Category - Developments

Developments

PharmaJet Tropis system authorized for 2 nucleic acid vaccines

PharmaJet’s Tropis system is now the exclusive intradermal delivery system for two authorized novel COVID-19 vaccines. They include: The world’s first plasmid DNA COVID-19 vaccine for administration in humans from Zydus...

June 28, 2023

Developments

Cognition posts positive topline Phase 2 results in AD

Cognition Therapeutics (NASDAQ:CGTX) reported topline results from its Phase 2 double-blind, single-crossover SEQUEL study of CT1812 in 16 adults with mild-to-moderate Alzheimer’s disease that met its primary endpoints...

June 28, 2023

Developments

FDA clears BriaCell pivotal study in breast cancer

The FDA approved BriaCell Therapeutics’ (NASDAQ:BCTX; TSX: BCT) pivotal registrational study design for Bria-IMT in combination with a checkpoint inhibitor in advanced metastatic breast cancer, including the study...

June 27, 2023

Developments

FDA lifts clinical hold on deucrictibant for on-demand treatment of HAE

The FDA lifted the clinical hold on Pharvaris’ (NASDAQ:PHVS) IND application for deucrictibant for the on-demand treatment of hereditary angioedema (HAE) following a review of data from a preplanned interim analysis of...

June 26, 2023

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

Category - Developments

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