Designation Supported by CLOVER WaM Phase 2 Study DataWhich Reported an 83.6% Overall Response Rate (ORR) Seeking Guidance from EMA to Determine if CLOVER WaM Phase 2 Data Meets Criteria to Apply for Fast-Track, Conditional Marketing Authorization, Answer Expected Late July FLORHAM PARK, N.J., June 04, 2025 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, today announ ...

Core Viewpoint - Innovent Biologics has presented promising Phase 1 study results for IBI343, a novel anti-CLDN18.2 ADC, for advanced pancreatic cancer, indicating its potential as a breakthrough therapy in a challenging-to-treat malignancy [2][4]. Company Overview - Innovent Biologics is a leading biopharmaceutical company founded in 2011, focused on developing high-quality medicines for various diseases, including oncology, cardiovascular, and autoimmune disorders [10]. - The company has launched 15 products and has multiple assets in various stages of clinical trials, partnering with over 30 global healthcare companies [10]. Clinical Study Results - The Phase 1 study of IBI343 showed a confirmed overall objective response rate (cORR) of 22.7% and a disease control rate (DCR) of 81.8% in patients with CLDN18.2 expression treated at a 6mg/kg dose [6]. - The median progression-free survival (mPFS) was reported at 5.4 months, and the median overall survival (mOS) was 9.1 months, with variations based on prior treatments [6]. - The safety profile of IBI343 was favorable, with a low rate of gastrointestinal toxicity and no new safety signals reported [6]. Market Context - Pancreatic cancer is one of the most aggressive cancers, with a global 5-year survival rate of less than 10% and approximately 510,000 new cases and 467,000 deaths annually [3][4]. - The clinical options for second-line treatment of advanced pancreatic cancer are limited, highlighting the urgent need for effective therapies [4]. Regulatory Designations - IBI343 has received Breakthrough Therapy Designation (BTD) from China's National Medical Products Administration (NMPA) and Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) [2][9].

Core Points - Belite Bio, Inc. has received Breakthrough Therapy Designation from the FDA for Tinlarebant, aimed at treating Stargardt disease (STGD1), which currently has no approved therapies [1][2] - The designation is based on interim data from the Phase 3 DRAGON trial, indicating substantial improvement over existing therapies and a favorable safety profile [2][6] - The DRAGON trial is a global study involving 104 subjects across 11 jurisdictions, designed to evaluate the safety and efficacy of Tinlarebant [5][6] Company Overview - Belite Bio is focused on developing novel therapeutics for degenerative retinal diseases, including STGD1 and Geographic Atrophy (GA) [8] - Tinlarebant is an orally administered tablet intended for early intervention in maintaining retinal health, with no current FDA-approved treatments for STGD1 or GA [7][8] - The company is also conducting a Phase 2/3 study (DRAGON II) and a Phase 3 study (PHOENIX) for other related conditions [8] Clinical Trial Insights - The Phase 3 DRAGON trial is randomized, double-masked, and placebo-controlled, with a primary efficacy endpoint focused on the growth rate of atrophic lesions [5] - The trial's completion is expected by Q4 2025, including a three-month follow-up period [6] - Tinlarebant has previously received multiple designations, including Fast Track and Rare Pediatric Disease Designations in the U.S. [6]

sunRIZE enrollment on track including U.S. sites and expected to be completed in May 2025; topline data anticipated in December 2025 U.S. Food and Drug Administration (FDA) grants Breakthrough Therapy Designation to ersodetug for hypoglycemia due to tumor hyperinsulinism REDWOOD CITY, Calif., May 13, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism (HI), today reported financial ...

SOUTH SAN FRANCISCO, Calif., March 31, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) for darovasertib, a potential first-in-class protein kinase C (PKC) inhibitor, for the neoadjuvant treatment of adult patients with primary uveal melanoma (UM) for whom enucleation has bee ...