRm NSCLC Novel Combination Study. Status Change: "Recruiting", Actual Study Start: "2018/5/8", Study Completion: "2022/1/13 [Anticipated]". (5/16update)
※AstraZeneca Clinical Trials Appendix, Q1 2018 Results update: AZD4635 (A2aR inhibitor solid tumours): Cancer: Phase 1 (NCT02740985): "Data Anticipated: 2018". (5/18)
※SOSEI Presentation: "Sosei Group Corporation, UBS Global Healthcare Conference": Global operations and aspirations - aiming to build Japan’s first global biotech champion: Drive Global Growth Strategy. (5/21Presented, 5/22up)
[Partnered GPCR Pipeline]: AZD4635 has emerged as a potential next-generation I/O therapy, First A2a R antagonist structurally derived from StaR and SBDD: Two Product/Program (Two Trials).
・Checkpoint inhibitors are highly effective against certain types of tumors (e.g. lung, skin, and renal). ・Next-gen I/O may enhance efficacy of approved checkpoint inhibitors across more tumor types.

40山師さん@トレード中 (ニククエ 4b8e-9nzk [ [上級国民]])2018/07/29(日) 13:01:26.69ID:W3QsNmv90NIKU
※ClinicalTrials(NCT02740985): A Phase 1 (Ph1b Expansion Cohorts) Clinical Study of AZD4635 and Durvalumab in Patients With Advanced Solid Malignancies. Change, Study Officials: Todd Bauer→Johanna Bendell. (5/24update)
※ClinicalTrials(NCT03381274): Phase 1b/2, Oleclumab (MEDI9447) EGFRm NSCLC Novel Combination Study. "Title Change", Study Completion: "2022/1/13 [Anticipated]". Locations Status Change: US Connecticut, Korea Seoul: "Recruiting" (6/6update)
※Heptares_HP: Download Corporate Presentation: "2018.06.08 Corporate Presentation (Sosei Group Corporation Corporate Presentation June 2018)". (6/8up)
※SOSEI 第28回定時株主総会事業報告:グローバルリーダーとのパートナー提携:次世代療法によるがん治療 (提携先:AstraZeneca):より多くの腫瘍タイプに対して免疫チェックポイント阻害剤の効果を高める併用療法が次世代の治療法として期待される。(6/22)
※LSX CEO Forum: Case Studies and Peer Review: "Sosei - AZ immune-oncology collaboration" - Malcolm Weir, Chief R&D officer, Sosei (CEO Heptares) (Invited). (6/28 Presented)
※ClinicalTrials(NCT03381274): Phase 1b/2, Oleclumab(MEDI9447) EGFRm NSCLC Novel Combination Study. (MEDI9447 with Osimertinib or AZD4635, AZD4635 with MEDI9447). Research Site Status Change: Korea Seoul (03080): "Recruiting". (6/29update)
※ClinicalTrials(NCT02740985): A Phase 1 (Ph1b Expansion Cohorts) Clinical Study of AZD4635 and Durvalumab in Patients With Advanced Solid Malignancies. Enrollment: 156→"206”(Change), Secondary Outcome Measures (Change), Eligibility (Change), Study Research Site (Add). (7/16update)
※AstraZeneca H1 and Q2 2018 Results: Clinical Trials Appendix Q2 2018 results update. (7/26)
・Movement since Q1 2018 update: New to Phase I (Additional indications): "oleclumab+AZD4635 (CD73 mAb + A2aR inhibitor EGFRm NSCLC)"
・Q2 2018 New Molecular Entity (NME) Pipeline: Phase I: "Small molecule: AZD4635 (A2aR inhibitor solid tumours)"
・Q2 2018 Lifecycle Management (LCM) Pipeline: Phase I (Oncology Combinations): "oleclumab + AZD4635 (CD73+A2aR EGFRm NSCLC)"
※Medicinal Chemistry GRC: "Novel Adenosine 2A Receptor Antagonist AZD4635: From the Brain to the Tumor Microenvironment": Michelle Lamb, AstraZeneca USA. (8/6 9:45 Presenting)


