Soleno Therapeutics, Inc.

Soleno Therapeutics secured a $200M loan from Oxford Finance LLC, with an initial $50M drawn. The loan supports Soleno's DCCR tablets for Prader-Willi syndrome, pending FDA approval. Soleno's financials show $334.7M in cash and equivalents post-initial draw. The loan terms include a 48-month interest-only period and a 60-month term.

Soleno Therapeutics received FDA feedback on DCCR for Prader-Willi syndrome (PWS) treatment, agreeing on a Phase III study design focusing on hyperphagia score change. The study, targeting 100 patients, is set to start by end of 2017, aiming for a shorter duration and long-term safety assessment.

Soleno Therapeutics announced the FDA extended the PDUFA target action date for DCCR tablets to March 27, 2025, due to a major amendment to the NDA. DCCR, aimed at treating Prader-Willi syndrome, showed promise in addressing hyperphagia and other symptoms in clinical trials.

Soleno Therapeutics announced the FDA extended the review period for DCCR tablets' NDA for Prader-Willi syndrome treatment to March 27, 2025, due to a major amendment. No safety or efficacy concerns were cited. DCCR targets hyperphagia, a key PWS symptom, with no current approved therapies addressing it.

Soleno Therapeutics announced the FDA extended the PDUFA target action date for DCCR tablets to March 27, 2025, due to a major amendment to the NDA. DCCR, aimed at treating Prader-Willi syndrome, has shown promise in addressing hyperphagia and other symptoms. No safety or efficacy concerns were cited by the FDA.

Soleno Therapeutics announced the FDA extended the review period for DCCR tablets' NDA for Prader-Willi syndrome treatment to March 27, 2025, due to a major amendment. No safety or efficacy concerns were cited. DCCR targets hyperphagia, a key PWS symptom, with no current approved therapies addressing it.

Soleno Therapeutics announced the FDA extended the PDUFA target action date for DCCR tablets to March 27, 2025, due to a major amendment to the NDA. DCCR, aimed at treating Prader-Willi syndrome, has shown promise in addressing hyperphagia and other symptoms. No safety or efficacy concerns were cited by the FDA.

Soleno Therapeutics announced the FDA extended the review period for DCCR tablets' NDA for Prader-Willi syndrome treatment to March 27, 2025, due to a major amendment. No safety or efficacy concerns were cited. DCCR targets hyperphagia, a key PWS symptom, with no current approved therapies addressing it.