Day: November 12, 2024

A Phase 1 SAD/MAD study of OV329 is progressing as planned, and based on encouraging human safety data to date, Ovid will engage regulators about adding cohorts to increase potential dosing opportunities for Phase 2 programs. A regulatory application for a Phase 1 trial of OV350, the first candidate from Ovid’s KCC2 direct activator library, is expected to be filed in Q4 2024. The Company will host a KCC2 Download Day on November 13 to provide updates on Ovid’s platform of KCC2 direct activators and their broad therapeutic potential. Ovid and Graviton are pausing the initiation of a Phase 2 study of OV888/GV101 to evaluate emerging insights from two recently completed competitor trials in cerebral cavernous malformations. Cash and marketable securities of $62.7 million as of September 30, 2024, is expected to support operations...

— Ongoing patient enrollment in Phase 2b CHASE trial of KPI-012 in Persistent Corneal Epithelial Defect (PCED); topline results expected in 2Q 2025 — — Initiated five clinical trial sites for the CHASE trial in Argentina; additional sites in Latin America in process, subject to regulatory clearance — ARLINGTON, Mass., Nov. 12, 2024 (GLOBE NEWSWIRE) — KALA BIO, Inc. (NASDAQ:KALA), a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovative therapies for rare and severe diseases of the eye, today reported financial results for the third quarter ended September 30, 2024 and provided a corporate update. “We remain focused on advancing patient enrollment in our Phase 2b CHASE trial evaluating KPI-012 for the treatment of PCED and are targeting topline...

Completed Pre-Biologics License Application (BLA) meeting with the U.S. Food and Drug Administration (FDA) and remain on track to submit a BLA for RP1 plus nivolumab in anti-PD1 failed melanoma via the accelerated approval pathway before the end of the yearIGNYTE-3 confirmatory trial of RP1(vusolimogene oderparepvec) in advanced melanoma underway with first patient enrolled in AugustPresented late-breaking abstracts at ESMO and SITC featuring the IGNYTE trial primary analysis showing clinical activity with RP1 plus nivolumab in anti-PD1 failed melanomaWOBURN, Mass., Nov. 12, 2024 (GLOBE NEWSWIRE) — Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of a novel class of oncolytic immunotherapies, today announced financial results for the fiscal second quarter ended September 30,...

Revenues Increased 19% Over the Third Quarter of 2023 CUPERTINO, Calif., Nov. 12, 2024 (GLOBE NEWSWIRE) — Aemetis, Inc. (NASDAQ: AMTX), a renewable natural gas and renewable fuels company focused on low and negative carbon intensity products that replace fossil fuels, today announced its financial results for the three and nine months ended September 30, 2024. Revenues of $81.4 million for the third quarter of 2024 reflect strong execution by all three of the company’s operating segments, with the California Ethanol business generating $45.0 million in revenues, the India Biodiesel business generating $32.2 million in revenues, and the Dairy Renewable Natural Gas (RNG) business generating $4.2 million in revenues. “Each of the Aemetis segments increased revenue during the third quarter of 2024 compared to the second quarter of...

Submitted New Drug Application (NDA) to FDA for TNX-102 SL for fibromyalgia based on two statistically significant Phase 3 studies Granted Fast Track Designation by FDA in July 2024 for TNX-102 SL, a centrally-acting, non-opioid analgesic; Fibromyalgia is a common chronic pain condition that affects mostly women Expect FDA decision in December 2024 on TNX-102 SL NDA acceptance for review and 2025 PDUFA date; If FDA-approved in 2025, TNX-102 SL would be the first new drug for fibromyalgia in more than 15 years Presented new data on potential mpox vaccine, TNX-801, in September and October 2024, demonstrating tolerability in immunocompromised animals; Previously reported studies showed a single-dose provided immune protection against a monkeypox challenge Awarded U.S. Department of Defense (DoD) contract for up to $34 million over five...

In October, Ocuphire Pharma acquired Opus Genetics, creating a leading, clinical-stage company focused on the development of gene therapy treatments for rare inherited retinal diseases (IRDs) The pro forma cash balance of the combined company was approximately $37 million as of September 30, 2024 (preliminary and unaudited), expected to extend runway into 2026 Four clinical data readouts expected in 2025 FARMINGTON HILLS, Mich., Nov. 12, 2024 (GLOBE NEWSWIRE) — Opus Genetics, Inc. (Nasdaq: IRD), a clinical-stage ophthalmic biotechnology company developing gene therapies for the treatment of inherited retinal diseases (IRDs) and other ophthalmologic disorders, today announced financial results for the third quarter ended September 30, 2024 and provided a corporate update. “In October 2024, we acquired Opus Genetics with the goal...

Target patient enrollment of 92 evaluable patients achieved in the VIRAGE Phase 2b clinical trial of VCN-01 in patients with metastatic pancreatic ductal adenocarcinoma Manufacturing funding awarded by the Spanish Government’s National Knowledge Transfer Program Data and Safety Monitoring Committee Review of Phase 1b/2a SYN-004 in allogeneic hematopoietic cell transplant recipients recommends expansion to Cohort 3 Orphan Medicinal Product Designation granted by the European Commission to VCN-01 for the treatment of retinoblastoma Rare Pediatric Disease Designation granted by the FDA for the treatment of retinoblastoma Placed Second in International Competition for Merck KGaA’s EMEA Advance Biotech Grant ROCKVILLE, Md., Nov. 12, 2024 (GLOBE NEWSWIRE) —  Theriva™ Biologics (NYSE American: TOVX), a diversified clinical-stage...