FDA Grants Three Fast Track Tags to Allogene's Autoimmune Disease Drug

Allogene Therapeutics ALLO announced that the FDA has granted three fast track designations to its investigational CRISPR-based allogeneic CAR-T therapy, ALLO-329.

These designations apply to three autoimmune diseases — systemic lupus erythematosus (SLE), idiopathic inflammatory myopathy (IIM) and diffuse systemic sclerosis (SSc).

How Does the Fast Track Tag Benefit ALLO’s Drug Development?

Fast track designation is designed to facilitate the development and expedite the review of drugs that treat serious conditions, meet an unmet medical need, or offer a potential advantage over existing treatments. Per the FDA, the purpose of granting this designation is to ‘get important new drugs to the patient earlier.’

A candidate with the fast track designation is also eligible for rolling review. This could allow Allogene to submit completed sections of its regulatory filing for ALLO-329 to the FDA as they become available, rather than waiting for the entire application to be complete. This can potentially expedite the review process, as the FDA typically does not begin reviewing a submission until all sections of the application have been filed.

ALLO Stock’s Performance

Shares of Allogene have lost 33% year to date compared with the industry’s 7% decline.

More on Allogene’s ALLO-329

Allogene intends to start the phase I RESOLUTION basket study in mid-2025, which will evaluate the safety and preliminary efficacy of ALLO-329 in SLE, IIM and SSc indications. The company expects to have proof-of-concept data from this study before this year’s end.

A next-generation allogeneic CAR T-cell therapy, ALLO-329, works by targeting both CD19+ B-cells and CD70+ activated T-cells. Additionally, this candidate incorporates Allogene’s proprietary Dagger technology, which is designed to reduce or eliminate the need for lymphodepletion (a preconditioning process that involves the use of chemotherapy).

ALLO’s Zacks Rank

Allogene currently carries a Zacks Rank #3 (Hold).

Allogene Therapeutics, Inc. Price

Allogene Therapeutics, Inc. price | Allogene Therapeutics, Inc. Quote

Key Picks Among Biotech Stocks

Some better-ranked stocks from the sector are ANI Pharmaceuticals ANIP, CytomX Therapeutics CTMX and 89bio ETNB. While ANIP and CTMX sport a Zacks Rank #1 (Strong Buy) each at present, ETNB carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for ANI Pharmaceuticals’ 2025 earnings per share (EPS) have risen from $5.54 to $6.35. EPS estimates for 2026 have increased from $6.75 to $7.21 during the same period. Year to date, shares of ANIP have risen 21%.

ANIP’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 17.32%.

In the past 60 days, estimates for CytomX Therapeutics’ 2025 EPS have improved from a loss of 31 cents to a profit of 25 cents. During the same timeframe, estimates for loss per share for 2026 have narrowed from 65 cents to 31 cents. Year to date, shares of the company have lost 58%.

CTMX’s earnings beat estimates in three of the trailing four quarters and missed the mark once, delivering an average surprise of 180.70%.

Estimates for 89bio’s loss per share have narrowed from $2.51 to $1.98 for 2025 in the past 60 days. During the same time frame, estimates for 2026 loss per share have improved from $2.94 to $2.15. ETNB’s shares have lost 30% year to date.

89bio’s earnings missed estimates in three of the trailing four quarters and beat the mark on one occasion, delivering an average negative surprise of 46.18%.

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