Category - Developments

Developments

Hemogenyx, Cellin sign LOI to commercialize cell therapy for R/R AML in Estonia

Hemogenyx Pharmaceuticals (LSE: HEMO) has announced the signing of a letter of intent (LOI) with closely held Cellin Technologies to explore the commercialization of its HG-CT-1 CAR-T cell therapy for the treatment of...

September 23, 2025

Developments

EC and Swissmedic approve KalVista’s oral treatment for HAE

KalVista Pharmaceuticals (NASDAQ: KALV) announced that the European Commission (EC) and Swiss Agency for Therapeutic Products (Swissmedic) have approved EKTERLY (sebetralstat), a novel, oral plasma kallikrein inhibitor...

September 19, 2025

Developments

Palisade announces positive PALI-2108 data

Palisade Bio (NASDAQ: PALI) has announced new data from its ongoing clinical program evaluating PALI-2108, a first-in-class, ileocolonic-targeted PDE4 B/D inhibitor. The company plans to present the results in an oral...

September 17, 2025

Developments

Vivos unveils landmark trial results in pediatric OSA treatment

Vivos Therapeutics (NASDAQ: VVOS) has announced first time, peer-reviewed published data confirming that the Vivos Daytime-Nighttime Appliance (DNA) is both safe and efficacious in treating children suffering from...

September 17, 2025

Developments

FDA grants Corbus fast track designation for CRB-701 in HNSCC

Corbus Pharmaceuticals (NASDAQ: CRBP) has announced that the FDA has granted fast track designation to its next-generation Nectin-4 antibody drug conjugate CRB-701 for the treatment of recurrent or metastatic head and...

September 16, 2025

Developments

Adagene, Exelixis amend license agreement to develop third masked mAb

Adagene (NASDAQ: ADAG) has announced an amendment to the 2021 collaboration and license agreement with Exelixis (Nasdaq: EXEL) to enable the development of a third novel masked monoclonal antibody (mAb) drug conjugate...

September 16, 2025

Developments

Actinogen, FDA agree on activities toward marketing approval of Xanamem for AD

Actinogen Medical (ASX: ACW) has announced that an agreement with the FDA has been reached in a scheduled Type C meeting on the manufacturing, clinical, and nonclinical activities required for a future US marketing...

September 16, 2025

Developments

Entera reports positive data for oral GLP-2 tablet for SBS at 2025 ESPEN Congress

Entera Bio (NASDAQ: ENTX) has announced the presentation of a poster highlighting pharmacokinetic data relating to its first-in-class oral GLP-2 analog program for the treatment of short bowel syndrome (SBS), at the...

September 16, 2025

Developments

Cocrystal showcases potential first oral antiviral for norovirus

Cocrystal Pharma (NASDAQ: COCP) has announced that the scientific foundation and clinical progress of its lead pan-viral protease inhibitor, CDI-988, was discussed by President and CEO, Dr. Sam Lee, in a presentation at...

September 12, 2025

Developments

Karyopharm completes enrollment of Phase 3 SENTRY trial in MF

Karyopharm Therapeutics (NASDAQ: KPTI) has announced enrollment completion in its Phase 3 SENTRY trial, designed to evaluate selinexor in combination with ruxolitinib in JAKi-naïve myelofibrosis (MF) patients. According...

September 10, 2025

Category - Developments

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