Streetbeat News

Regulatory

MRK

Merck announced that the FDA has accepted a priority review for a new supplemental biologics license application for Keytruda in combination with chemotherapy for the first-line treatment of advanced or metastatic malignant pleural mesothelioma. The FDA's target action date is September 25, 2024.

Portfolio Pulse from Benzinga Newsdesk

May 29, 2024 | 11:20 am

RCKT

The European Commission has granted Orphan Medicinal Product Designation to Rocket Pharmaceuticals' RP-A601, an AAV.RH74-based gene therapy candidate for Plakophilin-2 related arrhythmogenic cardiomyopathy.

Portfolio Pulse from Benzinga Newsdesk

May 29, 2024 | 11:16 am

IMCR

Immunocore has announced the conversion of its TEBE-AM Phase 2/3 clinical trial into a Phase 3 trial for Kimmtrak, targeting previously treated advanced cutaneous melanoma, following consultation with the FDA.

Portfolio Pulse from Benzinga Newsdesk

May 29, 2024 | 11:14 am

BMY

The European Commission has approved Bristol Myers Squibb's Opdivo (Nivolumab) in combination with Cisplatin and Gemcitabine for the first-line treatment of unresectable or metastatic urothelial carcinoma. This approval is based on the results from the CheckMate -901 Phase 3 trial, which demonstrated a survival benefit over standard-of-care chemotherapy alone.

Portfolio Pulse from Benzinga Newsdesk

May 29, 2024 | 11:11 am

BLUE

bluebird bio announced it will restate its financial statements for 2022 and 2023, delaying its 2023 Annual Report and Q1 2024 Form 10-Q. The restatement is not expected to impact cash position or revenue. Sterling will oversee the process upon his start date.

Portfolio Pulse from Benzinga Newsdesk

May 29, 2024 | 11:09 am

TCRX

TScan Therapeutics announced that the FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its two lead TCR-T therapy candidates, TSC-100 and TSC-101, for the treatment of heme malignancies.

Portfolio Pulse from Benzinga Newsdesk

May 29, 2024 | 11:05 am

MIST

The FDA has accepted Milestone Pharmaceuticals' New Drug Application for Cardamyst (Etripamil) nasal spray, aimed at managing paroxysmal supraventricular tachycardia. The Prescription Drug User Fee Act date is set for May 26, 2024.

Portfolio Pulse from Benzinga Newsdesk

May 29, 2024 | 11:05 am

BITF

Trading for BITF was halted at 6:55:00 a.m. ET due to pending news. Investors should stay tuned for further updates.

Portfolio Pulse from Benzinga Newsdesk

May 29, 2024 | 10:55 am

VFS

VinFast Auto Ltd. (NASDAQ: VFS) shares are trading slightly lower premarket as the company considers postponing its $4 billion factory in North Carolina due to challenges in appealing to American consumers. The factory, initially planned for completion in July 2024, was already delayed to 2025 and may face further delays. VinFast sold fewer than 1,000 cars in North America last year and is currently reviewing all aspects of the construction process.

Portfolio Pulse from Nabaparna Bhattacharya

May 29, 2024 | 10:51 am

AAUKF

BHP

BHP Group has requested an extension beyond the 4 PM GMT deadline to finalize its $50 billion takeover bid for Anglo American. The extension is needed due to the complex structure of the deal and ongoing negotiations over South African assets. Key shareholders support extending the talks.

Portfolio Pulse from Stjepan Kalinic

May 29, 2024 | 10:45 am