The US biotech has released new positive data from two late-stage studies in the rare disease after the US FDA asked for more controlled data following an initial disappointment.

US FDA points to inconsistency in Phase II and Phase III study results, lack of additional substantiating studies and lack of robust statistical findings. Advisory committee is to vote on whether there is ‘substantial evidence’ that the nasal spray is effective in treatment of hyperphagia associated with Prader-Willi syndrome.

Tempest goes public via a reverse merger with Millendo. Takeda inks its ninth deal of 2021, a discovery pact with BridGene around its chemoproteomics technology.

The US FDA has asked Soleno to conduct another Phase III Study evaluating its chief asset in Prader-Willi syndrome patients prior to any NDA submission, rattling investors and clouding the company’s prospects.