MoonLake Immunotherapeutics Receives Unanimous Support for Phase 3 Trial of Sonelokimab in Hidradenitis Suppurativa from FDA and EMA Company: MoonLake Immunotherapeutics Indication: Hidradenitis Suppurativa (HS) Drug: Sonelokimab (SLK) Trial Phase: Phase 3 NCT ID: NCT05322473 Overview MoonLake Immunotherapeutics, a clinically-focused biopharmaceutical company, has announced a significant milesto..
Akili and Shionogi Declare Success in Phase 3 Clinical Trial for EndeavorRx as ADHD Treatment for Japanese Children Overview Company: Akili, Inc. & Shionogi & Co. Ltd Indication: Pediatric ADHD Drug: SDT-001 (localized version of AKL-T01 / EndeavorRx) Trial Phase: Phase 3 NCT ID: N/A Akili, Inc., in collaboration with Shionogi & Co. Ltd, announced the successful completion of a Phase 3 clinical ..
CG Oncology Initiates PIVOT-006 Phase 3 Trial for Cretostimogene Targeting Intermediate-risk NMIBC Overview Company: CG Oncology, Inc. Indication: Intermediate-risk Non-Muscle Invasive Bladder Cancer (NMIBC) Drug: Cretostimogene Trial Phase: Phase 3 NCT ID: NCT06111235 Trial Details On February 27, 2024, CG Oncology announced the commencement of their Phase 3 PIVOT-006 clinical trial. This pivot..
Tonix Pharmaceuticals Reveals Promising Pharmacokinetics of Cyclobenzaprine for Fibromyalgia in Japan and China Company: Tonix Pharmaceuticals, Inc. Indication: Fibromyalgia Drug: Tonmya™ (TNX-102 SL, cyclobenzaprine HCl sublingual tablets) Trial Phase: Phase 3 NCT ID: N/A Overview Tonix Pharmaceuticals, Inc., a pioneering biopharmaceutical company, disclosed favorable outcomes from its pharmaco..
PolarityTE Commences Phase III Trial for SkinTE in Diabetic Foot Ulcers Overview Company: PolarityTE Indication: Diabetic foot ulcers Drug: SkinTE Trial Phase: Phase 3 NCT ID: Not provided PolarityTE has initiated the first subject screening for their Phase III pivotal study, entitled 'COVER DFUS II', which investigates the use of their novel product SkinTE for the treatment of Wagner grade 1 di..
MoonLake Immunotherapeutics Receives Endorsement from FDA and EMA for Phase 3 Program of Sonelokimab in Treating Hidradenitis Suppurativa MoonLake Immunotherapeutics, an innovative biopharmaceutical company, has received the green light from key health authorities—the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA)—for the advancement of their Phase 3 clinical tri..
Harmony Biosciences, a pharmaceutical company focused on developing therapies for rare neurological diseases, has announced its plans to conduct a Phase 3 registrational study of pitolisant in individuals with Prader-Willi syndrome (PWS) who are experiencing excessive daytime sleepiness (EDS). This study will include children, adolescents, and adults with PWS. The decision to proceed with the st..
Akari Therapeutics, a late-stage biotechnology company, has provided updates on the development of its drug nomacopan for the treatment of pediatric and adult hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA). The company is making progress towards initiating a Phase 3 study of nomacopan in pediatric HSCT-TMA by the end of 2023. Furthermore, Akari plans to commence..
Biophytis, a clinical-stage biotechnology company, has submitted an application for authorization with the FDA to initiate the SARA-31 Phase 3 study in sarcopenia. The purpose of this study is to assess the effectiveness and safety of Sarconeos (BIO101) in treating sarcopenic patients who are at risk of mobility disability. The company anticipates receiving a response from regulatory authorities..
