Recent FDA Decisions and Clinical Trial Developments Influencing Current Biotech Run

Thursday, August 3, 2017 Clinical Trials News
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PALM BEACH, Florida, August 3, 2017 /PRNewswire/ --

The biotech

and biopharma sector continues to grow as Biotechnology stocks maintain a solid pace amid clinical trials activity, recent FDA decisions/approvals, new leadership and investment decisions from insiders. The big pharma and biotech companies are in the
spotlight these days evidenced by the dramatic shift in the NASDAQ Biotechnology Index (NBI) increasing by as much as 33% after hitting new highs in July. Active biotechs this week include: Moleculin Biotech Inc. (NASDAQ: MBRX), Dynavax Technologies Corporation (NASDAQ: DVAX), AstraZenaca PLC (NYSE: AZN), Corcept Therapeutics Incorporated (NASDAQ: CORT) and Agios Pharmaceuticals Inc. (NASDAQ: AGIO).

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 MD Anderson Cancer Center, today announced it has selected Bioscience SA ('Bioscience'), a Polish contract research organization ('CRO') to begin identifying and preparing clinical testing sites in Poland for Annamycin, its drug candidate for the treatment of relapsed or refractory acute myeloid leukemia (AML). The Company announced on June 15th, an expansion of its agreement with Theradex Systems, Inc. to include oversight of clinical trial activity in Poland and the appointment of a Lead European Principal Investigator on July 6, 2017. Read this and more news for Moleculin Biotech at:

"Engaging Bioscience gives us experienced boots on the ground in Poland," commented Walter Klemp, CEO of Moleculin, "which we believe is critical, not only for ensuring tight coordination between the US and Polish sites in our upcoming Annamycin clinical trial (which would commence only if our IND for Annamycin is permitted), but also to ensure we have the full benefit of local knowledge regarding site performance and regulatory compliance."

Mr. Klemp continued, "one of the biggest challenges for most clinical trials is recruiting the right patients on a timely basis. We believe adding Polish sites to our planned trial introduces a significant population of qualified patients, and selecting Bioscience helps ensure we reach those patients effectively and efficiently."

In other industry news and market performances of note:  

Dynavax Technologies Corporation (NASDAQ: DVAX) closed up 5.59% on Wednesday at $16.05 with over 6.6 million shares traded on the day and was up slightly in afterhours trading. The company recently announced financial results for the second quarter ended June 30, 2017. Cash, cash equivalents and marketable securities were $127.0 million at June 30, 2017 compared to $81.4 million at December 31, 2016. The increase was primarily due to net proceeds of $88.2 million during the first half of 2017 from sales of common stock under an at-the-market sales agreement. Read more here:

AstraZenaca PLC (NYSE: AZN) closed up slightly on Wednesday at $30.33 with over 5.6 million shares traded by the market close. The company recently announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for acalabrutinib for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Acalabrutinib is an investigational, highly selective, potent Bruton tyrosine kinase (BTK) inhibitor in development for the treatment of multiple B-cell cancers.

Corcept Therapeutics Incorporated (NASDAQ: CORT) came to a close up 8.78% on Wednesday at $13.38 with more than 3.9 million shares traded by the market and was up slightly in after hours trading. The company recently announced financial results for the quarter ended June 30, 2017. Corcept reported quarterly revenue of $35.6 million, compared to revenue of $19.7 million in the second quarter of 2016, an increase of 80 percent. The company raised its 2017 revenue guidance from $125-135 million to $145-155 million. Read the full release here:

Agios Pharmaceuticals Inc. (NASDAQ: AGIO) finished Wednesday up 5.10% at $61.64 with over 1.4 million shares traded by the market close but was down slightly in after hours trading. The company recently announced it will host a conference call and live webcast on Tuesday, August 8, 2017 at 8:00 a.m. ET to report its second quarter 2017 financial results and discuss recent clinical development and corporate activities. The live webcast can be accessed under 'Events & Presentations' in the Investors section of the company's website at The conference call can be accessed by dialing 1-877-377-7098 (domestic) or 1-631-291-4547 (international) and refer to conference ID 61600194. The webcast will be archived and made available for replay on the company's website beginning approximately two hours after the event.

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 thirty-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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