Streetbeat News

Regulatory

AMLX

Amylyx Pharmaceuticals has been informed that the CHMP is trending toward a negative opinion on the application for conditional marketing authorization for AMX0035, a treatment for ALS.

Portfolio Pulse from Benzinga Newsdesk

May 30, 2023 | 12:05 pm

WEJO

Trading of Wejo Group shares has been halted due to pending news related to a code.

Portfolio Pulse from Benzinga Newsdesk

May 30, 2023 | 12:04 pm

AKBA

The FDA has denied Akebia Therapeutics' appeal for vadadustat but provided a path forward for resubmitting the new drug application (NDA) for treating anemia due to chronic kidney disease (CKD) in dialysis-dependent patients.

Portfolio Pulse from Benzinga Newsdesk

May 30, 2023 | 11:32 am

GNPX

Genprex has received approval from the Safety Review Committee to advance to the Phase 2 expansion portion of the Acclaim-1 clinical trial of REQORSA in combination with Tagrisso for advanced non-small cell lung cancer.

Portfolio Pulse from Benzinga Newsdesk

May 30, 2023 | 11:31 am

ATHE

Alterity Therapeutics has initiated a second Phase 2 study for its drug candidate ATH434 in the treatment of Multiple System Atrophy (MSA), a rare Parkinsonian disorder. The study aims to evaluate the safety, tolerability, and efficacy of the drug.

Portfolio Pulse from Benzinga Newsdesk

May 30, 2023 | 11:26 am

BGNE

BeiGene announced that its drug BRUKINSA has been approved in Canada for the treatment of chronic lymphocytic leukemia. This approval could potentially boost BeiGene's (BGNE) revenues and expand its market presence.

Portfolio Pulse from Benzinga Newsdesk

May 30, 2023 | 11:12 am

AAPL

INDA

Apple is resisting an order from Indian officials to remove betting apps from the App Store, potentially leading to a conflict with the Indian government.

Portfolio Pulse from Charles Gross

May 30, 2023 | 11:10 am

CANF

Can-Fite BioPharma's study on Namodenoson's inhibition of pancreatic carcinoma has been published in the Journal of Clinical Oncology supplement of the 2023 ASCO Annual Meeting Proceedings. The company focuses on developing small molecule drugs for oncology, inflammatory, and liver diseases.

Portfolio Pulse from Benzinga Newsdesk

May 30, 2023 | 11:02 am

BMY

The FDA has accepted Bristol Myers Squibb's New Drug Application for repotrectinib, a treatment for ROS1-positive non-small cell lung cancer, granting it Priority Review with a PDUFA goal date of November 27, 2023.

Portfolio Pulse from Benzinga Newsdesk

May 30, 2023 | 11:00 am

GRNA

Greenlight Biosciences' trading has been halted pending news. The company is listed under the symbol GRNA.

Portfolio Pulse from Charles Gross

May 30, 2023 | 10:59 am