Streetbeat News

Regulatory

SPRY

ARS Pharmaceuticals has announced that its Neffy Epinephrine Nasal Spray is now available by prescription in the U.S. This follows FDA approval for its use in treating Type I allergic reactions, including anaphylaxis.

Portfolio Pulse from Benzinga Newsdesk

September 23, 2024 | 12:10 pm

BAK

Braskem has been selected by the U.S. Department of Energy to negotiate a $50 million award to enhance its UHMWPE production in Texas, focusing on the lithium-ion battery separator market.

Portfolio Pulse from Benzinga Newsdesk

September 23, 2024 | 12:10 pm

AIMD

Ainos is set to begin a clinical study in Taiwan for its product VELDONA, targeting Sjögren's Syndrome. The company aims to complete all necessary regulatory approvals by Q4 2024.

Portfolio Pulse from Benzinga Newsdesk

September 23, 2024 | 12:09 pm

ATLX

Atlas Lithium Corporation (NASDAQ:ATLX) has received a favorable recommendation from the Minas Gerais Environmental Foundation for its permit application, advancing its Neves Project towards the operation of a lithium processing plant.

Portfolio Pulse from Benzinga Newsdesk

September 23, 2024 | 12:04 pm

AZN

AstraZeneca's Phase 3 trial of datopotamab deruxtecan (Dato-DXd) for breast cancer did not achieve statistical significance in overall survival, though it showed improvement in progression-free survival and patient-reported outcomes. The safety profile was consistent with previous analyses. AstraZeneca's stock is down 1.86% in premarket trading.

Portfolio Pulse from Vandana Singh

September 23, 2024 | 11:44 am

ATHE

Alterity Therapeutics will present key Phase 2 data at the International Congress of Parkinson's Disease and Movement Disorders in 2024. The presentations will include interim data from their ATH434-202 trial for multiple system atrophy.

Portfolio Pulse from Benzinga Newsdesk

September 23, 2024 | 11:40 am

ELEV

Elevation Oncology's EO-3021 has received FDA Fast Track designation for treating advanced gastric cancer, highlighting its potential to address unmet medical needs. The designation is based on promising early clinical trial results.

Portfolio Pulse from Benzinga Newsdesk

September 23, 2024 | 11:36 am

BHVN

Biohaven Ltd. (NYSE:BHVN) announced positive 3-year results for troriluzole in treating Spinocerebellar Ataxia (SCA), showing significant slowing of disease progression. The study met its primary endpoint, and Biohaven plans to submit a New Drug Application to the FDA in Q4 2024.

Portfolio Pulse from Benzinga Newsdesk

September 23, 2024 | 11:32 am

ARWR

Arrowhead Pharmaceuticals has filed for regulatory clearance to start a Phase 1/2a trial for ARO-INHBE, an RNAi therapeutic for obesity. The trial will assess the safety and efficacy of ARO-INHBE alone and in combination with tirzepatide. Arrowhead plans to file for another trial for ARO-ALK7 by the end of 2024.

Portfolio Pulse from Benzinga Newsdesk

September 23, 2024 | 11:31 am

KMDA

Kamada Ltd. has expanded its US plasma operations by opening a new plasma collection center in Houston, TX, and plans to submit for FDA approval. The center is expected to significantly increase Kamada's plasma collection capacity and contribute to its revenue growth.

Portfolio Pulse from Benzinga Newsdesk

September 23, 2024 | 11:19 am