Shots:
The US FDA has granted Nereus for the prevention of vomiting induced by motion, backed by 3 trials, incl. 2 P-III real-world boat studies (Motion Syros & Motion Serifos) & 1 supporting study in pts with documented motion sickness
In Motion Syros (n=365) & Motion Serifos (n=316), vomiting incidence was 18.3–19.5% & 10.4–18.3% vs 44.3%…
Shots:
The FDA has received Vanda’s BLA for imsidolimab to treat GPP, with a priority review requested that could enable potential approval as early as mid-2026
BLA was supported by global P-III (GEMINI-1 & 2) trials, where GEMINI-1 (n=45) evaluated a single IV dose of imsidolimab (300 or 750mg) vs PBO, & GEMINI-2 re-randomized pts…
Shots:
The US FDA has accepted NDA of Bysanti, an active metabolite of iloperidone to treat acute bipolar I disorder & schizophrenia (PDUFA: Feb 21, 2026). If approved, Bysanti may receive 5yrs. of data exclusivity, with pending patents extending into the 2040s
NDA is backed by various iloperidone trials, incl. 2 in acute schizophrenia, 1…
Shots:
Vanda received exclusive rights to develop, manufacture & commercialize imsidolimab which has completed 2 P-III (GEMINI-1 & GEMINI-2) trials for generalized pustular psoriasis
As per the terms, Anaptys will get $10M upfront, $5M for existing drug supply, & ~$35M in regulatory & sales milestones, plus 10% royalty on net sales, whereas Vanda will…

