Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

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

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

Developments

Confo, AbCellera in GPCR-targeting antibody discovery program

Confo Therapeutics of Belgium entered into a research collaboration with AbCellera Biologics (NASDAQ:ABCL) for the discovery of therapeutic antibody candidates targeting two undisclosed GPCR targets (G protein-coupled...

June 15, 2023

Developments

Blue Water acquires 6 FDA-approve drugs across various indication

Blue Water Biotech (NASDAQ:BWV) signed asset purchase agreements with WraSer and Xspire Pharma to acquire six FDA-approved assets across multiple indications, including cardiology, otic infections, and pain management...

June 14, 2023

Developments

Annovis Bio completes enrollment in Phase 3 Parkinson’s trial

Annovis Bio’s (NYSE:ANVS) Parkinson’s disease (PD) Phase 3 clinical trial of its lead compound, buntanetap, reached full enrollment in a record nine months after it began. Since the first patient was dosed in late...

June 8, 2023

Developments

FibroGen flunks Phase 3 in non-ambulatory DMD

FibroGen’s (NASDAQ: FGEN) Phase 3 LELANTOS-1 placebo-controlled trial of pamrevlumab for the treatment of non-ambulatory patients with Duchenne muscular dystrophy (DMD) on background corticosteroids did not meet the...

June 8, 2023

Developments

Vistagen posts positive Phase 2A study in women with menopausal hot flashes

Vistagen (NASDAQ:VTGN) reported that PH80, one of the company’s five investigational neuroactive nasal sprays, demonstrated statistically significant efficacy versus placebo in an exploratory Phase 2A study for the...

June 7, 2023

Developments

Check-Cap reviewing strategic alternatives

Check-Cap (NASDAQ:CHEK) is exploring strategic alternatives, such as the sale of all or part of the company, licensing, merger or reverse merger, and has retained Ladenburg Thalmann as an advisor to the company. Check...

June 6, 2023

Subscribe