Streetbeat News

Regulatory

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

BA

HELE

QQQ

SPR

SPY

Dow futures indicate a lower market opening, influenced by Boeing's (NYSE:BA) 737 MAX 9 jets grounding after an accident, affecting airline stocks. Traders are cautious ahead of inflation reports and bank earnings. U.S. stocks retreated last week, with tech and small-cap stocks dragging indices down after a nine-week rally. Analysts predict volatility but suggest solid fundamentals may limit damage. SPDR S&P 500 ETF Trust (NYSE:SPY) and Invesco QQQ ETF (NASDAQ:QQQ) saw slight premarket declines. Boeing shares dropped over 8%, and Spirit AeroSystems Holdings, Inc. (NYSE:SPR) fell nearly 20% due to its connection to the Boeing incident. Helen of Troy Limited (NASDAQ:HELE) is set to release earnings. Oil prices recoiled, and Bitcoin (CRYPTO:BTC) remained positive.

Portfolio Pulse from Shanthi Rexaline

January 08, 2024 | 12:26 pm

BA

LMT

United Launch Alliance (ULA), a joint venture between Lockheed Martin (NYSE:LMT) and Boeing (NYSE:BA), launched the Vulcan rocket carrying human remains for 'space burials,' despite objections from the Navajo Nation. The Navajo Nation President, Buu Nygren, had previously urged NASA to consult with them, citing the Moon's sacred status in indigenous cultures. The White House held a meeting to address these concerns. The launch is a milestone in U.S. space exploration, with the Vulcan rocket set to compete with SpaceX's Falcon 9 and carry various payloads, including NASA instruments for lunar research.

Portfolio Pulse from Pooja Rajkumari

January 08, 2024 | 12:22 pm

AGIO

Agios Pharmaceuticals, Inc. (NASDAQ:AGIO) announced its strong cash position, which is expected to support the completion of ongoing programs and disciplined pipeline expansion into at least 2026. The company highlighted its PK Activator Franchise's clinical efficacy in four hematological diseases and expects four additional Phase 3 readouts by the end of 2025, with potential FDA approvals in Thalassemia in 2025 and Sickle Cell Disease in 2026. Agios will present at the 42nd Annual J.P. Morgan Healthcare Conference and will provide a live webcast.

Portfolio Pulse from Charles Gross

January 08, 2024 | 12:21 pm