Streetbeat News

Regulatory

PBLA

Panbela Therapeutics, Inc. (NASDAQ:PBLA) has announced the issuance of a new patent in Chile for its product Flynpovi, a fixed dose formulation of eflornithine and sulindac developed in collaboration with Sanofi. The patent, which is valid until 2036, has also been issued in the US, Australia, Mexico, and Taiwan. Flynpovi is Panbela's lead investigational product for the treatment of Familial Adenomatous Polyposis (FAP).

Portfolio Pulse from Happy Mohamed

September 05, 2023 | 12:16 pm

CING

Cingulate Therapeutics has announced the presentation of full trial results from its Phase 3 adult efficacy and safety trial of CTx-1301 for ADHD at Psych Congress 2023.

Portfolio Pulse from Benzinga Newsdesk

September 05, 2023 | 12:13 pm

CVKD

Cadrenal Therapeutics, Inc. (NASDAQ:CVKD) is developing tecarfarin, a novel Vitamin K Antagonist, to prevent heart attacks, strokes, and deaths due to blood clots in patients with certain rare medical conditions. The company believes tecarfarin is the solution for an unmet need, as recent data from the European Society of Cardiology Congress revealed more bleeding complications when switching from VKA treatment to direct oral anticoagulants in frail older patients. Cadrenal's tecarfarin has orphan drug and Fast Track designations for the prevention of systemic thromboembolism in patients with ESKD and AFib, presenting a U.S. market opportunity in excess of $2 billion per year.

Portfolio Pulse from Happy Mohamed

September 05, 2023 | 12:12 pm

DATS

DatChat has filed a patent for a technology that allows secure access to group-based digital assets across its metaverse and social media platforms. The technology aims to provide users with control over their digital assets and privacy.

Portfolio Pulse from Benzinga Newsdesk

September 05, 2023 | 12:09 pm

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