Dec. 19, 2024 -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that YORVIPATH® (palopegteriparatide; developed as TransCon PTH) is now commercially available by prescription in the United States. YORVIPATH is a prodrug of parathyroid hormone (PTH [1-34]), administered once-daily, designed to provide continuous exposure to active PTH over the 24-hour dosing period. It is the first and only medicine approved by the U.S. Food & Drug Administration (FDA) for the treatment of hypoparathyroidis

APOLLO study investigating MT-601 in patients with relapsed lymphoma: 78% of patients achieved objective response rates, with 44.4% demonstrating complete response (CR) MT-601 was observed to be well tolerated in all study participants with no observation of immune-effector cell associated neurotoxicity syndrome (ICANS) Dec. 19, 2024 -- Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company focusing on developing next-generation T cell-based immunotherapies for the t

Agreement Reached on Primary Endpoint and Phase 3 Trial Design Oral APX3330 is a Late-Stage Clinical Asset Available for Partnering Dec. 19, 2024 -- Opus Genetics, Inc. (Nasdaq: IRD), a clinical-stage ophthalmic biotechnology company developing gene therapies for the treatment of inherited retinal diseases (IRDs) and small-molecule drugs to treat other ophthalmologic disorders, today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol A

Partnership leverages proprietary PHICS™ technology to bring together a kinase and target of interest to modulate protein function, in this case an undisclosed cardiometabolic target Total potential deal value up to $186M in upfront, development and commercial milestone payments, in addition to R&D funding and tiered royalty payments on commercial sales Dec. 18, 2024 -- Photys Therapeutics, Inc., a proximity-based therapeutics company, today announced a multi-year collaboration and license agre

Proposed Merger to create a Nasdaq-listed, clinical-stage biopharmaceutical company developing novel treatments targeting STAT3 to treat fibrosis-driven diseases Tvardi has recently completed an approximately $28 million private financing, which, together with Tvardi’s existing cash and Cara’s anticipated cash balance, is expected to fund the combined company into the second half of 2026 Tvardi anticipates reporting topline data in the second half of 2025 from two Phase 2 clinical programs utili

VG801 is the first FDA IND clearance for novel mRNA trans-splicing gene therapy, delivering the full-length functional ABCA4 gene to target the genetic root cause of retinal dystrophies associated with ABCA4 mutations VG801 IND clearance expands ViGeneron’s clinical-stage pipeline to two programs, utilizing its novel gene therapy delivery technology platforms vgAAV capsid and REVeRT Selected by FDA for the Rare Disease Endpoint Advancement (RDEA) Pilot Program Dec. 18, 2024 -- ViGeneron GmbH, a

Data from lowest dose level cohorts demonstrate a favorable safety and efficacy profile Data includes complete results from cohort 1 and initial results from cohort 2 Early exercise of common stock warrants from stockholder generates cash proceeds of approximately $12.7 million Company to host conference call and webcast today at 8:00 a.m. ET / 5:00 a.m. PT Dec. 18, 2024 -- Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced interim data from

EYLEA HD demonstrated non-inferior vision gains with an every 8-week dosing regimen compared to EYLEA® (aflibercept) Injection 2 mg dosed every 4 weeks Safety data remains consistent with the known EYLEA HD and EYLEA safety profiles Supplementary biologics license application planned for submission to the U.S. Food and Drug Administration in the first quarter of 2025 Dec. 17, 2024 -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the primary endpoint was met in the Phase 3 QUASA

Duvakitug positive phase 2b results demonstrate best-in-class potential in ulcerative colitis and Crohn’s disease Primary endpoints met in ulcerative colitis (UC) and Crohn’s disease (CD), the most common forms of inflammatory bowel disease (IBD) Primary endpoint results in UC and CD for high dose represent the highest achieved with any TL1A monoclonal antibody Sanofi and Teva plan to initiate phase 3 development in IBD, pending regulatory discussions Program underscores Sanofi's Immunology lea

Dec. 18, 2024 -- Tessera Therapeutics, a biotechnology company pioneering a new approach to genome engineering through the development of its Gene Writing™ and delivery platforms, announced today that it has entered into an agreement with the Bill & Melinda Gates Foundation to jointly fund the company’s in vivo program for sickle cell disease (SCD). The funding includes an initial investment, with potential total investment of up to $50 million, from the Gates Foundation intended to support the