Neurogene Announces FDA Breakthrough Therapy Designation for NGN-401 Gene Therapy for Rett Syndrome
Neurogene Inc. (NGNE)
Company Research
Source: Business Wire
Breakthrough Therapy designation granted based on interim NGN-401 Phase 1/2 data demonstrating clinically meaningful, durable and multidomain functional improvementsOn track to complete dosing in Embolden™ registrational trial of NGN-401 in second quarter of 2026Plans to present additional interim Phase 1/2 clinical data in mid-2026 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 that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to NGN-401, an investigational gene therapy in late-stage clinical development as a potential best-in-class treatment for Rett syndrome.The Breakthrough Therapy designation was based on the FDA’s review of interim efficacy and safety data from the Phase 1/2 trial as of the data cutoff date of October 30, 2025, including patient-level data and supportin
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News
- Neurogene Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) [Yahoo! Finance]Yahoo! Finance
- Neurogene Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)Business Wire
- Neurogene (NGNE) is now covered by Canaccord Genuity Group Inc.. They set a "buy" rating and a $200.00 price target on the stock.MarketBeat
- Neurogene Announces FDA Breakthrough Therapy Designation for NGN-401 Gene Therapy for Rett Syndrome [Yahoo! Finance]Yahoo! Finance
- Neurogene to Participate in Upcoming Investor ConferencesBusiness Wire
NGNE
Earnings
- 11/13/25 - Beat
NGNE
Sec Filings
- 3/3/26 - Form 4
- 2/27/26 - Form 144
- 2/26/26 - Form 8-K
- NGNE's page on the SEC website