Nimodipine

Acasti Announces Third Fiscal Quarter 2024 Financial Results and Business Highlights

Retrieved on: 
Monday, February 12, 2024
Well, Research, Investment, FDA, Calendar, ACST, Conference, Nimodipine, Patient, Poster, Pivotal, NDA, Pharmaceutical industry

Having dosed the first patient in October, we’ve continued to enroll more patients and sites since that time,” said Prashant Kohli, CEO of Acasti.

Key Points: 
  • Having dosed the first patient in October, we’ve continued to enroll more patients and sites since that time,” said Prashant Kohli, CEO of Acasti.
  • STRIVE-ON trial on track for potential NDA submission with the FDA anticipated to occur in the first half of calendar 2025.
  • Overview of STRIVE-ON trial presented as a poster at the 2024 International Stroke Conference.
  • The Company believes its cash, cash equivalents and short-term investments are sufficient to fund its operations into the second calendar quarter of 2026.

Acasti Announces Poster Detailing its GTX-104 STRIVE-ON Trial

Retrieved on: 
Thursday, February 1, 2024
Poster, ACST, Safety, Phase 3, Capsule, Hypotension, Nimodipine, Conference, Hospital, Pharmaceutical industry

The poster, Safety and Tolerability of Intravenous Versus Enteral Nimodipine in Patients with Aneurysmal Subarachnoid Hemorrhage, will be presented Thursday February 8th during the Ongoing Clinical Trials session of the conference.

Key Points: 
  • The poster, Safety and Tolerability of Intravenous Versus Enteral Nimodipine in Patients with Aneurysmal Subarachnoid Hemorrhage, will be presented Thursday February 8th during the Ongoing Clinical Trials session of the conference.
  • The STRIVE-ON trial is a prospective, open-label, randomized (1:1 ratio), parallel group trial of GTX-104 compared with oral nimodipine, in patients hospitalized for aSAH.
  • Key trial design features include:
    Approximately 100 patients are expected to be enrolled at an estimated 25 hospitals in the U.S.
  • The primary endpoint is safety and will be measured as comparative adverse events, including hypotension, between the two groups.

Acasti to Participate in Upcoming San Francisco Investor Conferences in January 2024

Retrieved on: 
Wednesday, December 13, 2023
ACST, Nimodipine

PRINCETON, N.J., Dec. 13, 2023 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Nasdaq: ACST) (Acasti or the Company), a late-stage, biopharma company advancing GTX-104, its novel intravenous formulation of nimodipine being developed to address the high unmet medical needs for a rare disease, aneurysmal Subarachnoid Hemorrhage (aSAH), today announced that Chief Executive Officer Prashant Kohli will participate in the following investor and industry networking events in San Francisco, California during the week of January 7-12, 2024.

Key Points: 
  • PRINCETON, N.J., Dec. 13, 2023 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Nasdaq: ACST) (Acasti or the Company), a late-stage, biopharma company advancing GTX-104, its novel intravenous formulation of nimodipine being developed to address the high unmet medical needs for a rare disease, aneurysmal Subarachnoid Hemorrhage (aSAH), today announced that Chief Executive Officer Prashant Kohli will participate in the following investor and industry networking events in San Francisco, California during the week of January 7-12, 2024.

Acasti Announces Second Quarter 2024 Financial Results and Business Highlights

Retrieved on: 
Monday, November 13, 2023
Well, NDA, Research, ACST, Food, SAH, ADAR1, Bank statement, Investment, Clinical trial, Depreciation, Patient, Calendar, FDA, Nimodipine, Neurocritical Care Society, Potential New Boyfriend, Massachusetts General Hospital, Doctor of Philosophy, LP, Poster, Cryptocurrency, Pharmaceutical industry, Nursing, Security (finance), MD

The prestigious UTHealth Houston is the first site to enroll an aSAH patient in the STRIVE-ON trial.

Key Points: 
  • The prestigious UTHealth Houston is the first site to enroll an aSAH patient in the STRIVE-ON trial.
  • STRIVE-ON trial on track for potential NDA submission with the FDA anticipated to occur in the first half of calendar 2025.
  • Acasti previously announced alignment with FDA on GTX-104 pivotal Phase 3 trial protocol and obtained guidance on potential NDA submission package.
  • Results of a pharmacokinetic comparison of GTX-104 with oral nimodipine presented as a poster at the 2023 Neurocritical Care Society annual meeting.

Acasti Announces Dosing of First Patient in GTX-104 STRIVE-ON Trial

Retrieved on: 
Monday, October 23, 2023
Massachusetts General Hospital, FDA, ACST, Food, Doctor of Philosophy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, New Drug Application, Nimodipine, NDA, Patient, Calendar, Pharmaceutical industry, MD

UTHealth Houston is the first site to enroll an aSAH patient in the STRIVE-ON trial.

Key Points: 
  • UTHealth Houston is the first site to enroll an aSAH patient in the STRIVE-ON trial.
  • “The dosing of our first patient in the STRIVE-ON trial is a significant milestone for Acasti, demonstrating our ability to execute our clinical development program for GTX-104,” said Prashant Kohli, CEO of Acasti.
  • “We’re pleased to be working with a prestigious neurocritical care team such as UTHealth Houston, and look forward to welcoming additional centers.
  • GTX-104 has already been administered in over 160 healthy subjects in prior Phase 1 trials and has a well-established safety profile.

