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Latest From Soleno Therapeutics, Inc.
Promising Pathway Act Would Fill Gap For Rare Disease Treatments That Don’t Fit Accelerated Approval, Advocates Say
Bill would enable two-year provisional approval of drugs to treat life-threatening illnesses, such as ALS, based on substantial evidence of safety and early evidence of efficacy. At a Senate committee hearing, rare disease advocates said it would remedy the FDA’s inconsistent application of regulatory flexibility, but a bioethicist cautions it would lower the bar for approval.
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.
Novartis revealed detailed terms and a 4 October spin-off date for Sandoz’s standalone debut. Also, MIRA launched a small IPO, but two firms plan to go public in SPAC mergers. Also, Mirati’s $345m offering leads follow-ons offerings and Sangon Biotech raised $290m in venture capital.
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.
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- Capnia, Inc.
- Essentialis, Inc.
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