SubArachnoid Space

Sosei Group Announces Marketing Approval for PIVLAZ™ (clazosentan sodium) 150 mg in South Korea

Retrieved on: 
Thursday, December 7, 2023
Marketing, Artery, Hospital, Cerebral vasospasm, Neurosurgery, Culture of Korea, IPJ, Rupture, Physician, Acquisition, Bleeding, Mortality, SubArachnoid Space, Brain, Incidence, Subarachnoid hemorrhage, Death, Ministry, Constriction, Aneurysm, IPK, Patient, MFDS, Pharmaceutical industry

Tokyo, Japan, Seoul, South Korea, and Cambridge, UK, 7 December 2023 – Sosei Group Corporation (“Sosei Heptares” or “the Company”; TSE: 4565) today announces that PIVLAZ™ (clazosentan sodium) 150 mg has received marketing approval from the Ministry of Food and Drug Safety (MFDS) in South Korea for the prevention of cerebral vasospasm, vasospasm-related cerebral infarction, and cerebral ischemic symptoms after aneurysmal subarachnoid hemorrhage (aSAH) securing.

Key Points: 
  • Tokyo, Japan, Seoul, South Korea, and Cambridge, UK, 7 December 2023 – Sosei Group Corporation (“Sosei Heptares” or “the Company”; TSE: 4565) today announces that PIVLAZ™ (clazosentan sodium) 150 mg has received marketing approval from the Ministry of Food and Drug Safety (MFDS) in South Korea for the prevention of cerebral vasospasm, vasospasm-related cerebral infarction, and cerebral ischemic symptoms after aneurysmal subarachnoid hemorrhage (aSAH) securing.
  • The MFDS approval is based on scientific and clinical data from an extensive Japanese Phase 3 program submitted by Idorsia Pharmaceuticals Korea (“IPK”), a Sosei Group company.
  • In South Korea, the Marketing Authorization of PIVLAZ™ is held by IPK and will become commercially available to patients in early 2025.
  • PIVLAZ™ received marketing approval in Japan in January 2022 and was launched in April 2022 by Idorsia Pharmaceuticals Japan ("IPJ”), also a Sosei Group company.

Acasti Pharma to Host KOL Event on GTX-104: A Potential New Treatment Standard for Rare and Life-Threatening aneurysmal Subarachnoid Hemorrhage (aSAH)

Retrieved on: 
Wednesday, October 4, 2023
KOL, Bleeding, ACST, Skull, Brain, Doctor of Philosophy, SubArachnoid Space, MD, Patient, Nimodipine, Massachusetts General Hospital, Pharmaceutical industry

To register, click here .

Key Points: 
  • To register, click here .
  • The event will highlight Acasti's lead clinical asset, GTX-104, a novel formulation of nimodipine currently in Phase 3 targeting aSAH as an intravenous infusion.
  • Acasti leadership will provide insight into trial design, market dynamics, and future directions.
  • A live question and answer session will follow the formal presentations.

Acasti Pharma Reports Third Quarter 2023 Operational Results

Retrieved on: 
Tuesday, February 14, 2023
Bank statement, Subarachnoid hemorrhage, Toxicity, Caregiver, Brain, Dizziness, Nimodipine, NDA, AUC, Bupivacaine, Trial of the century, OS, Human, Blood, Postherpetic neuralgia, PK, Cmax, TSX, Hypoesthesia, Aes, Investment, SAH, Safety, Literature, Acquisition, Tmax, Anesthesiology, Patient, PHN, Telephone, AE, Skin, Food, Skull, Research, Government, Aneurysm, Risk, IM, SubArachnoid Space, Betamethasone, Plasma, Tongue, FDA, Nausea, A-T, Food and Drug Administration Amendments Act of 2007, Calendar, Bleeding, Type, Ataxia–telangiectasia, ACST, Pharmacokinetics, Rupture, Headache, Pharmaceutical industry, Vaccine, Cryptocurrency

LAVAL, Québec, Feb. 14, 2023 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti” or the “Company”) (Nasdaq: ACST and TSX-V: ACST), a late-stage, specialty pharma company advancing three clinical stage drug candidates addressing rare and orphan diseases, today announced financial and operational results for the third quarter ended December 31, 2022

Key Points: 
  • These positive results allow us to advance both programs to the next stage of clinical development in 2023.
  • We expect 2023 to be very exciting for Acasti with two of our drug candidates ready to enter Phase 3.
  • Topline results from this study were reported on December 23, 2022, and the results met all primary outcome measures.
  • Acasti will host a conference call on Tuesday, February 14, 2023, at 1:00 PM Eastern Time to discuss the Company’s corporate progress and other developments, as well as financial results for its quarter ended December 31, 2022.

