SpringWorks scores FDA priority review: The agency accepted mirdametinib’s new drug application and granted it a priority review for the treatment of adult and pediatric patients with neurofibromatosis type 1-associated plexiform neurofibromas. The PDUFA date is Feb. 28, 2025. According to SpringWorks, if approved the MEK inhibitor would be the first approved therapy for the treatment of adult patients. The company said the FDA is not planning to hold an advisory committee meeting. — Katherine Lewin
Jeune Aesthetics touts positive Phase 1 data for skin aging treatment: In interim data revealed Wednesday, Jeune said its drug KB301 increased collagen levels in the skin of patients and improved signs of wrinkles. Patients in two cohorts — one with dynamic wrinkles and another with crow’s feet — also saw improvements in other skin assessments including hydration and radiance. — Katherine Lewin
Hyundai Bioscience targets emergency use of Covid treatment in Korea: Hyundai submitted an application for its treatment Xafty to Korea’s regulatory agency on Tuesday for mild-to-moderate cases of Covid-19 in patients with a risk of developing severe complications, including those over 60 or who are immunocompromised. Hyundai CEO Oh Sang-gi said the company will continue the emergency authorization process while also conducting another Phase 3 trial in high-risk patients. — Katherine Lewin
Arcus Biosciences takes loan to fund kidney cancer drug: The biotech company is borrowing up to $250 million from Hercules Capital to fund the development of its drug casdatifan in clear cell renal cell carcinoma, a form of kidney cancer. Arcus has drawn $50 million of the loan already, with another $100 million approved for use. Hercules would have to agree to lend the additional $100 million. — Drew Armstrong