GRCL - Gracell spikes as H.C. Wainwright initiates with Buy on upcoming catalyst

Chinese biotech Gracell Biotechnologies ( NASDAQ: GRCL ) traded higher for the second straight session on Thursday after H.C. Wainwright launched its coverage with a Buy rating, noting a possible acceptance of a clinical trial application the company intends to file in the U.S. later this year.

Gracell ( GRCL ) anticipates a potentially registrational trial for its lead asset GC012F in r/r multiple myeloma with the filing of its Investigational New Drug Application (IND) to the FDA, expected by the year-end.

The analyst Emily Bodnar who issues a $6 per share target on the stock, notes that the risk of the FDA rejecting the IND is low given the precedent from companies such as Legend Biotech ( LGND ) and BeiGene ( BGNE ), which also have assets targeting multiple myeloma.

"We believe shares continue to be stagnant as the company's assets are currently being developed in China and the company has not yet entered into the U.S. development market, though we expect this to change in early 2023 which may be a significant catalyst," Bodnar wrote.

She also highlights Gracell's ( GRCL ) FasTCAR technology platform, noting that it accelerates the manufacturing of CAR-T therapies to 22-36 hours, from 2-6 weeks, under traditional methods.

The company has revamped its leadership team in recent months with the appointments of a chief business officer and chief medical officer.

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