Strategic Reprioritization of Pipeline
The company has refocused its pipeline to prioritize the development of lonigutamab for thyroid eye disease (TED), showing positive proof-of-concept data with rapid improvements noted within 3 weeks.
Successful Financial Management
The company ended the third quarter with $562.4 million in cash. R&D expenses decreased from $74.6 million in Q3 2023 to $31.6 million in Q3 2024, mainly due to reduced clinical activity in certain trials.
Positive End of Phase II Meeting with FDA
The company completed a positive end of Phase II meeting with the FDA for the lonigutamab program, aligning on important elements for the Phase III registrational program.
Manufacturing Commitments Resolved
Resolved outstanding manufacturing commitments for izokibep, resulting in a net expense of $7.2 million, with a $35.7 million credit voucher for future manufacturing services.
Uveitis Program Progress
Completed enrollment for Phase IIb/III uveitis trial, with results expected in December. Potential for significant market opportunity given its orphan disease status.