Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

Developments

Morphic posts positive cohort data in ulcerative colitis

Morphic Therapeutic (NASDAQ:MORF) reported positive topline data from the main cohort of the open-label EMERALD-1 Phase 2a study of MORF-057, an oral small molecule inhibitor of the α4β7 integrin, in adults with...

April 25, 2023

Developments

Lyra restarts Phase 3 trial in chronic rhinosinusitis

Lyra Therapeutics (NASDAQ:LYRA) resumed screening and enrollment in ENLIGHTEN II, its second Phase 3 clinical trial of LYR-210 in patients with chronic rhinosinusitis (CRS). LYR-210 is a bioresorbable nasal implant...

April 25, 2023

Developments

Blue Water Vaccines changes name to Blue Water Biotech

Blue Water Vaccines changed its corporate name to Blue Water Biotech, following its recent acquisition of ENTADFI, an FDA-approved treatment for benign prostatic hyperplasia, which has begun Blue Water’s transition into...

April 25, 2023

Developments

Lantheus, POINT get FDA fast track for mCRPC

The FDA granted Lantheus Holdings (NASDAQ:LNTH) and POINT Biopharma (NASDAQ:PNT) fast track designation for 177Lu-PNT2002 for the treatment of metastatic castration resistant prostate cancer (mCRPC). PNT2002 is an...

April 24, 2023

Developments

Visus posts positive Phase 3 data to treat presbyopia

Visus Therapeutics reported positive topline results from its Phase 3 pivotal BRIO-I trial, demonstrating highly statistically significant improvements in near and distance binocular visual acuity at multiple...

April 20, 2023

Developments

MAIA Biotechnology reports preliminary Phase 2 survival data for NSCLC

MAIA Biotechnology (NYSEA:MAIA) announced preliminary survival data in the Part A safety lead-in of its ongoing Phase 2 trial, THIO-101, evaluating THIO in patients with advanced non-small cell lung cancer (NSCLC). The...

April 20, 2023

Developments

Cali initiates Phase 3 studies to decrease post-operative pain; cut opioid use

Cali Biosciences initiated Phase 3 studies of its core product, CPL-01, a long-acting ropivacaine, with dosing in hernia patients already begun and dosing in bunion patients scheduled to start next month. CPL-01 is an...

April 19, 2023

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

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