Year: 2024

– Late-Breaking Abstract on Results of Phase 3 BOND-003 Trial of Cretostimogene Monotherapy in BCG-Unresponsive NMIBC Accepted at the Society of Urologic Oncology (SUO) 25th Annual Meeting – IRVINE, Calif., Nov. 12, 2024 (GLOBE NEWSWIRE) — CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients with bladder cancer, today reported financial results for the third quarter ended September 30, 2024, and provided business updates. “This quarter, we’ve continued to make significant advancements across our pipeline to bring forward a potential backbone bladder-sparing therapy for patients with Non-Muscle Invasive Bladder Cancer (NMIBC),” said Arthur Kuan, Chairman & Chief Executive Officer at...

SOUTH SAN FRANCISCO, Calif., Nov. 12, 2024 (GLOBE NEWSWIRE) — RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based therapeutics company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in inflammatory diseases and oncology, today reported financial results for the third quarter and nine months ended September 30, 2024. Financial Results for the Third Quarter and Nine Months Ended September 30, 2024 Third Quarter Ended September 30, 2024 Net loss for the third quarter of 2024 was $18.4 million, compared to $31.4 million for the third quarter of 2023. Research and development expenses for the third quarter of 2024 were $13.3 million, compared to $27.0 million for the same period in 2023. The decrease in research and development expenses...

NEW YORK, Nov. 12, 2024 (GLOBE NEWSWIRE) — Indaptus Therapeutics, Inc. (Nasdaq: INDP) (“Indaptus” or the “Company”), a clinical stage biotechnology company dedicated to pioneering innovative cancer and viral infection treatments, today announced financial results for the third quarter ended September 30, 2024, and provided a corporate update. Jeffrey Meckler, Indaptus Therapeutics’ Chief Executive Officer, commented, “The recent announcement highlighting our clinical supply agreement with BeiGene is an important milestone, representing a significant step forward in our clinical development as we plan the first clinical trial combining BeiGene’s anti-PD-1 antibody, tislelizumab, with Indaptus’ Decoy20 product candidate for cancer treatment. PD-1 inhibitors have proven meaningful in treating multiple cancer types, and we are...

Completed a successful end of Phase 2 meeting with the FDA for bitopertin in erythropoietic protoporphyria (EPP), reaching alignment on all proposed study parameters with the potential for accelerated approval based on existing data Presented proof-of-mechanism data for Phase 1b trial of DISC-0974 in patients with non-dialysis-dependent chronic kidney disease (NDD-CKD) and anemia at the American Society of Nephrology (ASN) Kidney Week 2024 Eight posters and an oral presentation across all three clinical-stage assets to be presented at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition Strong financial position ending Q3 with $487 million in cash, cash equivalents, and marketable securities, further strengthened by closing a $200 million non-dilutive debt financing in November 2024 increasing future financing optionalityWATERTOWN,...

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...