Forty Seven, Inc. Granted Fast Track Designation for Magrolimab (5F9) for the Treatment of Myelodysplastic Syndrome and Acute Myeloid Leukemia
“We are pleased to receive Fast Track Designation for magrolimab in both MDS and AML, emphasizing the unmet need among these patients, and further equipping us to execute on our goal of delivering magrolimab as a promising new option to treating physicians,” said
The FDA’s Fast Track program is designed to facilitate the development and expedite the review of medicines that may treat serious or life-threatening conditions and address significant unmet medical needs. The designation provides the opportunity for more frequent meetings with the
Magrolimab is a monoclonal antibody against CD47 that is designed to interfere with recognition of CD47 by the SIRPα receptor on macrophages, thus blocking the "don't eat me" signal used by cancer cells to avoid being ingested by macrophages.
Forward Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These statements include those related to the potential of macrophage activation for the treatment of cancer; Fast Track Designation for magrolimab in both MDS and AML, further equipping Forty Seven to execute on its goal of delivering magrolimab as a promising new option to treating physicians; the sufficiency of single arm pivotal trials to support registration of magrolimab in combination with azacitidine in untreated higher risk MDS and magrolimab in combination with rituximab in heavily pre-treated relapsed or refractory DLBCL patients, respectively; and magrolimab’s eligibility for Accelerated Approval and Priority Review if relevant criteria are met.
Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward looking statements. The potential product candidates that Forty Seven develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all. In addition, clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release. Such product candidates may not be beneficial to patients or successfully commercialized. The failure to meet expectations with respect to any of the foregoing matters may have a negative effect on Forty Seven's stock price. Additional information concerning these and other risk factors affecting Forty Seven's business can be found in Forty Seven's periodic filings with the
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Source: Forty Seven, Inc.