FDA Grants Fast Track Designation to Healx NF1 Treatment

The Children's Tumor Foundation's support of the NF1 programs at Healx is accelerating progress! We are happy to share that Healx's lead compound, HLX-1502, has been grantedFast Track designation by the Food and Drug Administration (FDA) for the treatment of NF1. This recognition affirms the critical patient need for new therapeutic solutions in NF1 and opens an expedited regulatory pathway, helping bring the HLX-1502 drug candidate to patients more swiftly.

The Fast Track designation is awarded by the FDA to facilitate the development and review of drugs that treat serious conditions and fill unmet medical needs. Ultimately, it helps streamline the path to patients, ensuring more regulatory support and reducing time to marketing approval.

Healx partnered with CTF in 2020 to combine its cutting-edge AI platform and drug discovery expertise in identifying novel treatments for rare diseases such as NF1 with CTF's preclinical and clinical research and patient knowledge.

Tim Guilliams, PhD, co-founder and CEO, Healx said of the investment from CTF: "CTF is a long-standing partner of Healx, and this investment underscores their confidence in the potential of Healx's neurofibromatosis program to bring novel treatments to patients with unmet need."

Simone Manso, Head of NF Strategic Partnerships at Healx, leads the collaborative drug discovery efforts and serves as a member of the Board of Directors of CTF Europe and CTF.

Click here to read more from our partners at Healx.