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Cullinan Gets FDA Investigational Clearance for Leukemia Drug

Cullinan received FDA clearance to test a 'differentiated treatment approach' for acute myeloid leukemia 'by targeting extracellular FLT3.'
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Cullinan Oncology CGEM shares rose Monday, after the biotech company received investigational new drug clearance from the Food and Drug Administration for CLN-049, its treatment for acute myeloid leukemia.

“The U.S. Food and Drug Administration has cleared Cullinan Florentine’s [investigational new drug] application for CLN-049, an … antibody for the treatment of relapsed/refractory AML,” the company said.

Cullinan Oncology recently traded at $33.51, up 1.2%. The shares have climbed 13% over the past six months.

“IND clearance by the FDA paves the way to test a differentiated treatment approach by targeting extracellular FLT3, an oncogenic driver in AML,” said Patrick Baeuerle, Cullinan’s chief scientific officer for biologics. 

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The company will "initiate human dosing of CLN-049, a T cell-engaging, IgG-like antibody in patients with relapsed/refractory AML.”

In other healthcare news Monday, Biogen  (BIIB) - Get Report shares soared after the FDA approved aducanumab, its treatment for Alzheimer’s.

The decision makes the drug the first new treatment for Alzheimer’s disease in nearly two decades. It's marketed as Aduhelm.

"This approval is significant in many ways. Aduhelm is the first novel therapy approved for Alzheimer's disease since 2003," the FDA said in a statement. 

"Perhaps more significantly, Aduhelm is the first treatment directed at the underlying pathophysiology of Alzheimer's disease, the presence of amyloid beta plaques in the brain."

Also Monday, ChromaDex  (CDXC) - Get Report, a bioscience company focused on aging, unveiled a deal to sell its flagship consumer product at Walmart  (WMT) - Get Report.

“Tru Niagen is a unique form of vitamin B3 that is clinically proven to elevate NAD+, reducing the impact of aging and daily wear and tear on the body,” ChromaDex said.