Heron earns a sec­ond slap­down from the FDA on pain med — shares with­er

In­ter­cept wasn’t the on­ly biotech in line for a drub­bing to­day. In ad­di­tion to the re­jec­tion for NASH, Heron Ther­a­peu­tics $HRTX put out word this morn­ing that the FDA found its ap­pli­ca­tion for the pain drug HTX-011 was want­i­ng, war­rant­i­ng an­oth­er CRL.

Heron says there was noth­ing clin­i­cal about the slap­down, with no de­mands for new safe­ty or ef­fi­ca­cy da­ta, or even a chal­lenge on CMC — which was what they said was be­hind the first re­jec­tion that ar­rived for HTX-011 a lit­tle more than a year ago. In­stead, the biotech re­port­ed that the agency had 4 ba­sic con­cerns about the drug, de­signed to ad­dress post-op­er­a­tive pain.

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