Clinical Trial SuccessDCCR achieved placebo-controlled statistical significance on the primary endpoint, which strengthens its case for approval.
Financial PositionAs of September 30, Soleno had cash, equivalents, and marketable securities of $284.7M, indicating a strong financial position.
Regulatory ProgressThe FDA accepted the NDA for DCCR with priority review, indicating a fast-tracked process due to its potential impact on a high unmet need patient population.