Biotechs Jump on Major Acquisitions, FDA Clearance and Clinical Trial Developments

PALM BEACH, Florida, August 29, 2017 /PRNewswire/ --

Biotechnology indexes yesterday traded to the upside, driving the NYSE Arca Biotechnology Index up by 3 percent. On Monday, the Nasdaq Composite Index added 11 points, or 0.2%, at 6,276, driven by gains in technology and biotech names and the iShares Nasdaq Biotechnology ETF (IBB) trading 1.9% higher. Biotech and pharmaceutical leaders are progressing under a positive environment fostered by FDA approvals, clinical trial advancements, as well as latest mergers and acquisitions for companies such as: Moleculin Biotech, Inc., (NASDAQ: MBRX), AVEO Pharmaceuticals Inc. (NASDAQ: AVEO), Endo International plc (NASDAQ: ENDP), Kite Pharma Inc. (NASDAQ: KITE) and Juno Therapeutics Inc. (NASDAQ: JUNO)

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 it has filed with the Food and Drug Administration (FDA) an Investigational New Drug (IND) application to study Annamycin in the treatment of relapsed or refractory acute myeloid leukemia (AML). Read this and more news for Moleculin Biotech at: http://www.marketnewsupdates.com/news/mbrx.html

Submitting this revised IND marks a significant milestone for Moleculin. FDA allowing the IND to go into effect - which is the anticipated next step and normally would occur within 30 days - will allow the Company to begin additional clinical trials as part of demonstrating the safety and effectiveness of Annamycin. The current plan is to seek approval for treating relapsed or refractory acute myeloid leukemia. If the IND goes into effect as planned, the Company expects to begin clinical trials during the fourth quarter of this year. There can be no assurance, however, that the IND will go into effect within in expected time frame, or at all.

"It took considerable time to produce the additional CMC data requested by the FDA," commented Walter Klemp, Chairman and CEO of Moleculin. "But now that we have all of what the FDA requested, we are pleased to submit a revised IND. We have seen considerable interest from Principle Investigators who are eager to enroll AML patients in an Annamycin clinical trial, so this is a critical step for us." The Company previously filed an IND, in response to which the FDA requested certain revisions to the protocol, additional information, and additional data related to Chemistry, Manufacturing and Controls (CMC). The Company withdrew its original application in order to develop the additional information and CMC data and revise the protocol, with the goal of resubmitting the application when that was accomplished. The current IND submission represents the completion of that process.

In other industry news of note: 

AVEO Pharmaceuticals Inc. (NASDAQ: AVEO) closed up at $3.84 on Monday with a volume worth of 31.5 million shares traded on the day. The company recently announced that the European Commission (EC) has approved FOTIVDA^® (tivozanib) for the treatment of adult patients with advanced renal cell carcinoma (RCC) in the European Union plus Norway and Iceland. Tivozanib is indicated for the first line treatment of adult patients with advanced RCC and for adult patients who are vascular endothelial growth factor receptor (VEGFR) and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for advanced RCC. EUSA Pharma, a specialty pharmaceutical company with a focus on oncology and oncology supportive care, is the European licensee for tivozanib. Tivozanib is an oral, once-daily, potent and highly-selective vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI).

Endo International plc (NASDAQ: ENDP) came up slightly at $9.00 on Monday evening with over 4.5 million shares traded by the market close. The company recently announced that one of its operating companies, Par Pharmaceutical, has begun shipping vigabatrin for oral solution USP, 500 mg per packet following final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application. Par's vigabatrin for oral solution is the generic version of Lundbeck LLC's Sabril® and is the first and currently the only generic version available. Vigabatrin is available only through certified healthcare providers and specialty pharmacies. "We are pleased to be able to offer patients a cost-effective option to Sabril®," said Tony Pera, President of Par Pharmaceutical. "Par's vigabatrin for oral solution is therapeutically equivalent to the brand and is therefore substitutable. We are proud to continue our tradition at Par of providing high quality, affordable medicines."

After news of Gilead Sciences Inc.'s (NASDAQ: GILD) about $11 billion acquisition of Kite Pharma Inc. (NASDAQ: KITE), Juno Therapeutics Inc. (NASDAQ: JUNO) shares surged 16.3 in extremely heavy midday trade Monday. The Kite Pharma acquisition marks a large investment by Gilead into a cancer treatment called chimeric antigen receptor T-cell therapy, or CAR-T, which uses a patient's immune T-cells and re-engineers them to better fight cancer. Juno, Bluebird and Cellectis are other biotech companies working in CAR-T. BTIF analyst Dane Leone upgraded Juno on Monday, adding, "We continue to be skeptical of JUNO's current competitive positioning, but upgrade our ranking to Neutral from Sell, as there is not a near term catalyst to offset the positive tailwind for the entire CAR T space."

Though there has been speculation about Celgene -- which owns about 10% of Juno's current shares outstanding -- acquiring Juno, "We would be surprised by a full acquisition", said Leone. Leone further added, "Since, at this juncture with emerging overlap in Multiple Myeloma and third to market status in CD19 hematological malignancies, we struggle to find a rationale for Celgene wanting to fully own Juno." Read the full article published yesterday on MarketWatch.com here: http://www.marketwatch.com/story/biotech-stocks-surge-on-gileads-kite-pharma-acquisition-2017-08-28?siteid=yhoof2&yptr=yahoo

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