Latest R&D Success, FDA Approvals and Significant Advances in Clinical Trials Boosting Biotech Sector

PALM BEACH, Florida, August 9, 2017 /PRNewswire/ --

Biotech stocks have had an impressive run so far in 2017 with the NASDAQ Biotechnology Index (NBI) increasing over 19% year-to-date (YTD). Headlines in the active biotech sector include significant progress made in clinical trials, R&D success and innovation as well as a favorable FDA policy environment as progress allows numerous industry players to grow and thrive in a rebounding sector. Active in the biotech and big pharma industry with market performance and new developments include Moleculin Biotech Inc. (NASDAQ: MBRX), FibroGen Inc. (NASDAQ: FGEN), Cellectar Biosciences Inc. (NASDAQ: CLRB), Esperion Therapeutics Inc. (NASDAQ: ESPR) and MyoKardia Inc. (NASDAQ: MYOK)

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 commented on several recent FDA approvals for new drugs for the treatment of acute myeloid leukemia (AML). Read this and more news for Moleculin Biotech at: http://www.marketnewsupdates.com/news/mbrx.html

Walter Klemp, CEO of Moleculin commented, "The recent approvals of three new drugs (Rydapt, Vyxeos and Idhifa) for the treatment of AML are exciting, since they provide additional options for treatments in defined subpopulations, and because they help underscore the magnitude of the potential opportunity for Annamycin, which we will be studying for relapsed or refractory AML. With regard to AML, Rydapt is approved only for patients with a specific gene mutation, and for use in combination with the standard of care chemotherapy. Vyxeos is approved as an option to the standard of care, but only for specific AML patients, namely those with newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC). Jazz Pharmaceuticals purchased this drug in their $1.5 billion acquisition of Celator Pharmaceuticals." 

Mr. Klemp continued, "Although FDA approval of both of those drugs was based on overall survival comparisons with a standard of care, Idhifa was approved based on an accelerated clinical trial design that showed a 19% response rate in patients with relapsed or refractory AML and IDH2 mutation. What's interesting is that Idhifa was approved with a single Phase 1/2 clinical trial based on response rate, not overall survival, and a relatively low response rate at that. Also, the patient population for which it is approved represents only 13% of all AML patients. We look forward to working with FDA on a similar approach for Annamycin - reliance on response rate in an accelerated path - but for a larger population of AML patients."

In other industry happenings and market performances of note: 

FibroGen Inc. (NASDAQ: FGEN) closed up 48.20% on Tuesday at $49.50 with over 9.3 million shares traded by the market close. The company announced positive topline results from the company's Phase 2 randomized, double-blind, placebo-controlled study and two combination safety sub-studies of pamrevlumab in patients with idiopathic pulmonary fibrosis (IPF). Pamrevlumab is a proprietary, first-in-class, anti-connective tissue growth factor (CTGF) antibody being evaluated in fibrotic disease and cancer. "I am pleased to see positive Phase 2 results with pamrevlumab -- an antibody against CTGF, a new target in fibrosis -- which has a good safety profile and the potential to provide alternative, much-needed new treatment options for IPF patients," said Luca Richeldi, M.D., Ph.D., Head of the Division of Pulmonary Medicine at Agostino Gemelli University Hospital of the Catholic University of the Sacred Heart in Rome, Italy.

Cellectar Biosciences Inc. (NASDAQ: CLRB) came to a close up 11.39% on Tuesday at $1.76 with a volume of over 5.9 million shares traded by the market close. The company recently announced its lead PDC compound, CLR 131 has achieved a median overall survival of 22.5 months to date after a single dose infusion of 12.5 mCi/m2 in patients with multiple myeloma. Patients in the first cohort of the company's Phase 1 clinical trial had an average of 5.8 prior lines of treatment and therefore were considered to be heavily pretreated. It is important to note that the trial remains ongoing, and the overall survival could continue to increase over time. While there have been no head-to-head studies, for comparison, this ongoing overall survival length from the company's Phase 1 clinical trial exceeds historic published outcomes of currently marketed second and third line treatment modalities for multiple myeloma.

Esperion Therapeutics Inc. (NASDAQ: ESPR) finished up 15.41% on Tuesday at $52.13 with north of 4.1 million shares traded on the day. The company recently announced it intends to offer and sell, subject to market and other conditions, $150 million of its common stock in an underwritten public offering. Esperion expects to grant the underwriters a 30-day option to purchase up to $22,500,000 of additional shares of its common stock.

MyoKardia Inc. (NASDAQ: MYOK) closed up 15.10% on Tuesday at $36.20 with over 3.6 million shares traded by the market close. The company recently announced it has commenced a proposed underwritten public offering of 3,500,000 shares of its common stock. All shares of common stock will be offered by MyoKardia. In addition, MyoKardia expects to grant the underwriters a 30-day option to purchase an additional 525,000 shares of common stock at the public offering price, less the underwriting discount. MyoKardia anticipates using the net proceeds from the offering, together with its existing cash and cash equivalents, to fund research and development activities for its development programs, including, but not limited to, its ongoing and planned clinical trials for mavacamten (formerly MYK-461) and MYK-491, its ongoing preclinical, discovery and research programs and the expansion of its platform, and for working capital and other general corporate purposes.

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