Equities have edged higher in trading today even as investors digested the Federal Reserve Chair Janet Yellen’s Jackson Hole speech. Speaking at the annual symposium of central banks in Jackson Hole, the Fed Chair was hawkish in her tone.
Yellen indicated at least one rate hike in 2016. Later, Stanley Fischer, Vice Chair of the Fed, clarified that Yellen’s speech does not rule out a rate hike in September itself. In fact, Fischer said that the speech has also not ruled out two rate hikes for 2016.
A hawkish Fed is negative for risk assets such as equities, but U.S. investors seem to be brushing this aside. At last check, all three major indexes were higher. However, the biotech sector is continuing to see weakness. Biotech’s weakness though can be attributed more to a statement from Presidential candidate Hillary Clinton.
Last week, Clinton criticized Mylan Inc. (NASDAQ:MYL) for hiking the price of EpiPen injection by 400% since acquiring the asset. Clinton’s comments have brought the drug pricing issue at the center stage once again and it seems to be putting pressure on the biotech sector.
One biotech stock though is bucking the trend in trading today. Shares of Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) have edged higher in today’s trade.
TNXP shares are gaining momentum after the company announced the successful End-of-Phase 2/Pre-Phase 3 meeting with the FDA. The company said the minutes confirmed the regulator's acceptance of its planned final stage trial and the proposed NDA data package to support the registration of TNX-102 SL for post-traumatic stress disorder.
Tonix said the final minutes from the FDA suggested the positive results from two well-controlled final phase efficacy and safety studies. Aside from this, the long-term safety exposure studies would offer enough proof of efficacy and safety to support TNX-102 SL registration. The company expects the first final phase trial to be in military-related PTSD patients and the second final stage trial would be predominantly civilian PTSD patients.
Seth Lederman, President & CEO at Tonix Pharmaceuticals, said that considering the FDA’s concurrence that the primary endpoint used in the AtEase study will be the same primary endpoint for both upcoming Phase 3 trials, the company remains confident in achieving this important milestone.
At last check, TNXP shares were trading 2.05% higher at $2.49 on volume of 1.30 million, which is well above the daily average volume of 344,032. TNXP shares have gained more than 20% in the last month. While share have had a good August, overall TNXP is near its 52 week low as the biotech sector continues to not get much love from investors in 2016.
