FDA & Clinical Trials
Upstream Bio Details 56% Reduction in Asthma Exacerbations
Upstream Bio Inc. (Nasdaq: UPB) presented detailed Phase 2 results for verekitug in severe asthma at the European Respiratory Society Congress on September 8, 2026. The company reported that 100 mg of verekitug administered every 12 weeks reduced the annualized asthma exacerbation rate by 56% compared with placebo, meeting the trial’s primary endpoint with a…
CorrectSequence Publishes New Base-Editing Trial Data
The peer-reviewed journal Cell Stem Cell published a study online on September 7 from CorrectSequence Therapeutics (Correctseq), a private, clinical-stage Chinese biotech, describing base-editing gene therapies CS-101 and CS-206 in nine patients with sickle cell disease (SCD) or transfusion-dependent beta-thalassemia (TDT) across several countries. The paper, co-authored with multiple Chinese academic and hospital institutions, extends…
Clover Reports Phase 2 Data for RSV/hMPV/PIV3 Vaccines
Clover Biopharmaceuticals, Ltd. (HKEX: 02197) announced on September 6 positive preliminary Phase 2 data from a trial in Australia testing two combination vaccine candidates, SCB-1022 (targeting RSV and hMPV) and SCB-1033 (targeting RSV, hMPV, and PIV3), in adults ages 60 to 85. The results are notable partly because two of the three viruses involved, human…
Norroy Starts Phase III Trial for Prostate Cancer Therapy
Norroy Bioscience Co., Ltd., a private clinical-stage radiopharmaceutical company based in Wuxi, China, announced on September 2 that China’s National Medical Products Administration (NMPA) has cleared it to begin a pivotal Phase III trial of 177Lu-NYM032, an investigational PSMA-targeted radioligand therapy for metastatic castration-resistant prostate cancer (mCRPC). Norroy is privately held and does not trade…
Akeso Says Ivonescimab Beat Pembrolizumab on Survival
Akeso, Inc. (HKEX: 9926.HK) announced on September 2 that a pre-specified interim analysis of overall survival in its Phase III HARMONi-2 trial met the study’s key secondary endpoint, with what the company describes as a statistically significant and clinically meaningful improvement for ivonescimab over pembrolizumab. Notably, the release does not disclose the actual hazard ratio,…
Ascletis’ ASC30 Enters Phase III After Mixed Phase II Data
Ascletis Pharma Inc. (HKEX: 1672) announced on August 30 that the first participant has been dosed in its global Phase III program for ASC30, an investigational once-daily oral small molecule GLP-1 receptor agonist for chronic weight management. The program consists of two pivotal trials, AURORA-1 (NCT07743463) and AURORA-2 (NCT07743450), expected to enroll roughly 4,600 participants…
FDA Approves J&J’s IMAAVY for Warm Autoimmune Hemolytic Anemia
Johnson & Johnson (NYSE: JNJ) announced on August 24 that the FDA has approved IMAAVY (nipocalimab-aahu) for warm autoimmune hemolytic anemia (wAIHA) in adults and adolescents 12 and older who are currently or previously treated with corticosteroids, making it the first FDA-approved therapy specifically for the disease. The approval followed FDA Priority Review and is…
What Is an Investigator-Initiated Trial? How Academic Research Shapes Drug Development
Not every clinical trial that generates important data about a drug is designed, funded, and run by the company that owns it. Investigator-initiated trials — studies designed and led by independent academic researchers rather than the pharmaceutical or biotech sponsor — are a distinct and often underappreciated category of clinical evidence generation. For biotech investors,…
C2N’s PrecivityAD2 Blood Test Wins Expanded FDA Clearance
The FDA announced on August 20 that it has cleared C2N Diagnostics’ PrecivityAD2 blood test for use in adults as young as 40 who are experiencing signs of cognitive impairment, expanding its authorized use below the 50-and-older threshold the test previously carried. The clearance was announced not by C2N itself but by the Alzheimer’s Drug…
Rein Therapeutics Receives FDA Fast Track Status for LTI-03 in IPF
Rein Therapeutics Inc. (Nasdaq: RNTX) has received U.S. Food and Drug Administration Fast Track designation for LTI-03, its investigational treatment for idiopathic pulmonary fibrosis. The company announced the designation on August 20, 2026, while enrolling patients in its global Phase 2 RENEW trial. Fast Track designation is intended to facilitate the development and review of…
