Dr Arun Swaminathan tells Salong Debbarma how COYA 302’s FDA fast track status is shaping Coya’s next steps, from accelerating ALSTARS enrolment to aligning earlier with regulators on a path to clinically meaningful benefit.
Parabilis’ US listing means the biotech IPO record has been broken twice in as many months as public listings continue hot streak.
If approved, adrabetadex would be the third addition to the I-NPC treatment paradigm.
XtalPi stands to receive further payments based on clinical and commercial milestones, as well as future royalties.
The application is supported by data from the Phase III OCEANIC-STROKE study.
Phase III data suggest oral PCSK9 inhibitor enlicitide delivers substantial LDL-C lowering without compromising glycemic control.