FDA gives thumbs-down on hear­ing loss drug, cit­ing man­u­fac­tur­ing is­sues, and sends Fen­nec stock reel­ing

A small, North Car­oli­na-based biotech has run in­to some head­winds in its ef­forts to de­vel­op a com­pound that pre­vents hear­ing loss as­so­ci­at­ed with cis­platin chemother­a­py treat­ments.

The FDA hand­ed down a com­plete re­sponse let­ter to Fen­nec Phar­ma­ceu­ti­cals $FENC for its Ped­mark drug late Mon­day night, cit­ing man­u­fac­tur­ing is­sues with the com­pa­ny’s sup­pli­er. Fen­nec hopes to meet with reg­u­la­tors some­time with­in the next month or two, CEO Ros­ty Raykov said in a call with in­vestors Tues­day morn­ing, in or­der to re­solve the is­sue.

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