Tags : Acceptance

Regulatory

Exelixis Reports the US FDA’s Acceptance of IND for XB002

Shots: The US FDA has accepted IND to assess the safety, tolerability, PK, and preliminary antitumor activity of XB002 in patients with advanced solid tumors. The P-I trial is expected to initiate in Q2’21 The preclinical data demonstrated that XB002 binds to tissue factors without affecting the coagulation cascade, in contrast with prior therapies in […]Read More

Regulatory

BMS Reports the US FDA’s Acceptance of NDA for Mavacamten

Shots: The NDA submission is based on results from the P-III EXPLORER-HCM trial involves assessing Mavacamten vs PBO in 251 patients with symptomatic oHCM. The FDA has anticipated a PDUFA date of January 28, 2022 The P-III EXPLORER-HCM trial results demonstrated the robust treatment effect, with patient responses to treatment, including reductions in symptoms, functional […]Read More

Regulatory

Regeneron and Sanofi Report the US FDA’s Acceptance of sBLA

Shots: The sBLA is based on P-III study assessing Dupixent + SOC maintenance therapy in children aged 6-11yrs. with moderate-to-severe asthma with type 2 inflammation The study resulted in a reduction of severe asthma attacks and rapidly improved lung function within 2wks, safety results were generally consistent with the known safety profile of Dupixent. Dupixent […]Read More

Regulatory

Incyte Reports the US FDA’s Acceptance of sNDA for Priority

Shots: The sNDA submission is based on the P-III REACH3 study assessing ruxolitinib vs best available therapy in adult and pediatric patients ≥12yrs. with steroid-refractory chronic GVHD. The findings were recently presented at the 62nd ASH Annual Meeting & Exposition The study showed greater ORR @24wks. i.e 1EPs (49.7% vs 25.6%); @24wks. mFFS (not reached […]Read More