Positive Developments From Clinical Studies and FDA Approvals Pushing Biotech Stocks to New Highs

PALM BEACH, Florida, October 18, 2017 /PRNewswire/ --

Biotech Briefing: The Biotech Sector continues to impress and even surprise many as the SPDR S&P Biotech ETF (XBI) has surged 49 percent in 2017 to its highest level in more than two years and some industry professionals believe the climb isn't over just yet. Erin Gibbs, a portfolio manager with S&P Global, stands by the fact the "the average stock in the XBI is trading at 21 percent below its [average] analyst target price. The average stock is rated a buy." The health care sector in general has enjoyed a strong year this year, up 20 percent since January, as many biotechs have the attention of Wall Street ahead of the third-quarter earnings season such as: Moleculin Biotech, Inc. (NASDAQ: MBRX), AmpliPhi Biosciences Corporation (NYSE: APHB), Ionis Pharmaceuticals Inc. (NASDAQ: IONS), Abeona Therapeutics Inc. (NASDAQ: ABEO), Acadia Pharmaceuticals Inc. (NASDAQ: ACAD).

Moleculin Biotech, Inc. (NASDAQ: MBRX), a 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 that 14 qualified cancer clinics have requested to participate in its clinical trial to study Annamycin for 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  

"We've had a very positive response from the hematology oncology community," commented Walter Klemp, Chairman and CEO of Moleculin. "With little to no cardiotoxicity and a structure that has been shown to avoid the multidrug resistance mechanisms that often defeat the current first line standard of care for AML, a number of clinicians recognize that Annamycin could provide a second chance to patients who have run out of options."

Mr. Klemp continued: "We are pleased to have so many sites express interest in this trial, as it should help improve our chances for timely patient recruitment. In addition, seven of these interested sites are in Poland where we believe we will have access to a higher percentage of patients who are what we call "treatment naive", meaning they have not been subjected any experimental therapies before entering our trial." 

In other biotech developments in the markets: 

AmpliPhi Biosciences Corporation (NYSE: APHB) close up over 26% on Tuesday with over 4.7 million shares traded by the market close. AmpliPhi Biosciences Corporation recently announced the publication of preclinical data demonstrating the activity of AB-PA01 in reducing biofilms. The paper, titled "Activity of Bacteriophages in Removing Biofilms of Pseudomonas aeruginosa Isolates from Chronic Rhinosinusitis Patients," was published on September 22, 2017, in the journal Frontiers in Cellular and Infection Microbiology and can be found here. "We're excited to publish these findings, which continue to show the potential of phage therapy to target infection-associated biofilms and multidrug-resistant bacteria," said Paul C. Grint, M.D., CEO of AmpliPhi Biosciences. "Pseudomonas aeruginosa infections are prevalent among chronic rhinosinusitis sufferers and many strains form difficult-to-penetrate biofilms, leading to treatment failure. In this in vitro study, a single dose of AB-PA01 significantly reduced biofilms. Furthermore, AB-PA01 was shown to be active against 89% of the P. aeruginosa isolates tested. These preclinical data further support the promise of AmpliPhi's technology to develop novel, targeted antibacterial therapies in an age of increasing antibiotic resistance."

Ionis Pharmaceuticals Inc. (NASDAQ: IONS) closed up over 4% on Tuesday at $63.85 on over 1.9 million shares traded by the market close. The company recently announced that new data from the Phase 3 NEURO-TTR study with inotersen in patients with hereditary TTR amyloidosis (hATTR) with polyneuropathy were presented at the 142ndannual meeting of the American Neurological Association (ANA) in San Diego, California. In the study, inotersen-treated patients achieved a mean 19.73-point benefit in the mNIS+7 co-primary endpoint after 15 months of treatment, compared to placebo-treated patients (p = 0.00000004), further demonstrating the clinically meaningful benefit of inotersen treatment. A statistically significant benefit in mNIS+7 was also observed at eight months. Key safety findings of thrombocytopenia and renal events identified during the study were shown to be monitorable and manageable with routine blood and urine testing.

Abeona Therapeutics Inc. (NASDAQ: ABEO) closed up over 7% on Tuesday at $17.90 with over 3.9 million shares traded by the market close. The company announced earlier in the week the pricing of an underwritten public offering of five million shares of common stock at a public offering price of $16.00 per share. The gross offering size for this offering is expected to be approximately $80 million, before deducting the underwriting discounts and commissions and estimated offering expenses payable by the Company. The Company has granted to the underwriters participating in the offering a 30-day option to purchase up to an additional 750,000 shares of common stock. The offering is expected to close on or about October 19, 2017, subject to customary closing conditions. Abeona intends to use the net proceeds of the offering for working capital and corporate purposes, including, without limitation, development of its product candidates, manufacturing and general and administrative expenses.  

Acadia Pharmaceuticals Inc. (NASDAQ: ACAD) closed up slightly on Tuesday on over 1.2 million shares traded by the market close. ACADIA Pharmaceuticals announced earlier this month the initiation of HARMONY, a Phase III study to evaluate pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis, a serious medical condition for which there is no therapy approved by the U.S. Food and Drug Administration (FDA). The company also announced that the FDA has granted Breakthrough Therapy Designation to pimavanserin for dementia-related psychosis. Dementia-related psychosis includes psychosis in patients with Alzheimer's disease, dementia with Lewy bodies, Parkinson's disease dementia, vascular dementia, and frontotemporal dementia. If the clinical development program is successful, and pimavanserin is ultimately approved by the FDA for the treatment of dementia-related psychosis, it would represent a significant expansion of the approved use of pimavanserin.

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