Streetbeat News

Regulatory

BFLY

Butterfly Network has received FDA clearance for its Butterfly iQ3, a handheld ultrasound system. This third iteration boasts an ergonomic design, doubled data processing speed, enhanced image resolution, sensitivity, penetration, and faster 3D capabilities with new automated image capture modes, iQ Slice and iQ Fan.

Portfolio Pulse from Benzinga Newsdesk

January 08, 2024 | 1:05 pm

AVXL

Anavex Life Sciences has been granted U.S. Patent No. 11,839,600 for Blarcamesine (ANAVEX2-73), a treatment for neurodevelopmental disorders. The patent was issued by the United States Patent and Trademark Office (USPTO) for patent application number 17/890,083.

Portfolio Pulse from Benzinga Newsdesk

January 08, 2024 | 12:51 pm

ARQT

Arcutis Canada has announced that Health Canada has accepted a supplement to a New Drug Submission for Roflumilast Foam 0.3% intended for the treatment of Seborrheic Dermatitis in individuals aged 9 years and older.

Portfolio Pulse from Benzinga Newsdesk

January 08, 2024 | 12:44 pm

ZVRA

Zevra has announced that the FDA has accepted the resubmission of its New Drug Application (NDA) for Arimoclomol, a proposed treatment for Niemann-Pick Disease Type C. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date for June 21, 2024, and plans to discuss the resubmission in an advisory committee.

Portfolio Pulse from Benzinga Newsdesk

January 08, 2024 | 12:43 pm

BABA

BIDU

NVDA

TCEHY

Nvidia Corp (NVDA) faces challenges in the Chinese market due to U.S. regulations barring high-performance AI chip sales. Major Chinese cloud companies like Alibaba (BABA) and Tencent (TCEHY) plan to reduce Nvidia chip orders, turning to local alternatives and in-house developments. Baidu (BIDU) and ByteDance are also shifting towards domestic producers like Huawei. Despite this, Nvidia sold over $1 billion of modified chips in China in 2023 and is developing new AI chips like the H20 for the Chinese market, set for production in Q2 2024. Nvidia's stock saw a slight increase on Monday.

Portfolio Pulse from Anusuya Lahiri

January 08, 2024 | 12:40 pm

SNGX

Soligenix announced that its SGX945 (dusquetide) development program for the treatment of oral lesions in Behçet's Disease has been granted 'Fast Track' designation by the FDA. This designation is intended to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need.

Portfolio Pulse from Benzinga Newsdesk

January 08, 2024 | 12:32 pm

BLCO

Bausch + Lomb, a global eye health company, has announced that the FDA has approved its TENEO Excimer Laser Platform for use in LASIK surgery for myopia and myopic astigmatism. This approval could enhance the company's product offerings in the vision correction surgery market.

Portfolio Pulse from Benzinga Newsdesk

January 08, 2024 | 12:31 pm

AMAM

Trading on AMAM was halted at 7:30:02 a.m. ET due to pending news. The halt is in place to ensure a fair and orderly market until the news is released.

Portfolio Pulse from Benzinga Newsdesk

January 08, 2024 | 12:30 pm

RGNX

SRPT

The U.S. District Court for the District of Delaware ruled in favor of Sarepta Therapeutics, granting summary judgment on invalidity in a patent infringement lawsuit filed by REGENXBIO Inc. and the University of Pennsylvania. The patent in question, used by Sarepta to produce SRP-9001 for Duchenne muscular dystrophy treatment, was exclusively licensed to REGENXBIO by Penn. REGENXBIO plans to appeal the decision, which does not affect its current licenses or therapeutic pipeline.

Portfolio Pulse from Benzinga Newsdesk

January 08, 2024 | 12:27 pm

GLUE

Monte Rosa Therapeutics (NASDAQ:GLUE) announced its cash position is expected to fund operations into the first half of 2026. The company will present at the 42nd Annual J.P. Morgan Healthcare Conference, focusing on 2024 strategic priorities, including the Phase 1/2 clinical trial of MRT-2359 for MYC-driven solid tumors and development plans for MRT-2359 and MRT-6160. MRT-2359 has received US FDA Fast Track Designation for small cell lung cancer and the recommended Phase 2 dose is expected in Q2 2024. MRT-6160 is anticipated to begin Phase 1 study in mid-2024 for autoimmune diseases.

Portfolio Pulse from Charles Gross

January 08, 2024 | 12:27 pm