A few biotech companies made impressive runs over the course of this past week. In the past 52 weeks, biotech and pharmaceutical stocks have been absolutely crushed. However the year before that, the health care sector was on fire from positive trials, U.S. Food and Drug Administration (FDA) approvals and mergers and acquisitions. With American Society of Clinical Oncology (ASCO) annual meeting just around the corner, we wonder if this could be the catalyst to pull the health care sector out of this rut.
These companies 24/7 Wall St. has picked stood out from the rest over the course of this week. We have included information about each company, as well as recent trading activity and the consensus price target.
Shares of Retrophin Inc. (NASDAQ: RTRX) climbed early on Wednesday following positive top-line news from its mid-stage trial for the treatment of focal segmental glomerulosclerosis. Overall, the study achieved statistical significance in the primary efficacy endpoint for the overall sparsentan treatment group, demonstrating a greater than two-fold reduction of proteinuria compared to irbesartan after the eight-week, double-blind treatment period. Keep in mind that although the comparison of individual sparsentan dose cohorts to irbesartan showed clear signals of relative improvement, they did not reach statistical significance.
Over the course of the week, shares were up 32.3%, to close out at $21.30. The stock has a consensus analyst price target of $33.33 and a 52-week trading range of $11.60 to $29.64.
Evoke Pharma Inc. (NASDAQ: EVOK) made a handy gain in Wednesday’s session following a pre-New Drug Application (NDA) meeting with the FDA. Coming out of this meeting, the company believes that it now has the data it needs to complete the NDA and move the process forward for its lead product candidate, Gimoti, also known as EVK-001.
This is welcome news after the stock cratered (80%) in mid-July after its late-stage clinical trial did not achieve its primary endpoints. Management called these top-line results “unexpected and an anomaly,” considering that the drug has been approved for this indication for over 35 years. Seemingly all that has changed is the delivery system.
Last week, shares were up 10.3%, to end at $2.03. The consensus price target is $9.61, and the 52-week range is $1.52 to $11.11.
A move out of left field by Celgene Corp. (NASDAQ: CELG) sent shares of its partner, Agios Pharmaceuticals Inc. (NASDAQ: AGIO), significantly higher. In a surprise move, Celgene is expected to disclose the planned enasidenib (Ag-221) NDA submission at the Citi 11th Annual Biotech Conference in Boston on Wednesday. The planned NDA will be based on the ongoing Phase 1/2 expansion cohort data and is expected to be completed by the end of 2016, which is well ahead of schedule — Janney is saying two years ahead of schedule.
The completed NDA implies a first-in-class drug for relapsed and/or refractory acute myeloid leukemia patients with IDH2 mutation is likely to be commercial during the second half of 2017. Currently, Janney is assuming this is an accelerated approval filing with conversion to full approval upon completion of Phase 3, and expects to get additional clarity after the Celgene webcast.
Agios shares were up 18.3% last week and closed out at $43.00. The consensus price target is $62.83. The 52-week range is $33.50 to $99.46.
On Friday, Lexicon Pharmaceuticals Inc. (NASDAQ: LXRX) saw a handy gain after late-stage results came out. The company announced that its pivotal inTandem1 Phase 3 clinical trial of sotagliflozin met its primary endpoint showing a statistically significant reduction in A1C at 24 weeks in patients with type 1 diabetes on a background of optimized insulin. Two primary safety concerns for patients with type 1 diabetes are severe hypoglycemia and diabetic ketoacidosis. In the trial, the statistically significant and clinically meaningful improvement in A1C for both doses of sotagliflozin was achieved without an increase in severe hypoglycemia, one of the most prevalent serious health challenges in type 1 diabetes, which was seen less frequently in both treatment arms than placebo.
Over the course of the week, shares were up 25.6%. They closed on Friday at $17.85, within a 52-week range of $7.65 to $21.74. The consensus price target is $21.90.
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