Fortress Biotech Inc (NASDAQ:FBIO)
Fortress Biotech Inc (NASDAQ:FBIO) reported the creation of a new subsidiary firm, Cyprium Therapeutics, Inc., to advance therapies for the cure of Menkes disease and linked copper metabolism disorders. The subsidiary firm has entered into a CRADA with the Eunice Kennedy Shriver NICHD, part of the NIH, to support the clinical advancement of Phase III candidate CUTX-101 for the cure of Menkes disease.
Additionally, NICHD and Cyprium have entered into an international, exclusive licensing deal to commercialize and develop adeno-associated virus based gene therapy, termed AAV-ATP7A, to offer working prints of the copper transporter that is flawed in Menkes patients, and to be utilized together with CUTX-101.
Under the CRADA terms, Fortress Biotech Inc (NASDAQ:FBIO)’s new subsidiary firm is approved to reference the IND application presently held by NICHD and any report generated at NICHD to support the advancement of CUTX-101, counting the submission of an NDA and commercialization in the United States and other territories.
Moreover, Cyprium will be accountable for the manufacturing of CUTX-101 under cGMP regulations to boost ongoing clinical trials at NICHD. Cyprium will also offer logistical and financial support for basic science and clinical research on Menkes disease and other linked copper metabolism problems at NICHD.
Stephen G. Kaler, M.D., the Senior Investigator, heads the Menkes disease research plan at NICHD. Dr. Kaler will be the principal investigator of the planned clinical trials and studies of CUTX-101 and AAV-ATP7A gene treatment.
Lindsay A. Rosenwald, M.D., the Chairman, President and CEO of Fortress Biotech Inc (NASDAQ:FBIO), stated that their firm’s objective is to advance products that enhance the lives of people across numerous diseases. They are delighted to release another subsidiary firm Cyprium Therapeutics, which they consider will further broaden their rare disease platform via the advancement of novel treatments for the cure of Menkes disease and other linked ailments.
CUTX-101 is in advancement to supplement copper levels in people with Menkes disease and associated disorders. It is a subcutaneous injectable preparation of Copper Histidinate made under cGMP that is designed to enhance tolerability and avoid the oral absorption of copper, which is reduced in people with Menkes disease. In planned Phase 1/2 clinical trials performed at NICHD, early cure of Menkes subjects with CUTX-101 led to an enhancement in neurodevelopmental survival and outcomes.
On Tuesday, the stock price of Fortress Biotech Inc (NASDAQ:FBIO) declined more than 2% to close the session at $3.49.
|Last Price a/o 3:21 PM EST||$3.49|
|Market Cap (mlns)||$167.73M|
|Shares Outstanding (mlns)||48.06M|
|Share Float (mlns)||27.90M|
|Short Interest Ratio||12.25|
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About the author: Monica Gray has an undergraduate degree in Accounting and an MBA – earned with Honors. She has six years of experience in the financial markets and has been a securities analyst for the past two years.