Nimodipine

Acasti Pharma Inc. Discusses Year-End Results and Clinical Development Progress with The Stock Day Podcast

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Thursday, July 7, 2022
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Phoenix, Arizona--(Newsfile Corp. - July 7, 2022) - The Stock Day Podcast welcomed Acasti Pharma Inc. (NASDAQ: ACST) ("the Company"), a specialty pharma company with drug delivery technologies and novel drug candidates addressing rare and orphan diseases.

Key Points: 
  • Phoenix, Arizona--(Newsfile Corp. - July 7, 2022) - The Stock Day Podcast welcomed Acasti Pharma Inc. (NASDAQ: ACST) ("the Company"), a specialty pharma company with drug delivery technologies and novel drug candidates addressing rare and orphan diseases.
  • Copley began the interview by asking about one of the Company's lead clinical assets, GTX-104, targeting underserved orphan diseases.
  • "Based on these results, we plan to proceed with our Phase III study in patients with Subarachnoid Hemorrhage (SAH)," she continued.
  • Copley then asked about the Company's additional drug candidates, which are currently under clinical development, GTX-102 and GTX-101.

Acasti Pharma Announces the Issuance of Additional Patents for GTX-104 and GTX-101

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Tuesday, June 14, 2022
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Acasti recently reported positive results for a pharmacokinetic (PK) study, with intravenous GTX-104 meeting all endpoints.

Key Points: 
  • Acasti recently reported positive results for a pharmacokinetic (PK) study, with intravenous GTX-104 meeting all endpoints.
  • Acasti is now working with the U.S. FDA to commence a Phase 3 study on GTX-104, which is expected to be the final step required to seek regulatory approval.
  • Acasti is a late-stage specialty pharma company with drug delivery capability and technologies 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 Announces Positive Results for Pharmacokinetic Bridging Study, With Intravenous GTX-104 Meeting All Endpoints

Retrieved on: 
Wednesday, May 18, 2022
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LAVAL, Québec, May 18, 2022 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti” or the “Company”) (Nasdaq: ACST and TSX-V: ACST) announced today that the top line results of its pharmacokinetic (PK) bridging study with IV GTX-104, the Company’s lead drug candidate for the treatment of Subarachnoid Hemorrhage (SAH), met all its planned study endpoints. The primary objective of the study was to evaluate the relative bioavailability of IV GTX-104 compared to oral nimodipine in healthy adult male and female subjects, while the secondary objective was to assess its safety and tolerability. The Company plans to submit these results to the US Food and Drug Administration (FDA), along with its proposed study design for the Phase 3 safety study which is on track to start in the second half of 2022. The safety study is expected to be the final step required to seek regulatory approval under the 505(b)(2) regulatory pathway before submitting a New Drug Application to the FDA.

Key Points: 
  • In addition, the diurnal variation associated with IV GTX-104 was approximately half of that seen with the oral nimodipine capsules.
  • Diurnal variation takes into consideration variation in body functions (blood flow, renal function and hepatic metabolism) over the course of a day.
  • Acasti will host a conference call on Wednesday, May 18, 2022 at 1:00 PM Eastern Time to discuss the results of the trial.
  • Acasti is a late-stage specialty pharma company with drug delivery technologies and drug candidates addressing rare and orphan diseases.

Acasti Pharma Announces Patents for GTX-104 in Europe, GTX-102 in the U.S. and GTX-101 in Japan

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Tuesday, March 22, 2022
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A-T is a progressive, neurodegenerative genetic disease that primarily affects children, causing severe physical disability, for which no treatment currently exists.

Key Points: 
  • A-T is a progressive, neurodegenerative genetic disease that primarily affects children, causing severe physical disability, for which no treatment currently exists.
  • The Japanese Patent Office granted a composition of matter patent for the Companys topical spray GTX-101 targeting postherpetic neuralgia (PHN).
  • We believe these drug candidates may also have a faster path to regulatory approval and commercialization via the FDAs 505(b)(2) pathway.
  • Acasti is an advanced-stage specialty pharma company with drug delivery technologies and drug candidates addressing rare and orphan diseases.

Acasti Pharma Celebrates Rare Disease Day

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Monday, February 28, 2022
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LAVAL, Qubec, Feb. 28, 2022 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Acasti or the Company) (Nasdaq: ACST and TSX-V: ACST), today recognizes and celebrates Rare Disease Day (February 28), as established by the European Organisation for Rare Diseases.

Key Points: 
  • LAVAL, Qubec, Feb. 28, 2022 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Acasti or the Company) (Nasdaq: ACST and TSX-V: ACST), today recognizes and celebrates Rare Disease Day (February 28), as established by the European Organisation for Rare Diseases.
  • Rare Disease Day is the globally coordinated movement on rare diseases, working towards equity in social opportunity, healthcare, and access to diagnosis and therapies for people living with a rare disease.
  • Since its creation in 2008, Rare Disease Day has played a critical part in building an international rare disease community that is multi-disease, global and diverse but united in purpose.
  • Rare Disease Day is observed every year on 28 February (or 29 in leap years) the rarest day of the year.

Acasti Pharma Announces Interim Data Meets All Primary Endpoints for Pivotal PK Study for GTX-104

Retrieved on: 
Thursday, December 2, 2021
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As observed in a previous PK study, the inter- and intra-subject variability in the interim analysis was much lower for GTX-104 as compared with oral nimodipine.

Key Points: 
  • As observed in a previous PK study, the inter- and intra-subject variability in the interim analysis was much lower for GTX-104 as compared with oral nimodipine.
  • "This interim data is very encouraging, as it suggests that our current infusion protocol is on track to meet the objectives for this pivotal PK study.
  • In just three months since completing the acquisition, we launched this pivotal PK bridging study for GTX-104 and already have positive interim data with more data to follow in the first half of 2022.
  • The PK bridging study for GTX-104 is being conducted in a total of 50 healthy subjects as a single center, randomized, two-period crossover study.

Acasti Pharma Announces Initiation of Pharmacokinetic Bridging Study for GTX-104, the Company’s Lead Drug Candidate for the Treatment of Subarachnoid Hemorrhage

Retrieved on: 
Monday, September 27, 2021
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This latest study follows an earlier safety and dose-escalation crossover study conducted by Grace, which reported encouraging results.

Key Points: 
  • This latest study follows an earlier safety and dose-escalation crossover study conducted by Grace, which reported encouraging results.
  • Moreover, it could provide a more convenient dosing schedule that would be easier to administer to patients who are unconscious.
  • The PK bridging study is a single center, randomized, two-period crossover study in 50 healthy subjects.
  • Acasti is a late-stage specialty pharma company with drug delivery technologies and drug candidates addressing rare and orphan diseases.