Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

Developments

TC BioPharm begins dosing Phase 2b AML study

TC BioPharm (NASDAQ:TCBP) began dosing the first three patients in its Phase 2b ACHIEVE clinical trial of OmnImmune, an allogeneic unmodified cell therapy focused on treating acute myeloid leukemia (AML). The initial...

November 22, 2022

Developments

Palisade Bio gets FDA fast track for return of bowel function after GI surgery

The FDA granted fast tract designation to Palisade Bio’s (NASDAQ:PALI) LB1148 for the acceleration of time to return of bowel function following surgery. By inhibiting the activity of digestive proteases, the company...

November 22, 2022

Developments

IntelGenx receives FDA PDUFA date for RIZAFILM

The FDA accepted for review IntelGenx’s (TSX:IGX; OTCQB:IGXT) Class 2 response to a 2020 complete response letter for the company’s 505(b)(2) NDA for RIZAFILM VersaFilm for the treatment of acute migraine. The FDA has...

November 22, 2022

Developments

Kiora doses first patient in Phase 1b retinitis pigmentosa trial

Kiora Pharmaceuticals (NASDAQ:KPRX) dosed the first patient in a first-in-human open-label clinical trial for KIO-301, intended to restore vision loss in patients with retinitis pigmentosa, a rare, inherited genetic eye...

November 17, 2022

Developments

Azura posts positive Phase 2b results in meibomian gland dysfunction

Azura Ophthalmics reported positive 3-month efficacy and safety results from its Phase 2b study of AZR-MD-001 0.5% in meibomian gland dysfunction (MGD), a leading cause of dry eye disease and contact lens discomfort...

November 17, 2022

Developments

NeuroSense receives IND clearance for Phase 2b ALS study

The FDA cleared NeuroSense Therapeutics’ (NASDAQ:NRSN) IND for its Phase 2b PARADIGM study with its lead drug candidate, PrimeC, in the treatment of amyotrophic lateral sclerosis (ALS). PARADIGM is currently enrolling...

November 15, 2022

Developments

Raymond James sees high likelihood of CPT-1 reimbursement for Profound’s TULSA-PRO

Analyst Rahul Sarugaser, Ph.D., writes that there is a high likelihood that Profound Medical (NASDAQ:PROF) will receive a category-1 CPT code from the Centers for Medicare and Medical Services when it files an...

November 15, 2022

Developments

Lanier Biotherapeutics receives U.S. patent for IL-25 binding molecules

Lanier Biotherapeutics announced that the United States Patent and Trademark Office has issued U.S. Patent 11,492,397, entitled, “Neutralizing Monoclonal Antibodies to IL-25 and Uses Thereof.” The patent covers...

November 14, 2022

Developments

Lantheus, POINT Biopharma to commercialize PNT2002 & PNT2003

Lantheus Holdings (NASDAQ:LNTH) and POINT Biopharma Global (NASDAQ:PNT) announced a set of strategic collaboration agreements in which Lantheus would license exclusive worldwide rights to POINT’s PNT2002 and PNT2003...

November 14, 2022

Developments

Oramed to commercialize oral insulin in Korea with Medicox

Oramed Pharmaceuticals (NASDAQ, TASE:ORMP) signed an exclusive commercial distribution agreement for the Republic of Korea with Medicox, an emerging biotech company with proven partnerships in the Korea. The agreement...

November 14, 2022

Developments

CytoSorbents appears to validate Sigyn’s therapeutic strategy

CytoSorbents (NASDAQ:CTSO) has received a research grant from a division of the NIH to test the ability of its existing polymers to remove cytokines and lipopolysaccharide (LPS) endotoxin from septic porcine plasma, a...

November 10, 2022

Developments

IntelGenx in feasibility, development agreement for CBD-infused VetaFilm for pets

IntelGenx (TSX:IGX; OTCQB:IGXT) entered into a feasibility study and development agreement with an undisclosed animal health company focused on advancing a VetaFilm-based oral film formulation containing CBD for use in...

November 9, 2022

Developments

Hepion to present rencofilstat’s poly-indication potential at antifibrotic summit

Hepion Pharmaceuticals’ (NASDAQ:HEPA) chief scientific officer, Daren Ure, Ph.D., will present data highlighting the poly-indication potential of the company’s lead drug candidate, rencofilstat, at the upcoming 6th...

November 7, 2022

Developments

Hepion to present 2 posters at upcoming AASLD liver meeting

Hepion Pharmaceuticals (NASDAQ:HEPA) is presenting two poster presentations highlighting its lead drug candidate, rencofilstat, at the Liver Meeting 2022, to be hosted by the American Association for the Study of Liver...

November 2, 2022

Developments

Rhythm to launch Phase 3 hypothalamic obesity trial in early 2023

Rhythm Pharmaceuticals (NASDAQ:RYTM) plans to initiate a Phase 3 clinical trial in acquired hypothalamic obesity in early 2023, following recent discussions with the FDA. The Phase 3 clinical trial will enroll 120...

November 2, 2022

Developments

IntelGenx files for U.S. oral film patent improving cannabinoid onset of action

IntelGenx (TSX:IGX; OTCQB:IGXT) filed a new provisional patent application with the United States Patent and Trademark Office (USPTO) entitled, “Advanced Oral Film Formulations.” The patent application...

November 2, 2022

Developments

Atossa to acquire stake in Dynamic Cell Therapies

Atossa Therapeutics (NASDAQ:ATOS) is acquiring 19.99% of the capital stock of closely-held Dynamic Cell Therapies for $2-million, in addition to $3-million previously paid to Dynamic, “This investment in Dynamic...

November 1, 2022

Developments

Rhythm Pharma gets FDA breakthrough status in hypothalamic obesity

Rhythm Pharmaceuticals’ (NASDAQ:RYTM) setmelanotide received breakthrough therapy designation from the FDA for the treatment of hypothalamic obesity. Hypothalamic obesity is a rare, acquired form of extreme obesity that...

November 1, 2022

Developments

OpSens starts SavvyWire study in Europe

OpSens (TSX:OPS; OTCQX:OPSSF) announced the successful completion of the first cases in a clinical study, named SAFE-TAVI, studying SavvyWire left ventricular rapid pacing in transcatheter aortic valve replacement...

October 26, 2022

Developments

Hepion Pharmaceuticals Phase 2a AMBITION results published

The peer-reviewed journal, Hepatology Communications, has published a paper by Harrison et al. entitled, “Rencofilstat, a cyclophilin inhibitor: A phase 2a, multicenter, single-blind, placebo-controlled study in...

October 26, 2022

Developments

IntelGenx receives FDA GDUFA date for partnered buprenorphine buccal film

IntelGenx’s (TSX:IGX; OTCQB:IGXT) previously undisclosed development candidate, buprenorphine buccal film, for which an abbreviated new drug application (ANDA) has been filed by Chemo Research through its agent and...

October 25, 2022

Developments

PharmaJet gets USAID contract to evaluate needle-free delivery in polio shots

Closely-held PharmaJet received a multi-year, $1.5-million grant from the United States Agency for International Development (USAID) to evaluate the impact of intradermal vaccine administration using the company’s...

October 24, 2022

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