Category - Developments

Developments

AVROBIO to sell cystinosis gene therapy program for $87.5-million

AVROBIO (NASDAQ:AVRO) agreed to sell its investigational hematopoietic stem cell (HSC) gene therapy program for the treatment of cystinosis to Novartis for $87.5-million. Cystinosis is a rare, multisystem genetic...

May 22, 2023

Developments

Hepion Phase 2 ALTITUDE-NASH trial achieves all endpoints, improvement in liver function and NASH biomarkers

Hepion Pharmaceuticals (NASDAQ:HEPA) reported positive topline results from its recently completed Phase 2 ALTITUDE-NASH clinical trial with lead drug candidate, rencofilstat. ALTITUDE-NASH met its primary endpoint by...

May 22, 2023

Developments

Centessa receives FDA fast track in hemophilia B

The FDA granted fast track designation to Centessa Pharmaceuticals’ (NASDAQ:CNTA) SerpinPC, an investigational novel inhibitor of activated protein C (APC) being developed for the treatment of hemophilia B, with or...

May 22, 2023

Developments

Hepion to release Phase 2 ALTITUDE-NASH results pre-market on May 22

Hepion Pharmaceuticals (NASDAQ:HEPA) expects to release topline results from the Phase 2 ALTITUDE-NASH clinical trial with its rencofilstat drug candidate before the market opens on Monday, May 22, 2023. The company...

May 19, 2023

Developments

HanAll BioPharma flunks Phase 3 dry eye disease trial

The Velos-3 pivotal trial of HanAll BioPharma’s (KRX:009420. KS) tanfanercept did not demonstrate statistical significance in either of the primary outcome measures of improvement in central corneal staining score or in...

May 19, 2023

Developments

Stereotaxis, Abbott collaborate in cardiac mapping and robotics

Stereotaxis (NYSE:STXS) and Abbott (NYSE:ABT) agreed to a global collaboration to integrate Abbott’s EnSite X EP System with its Robotic Magnetic Navigation systems. The combination brings together highly detailed real...

May 19, 2023

Developments

EyePoint to sell YUTIQ to Alimera Sciences for $82.5-million

EyePoint Pharmaceuticals (NASDAQ:EYPT) entered into a definitive agreement for the sale of YUTIQ (fluocinolone acetonide intravitreal implant) 0.18mg to Alimera Sciences (NASDAQ:ALIM). Under the accord, EyePoint...

May 18, 2023

Developments

FDA eases partial clinical hold on Avidity dosing

The FDA eased a partial clinical hold on AOC 1001, allowing Avidity Biosciences (NASDA:RNA) to double the number of participants in the MARINA open-label extension (MARINA-OLE) study receiving 4 mg/kg of AOC 1001. The...

May 17, 2023

Developments

IntelGenx receives amended Health Canada license for third-party testing

IntelGenx (TSX:IGX; OTCQB:IGXT) received an amended Drug Establishment License (DEL) from Health Canada, allowing the company to conduct third-party testing. Analytical testing of finished products and intermediates is...

May 17, 2023

Developments

Dermavant posts positive results in second Phase 3 for atopic dermatitis

Dermavant Sciences, a subsidiary of Roivant Sciences (NASDAQ:ROIV), reported positive results from ADORING 1, the second of two double-blind, randomized, vehicle-controlled Phase 3 studies to evaluate the efficacy and...

May 16, 2023

Category - Developments

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