Soleno Bounces Back With New Prader-Willi Data After Regulatory Setbacks
Executive Summary
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.
You may also be interested in...
Finance Watch: Adlai Nortye Raises $97.5m In IPO, Brings US Total To 18
Public Company Edition: Cancer-focused Adlai Nortye launched a concurrent initial public offering and private placement, while four other drug developers announced or completed SPAC mergers. Also, Sobi grossed $540m in a rights issue and Immunovant followed early data with a $450m FOPO.
Soleno Shaken By FDA Demand For Second DCCR Phase III Trial In PWS
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.
Levo Product Joins List Of Prader-Willi Syndrome Trial Failures
Attempts at developing an effective therapy for PWS, and the abnormal desire for food associated with the rare disorder, have been fruitless but Levo Therapeutics' enthusiasm for LV-101 remains high, despite a Phase III setback.