Plus Therapeutics Provides Updates on ReSPECT™ Clinical Trials at the 27th Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology

Retrieved on: 
Saturday, November 19, 2022
Drug discovery, LM, Toxic leukoencephalopathy, Perception, Report, HGG, University of Texas System, Neurosurgery, Glioblastoma, Rhenium, Hospital, Brain, Cancer, IND, Safety, Therapy, Overalls, Cox, Patient, Society, CED, Catheter, Neoplasm, University, Radiation, PSTV, SubArachnoid Space, SNO, Plus, Senior, Index (publishing), CNS, Education, GBM, Death, Research, Glioma, Convection, Neurology, Survival, Cerebrospinal fluid, CSF, FDA, Ayub Ommaya, Medical imaging, Pharmaceutical industry

AUSTIN, Texas, Nov. 19, 2022 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, presented data from two ongoing clinical trials evaluating the Company’s lead investigational targeted radiotherapeutic, rhenium (186Re) obisbemeda, in recurrent glioblastoma (GBM), leptomeningeal metastases (LM), as well as clinical trial plans for pediatric brain cancer at the 27th Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology (SNO).

Key Points: 
  • This data strongly supports continued clinical development for several very difficult to treat CNS indications.
  • Continued dose escalation will be performed to assess the potential to treat tumors larger than 20 mL.
  • All patients showed a decreased CSF tumor cell count by microfluidic chamber assay after treatment, ranging from 46% to 92%.
  • The standard of care for pediatric brain cancer is insufficient given the current limitations surrounding traditional external beam radiation therapy.

Acasti Pharma to Present at Q4 Investor Summit

Retrieved on: 
Wednesday, November 9, 2022
GLOBE, Marketing, PHN, Skull, FDA, Risk, Private Securities Litigation Reform Act, Bleeding, Securities Act of 1933, Nerve Damage, Postherpetic neuralgia, SEC, NASDAQ, Brain, Summit, Compliance, Securities Exchange Act of 1934, Company, ACST, Disability, Assam Global Investors' Summit, Neuropathic pain, Subarachnoid hemorrhage, SubArachnoid Space, CEO, TSX, A-T, SAH, Pharmaceutical industry, Security (finance), Ataxia–telangiectasia

LAVAL, Qubec, Nov. 09, 2022 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Acasti or the Company) (Nasdaq: ACST and TSX-V: ACST), a late-stage, specialty pharma company advancing three clinical stage drug candidates addressing rare and orphan diseases, today announced that Jan DAlvise, President and CEO of Acasti Pharma will be presenting virtually at the Q4 Investor Summit.

Key Points: 
  • LAVAL, Qubec, Nov. 09, 2022 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Acasti or the Company) (Nasdaq: ACST and TSX-V: ACST), a late-stage, specialty pharma company advancing three clinical stage drug candidates addressing rare and orphan diseases, today announced that Jan DAlvise, President and CEO of Acasti Pharma will be presenting virtually at the Q4 Investor Summit.
  • Investors interested in participating in one-on-one meetings should contact Acasti Investor Relations at [email protected] , or their Investor Summit representatives.
  • Acasti is a specialty pharma company advancing three clinical stage drug candidates addressing rare and orphan diseases.
  • Acasti undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Acasti Pharma to Report Second Quarter 2023 Financial Results on Monday, November 14, 2022

Retrieved on: 
Monday, November 7, 2022
GLOBE, Marketing, PHN, Skull, FDA, Risk, Telephone, Private Securities Litigation Reform Act, Bleeding, Securities Act of 1933, Nerve Damage, Postherpetic neuralgia, SEC, NASDAQ, Brain, Compliance, Securities Exchange Act of 1934, ACST, Disability, Neuropathic pain, Subarachnoid hemorrhage, SubArachnoid Space, TSX, A-T, SAH, Pharmaceutical industry, Internet service provider, Ataxia–telangiectasia

A webcast of the call may be accessed at https://app.webinar.net/KP8QXdZzj5R or on the Companys Investor Relations section of the website: https://www.acastipharma.com/investors/ .

