Clinical and Regulatory Progress Boosting Biotech Sector

PALM BEACH, Florida, August 22, 2017 /PRNewswire/ --

The biotech sector is continuing to elevate its performance behind clinical and regulatory advancements as industry leaders develop the latest drugs and technologies as well as their respective drug candidates approach the finish line or move towards getting a green light to proceed. Escalating technological advancements in last few years has enabled Companies to introduced new systems that are anticipated to accomplish chromatographic events in less time and deliver more thorough results. Advancing biotechs this week include: Moleculin Biotech, Inc., (NASDAQ: MBRX), Pfizer Inc. (NYSE: PFE), Merck & Co. (NYSE: MRK), AVEO Pharmaceuticals Inc. (NASDAQ: AVEO), Sucampo Pharmaceuticals Inc. (NASDAQ: SCMP)

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 will meet with the European Medicines Agency (EMA) on Wednesday, August 30, 2017 to discuss Clinical Trial Authorization for the study of Annamycin for the treatment of acute myeloid leukemia. Read this and more news for Moleculin Biotech at:http://www.marketnewsupdates.com/news/mbrx.html.

The European Medicines Agency is the European equivalent to the U.S. Food and Drug Administration (FDA) and oversees the approval of new drugs for the European Union. "With our planned clinical trial for Annamycin in the U.S. and Poland which may begin shortly, dependent upon the filing and allowance of an IND with the FDA," commented Walter Klemp, Chairman and CEO of Moleculin. "We want to be in a position to move quickly with Annamycin in the rest of Europe. This meeting will lay the groundwork for expanding Annamycin's market throughout the European Union."

In other industry developments of note: 

Pfizer Inc. (NYSE: PFE) closed up slightly on Monday at $32.76 with over 16.9 million shares traded on the day. The company recently announced that 15 abstracts have been accepted for presentation at the ESC Congress 2017, organized by the European Society of Cardiology, on August 26-30 in Barcelona, Spain. Investigational data from the EMANATE [Eliquis evaluated in acute cardioversion compared to usual treatments for Anticoagulation in subjects with non-valvular atrial fibrillation (NVAF)] clinical trial will be presented during the Late-Breaking Science hot line session and official ESC press conference. EMANATE is a Phase 4 clinical trial exploring Eliquis®(apixaban) versus standard of care (parenteral heparin and/or oral anticoagulation with a vitamin K antagonist) in patients with NVAF expected to undergo cardioversion to re-establish a regular heart rhythm.

Merck & Co. (NYSE: MRK) was up slightly in afterhours trading on Monday after closing up slightly trading over 7.1 million shares traded by the market close. The company recently announced that the U.S. Food and Drug Administration (FDA) has granted approval for the PARP inhibitor, LYNPARZA (olaparib). Eric Pujade-Lauraine, Head of the women cancers and clinical research department at Hôpitaux Universitaires Paris Centre, site Hôtel-Dieu, AP-HP and principal investigator of the SOLO-2 trial, one of the trials supporting the approval, said, "Today's approval is welcome news for U.S. patients with ovarian cancer, who are now able to benefit from treatment with olaparib irrespective of their BRCA-mutation status. This latest regulatory milestone underscores the breadth and depth of clinical data on olaparib, and not only demonstrates its efficacy as maintenance therapy, but adds to the data presented earlier this year showing sustained quality of life for patients undergoing treatment for this serious disease."

AVEO Pharmaceuticals Inc. (NASDAQ: AVEO) closed up 8.79% on Monday at $3.34 with over 6.8 million shares traded on the day and was also up slightly in afterhours trading on Monday as well. AVEO Pharmaceuticals, Inc., a biopharmaceutical company, develops targeted therapies for cancer and related diseases. The company's pipeline of product candidates include Tivozanib, a vascular endothelial growth factor (VEGF) to optimize VEGF blockade; Ficlatuzumab, a hepatocyte growth factor (HGF) inhibitory antibody, which has completed Phase II trial that inhibits the activity of the HGF/c-Met pathway; and AV-203, an anti-ErbB3 specific monoclonal antibody that has completed a Phase I dose escalation study. Its development programs also comprise AV-380, a humanized IgG1 inhibitory monoclonal antibody for the treatment or prevention of cachexia; and the AV-353 platform for the potential treatment of pulmonary arterial hypertension.

Sucampo Pharmaceuticals Inc. (NASDAQ: SCMP) closed Monday up over 7% at $11.05 with a volume north of 1.7 million by the market close. Sucampo Pharmaceuticals, Inc., a biopharmaceutical company, focuses on developing, identifying, acquiring, and marketing medicines that meet unmet medical needs, primarily in gastroenterology, ophthalmology, and oncology-related disorders in the United States, Japan, Switzerland, and internationally.

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