Streetbeat News

Regulatory

CING

The FDA has cleared Cingulate to file for marketing approval of CTx-1301, a treatment for ADHD. Phase 3 data collected so far is sufficient for a New Drug Application. CTx-1301 could benefit over 60% of ADHD patients currently using immediate-release booster doses. Cingulate is advancing discussions with commercialization partners and is ready to engage with payers for reimbursement and market access.

Portfolio Pulse from Benzinga Newsdesk

May 21, 2024 | 1:21 pm

ASML

BABA

BIDU

NVDA

TSM

ASML and Taiwan Semiconductor Manufacturing Co (TSMC) have the capability to remotely shut down their advanced chipmaking machines in the event of a China-Taiwan conflict. This measure is part of broader discussions involving U.S., Dutch, and Taiwanese authorities about the potential consequences of Chinese aggression towards Taiwan. ASML's EUV machines, crucial for advanced microchip production, are tightly regulated and restricted from being sold to China. The news has led to a 1.21% drop in ASML's share price.

Portfolio Pulse from Anusuya Lahiri

May 21, 2024 | 1:19 pm

CZOO

Cazoo Group Ltd (NYSE: CZOO) has received a non-compliance notice from the New York Stock Exchange (NYSE) due to its stock price falling below the required minimum. The company has six months to regain compliance by meeting the minimum share price requirement.

Portfolio Pulse from Benzinga Newsdesk

May 21, 2024 | 1:12 pm

SCNI

Trading halt status was updated at 8:55:00 AM ET, indicating a resumption of quotations. The news and resumption times are provided.

Portfolio Pulse from Benzinga Newsdesk

May 21, 2024 | 12:55 pm

LYRA

Trading for LYRA was halted at 8:55:00 a.m. ET due to pending news.

Portfolio Pulse from Benzinga Newsdesk

May 21, 2024 | 12:55 pm

PTCT

The European Commission has requested the Committee for Medicinal Products for Human Use (CHMP) to review its January opinion on the renewal of the marketing authorization for Translarna.

Portfolio Pulse from Benzinga Newsdesk

May 21, 2024 | 12:46 pm

PALI

Palisade Bio's PALI-2108 shows promising preclinical results in mouse models for Ulcerative Colitis, demonstrating safety, efficacy, and local bioactivation. The company plans to start Phase 1 human trials by the end of the year.

Portfolio Pulse from Benzinga Newsdesk

May 21, 2024 | 12:41 pm

ETHUSD

FDLRX

Fidelity has filed an amended S-1 application with the SEC for a spot Ether ETF, which could mark a significant milestone in the mainstream adoption of Ethereum. Bloomberg analysts estimate a 75% chance of approval, which could have a profound impact on the cryptocurrency market and set a precedent for other asset managers.

Portfolio Pulse from Murtuza Merchant

May 21, 2024 | 12:39 pm

GRI

GRI Bio presented preclinical data on its NKT cell modulators for Systemic Lupus Erythematosus at the 14th International Congress on Autoimmunity. The data is promising and comparable to OFEV® (nintedanib), a leading tyrosine kinase inhibitor. GRI Bio plans to file an IND for GRI-0803 in Q3 2024, with topline data expected in Q4 2024.

Portfolio Pulse from Benzinga Newsdesk

May 21, 2024 | 12:37 pm

LHX

SIDU

The Department of Defense (DoD) has extended the Mentor-Protégé Program between Sidus Space, Inc. (NASDAQ:SIDU) and L3Harris Technologies (NYSE:LHX) for an additional year. This program aims to foster partnerships between established defense contractors and smaller, emerging businesses to help them expand in the defense industry.

Portfolio Pulse from Benzinga Newsdesk

May 21, 2024 | 12:36 pm