Acasti Pharma, Inc. - ACST STOCK NEWS

Acasti Pharma reported its fiscal year 2022 results, ending March 31, with a net loss of $9.8 million, or $0.27 per share, an improvement from a loss of $19.7 million the previous year. The company has $43.7 million in cash and short-term investments. Acasti is advancing three drug candidates: GTX-104, GTX-102, and GTX-101, all expected to enter new clinical trials in late 2022. Significant milestones include positive results from GTX-104’s pharmacokinetic study and patent allowances for its drug formulations, which may lead to increased market exclusivity.

Acasti Pharma will host a conference call on June 21, 2022, at 1:00 PM ET, to discuss its fiscal year 2022 results, which ended on March 31, 2022. The call will provide insights into the company's corporate progress and developments within its clinical pipeline, including investigational treatments for rare diseases such as GTX-104, GTX-102, and GTX-101, all of which hold Orphan Drug Designation from the FDA. A webcast will be available live and for replay on Acasti's website.

Acasti Pharma announced the issuance of three composition of matter patents for GTX-104 by U.S., Japanese, and Australian patent offices, with an additional patent granted in India, all valid until 2037. GTX-104 is an intravenous formulation of nimodipine aimed at treating Subarachnoid Hemorrhage, impacting approximately 110,000 patients annually in the U.S. and Europe. Following successful pharmacokinetic study results, Acasti is preparing for a Phase 3 study to seek regulatory approval. Additionally, a patent for GTX-101, targeting Postherpetic Neuralgia, was allowed in Canada, valid until 2036.

Acasti Pharma Inc. (Nasdaq: ACST) has engaged Lytham Partners to enhance its investor relations and shareholder communications. This collaboration aims to improve visibility among institutional investors as Acasti advances its drug candidates targeting rare diseases, including GTX-104, which recently met its study endpoints for treating Subarachnoid Hemorrhage. The investor relations agreement includes a monthly fee of $9,500, with a flexible termination clause. Acasti will also participate in the upcoming Lytham Partners Summer 2022 Investor Conference from June 21-22.

Acasti Pharma announced positive results from its pharmacokinetic (PK) bridging study for IV GTX-104, showing favorable bioavailability compared to oral nimodipine and no serious adverse events.

The company plans to submit these findings to the FDA and is on track to initiate a Phase 3 safety study for GTX-104 by year-end 2022. With an estimated market potential of over $300 million for Subarachnoid Hemorrhage (SAH), GTX-104 demonstrates lower variability and improved absorption, positioning it as a promising option for treatment.

Acasti Pharma announced that CEO Jan D'Alvise will present at the Spring Into Action- Best Ideas Investor Conference on May 18, 2022, at 4:00 p.m. ET. The presentation will be live-streamed and available for replay. Interested investors can schedule one-on-one meetings during the event. Acasti focuses on developing innovative drug delivery technologies for orphan diseases, with three lead clinical assets, GTX-104, GTX-102, and GTX-101, all granted Orphan Drug Designation by the U.S. FDA, ensuring seven years of marketing exclusivity.

Acasti Pharma (NASDAQ:ACST) announced that CEO Jan D'Alvise will present at the Spring Into Action - Best Ideas Investor Conference from May 16-20, 2022. D'Alvise's presentation is scheduled for May 16 at 1:30 p.m. ET, available for live webcast and replay. The virtual conference features 36 companies recommended as top ideas for investors. Acasti specializes in drug delivery technologies for rare diseases and holds orphan drug designations from the FDA for three key assets: GTX-104, GTX-102, and GTX-101.

Acasti Pharma announced that Prashant Kohli, the Vice President of Commercial Operations, will present at the B. Riley Securities' 2022 Virtual Neuro & Ophthalmology Conference on April 28, 2022, at 4:30 pm ET. A live webcast of the presentation will be available on the company's website. Acasti focuses on drug delivery technologies addressing rare diseases, with three lead clinical assets holding Orphan Drug Designation from the U.S. FDA, including GTX-104 for Subarachnoid Hemorrhage, GTX-102 for Ataxia-telangiectasia, and GTX-101 for Postherpetic Neuralgia.

Acasti Pharma Inc. has appointed Michael L. Derby to its Board of Directors, as announced on March 25, 2022. With over two decades in the biopharmaceutical industry, Derby's expertise in drug repurposing is expected to enhance the company’s development of its three lead clinical assets. These assets target rare diseases and have received Orphan Drug Designation by the FDA, granting them seven years of marketing exclusivity post-launch. Derby's experience includes founding multiple biopharmaceutical firms and leading companies through clinical trials. The appointment signals a strategic move to strengthen Acasti's leadership.