# Exclusive | FDA Gives Third Rare-Disease Drug Another Shot, Regenxbio Says

> **Open Intelligence Dossier** · First detected: 2026-06-22 12:07 UTC · Category: Business

## Executive Summary
The FDA is allowing Regenxbio to resubmit its gene therapy for Hunter syndrome, marking a reversal of a previous rejection.

## Intelligence Brief
Regenxbio has been granted a path to resubmit its gene therapy, known as NAVSUNLI, for the treatment of Hunter syndrome (MPS II). This follows a previous rejection by the FDA regarding the childhood treatment.


Coverage from the Wall Street Journal, Endpoints News, Stat News, Stock Titan, and Seeking Alpha highlights the regulatory shift. Reports emphasize that this marks a broader trend of the FDA reconsidering previous decisions for rare-disease drugs.


Regenxbio is expected to move forward with the resubmission process for the drug. Market observers note that the company faces heightened pressure to deliver results regarding its wider pipeline, including ongoing work in Duchenne muscular dystrophy.

## Multi-Source Evidence Table
| Source Outlet | Headline | Verification URL |
|---|---|---|
| Yahoo Finance | REGENXBIO Announces Alignment with FDA on Path Forward for NAVSUNLI™ BLA Resubmission for Accelerated Approval; First Potential Gene Therapy for MPS II | [Source Link](https://news.google.com/rss/articles/CBMioAFBVV95cUxQYmpJTWwyTkt6Z25CYWF2bWF2Rk43ekotVi1yVExldkVNX1pmVFRwWElFWXpsVTA1QUlBWlVZZEdHdkNsanhUTmRxVlpVaFcwb2o2N2YxR3p2YmI3c2pnSlN1bXltUDV2bnpkbHV4Y19YaDVwdHkwSHRfaVV2U0szempxVW9WNDlWdEJWZHhrREJwNWNqMmhDN3dNbXBubGtr?oc=5) |
| Baton Rouge Business Report | FDA reconsiders rejected rare-disease gene therapy | [Source Link](https://news.google.com/rss/articles/CBMikwFBVV95cUxPUktnM05seDNmSkExcTNabXBzMVFITk9qV25ZWklabE5EcVVHeXgzZF9BbEIycHJGMmRIclFPOXJPTzQzWVlGSUdvcEFCODdjU0d2OFBQbTQ1M1RUZGwzQWJtRE96Z25UY0phSkFhTzFmWldVRGhGcC1xaHJsU1F2SUMtVWQzd2Q5alQzX3hvZHBrZGvSAZsBQVVfeXFMUHNNSzRyRVNiY3U3WC1EMFA5Um1QdkxhRVVWU09LWndhVUVUYkl3dFc1aXlpX2p5MUU5NTQycXlmVHVmdnBGai1oQzBRcENfUE1lYjFSaVA1bTcwRTYxci1pWklBRTh1SnpmeXJrT3VsdXdGR3JGX1o2VjNia21RWEdnQ0o3Mk9vRS14eUZZU0xiMnNCTjFmdnFWZmc?oc=5) |
| Reuters | US FDA reverses course on Regenxbio's rare-disease gene therapy, backs accelerated approval bid | [Source Link](https://news.google.com/rss/articles/CBMizwFBVV95cUxPcGZad2VPWmpRYUZtS1MxYUJZejgtNi1mdFpOYkZ5c3pnZjQ0VWxBWGxMQ043a3R5MEp2QlNOQlN0YW9DS0ZGT2F4Rk9HUURkWk1pNU9FUjBGMTdHMjlWcENybGdmUmp3d3FST0hjdVFwMEVZYzM2WHBlR2pENjVqeWV0eHFDNU12cXB5Xy0tRkpYNnRjSEZDTlRSeFFxeXJWQkZ6aGFKaWVYbDZ0dmtRc2piaDg4M1E5S19XcGtWcWF3MlY2QV9UTUh6SXpMZGM?oc=5) |
| BioSpace | REGENXBIO to resubmit application for Hunter gene therapy after FDA’s most recent pivot | [Source Link](https://news.google.com/rss/articles/CBMitgFBVV95cUxQTENSUUs1ZFZTYUlLdFV5Uy10V1VsRzBxaVRKaDROdHh6ejlxb0dqaHhzUFFFYnNONzU5QmRmUEtHUFByTkN3a0JncDczaENCTWlsaTJvaHVJSzFnS1ktcHAtRktQaU1QQnNzUFVsbzZ0WGNZam9ZX3U2UWthWlZITkcwRVVSVGxzTWZ1amR3RzV1dlozQm82Tzk1dnUzcTVUZkVZUE9YeEJkRFdXNnVQWVhhMmJaUQ?oc=5) |
| Fierce Biotech | In another reversal for rare disease field, FDA to reconsider Regenxbio gene therapy | [Source Link](https://news.google.com/rss/articles/CBMiqAFBVV95cUxNRk1UVDJjWXREYkd1WGpsYkplRi1ZRExkbnlaMGQtR1lvTFg1ZE9oQmRMV0ZqR1VzS3NZbW50TlItdjRQODlsT2Y3di1jR3d3eHRQSmk5QThoQTl4ZnVNRW91NVRERkwyRFdILVdnR052NnhqT0FsdlYzWjdlaG9Sck50N0ZCSzE5LWlxYmdOVXhTNHJQeXRBLUg3eG1mQ0NKTXpBRzdjeGE?oc=5) |
