Receiving a third complete response letter (CRL) from the U.S. FDA for its bevacizumab formulation, ONS-5010, to treat wet age-related macular degeneration, Outlook Therapeutics Inc. watched its stock (NASDAQ:OTLK) plummet nearly 62% to a 52-week low of 60 cents on Jan. 2.

Over the course of the year, and continuing into the latest scientific meetings, an extraordinary breadth of new antibody-drug conjugate (ADC) designs was reported, with innovations spanning targets, linkers, payloads, conjugation chemistries and overall architectures. Once defined by a simple “one target, one payload” model, the field is lately expanding into a more versatile and diverse therapeutic space.

On the last day of the year, shares of Axsome Therapeutics Inc. rose 22% on news that the U.S. FDA accepted and granted priority review of the company’s supplemental NDA for AXS-05 to treat Alzheimer’s disease agitation, a $1 billion-plus opportunity, scheduling the PDUFA date for April 30.

Wife-and-husband team, J. Jean Cui and Y. Peter Li, launched Blossomhill Therapeutics Inc. in mid-2020 to focus on next-generation, macrocyclic inhibitors against oncology targets. The couple had planned to take some time off to rest and do a little traveling, but then the pandemic hit. “This was a great time [to start a new company],” Cui told BioWorld. “Nothing to do but reading and thinking.”

The U.S. FDA dashed hopes that Corcept Therapeutics Inc. might be able to launch its selective glucocorticoid receptor antagonist in two indications in 2026, issuing a complete response letter for relacorilant for use in patients with hypertension secondary to hypercortisolism, also known as Cushing syndrome. Focus is now on the July 2026 PDUFA date, as Corcept seeks approval for the same drug as a treatment for patients with platinum-resistant ovarian cancer.

The U.S. FDA has approved its first pharma treatment in more than 40 years for motion sickness. The green light for Nereus (tradipitant), from Vanda Pharmaceuticals Inc., was based on three clinical studies, all pivotal, including two phase III real-world trials with patients on boats and another supporting study.