42山師さん@トレード中 (ニククエ MM0f-eOoN [])2018/07/29(日) 15:13:42.64ID:JS1b8sq6MNIKU

43山師さん@トレード中 (ニククエWW b711-Pd1V [ [上級国民]])2018/07/29(日) 15:33:27.72ID:HRUWsRf40NIKU

44山師さん@トレード中 (ニククエ Sd62-8trp [])2018/07/29(日) 16:14:38.86ID:dWtk5LgqdNIKU

45山師さん@トレード中 (ニククエ 4b8e-9nzk [ [上級国民]])2018/07/29(日) 18:00:39.56ID:W3QsNmv90NIKU
MiNA Therapeutics:
:直近12-18 ヶ月の見通し:MiNA:パイプラインがPh2b/3臨床試験へと進展。(MTL-CEBPA 進行性肝がん(HCC)を適用としたPh1/2aの臨床データ読み出し:Ph2b/3へと開発が進捗。)
※ClinicalTrials: Phase 1/2a, First-in-Human Safety and Tolerability Study of MTL-CEBPA in Patients With Advanced Liver Cancer (OUTREACH): "Add, 2a Protocol". (2017/5/24update)
※ClinicalTrials: First-in-Human Safety and Tolerability Study of MTL-CEBPA in Patients With Advanced Liver Cancer: Primary Completion: 2017-09→"2018-09" Study Completion: 2017-12→"2018-12". (2017/6/14update)
※SOSEI (English):Presentation Material as of July 2017: "For Further Growth.", "Potential to have Two Discovery Engines: StaR & SBDD (Heptares), saRNA Therapeutics (MiNA)". (2017/7/5)
・saRNA Technology offers potential for new discovery engine: RNAa represents a platform technology that can rapidly generate a portfolio of programs: "12 months from target selection to development candidate".
※MiNA Therapeutics: Announces Publication of Pre-Clinical Data Supporting On-Target Mechanism of Action of Clinical Candidate MTL-CEBPA. (2017/9/6)
※MiNA Therapeutics: MiNA Research Team at OTS2017. "MTL-CEBPA has Efficacy in a Broad Range of Liver Disease Models and Encouraging Early Clinical Data in a Phase 1 Trial in HCC." (2017/9/22 Presented)
※MiNA Therapeutics: MiNA Research Featured as a HOT PAPER by OTS. Best Ones to Highlight Them! "Novel Therapeutic in Clinical Trials for Liver Cancer." (2017/10/23)

46山師さん@トレード中 (ニククエ 4b8e-9nzk [ [上級国民]])2018/07/29(日) 18:01:01.19ID:W3QsNmv90NIKU
※MiNA Therapeutics: Innovate UK Awards Grant to "MiNA" and "LGC LINK": Exciting New Area of Research in Collaboration. Grant of up to Approximately £400,000 will Support a Two-Year. (2017/11/2)
※MiNA Therapeutics: Boehringer Ingelheim and MiNA Therapeutics to Develop Novel Treatment Approaches for Fibrotic Liver Diseases. (2017/11/8)
・"This collaboration is a recognition of our platform and expertise in liver-based diseases as well as validation from an established pharmaceutical leader in what has been an exciting year for the company."
・"This new collaboration is another sign of our ongoing commitment to patients with cardio-metabolic diseases, including NASH."
・"It will combine MiNA’s pioneering work with saRNAs with our expertise in biopharmaceutical research and development."
※SOSEI:MiNA社、Boehringer Ingelheim社と線維性肝疾患の新治療法開発でライセンス契約締結。契約一時金や研究資金に加え、最大総額307百万ユーロのマイルストンを受領予定。(2017/11/8)
・MiNA社への戦略的な投資により、将来性の高いRNA治療薬領域に参入:Boehringer Ingelheim社との提携は、MiNA社が有するsaRNA技術の高い可能性を立証。
※米国特許出願(MiNA):Albumin Production and Cell Proliferation. (2017/11/9公開)
※MiNA Therapeutics: "Development and Mechanism of Small Activating RNA Targeting CEBPA, a Novel Therapeutic in Clinical Trials for Liver Cancer" (2017/12/1up)

