Health and Healthcare
Massive Biopharma Movers of the Past Week
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Even though the markets are in the summer doldrums, the health care sector has been incredibly active. In fact, a few biopharma stocks made massive runs over the course of this past week, some losing more than half their cap. Although not all these moves were negative, the overall sentiment was negative.
What has been driving these companies this week was positive clinical trial results and U.S. Food and Drug Administration (FDA) approvals. 24/7 Wall St. has compiled a list some of the biggest of those stocks moving. We have included a little color on each, as well as a recent trading history and consensus price target.
Achieve Life Sciences Inc. (NASDAQ: ACHV) saw its shares skyrocket early in the week after the company announced positive results from its smoking cessation study. Overall, the study demonstrated that cytisine has no clinically significant interaction with any of the hepatic enzymes commonly responsible for drug metabolism nor clinically significant interaction with drug transporters. These results suggest that cytisine may be administered with other medications without the need to modify the dose of the co-administered drug.
Shares of Achieve closed the week at $3.78, with a consensus analyst price target of $0.90 and a 52-week trading range of $3.28 to $62.70. Over the course of the past week, the stock ended relatively flat, but the single-day gain on Tuesday was 34%.
Aquinox Pharmaceuticals Inc. (NASDAQ: AQXP) saw its shares crash on Wednesday after the firm gave a disappointing update for a late-stage trial. Unfortunately, the firm’s Phase 3 LEADERSHIP 301 clinical trial evaluating rosiptor (AQX-1125) for the treatment of interstitial cystitis/bladder pain syndrome failed to meet its primary endpoint.
Essentially, rosiptor failed to achieve a statistically significant reduction in the mean change from the baseline at week 12 in maximum daily bladder pain score compared to the placebo arm in the female subjects.
However, it got worse from there. Management believes that these results support halting all further development activities with rosiptor. Following the results of this trial, the firm will be undertaking a thorough evaluation of its pipeline and other strategic options available to the company.
Shares of Aquinox closed Friday at $2.65, with a consensus price target of $14.00 and a 52-week range of $1.96 to $16.90. Over the past week, the stock fell 83%.
Summit Therapeutics PLC (NASDAQ: SMMT) was another biopharma company that paid the price on Wednesday. In this case, Summit failed to meet its primary or secondary endpoints for its PhaseOut DMD trial of ezutromid in patients with Duchenne muscular dystrophy (DMD). Based on this outcome, the company is discontinuing its development of ezutromid and, as a result, will be implementing cost reduction measures.
Shares of Summit closed out the week at $2.45, with a consensus price target of $19.88 and a 52-week range of $2.17 to $16.86. Over the past week, the stock fell 80%.
Cara Therapeutics Inc. (NASDAQ: CARA) shares made a solid gain on Wednesday after the biotech announced positive results from a midstage trial. The positive top-line data comes from the firm’s adaptive Phase 2/3 trial of IV CR845 in patients undergoing abdominal surgeries. At the 1.0 mcg/kg dose, IV CR845 demonstrated statistically significant reductions in pain intensity compared to the placebo at all pre-specified post-operative periods of 0 to 6 hours, 0 to 12 hours, 0 to 18 hours and 0 to 24 hours.
Shares of Cara closed Friday at $19.15, in a 52-week range of $11.11 to $22.29. Over the course of the week, the stock rose 15%.
Pain Therapeutics Inc. (NASDAQ: PTIE) shares were destroyed on Wednesday after a vote from the FDA was announced. As we have said before, the FDA has the potential to make or break biopharmaceutical companies. In this case, Pain Therapeutics has been broken.
The FDA had a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee, which precipitated a vote of 14 to three against the approval of Pain Therapeutics’ Remoxy ER.
Looking ahead, the FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of August 7, 2018, for completion of its review of the New Drug Application (NDA) for Remoxy ER.
Shares of Pain Therapeutics were last seen at $2.06, with a 52-week trading range of $2.04 to $12.80. The stock fell 75% last week.
Arsanis Inc. (NASDAQ: ASNS) shares were absolutely crushed on Thursday after the company provided an update from its midstage trial. The company decided that it will cut and run, ultimately discontinuing its pneumonia trial. Arsanis decided that it will discontinue its Phase 2 clinical trial of ASN100 for the prevention of S. aureus pneumonia in high-risk, mechanically ventilated patients following the completion of a planned interim analysis of unblinded trial data by an independent data review committee.
Shares of Arsanis closed the week at $3.63, with a consensus price target of $20.50 and a 52-week range of $3.55 to $28.69. Over the course of the past week, the stock fell 81%.
Gemphire Therapeutics Inc. (NASDAQ: GEMP) shares more than doubled early on Thursday after the company announced results from its midstage trial. Specifically, these are results from its Phase 2b INDIGO-1 trial in severe hypertriglyceridemia. Ultimately, the study met the primary endpoint with median triglycerides significantly decreased by 47% in gemcabene (600 mg) treated patients compared to 27% for placebo-treated patients.
Shares of Gemphire traded at $10.19 on Friday’s close, in a 52-week range of $4.75 to $21.59. The consensus analyst target is $23.60. The stock rose 77% last week.
24/7 Wall St.Dermira Inc. (NASDAQ: DERM) shares made a solid gain to close out the week after the firm announced a key approval from the FDA. Essentially, the agency approved Qbrexza (glycopyrronium) cloth. The approval is based on results from two Phase 3 clinical trials, ATMOS-1 and ATMOS-2, which evaluated the efficacy and safety of Qbrexza in patients with primary axillary hyperhidrosis, or excessive underarm sweating. Qbrexza is expected to be available for prescribing in October 2018.
Shares of Dermira closed Friday at $9.20, with a consensus price target of $17.14 and a 52-week range of $6.98 to $31.42. The stock fell 12% last week.
Acceleron Pharma Inc. (NASDAQ: XLRN) and Celgene Corp. (NASDAQ: CELG) each saw gains on Friday after they reported results from a late-stage trial. Ultimately the Phase 3 clinical study (MEDALIST) of luspatercept achieved a highly statistically significant improvement in the primary endpoint of red blood cell transfusion independence of at least eight consecutive weeks during the first 24 weeks compared to placebo. The companies plan to submit regulatory applications in the United States and Europe in the first half of 2019.
Shares of Acceleron closed Friday at $48.52. The consensus price target is $54.08, and a 52-week range is $29.57 to $50.00. The stock rose 30% last week.
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