First Wave BioPharma (NASDAQ:FWBI) shares have surged by nearly 101% in the pre-market session today, as the clinical-stage biopharmaceutical company announced a licensing deal with Sanofi (NASDAQ:SNY) for capeserod. FWBI plans to repurpose and develop the drug for gastrointestinal (GI) indications.
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The deal grants FWBI an exclusive, global license for capeserod, and the company will assume responsibility for its future clinical advancement. The agreement involves a modest upfront payment, backend milestone payments, and single-digit royalties on net sales of the product.
Furthermore, Sanofi has a right of first refusal to reacquire capeserod after certain clinical development and commercialization stages of the product. Capeserod has potential applications in multiple gastrointestinal disorders. Sanofi has so far conducted seven Phase 1 and 2 studies of the drug in neurological disorders.
The drug has been observed to be safe and well tolerated, and FWBI plans to immediately seek a meeting with the U.S. Food and Drug Administration to set up a development and regulatory plan for the drug in GI diseases. Next, the biotech plans to begin Phase 2 clinical studies for capeserod in 2024.
Today’s price gains come after a nearly 97.5% nosedive in First Wave shares over the past year.
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