47山師さん@トレード中 (ニククエ 4b8e-9nzk [ [上級国民]])2018/07/29(日) 18:01:43.39ID:W3QsNmv90NIKU
※SOSEI (English) Presentation Material: (J.P. Morgan Healthcare Conference: 1/8): Strategic investment in saRNA therapeutics with lead candidate in Phase 1/2a for liver cancer, an orphan indication. (1/16up)
・We are excited about the potential of saRNA therapeutics. MiNA’s recent deal with Boehringer Ingelheim further supports MiNA/saRNA’s potential.
※米国特許(MiNA):Methods of Inducing Insulin Production. (2/6公開)
※RNA Therapeutics Conference, London: "Utilising Small Activating RNA (saRNA) for Therapeutic Opportunities": Nagy Habib, Chairman and Co-Founder, MiNA Therapeutics. Attend: Heptares. (2/21 Presented)
※欧州特許出願(MiNA):Sarna Compositions and Methods of Use. (2/28公開)
※欧州特許出願(MiNA):C/EBP Alpha Sarna Compositions and Methods of Use. (2/28公開)
※MiNA Therapeutics: Read about Our CEO Robert Habib in an Interview with OTS (Oligonucleotide Therapeutics Society). (3/2)
※Oncogene: "Gene activation of CEBPA using saRNA: preclinical studies of the first in human saRNA drug candidate for liver cancer" (3/7)
※MiNA Therapeutics: Small Step Up to 1st Floor at the Translation & Innovation Hub (Imperial College London White City Campus). (3/8)
※MiNA Therapeutics: Announces Publication of Pre-Clinical Data Supporting Therapeutic Potential of Clinical Candidate MTL-CEBPA in Liver Cancer and Liver Disease. (3/9)
※米国特許(MiNA):Albumin production and cell proliferation. (4/17公開)
※米国特許出願(MiNA): Methods of Inducing Insulin Production. (4/26公開)

48山師さん@トレード中 (ニククエ 4b8e-9nzk [ [上級国民]])2018/07/29(日) 18:02:22.96ID:W3QsNmv90NIKU
※SOSEI:2018年3月期決算説明会:「戦略プランを着実に実行し2017年度は著しい進捗を達成」。MiNA Therapeuticsにおける開発は順調に進行。(5/10)
※TIDES: Oligonucleotide and Peptide Therapeutics 2018: "RNA Activation in NASH, Liver Failure and Hepatocellular Carcinoma": Nagy Habib, MiNA Therapeutics. (5/10 Presented)
※MiNA Therapeutics to Present Initial Results from First-in-Human MTL-CEBPA Study at the 2018 ASCO Annual Meeting. MiNA will Announce the Results Through a Press Release Following the Presentation. (5/16)
※ASGCT: "Short Activating RNAs. MTL-CEBPa has a Broad Range of Liver Disease Models and Encouraging Early Clinical Data in a Phase 1 Trial in HCC": Nagy Habib, MiNA Therapeutics. (5/18 Presented)
※SOSEI Presentation: "Sosei Group Corporation, UBS Global Healthcare Conference": Global operations and aspirations - aiming to build Japan’s first global biotech champion: Drive Global Growth Strategy. (5/21Presented, 5/22up)
・Strategic investment in saRNA technology, Exclusive option to move from 25.6% to 100% ownership at pre-determined economics: MiNA Therapeutics.
・Strategic investment in saRNA therapeutics with lead candidate in Phase 1/2a for liver cancer, an orphan indication: MiNA Therapeutics.
※ASCO 2018: "Preliminary results of a first-in-human, first-in-class phase I study of MTL-CEBPA, a small activating RNA targeting the transcription factor C/EBP-α in patients with advanced liver cancer": MiNA Therapeutics. (6/4 Presented)
※MiNA Therapeutics Presents Initial Results from First-in-Human MTL-CEBPA Study in Advanced Liver Cancer Patients. First look at saRNA therapeutics in patients - Initial results from Phase 1 study of MTL-CEBPA in patients with liver cancer presented. (6/4)
※Robert Habib: A very promising start for saRNA medicines in patients! Looking forward to future development of MTL-CEBPA drug candidate. Dr Sarker from GSTTnhs presenting initial clinical results of MTL-CEBPA today at ASCO 2018. (6/4)
※SOSEI:MiNA Therapeuticsが進行肝がん患者を対象とする MTL-CEBPA の初めてのヒト試験の初期結果を発表:正常肝機能および肝機能障害のある患者において良好な忍容性がみられた。血液検体の解析によりRNA活性機序を実証。薬効標的への作用を確認。(6/5)