Key Points: 
  • A webcast of the call may be accessed at https://app.webinar.net/KP8QXdZzj5R or on the Companys Investor Relations section of the website: https://www.acastipharma.com/investors/ .
  • A webcast replay will be available on the Companys Investors News/Events section of the website ( https://www.acastipharma.com/investors/ ) through November 14, 2023.
  • Acasti is a specialty pharma company advancing three clinical stage drug candidates addressing rare and orphan diseases.
  • Acasti undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Plus Therapeutics Presents Preliminary Safety and Feasibility Data from ReSPECT-LM Clinical Trial at the European Association of Nuclear Medicine Congress

Retrieved on: 
Wednesday, October 19, 2022
U.S. Securities and Exchange Commission, GBM, Therapy, CSF, Neoplasm, National Institute for Health and Care Excellence, CGMP, SubArachnoid Space, PSTV, Patient, Perception, EANM, Research, NIH, Nasdaq, Senior, Cancer, Company, Liposome, Plus, Cerebrospinal fluid, National, Association, Nuclear medicine, Adult, Safety, LM, CNS, Survival, Radiation, GLOBE, Grey, European Association for the Study of the Liver, Glioblastoma, Survival rate, Feasibility, Top-rated United States television programs by season, Pharmaceutical industry, Medical imaging

AUSTIN, Texas, Oct. 19, 2022 (GLOBE NEWSWIRE) --  Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, presented data from two ongoing clinical trials evaluating the Company’s lead investigational targeted radiotherapeutic, Rhenium-186 NanoLiposome (186RNL), in leptomeningeal metastases (LM) and recurrent glioblastoma (GBM) at the 35th Annual Congress of the European Association of Nuclear Medicine (EANM). The Company’s ReSPECT-GBM presentation was selected for inclusion in the opening Plenary Highlights Lecture, signaling significant clinical interest in the field.

Key Points: 
  • The Companys ReSPECT-GBM presentation was selected for inclusion in the opening Plenary Highlights Lecture, signaling significant clinical interest in the field.
  • Combined with our Phase 1 data in recurrent glioblastoma, these presentations reinforce the tremendous potential of 186RNL as a versatile radiotherapeutic treatment option for multiple CNS cancers.
  • All patients showed a decreased CSF cell count by microfluidic chamber assay after treatment, ranging from 46% to 92%.
  • Cohort 2 in the ReSPECT-LM trial has commenced, with interim data from the first two patient cohorts expected by the end of 2022.

Acasti Announces Court Dismissal of Stockholder Litigation

Retrieved on: 
Friday, September 30, 2022
Securities Exchange Act of 1934, Disability, TSX, COVID-19, Mergers and acquisitions, Bleeding, FDA, Brain, PHN, Securities Act of 1933, Neuropathic pain, Subarachnoid hemorrhage, Acquisition, Compliance, U.S. Securities and Exchange Commission, Risk, SAH, Skull, Postherpetic neuralgia, SubArachnoid Space, A-T, Private Securities Litigation Reform Act, NASDAQ, Nerve Damage, Security (finance), District court, GLOBE, Marketing, ACST, Pharmaceutical industry, Ataxia–telangiectasia

The remaining two cases were consolidated before Judge Katherine Polk Failla in the United States District Court for the Southern District of New York.

Key Points: 
  • The remaining two cases were consolidated before Judge Katherine Polk Failla in the United States District Court for the Southern District of New York.
  • Acasti and the individual defendants filed a motion to dismiss on February 25, 2022.
  • Accordingly, subject to any appeal that may be taken in response to todays ruling, all four stockholder suits filed in connection with the Merger have now been dismissed.
  • Acasti is a late-stage, specialty pharma company advancing three clinical stage drug candidates addressing rare and orphan diseases.

