Streetbeat News

Regulatory

ARM

FXI

China's Vice Industry Minister has met with the Executive VP of Arm Holdings to discuss the company's development in China and the application of semiconductor technology, according to a statement cited by Reuters.

Portfolio Pulse from Benzinga Newsdesk

October 26, 2023 | 1:53 pm

VCNX

Vaccinex, Inc. (NASDAQ:VCNX) has reported new findings for its lead product, pepinemab, at the Clinical Trials on Alzheimer's Disease (CTAD) Conference. The company has previously reported that pepinemab treatment prevents decline in glucose uptake and significantly slows cognitive decline in Huntington's disease. The new data indicates that pepinemab treatment significantly reduced blood levels of GFAP, a biomarker of reactive astrocytes, providing further evidence of the drug's potential to reverse harmful astrocyte activation and brain inflammation. The company is testing similar effects of pepinemab treatment in an ongoing trial for Alzheimer's disease.

Portfolio Pulse from Benzinga Newsdesk

October 26, 2023 | 1:31 pm

MULN

Mullen Automotive Inc. (NASDAQ:MULN) has been granted a request to continue its listing on The Nasdaq Capital Market by the Nasdaq Hearings Panel. The company must demonstrate compliance with Listing Rule 5550(a)(2) by maintaining a closing bid price of $1 per share for 20 consecutive trading sessions on or before Jan. 22, 2024. Additionally, it must comply with Listing Rule 5620(a) by holding an annual shareholder meeting on or before March 8, 2024.

Portfolio Pulse from Benzinga Newsdesk

October 26, 2023 | 1:27 pm

RKLB

Rocket Lab USA Inc (NASDAQ:RKLB) shares are trading higher after the company announced it received Federal Aviation Administration (FAA) authorization to resume launches. The company had experienced an in-flight anomaly during one of its Electron launches in September. Rocket Lab is finalizing its investigation into the anomaly and expects to return to flight later this quarter.

Portfolio Pulse from Adam Eckert

October 26, 2023 | 1:18 pm

ONCT

Oncternal Therapeutics has announced that the FDA has granted Fast Track designation for ONCT-534, a treatment for metastatic castration-resistant prostate cancer.

Portfolio Pulse from Benzinga Newsdesk

October 26, 2023 | 1:12 pm

IBRX

The U.S. Food and Drug Administration (FDA) has accepted ImmunityBio's resubmission of its Biologics License Application (BLA) for N-803, a first-in-class IL-15 superagonist, plus Bacillus Calmette-Guérin (BCG) for the treatment of BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ (CIS) with or without Ta or T1 disease. The FDA has set a user fee goal date (PDUFA date) of April 23, 2024.

Portfolio Pulse from Benzinga Newsdesk

October 26, 2023 | 1:08 pm

CMPS

CYBN

DRUG

ENVB

MNMD

SEEL

Activists in California are planning to submit a proposed ballot measure this week that would legalize the use, production, and sales of most psychedelics. The proposal, called the Psychedelic Wellness and Healing Initiative of 2024, would allow people to grow psychedelic plants and fungi at home for personal use. The initiative aims to provide a path for safe, legal access to psychedelics for medical treatment, therapy, or spiritual use. The proposal would also allow businesses to cultivate, manufacture, and distribute psychedelics as a wholesaler as of January 1, 2025, and sell psychedelics from April 19, 2025.

Portfolio Pulse from Benzinga Newsdesk

October 26, 2023 | 1:08 pm

MBIO

Mustang Bio, Inc. (NASDAQ:MBIO) has announced that the FDA has accepted the company's Investigational New Drug (IND) application for MB-109, a combination of MB-101 and MB-108, for the treatment of recurrent glioblastoma and high-grade astrocytoma. The Phase 1 study will assess the safety, tolerability, and efficacy of MB-109 and is expected to begin enrolling patients in 2024.

Portfolio Pulse from Benzinga Newsdesk

October 26, 2023 | 1:06 pm

ABVC

ALT

MAT

ABVC BioPharma has entered into a term sheet to license global rights of CNS drugs to AiBtl BioPharma at a valuation of $667 million. Mattel shares are trading lower following the company's Q3 financial results. Altimmune has been granted Fast Track Designation by the FDA for Pemvidutide for the treatment of Non-Alcoholic Steatohepatitis (NASH).

Portfolio Pulse from ryanfaloona@benzinga.com

October 26, 2023 | 12:46 pm

XXII

22nd Century Group, Inc. (NASDAQ:XXII) has expressed support for the US FDA's move to ban menthol in cigarettes and flavored cigars. The FDA's proposed policies, which are currently under review by the White House Office of Management and Budget, aim to reduce disease and death associated with smoking and support smoking cessation. The company believes that these could be the most transformative proactive public health policies of a generation.

Portfolio Pulse from Benzinga Newsdesk

October 26, 2023 | 12:38 pm