49山師さん@トレード中 (ニククエ 4b8e-9nzk [ [上級国民]])2018/07/29(日) 18:03:08.70ID:W3QsNmv90NIKU
※Heptares_HP: Download Corporate Presentation: "2018.06.08 Corporate Presentation (Sosei Group Corporation Corporate Presentation June 2018)". (6/8up)
※Robert Habib: "Benchling" growing (Today, Announce our Series B funding.). We are happy customers. MiNA Therapeutics. (6/15)
※EHA: "MTL-CEBPA, a Small Activating RNA for Intravenous Administration to Enhance C/EBPΑ Expression in Patients with Liver Cancer Shows Potential Use in Neutropenia": Choon Ping Tan, MiNA Therapeutics. (6/16 Presented)
※City of Hope: Researchers Use Nanoparticles to Test Treatment for Liver Disease. Promising Results: In the study, saRNAs aimed at upregulating CEBPA were encapsulated in SMARTICLES nanoparticles to deliver a treatment called MTL-CEBPA in multiple liver disease models. (6/25)
・In a model of advanced liver cirrhosis, MTL-CEBPA significantly reversed liver fibrosis and liver dysfunction, enhancing survival.
・MTL-CEBPA also reversed the buildup of fat in a model of nonalcoholic fatty liver disease, improved liver function and reduced tumor size in a model of primary liver cancer.
・According to Rossi, research into the precise mechanism of action in CEBPA is currently under investigation in his laboratory.
・In addition to Rossi and Habib, additional researchers from Imperial College London, Queen Mary University of London, National Taiwan University, Norwegian University of Science and Technology, the Biomedical Research Foundation of the Academy of Athens,
・MiNA Therapeutics and BioTD Strategies LLC collaborated on the work.
※MiNA Therapeutics_HP: Renewal. "Development Programs" update. (7/3up) ※MiNA Therapeutics: Exited to launch our new website. Head minatx.com to learn more about small activating RNA medicines. (7/6)
※日本核酸医薬学会第4回年会 博多:Oligonucleotide Therapeutics Societyシンポジウム:OTS-1:"MTL-CEBPA has efficacy in a broad range of liver disease models and encouraging early clinical data in a Phase 1 trial in HCC": MiNA Therapeutics. (7/11 Presented)
※MiNA Therapeutics: MiNA research lab very happy with our new western blot machine. Cool technology that gives us better results, faster. ProteinSimple. (7/13)
※米国特許出願(MiNA):"Albumin Production and Cell Proliferation". (7/19公開)

50山師さん@トレード中 (ニククエ 4b8e-9nzk [ [上級国民]])2018/07/29(日) 18:16:10.36ID:W3QsNmv90NIKU

51山師さん@トレード中 (ニククエ 4b8e-9nzk [ [上級国民]])2018/07/29(日) 18:19:34.95ID:W3QsNmv90NIKU
※Imperial College London, Imperial Innovations: "Incubator 18 Month Review and MiNA Therapeutics Graduation" (7/31 18:00-20:30)

52山師さん@トレード中 (ニククエ 4b8e-9nzk [ [上級国民]])2018/07/29(日) 18:30:32.35ID:W3QsNmv90NIKU
※ILCA Annual Conference, London, UK: MiNA Therapeutics. (9/14-16)
※OTS(Oligonucleotide Therapeutics Society) Annual Meeting 2018, Seattle, USA: MiNA Therapeutics. (9/30-10/3)
※BIO-Europe, Copenhagen, Denmark: MiNA Therapeutics. (11/5-7)
※AASLD Liver Meeting 2018, San Francisco, USA: MiNA Therapeutics. (11/9-13)
※Jefferies London Healthcare Conference, London, UK: MiNA Therapeutics. (11/14-15)