Acasti Announces Voting Results from 2022 Annual and Special Meeting of Shareholders

Retrieved on: 
Thursday, September 29, 2022
Securities Exchange Act of 1934, Disability, LTIP, Remuneration, Indian stock exchange, TSX, COVID-19, Director, Bleeding, FDA, Brain, PHN, Securities Act of 1933, Neuropathic pain, Subarachnoid hemorrhage, Company, CDN, Compliance, Special, Cyprus Securities and Exchange Commission, Audit committee, Risk, SAH, Skull, Exercise, Postherpetic neuralgia, SubArachnoid Space, Chair, A-T, Private Securities Litigation Reform Act, KPMG LLP, NASDAQ, Board, Nerve Damage, KPMG, Security (finance), GLOBE, Marketing, ACST, Risk management, Pharmaceutical industry, Ataxia–telangiectasia

LAVAL, Qubec, Sept. 29, 2022 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Acasti or the Company) (NASDAQ: ACST and TSX-V: ACST), a late-stage, specialty pharma company advancing three clinical stage drug candidates addressing rare and orphan diseases, announced today the voting results from its Annual General and Special Meeting of Shareholders (the Meeting) which was held virtually on Wednesday September 28, 2022.

Key Points: 
  • LAVAL, Qubec, Sept. 29, 2022 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Acasti or the Company) (NASDAQ: ACST and TSX-V: ACST), a late-stage, specialty pharma company advancing three clinical stage drug candidates addressing rare and orphan diseases, announced today the voting results from its Annual General and Special Meeting of Shareholders (the Meeting) which was held virtually on Wednesday September 28, 2022.
  • At the Meeting, shareholders passed an advisory (non-binding) resolution approving the compensation of Acastis named executive officers.
  • At the Meeting, disinterested shareholders approved the amendments described above to the Stock Option Plan and the Equity Incentive Plan.
  • The Governance & Human Resources Committee is now composed of Mr. Donald Olds, Chair, Mr. Vimal Kavuru and Mr. John Canan.

Acasti Pharma Inc. Discusses Clinical Progress of Lead Assets and 2022 Catalysts with The Stock Day Podcast

Retrieved on: 
Wednesday, September 21, 2022
Securities Exchange Act of 1934, Pain scale, Disability, PK, Trial of the century, IV, COVID-19, Blood pressure, Bleeding, FDA, Brain, Phase, PHN, Drug Quality and Security Act, Betamethasone, Subarachnoid hemorrhage, Neuropathic pain, Company, Compliance, Securities Act of 1933, Heredity, Nimodipine, U.S. Securities and Exchange Commission, Patient, Risk, SAH, Skull, Bupivacaine, Postherpetic neuralgia, A-T, Pain, SubArachnoid Space, Private Securities Litigation Reform Act, NASDAQ, Nerve Damage, Interview, Security (finance), Neurodegeneration, Marketing, ACST, Disease, Fine chemical, Vaccine, Pharmaceutical industry, Ataxia–telangiectasia

Phoenix, Arizona--(Newsfile Corp. - September 21, 2022) - The Stock Day Podcast welcomed Acasti Pharma Inc. (NASDAQ: ACST) ("the Company"), a specialty pharma company with drug delivery technologies and drug candidates addressing rare and orphan diseases.

Key Points: 
  • Phoenix, Arizona--(Newsfile Corp. - September 21, 2022) - The Stock Day Podcast welcomed Acasti Pharma Inc. (NASDAQ: ACST) ("the Company"), a specialty pharma company with drug delivery technologies and drug candidates addressing rare and orphan diseases.
  • Jolly then asked about one of the Company's additional assets, GTX-104, an intravenous infusion targeting Subarachnoid Hemorrhage (SAH).
  • "At the end of the day, it's all about getting these drugs approved to treat these rare and orphan diseases."
  • All forward looking statements contained in this press release speak only as of the date on which they were made.