Biotech Stocks Ride Momentum in Anticipation of Favorable Governmental Policy Environment

PALM BEACH, Florida, July 12, 2017 /PRNewswire/ --

Biotech and Pharma Companies with innovative technologies and development pipelines are gaining strong interest among investors as treatments and therapies for serious diseases and conditions are in high demand. As competition within the biotech space heats up while awaiting government policy to become clearer, the industry appears more comfortable with the evolving drug pricing scenario and are beggining to take a closer look at the fundamentals of the entire sector. Pharma and Biotech stocks this week, with developments or positive movement in trading in the sector include: Moleculin Biotech Inc. (NASDAQ: MBRX), Amicus Therapeutics, Inc. (NASDAQ: FOLD), Arena Pharmaceuticals Inc. (NASDAQ: ARNA), Ocular Therapeutix Inc. (NASDAQ: OCUL) and Catalyst Pharmaceuticals Inc. (NASDAQ: CPRX)

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 that it received notice from The NASDAQ Stock Market LLC (NASDAQ) on July 6, 2017 indicating that the Company has regained compliance with the minimum bid price requirement under NASDAQ Listing Rule 5550(a)(2) for continued listing on The NASDAQ Capital Market. Accordingly, Moleculin is in compliance with the minimum bid price requirement and NASDAQ considers the matter closed. Read this and more news for Moleculin Biotech at http://www.marketnewsupdates.com/news/mbrx.html.

About Moleculin Biotech, Inc. - Moleculin Biotech, Inc. is a preclinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at M.D. Anderson Cancer Center. Their lead product candidate is Annamycin, an anthracycline being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. They also have two preclinical small molecule portfolios, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient's own immune system. The other portfolio targets the metabolism of tumors.

In notable trading activity in the industry and recent developments: 

Amicus Therapeutics, Inc. (NASDAQ: FOLD) closed up over 25% on Tuesday at $12.92 with over 24 million shares traded by the market close. The company recently announced plans to submit a new drug application (NDA) to the U.S. FDA for the oral precision medicine migalastat for Fabry disease in the fourth quarter of 2017. Based on a series of discussions with and written communication received from the FDA, the Agency has informed Amicus that it may now submit an NDA for migalastat. Amicus is preparing the NDA submission under Subpart H, which provides for accelerated approval. Amicus intends to base its NDA on existing data, including reduction in disease-causing substrate (GL-3), as well as the totality of data from completed clinical studies. Progressive accumulation of GL-3 is believed to lead to the morbidity and mortality of Fabry disease, including pain, kidney failure, heart disease and stroke.

Arena Pharmaceuticals Inc. (NASDAQ: ARNA) had a strong day of trading as well on Tuesday closing up over 40% with a volume north of 14.6 million shares traded by the market close. The company recently announced that it intends to offer and sell, subject to market and other conditions, $150.0 million of shares of its common stock in an underwritten public offering. Arena expects to grant the underwriters an option to purchase up to an additional $22.5 million of shares of its common stock at the public offering price, less the underwriting discounts and commissions. All of the shares are being offered by Arena. There can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Ocular Therapeutix Inc. (NASDAQ: OCUL) closed up over 17% on Tuesday at $7.60 after seeing 5.9 million shares traded on the day. The company recently announced that it has submitted details of a manufacturing equipment change as an amendment to the NDA resubmission for DEXTENZA™ (dexamethasone insert) 0.4 mg, for intracanalicular use, for the treatment of ocular pain following ophthalmic surgery currently under review by the U.S. Food and Drug Administration (FDA). The Company is requesting FDA to consider this submission a major amendment and extend the current NDA target action date of July 19, 2017 under the Prescription Drug Fee User Act (PDUFA) by three months and to review the submission during the current review cycle. As detailed in the amendment, Ocular Therapeutix has modified a piece of manufacturing equipment referenced in the NDA resubmission and will be submitting data on a new commercial batch to demonstrate that this modification, along with other improvements, has addressed outstanding issues regarding particulate matter.

Catalyst Pharmaceuticals Inc. (NASDAQ: CPRX) closed up over 9% on Tuesday at $3.08 with 2.7 million shares traded by the market close. Catalyst Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating neuromuscular and neurological diseases, including Lambert-Eaton myasthenic syndrome (LEMS), congenital myasthenic syndromes (CMS), MuSK antibody positive myasthenia gravis and infantile spasms. Firdapse® has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the treatment of LEMS and Orphan Drug Designation for LEMS, CMS and myasthenia gravis. Firdapse is the first and only approved drug in Europe for symptomatic treatment in adults with LEMS.

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