Neurogene Announces Positive Regulatory Update for NGN-401 Gene Therapy in Rett Syndrome with Plans to Initiate Dosing in Embolden™ Registrational Trial in Q4 2025
Neurogene Inc. (NGNE)
Company Research
Source: Business Wire
Completed discussions with FDA on registrational protocol; 13 sites to allow for rapid enrollmentNew preclinical data at ESGCT Congress highlight NGN-401 best-in-class potential and add to body of evidence that ICV administration is superior to IT-L in reaching key brain regions underlying Rett syndromeAs previously reported, the first four participants in the NGN-401 Phase 1/2 trial gained 23 developmental milestones/skills, representing multi-domain improvement that requires transduction of key brain regions and nervous systemThe preclinical data also provide evidence-based confirmation that ICV and IT-L administration result in comparable peripheral organ transduction, showing no liver-sparing benefit to IT-L when compared to ICV NEW YORK--(BUSINESS WIRE)--Neurogene Inc. (Nasdaq: NGNE), a clinical-stage company founded to bring life-changing genetic medicines to patients and families affected by rare neurological diseases, today announced the Company has completed discussions wi
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News
- Neurogene Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)Business Wire
- Neurogene (NASDAQ:NGNE) had its price target raised by analysts at HC Wainwright from $65.00 to $70.00. They now have a "buy" rating on the stock.MarketBeat
- Neurogene Reports Positive Interim Data in Pediatric Cohort from NGN-401 Gene Therapy Trial for Rett Syndrome [Yahoo! Finance]Yahoo! Finance
- Neurogene Reports Positive Interim Data in Pediatric Cohort from NGN-401 Gene Therapy Trial for Rett SyndromeBusiness Wire
- Neurogene Announces First Participant Dosed in Embolden™ Registrational Trial of NGN-401 Gene Therapy for Rett Syndrome [Yahoo! Finance]Yahoo! Finance
NGNE
Earnings
- 11/13/25 - Beat
NGNE
Sec Filings
- 11/14/25 - Form SCHEDULE
- 11/12/25 - Form 8-K
- 11/6/25 - Form 8-K
- NGNE's page on the SEC website