Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

Developments

FDA clears Tonix IND in major depressive disorder

The FDA approved Tonix Pharmaceuticals’ (NASDAQ:TNXP) IND application to support a Phase 2 clinical trial with TNX-601 ER, a once-daily formulation of tianeptine as a potential treatment for major depressive disorder...

October 3, 2022

Developments

VoxNeuro, CAF in study to measure training-related sub-concussive exposure

VoxNeuro, a closely-held software-as-a-medical-device (SaMD) brain health company, has partnered with the Canadian Armed Forces (CAF) to study the cognitive effects following intense military training regimens designed...

September 28, 2022

Developments

atai unit initiates Phase 1 trial for MDMA derivative EMP-01

EmpathBio, a unit of atai Life Sciences (NASDAQ:ATAI), received regulatory and ethics approval to begin enrollment of its Phase 1 study of EMP-01, a 3,4-methylenedioxy-methamphetamine (MDMA) derivative for the treatment...

September 28, 2022

Developments

SAB Biotherapeutics presents new influenza and COVID-19 data

SAB Biotherapeutics (NASDAQ:SABS) presented new data at the Options for Control of Influenza conference in Belfast, showing its fully-human polyclonal antibody platform maintains its efficacy against multiple variants...

September 28, 2022

Developments

Maxim survey finds two-thirds of respondents planning to attend JMP

A survey of 150 people to a recent Maxim Group survey about the upcoming J.P. Morgan Healthcare Conference found that 69% of respondents are planning to attend the conference in person, while 52% would choose in person...

September 26, 2022

Developments

Profound Medical presents durable and stable positive 4-year trends from TACT pivotal trial

An investigator for Profound Medical (NASDAQ:PROF; TSX:PRN) presented four-year follow-up data from the TACT clinical study with Profound’s TULSA-PRO device that continue to demonstrate durable and stable safety and...

September 26, 2022

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

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