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REPH

Recro Pharma

$8.71

0.04 (0.46%)

07:32
02/20/19
02/20
07:32
02/20/19
07:32

Recro Pharma announces publication of new IV meloxicam data

Recro Pharma announced the publication of new intravenous, or IV, meloxicam data. The articl was published online in Regional Anesthesia & Pain Medicine. A new drug application, or NDA, for IV meloxicam is currently under review by the FDA and the company is currently awaiting its assigned PDUFA goal date of March 24. The published data describe the pooled safety across a total of seven clinical studies, where IV meloxicam was evaluated in patients following several types of surgeries, including dental impaction surgery, open abdominal hysterectomy, abdominal laparoscopic surgery, bunionectomy, and abdominoplasty, among others. In this pooled analysis, IV meloxicam was generally well-tolerated, with the incidence of TEAEs occurring in a lower percentage of IV meloxicam-treated patients than in placebo-treated patients. The most commonly reported TEAEs across all treatment groups were nausea, headache, vomiting and dizziness. Notably, TEAE incidence was generally similar between the overall study populations and older patients with impaired renal function. There were no drug-related deaths for patients treated with IV meloxicam. Serious adverse events occurred at a lower frequency in the 30mg IV meloxicam treated group compared to the placebo group. In the Phase II/III postsurgical study program where opioid rescue medication consumption was monitored, IV meloxicam was often associated with prolonged time to first rescue medication use and reduced rescue medication requirements. In the Phase III, randomized, double-blind, placebo-controlled trial evaluating IV meloxicam following major surgery, IV meloxicam was associated with reduced opioid consumption. Mean opioid consumption in the overall population was significantly less in the IV meloxicam group compared with the placebo group. Decreased opioid use among patients treated with IV meloxicam compared with placebo-treated subjects was observed across all subgroups. In the IV meloxicam treatment group, decreased opioid use corresponded to fewer TEAEs commonly associated with opioid administration during the initial postoperative period. Additionally, in both the Phase II dental impaction and hysterectomy studies, the percentage of subjects using opioid medication after surgery was lower in the IV meloxicam group compared with the placebo group. Although a statistical evaluation was not conducted across the pooled studies, a trend indicating a decrease in adverse events commonly associated with opioid administration such as nausea, vomiting, constipation and pruritus was observed.

  • 24

    Mar

REPH Recro Pharma
$8.71

0.04 (0.46%)

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.

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