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FDA Sets Action Date for Recro's Pain Management Candidate
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Recro Pharma, Inc. 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.
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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FDA Sets Action Date for Recro's Pain Management Candidate
Recro Pharma, Inc. 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.
Recro Pharma, Inc. Price
Recro Pharma, Inc. Price | Recro Pharma, Inc. Quote
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
Today's Stocks from Zacks' Hottest Strategies
It's hard to believe, even for us at Zacks. But while the market gained +21.9% in 2017, our top stock-picking screens have returned +115.0%, +109.3%, +104.9%, +98.6% and +67.1%.
And this outperformance has not just been a recent phenomenon. Over the years it has been remarkably consistent. From 2000 - 2017, the composite yearly average gain for these strategies has beaten the market more than 19X over. Maybe even more remarkable is the fact that we're willing to share their latest stocks with you without cost or obligation.
See Them Free>>