53山師さん@トレード中2018/07/29(日) 20:09:16.48ID:O9sLBFl7


54山師さん@トレード中2018/07/29(日) 20:29:43.87ID:O9sLBFl7

55山師さん@トレード中 (ニククエ 4b8e-3ouB [])2018/07/29(日) 21:00:08.56ID:W3QsNmv90NIKU
※新春展望Peter Bains:日本に軸足をおいた国際的なバイオ企業、国際的なステージに展開へ。2018年主要テーマ:提携プログラム臨床開発の進捗、3プログラムの臨床入りで自社パイプライン拡大、株主価値の向上。(1/2)
※SOSEI (English) Presentation Material: J.P. Morgan Healthcare Conference: "Strong Cash Position of c.$300m to Drive Global Growth Strategy: Provides Runway of Approx 2-3 Years Based on Organic Business Plan". (1/8)
※個別株情報:みずほ証券レポート発行。開発中の申請・承認などでバイオベンチャー企業が2018年に変曲点を迎える可能性、2018年に期待される進捗:(QVM149:試験結果開示、承認申請) (SO-1105:承認取得)。(1/9)

56山師さん@トレード中 (ニククエ 4b8e-9nzk [ [上級国民]])2018/07/29(日) 21:01:40.93ID:W3QsNmv90NIKU
※SOSEI 2018年3月期決算:売上収益6,955百万円(前年同期比63.2%減)、営業利益△2,291百万円、税引前利益△3,702百万円、当期利益△2,654百万円。研究開発費4,818百万円(54%増加)97%は英国活動。当社独自パイプラインが大幅に進展。自社開発品拡充。(5/10)
※SOSEI Presentation: "Sosei Group Corporation, UBS Global Healthcare Conference": Drive Global Growth Strategy:Strong cash position of ~$260m to drive global growth strategy. (5/21Presented, 5/22up)

57山師さん@トレード中 (ニククエ 4b8e-9nzk [ [上級国民]])2018/07/29(日) 21:03:09.03ID:W3QsNmv90NIKU
※Heptares_HP: Download Corporate Presentation: "2018.06.08 Corporate Presentation (Sosei Group Corporation Corporate Presentation June 2018)". (6/8up)
【谷 間】9カ月変則決算。慢性閉塞性肺疾患治療薬の販売ロイヤルティは着実増。ただ提携先からの大型開発マイルストーンは見込み薄。自社開発進捗順調で研究開発など先行費用増も重荷。赤字幅が急増。
・19.12期連/売上高12,000百万円/営業利益__-500百万円/経常利益-1,000百万円/純利益__-500百万円/EPS _-28.30円/配当0.00円

58山師さん@トレード中 (ニククエ 4b8e-9nzk [ [上級国民]])2018/07/29(日) 21:04:29.21ID:W3QsNmv90NIKU
※SOSEI定時株主総会:「当社事業の飛躍的な拡大」:COPDフランチャイズ売上は順調推移・複数の共同開発プログラム保有・自社PLの迅速な拡充。日本から世界へ:新たなグローバルブランドへ統一:2018年内に運用開始。(6/22) ※個人投資家説明会(名古屋・大阪:6/25)
※アイフィス株予報:日系大手証券(野村證券) 、そーせいレーティング強気(Buy)継続、目標株価11,000円(4/6)→2,750円。目標株価コンセンサスは3,667円。(6/27)
※アイフィス株予報:2018年12月期 業績予想コンセンサス(5/11→5/18→5/21→6/19→7/17→※7/24更新):売上高3,371百万円、営業利益-7,902百万円、経常利益-7,870百万円、当期利益-6,579百万円。(7/24up)

