Biotech Sector Continued Resurgence Fueled by Increasing Clinical Trial Activity & Business Friendly FDA Leadership

PALM BEACH, Florida, July 25, 2017 /PRNewswire/ --

The rising stability provided by business friendly leadership at the top of the Federal Food & Drug Administration these days has created a healthy and conducive environment for biotech stocks to perform and take advantage of the recent revival of the biotech/pharma growth. This week's sector performers and leaders in the industry that are welcoming the FDA's new approach to streamlining the drug development and approval process include: Moleculin Biotech Inc. (NASDAQ: MBRX), NeuroDerm Ltd. (NASDAQ: NDRM), Reata Pharmaceuticals Inc. (NASDAQ: RETA), Novavax Inc. (NASDAQ: NVAX) and Genocea Biosciences Inc. (NASDAQ: GNCA).

Moleculin Biotech, Inc. (NASDAQ: MBRX), a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced it has agreed to provide support to help accelerate the start of a physician-sponsored Investigational New Drug (IND) application to study the Company's drug candidate WP1066 for the treatment of adult glioblastoma (brain tumors). Read this and more news for Moleculin Biotech at:

Dr. Robert Shepard, Moleculin's Chief Medical Officer added, "We have never seen a drug like WP1066 that appears capable in vitro of both stimulating a natural immune response and directly killing tumor cells to block tumor progression. There continues to be a serious unmet need for the treatment of glioblastomas, the most aggressive and lethal form of brain cancer, which is why we are working so hard and are excited to get WP1066 into the clinic."

A recent Facebook post by MD Anderson Brain and Spine expanded, "The drug, known as WP1066, is modeled after a natural compound that has certain tumor-fighting properties. WP1066 amplifies these properties to potent levels, and it can cross the blood-brain barrier. WP1066 belongs to a class of drugs known as STAT3 inhibitors; they prevent tumors from using the STAT3 pathway to evade the immune system. WP1066 can also induce tumor cell death. It's effective against human glioblastoma in preclinical models. The next step is to see if this unique drug is effective when given to glioblastoma patients."

In other industry related developments or market performances of note include: 

NeuroDerm Ltd. (NASDAQ: NDRM) closed up over 15% on Monday at $38.35 with just under 10 million shares traded by the market close. The company recently announced it has signed a definitive agreement under which Mitsubishi Tanabe Pharma Corporation ("MTPC"), a publicly traded company on the Tokyo Stock Exchange, will acquire NeuroDerm for US$39 per share in cash. The transaction has received unanimous approval by NeuroDerm's Board of Directors and implies an equity value of approximately US$1.1 billion. The offer of US$39 per share in cash represents a premium of 79 percent over the unaffected price on June 9, 2017 of NeuroDerm's ordinary shares on the Nasdaq Stock Market and a 17 percent premium over the closing stock price on July 21, 2017.  

Reata Pharmaceuticals Inc. (NASDAQ: RETA) came to a close up over 14% on Monday at $35.47 after more than 1 million shares were traded by the market close. The company recently reported initial data from the ongoing open-label Phase 2 portion of CARDINAL, a Phase 2/3 trial evaluating bardoxolone methyl ("bardoxolone") in patients with chronic kidney disease ("CKD") caused by Alport syndrome. Based upon these data, the Company has initiated screening in the Phase 3 portion of the trial and is planning to launch additional Phase 2 studies in rare renal diseases during the first half of 2018. The Phase 2 portion of the trial enrolled 30 patients, and all patients remain on study.  

Novavax Inc. (NASDAQ: NVAX) finished Monday up at $1.51 with just over 34.7 million shares traded by the market close. The company announced yesterday positive topline data from its Phase 2 safety and immunogenicity trial of the RSV F Vaccine in older adults, new preclinical data on its RSV F Vaccine construct, additional findings from the prior Phase 2 and Phase 3 clinical trials in older adults (E201 and E301), and an operational update on the Phase 3 clinical trial of the RSV F Vaccine for infants via maternal immunization, known as Prepare(TM). The Company anticipates initiating a Phase 2 efficacy trial in older adults in 2018. Topline data from the Phase 2 older adult safety and immunogenicity trial (E205) demonstrate the benefit of adjuvant formulations and two-dose regimens. The objective of the Phase 2 randomized, observer-blinded, placebo-controlled trial was to assess safety and immunogenicity of one and two-dose regimens of the RSV F Vaccine, with and without aluminum phosphate or Novavax proprietary Matrix-M(TM) adjuvant, in 300 older adults.

Genocea Biosciences Inc. (NASDAQ: GNCA) closed up over 15% on Monday at $5.83 with just over 8.1 million by the market close. The company announced yesterday positive 12-month top-line data from the Phase 2b clinical trial for GEN-003, its immunotherapy candidate for patients with genital herpes. In this 131-subject Phase 2b clinical trial, GEN-003 reduced the median genital lesion rate (or percent days with genital lesions) versus placebo by 49 percent (p=0.01) over the 12 months' post dosing at the 60 µg per antigen / 50 µg of adjuvant dose. Importantly, these results were achieved at the Phase 3 dose and expected Phase 3 primary endpoint. Other clinical endpoints for this dose improved or were consistent with previously reported positive data. No changes were observed to the previously established safety profile of GEN-003.

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