Question · Q3 2025
Crypto Vericonda asked about the rationale for developing a 989 Ruxolitinib combination in both suboptimal responders and Ruxolitinib-naive patients, or if focusing on one would be a better long-term strategy. He also inquired about FDA guidance for 989 endpoints, specifically if SVR35 and TSS50 would be co-primary endpoints and if both must be hit.
Answer
President Pablo Cagnoni stated that decisions on specific pivotal trials for MF are being made, with updates in early 2026. He confirmed the intent to develop 989 to address all mutant CALR-positive MF patients, including naive and Jakafi-treated (suboptimal/intolerant), where both monotherapy and combination with ruxolitinib could play a role. Regarding FDA guidance, he mentioned ongoing discussions for this novel treatment paradigm, believing it will be based predominantly on clinical endpoints. He suggested there's an argument for modifying previous co-primary endpoints (SVR35 and TSS50) and that impact on anemia could be important for the FDA.