Highest-materiality recent filing
Grace Therapeutics FY2026 net loss $7.8M; FDA CRL for GTx-104; Type A meeting set
Net loss of $7.8M ($0.47 loss per share) for FY2026, improved from $9.6M loss in FY2025.
FDA CRL for GTx-104 (nimodipine IV) in aSAH; no additional clinical data requested.
Net loss of $2.3M ($0.14 per share) improved from $4.2M loss ($0.36 per share) in prior year quarter.
Grace Therapeutics reports Q2 loss of $0.9M; FDA accepts NDA for GTx-104 with PDUFA April 23, 2026
Net loss $0.9M ($0.06 loss per share) vs $3.4M ($0.30 loss) in Q2 last year.
FDA accepts Grace Therapeutics' NDA for GTx-104; PDUFA date set for April 23, 2026
FDA accepted NDA for GTx-104 (injectable nimodipine) for aSAH treatment; PDUFA target April 23, 2026.
Grace Therapeutics reports Q1 net loss $3.4M; submits GTx-104 NDA to FDA
Net loss $3.4M ($0.21/sh) vs $2.6M ($0.24/sh) in prior-year quarter; R&D down $1.8M to $0.9M.
Grace Therapeutics submits NDA for GTx-104 in aSAH; Phase 3 data positive
NDA for GTx-104 (injectable nimodipine) submitted to FDA for aneurysmal subarachnoid hemorrhage.
Net loss of $9.6M ($0.79 per share) vs $12.9M ($1.35) in FY2024, decrease driven by change in warrant liabilities.
Primary endpoint met: 19% reduction in clinically significant hypotension (28% GTx-104 vs 35% oral nimodipine).
Grace Therapeutics Q3 net loss $4.2M; Phase 3 STRIVE-ON meets endpoint; $15M placement
Net loss $4.2M ($0.36/sh) vs $2.4M ($0.21/sh) YoY; R&D $2.2M up from $1.4M on GTx-104 trial.
Grace Therapeutics: Phase 3 STRIVE-ON trial meets endpoint; announces up to $30M private placement
Phase 3 STRIVE-ON safety trial met primary endpoint: 19% reduction in clinically significant hypotension vs oral nimodipine; NDA submission expected H1 2025.
Grace Therapeutics reports Q2 net loss $3.4M; Phase 3 STRIVE-ON data due Q1 2025; cash into Q2 2026
Net loss of $3.4M ($0.30 per share) vs $3.3M ($0.43 per share) in prior year; R&D spend up to $3.0M on pivotal trial.
Acasti Pharma rebrands as Grace Therapeutics; new ticker GRCE effective Oct 28
Company renamed Grace Therapeutics, Inc.; common stock begins trading as GRCE on Nasdaq at market open Oct 28, 2024.
Acasti Pharma completes enrollment in pivotal Phase 3 STRIVE-ON trial of GTX-104 for aSAH
Patient enrollment completed for GTX-104 (injectable nimodipine) vs oral nimodipine in 100 patients across ~25 U.S. hospitals.
Acasti Pharma Q1 FY2025 net loss $2.6M; STRIVE-ON trial enrollment exceeds 50%
Net loss of $2.6M ($0.24 loss per share) vs $4.0M ($0.54) in prior-year quarter.
Acasti achieves >50% enrollment in pivotal Phase 3 STRIVE-ON safety trial for GTX-104
Phase 3 STRIVE-ON trial of GTX-104 (IV nimodipine) for aneurysmal subarachnoid hemorrhage (aSAH) surpassed 50% patient enrollment.
Acasti Pharma FY2024 net loss $12.9M; STRIVE-ON trial on track for NDA in H1 2025
FY2024 net loss $12.9M ($1.35 per share), down from $42.4M in FY2023; decrease due to prior year impairments not recurring and restructuring.
