Dec. 6 Quick Takes: Acadia looks to mid-2022 NDA for trofinetide after Rett data

Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) rose $4.23 (22%) to $23.63 in after-hours trading Monday after it reported top-line results from a Phase III study of trofinetide in Rett syndrome, a rare neurological disorder. The synthetic analog of the amino‐terminal tripeptide of IGF-1 demonstrated a statistically significant improvement over placebo for both co-primary endpoints — symptom improvement as measured by the Rett Syndrome Behavior Questionnaire, where the change from baseline to week 12 was -5.1 vs. -1.7 (p=0.0175; effect size=0.37); and Clinical Global Impression–Improvement score at week 12, which was 3.5 vs. 3.8 (p=0.0030; effect size=0.47). Acadia plans to submit an NDA in mid-2022.

Johnson & Johnson (NYSE:JNJ) is making the case for a modality mix-and-match booster strategy for COVID-19, showing its Ad26.COV2.S vaccine, when used as a booster dose after an mRNA vaccine, led to comparable antibody levels and a greater T cell response. In an Israeli study of 65 participants who received two doses of BNT162b2 from Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) at least six months earlier, an Ad26.COV2.S booster (n=41) increased median neutralizing antibody levels four weeks after the boost to 3,597, 2,198 and 1,924 against the WA1/2020, delta and beta variants, respectively, whereas a BNT162b2 boost led to median increases of 5,553, 1,968 and 1,576 in a pseudovirus assay. The Ad26.COV2 booster led to S-specific CD8+ T cell responses between 0.72% and 0.83% against the three strains, vs. 0.18-0.26% after the BNT162b2 boost...