Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

Developments

Ondine receives TAYYABA HASAN IMPACT AWARD at IPA World Congress

Ondine Biomedical (LON:OBI) was awarded the TAYYABA HASAN IMPACT AWARD at the 18th World Congress of International Photodynamic Association (IPA) in Finland for demonstrating “exceptional perseverance and clinical...

July 17, 2023

Developments

Athira presents biomarker data in Alzheimer’s

Athira Pharma (NASDAQ:ATHA) is presenting new data supporting its pipeline of small molecule therapeutic candidates designed to enhance the HGF/MET neurotrophic system at the Alzheimer’s Association International...

July 17, 2023

Developments

First Wave BioPharma unlikely to hit primary endpoint in CF

First Wave BioPharma’s (NASDAQ:FWBI) is unlikely to achieve the primary endpoint based on preliminary results from the Phase 2 SPAN study for the treatment of exocrine pancreatic insufficiency in patients with cystic...

July 13, 2023

Developments

FDA clears Tryp’s IND for Phase 2a IBS study at MGH

The FDA completed a review of Tryp Therapeutics’ (CSE:TRYP; OTCQB:TRYPF) investigational new drug application, permitting the company to proceed with a Phase 2a clinical trial at Massachusetts General Hospital (MGH)...

July 13, 2023

Developments

Theratechnologies reduces R&D headcount on sales shortfall

With sales falling short of expectations, Theratechnologies (TSX:TH; NASDAQ:THTX) is reducing its R&D head count. Second quarter revenue fell 8.9% to $17.5-million (U.S.) from $19.3-million a year ago. “Second...

July 12, 2023

Developments

Synlogic gets FDA fast track to treat phenylketonuria

The FDA granted fast track designation to Synlogic’s (NASDAQ:SYBX) labafenogene marselecobac (previously known as SYNB1934) for the treatment of phenylketonuria (PKU). Labafenogene marselecobac also has received rare...

July 11, 2023

Developments

Anixa Biosciences receives Canadian patent for CAR-T cancer therapy technology

The Canadian Intellectual Property Office issued a patent covering Anixa Biosciences’ (NASDAQ:ANIX) novel chimeric antigen receptor T-cell (CAR-T) cancer treatment technology, which has been licensed from The Wistar...

July 11, 2023

Developments

MAIA updates survival data from Phase 2 NSCLC trial

MAIA Biotechnology (NYSEA: MAIA) updated preliminary survival data in the Part A safety lead-in of its ongoing THIO-101 phase 2 trial, evaluating THIO in sequential combination with cemiplimab in patients with advanced...

July 10, 2023

Developments

ZyVersa receives European patent for VAR 200 in kidney disease

The European Patent Office granted a patent covering ZyVersa Therapeutics’ (NASDAQ:ZVSA) Phase 2a-ready Cholesterol Efflux Mediator VAR 200 for use in diabetic nephropathy/diabetic kidney disease. “Approval of this...

July 7, 2023

Developments

Vaxart posts positive Phase 2 data from bivalent norovirus vaccine

Vaxart (NASDAQ:VXRT) reported positive topline data from the dose-ranging Phase 2 clinical trial of its oral pill bivalent norovirus vaccine candidate. Norovirus is the leading cause of acute viral gastroenteritis in...

July 7, 2023

Developments

Revive oral Bucillamine flunks Phase 3 COVID-19 study

Revive Therapeutics (OTCQB:RVVTF; CSE:RVV) reported that its Phase 3 clinical study evaluating the safety and efficacy of oral Bucillamine in patients with mild- to-moderate COVID-19 did not achieve statistical...

July 6, 2023

Developments

ASLAN posts positive Phase 2b results in atopic dermatitis

ASLAN Pharmaceuticals (NASDAQ:ASLN) reported positive topline data from its Phase 2b dose-ranging study of eblasakimab in adult patients with moderate-to-severe atopic dermatitis, which is often referred to as eczema...

July 6, 2023

Developments

FDA clears protocol for Acasti Phase 3 trial in aSAH

Acasti Pharma (NASDAQ:ACST) and the FDA agreed on the protocol of a Phase 3 trial of GTX-104 in patients with aneurysmal subarachnoid hemorrhage (aSAH), a rare disease with bleeding over the surface of the brain in the...

July 5, 2023

Developments

Palisade Bio completes enrollment in dose optimization study

Palisade Bio (NASDAQ:PALI) completed patient enrollment in its dose optimization study of LB1148, a broad-spectrum serine protease inhibitor that acts to neutralize digestive enzymes, potentially reducing intestinal...

July 5, 2023

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

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