Increasing Flurry of FDA Orphan Drug Development Activity Fueling Uptick of Enthusiasm for Few Pharma Stocks

Tuesday, May 23, 2017 Drug News
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PALM BEACH, Florida, May 23, 2017 /PRNewswire/ --

The Health

Care Sector which includes biotech, pharmaceutical and medical device stocks, continues to forge ahead despite recent concerns in the markets as some of the larger companies show attractive earnings growth potential all tied to new drug innovation, FDA
approvals and device roll-outs. A few industry professionals believe the Health Care sector coupled with stable earnings growth presents some sort of rising trend of enthusiasm as one of the more attractive sectors in the markets ahead. Health Care and Pharma stocks with developments and market performance of note include: Moleculin Biotech, Inc. (NASDAQ: MBRX), Puma Biotechnology, Inc. (NASDAQ: PBYI), Radius Health, Inc. (NASDAQ: RDUS), MannKind Corporation (NASDAQ: MNKD) and BioPharmX Corporation (NYSE: BPMX).

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 ('MD Anderson'), today issued a Letter to Shareholders to provide an update on recent and planned activities at Moleculin. Read the full shareholder update and recent news for Moleculin Biotech at:

Highlights included in the announcement from Moleculin: As an overview, we recently received Orphan Drug designation from the Food and Drug Administration (FDA) for Annamycin and we continue to make progress toward submitting an IND for Annamycin for the treatment of relapsed or refractory adult AML. As well, the deadline for exercise of short-term warrants connected with our recent offering of common stock has now passed, removing over 5 million shares of overhang from our stock.

Potential: As we transition from a preclinical to a clinical-stage company, it is important to keep in mind the potential we see for Annamycin. The good news for AML patients currently is that bone marrow transplants are successful in curing AML about 80% of the time. The bad news, however, is that patients must first completely clear their bone marrow blasts (tumor cells) before qualifying for a transplant and the 'induction therapy' used to do so only succeeds about 20% of the time. That leaves about 80% of AML patients without hope because there is no approved second-line therapy once the first-line therapy fails.

Progress: The Orphan Drug designation granted to Annamycin as of March of this year for the treatment of AML (Acute Myeloid Leukemia) represents a significant development milestone for Moleculin. The FDA grants Orphan Drug designation to investigational drugs to facilitate drug development for rare diseases which may provide several benefits to Moleculin, including assistance with clinical study design and drug development, tax credits for qualified clinical trial costs, exemptions from certain FDA application fees, and seven years of market exclusivity in the U.S. upon regulatory product approval.

Sector related market standouts this week includes: 

Puma Biotechnology, Inc. (NASDAQ: PBYI) closed up over 39% on Monday at $52.60 trading over 12.2 Million shares by the market close. Puma Biotechnology announced yesterday that the U.S. Food and Drug Administration (FDA) posted briefing documents on its website in preparation for the May 24 Oncologic Drugs Advisory Committee (ODAC) meeting scheduled to review PB272 (neratinib) for the extended adjuvant treatment of HER2-positive early stage breast cancer. ODAC is an independent panel of experts that evaluates data concerning the efficacy and safety of marketed and investigational cancer treatments and makes appropriate recommendations to the FDA. Its comments are not binding, but are considered by the FDA in its decision-making process.

Radius Health, Inc. (NASDAQ: RDUS) also closed up on Monday over 6% at $37.24 trading over 7.4 Million shares by the market close. Radius Health announced that on May 15, 2017, the Company's Board of Directors granted Jose (Pepe) Carmona, the Company's Chief Financial Officer, an option to purchase 125,000 shares of the Company's common stock with a per share exercise price of $34.96, the closing trading price of the Company's common stock on the NASDAQ Global Market on the grant date of May 15, 2017. The option vests 25% on the first anniversary of the grant date, with the remaining 75% to vest in monthly installments over the three years thereafter, and has a ten-year term.

MannKind Corporation (NASDAQ: MNKD) closed up over 21% on Monday at $1.37 trading 8.6 Million shares by the market close. MannKind Corporation focuses on the discovery, development and commercialization of therapeutic products for patients with diseases such as diabetes.

BioPharmX Corporation (NYSE: BPMX) closed up over 25% at $0.6165 on Monday trading over 7.39 Million shares by the market close. BioPharmX Corporation is a Silicon Valley-based specialty pharmaceutical company that seeks to provide products through proprietary platform technologies for prescription, over-the-counter and supplement applications in the health and wellness markets, including dermatology and women's health.

DISCLAIMER: (MNU) is a third party publisher and news dissemination service provider, which disseminates electronic information through multiple online media channels. MNU is NOT affiliated in any manner with any company mentioned herein. MNU and its affiliated companies are a news dissemination solutions provider and are NOT a registered broker/dealer/analyst/adviser, holds no investment licenses and may NOT sell, offer to sell or offer to buy any security. MNU's market updates, news alerts and corporate profiles are NOT a solicitation or recommendation to buy, sell or hold securities. The material in this release is intended to be strictly informational and is NEVER to be construed or interpreted as research material. All readers are strongly urged to perform research and due diligence on their own and consult a licensed financial professional before considering any level of investing in stocks. All material included herein is republished content and details which were previously disseminated by the companies mentioned in this release. MNU is not liable for any investment decisions by its readers or subscribers. Investors are cautioned that they may lose all or a portion of their investment when investing in stocks. For current services performed MNU has been compensated three thousand nine hundred dollars for news coverage of the current press release issued by Moleculin Biotech, Inc., by the company. MNU HOLDS NO SHARES OF ANY COMPANY NAMED IN THIS RELEASE.

This release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. "Forward-looking statements" describe future expectations, plans, results, or strategies and are generally preceded by words such as "may", "future", "plan" or "planned", "will" or "should", "expected," "anticipates", "draft", "eventually" or "projected". You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in a company's annual report on Form 10-K or 10-KSB and other filings made by such company with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and MNU undertakes no obligation to update such statements.

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