FDA's Efforts to Accelerate New Drug Development is a Big Bonus for Biotech and Pharma Stocks

PALM BEACH, Florida, November 1, 2017 /PRNewswire/ --

The U.S Food and Drug Administration is taking advantage of latest policy guidance spelled out in past years to speed drug approvals. Thirty-four new drug products and advanced medicines, treating everything from cancer to rare genetic diseases, have been approved so far this year. Based on that pace it is expected to nearly double last year's drug approvals. Wall Street and retail investors are paying attention, with some portfolio managers shifting their strategies, anticipating faster approvals and less restrictive labels. Active in market today includes: Moleculin Biotech, Inc. (NASDAQ: MBRX), Stemline Therapeutics Inc. (NASDAQ: STML), Endo International plc (NASDAQ: ENDP), TEVA Pharmaceuticals Industries Limited (NYSE: TEVA), Novavax Inc. (NASDAQ: NVAX).

Moleculin Biotech, Inc.  (NASDAQ: MBRX), a clinical stage 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 that responses to U.S. Food and Drug Administration ("FDA") requests for additional information relating to the physician-sponsored Investigational New Drug ("IND") application to study WP1066 as a potential treatment for brain tumors have been submitted. "We have been working closely with MD Anderson to help them respond to questions from the FDA," commented Walter Klemp, Chairman and CEO of Moleculin. "A favorable response from the FDA on this request for IND would mean we will have two distinctly different potential cancer drugs in clinic, both Annamycin and WP1066." Read this and more news for Moleculin Biotech at: http://www.marketnewsupdates.com/news/mbrx.html

As the Moleculin Biotech has disclosed previously, the physician-sponsored IND had been placed on clinical hold pending satisfactory responses to questions provided by the FDA. An MD Anderson physician is planning to conduct a Phase 1 clinical trial to study WP1066 in patients with glioblastoma or melanoma that has metastasized to the brain. Standard FDA procedure is to respond to such IND submissions within 30 days. 

In other biotech developments in the markets: 

Stemline Therapeutics Inc. (NASDAQ: STML) closed up Tuesday over 29% at $13.65 with over 3 million shares traded by the market close. Yesterday, the company announced that the pivotal Phase 2 trial of SL-401 in blastic plasmacytoid dendritic cell neoplasm (BPDCN) has met its primary endpoint. Based on feedback from the U.S. Food and Drug Administration (FDA), Stemline remains on track to begin submission of its Biologics License Application (BLA) in the 4Q17-1Q18 timeframe. SL-401 has been granted Breakthrough Therapy Designation (BTD) by the FDA for the treatment of BPDCN, and Orphan Drug Designation (ODD) by the FDA and EU for the treatment of patients with BPDCN and acute myeloid leukemia (AML).

Endo International plc (NASDAQ: ENDP) closed up over 7% on Tuesday at $6.38 with over 15.2 million shares traded on the day. Earlier In the week, the company announced preliminary results for the quarter ended September 30, 2017, including expected: (i) revenues of approximately $785 million; (ii) reported (GAAP) net loss attributable to Endo of approximately $100 million; (iii) adjusted earnings before interest, taxes, depreciation and amortization (EBITDA) from continuing operations of approximately $370 million; (iv) reported (GAAP) loss per share from continuing operations of approximately $0.45; and (v) adjusted diluted earnings per share (EPS) from continuing operations of approximately $0.85. Endo also affirmed that for the twelve months ending December 31, 2017, the Company expects revenues to be between $3.38 billion and $3.53 billion. The Company further expects adjusted EBITDA from continuing operations and adjusted diluted EPS from continuing operations to be at the upper end of the 2017 financial guidance ranges provided in August of $1.48 billion to $1.56 billion and $3.35 to $3.65, respectively.

TEVA Pharmaceuticals Industries Limited (NYSE: TEVA) closed up slightly on Tuesday at $13.80 with over 32 million shares traded by the market close as was also up slightly in afterhours trading. The company recently announced that the United States District Court for the District of Delaware has ruled in the Company's favor in patent litigation involving Teva's abbreviated new drug application (ANDA) directed to a generic version of Valeant's Uceris® (budesonide ER) tablets. At trial in May, the Court found that Plaintiffs did not meet the threshold to establish infringement, and the Court has now issued its written decision confirming that Teva's ANDA product does not infringe the asserted patent. We are pleased to have another legal win on one of our first-to-file PIV patent challenges brought in through the Actavis Generics acquisition." said Dipankar Bhattacharjee, President and CEO, Global Generic Medicines, Teva. "This presents another first generic opportunity for Teva and we look forward to offering this product to our customers when otherwise able to."

Novavax Inc. (NASDAQ: NVAX) closed Tuesday up over 6% at $1.09 with over 7 million shares traded by the market close. The company announced yesterday it will report its third quarter financial and operating results following the close of U.S. financial markets on Tuesday, November 7, 2017. Novavax, Inc. is a clinical-stage biotechnology company committed to delivering novel products to prevent a broad range of infectious diseases. Its recombinant nanoparticles and Matrix-M™ adjuvant technology are the foundation for groundbreaking innovation that improves global health through safe and effective vaccines.

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