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.
Three relate to confirming exposure of excipients in preclinical reproductive toxicology studies, and the fourth relates to changing the manufacturing release specification of the allowable level of an impurity based on animal toxicology coverage.
All of that could be addressed in a timely fashion, noted Heron execs, but investors weren’t in a forgiving mood when it comes to scheduling forecasts from this biotech. Heron’s shares tumbled 35% on the setback.
“We are committed to resolving the non-clinical issues outlined in the CRL with the FDA and resubmitting an NDA as soon as possible to bring this important non-opioid analgesic to patients,” said CEO Barry Quart.