Global Biotech Weekly

This week, we highlight key PDUFA and regulatory catalysts for the next 6 months.Verastem (NASDAQ: VSTM) is a late-stage oncology company with a market cap of approximately US$227m and a float of 30.33m shares. As of year-end 2024, it reported US$88.8m in cash and investments, with a pro forma balance of US$151.3m following debt refinancing and equity issuance. Despite a signifiThe company’s lead program the combination of avutometinib (RAF/MEK clamp) and defactinib (FAK inhibitor) targets KRAS mutant recurrent low-grade serous ovarian cancer (LGSOC). The New Drug Application (NDA) for this combo therapy was accepted by the FDA under the accelerated approval pathway and grAbeona Therapeutics (NASDAQ: ABEO) is a clinical-stage biotech company with a market cap of approximately US$214m and a float of 32.13m shares. As of 31 December 2024, the company reported US$98.1m in cash, short-term investments, and restricted cash, an increase from US$52.6m a year earlier. This pAbeona’s lead program, pz-cel (prademagene zamikeracel), is an autologous, COL7A1 gene-corrected epidermal sheet therapy in development for recessive dystrophic epidermolysis bullosa (RDEB), a devastating genetic skin disorder. The BLA is under FDA priority review, with a PDUFA date of 29 April 2025Outlook Therapeutics (NASDAQ: OTLK) is a development-stage biopharmaceutical company with a market cap of approximately US$41m and a float of 22.54m shares. The company is pre-revenue, reporting an annual net loss of nearly US$74m, and holds about US$6.6m in cash, suggesting a need for additional caONS-5010 / LYTENAVA is currently under review by the U.S. FDA, with a Class 2 resubmission of its BLA accepted on 28 February 2025, and a new PDUFA date set for 27 August 2025. The resubmission follows a CRL issued in August 2023 and includes updated CMC data and full results from the pivotal NORSE