Neurogene's 15-minute chart triggered Bollinger Bands Narrowing, KDJ Death Cross observed.

According to Neurogene's 15-minute chart, a narrowing of the Bollinger Bands and a KDJ Death Cross at 10/17/2025 14:45 indicate that the magnitude of stock price fluctuations is decreasing, and the momentum of the stock price is shifting towards the downside, potentially leading to further decreases.

Rocket Pharmaceuticals has taken a significant step forward in its quest to bring a revolutionary gene therapy to market. The FDA has set the PDUFA action date for the biologics license application (BLA) for Kresladi, a genetically modified autologous hematopoietic stem cell therapy intended to treat leukocyte adhesion deficiency type 1 (LAD-I), at March 28, 2026, according to a CGTLive report (BLA for Rocket’s LAD-I Gene Therapy Under Review by FDA Again). This move follows the FDA's acceptance of Rocket's resubmitted BLA, which includes data from a global phase 1/2 clinical trial that demonstrated a 100% overall survival rate for at least one year post-treatment, as noted in the CGTLive report.

The clinical trial, NCT03812263, met all its primary and secondary endpoints, showing substantial reductions in significant infections, improvements in skin lesions, and restored wound-healing capabilities. The therapy was deemed "well-tolerated" with no serious adverse events related to treatment reported, according to the CGTLive report. Gaurav Shah, MD, CEO of Rocket Pharmaceuticals, expressed optimism about the BLA's progress, stating that it brings the company closer to its goal of delivering a one-time gene therapy to patients suffering from severe LAD-I, as described in the CGTLive report.

Rocket Pharmaceuticals had previously submitted a BLA for Kresladi in October 2023, which was granted priority review. However, the FDA requested additional Chemistry Manufacturing and Controls (CMC) information, leading to a complete response letter (CRL) in June 2024 . The company has since aligned with the FDA on the requested information and extended the PDUFA date to June 30, 2024, to allow for additional review .

Notably, Rocket Pharmaceuticals has also withdrawn its BLA for mozafancogene autotemcel, a gene therapy product for Fanconi anemia (FA), citing strategic and regulatory considerations . The company has decided to focus its resources on "programs with the clearest regulatory and commercial pathways" .

The FDA's acceptance of the resubmitted BLA for Kresladi marks a critical milestone for Rocket Pharmaceuticals. The company's commitment to providing a one-time gene therapy for LAD-I patients, for whom survival beyond childhood is uncommon and bone marrow transplant is the only available treatment, is commendable. With the PDUFA date set for March 2026, investors and financial professionals will closely monitor the progress of this promising therapy.