U.S. FDA Grants Fast Track designation for HLX-1502 in Neurofibromatosis Type 1 (NF1) Treatment

We are proud to announce a significant milestone for Healx: our lead program asset, HLX-1502, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of neurofibromatosis type 1 (NF1). This recognition not only affirms the critical patient need for new therapeutic solutions in NF1, but also opens an expedited regulatory pathway, helping us bring the HLX-1502 drug candidate to patients more swiftly. Why Fast Track designation Matters 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. For our team, it means increased interaction with FDA experts throughout the development process, allowing us to gain early feedback on crucial steps, such as clinical trial design and approval pathways. Ultimately, it helps streamline our path to patients, ensuring more regulatory support and reducing time to marketing approval. The Urgent Need in NF1 NF1 is a rare genetic disorder associated with predisposition to develop multiple benign and malignant tumors. It affects approximately 1 in 2,500 individuals. Two notable types of tumors associated with NF1 are plexiform neurofibromas and cutaneous neurofibromas. Plexiform neurofibromas are complex tumors growing aggressively along nerves, which often lead to significant morbidity and risk of malignant transformation. The current treatment options for NF1 are limited, and there is a pressing need for new therapies that can provide safe, effective relief from symptoms and improve quality of life for those affected. Our Work with HLX-1502 At Healx, we have dedicated our research to developing innovative therapies to address rare diseases, with HLX-1502 leading the way in our NF1 program. The Fast Track designation reinforces our belief in HLX-1502’s first-in-class disease-modifying potential to change the treatment landscape for NF1 and ultimately, improving patients’ lives. What’s Next for HLX-1502 As we progress, we’ll be sharing more updates on the clinical development of HLX-1502. Our mission is to keep advancing toward our goal of offering transformative solutions in rare disease therapeutics. We’re grateful for the continued support of the NF1 community, our partners, academic collaborators and the FDA as we work together to make a difference. Stay tuned for more developments, and thank you for joining us on this journey. Together, we’re advancing the future of rare disease treatments. Share this story You might also like: News & Opinion Healx Announces First Patient Dosed in Phase 1/2 Trial to Evaluate the Effect of HLX-4310 on Metastatic Recurrence and Progression in Sarcomas with a Focus on Osteosarcoma [email protected] In the media Giovanni Cincilla, Peter Wright and Triin Tammsalu explore Target Tractability with KNIME in the latest Medium blog post [email protected] News & Opinion Healx Strengthens Focus on Preventing Cancer Recurrence by Leveraging Its AI-Powered Platform and Advancing Its Oncology Pipeline Through a Strategic Transaction with Vuja De Sciences Robert Bogdan Headquarters Healx Ltd. Charter House 66-68 Hills Rd Cambridge, CB2 1LA, UK Tel: 01223 901980 Our company About Technology Pipeline Our work Community Engagement Partnerships News & Events Policies Cookie policy Diversity, Equity and Inclusion policy Privacy policy Compassionate use policy Get in touch Careers Contact © Healx. All rights reserved. Company registration: 09018507. VAT number GB212364641. We use cookies to help us improve our website. For more information, please review our Cookie Policy . Accept cookies

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