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GME

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SPY

U.S. stocks are set to open lower due to rising bond yields and cooling meme stock rallies. Key retail earnings reports, Federal Reserve speeches, and geopolitical tensions are also influencing market sentiment. Notable premarket movements include American Airlines falling over 8% and Robinhood climbing over 4%.

Portfolio Pulse from Shanthi Rexaline

May 29, 2024 | 11:35 am

BITF

Trading halt status was updated at 7:25:00 AM ET, with details on quotation resumption and news resumption times.

Portfolio Pulse from Benzinga Newsdesk

May 29, 2024 | 11:25 am

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