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Regulatory

V

Visa (NYSE:V) is expanding its stablecoin settlement capabilities to the Solana blockchain and is working with merchant acquirers Worldpay and Nuvei. The company has already moved millions of USDC between its partners over the Solana and Ethereum blockchain networks to settle fiat-denominated payments. This move is expected to improve the speed of cross-border settlement and provide a modern option for clients to send or receive funds. Visa's work with Worldpay and Nuvei represents a significant stride in embracing the innovative potential of digital currencies.

Portfolio Pulse from Happy Mohamed

September 05, 2023 | 12:07 pm

GH

Guardant Health has received regulatory approval in Japan for its Guardant360 CDx as a companion diagnostic to ENHERTU for the treatment of non-small cell lung cancer patients with HER2 mutations.

Portfolio Pulse from Benzinga Newsdesk

September 05, 2023 | 12:07 pm

ICCM

IceCure Medical Ltd. (NASDAQ:ICCM) has received regulatory approval from the Brazilian Health Regulatory Agency for its ProSense Cryoablation System. The company expects $6.6 million in sales in the Brazilian market over the next five years. The ProSense system is a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal. The approval is expected to translate into near-term revenues due to strong demand in Brazil, which has an urgent need for minimally invasive cancer treatments.

Portfolio Pulse from Happy Mohamed

September 05, 2023 | 12:06 pm

XFOR

X4 Pharmaceuticals has submitted a marketing application to the FDA for the approval of Mavorixafor, a once-daily oral medication for individuals aged 12 and older with WHIM syndrome, a rare immunodeficiency.

Portfolio Pulse from Benzinga Newsdesk

September 05, 2023 | 12:04 pm

INMB

INmune Bio, Inc. (NASDAQ:INMB) has received approval from the U.K. Medicines and Healthcare Products Regulatory Agency to expand its ongoing Phase 2 trial of XPro in patients with early Alzheimer's disease to the U.K. The trial is also enrolling patients in Australia and Canada. In a prior Phase I trial, INmune Bio met all primary and secondary endpoints, with patients showing significant reductions in neuroinflammation and improvements in axonal integrity and synaptic function.

Portfolio Pulse from Happy Mohamed

September 05, 2023 | 12:03 pm

ENVB

Enveric Biosciences (NASDAQ:ENVB) has been granted a new U.S. patent for C4-Carboxylic Acid-Substituted Tryptamine Derivatives, which includes EB-373, a new chemical entity psilocin prodrug. The patent provides Enveric with intellectual property rights for compositions and methods for tryptamine-derived prodrugs. This strengthens Enveric's intellectual property portfolio and distinguishes its tryptamine-based prodrugs from similar compounds being developed for the treatment of mental health disorders.

Portfolio Pulse from Happy Mohamed

September 05, 2023 | 12:03 pm

WVE

Wave Life Sciences has submitted its first clinical trial application for WVE-006 in Alpha-1 Antitrypsin Deficiency. The company expects to initiate dosing in 4Q 2023 and deliver AAT protein restoration data in 2024.

Portfolio Pulse from Benzinga Newsdesk

September 05, 2023 | 11:32 am

CYBN

Cybin Inc. (NYSE:CYBN), a clinical-stage biopharmaceutical company, has been granted a US patent for deuterated tryptamine compounds and pharmaceutical compositions thereof, with exclusivity until 2041. The patent covers deuterated 5-methoxy-dimethyltryptamine analogs in the company's pre-clinical deuterated tryptamine portfolio and strengthens Cybin's position in the development of potential therapeutics for the treatment of mental health conditions.

Portfolio Pulse from Benzinga Newsdesk

September 05, 2023 | 11:31 am

BCDA

Biocardia has announced interim efficacy results for its Phase 3 CardiAMP Cell Therapy Heart Failure Trial. The first-tier, all-cause death at 12 months was 5.6%, compared to 5.3% in the control group, a difference that was not statistically significant (P = 0.42).

Portfolio Pulse from Benzinga Newsdesk

September 05, 2023 | 11:20 am

HSDT

Helius Medical Technologies has received formal notice of its compliance with all applicable Nasdaq listing criteria.

Portfolio Pulse from Benzinga Newsdesk

September 05, 2023 | 11:14 am