Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

Developments

OpSens SavvyWire in first U.S. procedure

Dr. Philippe Genereux, director of the Structural Heart Program at Morristown Medical Center in New Jersey, and his team, performed the first use of OpSens’ (TSX:OPS; OTCQX:OPSSF) SavvyWire in a transcatheter aortic...

September 23, 2022

Developments

Novo Nordisk Foundation investing $200-million for first quantum computer for life sciences research

The Novo Nordisk Foundation has awarded a grant of $200-million to establish the first full-scale quantum computer for the development of new medicines as well as providing new insights into climate change and the green...

September 21, 2022

Developments

MindMed collaborators begin dosing in Phase 1 trial of MDMA-like substances

The first patient has been dosed in a Phase 1 investigator-initiated study led by MindMed (NASDAQ:MNMD; NEO:MMED) collaborator Prof. Dr. Matthias Liechti at University Hospital Basel to evaluate the effects of MDMA-like...

September 20, 2022

Developments

Zucara secures Phase 2 funding for hypoglycemia trial

Closely held Zucara Therapeutics’ positive proof-of-concept data has enabled the company to secure continued funding for a Phase 2 clinical study of ZT-01 to prevent hypoglycemia in people with Type 1 diabetes, which is...

September 19, 2022

Developments

Profound Medical realigns commercial organization to support continued growth

Profound Medical (NASDAQ:PROF; TSX:PRN) has changed its management team and structure to further position the company for continued sales success and global growth. Abbey Goodman and Hartmut Warnken have been appointed...

September 15, 2022

Developments

FDA clears OpSens SavvyWire for transcatheter aortic valve replacement

OpSens (TSX:OPS; OTCQX:OPSSF) received 510(k) regulatory clearance from the FDA for SavvyWire, its new guidewire for transcatheter aortic valve replacement procedures, or TAVR. In a statement, Louis Laflamme, president...

September 15, 2022

Developments

Sigyn Therapeutics to pursue first-In-human studies in end-stage renal disease

Sigyn Therapeutics (OTCQB:SIGY) plans to pursue first-in-human feasibility studies of its Sigyn Therapy in end-stage renal disease (ESRD) patients suffering from excess inflammation and/or endotoxemia. Sigyn Therapy is...

September 14, 2022

Developments

Hepion collaborators to present new rencofilstat findings in alcohol-related liver disease

Hepion Pharmaceuticals’ (NASDAQ:HEPA) collaborators from London’s Institute of Hepatology will present new findings on Hepion’s cyclophilin inhibitor, rencofilstat, in an awarded oral presentation at the...

September 14, 2022

Developments

Annovis Bio receives additional U.S. patents

Annovis Bio (NYSE:ANVS) announced the publication of three granted U.S. patents that cover methods of treating amyloid lateral sclerosis, Huntington’s disease, and prion diseases by administering buntanetap. The...

September 13, 2022

Developments

Fresh Tracks starts Phase 1 MAD study of DYRK1A inhibitor

Fresh Tracks Therapeutics (NASDAQ:FRTX), formerly Brickell Biotech, initiated the multiple ascending dose (MAD) portion of the ongoing Phase 1 clinical trial in Canada, evaluating FRTX-02, its lead drug candidate, in...

September 13, 2022

Developments

Hepion initiates dosing in Phase 2 ALTITUDE-NASH liver function trial

Hepion Pharmaceuticals (NASDAQ:HEPA) dosed the first stage 3 (F3) NASH subject with rencofilstat in a Phase 2 clinical trial designed to measure hepatic function. The trial is being conducted in collaboration with...

September 12, 2022

Developments

POINT Biopharma presents early Phase 3 prostate cancer data

POINT Biopharma Global (NASDAQ:PNT) published a poster at ESMO Congress 2022 containing updated efficacy and safety data from the 27-patient safety and dosimetry lead-in cohort for the company’s Phase 3 SPLASH...

September 12, 2022

Developments

Vistagen continuing second Phase 3 trial in social anxiety disorder

Vistagen Therapeutics (NASDAQ:VTGN) announced completion of an interim analysis of PALISADE-2, its second Phase 3 clinical trial assessing drug candidate, PH94B, as an acute treatment of anxiety in adults with social...

September 8, 2022

Developments

Enrollment reaches halfway in IntelGenx Phase 2a Montelukast VersaFilm AD trial

Patient enrollment in the IntelGenx (TSX:IGX; OTCQB:IGXT) ongoing Montelukast VersaFilm Phase 2a BUENA clinical trial in patients with mild-to-moderate Alzheimer’s disease (AD) has reached the halfway mark. This...

September 8, 2022

Developments

VoxNeuro, Boston U collaborating in concussion, AD studies

Closely held VoxNeuro, a software-as-a-medical-device brain (SaMD) health company, is collaborating with Boston University to launch two studies that will evaluate the company’s cognitive health assessment platform in...

September 7, 2022

Developments

Brickell Biotech changes name to Fresh Tracks Therapeutics

Brickell Biotech (NASDAQ:BBI) changed its name to Fresh Tracks Therapeutics, with a new stock symbol, FRTX, effective at the NASDAQ opening on Sept. 8, 2022. The unveiling of the company’s rebranding reinforces...

September 7, 2022

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

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