December 29, 2016: Sell Recro Pharmaceuticals for a 19.74% win in 11 trading days. Congratulations if you were able to make money on the trade.
December 19, 2016: Piper Jaffray/Simmons initiates coverage of Recro Pharmaceuticals with an Overweight rating, and sets a price target of $12.
December 14, 2016: Broadfin Capital discloses amended 16.43% stake in biotechnology firm Recro Pharma according to a 13D/A filing.
November 29, 2016: H.C. Wainwright/Rodman & Renshaw reiterates a Buy rating on Recro Pharma and sets a price target of $19.
November 28, 2016: Janney making positive comments on Recro Pharma and they reiterate their Buy rating on the stock. Janney set a price target of $21 on Recro Pharma. Janney said that this morning REPH announced positive results from its 219-patient Phase 3 study of IV meloxicam to treat pain following abdominoplasty surgery. The drug achieved statistical significance for the primary endpoint and 10 of the secondary endpoints in this study. The results successfully complete the efficacy portion of the Phase 3 program, which included both hard tissue (bunionectomy) and soft tissue (abdominoplasty) in separate Phase 3 studies designed to ensure IV Meloxicam receives a broad label claim (e.g. for the treatment of acute post-surgical pain) from the FDA. The results eliminate a risk and mark a major advance toward to the ultimate goal of gaining FDA approval for a new non-opioid alternative for use to treat postsurgical pain.
November 28, 2016: Roth Capital making positive comments on Recro Pharma. Roth reiterates a Buy rating on the stock and set a price target of $24. Roth says there’s a 50% chance of approval for IV meloxicam. Increasing this probability towards 75% (post the second positive phase 3 readout) would motivate a $5 to $7 share increase in their price target.
November 28, 2016: Recro Pharma announced positive results from its second of two Phase III clinical trials evaluating intravenous (IV) meloxicam for the treatment of acute postoperative pain. In this trial, IV meloxicam achieved the primary endpoint of a statistically significant difference in Summed Pain Intensity Difference (SPID) over the first 24 hours (SPID24), compared to placebo, in patients following abdominoplasty surgery. With the positive data from this study, the Company believes this completes the efficacy program for the IV meloxicam New Drug Application (NDA).
In this multicenter, randomized, double-blind, placebo-controlled clinical trial, 219 patients were enrolled and randomly assigned to receive a postoperative regimen of IV meloxicam (30mg bolus injection) or placebo in a 1:1 ratio, once every 24 hours. The IV meloxicam treatment arm demonstrated a statistically significant reduction in SPID24 (p=0.0145) compared to the placebo arm. The study also achieved statistical significance for 10 of the secondary endpoints, including statistically significant differences in SPID12 (p=0.0434), time to perceptible pain relief (p=0.0050), subjects with =30% improvement at 24 hours (p=0.0178), number of times patients required rescue in the first 24 hours after randomization (p=0.0275), as well as number of times rescued from 24 to 48 hours (p=0.0009), and several other pain relief metrics, compared to placebo.
The safety results demonstrated that IV meloxicam was well tolerated with no difference in serious adverse events (SAEs) related to bleeding for IV meloxicam treated patients versus placebo (1 each). There were two additional SAEs observed in the placebo group. The most common (=2% in the IV meloxicam group) adverse events (AEs) were nausea, headache, vomiting, and dizziness. The incidence of these events was lower than those observed in the placebo group. The majority of AEs were mild in nature and one patient in the placebo group discontinued treatment due to an adverse event of post-procedural bleeding.
There were no meaningful differences between treatment groups in vital signs, ECGs or clinical lab assessments.
Recro Pharma Stock Chart
Recro Pharma, Inc., a specialty pharmaceutical company, engages in developing non-opioid products for the treatment of acute pain. Its lead product candidate includes injectable meloxicam, a development stage product for the treatment of acute post-operative pain.