After changing its name from Yaupon Therapeutics Inc. to Ceptaris Therapeutics Inc. in January, Ceptaris has raised $15 million in a venture debt financing to help fund its transformation from a clinical-stage company to one that anticipates commercializing its first product later this year. Mechlorethamine gel, a topical gel formulation of a generic cytotoxin, has a PDUFA date of May 27 for an indication of early-stage cutaneous T-cell lymphoma (CTCL).
Ceptaris filed an NDA last July 28 for its stable formulation of mechlorethamine, backed by a 260-patient pivotal Phase III trial in which the gel demonstrated non-inferiority against a compounded ointment form of the chemotherapeutic. The primary endpoint was a 50% score improvement on the Composite Assessment of Lesion Index scoring system
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