| Devdiscourse | Reuters US Domestic News Summary | [Source Link](https://news.google.com/rss/articles/CBMijAFBVV95cUxQM3lobDdERDRvM3lHdTRmQUdPNDY5cThTN0RWbFdfZHB6azFPNmJYTGxDOWxMOGFnYTVGSXA0ZElnejl3TGdEbzMtWi1DLWwyUUV6dDNjZ3NsVnQ5eGNWUk0wbWM4UF9KQ0tuSEdzMnVzTGJCbkxiNXN5b0ZQWkxTaktITXZjdWNqQkc5SNIBkgFBVV95cUxPRWVncnY0SUFLdUN3LXBXTEVfV1RrUlFVeVZUNVkwTEdTX3B2NDNPbG0za2NBXy1oUWl4TVpzb2NUVmtZaGp1aDh6ekxDdVZZUnJsOWtfRlJ0NXJoNTU5cVZwN1d0dUwyOEZpSUhzR3FRU1lGVGNMWnpHbWJxVHJCNlVHeHowbXV0d0tXdEVNRjRRZw?oc=5) |
| U.S. News & World Report | US FDA Reverses Course on Regenxbio's Rare-Disease Gene Therapy, Backs Accelerated Approval Bid | [Source Link](https://news.google.com/rss/articles/CBMi3AFBVV95cUxPSmV1Ym5QSzZfRW12dllQei1RbGlNaTB6WXpybU1rZm9HZWxaQ1E2OFRyc1JaUkRTcUg1NDNiV3lqU0xRRm85Mk1XYnpSeURFZHZtTmFGRmpFRVpnRkVDb0dVY0FsdG15Umt3ck1tVE5YZzljWWpsY3U0SGpnNjVvcnp0LXB3VVhwUk40dU1aakdHQnpVeFdVOGFNN3RHVEtuRmpZZWxzdjFOVFJhY0M0b3Q0WUdJU1k4d29la2dFdDg5c0o5OXNNUnZrZEtPaDJ2MzF6X2pkdzEzazBY?oc=5) |
| Endpoints News | Regenxbio to resubmit Hunter syndrome gene therapy as FDA rare disease about-face continues | [Source Link](https://news.google.com/rss/articles/CBMilwFBVV95cUxQYnJNa3Zya2ZreW5FNVhJbWwwVG56Q3Bic2syRzlqTnR0ZmFyMEUzdld5MXE4UG1ZaC1NTmE1dC1yaDA3NXlGS09kMThDMTRmNXh6QmFuZy10YVJTeFlOOGdwb1M0WkRKR1RONloyNGdpd0wyZGJ1dXlsazZoLXBhT0JVYkd6S1dVc1J2QVJXMjhCVlVVVnRJ?oc=5) |
| Stock Titan | REGENXBIO gets FDA path to resubmit NAVSUNLI for MPS II | [Source Link](https://news.google.com/rss/articles/CBMiswFBVV95cUxOcGxveGdJWUp6RGNwS1hRemRZaTdSNmViM0RDMF90NHlSWWxOZ0I3a1dFdlJEWFNpelZyWm1NdTVDd2lEaVNwWTlyTk5DeTd6STJCcERUNlAzS0JGcFpCejlrcC1mbVNuVlhrcnZPRFo0UFlWWU1SeHN6NHUxMDB4ZGpqQU5MdWE4U2hqSWdNNWN2TzdiSl9xUUxMSTRKS2czNWFfRExjTFVuT2EtWnlocUlDTQ?oc=5) |
| Seeking Alpha | REGENXBIO’s Duchenne Data Keeps Me Bullish, But There’s Less Room For Setbacks Now (RGNX) | [Source Link](https://news.google.com/rss/articles/CBMivAFBVV95cUxPZjZUd0VGS0NBeHBoNF80cHhOMXQ5eFAwSHY3VHp0LUU5VGkxUW8zRGpzVG5NRDdlaEVZeW1qVjdhUVc3MVlnQ3cyU0Q3YWNvSF9rVkpkZE5Yd1hOOTlkZi1tZzNENExGbG9CQTN0Y2s1ZVltY3JpY3hZRnl1RzNtX3hiVWNIZHJRYUg3M0F6NkFVQnJLeW9UOGtELVlSdi1JcG5qZlNTMUtaV3FVV0tuNm05ZDZkNHpyUlFuVg?oc=5) |
| statnews.com | FDA reverses course on Regenxbio’s childhood gene therapy after rejection | [Source Link](https://news.google.com/rss/articles/CBMipwFBVV95cUxNZ2I2blByWlU2REw4cW43WThaaFRBbFRId3NqMDR6MjNNT083YXRHbWZKQ3UxMmMwNDliNVVyUEpGY01ZYnhPTndkT2R4MFlxdmZsLXhSdXNIWE44dm0zSlJ1V2laSnVuX1pRR1V2R0F5ZFJlWFJNa2h4ZUlKZ18waVN6QU9NU2g5aDh5NDZXQl9VbWdja0VtVlFQZ0lHX2M0alFSVk5ucw?oc=5) |
| WSJ | Exclusive - FDA Gives Third Rare-Disease Drug Another Shot, Regenxbio Says | [Source Link](https://news.google.com/rss/articles/CBMirwFBVV95cUxOc2N2cW5RczhjMXdrS2VOMEppMW5xZGVfT1pqZnlFeGNybDJFQnNLRHA0YlFDS3RFLVNjYjhXS291SG1NaWwtbUlUSFhTZEFVT3hhNm9hRFRkUUR4dGtXcjhyV3pYbS1YY29KUjVjR0xRUTVjVGYwbzlWR2hKcDZpS0NXTHItWEplZGs2TUUyeEtCcFhSNmlxeDRIeFJwS0xKUndIX2syc2t4OTBMUmUw?oc=5) |

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*Canonical Source: https://pulse.byoviral.com/trend/2026-06-22/exclusive-fda-gives-third-rare-disease-drug-another-shot-regenxbio-says*