REGULATORYRFK Jr.: 14 peptides returning to Category 1 — FDA advisory committee July 2026UPDATESemaglutide and tirzepatide compounding ended — shortage resolved Feb/May 2025REGULATORYBPC-157, TB-500, thymosin alpha-1, CJC-1295, ipamorelin: expected Category 1 reclassification pendingFDAFDA advisory committee meetings scheduled: late July 2026RESEARCHTranslational Health Research Into Vascular and Neurocognitive Effects of Weight Loss [NCT07592546]RESEARCHA Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes) [NCT07165028]RESEARCHTirzepatide in the Treatment of Endometrial Cancer [NCT07605247]RESEARCHA Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes During Ramadan [NCT06635057]RESEARCHA Study of LY3457263 Compared With Placebo in Participants With Type 2 Diabetes on a Stable Dose of Semaglutide or Tirzepatide [NCT06897475]RESEARCHA Phase 2 Study of Vosoritide in Children With Idiopathic Short Stature [NCT06382155]RESEARCHMetabolic Effects of Angiotensin-(1-7) [NCT02646475]RESEARCHMulti-Site Trial of Tirzepatide for Smoking Cessation [NCT07602699]RESEARCHEvaluation of Tirzepatide as an Adjunct to Buprenorphine for the Treatment of Opioid Use Disorder [NCT06651177]NEWSOorja, run by Acceleron veterans, launches to make new fibrosis drugsREGULATORYRFK Jr.: 14 peptides returning to Category 1 — FDA advisory committee July 2026UPDATESemaglutide and tirzepatide compounding ended — shortage resolved Feb/May 2025REGULATORYBPC-157, TB-500, thymosin alpha-1, CJC-1295, ipamorelin: expected Category 1 reclassification pendingFDAFDA advisory committee meetings scheduled: late July 2026RESEARCHTranslational Health Research Into Vascular and Neurocognitive Effects of Weight Loss [NCT07592546]RESEARCHA Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes) [NCT07165028]RESEARCHTirzepatide in the Treatment of Endometrial Cancer [NCT07605247]RESEARCHA Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes During Ramadan [NCT06635057]RESEARCHA Study of LY3457263 Compared With Placebo in Participants With Type 2 Diabetes on a Stable Dose of Semaglutide or Tirzepatide [NCT06897475]RESEARCHA Phase 2 Study of Vosoritide in Children With Idiopathic Short Stature [NCT06382155]RESEARCHMetabolic Effects of Angiotensin-(1-7) [NCT02646475]RESEARCHMulti-Site Trial of Tirzepatide for Smoking Cessation [NCT07602699]RESEARCHEvaluation of Tirzepatide as an Adjunct to Buprenorphine for the Treatment of Opioid Use Disorder [NCT06651177]NEWSOorja, run by Acceleron veterans, launches to make new fibrosis drugs

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Pharma

Bicycle Therapeutics

Cambridge, UK
BCYC
W

About

Bicycle Therapeutics is a UK-based clinical-stage biopharmaceutical company pioneering a new class of medicines called Bicycle drug conjugates (BDCs). The company's proprietary Bicycle platform generates fully synthetic, constrained bicyclic peptides that combine the pharmacology of biologics with the properties of small molecules. Their lead candidate, zeladenoson (BT8009), is a Nectin-4 targeting BDC in clinical trials for advanced solid tumors. The company is also advancing BT5528 (EphA2-targeting) and BT7480 (Nectin-4 × CD137 bispecific) through clinical development. Bicycle Therapeutics is headquartered in Cambridge, UK with operations in Cambridge, MA and is listed on NASDAQ (BCYC).

Approved Drugs

BT8009BT5528bicycle peptide