Financings in Brief: Applied Immune Sciences
This article was originally published in The Gray Sheet
Executive SummaryApplied Immune Sciences: Receives $21.5 mil. in cash from the sale of newly issued common stock to Rhone-Poulenc Rorer. The sale was made in conjunction with AIS' meeting the second of three funding milestones under a 1993 strategic alliance between the two companies ("The Gray Sheet" June 7, 1993, p. 10). AIS reached the milestone by gaining FDA approval for a clinical trial investigating "a new approach to adjunctive leukemia therapy that is based on research indicating that infused T cell depleted donor peripheral blood improves the immune response of the leukemia patient after allogeneic bone marrow transplantation." AIS received a $21 mil. investment from RPR in January following approval of an investigational device exemption for the AIS CELLector device for purging T and B cells from allogeneic bone marrow ("The Gray Sheet" Jan. 23, 1995). The CELLector will be used in the newly approved trial as well...
You may also be interested in...
Attorneys say Sarepta did not have an obligation to report its appeal, particularly since winning a formal dispute filing with the US FDA is a long shot.
Sarepta’s Vyondys: Renal Toxicity Concerns That Delayed Approval Get Enhanced Postmarketing Scrutiny, Label Warning
Sarepta must perform enhanced pharmacovigilance for serious renal toxicity events and rhabdomyolysis with the Duchenne muscular dystrophy drug, which carries a label warning for renal toxicity. Approval letter includes 2024 target completion date for ESSENCE confirmatory trial.
Efficacy data were striking to committee members, but they want to ensure postmarketing plans gather adequate data to address safety questions.