Weeks af­ter rare dis­ease drug got spurned, Ac­er re­turns to FDA for sec­ond shot

Less than a month af­ter the FDA re­ject­ed Ac­er Ther­a­peu­tics’ treat­ment for urea cy­cle dis­or­ders be­cause its con­tract pack­ag­ing man­u­fac­tur­er wasn’t ready for an in­spec­tion, the biotech said it’s sort­ed things out.

The biotech has re­filed an NDA for AC­ER-001, it an­nounced Mon­day morn­ing, and be­lieves the re­sub­mis­sion ad­dress­es all the con­cerns raised in the com­plete re­sponse let­ter.

In a state­ment, founder and CEO Chris Schelling praised his team’s “out­stand­ing job” re­sub­mit­ting the NDA one month af­ter the CRL.

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