The FDA has approved Syndax Pharmaceuticals' Revuforj (revumenib) for adults and children with relapsed or refractory acute leukemia with KMT2A rearrangement.

Acadia Pharmaceuticals has successfully sold its FDA priority review voucher for $150 million, marking one of the highest valuations for such vouchers in recent transactions.

Corvus Pharmaceuticals has initiated a Phase 3 clinical trial for soquelitinib in patients with relapsed/refractory peripheral T-cell lymphoma (PTCL).

The U.S. District Court for the District of Delaware ruled in favor of Acadia Pharmaceuticals, upholding their '721 formulation patent for Nuplazid against Aurobindo Pharma's generic challenge.

Enanta Pharmaceuticals' zelicapavir achieved a significant 0.7 log reduction in peak viral load on Day 9 in a Phase 2 trial for pediatric RSV patients.

X4 Pharmaceuticals announced positive Phase 2 results for mavorixafor in chronic neutropenia (CN), demonstrating increased neutrophil counts.

Apellis Pharmaceuticals faces headwinds with a negative CHMP opinion on Syfovre, impacting its European market prospects.

Acumen Pharmaceuticals is using a validated plasma pTau217 assay to screen participants for its Phase 2 ALTITUDE-AD trial of sabirnetug in early Alzheimer's disease.

Recce Pharmaceuticals announced positive interim efficacy and safety data from its Phase II clinical trial of RECCE® 327 Topical Gel (R327G) for acute bacterial skin and skin structure infections (ABSSSI).

Tonix Pharmaceuticals has submitted a New Drug Application (NDA) to the FDA for TNX-102 SL for treating fibromyalgia.

Vanda Pharmaceuticals has formally requested either approval of its new drug application or an opportunity for a hearing, following a complete response letter from regulatory authorities. This move underscores the company's commitment to advancing its pharmaceutical R&D efforts and addressing regulatory feedback.

NeuroBo Pharmaceuticals has completed the last patient visit in its Phase 2a clinical trial evaluating DA-1241 for metabolic dysfunction-associated steatohepatitis (MASH).

CASI Pharmaceuticals has dosed the first patient in a Phase 1/2 trial of CID-103 for chronic Immune Thrombocytopenia (ITP) in China.

Acadia Pharmaceuticals has submitted a Marketing Authorization Application (MAA) to the EMA for trofinetide to treat Rett syndrome in adults and children.

Woolsey Pharmaceuticals has finished recruiting 31 patients for the high-dose (300 mg/day) arm of the REAL study, which is testing BRAVYL (oral fasudil) for treating Amyotrophic Lateral Sclerosis (ALS).

Marinus Pharmaceuticals shifts focus to oral ganaxolone (O-GNX) for tuberous sclerosis complex (TSC) after IV ganaxolone (IV-GNX) fails a Phase 3 trial for refractory status epilepticus (RSE).

NRx Pharmaceuticals is on track to file NDAs for NRX-100 (IV Ketamine) for suicidal ideation in depression and NRX-101 (Oral D-Cycloserine/Lurasidone) for bipolar depression with suicidality by year-end 2024.

Recce Pharmaceuticals has made significant strides in its clinical trials, marking progress in its anti-infective programs.

Cardurion Pharmaceuticals has been named one of the Endpoints 11 most promising private biotechnology companies of 2024, recognizing its innovative approach to cardiovascular disease treatment.

Cosmo Pharmaceuticals reported a 186% increase in full-year 2024 revenue, reaching €265.7 million, driven by collaborations and AI advancements in the GI Genius platform.