Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

Developments

Europe clears Rhythm’s IMCIVREE for obesity and hunger in BBS

The European Commission has expanded the marketing authorization for Rhythm Pharmaceuticals’ (NASDAQ:RYTM) IMCIVREE (setmelanotide) to include the treatment of obesity and control of hunger associated with genetically...

September 7, 2022

Developments

Hepion Pharmaceuticals initiates Phase 2b ASCEND-NASH trial

Hepion Pharmaceuticals (NASDAQ:HEPA) screened the first subject in its ASCEND-NASH clinical trial being conducted at up to 121 sites in seven countries, including 85 sites in the U.S. The Phase 2b, randomized, multi...

August 31, 2022

Developments

HCW ups Calithera to buy on steady progress of clinical programs

H.C. Wainwright upgraded Calithera Biosciences (NASDAQ:CALA) to “buy” from “neutral” with a 12-month price target of $8, citing two ongoing clinical development programs that are expected to provide data updates in the...

August 29, 2022

Developments

First patient dosed in MindMed GAD study with LSD

MindMed (NASDAQ:MNMD; NEO:MMED) announced first patient dosing in its Phase 2b dose-optimization trial of MM-120, a pharmaceutically optimized form of lysergic acid diethylamide (LSD), for the treatment of generalized...

August 29, 2022

Developments

First patient dosed in Annovis Bio Phase 3 trial in early PD

The first patient has been dosed in Annovis Bio’s (NYSE:ANVS) Phase 3 clinical trial evaluating its buntanetap in early Parkinson’s disease (PD). The Phase 3 trial will enroll 450 early PD patients to be treated...

August 24, 2022

Developments

Tonix begins Phase 2 trial of TNX-102 SL in Long COVID

Tonix Pharmaceuticals (NASDAQ:TNXP) enrolled the first participant in the Phase 2 PREVAIL study of TNX-102 SL as a potential treatment for a subset of patients with Long COVID syndrome whose symptoms overlap with...

August 22, 2022

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

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