Streetbeat News

Regulatory

ATXS

The European Commission has granted Orphan Medicinal Product Designation to Astria Therapeutics' drug, Navenibart, for the treatment of hereditary angioedema. The Phase 1b/2 trial demonstrated a 90-96% reduction in monthly attack rates with a favorable safety profile.

Portfolio Pulse from Benzinga Newsdesk

October 16, 2024 | 12:13 pm

ALNY

Alnylam Pharmaceuticals has submitted a regulatory application to the European Medicines Agency for Vutrisiran, a treatment for ATTR amyloidosis with cardiomyopathy. This submission is based on positive Phase 3 results from the HELIOS-B study, which showed a significant reduction in death and cardiovascular events.

Portfolio Pulse from Benzinga Newsdesk

October 16, 2024 | 12:12 pm

BIAF

bioAffinity's CyPath Lung Cancer Test has received support from new flow cytometry guidelines. VP Jennifer Rebeles contributed to an expert panel that published best practices for rare sample testing in a peer-reviewed journal.

Portfolio Pulse from Benzinga Newsdesk

October 16, 2024 | 12:11 pm

NVAX

Novavax shares declined after the FDA placed a clinical hold on its investigational new drug application for COVID-19-influenza combination and standalone influenza vaccine candidates.

Portfolio Pulse from Benzinga Newsdesk

October 16, 2024 | 12:10 pm

TNXP

Tonix Pharmaceuticals has submitted a New Drug Application (NDA) to the FDA for TNX-102 SL, a non-opioid analgesic for fibromyalgia treatment. The drug showed significant pain reduction in Phase 3 studies and has received Fast Track designation.

Portfolio Pulse from Benzinga Newsdesk

October 16, 2024 | 12:10 pm

NVAX

Novavax announced that the FDA has placed a clinical hold on its investigational new drug applications for both its COVID-19-influenza combination and standalone influenza vaccine candidates. This decision follows a report of a serious adverse event involving motor neuropathy.

Portfolio Pulse from Benzinga Newsdesk

October 16, 2024 | 12:08 pm

VS

Versus Systems Inc. (NASDAQ:VS) shares surged over 300% premarket due to two major agreements with Aspis Cyber Technologies. These include a $2.5 million investment and a licensing deal for Versus' technology. The agreements aim to help Versus meet Nasdaq's equity requirements.

Portfolio Pulse from Lekha Gupta

October 16, 2024 | 11:56 am

SVC

Trading for a certain asset was halted at 7:55 a.m. ET due to pending news. This indicates that significant information is expected to be released, which could impact the asset's price.

Portfolio Pulse from Benzinga Newsdesk

October 16, 2024 | 11:55 am

BDRX

Biodexa Pharmaceuticals shares rose after successfully appealing Nasdaq's delisting decision, gaining more time to comply with listing rules.

Portfolio Pulse from Benzinga Newsdesk

October 16, 2024 | 11:53 am

INTC

Intel shares are experiencing a decline following reports that the Cybersecurity Association has recommended a cybersecurity review of Intel products sold in China.

Portfolio Pulse from Benzinga Newsdesk

October 16, 2024 | 11:49 am