59山師さん@トレード中 (ニククエ 4b8e-9nzk [ [上級国民]])2018/07/29(日) 21:06:07.82ID:W3QsNmv90NIKU
※Reuters:SOSEI 2018-2022業績予想コンセンサス。(5/11→5/20→5/24→6/19→6/20→6/28→6/29→7/3→7/4→7/5→7/6→7/9→7/17→7/18→7/25→7/27→※7/28update)
・2018業績予想:売上高_6,000百万円、EBITDA -6,000百万円、税引前利益-7,000百万円、当期利益-6,000百万円、EPS-84.0 (7/28update)
・2019業績予想:売上高17,000百万円、EBITDA _7,000百万円、税引前利益_5,000百万円、当期利益_4,000百万円、EPS_20.2 (7/25update)
・2020業績予想:売上高11,000百万円、EBITDA _______百万円、税引前利益-2,000百万円、当期利益-2,000百万円、EPS-31.4 (7/25update)
・2021業績予想:売上高16,000百万円、EBITDA _4,000百万円、税引前利益_2,000百万円、当期利益_1,000百万円、EPS19.2 (7/27update)
・2022業績予想:売上高14,000百万円、EBITDA _1,000百万円、税引前利益-1,000百万円、当期利益-1,000百万円、EPS-16.8 (7/17update)
※SOSEI 2018年12月期第1四半期決算発表:(8/9)
※四季報 2018年4集・秋号発売(更新):9月中旬(四季報先取り:9月上旬)

60山師さん@トレード中 (ニククエT Sa9b-tjON [])2018/07/29(日) 21:06:47.01ID:dmpH+V2GaNIKU

61山師さん@トレード中 (ニククエ 4b8e-9nzk [ [上級国民]])2018/07/29(日) 23:30:20.77ID:W3QsNmv90NIKU
・フィデリティ投信 変更報告書。保有割合:9.35%(1.04減少)。(報告義務発生日:2013/5/1、2013/5/10提出)
・フィデリティ投信 変更報告書。保有割合:8.13%(1.22減少)。(報告義務発生日:2013/5/15、2013/5/22提出)
・フィデリティ投信 変更報告書。保有割合:3.21%(4.92減少)。(報告義務発生日:2014/2/28、2014/3/7提出)

62山師さん@トレード中 (ニククエ 4b8e-9nzk [ [上級国民]])2018/07/29(日) 23:30:34.40ID:W3QsNmv90NIKU
・資金(企業買収における株式取得資金等)の借入(200億円、みずほ銀行、返済日2015/9/30)、英国へプタレス社株式取得・子会社化。(2015/2/20) / 新株式発行(公募価額3647円)・シンジケートローン契約締結(借入100億円、5年)。(2015/9)
・五味大輔(個人) 大量保有報告書。保有割合は5.08%(0.12増加)。保有目的は「純投資」。(報告義務発生日:2017/2/13、2017/2/13提出)

63山師さん@トレード中 (ニククエ 4b8e-9nzk [ [上級国民]])2018/07/29(日) 23:31:04.13ID:W3QsNmv90NIKU
・ドイツ銀行ロンドン支店大量保有報告書。共同保有割合:5.13%(0.44増加)、筆頭保有割合:5.13%(0.44増加)。 (報告義務日:4/13、4/20提出)
・JPモルガン・アセット・マネジメント変更報告書。共同保有割合:5.86%(0.23減少)、筆頭保有割合:4.83%(0.01減少)。 (報告義務日:5/15、5/21提出)

64山師さん@トレード中 (ニククエ 4b8e-9nzk [ [上級国民]])2018/07/29(日) 23:31:22.95ID:W3QsNmv90NIKU
・ドイツ銀行ロンドン支店大量保有報告書。共同保有割合:5.13%(0.44増加)、筆頭保有割合:5.13%(0.44増加)。 (報告義務日:4/13、4/20提出)
・JPモルガン・アセット・マネジメント変更報告書。共同保有割合:5.86%(0.23減少)、筆頭保有割合:4.83%(0.01減少)。 (報告義務日:5/15、5/21提出)

