The FDA has granted Breakthrough Therapy designation to Legacy Healthcare's investigational topical treatment CINAINU for moderate-to-severe alopecia areata from age two. A pediatric trial showed statistically significant hair-regrowth benefits, although the primary efficacy analysis included only 62 of 107 randomized patients.
TuHURA has secured a US patent covering TBS-2025 and related VISTA-targeting antibody designs through February 2042. The intellectual property expansion follows FDA clearance of an early-stage AML study, but clinical efficacy and commercialization remain unproven.
The FDA has accepted FYB206, a proposed biosimilar to Merck's Keytruda, for review, with a decision potentially due in the third quarter of 2027. Zydus and Formycon pursued a streamlined development programme without a comparative Phase 3 efficacy trial, but approval, patent clearance and commercial launch remain separate hurdles.
New Phase 3 AFFIRM data show 35.8% endoscopic remission and 36.6% ulcer-free endoscopy with subcutaneous Skyrizi at Week 24. The findings support regulatory applications for an alternative to intravenous induction, although differences in treatment allocation after Week 12 require careful interpretation.
Paradigm Therapeutics has received its second consecutive Prix Galien USA nomination for SD-101, an investigational whole-body epidermolysis bullosa cream. A new pediatric Phase 3 study offers another opportunity to establish efficacy after the earlier ESSENCE trial failed its primary endpoints.
Avenzo's partner VelaVigo will disclose early human safety and efficacy findings for the Nectin-4/TROP2 antibody-drug conjugate VBC103 at ESMO Asia 2026. The presentation could clarify the clinical potential of dual-antigen targeting, while a separate United States study advances in urothelial cancer.
Applied Biologics begins Phase 3 testing of BIOxHEAL for diabetic foot ulcers. Explore its wound-healing potential and trial milestones.
Entera Bio reports stronger EB613 bone density gains in Phase 2 osteoporosis analysis. Explore the results and upcoming Phase 3 trial plans.
Soufflé secures $135 million as its FSHD RNA therapy trial recruits patients. Examine the REMEDY platform, Bayer partnership and clinical risks.
Aulos Bioscience will present Phase 2 findings for imneskibart, low-dose interleukin-2 and avelumab in checkpoint-resistant lung adenocarcinoma. Earlier findings showed tumor shrinkage in a small cohort, but the forthcoming ESMO data must establish response rates, durability and safety more clearly.