Regulatory tracker

Therapy Status Board

The current FDA status of the cell and gene therapy programs CGTlive® tracks. Each tile is verified against FDA actions as of its dateline and links to the reporting behind its latest change.

6 tracked programs · Updated September 8, 2026

Elevidys (delandistrogene moxeparvovec-rokl)

Sarepta Therapeutics

Approved — ambulatory only

Boxed warning: acute liver injury/failure

November 14, 2025 · Boxed warning added; non-ambulatory eligibility removed

As of September 8, 2026
Carvykti (ciltacabtagene autoleucel)

Johnson & Johnson / Legend Biotech

Approved — r/r myeloma, ≥1 prior line

Boxed warnings incl. secondary malignancy

October 10, 2025 · Boxed warning added: immune effector cell-associated enterocolitis

As of September 8, 2026
Lyfgenia (lovotibeglogene autotemcel)

Genetix Biotherapeutics (formerly bluebird bio)

Approved — SCD, ages 12+

Boxed warning: hematologic malignancy

September 18, 2025 · bluebird bio, taken private, rebrands as Genetix Biotherapeutics

As of September 8, 2026
Lonvo-z (lonvoguran ziclumeran)

Intellia Therapeutics

BLA accepted — priority review

PDUFA target date Mar 10, 2027

September 8, 2026 · FDA accepts BLA with priority review; PDUFA target March 10, 2027

As of September 8, 2026
Casgevy (exagamglogene autotemcel)

Vertex Pharmaceuticals / CRISPR Therapeutics

Approved — SCD & TDT, ages 2+

July 1, 2026 · FDA expands both indications to ages 2+

As of September 8, 2026
Zevaskyn (prademagene zamikeracel)

Abeona Therapeutics

Approved — RDEB wounds

April 28, 2025 · FDA approval for RDEB wounds (adult and pediatric)

As of September 8, 2026