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Regulatory

VGK

The European Central Bank (ECB) has decided to leave the deposit rate unchanged at 4.0%.

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October 26, 2023 | 12:26 pm

NVNO

enVVeno Medical Corporation (NASDAQ:NVNO) reported Q3 2023 financial results, ending the quarter with $25.7M in cash and investments. The company achieved full enrollment for its VenoValve U.S. pivotal trial and plans to expedite the development of enVVe, a transcatheter replacement venous valve. The company's cash burn for the quarter was $4.1M, in line with previous guidance. The company also closed a $28M private placement, which is expected to fund the company through several significant milestones.

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October 26, 2023 | 12:24 pm

RNAZ

TransCode Therapeutics, Inc. (NASDAQ:RNAZ) announced improved survival in murine models bearing human glioblastoma multiforme (GBM) tumors treated with its lead therapeutic candidate, TTX-MC138. The study showed that mice treated with TTX-MC138 survived significantly longer than those in the control group. TransCode believes that TTX-MC138 could be an alternative treatment in cases where resistance to standard-of-care chemotherapy has occurred. The company is enrolling patients in a first-in-human clinical trial with TTX-MC138 in patients with advanced solid cancers.

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October 26, 2023 | 12:20 pm

BIVI

BioVie Inc. (NASDAQ:BIVI) has announced that clinical safety data from its Phase 2 study on BIV201, a drug for the treatment of advanced liver disease and neurological disorders, will be presented at The American Association for the Study of Liver Diseases (AASLD) - The Liver Meeting® 2023. The details of the presented data and conclusions will be announced once the presentations are made public at the conference.

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October 26, 2023 | 12:19 pm

AMRN

Amarin Corporation (NASDAQ:AMRN) announced that new research from the REDUCE-IT cardiovascular outcomes trial on the effects of VASCEPA/VAZKEPA in specific patient subgroups has been accepted for presentation at the American Heart Association (AHA) Scientific Sessions 2023. The research includes a presentation on the reduction in first and total CV events following treatment with VASCEPA/VAZKEPA in a high-risk patient subgroup with a history of Metabolic Syndrome but without diabetes.

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October 26, 2023 | 12:16 pm

NKGN

NKGen Biotech Inc. (NASDAQ:NKGN) presented Phase I trial data on its investigational NK cell therapy, SNK01, for Alzheimer's disease at the Clinical Trials on Alzheimer's Disease Annual Meeting. The data showed that 90% of patients demonstrated improvement or maintained stable cognitive function following 11 weeks of treatment. SNK01 appears to cross the blood-brain barrier to reduce Cerebrospinal Fluid Aβ42/40 and pTau181 levels and neuroinflammation. The company has received U.S. IND clearance for a Phase I/IIa study in patients with moderate stage Alzheimer's disease.

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October 26, 2023 | 12:12 pm

EWTX

Edgewise Therapeutics, Inc. (NASDAQ:EWTX) has announced the expansion of their clinical development program of EDG-5506, a drug designed to prevent muscle damage in dystrophinopathies, including Duchenne. The company is initiating a new Phase 2 trial (FOX) for boys with Duchenne who have been previously treated with gene therapy. They are also continuing dose escalation and expanding enrollment in their Phase 2 LYNX trial. The company expects to report Phase 2 interim data in the first half of 2024, with the Phase 3 dose identified.

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October 26, 2023 | 12:10 pm

AYTU

Aytu BioPharma has received approval from the U.S. Food & Drug Administration for the Prior Approval Supplement (PAS) of Cotempla XR-ODT, enabling the transfer of its manufacturing to a third-party manufacturer. This follows a similar approval for Adzenys XR-ODT in April 2023. The company expects to report enhanced ADHD product margins following the completion of the manufacturing transfer. The initial ramp-up of contract manufacturing of Adzenys and Cotempla is expected to begin in late 2023, with margin improvements expected from 2024.

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October 26, 2023 | 12:06 pm

CYBN

Cybin has been granted a European patent for its proprietary deuterated programs. This patent will provide protection for the company's intellectual property in Europe.

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October 26, 2023 | 11:33 am

ALT

The FDA has granted Fast Track Designation to Altimmune for Pemvidutide, a treatment for Non-Alcoholic Steatohepatitis (NASH). This designation will expedite the development and review process for the drug.

Portfolio Pulse from Benzinga Newsdesk

October 26, 2023 | 11:32 am