sNDA submission based on results from Phase 3 DUPLEX and Phase 2 DUET studies of FILSPARI in FSGS If approved, FILSPARI could become the first and only FDA-approved treatment for FSGS, a rare kidney condition and a leading cause of kidney failure Additionally, the FDA notified the Company that REMS monitoring for embryo-fetal toxicity is no longer necessary; the Company plans to submit an amendment to the REMS sNDA currently under review for modification of liver monitoring March 17, 2025 Trav

Study represents the first clinical application of CMND-100, the Company’s proprietary drug platform March 18, 2025 -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the “Company”), a clinical-stage biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, announces today that it initiated its Phase I/IIa clinical trial investigating the safety, tolerability and full pharmacokinetic profile

March 18, 2025 -- ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI or the Company) today announced that it has completed the buyout of its 3.125% perpetual royalty obligation to SWK Funding LLC (SWK) on worldwide net revenues of ILUVIEN and YUTIQ for a one-time payment of $17.25 million. Under the terms of the agreement, upon making the buyout payment, no further royalty is due to SWK on net revenues beginning January 1, 2025, forward. ANI funded the buyout with cash on hand. Nikhil Lalwani, Pres

March 18, 2025 -- Angitia Biopharmaceuticals, a global, clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for serious musculoskeletal diseases, today announced the presentation of data from its randomized, double-blind, placebo-controlled Phase 1/2 study evaluating AGA111 for use in spinal fusion procedures on March 12, 2025, at the 2025 American Academy of Orthopedic Surgeons (AAOS) Annual Meeting in San Diego, California. In the study, t

New trial arm to evaluate safety, dosing and preliminary anti-tumor activity in advanced solid tumors March 18, 2025 -- Indaptus Therapeutics, Inc. (Nasdaq: INDP), a clinical-stage biotechnology company dedicated to developing novel treatments for cancer and viral infections, today announced that it has advanced to a new expansion arm of its Phase 1b/2 clinical trial of Decoy20. This expansion will evaluate the combination of Decoy20 with BeiGene’s PD-1 checkpoint inhibitor, tislelizumab, with

March 17, 2025 -- Lirum Therapeutics, Inc. (“Lirum”), an innovative clinical-stage biopharmaceutical company focused on the treatment of debilitating diseases, announced today that its first data on LX-101 in Thyroid Eye Disease (TED) have been selected for presentation at the 51st Annual Meeting of the North American Neuro-Ophthalmology Society (NANOS), March 15-20 in Tucson, Arizona. These new results demonstrate the ability of LX-101 to effectively target the underlying processes that drive

Series C led by ARCH Venture Partners and TCGX with significant participation from existing and new investors Financing extends Arbor’s cash runway into 2027 and supports the clinical development of lead program ABO-101 and continued advancement of a broader portfolio of CNS-targeted gene editing therapeutics and reverse transcriptase (RT)-based editing programs March 18, 2025 -- Arbor Biotechnologies™, a biotechnology company discovering and developing the next generation of genetic medicines,

Antitumor activity observed with confirmed partial responses in 50% of patients at highest dose tested to date, across multiple tumor types PLN-101095 was generally well tolerated across all doses March 17, 2025 -- Pliant Therapeutics, Inc. (Nasdaq: PLRX) today announced data from the first three of five potential cohorts of its ongoing Phase 1 dose escalation clinical trial evaluating PLN-101095, an integrin αvβ8 and αvβ1 inhibitor, in combination with pembrolizumab, in patients with immune c

March 17, 2025 -- OPKO Health, Inc. (NASDAQ: OPK) and Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of oral peptides and proteins replacement therapies, entered into a collaboration and license agreement to advance into the clinic the first oral dual agonist GLP-1/glucagon peptide as a once-daily tablet treatment for patients with obesity, metabolic and fibrotic disorders. The program combines OPKO’s proprietary long-acting oxyntomodulin analog (OPK-88006) and Entera’s proprietary

March 18, 2025 -- – SCIENTURE HOLDINGS, INC. NASDAQ: SCNX), a holding company for existing and planned pharmaceutical operating companies focused on providing enhanced value to patients, physicians and caregivers through developing, bringing to market, and distributing novel specialty products to satisfy unmet market needs, is pleased to announce the U.S. Food and Drug Administration (FDA) has approved SCN-102, one of the products being developed by Scienture, LLC, a wholly owned subsidiary of