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Regulatory

MRUS

Merus N.V. has initiated dosing in a Phase 3 trial (LiGeR-HN1) to evaluate petosemtamab in combination with pembrolizumab for treating PD-L1+ recurrent/metastatic head and neck squamous cell carcinoma. The FDA has approved the dosage for further development.

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September 30, 2024 | 12:07 pm

CLDI

Calidi Biotherapeutics has announced that the FDA has cleared Northwestern University's IND application for the CLD-101 clinical trial targeting high-grade glioma. The Phase 1/2 trial is expected to begin in Q1 2025.

Portfolio Pulse from Benzinga Newsdesk

September 30, 2024 | 12:06 pm

AEON

AEON Biopharma has announced alignment with the FDA on the next steps for the 351(k) regulatory pathway to approve ABP-450 as a biosimilar, using BOTOX as the reference product.

Portfolio Pulse from Benzinga Newsdesk

September 30, 2024 | 12:05 pm

MDGL

Madrigal Pharmaceuticals announced positive results from the Phase 3 MAESTRO-NASH trial of Rezdiffra, showing significant improvements in health-related quality of life for NASH patients. Rezdiffra, the first FDA-approved NASH treatment, demonstrated efficacy in improving fibrosis and NASH resolution.

Portfolio Pulse from Benzinga Newsdesk

September 30, 2024 | 12:03 pm

BABA

JD

NIO

PDD

US-listed Chinese companies' shares are rising due to strong stimulus efforts and better-than-expected September PMI data, despite a decline in factory activity.

Portfolio Pulse from Benzinga Newsdesk

September 30, 2024 | 11:59 am

ALT

Altimmune has completed patient enrollment for its Phase 2B trial of pemvidutide in treating MASH, with results expected in Q2 2025. An FDA meeting for its obesity program is set for November 2024, and the company plans to submit IND applications for additional indications in late 2024.

Portfolio Pulse from Benzinga Newsdesk

September 30, 2024 | 11:38 am

BBIO

BridgeBio Pharma has completed enrollment for its Phase 3 FORTIFY study of BBP-418, targeting Limb-girdle Muscular Dystrophy Type 2I/R9. Topline data from the interim analysis is expected in 2025.

Portfolio Pulse from Benzinga Newsdesk

September 30, 2024 | 11:34 am

BHVN

Biohaven has initiated a pivotal Phase 2 study for its TRPM3 antagonist, BHV-2100, aimed at treating acute migraines. The trial will assess the efficacy and safety of two doses and is designed to support FDA registration.

Portfolio Pulse from Benzinga Newsdesk

September 30, 2024 | 11:34 am

TRAW

Traws Pharma announced positive Phase 1 results for its COVID-19 candidate, Ratutrelvir, an oral inhibitor. The drug was well-tolerated and achieved consistent plasma levels without ritonavir. Phase 2a study is expected in H1 2025.

Portfolio Pulse from Benzinga Newsdesk

September 30, 2024 | 11:32 am

MMC

Marsh McLennan (NYSE:MMC) is set to acquire McGriff Insurance Services for $7.75 billion, enhancing its capabilities in various insurance sectors. The deal is expected to close by year-end, pending regulatory approval.

Portfolio Pulse from Benzinga Newsdesk

September 30, 2024 | 11:31 am