Category - Developments

Developments

Cognition, AD consortium initiate Phase 2 START study

Cognition Therapeutics (NASDAQ:CGTX) and the Alzheimer’s Clinical Trials Consortium initiated the first clinical site in the 540-patient Phase 2 START study of CT1812 in adults with early Alzheimer’s disease (AD)...

July 5, 2023

Developments

RenovoRx presents positive interim Phase 3 data in pancreatic cancer

RenovoRx (NASDAQ:RNXT) presented new positive data on progression-free survival from the pivotal Phase 3 open label TIGeR-PaC study of RenovoGem (intra-arterial administration of gemcitabine) in locally advanced...

June 29, 2023

Developments

IntraBio posts positive Phase 3 trial in Niemann-Pick disease Type C

Closely-held IntraBio reported positive topline results from a Phase 3 clinical trial, showing IB1001 significantly improved symptoms, functioning, quality of life, and cognition in pediatric and adult patients with...

June 29, 2023

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

Category - Developments

Cognition, AD consortium initiate Phase 2 START study

RenovoRx presents positive interim Phase 3 data in pancreatic cancer

IntraBio posts positive Phase 3 trial in Niemann-Pick disease Type C

PharmaJet Tropis system authorized for 2 nucleic acid vaccines

Cognition posts positive topline Phase 2 results in AD

FDA clears BriaCell pivotal study in breast cancer

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

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

Talaris Therapeutics to merge with Tourmaline Bio

FDA lifts clinical hold on DiaMedica ischemic stroke trial

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