Fast track designation stories

Nov 1, 2026

Setara Biosciences launches with $90M for rare disease drug development

Setara Biosciences has started operations with $90 million in funding and a lead drug candidate already in clinical trials for Charcot-Marie-Tooth disease type 2C and overactive bladder.

Nov 1, 20264 sources

Sep 21, 2026

FDA grants breakthrough therapy designation for DT120 ODT in depression treatment

The FDA has granted breakthrough therapy designation to Definium Therapeutics' DT120 Orally Disintegrating Tablet after preliminary clinical evidence showed significant improvements in treating major depressive disorder.

Sep 21, 20261 source

May 10, 2026

China's NHWD-870 Receives Breakthrough Therapy Designation for Rare NUT Carcinoma

Chinese innovative drug NHWD-870 has received Breakthrough Therapy Designation for NUT carcinoma, a rare and aggressive cancer that has historically had very poor outcomes. The designation represents a significant milestone for patients with this previously untreatable condition.

May 10, 20261 source

May 7, 2026

Sanofi Withdraws Diabetes Drug from FDA's Expedited Review Program After Political Interference

Sanofi requested the FDA remove its type 1 diabetes drug from Commissioner Marty Makary's new speedy drug review voucher program after a political appointee interfered with the review process.

May 7, 20261 source

Top claims

▪Setara Biosciences applies a strategy that starts with rare genetic diseases to identify targets and then expands those biological insights to treat broader, more prevalent conditions
▪Setara Biosciences completed the healthy volunteer Phase 1 trial of STAR-0871 and plans to expand into a Phase 1b study in Charcot-Marie-Tooth disease type 2C patients in 2027
▪Investors participating in Setara Biosciences' $90 million Series A financing included Deerfield Management, Canaan, Droia Ventures, EcoR1, Euclidean Capital, Regeneron Ventures, and Jazz Pharmaceuticals

Subtopics

Accelerated approval pathways3 Drug Approval and Clinical Trials3 Drug Policy, Pricing & Approval3 Clinical trials2 Biotech startup1 Cancer & Oncology1 Cancer Treatment & Therapies1 Cancer Types1 Depression1 Drug development1 FDA considers first psychedelic drug approval1 Healthcare Policy1 Mental Health & Wellbeing1 Orphan drug designation1 Rare diseases1 Rare genetic diseases1 Stress, Burnout & Well-being1 Venture capital funding1

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