CHICAGO, Ill. — COUR Pharma, a clinical-stage biotechnology company developing first-in-class, antigen-specific immune tolerance therapies for autoimmune diseases, announced today the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to CNP-106, an investigational therapy for the treatment of generalized myasthenia gravis (gMG). CNP-106 is a biodegradable...
treatment News
HOUSTON, TX — Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company focused on developing biologics that enhance regulatory T cell (Treg) function in patients with neurodegenerative disorders, announces that the U.S. Food and Drug Administration (“FDA” or the “Agency”) has accepted its Investigational New Drug (IND) application for...
HOUSTON, Texas — Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company focused on developing biologics that enhance regulatory T cell (Treg) function in patients with neurodegenerative disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for COYA 302, a...
HOUSTON, Texas — Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company focused on developing biologics that enhance regulatory T cell (Treg) function in patients with neurodegenerative disorders, announced today the launch of the ALSTARS Trial, a Phase 2, randomized, multi-center, double-blind, placebo-controlled study to evaluate the...
HOUSTON, TX — Coya Therapeutics, Inc., a clinical-stage biotechnology company developing biologics primarily focused on the restoration of regulatory T cell (Treg) immunomodulatory function, announces the presentation of data demonstrating the role of the peripheral immune system in the pathophysiology of Frontotemporal Dementia (FTD) from a biomarker study conducted at...
HOUSTON, Texas — Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics intended to enhance Treg function, announces the publication of a research study led by Dr. David Beers and Dr. Stanley Appel at the Houston Methodist Neurological Institute. The study included the longitudinal measurement...
HOUSTON, Texas — Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics intended to enhance T-cell (Treg) function in patients with neurodegenerative disorder, today announced it will host a live webinar on February 17, 2026 at 3:00 p.m. ET/ 12:00 p.m. PT exploring the evolving...
SAN DIEGO, Calif. — Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the first presentation of new two-year data from the Phase 3 CAHtalyst® Adult study demonstrating sustained, substantial reductions in glucocorticoid (GC) doses in adults with classic congenital adrenal hyperplasia treated with CRENESSITY® (crinecerfont), with approximately 70% of patients achieving GC doses within the physiologic range. These...
SAN DIEGO, Calif. — Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced that the U.S. Food and Drug Administration (FDA) approved PALSONIFYTM (paltusotine) for the first-line treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option. PALSONIFY, a selectively-targeted somatostatin receptor type 2...
SAN DIEGO, Calif. — Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced that the first patient has been dosed in the CALM-CAH Phase 3 trial evaluating investigational candidate atumelnant, a novel, once-daily, oral adrenocorticotropic hormone (ACTH) receptor antagonist candidate for the proposed treatment of classic congenital adrenal hyperplasia (CAH). “Dosing the first...