Premarket Biotech Digest – $PLX provides updates, $MRK stops trial, $IART acquires new business
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Intellia Therapeutics ($NTLA) stock slumped over 9 percent in its Tuesday trading session as the investors reacted to a ruling passed by Patent Trial & Appeal Board of the U.S. Patent and Trademark Office on the motion filed by the University of California, the University of Vienna and Dr. Emmanuelle Charpentier and the Broad Institute, Harvard University and the Massachusetts Institute of Technology, related to CRISPR/Cas9 genome editing technology. The ruling discontinued the current interference. The board decided that the claim sets presented by the two parties were considered “patentably distinct” from each other.
However, the decision is not intended to nor does it establish which party actually invented first with respect to use of the CRISPR-Cas9 Technology in eukaryotic cells. The slump in the stock price wiped off its Year to Date gains. The company stock price is now 43 percent down in the past 12 months.
Protalix BioTherapeutics Inc. ($PLX) recently provided the update for its projects. The company also offered strategic outlook for 2017. It boosted its financial position as the company finalized its financing and the projected revenue stream from sales of alfataliglicerase in Brazil. In 2017 and 2018, Protalix plans to announce data from various drug trials including its phase III clinical trial on Fabry disease and final results from phase II clinical trial of alidornase alfa for the treatment of Cystic Fibrosis. The company also expects to release results from its phase II clinical trial of OPRX-106 for the treatment of ulcerative colitis.
The company stock has shown robust performance as it gained over 58 percent in the past 12 months. Its gain on Year to Date basis stands at impressive 180 percent.
• Merck & Co. Inc. ($MRK) announced that it has stopped a late-stage trial of an Alzheimer's drug, verubecestat. The decision was taken after determining that it had no chance of working. The company was testing its drug in patients with mild to moderate Alzheimer's disease. However, an independent data monitoring committee determined that there was "virtually no chance of finding a positive clinical effect". The committee recommended the trial be stopped for futility. Merck said another study of its drug in patients with prodromal, or very early, Alzheimer's disease would continue with results expected by February 2019.
• Celsion ($CLSN) announced that it has priced the public offering of nearly 21.7 million shares of common stock at $0.23 per share. Buyers will also be entitled to receive one five-year warrant to purchase 3/4 of a share of common at $0.23 with each share purchased. The closing date for the offering is February 21. Net proceeds will be used for funding clinical trials, working capital and general corporate purposes.
• Masimo ($MASI) announced that it has received CE Mark certification for measuring respiration rate on its MightySat Rx fingertip pulse oximeter. It is a non-invasive device that also measures oxygen saturation, pulse rate and perfusion index.
• Evoke Pharma ($EVOK) announced that the company has received the Food and Drug Administration's positive assessment of the its gastrointestinal disease treatment, Gimoti. The company is now exempted from a Human Factors Validation study for the late-stage product that is required prior to the submission of a new drug application. Evoke said the FDA's determination helps reduce potential risks and saves additional resources for NDA preparation.
• Integra LifeSciences Holdings ($IART) announced that it has agreed to acquire Codman Neurosurgery business from Johnson & Johnson. The deal is valued at $1.045 billion in cash. The unit's product lineup includes devices used in advanced hydrocephalus, neuro-critical care and operative neurosurgery. Codman is a part of JNJ's Depuy Synthes Companies.
• Insys Therapeutics ($INSY) announced that clinical investigators are continuing to provide its Cannabidiol Oral Solution on a no-cost compassionate use basis to children with treatment-resistant epilepsy who completed the 48-week safety study. In the initial safety and PK study, 61 subjects with refractory epilepsy, between the ages of one and 17 years, received total daily doses of 10 mg/kg, 20 mg/kg or 40 mg/kg. In nine of the 61 subjects where Delta-9-THC was measured, no quantifiable plasma levels of Delta-9-THC were detected. Cannabidiol Oral Solution was generally well tolerated.
• Natural Alternatives International Inc. ($NAII) reported the results for its second quarter. The company announced the net income of $2.5 million, or $0.37 per diluted share, on net sales of $30.6 million for the quarter ended December 31, 2016. The sales for the quarter increased $3.6 million, or 13.6%, from $26.9 million recorded in the comparable prior year period. Net sales during the six months ended December 31, 2016 increased $16.1 million, or 33.3%, from $48.5 million recorded in the comparable prior year period.
• Masimo Corporation ($MASI) reported that its revenue rose 10.0% to $175.7 million, compared to $159.8 million for the fourth quarter of fiscal year 2015. Its total revenue, including royalties, rose 9.5% to $183.2 million, up from $167.3 million for the fourth quarter of fiscal year 2015. Net income for the fourth quarter of 2016 was $215.3 million, or $3.97 per diluted share, compared to net income of $24.1 million, or $0.46 per diluted share, in the fourth quarter of 2015.
Brokerage Action Company Rating Price Target
Canaccord Genuity Downgrades ConforMIS (CFMS)
Buy -> Hold
J P Morgan Chase & Co Reiterates Incyte Corporation (INCY)
FBR & Co Downgrades TESARO (TSRO)
Outperform -> Market Perform
Off Wall Street Reiterates Zoetis (ZTS)
Strong Sell $35.00
Gainers (% price change) Last Trade Change Mkt Cap
Insys Therapeutics Inc
10.82 +1.18 (12.24%) 788.00M
10.80 +1.15 (11.92%) 270.55M
Genomic Health, Inc.
31.12 +2.89 (10.24%) 1.05B
Community Health Systems
7.11 +0.49 (7.40%) 825.82M
6.16 +0.38 (6.57%) 448.15M
Losers (% price change)
Syneron Medical Ltd.
10.00 -0.35 (-3.38%) 372.29M
16.20 -0.55 (-3.28%) 232.59M
Owens & Minor, Inc.
34.92 -1.15 (-3.19%) 2.16B
20.19 -0.56 (-2.70%) 104.60M
104.28 -2.74 (-2.56%) 2.18B
Most Actives (dollar volume)
33.51 +0.76 (2.32%) 204.22B
Merck & Co., Inc.
65.16 -0.50 (-0.76%) 182.12B
Gilead Sciences, Inc.
69.80 +2.25 (3.33%) 91.82B
36.77 +1.87 (5.36%) 37.21B
292.64 +7.50 (2.63%) 64.61B