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REPH

Recro Pharma

$9.73

0.1 (1.04%)

15:37
03/22/19
03/22
15:37
03/22/19
15:37

Recro Pharma CRL from FDA says meloxicam onset fails to meet expectations

Recro Pharma announced it has received a second complete response letter, or CRL, from the FDA Office of Drug Evaluation II regarding their new drug application, or NDA, seeking approval for intravenous, or IV, meloxicam for the management of moderate to severe pain. The FDA's comments in the CRL focused on onset and duration of IV meloxicam, noting that the delayed onset fails to meet the prescriber expectations for IV drugs. The CRL also cited regulatory concerns about the role of IV meloxicam as a monotherapy in acute pain, as well as how it would meet patient and prescriber needs in that setting, given the FDA's interpretation of the clinical trials data. The company strongly disagrees with FDA's interpretation and its views on the clinical utility of IV meloxicam in the acute pain setting. The FDA did not identify any CMC issues in this CRL. Recro intends to continue to pursue regulatory approval for IV meloxicam and will request a meeting with the FDA and work closely with them to resolve these issues.

  • 24

    Mar

REPH Recro Pharma
$9.73

0.1 (1.04%)

05/24/18
PIPR
05/24/18
NO CHANGE
Target $9
PIPR
Overweight
Recro Pharma price target lowered to $9 after 'baffling' CRL at Piper Jaffray
Piper Jaffray analyst David Amsellem lowered his price target on Recro Pharma shares to $9 from $17 after the company received a "cryptic and baffling" complete response letter regarding its NDA for the intravenous form of meloxicam for post-operative pain. Amsellem called the CRL "particularly vexing" given that meloxicam in oral form has been available since 2000 and the IV form was statistically superior to placebo on primary and secondary endpoints in two large Phase 3 studies, making him question if this is "a case of the FDA shifting the goalposts." The analyst, who still believes the product has a commercial future and thinks cash flows from Recro's Gainesville manufacturing facility should provide downside protection, keeps an Overweight rating on the stock, which has plunged over 57% to $5.26.
05/25/18
ROTH
05/25/18
NO CHANGE
Target $8.5
ROTH
Buy
Roth Capital says Recro Pharma manufacturing alone worth more than current price
Roth Capital analyst Scott Henry estimates Recro Pharma's manufacturing business, net of debt, is valued at $8.50 per share, which he noted remains well above the current share price after the stock declined about 55% following the CRL for IV meloxicam. While Henry is not counting on a future for IV meloxicam within his current valuation, he says such a scenario could present material upside. Henry lowered his price target on Recro shares to $8.50 from $18.00 and maintains a Buy rating on the stock, which closed yesterday at $5.63.
01/31/19
JANY
01/31/19
INITIATION
Target $13
JANY
Buy
Recro Pharma assumed with a Buy at Janney Montgomery Scott
Janney Montgomery Scott analyst Esther Hong assumed coverage of Recro Pharma with a Buy rating and $13 fair value estimate.
01/31/19
01/31/19
INITIATION

Fly Intel: Top five analyst initiations
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. At Home Group (HOME) initiated with a Hold at Gordon Haskett. 2. Teladoc (TDOC) initiated with a Buy at Berenberg. 3. Intercept (ICPT) initiated with an Outperform at Credit Suisse. 4. Recro Pharma (REPH), BioDelivery Sciences (BDSI), and Supernus (SUPN) were assumed with a Buy at Janney Montgomery Scott. 5. Green Thumb Industries (GTBIF) initiated with a Buy at Benchmark. This list is just a portion of The Fly's analyst coverage. To see The Fly's full Street Research coverage, click here.

TODAY'S FREE FLY STORIES

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PING

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CRON

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TECD

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T

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AGCO

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PBR

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CE

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STI

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WBS

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HSBC

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HES

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CSCO

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T

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CBPO

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T

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GSK

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