Year: 2025

Telitacicept Demonstrates Clinically Meaningful and Statistically Significant Impact on ESSDAI Compared to Placebo in Late-Breaking China Phase 3 Results in Primary Sjögren’s Disease at ACR 2025

Telitacicept met primary and all secondary endpoints, demonstrating clinically meaningful improvements in disease activity versus placebo ~71.8% of patients receiving...

Halda Therapeutics Announces Oral Plenary Presentation on HLD-0915 Clinical Data in Metastatic Castration-Resistant Prostate Cancer (mCRPC) at 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics on October 24, 2025

Ashvattha Therapeutics Appoints Ophthalmology Veteran Robert J. Dempsey as Interim CEO Following Positive Phase 2 Results and FDA Alignment on Pivotal Program

FDA agrees with Phase 2b/3 clinical design, including primary endpoint and development approach, providing clear regulatory pathway to conduct two...

Aprea Therapeutics Announces Presentations at EORTC-NCI-AACR International Conference on Molecular Targets and Cancer Therapeutics

DOYLESTOWN, Pa., Oct. 14, 2025 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical-stage biopharmaceutical...

Tr1X Announces FDA Clearance of IND Application for TRX319, a First-in-Class Allogeneic CAR-Tr1 Treg Cell Therapy for Progressive Multiple Sclerosis, and $50 Million in Additional Financing

FDA Accepts Cingulate’s New Drug Application for CTx-1301 in Attention-Deficit/Hyperactivity Disorder (ADHD) and sets a May 31, 2026 PDUFA Date

Once-daily Precision Timed Release™ (PTR™) stimulant designed to deliver rapid onset of effect and entire active-day duration NDA accepted under the...

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