Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

Developments

Zucara receives IND clearance for Phase 2 trial of ZT-01 for prevention of night-time hypoglycemia

The FDA has cleared Zucara Therapeutics’ IND application for a Phase 2a study of ZT-01 for the prevention of nocturnal hypoglycemia in patients with Type 1 Diabetes (T1D), with first patient dosing set in the third...

April 19, 2023

Developments

SAB Biotherapeutics nabs FDA breakthrough status for Influenza immunotherapy

The FDA granted breakthrough therapy designation for SAB Biotherapeutics’ (NASDAQ:SABS) SAB-176, an investigational therapeutic, for post-exposure prophylaxis for Type A and Type B influenza illness in high-risk...

April 18, 2023

Developments

Hepion to present data on synergistic effects of rencofilstat with anti-PD1 at AACR

Daren Ure, Ph.D., CSO of Hepion Pharmaceuticals (NASDAQ:HEPA) will present an abstract on April 18 highlighting the company’s lead drug candidate, rencofilstat, at the American Association for Cancer Research annual...

April 18, 2023

Developments

Kiora initiates Phase 2 Trial for ocular presentation of autoimmune diseases

Kiora Pharmaceuticals (NASDAQ:KPRX) enrolled the first patient in its Phase 2 trial of KIO-101 in the treatment of the ocular presentations of rheumatoid arthritis and other autoimmune diseases. The multi-center...

April 17, 2023

Developments

FDA approves IntelGenx’s RIZAFILM for acute migraine

The FDA has approved IntelGenx’s (TSX:IGX; OTCQB:IGXT) RIZAFILM VersaFilm 505(b)(2) new drug application for the treatment of acute migraine. RIZAFILM is a proprietary oral thin film formulation of rizatriptan benzoate...

April 17, 2023

Developments

MindMed collaborators post positive Phase 2 data with LSD in MDD

Prof. Matthias Liechti and Dr. Felix Mueller, Mind Medicine’s (NASDAQ:MNMD) collaborators at University Hospital Basel and the University Hospital of Psychiatry, released positive topline data from a double-blind...

April 14, 2023

Developments

FDA clears Candesant’s Brella to reduce excessive underarm sweating

The FDA cleared closely-held Candesant Biomedical’s Brella, the first and only three-minute SweatControl Patch for the reduction of excessive underarm sweating in adults with primary axillary hyperhidrosis. Brella uses...

April 13, 2023

Developments

Tonix expedites fibromyalgia and chronic migraine programs

Tonix Pharmaceuticals (NASDAQ:TNXP) is eliminating the interim analyses in its registration-enabling, confirmatory Phase 3 RESILIENT study of TNX-102 SL for fibromyalgia and its Phase 2 PREVENTION study of TNX-1900 for...

April 13, 2023

Developments

KOL urges offering Profound’s TULSA-PRO to prostate cancer patients as part of informed consent

Y. Mark Hong, M.D., a key opinion leader (KOL) and world recognized urologist, suggests that if physicians aren’t offering or at least talking to their prostate cancer patients about Profound Medical’s (NASDAQ:PROF;...

April 11, 2023

Developments

Cantor eyes next NASH readout for Hepion’s rencofilstat

Cantor Fitzgerald is eagerly awaiting data from Hepion Pharmaceuticals’ (NASDAQ:HEPA) Phase 2 ALTITUDE-NASH liver function trial with its cyclophilin inhibitor, rencofilstat, guided for the second quarter of 2023. “We...

April 11, 2023

Developments

OpSens completes enrollment in SavvyWire study in Europe

OpSens (TSX:OPS; OTCQX:OPSSF) completed enrollment in the SAFE–TAVI clinical study, which is studying left ventricular rapid pacing using SavvyWire in transcatheter aortic valve implantation (TAVI or TAVR) procedures...

April 11, 2023

Developments

Vistagen receives new European patent for AV-101

The European Patent Office granted Vistagen (NASDAQ:VTGN) a patent for AV-101, its oral NMDAR (N-methyl-D-aspartate receptor) glycine site antagonist, a potential new oral treatment alternative for multiple CNS...

April 6, 2023

Developments

Miromatrix, CareDx in pact for bioengineered organs in human transplant

Miromatrix Medical (NASDAQ:MIRO) and CareDx (NASDAQ:CDNA) entered an exclusive partnership aimed at advancing the next wave of innovation using fully transplantable human bioengineered organs. CareDx will develop an...

April 5, 2023

Developments

PharmaJet to present immune response DNA vaccine data

Closely held PharmaJet will present results of a comprehensive review of published scientific literature comparing data associated with various DNA vaccine delivery methods at the World Vaccine Congress 2023 on April 5...

April 4, 2023

Developments

Eckert & Ziegler to supply POINT Biopharma with Actinium-225

A subsidiary of POINT Biopharma Global (NASDAQ:PNT) signed an agreement for the supply of Actinium-225 (non-carrier-added Ac-225) from Eckert & Ziegler Strahlen EUZ (ETR) of Germany for POINT’s pipeline of next...

April 4, 2023

Developments

PharmaJet partner seeks EUA in India for needle-free Omicron booster

PharmaJet partner, Gennova Biopharmaceuticals, filed data for its mRNA-based Omicron specific COVID-19 booster shot for emergency use authorization (EUA) to the office of the Drug Controller General of India. The...

April 3, 2023

Developments

Tonix presents positive Phase 3 data in fibromyalgia

Tonix Pharmaceuticals (NASDAQ:TNXP) presented a poster at the 5th International Congress on Controversies in Fibromyalgia in Vienna that its TNX-102 SL met its pre-specified primary endpoint in the Phase 3 RELIEF trial...

March 30, 2023

Developments

Bolt posts positive Phase 1 data in HER2-expressing tumors

Bolt Biotherapeutics (NASDAQ:BOLT) reported positive topline data from its recently completed dose-escalation study of BDC-1001 in HER2-expressing solid tumors that support advancing into two Phase 2 studies. Topline...

March 30, 2023

Developments

Cognition presents proteomic biomarker data in Alzheimer’s

Cognition Therapeutics (NASDAQ:CGTX) presented results of a meta-analysis from the first cohort of 24 participants in the Phase 2 SHINE trial and the complete dataset from the Phase 1b SPARC studies in adults with mild...

March 28, 2023

Developments

NeuroSense, Mass General to collaborate on PrimeC in ALS

NeuroSense Therapeutics (NASDAQ:NRSN) signed a collaboration agreement with Dr. Ghazaleh Sadri-Vakili, Ph.D., and Massachusetts General Hospital’s NeuroEpigenetics lab to explore the neurotherapeutic effects of...

March 27, 2023

Developments

EyePoint completes enrollment in Phase 2 wet AMD trial

EyePoint Pharmaceuticals (NASDAQ:EYPT) completed enrollment in the Phase 2 “Durasert and Vorolanib in Ophthalmology 2” (DAVIO 2) clinical trial evaluating EYP-1901 as a potential six-month maintenance...

March 27, 2023

Developments

Vistagen posts positive Phase 3 open-label study of fasedienol in SAD

Vistagen (NASDAQ:VTGN) reported positive data from its Phase 3 open-label study designed to evaluate the safety and tolerability of multiple, as-needed intranasal administrations of fasedienol (PH94B) over time in...

March 22, 2023

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