Cyprium Therapeutics, a subsidiary of Fortress Biotech, is developing CUTX-101 for the treatment of Menkes diseaseCUTX-101 has potential to be first FDA-approved treatment for Menkes disease; rolling...
NEW YORK and SOLANA BEACH, Calif., Dec. 07, 2021 (GLOBE NEWSWIRE) -- Cyprium Therapeutics, Inc. (“Cyprium”), a Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) partner company, with support from its licensing partner Sentynl Therapeutics, Inc. (“Sentynl”), a wholly owned subsidiary of Cadila Healthcare Limited (“Zydus”), today announced the initiation of a rolling submission of a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for CUTX-101 (“Copper Histidinate”) for the treatment of Menkes disease. The companies expect to complete the submission of the NDA to the FDA in mid-2022.
NEW YORK and SOLANA BEACH, Calif., Oct. 08, 2021 (GLOBE NEWSWIRE) -- Cyprium Therapeutics, Inc. (“Cyprium”), a Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) partner company, with support from its licensing partner Sentynl Therapeutics, Inc. (“Sentynl”), a wholly owned subsidiary of Cadila Healthcare Limited (“Zydus”)
NEW YORK and SOLANA BEACH, Calif., Feb. 24, 2021 (GLOBE NEWSWIRE) -- Cyprium Therapeutics, Inc. (“Cyprium”), a Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) partner company, and Sentynl Therapeutics, Inc. (“Sentynl”), a U.S.-based specialty pharmaceutical company owned by the Zydus Group, today announced the execution of an asset purchase agreement to commit development funding for and acquire Cyprium’s proprietary rights to CUTX-101, its Copper Histidinate product candidate for the treatment of Menkes disease. Under the terms of the agreement, Sentynl will make an upfront cash payment to Cyprium, provide additional cash payments upon the achievement of certain regulatory milestones, and pay royalties and commercial milestone payments based on the net sales of CUTX-101. Cyprium will retain development responsibility of CUTX-101 through approval of the New Drug Application (“NDA”) by the U.S. Food and Drug Administration (“FDA”), and Sentynl will be responsible for commercialization of CUTX-101 as well as progressing newborn screening activities. Continued development of CUTX-101 will be overseen by a Joint Steering Committee consisting of representatives from Cyprium and Sentynl.
Cyprium Therapeutics, Inc. and Sentynl Therapeutics, Inc., a U.S.-based specialty pharma company owned by the Zydus Group, executed an agreement to acquire Cyprium’s rights to CUTX-101, its Copper Histidinate product candidate for the treatment of Menkes disease.