Epizyme’s Tazverik Gets To Market In Rare Sarcoma, Paving Way To Bigger Indications
Accelerated approval in epithelioid sarcoma may de-risk the firm’s goals for approval of Tazverik in follicular lymphoma and other larger indications.
You may also be interested in...
Lilly partners with Kumquat to discover small molecule IO drug. Kite, Appia Bio collaborate on allogeneic cell therapies. AstraZeneca and Regeneron pursue novel metabolic therapies targeting GPR75. Lexeo and Stelios merge to focus on gene therapies for rare cardiovascular indications.
US FDA reviewers recommended against accelerated approval of Epizyme’s tazemetostat for epithelioid sarcoma, finding the modest overall response rates were not substantial evidence of an improvement over available therapies; they were overruled by senior oncology review staff, who cited a unanimous ODAC endorsement and the regulatory flexibility encouraged for rare diseases.
Public Company Edition: The gene therapy firm’s IPO priced at $18 and ended its first day up 23.3% at $22.20 but fell to $21.50 when stocks recovered on 2 March. Also, RedHill raised $115m for product launches and Movantik purchase, and Avadel raised $65m to compete with Jazz.