Beam Therapeutics Shares Jump After FDA Lifts BEAM-201 Clinical Hold

Beam Therapeutics (NASDAQ: BEAM) shares have rallied premarket after the company revealed that the US Food and Drug Administration (FDA) has lifted the clinical hold for BEAM-201.

Beam, a biotechnology firm developing precision genetic medicines, said the FDA has lifted the clinical hold and cleared the Investigational New Drug application for BEAM-201 for treating relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL)/T-cell lymphoblastic lymphoma (T-LL).

A clinical Hold is an order by the FDA to delay or suspend a proposed or ongoing clinical investigation for a drug under an Investigational New Drug application.

The FDA put a clinical hold on BEAM-201 in late July, requesting further data from the company, such as additional control data and added analysis of specific off-target editing experiments.

“The FDA’s clearance of our IND for BEAM-201 is an exciting moment for Beam and for the field of gene editing, as it represents the first IND clearance for a multiplex-base edited investigational drug,” commented Beam chief executive officer John Evans.

“We believe the future of cell therapy involves high levels of cell engineering, enabled by multiplex base editing technology.”

The company said it will provide the next steps for the program in 2023 in due course.

Beam Therapeutics shares have jumped over 11% on the news to around $51 per share. However, the stock is down more than 42% in 2022 despite making gains in the last six months.