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Regulatory

ABEO

Abeona Therapeutics has concluded a Type A meeting with the FDA to align on the upcoming BLA resubmission for Pz-cel. The company continues to expect to resubmit the BLA in the second half of 2024.

Portfolio Pulse from Benzinga Newsdesk

August 12, 2024 | 11:31 am

AZN

CDT

Conduit Pharmaceuticals has selected initial indications for its lead clinical candidate, HK-4 Glucokinase Activator AZD1656, licensed from AstraZeneca. Conduit plans to initiate Phase 2a clinical trials to evaluate AZD1656 for the treatment of systemic lupus erythematosus and ANCA-associated vasculitis. Originally developed by AstraZeneca for diabetes mellitus, AZD1656 has undergone extensive safety testing. Conduit aims to leverage its safety profile and targeted mechanism to address autoimmune disorders.

Portfolio Pulse from Benzinga Newsdesk

August 12, 2024 | 11:27 am

ASND

Trading for Ascendis Pharma (ASND) was halted and then resumed at 7:25 AM ET. The halt was due to pending news.

Portfolio Pulse from Benzinga Newsdesk

August 12, 2024 | 11:25 am

HUMA

Humacyte shares are trading lower after the company announced that the FDA will require additional time to complete its review of the BLA for ATEV in the treatment of vascular trauma.

Portfolio Pulse from Benzinga Newsdesk

August 12, 2024 | 11:23 am

TRNR

Interactive Strength shares are trading higher after the company received a letter stating that the Nasdaq Hearings Panel granted its request for continued listing on the Nasdaq Stock Market.

Portfolio Pulse from Benzinga Newsdesk

August 12, 2024 | 11:21 am

TRNR

Interactive Strength has received a letter from the Nasdaq Hearings Panel granting the company's request for continued listing on the Nasdaq Stock Market.

Portfolio Pulse from Benzinga Newsdesk

August 12, 2024 | 11:14 am

ASND

The FDA has approved Ascendis Pharma's Yorvipath (Palopegteriparatide; developed as TransCon PTH) for the treatment of hypoparathyroidism in adults. Ascendis is finalizing the manufacturing process for the U.S. market and expects the initial supply to be available in Q1 of 2025.

Portfolio Pulse from Benzinga Newsdesk

August 12, 2024 | 11:05 am

MRKR

Marker Therapeutics, Inc. (NASDAQ:MRKR) has been awarded a $2 million grant from the NIH SBIR program to support the clinical investigation of MT-601 in relapsed non-Hodgkin's lymphoma patients. This funding will aid the Phase 1 APOLLO study, evaluating the safety and efficacy of MT-601.

Portfolio Pulse from Benzinga Newsdesk

August 12, 2024 | 11:03 am

ASND

Trading has been halted for a company at 6:55:00 a.m. ET due to pending news.

Portfolio Pulse from Benzinga Newsdesk

August 12, 2024 | 10:55 am

PFE

Pfizer Inc. (NYSE:PFE) announced positive results from a Phase 3 clinical trial for its ABRYSVO vaccine in immunocompromised adults at risk of severe RSV. The vaccine showed strong safety and immunogenicity, generating a robust neutralizing response against RSV-A and RSV-B. Pfizer plans to present these findings at a scientific conference and submit them to regulatory agencies.

Portfolio Pulse from Benzinga Newsdesk

August 12, 2024 | 10:47 am