Moleculin Biotech, Inc. (NASDAQ: MBRX), a preclinical and 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 it has received verbal positive guidance from the FDA regarding its planned IND submission indicating that the Company may incorporate by reference the IND established by a prior developer.
Read the full Moleculin Biotech (MBRX) Press Release at: http://marketnewsupdates.com/news/mbrx.html
Moleculin's Chairman and CEO, Walter Klemp, commented, "this new positive guidance removes a major question mark and allows us to create a tighter timeline for the estimated beginning of our next clinical trial. To be clear, we still can't rule out the possibility of a delay in the timeline, but with the knowledge that the FDA is encouraging us to simply incorporate by reference the prior developer's IND, we believe we can accelerate our IND submission process. On our current path, we expect to be able to file our IND submission before year end. Barring a negative surprise from the FDA's review of our submission, that should allow us to begin treating patients in our next clinical trial several months sooner than expected."
The Company has indicated in previous disclosures that it expected to begin its next clinical trial by the first half of 2017, however this development may reduce that time frame by several months. The Company has submitted a pre-IND briefing document to the FDA along with key questions regarding its clinical development plan and a request for a meeting, if the FDA deems it necessary. The FDA recently indicated in writing that it intends to provide written responses to the Company by December 6, 2016 and that it does not believe a live meeting is necessary. Once those written responses are received, the Company will adjust its final IND submission document accordingly and submit for final FDA review. IND submissions are normally reviewed within 30 days of filing.
In other Biotech developments and movement in the sector:
Exelixis, Inc. (NASDAQ: EXEL) this month announced the presentation of new data from clinical trials of cobimetinib in combination with other therapies to treat forms of advanced melanoma. Data from phase 1b trials of cobimetinib in combination with atezolizumab, and with atezolizumab and vemurafenib, respectively, form the basis for two Genentech-sponsored phase 3 pivotal trials anticipated to start in 2017. Additionally, data from a pooled analysis of the combination of cobimetinib and vemurafenib demonstrate the potential for the combination to deliver lasting clinical benefit.
Shares of clinical-stage biopharma Cara Therapeutics (NASDAQ: CARA) soared over 25% higher on Wednesday after analysts at Piper Jaffray upgraded their price target to $21 per share. Analyst Charles Duncan raised the price target for Cara Therapeutics after meeting with management and confirming his confidence in due diligence conducted with respect to the company's clinical programs. CARA closed up over 20% at $12.20 trading over 5.5 Million shares by the market close.
Ocular Therapeutix, Inc. (NASDAQ: OCUL), a biopharmaceutical company focused on the development and commercialization of innovative therapies for diseases and conditions of the eye, this week announced positive topline results from its phase 3 clinical trial of DEXTENZA™ (dexamethasone insert) 0.4 mg, for the treatment of post-surgical ocular inflammation and pain. DEXTENZA is a product candidate administered by a physician as a bioresorbable intracanalicular insert and designed for drug release to the ocular surface for up to 30 days.
Teva Pharmaceutical Industries Ltd., (NYSE: TEVA) recently announced approval of generic Tribenzor®1(olmesartan medoxomil, amlodipine and hydrochlorothiazide) tablets in the U.S. and is in the final stages of launch preparation. Teva also recently received approval and launched generic Azor®2 (amlodipine and olmesartan medoxomil) tablets in the U.S. These products enhance Teva's antihypertensive portfolio. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are a combination of an angiotensin II - receptor blocker, a dihydropyridine calcium channel blocker and a thiazide diuretic indicated for the treatment of hypertension, to lower blood pressure.
DISCLAIMER: MarketNewsUpdates.com (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.
Media Contact email: email@example.com , +1-561-325-8757