Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

Developments

FDA slaps clinical hold on Pharvaris trials of PHA121 in U.S.

The FDA verbally informed Pharvaris (NASDAQ:PHVS) that, based on its review of nonclinical data, it is placing a clinical hold on clinical trials of PHA121 in the U.S. under two Pharvaris IND applications for the...

August 22, 2022

Developments

Palisade Bio doses first patient in Phase 3 post-op return of bowel function trial

Palisade Bio (NASDAQ:PALI) dosed the first patient in its Phase 3 study evaluating LB1148 to accelerate the return of bowel function in adult patients undergoing gastrointestinal surgery. “With what we believe to be a...

August 17, 2022

Developments

Blue Water to explore development of VLP monkeypox vaccine

Blue Water Vaccines (NASDAQ:BWV) plans to explore the potential to develop a novel monkeypox vaccine using its norovirus shell and protrusion virus-like particle (VLP) platform. The company’s shell and protrusion...

August 17, 2022

Developments

First patients treated with LENSAR’s ALLY cataract treatment

The first commercial cases of the LENSAR (NASDAQ:LNSR) ALLY Adaptive Cataract Treatment System were performed by Robert Weinstock, M.D. at The Eye Institute of West Florida. Dr. Weinstock performed 15 laser-assisted...

August 16, 2022

Developments

Rani Therapeutics posts positive Phase 1 results in osteoporosis

Rani Therapeutics (NASDAQ:RANI) reported positive topline results from the single-ascending dose portion of its Phase 1 clinical study of RT-102, a RaniPill capsule containing a proprietary formulation of human...

August 11, 2022

Developments

SAB Biotherapeutics expanding pipeline for C. diff as DoD contract winds down

SAB Biotherapeutics (NASDAQ:SABS) will be discontinuing its work with the U.S. Department of Defense (DoD) under a prototype research and development agreement. The agreement, which was awarded in the summer of 2019...

August 10, 2022

Developments

Blue Water Vaccines in $10-million private placement

Blue Water Vaccines (NASDAQ:BWV) entered into definitive agreements with several healthcare-focused institutional investors for the purchase of 3,683,280 common shares of the company in a private placement priced at-the...

August 9, 2022

Developments

Sigyn Therapeutics to begin trading on OTCQB today

Shares of Sigyn Therapeutics (OTCQB:SIGY) will begin trading on the OTCQB Venture Exchange at the market open today. The company’s securities, which previously traded on the OTC Pink Market, will continue to trade...

August 3, 2022

Developments

PharmaJet partner, Scancell, to use needle-free delivery with melanoma vaccine

PharmaJet partner, Scancell, will include PharmaJet’s needle-free delivery system in a Phase 2 clinical study of a vaccine for treatment of patients with advanced melanoma. Scancell’s immunotherapy platform uses the...

August 2, 2022

Developments

Qualigen posts positive readout in triple negative breast cancer in vivo model

Qualigen Therapeutics (NASDAQ:QLGN) completed its in vivo efficacy analysis of QN-247 in solid tumors, with data demonstrating robust efficacy and no safety signals in a triple negative breast cancer (TNBC) model...

August 2, 2022

Developments

NeuroSense, NeuraLight in pact to detect ALS oculometric biomarkers

NeuroSense Therapeutics (NASDAQ:NRSN) and closely-held NeuraLight are collaborating to advance the science of digital biomarkers in the detection and monitoring of neurological diseases, including amyotrophic lateral...

July 28, 2022

Developments

NervGen NVG-291-R posts significant preclinical functional repair from stroke

The University of Cincinnati and Case Western Reserve University published a pioneering preclinical study in the peer-reviewed scientific journal, Cell Reports, demonstrating that NervGen Pharma‘s (TSXV:NGEN;...

July 28, 2022

Developments

Palisade Bio screens first patient in Phase 3 bowel function trial

Palisade Bio (NASDAQ:PALI) screened the first patient in its Phase 3 study evaluating LB1148 to accelerate the return of bowel function in adult patients undergoing gastrointestinal surgery. “With the first U.S...

July 27, 2022

Developments

180 Life Sciences, U of Oxford to study post operative delirium

A team led by researchers at University of Oxford have been awarded a grant from the National Institute for Health and Care Research (NIHR) in the U.K. to conduct a feasibility trial to investigate whether anti-tumor...

July 27, 2022

Developments

VistaGen fails Phase 3 trial in social anxiety disorder

VistaGen Therapeutics’ (NASDAQ:VTGN) topline results from its PALISADE-1 Phase 3 clinical trial of PH94B for the acute treatment of anxiety in adults with social anxiety disorder did not achieve its primary endpoint, as...

July 22, 2022

Developments

FDA clears Neuronetics TMS therapy for Anxious Depression

The FDA cleared a new indication for Neuronetics’ (NASDAQ:STIM) transcranial magnetic stimulation (TMS) system – NeuroStar Advanced Therapy for Mental Health – to treat anxiety symptoms for adult patients who suffer...

July 19, 2022

Developments

NICE recommends Rhythm’s IMCIVREE for treating obesity, controlling hunger

England’s National Institute for Health and Care Excellence (NICE) issued guidance that recommends Rhythm Pharmaceuticals’ (NASDAQ:RYTM) IMCIVREE as an option for treating obesity and controlling hunger caused by pro...

July 18, 2022

Developments

Soricimed Biopharma receives additional investment from NBIF

Closely held Soricimed Biopharma closed a $200,000 investment from the New Brunswick Investment Fund (NBIF) to continue developing its investigational SOR-13 oncology drug candidate. “We are grateful to NBIF for their...

July 13, 2022

Developments

Rhythm Pharma posts positive Phase 2 data in hypothalamic obesity

Rhythm Pharmaceuticals (NASDAQ:RYTM) reported positive interim results from a Phase 2 clinical trial evaluating setmelanotide, its MC4R agonist, for the treatment of severe obesity and hyperphagia in people living with...

July 12, 2022

Developments

Annovis Bio gets FDA okay for Phase 3 Parkinson’s trial

Annovis Bio, Inc. (NYSE:ANVS) received notice from the FDA that a Phase 3 clinical study with buntanetap in early Parkinson’s patients may proceed. The FDA accepted the final protocol and the clinical development...

July 7, 2022

Developments

Precigen to sell non-healthcare unit Trans Ova Genetics to URUS

Precigen (NASDAQ:PGEN) entered into a definitive agreement to sell its wholly-owned non-healthcare subsidiary, Trans Ova Genetics, an animal reproductive technologies company, to URUS, a holding company with cooperative...

July 5, 2022

Developments

FDA clears Titan Pharma IND for nalmefene implant

The FDA has cleared Titan Pharmaceuticals’ (NASDAQ:TTNP) investigational new drug application for a Phase 1 study of its six-month or longer subdermal formulation of nalmefene, an opioid antagonist, intended for the...

July 5, 2022

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