Keytruda SC, developed jointly by Merck and Alteogen using ALT-B4, received FDA approval with all doses and all indications covered — a faster-than-expected decision that positions the product for rapid global rollout.

Merck plans aggressive SC conversion, and with Europe also expected to approve in 4Q, global SC penetration is forecast to accelerate significantly across oncology indications.

Alteogen is set to recognize major milestones and royalty revenue, while additional licensing deals are expected as the FDA approval removes the final decision barrier for potential partners.