Neurogene Announces RMAT Designation for NGN-401 Investigational Gene Therapy for Rett Syndrome
Neurogene Inc. (NGNE)
Company Research
Source: Business Wire
Designation based on preliminary clinical evidence from ongoing NGN-401 clinical trial that shows potential to address unmet medical needs in Rett syndromeRMAT designation provides an opportunity for an Accelerated Approval pathway under the 21st Century Cures Act, and is in addition to NGN-401’s selection by the FDA for the START Pilot Program 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 NGN-401 received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) for the treatment of Rett syndrome. The designation was based on preliminary clinical evidence from the ongoing Phase 1/2 clinical trial with NGN-401 that shows potential to address unmet medical needs in this disease.“We appreciate the FDA’s ongoing commitment to expedite development of our NGN-401 gene t
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News
- Neurogene Inc. (NASDAQ: NGNE) had its price target lowered by analysts at HC Wainwright from $51.00 to $49.00. They now have a "buy" rating on the stock.MarketBeat
- Neurogene Reports Second Quarter 2024 Financial Results and Highlights Recent UpdatesBusiness Wire
- Neurogene to Participate in BMO Genetic Medicines SummitBusiness Wire
- Neurogene Announces Addition to Russell 3000® IndexBusiness Wire
- Neurogene Inc. (NASDAQ: NGNE) is now covered by analysts at BMO Capital Markets. They set an "outperform" rating and a $65.00 price target on the stock.MarketBeat
NGNE
Earnings
- 8/9/24 - Miss
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Sec Filings
- 8/9/24 - Form 10-Q
- 8/9/24 - Form 8-K
- 8/7/24 - Form 8-K
- NGNE's page on the SEC website