Roth Capital Partners downgraded Recro Pharma (NASDAQ:REPH) to “neutral” with a price target of $7.50 after the company received a second complete response letter (CRL) from the FDA about its NDA for meloxicam, an intravenous treatment for moderate-to-severe pain. The stock closed at $9.72 on March 22.
Analyst Scott Henry writes that the CRL was not expected, given the unmet need for non-opioid pain relievers. “We expect Recro to pursue a dispute resolution [with the FDA] and believe that the company needs to cut costs and pursue profitability with the contract development and manufacturing business near-term.”
The FDA issues appear focused on a delayed onset of action and concerns with the ability of meloxicam to be a monotherapy pain treatment, he added. “This was particularly surprising to us given that IV meloxicam offers a non-opioid alternative for patients.”
