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Regulatory

NUWE

Trading halt status for NUWE was updated at 8:55:00 AM ET. The halt was due to pending news and the resumption times will be announced.

Portfolio Pulse from Benzinga Newsdesk

June 28, 2024 | 12:55 pm

MRK

Merck & Co Inc (NYSE:MRK) received a unanimous recommendation from the CDC's ACIP for its Capvaxive vaccine for adults 65 and older, and certain adults 19-64 with underlying conditions. Additionally, the CHMP of the European Medicines Agency recommended the approval of Winrevair for PAH patients, with a final decision expected in Q3 2024. MRK shares were trading higher by 0.13% premarket on Friday.

Portfolio Pulse from Vandana Singh

June 28, 2024 | 12:39 pm

ATOS

LLY

Atossa Therapeutics announced protocol changes in its clinical trial evaluating (Z)-endoxifen in combination with Eli Lilly's abemaciclib for treating ER+/HER2- breast cancer.

Portfolio Pulse from Benzinga Newsdesk

June 28, 2024 | 12:36 pm

MIRM

Mirum Pharmaceuticals has submitted a New Drug Application (NDA) to the FDA for chenodiol, aimed at treating cerebrotendinous xanthomatosis (CTX). This submission is based on positive results from the Phase 3 RESTORE study. If approved, chenodiol would be the first and only therapy indicated for CTX in the US. Mirum holds orphan designation for this drug.

Portfolio Pulse from Benzinga Newsdesk

June 28, 2024 | 12:36 pm

BTCUSD

ETHUSD

SOLUSD

A new report by GSR suggests that the approval of a Solana (SOL) ETF could lead to significant price increases for SOL, with potential scenarios ranging from a 1.4x to an 8.9x price surge. The report highlights the changing regulatory environment under a Trump administration as a key factor.

Portfolio Pulse from Murtuza Merchant

June 28, 2024 | 12:23 pm

RCKT

Rocket Pharmaceuticals shares are trading lower after the FDA issued a Complete Response Letter for the License Application For KRESLADI, requesting additional Chemistry Manufacturing and Controls information.

Portfolio Pulse from Benzinga Newsdesk

June 28, 2024 | 12:18 pm

UNH

UnitedHealth's OptumRx has agreed to a $20 million settlement over claims of improperly filling opioid prescriptions. This is the first settlement of its kind involving a pharmacy benefit manager. The DEA's investigation revealed that OptumRx's California mail-order pharmacy filled opioid prescriptions alongside other drugs, raising red flags for potential illicit trafficking. The broader opioid crisis litigation has resulted in nearly $50 billion in settlements.

Portfolio Pulse from Vandana Singh

June 28, 2024 | 12:16 pm

NRXP

NRx Pharmaceuticals plans to file two New Drug Applications (NDAs) in 2024 for NRX-101 and NRX-100, targeting bipolar depression, akathisia, and suicidal depression. These drugs have received Breakthrough Therapy and Fast Track Designations, respectively. Potential revenue from these drugs could exceed $150 per NRXP share. Additionally, HOPE Therapeutics is progressing towards a public listing.

Portfolio Pulse from Benzinga Newsdesk

June 28, 2024 | 12:11 pm

RYTM

Rhythm Pharmaceuticals announced that the European Medicines Agency's CHMP has adopted a positive opinion recommending marketing authorization for IMCIVREE to include children aged 2 to under 6 with obesity due to specific genetic conditions. A decision from the European Commission is expected in the second half of 2024.

Portfolio Pulse from Benzinga Newsdesk

June 28, 2024 | 12:02 pm

SLNO

Soleno Therapeutics has submitted a New Drug Application to the FDA for DCCR extended-release tablets aimed at treating Prader-Willi syndrome in individuals aged four and older with hyperphagia.

Portfolio Pulse from Benzinga Newsdesk

June 28, 2024 | 12:02 pm