Acasti Pharma Q3 FY2024 net loss narrows to $2.4M; cash runway extends to early 2026
Net loss of $2.4M ($0.21/share) vs $3.9M ($0.52) in prior-year quarter.
Acasti Pharma Settles CaPre Dispute with Aker BioMarine and Doses First Patient in GTX-104 Trial
Acasti entered a Settlement Agreement with Aker BioMarine to resolve a $2.6 million dispute over a supply agreement for CaPre raw material.
Acasti Pharma closes $7.5M private placement for GTX-104 development
Closed private placement on Sept 25, 2023: 1.95M common shares at $1.848 each, pre-funded warrants for 2.11M shares, and common warrants for 2.54M shares at $3.003 exercise.
Acasti Pharma Q1 net loss $4.0M; FDA aligned on Phase 3 GTX-104 trial; cash runway to Q2 2025
Net loss $4.0M ($0.54 per share) vs $4.5M ($0.61 per share) year ago.
Acasti Pharma regains Nasdaq minimum bid price compliance after reverse split
Received Nasdaq notice on July 24, 2023 confirming compliance with Listing Rule 5550(a)(2).
Acasti aligns with FDA on GTX-104 Phase 3 safety trial protocol; STRIVE-ON to start Q4 2023
FDA confirmed alignment on STRIVE-ON trial design and dosing regimen for GTX-104 in aSAH patients.
Acasti Pharma reports FY2023 net loss of $42.4M, focuses on GTX-104 Phase 3
Net loss of $42.4M ($0.95 loss per share) vs $9.8M loss prior year; impairments of $33.5M.
Appointed Dr. R. Loch Macdonald as CMO, Carrie D'Andrea as VP Clinical Ops, Amresh Kumar as VP Program Mgmt; effective immediately or May 15.
Acasti appoints Prashant Kohli as CEO; FDA allows Phase 3 safety study for GTX-104 to proceed
Prashant Kohli appointed CEO effective April 4, 2023, succeeding Jan D'Alvise who mutually agreed to depart.
Carrie D’Andrea will cease serving as Vice President of Clinical Operations of the Company and will no longer be employed by the Company effective June 5, 2026
Concurrently with such appointment, the Board removed Brian Ford from the position of interim-Chief Financial Officer.
On January 5, 2024, the Board of Directors (the “Board”) of Acasti Pharma Inc. (the “Company”) approved the appointment of Robert J. DelAversano, the Company's Vice President, Finance, to the roles of principal financial officer and principal accounting officer of the Company, effective immediately.
On May 8, 2023, the Company terminated the employment of Brian Ford, Chief Financial Officer; Pierre Lemieux, Chief Operating Officer (Canada); and George Kottayil, Chief Operating Officer (US).
On May 8, 2023, the Company appointed Amresh Kumar, PhD, as its VP of Program Management, effective May 15, 2023.
On May 8, 2023, the Company terminated the employment of Brian Ford, Chief Financial Officer; Pierre Lemieux, Chief Operating Officer (Canada); and George Kottayil, Chief Operating Officer (US).
On May 8, 2023, the Company appointed Dr. R. Loch Macdonald, MD, PhD, as Chief Medical Officer, effective immediately.
On May 8, 2023, the Company terminated the employment of Brian Ford, Chief Financial Officer; Pierre Lemieux, Chief Operating Officer (Canada); and George Kottayil, Chief Operating Officer (US).
On May 8, 2023, the Company appointed Carrie D'Andrea as its VP Clinical Operations, effective immediately.
Ms. D'Alvise will also be stepping down from the Company's board of directors.
succeeding Jan D'Alvise, who has mutually agreed with the Company to depart.
On April 4, 2023, Acasti Pharma Inc. (the "Company") announced it has appointed Prashant Kohli as the Company's Chief Executive Officer, succeeding Jan D'Alvise, who has mutually agreed with the Company to depart.
Max materiality 0.85 · Median 0.62 · Most common event other_material