65山師さん@トレード中 (ワッチョイ 4b8e-9nzk [ [上級国民]])2018/07/30(月) 06:31:06.82ID:K3tp4eRQ0
Heptares is based the New Research Facility (Steinmetz Building) of Granta Park (Cambridge) from August 2018.
2010/12/30 (終値_338) ・(2010/10/15※最安値_163、2010/12/27最高値_437)
2011/12/30 (終値_318) ・(2011/_3/15※最安値_173、2011/_6/30最高値_420)
2012/12/28 (終値_522) ・(2012/_6/_6※最安値_238、2012/_9/_7最高値_742)
2013/12/30 (終値1079) ・(2013/_1/_4※最安値_513、2013/_5/_7最高値1525)
2014/_4/25 (終値_515) 売残高144800 買残高_4212800 ・(2014/_4/22最安値_464)※[成長回収期の入口]ステージへ
2015/_2/20 (終値_945) 売残高_56800 買残高_6123200 ・(2015/_3/16最安値_713)※Heptares [成功の序章ステージ]
2015/10/30 (終値1080) 売残高_45600 買残高_8871600 ・(2015/_9/24安値_888)※米国承認[次なる飛躍ステージへ]※[上抜け圏へ]
2016/_4/25 (終値5808) 売残高159200 買残高13619600 ・(2016_5/_9最高値6545)※Allergan[強気相場]
2016/_6/24 (終値3680) 売残高_42000 買残高_9944400 ・(2016/_6/24安値3240)※[強気相場解除]※[時間軸での調整局面へ]
2017/_3/31 (終値2720) 売残高_22400 買残高10487200 ・(2017/_4/_4安値2570)※[時間軸調整は順調に推移]※[振るい場・拾い場へ]
2017/_9/_8 (終値2175) 売残高__7600 買残高_8151200 ・(2017/_9/_6最安値2147)※[拾い場も順調に推移]
2018/_1/26 (終値3053) 売残高__3600 買残高_5716400 ・(1/22安値2740)※[振るいも順調に推移]
2018/_3/_9 (終値2378) 売残高_42000 買残高_7177600 ・(3/_5安値2195)※[悪地合いにて再びの拾い場へ]
2018/_3/16 (終値2268) 売残高_54000 買残高_8079600 ・(3/16安値_2268)
2018/_3/23 (終値2148) 売残高_56400 買残高_8186000 ・(3/23安値_2145)
2018/_3/30 (終値2205) 売残高_57600 買残高_8112000 ・(3/26安値2080)
2018/_4/_6 (終値2203) 売残高_68000 買残高_7926000 ・(4/_3安値2138)
2018/_4/13 (終値1960) 売残高_61600 買残高_8320800 ・(4/13安値1943)
2018/_4/20 (終値1820) 売残高_60400 買残高_8460800 ・(4/20安値1815)

66山師さん@トレード中 (ワッチョイ 4b8e-9nzk [ [上級国民]])2018/07/30(月) 06:32:01.68ID:K3tp4eRQ0
2018/_4/27 (終値1895) 売残高_70800 買残高_8453600 ・(4/23安値1803)
2018/_5/11 (終値1760) 売残高_84800 買残高_8396800(_-56800) ・(5/11安値1665)※(5/11空売り価格規制トリガー抵触)
2018/_5/18 (終値1900) 売残高_78800 買残高_8188800(-208000) ・(5/14安値1745)
2018/_5/25 (終値1793) 売残高_78000 買残高_8364400(+175600) ・(5/25安値1780)
2018/_6/_1 (終値1838) 売残高_92000 買残高_8324000(_-40400) ・(5/29安値1695)
2018/_6/_8 (終値1700) 売残高104800 買残高_8714800(+390800) ・(6/_7安値1618)※(6/_5空売り価格規制トリガー抵触)
2018/_6/15 (終値1713) 売残高_92000 買残高_8482000(-232800) ・(6/11安値1703)
2018/_6/22 (終値1693) 売残高___400 買残高_8232800(-249200) ・(6/20安値1595)
2018/_6/29 (終値1784) 売残高_____0 買残高_7931600(-301200) ・(6/26安値1663)
2018/_7/_6 (終値1387) 売残高__7300 買残高_7728300(-203300) ・※(7/2安値1584, 7/3安値1414, ※空売り価格規制トリガー抵触)・(7/5最安値1304[※年初来安])
2018/_7/13 (終値1412) 売残高__6800 買残高_7479600(-248700) ・(7/11安値1342)
2018/_7/20 (終値1329) 売残高_10700 買残高_7489500(__+9900)※7/24up ・(7/20安値1308)
2018/_7/23 (終値1331) 5日線乖離(-1.68%) 25日線乖離(-12.86%) 75日線乖離(-24.04%) 200日線乖離(-41.55%) (安値1325)
2018/_7/24 (終値1435) 5日線乖離(+5.08%) 25日線乖離(_-5.40%) 75日線乖離(-17.61%) 200日線乖離(-36.86%) (安値1355)
2018/_7/25 (終値1416) 5日線乖離(+3.21%) 25日線乖離(_-6.10%) 75日線乖離(-18.19%) 200日線乖離(-37.57%) (安値1406)
2018/_7/26 (終値1390) 5日線乖離(+0.71%) 25日線乖離(_-7.12%) 75日線乖離(-19.19%) 200日線乖離(-38.58%) (安値1371)
2018/_7/27 (終値1422) 5日線乖離(+1.66%) 25日線乖離(_-4.25%) 75日線乖離(-16.82%) 200日線乖離(-37.04%) (安値1375)


