A few biopharma stocks made massive runs on Wednesday morning as the result of clinical trial results and earnings. Although not all these moves were positive, the overall sentiment was positive.
The broad markets have dropped off from their all-time highs but are still at a respectable level. Much of this year’s rally is attributable to optimism in the health care sector and the changing outlook on the industry from the new administration. However there have been setbacks.
The recent denial for the repeal of the Affordable Care Act (ACA) may have been a setback, but the health care industry was largely unaffected, with the exception of some hospital stocks that rallied.
Over the past year, the health care sector has been in trouble, under fire from congressional hearings and politicians on the campaign trail. But 2017 could be different, with a new administration and new perspective that could lead to more positive trials, U.S. Food and Drug Administration (FDA) approvals and mergers and acquisitions.
The companies 24/7 Wall St. has picked stood out from the rest on Tuesday morning. We have included information about each company, as well as recent trading activity and the consensus price target.
Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) saw its shares jump following the announcement that the firm will be presenting an update on its FDA breakthrough therapy for its post-traumatic stress disorder (PTSD) clinical program. The presentation will take place at the MicroCap Conference in New York on April 4.
TNX-102 SL was recently granted Breakthrough Therapy designation by the FDA for the treatment of PTSD. This month, Tonix dosed the first patient for the “Honor” study, a Phase 3 clinical study evaluating TNX-102 SL, in military-related PTSD. The interim analysis of the Honor study is expected in the first half of 2018 and top-line results are expected in the second half of 2018.
Shares of Tonix were last seen up about 110% at $8.75, with a consensus analyst price target of $8.00 and a 52-week trading range of $0.33 to $9.40.
Vertex Pharmaceuticals Inc. (NASDAQ: VRTX) shares were jumping after the firm released results from two Phase 3 studies in the treatment of cystic fibrosis in ages 12 and older.
The 24-week Evolve study evaluated the combination treatment in people who have two copies of the F508del mutation. This study met its primary endpoint with a mean absolute improvement in percent predicted forced expiratory volume (ppFEV) in one second.
The second study, Expand, met the primary endpoints of absolute change in ppFEV from baseline to the average of the Week 4 and Week 8 measurements, with the tezacaftor/ivacaftor combination treatment demonstrating a mean absolute improvement of 6.8 percentage points compared to placebo.
Based on these results, Vertex plans to submit a New Drug Application (NDA) to the FDA and a Marketing Authorization Application (MAA) to the European Medicines Agency in the third quarter of 2017 for the tezacaftor/ivacaftor combination.
Shares of Vertex were trading up 22% at $109.50, with a consensus price target of $100.25 and a 52-week range of $71.46 to $111.73.
Pernix Therapeutics Holdings Inc. (NASDAQ: PTX) reported its fourth-quarter financial results after the markets closed on Tuesday. Revenues increased 9% sequentially to $45.4 million. However, the net loss for the fourth quarter of 2016 was $86.1 million, as compared to net loss of $26.4 million for the third quarter of 2016 and net loss of $81.7 million for the three months ended December 31, 2015. The increase in the net loss was due primarily to noncash charges related to the impairment of intangible assets and goodwill.
John Sedor, chairman and CEO of Pernix, commented:
Since July 2016, when we restructured our sales force, we have achieved significant progress in improving the performance of our business. Moreover, our prescription fulfillment program, Pernix Prescriptions Direct, continues to drive uptake of Treximet and Silenor. We remain focused on improving our commercial execution and driving further growth of our core brands. In addition, our business returned to positive adjusted EBITDA during the second half of 2016.
Pernix shares traded down 10% at $3.65, with a consensus price target of $30.00 and a 52-week range of $0.39 to $4.80.
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