Category - Developments

Developments

Tonix to acquire 2 FDA-approved migraine products from Upsher-Smith Labs

Tonix Pharmaceuticals (NASDAQ:TNXP) agreed to acquire two currently-marketed products from Upsher-Smith Laboratories: Zembrace SymTouch injection 3 mg, and Tosymra nasal spray 10 mg, for the treatment of acute migraine...

June 26, 2023

Developments

Talaris Therapeutics to merge with Tourmaline Bio

Talaris Therapeutics (NASDAQ:TALS) and closely-held Tourmaline Bio agreed to merge in an all-stock transaction. The combined company will focus on advancing Tourmaline’s lead program, TOUR006, a potentially best-in...

June 22, 2023

Developments

FDA lifts clinical hold on DiaMedica ischemic stroke trial

The FDA has removed a clinical hold placed on DiaMedica’s (NASDAQ:DMAC) investigational new drug application for its ReMEDy2 Phase 2/3 clinical trial studying DM199 in the treatment of acute ischemic stroke (AIS) and...

June 21, 2023

Developments

Annovis Bio gets positive DSMB review of Phase 3 PD trial

A Data and Safety Monitoring Board (DSMB) recommended that Annovis Bio (NYSE:ANVS) continue its Phase 3 trial as originally designed of buntanetap, a drug for early Parkinson’s disease (PD) patients. The DSMB decision...

June 20, 2023

Developments

Precigen receives FDA breakthrough nod for AdenoVerse in RRP

The FDA granted breakthrough therapy designation for Precigen’s (NASDAQ:PGEN) investigational PRGN-2012 AdenoVerse immunotherapy for the treatment of recurrent respiratory papillomatosis (RRP). Standard-of-care for RRP...

June 20, 2023

Developments

Rhythm presents BMI reduction data in hypothalamic obesity

Rhythm Pharmaceuticals (NASDAQ:RYTM) presented data that showed meaningful weight loss was sustained and progressed in patients with hypothalamic obesity treated with its setmelanotide for six months as part of the long...

June 19, 2023

Developments

Hepion to present 2 posters at EASL International Liver Congress

Hepion Pharmaceuticals (NASDAQ:HEPA) will present two abstracts for poster presentations at the European Association for the Study of the Liver (EASL) International Liver Congress 2023 taking place June 21 – 24 in...

June 16, 2023

Developments

Hepion Phase 2b ASCEND-NASH trial passes key safety milestone

A data and safety monitoring board (DSMB) has reviewed the current data for Hepion Pharmaceuticals’ (NASDAQ:HEPA) ASCEND-NASH Phase 2b trial with rencofilstat and issued a “study may proceed without modification”...

June 15, 2023

Developments

2seventy’s CAR-T trial halted after pediatric death

2seventy bio’s (NASDAQ:TSVT) partner, Seattle Children’s Hospital, paused a Phase 1 CAR T-cell therapy trial for pediatric acute myeloid leukemia after a patient death. The child was the first to receive the second dose...

June 15, 2023

Developments

Zucara receives additional JDRF funding for Phase 2 study

Closely-held Zucara Therapeutics received an additional $2-million in funding from JDRF (Juvenile Diabetes Research Foundation) to support Zucara’s planned Phase 2a study of the effect of its ZT-01 on nocturnal...

June 15, 2023

Category - Developments

Subscribe