Category - Developments

Developments

Wave Life flunks Phase 1b/2a study in ALS and dementia

Wave Life Sciences’ (NASDAQ:WVE) drug candidate, WVE-004, did not show clinical benefit, compared with placebo, in the Phase 1b/2a FOCUS-C9 study as an investigational treatment for C9orf72-associated amyotrophic...

May 23, 2023

Developments

T2 Biosystems exploring strategic alternatives

T2 BioSystems (NASDAQ:TTOO) initiated a process to explore a range of strategic alternatives focused on maximizing value and a restructuring plan, which includes a reduction in workforce. T2 has engaged an advisory firm...

May 23, 2023

Developments

MindBio gets ethics okay for take-home LSD-microdosing trial in MDD

MindBio Therapeutics (CSE:MBIO; Frankfurt:WF6) received ethics approval for a world’s first Phase 2a take-home LSD-microdosing clinical trial in patients with major depressive disorder (MDD) in New Zealand. The...

May 23, 2023

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

Category - Developments

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