Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

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

Developments

NeuroSense reports positive biomarker study in Alzheimer’s

NeuroSense Therapeutics (NASDAQ:NRSN) reported positive results from a biomarker study conducted to evaluate the potential of CogniC, NeuroSense’s combination drug for the treatment of Alzheimer’s disease...

June 30, 2022

Developments

Domain Therapeutics receives multimillion-dollar milestone from Merck

Domain Therapeutics, which operates in France and Canada, obtained a single-digit multimillion-dollar milestone payment from Merck as part of a €240 million collaboration and license partnership signed in 2017. Drug...

June 30, 2022

Developments

Palisade Bio initiates Phase 3 study for postoperative return of bowel function

Palisade Bio (NASDAQ:PALI) initiated a Phase 3 study evaluating LB1148 to accelerate the return of bowel function in adult patients undergoing gastrointestinal surgery. The first clinical site in the U.S. is now open...

June 29, 2022

Developments

ENDRA receives 28th U.S. patent for TAEUS system

The United States Patent and Trademark Office has issued a new ENDRA Life Sciences (NASDAQ:NDRA) patent to protect its TAEUS’ radiofrequency (RF) applicator for optimizing the delivery of RF energy to tissue. The...

June 28, 2022

Developments

NeuroSense posts positive results from stage 3 ALS biomarker study

NeuroSense Therapeutics (NASDAQ:NRSN) reported positive results from stage 3 of its biomarker study conducted in collaboration with Massachusetts General Hospital to evaluate PrimeC, NeuroSense’s lead combination...

June 27, 2022

Developments

Zucara Therapeutics reports positive results from Phase 1b trial in T1D

Closely held Zucara Therapeutics reported that its Phase 1b proof-of-concept trial demonstrated ZT-01’s ability to restore glucagon release in people with Type 1 diabetes. Data from 18 subjects that completed all three...

June 22, 2022

Developments

Hepion receives FDA orphan drug designation for rencofilstat in HCC

The FDA granted orphan drug designation to Hepion Pharmaceuticals’ (NASDAQ:HEPA) drug candidate, rencofilstat, a liver-targeting, orally administered, novel cyclophilin inhibitor, for the treatment of hepatocellular...

June 20, 2022

Developments

FDA clears Rhythm Pharma’s IMCIVREE in Bardet-Biedl Syndrome

The FDA has approved Rhythm Pharmaceuticals’ (NASDAQ:RYTM) supplemental NDA for IMCIVREE (setmelanotide) for patients with Bardet-Biedl syndrome (BBS). IMCIVREE is indicated for chronic weight management in adult and...

June 17, 2022

Developments

Hepion to present 5 posters at EASL International Liver Congress 2022

Hepion Pharmaceuticals (NASDAQ:HEPA) said five abstracts have been accepted for poster presentations at the European Association for the Study of the Liver (EASL) International Liver Congress taking place June 22...

June 15, 2022

Developments

Rhythm Pharma presents setmelanotide data at ENDO 2022

Rhythm Pharmaceuticals (NASDAQ:RYTM) and its collaborators presented new data at the Endocrine Society annual meeting from the company’s long-term extension trial with setmelanotide, which show continued body mass...

June 13, 2022

Developments

LENSAR receives FDA clearance of ALLY Adaptive Cataract Treatment System

The FDA cleared LENSAR’s (NASDAQ:LNSR) next-generation ALLY Adaptive Cataract Treatment System to enable cataract surgeons to complete the femtosecond-laser-assisted cataract surgery procedure seamlessly in a single...

June 13, 2022

Developments

Tonix Pharma TNX-1500 data presented at American Transplant Congress

Faculty at the Center for Transplantation Sciences, Massachusetts General Hospital, presented data at the 2022 American Transplant Congress about Tonix Pharmaceuticals’ (NASDAQ:TNXP) TNX-1500 product candidate in...

June 9, 2022

Developments

PharmaJet sponsor study published in The Lancet

A Phase 3 clinical study sponsored by PharmaJet’s partner, Zydus Lifesciences, featuring ZyCoV-D, the world’s first plasmid-DNA vaccine approved for use in humans and delivered by the PharmaJet Tropis Intradermal needle...

June 8, 2022

Developments

Qualigen acquires majority stake in NanoSynex

Qualigen Therapeutics (NASDAQ:QLGN) completed the acquisition of a majority stake in NanoSynex, an Israeli-based developer of next generation diagnostics technology. In a statement, Michael Poirier, chairman and CEO of...

June 2, 2022

Developments

NeuroSense enrolls first patient in Phase 2b ALS Trial with PrimeC

NeuroSense Therapeutics (NASDAQ:NRSN) enrolled the first patient in its Phase 2b PARADIGM trial for its lead drug candidate, PrimeC, for the treatment of amyotrophic lateral sclerosis (ALS). PARADIGM will enroll 69...

June 1, 2022

Developments

Hepion highlights upcoming Phase 2 rencofilstat trials at NASH Congress

Todd Hobbs, M.D. and CMO of Hepion Pharmaceuticals (NASDAQ:HEPA), gave a clinical presentation entitled, “Rencofilstat (CRV431): A liver-targeting drug candidate for NASH and HCC” at the Global NASH Congress...

May 27, 2022

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