Allogene Craters To 52-Week Low On FDA Clinical Hold Of CAR-T Trials, Drags Peers As Well

The FDA has sent shockwaves through the off-the-shelf CAR-T space after it slapped a clinical hold on all of the Allogene Therapeutics Inc ALLO AlloCAR T trials in response to an abnormality that could theoretically cause cancer.

Related: Allogene's BCMA-Targeted Therapy Gets US Orphan Drug Tag For Multiple Myeloma.

Here's what we know. A heavily pretreated lymphoma patient suffered a reduction in all blood cell lines after receiving an infusion of Allogene's anti-CD19 CAR-T candidate ALLO-501A. Analysis of the biopsy discovered anti-CD19 CAR-T cells with a chromosomal abnormality. The patient achieved a partial response to therapy.

The Company expects to provide additional updates in the coming weeks following consultation with the FDA. The FDA actively reviews the end of Phase 1 materials submitted in anticipation of an ALLO-501A pivotal Phase 2 trial.

Related: Allogene's Stock Jumps After Blood Cancer Candidates Show Durable Response.

Allogene's stock fell more than 30% in response to the news, affecting other companies too. Shares in Allogene's partner Cellectis SA CLLS, the biotech behind the TALEN gene-editing technology, fell almost 18%, and MaxCyte Inc MXCT also fell nearly 9%. In 2020, Allogene inked a licensing deal to develop allogeneic CAR-T therapies using MaxCyte's platform.

In contrast, shares in Autolus Therapeutics PLC AUTL rose 18% as investors re-evaluated its autologous CAR-Ts in light of the troubles of its off-the-shelf rival.

In reaction to the FDA hold, Goldman Sachs has downgraded Allogene from Buy to Neutral and slashed the price target from $71 to $20.

Related content: Benzinga's Full FDA Calendar.

Price Action: ALLO shares are down 38.4% at $15.02 during the premarket session on the last check Friday.