67山師さん@トレード中 (ワッチョイW b711-RE1O [])2018/07/30(月) 06:40:22.05ID:WJhc1PRA0


69山師さん@トレード中 (ワッチョイW fb6d-eOoN [])2018/07/30(月) 08:22:44.49ID:urWFC/PH0

70山師さん@トレード中 (ワッチョイWW 2223-Ip0i [])2018/07/30(月) 08:31:43.57ID:LZPgSNcy0

71山師さん@トレード中2018/07/30(月) 09:21:21.64ID:e3vbzqsJ


73山師さん@トレード中 (ワッチョイW 82f2-3zXB [])2018/07/30(月) 09:24:05.14ID:qJD0DnH90

74山師さん@トレード中2018/07/30(月) 09:24:40.83ID:e3vbzqsJ

75山師さん@トレード中 (アウアウカー Saa7-eOoN [])2018/07/30(月) 09:25:42.52ID:JMbU5BlNa


77山師さん@トレード中2018/07/30(月) 09:37:58.45ID:e3vbzqsJ



80山師さん@トレード中 (ワッチョイ 5fe3-tjON [])2018/07/30(月) 10:28:19.41ID:Zdy1rBXT0



83山師さん@トレード中 (オイコラミネオ MM5e-qLrP [])2018/07/30(月) 11:17:44.28ID:jLsfg9xIM


86山師さん@トレード中 (ラクッペ MM0f-eOoN [])2018/07/30(月) 12:34:37.94ID:I0d6dkjVM





今日のそーせいさんは、たったの3パーしか下げてない。 いつものそーせいさんと茶うわ


92山師さん@トレード中2018/07/30(月) 14:41:48.99ID:e3vbzqsJ

93山師さん@トレード中 (ブーイモ MMfe-Ip0i [])2018/07/30(月) 14:44:09.27ID:a4pfueOaM

94山師さん@トレード中 (アウアウカー Saa7-eOoN [])2018/07/30(月) 14:58:34.23ID:w3BZVHsIa

95山師さん@トレード中 (スップ Sd62-ozQz [])2018/07/30(月) 15:04:59.30ID:14sVLY83d

96山師さん@トレード中 (アウアウカー Saa7-eOoN [])2018/07/30(月) 15:37:02.16ID:oP2jrQAwa

97山師さん@トレード中 (ワッチョイWW db6d-cnlH [])2018/07/30(月) 15:52:12.67ID:G/JO8hnl0

98山師さん@トレード中 (アウアウカー Saa7-eOoN [])2018/07/30(月) 15:56:05.55ID:oP2jrQAwa

99山師さん@トレード中 (オイコラミネオ MM5e-qLrP [])2018/07/30(月) 16:03:53.81ID:jLsfg9xIM

100山師さん@トレード中 (ササクッテロ Spbf-0lUN [])2018/07/30(月) 16:25:55.41ID:6a2qNbLgp

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