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 Announces $7.5 Million Private Placement Equity Financing

Retrieved on: 
Tuesday, September 26, 2023
ACST, Clinical trial, Regulation D, Sale, Warrant, Sales management, Nimodipine, Power purchase agreement, Security (finance), Regulation of tobacco by the U.S. Food and Drug Administration, Food

The private placement closed on September 25, 2023.

Key Points: 
  • The private placement closed on September 25, 2023.
  • Each Pre-funded Warrant is exercisable for one common share at an exercise price of $0.0001 per common share, will be immediately exercisable and will expire once exercised in full.
  • The Company has agreed to file an initial registration statement with the SEC covering the resale of the common shares and the common shares underlying the Pre-funded Warrants and Common Warrants issued in the private placement no later than 30 days following the closing date of the private placement.
  • The gross proceeds to the Company from the private placement were approximately $7.5 million, before deducting fees and expenses.

Acasti to Participate in the H.C. Wainwright Global Investment Conference

Retrieved on: 
Wednesday, September 6, 2023
Nimodipine, ACST, Standard of care, Conference, Pharmaceutical industry

PRINCETON, N.J., Sept. 06, 2023 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Nasdaq: ACST) (Acasti or the Company), a late-stage, biopharma company advancing GTX-104, its novel formulation of nimodipine that addresses the high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced that the Company’s management will be participating in the 25th Annual H.C. Wainwright Global Investment Conference, to be held September 11-13 , 2023 in New York, NY.

Key Points: 
  • PRINCETON, N.J., Sept. 06, 2023 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Nasdaq: ACST) (Acasti or the Company), a late-stage, biopharma company advancing GTX-104, its novel formulation of nimodipine that addresses the high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced that the Company’s management will be participating in the 25th Annual H.C. Wainwright Global Investment Conference, to be held September 11-13 , 2023 in New York, NY.
  • Prashant Kohli, Chief Executive Officer of Acasti, will give a presentation Monday, September 11 at 2pm to highlight the potential of GTX-104 to change the standard of care for aSAH and discuss progress in the Company’s pivotal STRIVE-ON Phase 3 safety trial.
  • Mr. Kohli will also be available to attend one-on-one meetings.

Acasti Announces First Quarter 2024 Financial Results and Business Highlights

Retrieved on: 
Friday, August 11, 2023
SAB, Workforce, Subarachnoid hemorrhage, AUC, Hypotension, Bank statement, ACST, Calendar, NDA, Coronavirus Scientific Advisory Board, Research, Neurocritical Care Society, Doctor of Philosophy, Sale, NCS, Capsule, Hospital, Neurosurgery, MD, Patient, Physician, Pivotal, Depreciation, Poster, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Safety, Food, Wuxi, Pharmaceutical industry, Cryptocurrency, Risk management, Nimodipine

With the efficiencies gained through our operational realignment, we reiterate that our projected cash runway now extends to the second quarter of 2025, inclusive of the potential NDA submission.

Key Points: 
  • With the efficiencies gained through our operational realignment, we reiterate that our projected cash runway now extends to the second quarter of 2025, inclusive of the potential NDA submission.
  • Significant extension of the Company's cash runway facilitates the achievement of critical value inflection milestones, including a potential NDA filing for GTX-104.
  • Evaluation of strategic alternatives to maximize value of de-prioritized pipeline assets (GTX-102 and GTX-101) including out-licensing or sale.
  • Key trial design features include:
    Approximately 100 patients will be enrolled at an estimated 25 hospitals in the U.S.

Acasti to Present GTX-104 Pharmacokinetic Comparison Data at Neurocritical Care Annual Meeting

Retrieved on: 
Wednesday, August 9, 2023
ACST, NCS, Subarachnoid hemorrhage, Neurocritical Care Society, Pharmaceutical industry, Nimodipine

PRINCETON, N.J., Aug. 09, 2023 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Nasdaq: ACST) ("Acasti" or the "Company"), a late-stage, biopharma company advancing GTX-104 its novel formulation of nimodipine that addresses the high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced that a poster presenting a pharmacokinetic comparison of GTX-104 with oral nimodipine has been accepted for presentation at the 2023 Neurocritical Care Society (NCS) annual meeting, to be held in Phoenix, AZ August 15-18, 2023.

Key Points: 
  • PRINCETON, N.J., Aug. 09, 2023 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Nasdaq: ACST) ("Acasti" or the "Company"), a late-stage, biopharma company advancing GTX-104 its novel formulation of nimodipine that addresses the high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced that a poster presenting a pharmacokinetic comparison of GTX-104 with oral nimodipine has been accepted for presentation at the 2023 Neurocritical Care Society (NCS) annual meeting, to be held in Phoenix, AZ August 15-18, 2023.
  • Details of the presentation are as follows:
    GTX-104, Novel IV Formulation of Nimodipine to Treat Subarachnoid Hemorrhage: a Pharmacokinetic Comparison with Oral Nimodipine