Recro Pharma, Inc. (REPH - Free Report) announced that the FDA has set an action date of Mar 24, 2019 for its decision on the new drug application (NDA) for the company’s lead product candidate — intravenous (IV) meloxicam for the management of moderate to severe pain. Year to date, shares of the company have decreased 24.7% compared with the industry’s decline of 1.6%.
Recro resubmitted the NDA for IV meloxicam in September 2018 as the FDA had issued a Complete Response Letter (CRL) in May 2018. The CRL stated that although the outcome results from the pivotal phase III studies demonstrated statistically significant outcomes on the primary endpoints, the FDA is unable to approve the application in its current form.
The CRL stated that data from ad hoc analyses and selective secondary endpoints suggest that the analgesic effect does not meet the expectations of the agency. In addition, the CRL raised CMC related questions on extractable and leachable data provided in the NDA. The company had a Type A End-of-Review meeting with the FDA in July 2018 to address the concerns raised in the CRL.
The company’s lead product candidate is a proprietary injectable form of meloxicam, a long-acting preferential COX-2 inhibitor. IV meloxicam has successfully completed three phase III studies for the management of moderate to severe pain, consisting of two pivotal efficacy studies and a large double-blind phase III safety study along with other safety studies. As injectable meloxicam is in the non-opioid class of drugs, if approved, the company believes it has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics.
In April 2015, the company acquired certain assets from Alkermes plc. (ALKS - Free Report) , which included the worldwide rights to injectable meloxicam.
Zacks Rank & Key Picks
Recro currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Amgen Inc. (AMGN - Free Report) and CRISPR Therapeutics AG (CRSP - Free Report) . Both of them sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Amgen’s earnings per share estimates have moved up from $13.95 to $13.98 for 2018 and from $14.39 to $14.42 for 2019 in the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 4.29%. Share price of the company has increased 18.2% year to date.
CRISPR Therapeutics’ loss per share estimates have narrowed from $2.95 to $2.92 for 2018 and from $3.08 to $3.04 for 2019 over the past 60 days. The company delivered a positive earnings surprise in two of the trailing four quarters with an average beat of 19.50%. Share price of the company has increased 55.7% year to date
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