Cycle Pharmaceuticals Limited

Cycle Pharmaceuticals is a privately-owned, global biotechnology company headquartered in Cambridge, UK, with additional offices in Boston and Detroit, USA. Established in 2012, the company is dedicated to developing and delivering best-in-class drug treatments and support services for patients with rare diseases. Its mission centers on improving patient outcomes by reimagining how drugs can benefit individuals, particularly those with rare genetic metabolic disorders, neurological conditions, oncology, and immunology needs.

The company's portfolio includes a range of specialized treatments such as CAVHANZA™ (nilotinib) Orally Disintegrating Tablets, PHYRAGO™ (dasatinib) Tablets, HARLIKU™ (nitisinone) Tablets, BAFIERTAM® (monomethyl fumarate) Delayed-Release Capsules, VENXXIVA™ (tiopronin) Delayed-Release Tablets, ORMALVI (dichlorphenamide) Tablets, and NITYR® (nitisinone) Tablets. Cycle Pharmaceuticals also provides comprehensive patient support through its Cycle Vita™ program and a Free Goods Programme, aiming to enhance drug efficacy and accessibility through advanced formulation technologies like dissolvable and temperature-stable medications.

Under the leadership of Group CEO James Harrison, Cycle Pharmaceuticals has recently expanded its market presence and pipeline. Notable developments include the February 2026 acquisition of NASDAQ-listed Applied Therapeutics, Inc., which broadened its focus on rare metabolic diseases. The company also launched CAVHANZA™ in August 2026, an FDA-approved treatment for Philadelphia chromosome-positive chronic myeloid leukemia, and PHYRAGO™ in October 2025, marking its entry into the US oncology market. Additionally, HARLIKU™ received FDA approval in June 2025 for Alkaptonuria, further solidifying Cycle's commitment to underserved rare disease communities.