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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

RPTX

Repare Therapeutics Inc. (NASDAQ:RPTX) announced that initial data from its Phase 1 MINOTAUR study on lunresertib (RP-6306) in combination with FOLFIRI for advanced solid tumors will be presented at the ESMO GI Cancers Congress 2024.

Portfolio Pulse from Benzinga Newsdesk

May 29, 2024 | 11:19 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

RIVN

Rivian Automotive (NASDAQ:RIVN) is considering offering its Performance Pack as a software update for all dual-motor R1 models. This upgrade, initially available only for new trucks, significantly enhances the vehicle’s power and speed. The Performance Pack, priced at $5,000, boosts horsepower and torque, improving acceleration times. Rivian's first-quarter revenue beat estimates, but its loss per share was higher than expected.

Portfolio Pulse from Anan Ashraf

May 29, 2024 | 11:14 am

BITF

Bitfarms has reaffirmed its confidence in its business operations and has provided guidance of achieving 21 EH/s and 21 w/TH by 2024.

Portfolio Pulse from Benzinga Newsdesk

May 29, 2024 | 11:13 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

PMVP

Foundation Medicine and PMV Pharmaceuticals have partnered to develop a genomic profiling test as a companion diagnostic for PMV Pharma's investigational therapy, rezatapopt, targeting TP53 Y220C mutations in advanced cancers.

Portfolio Pulse from Benzinga Newsdesk

May 29, 2024 | 11:10 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