Streetbeat News

Regulatory

ACET

Adicet Bio has received FDA clearance for its IND application for ADI-270, a treatment for renal cell carcinoma.

Portfolio Pulse from Benzinga Newsdesk

June 24, 2024 | 11:11 am

TFFP

TFF Pharmaceuticals announced a regulatory update on its TFF TAC clinical program following recent interactions with the FDA. The FDA provided constructive feedback, and the company does not expect significant changes to its timelines or costs. A more detailed update will be provided in Q3 2024.

Portfolio Pulse from Benzinga Newsdesk

June 24, 2024 | 11:10 am

RGLS

Regulus Therapeutics Inc. (NASDAQ:RGLS) announced positive topline results from the third cohort of its Phase 1b study of RGLS8429 for ADPKD treatment. The study showed that RGLS8429 was well tolerated and demonstrated a dose response in reducing disease severity markers. Enrollment for the fourth cohort has begun, and the company plans to discuss a potentially pivotal Phase 2/3 study with the FDA.

Portfolio Pulse from Benzinga Newsdesk

June 24, 2024 | 11:10 am

COIN

HOOD

MARA

MSTR

RIOT

The anticipated approval of spot Ethereum ETFs could lead to a significant drop in Ether's price, with potential impacts on various crypto-related stocks. Analysts are divided on the potential benefits and consequences of the ETF launch.

Portfolio Pulse from Benzinga Neuro

June 24, 2024 | 11:08 am

AN

CDK

AutoNation was notified by CDK Global of a cyber incident affecting its dealer management system. AutoNation has taken precautionary steps and is reviewing the impact.

Portfolio Pulse from Benzinga Newsdesk

June 24, 2024 | 11:07 am

RGNX

REGENXBIO has announced the expansion of its AFFINITY DUCHENNE trial to include a new cohort of younger patients. This move aims to broaden the scope of the trial and potentially accelerate the development of treatments for Duchenne Muscular Dystrophy.

Portfolio Pulse from Benzinga Newsdesk

June 24, 2024 | 11:06 am

HRMY

Harmony Biosciences has received FDA approval for a supplemental new drug application for WAKIX, which is expected to enhance its market position and potentially increase revenues.

Portfolio Pulse from Benzinga Newsdesk

June 24, 2024 | 11:05 am

CANF

Can-Fite BioPharma Ltd. (NYSE:CANF) announced breakthrough findings on Namodenoson's dual anti-cancer and liver protective effects, mediated by the signalling protein adiponectin. These findings will be presented at the IDDST-2024 conference in Shanghai. Namodenoson is currently in Phase III and Phase IIb clinical trials for advanced liver cancer and MASH, respectively.

Portfolio Pulse from Benzinga Newsdesk

June 24, 2024 | 11:04 am

AXGN

Axogen, Inc. (NASDAQ:AXGN) has launched a new product, Avive+ Soft Tissue Matrix, designed to aid in nerve healing. This product is a resorbable, multi-layer amniotic membrane allograft that provides temporary protection and tissue separation during the critical phase of peripheral nerve healing. The product complies with FDA regulations and aims to address a significant need in the $800 million nerve protection market.

Portfolio Pulse from Benzinga Newsdesk

June 24, 2024 | 11:03 am

BNTX

BioNTech and Duality Biologics announced that the FDA has granted Fast Track Designation for BNT324/DB-1311 for advanced or metastatic castration-resistant prostate cancer patients who have progressed on or after standard systemic regimens.

Portfolio Pulse from Benzinga Newsdesk

June 24, 2024 | 11:02 am