Around the Helix: Cell and Gene Therapy Company Updates – February 11, 2026

The cell and gene therapy sectors are growing exponentially, with new players emerging daily and much progress being made both in and out of the lab. CGTLive®’s Around the Helix is your chance to catch up with the latest news in cell and gene therapies, including partnerships, pipeline updates, and more.

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1. FDA Slams REGENXBIO's MPS II Gene Therapy RGX-121 With CRL

The FDA has issued a complete response letter (CRL) to REGENXBIO’s biologics license application for clemidsogene lanparvovec (RGX-121), an investigational adeno-associated virus (AAV) vector–based gene therapy being developed for the treatment of mucopolysaccharidosis type 2 (MPS II), also known as Hunter syndrome.

2. American College of Physicians Calls for An End of the Term 'Provider' in Policy Paper

The American College of Physicians has released a policy paper asserting that the use of the term “provider” to describe physicians carries ethical implications that go beyond semantics and may contribute to the erosion of professional identity, trust, and the physician–patient relationship.

3. ImmunoLogic, Episode 8: "Surgery Meets Immunotherapy: A One-Two Punch for Breast Cancer" With Julia C. Tchou, MD, PhD, FACS

In this episode, the cohosts speak with Julia C. Tchou, MD, PhD, the director of the Breast Surgery Research Program at Perelman School of Medicine at the University of Pennsylvania, about the potential of combining immunotherapy approaches and surgery in the treatment of breast cancer.

4. Gyala Therapeutics Launches Trial for Acute Leukemia CAR-T in Spain

Gyala Therapeutics has launched a phase 1/2a clinical trial evaluating GYA01, an investigational CD84-directed chimeric antigen receptor T-cell (CAR-T) therapy, for the treatment of relapsed/refractory acute myeloid leukemia or T-cell acute lymphoblastic leukemia. The study, which is being conducted in Spain, has received €3.7 million worth of funding from the country’s government.

5. Solid Biosciences Comes Into Accord With FDA on Phase 3 Plan for DMD Gene Therapy

Solid Biosciences and the FDA have come into alignment on the company’s plans for a double-blind, randomized, placebo-controlled phase 3 IMPACT DUCHENNE clinical trial for SGT-003, an investigational next-generation AAV vector-based gene therapy intended to treat Duchenne muscular dystrophy (DMD). The accord was reached in the context of a Type C meeting between Solid and the agency, and the company expects that the first patient in the phase 3 study will be dosed before the end of the first quarter of this year.

6. Anixa Cleared to Up Dose in Lira-Cel Trial

Anixa Biosciences and its partner Moffitt Cancer Center have secured Institutional Review Board clearance to use a dose level up to 2 orders of magnitude higher than the previous allowed dose range in its phase 1 clinical trial evaluating liraltagene autoleucel (lira-cel), an investigational follicle-stimulating hormone receptor–targeting chimeric antigen receptor (CAR)/chimeric endocrine receptor (CER) T-cell therapy intended to treat ovarian cancer. "The absence of dose-limiting toxicities observed thus far has given us the flexibility to safely explore higher dose levels than originally planned,” principal investigator Robert Wenham, MD, MS, FACOG, FACS, chair of the Gynecologic Oncology Department at Moffitt, said in a statement. “With regulatory approval now in place, the program is positioned to advance into higher-dose evaluation under the amended protocol. This amendment allows us to further evaluate both safety and potential therapeutic benefit as the study advances."