More man­u­fac­tur­ing is­sues: Fen­nec preps for sec­ond CRL for po­ten­tial hear­ing loss drug

Shares of Fen­nec Phar­ma­ceu­ti­cals stock were cut al­most in half ear­ly Mon­day as the com­pa­ny said man­u­fac­tur­ing is­sues caused an­oth­er FDA re­jec­tion of its re­for­mu­lat­ed ver­sion of sodi­um thio­sul­fate, which is in­tend­ed to help kids who lose hear­ing due to chemo treat­ment.

The biotech had re­sub­mit­ted an NDA for the drug to treat plat­inum-based, chemo-re­lat­ed oto­tox­i­c­i­ty in young chil­dren ear­li­er this year. The first NDA was de­nied by the FDA last year, with the agency cit­ing man­u­fac­tur­ing is­sues with the biotech’s sup­pli­er.

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