Stockwinners Market Radar for November 08, 2020 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

FFIV...

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20:03 EST Fly Intel: Top five weekend stock stories - Catch up on the weekend's top five stories with this list compiled by The Fly: 1. Late Saturday morning, Associated Press reported that Democrat Joe Biden had defeated President Donald Trump to become the 46th president of the United States. His victory came after more than three days of uncertainty as election officials sorted through a surge of mail-in votes that delayed the processing of some ballots. Biden crossed 270 Electoral College votes with a win in Pennsylvania, the publication said. 2. Activist investor Elliott Management has taken a stake in F5 Networks (FFIV) and spoken to the software company's management in recent weeks about ways to boost its lagging stock, The Wall Street Journal's Corrie Driebusch reported, citing people familiar with the matter. The exact size of Elliott's stake couldn't be learned, though it falls below the 5% threshold that would require regulatory disclosure, the people said. 3. California voters passed Proposition 22 on Tuesday, which exempts ride-sharing and food-delivery companies from a state law that would have required them to classify their drivers as employees, rather than contractors, Eric Savitz wrote in this week's edition of Barron's. The Uber (UBER) and Lyft (LYFT) position their Prop 22 victory as a landmark win for drivers, the publication notes. Outside California, the vote might appear to be a victory for the tech business, demonstrating the average Californian's admiration for innovative homegrown digital companies. But the proposition lost by a 60/40 margin in San Francisco, where the companies are based, and it also was defeated in Santa Clara and San Mateo counties, which make up Silicon Valley, the author added. 4. Berkshire Hathaway (BRK.A, BRK.B) reported third quarter earnings per share of $18,994 versus $10,119, and revenue for the quarter of $63.02B versus $64.97B last year. Approximately $9B was used to repurchase Berkshire shares during the third quarter, bringing the nine-month total to approximately $16B. The company said that about 70% of its aggregate fair value was concentrated in four companies: American Express (AXP) at $15.2B; Apple (AAPL) at $111.7B; Bank of America (BAC) at - $24.9B and The Coca-Cola Company (KO) at $19.7B. 5. Danone (DANOY) saw a positive mention in this week's edition of Barron's, while Biogen (BIIB) was mentioned cautiously.
LMNL

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20:01 EST Liminal BioSciences announces FDA extension of review period for Ryplazim BLA - Liminal BioSciences announced that the U.S. Food and Drug Administration has notified the company that it has extended the review period for the Biologics License Application for Ryplazim, or plasminogen, for the treatment of clinical signs and symptoms associated with congenital plasminogen deficiency. The new Prescription Drug User Fee Act target action date has been extended by the FDA by three months to June 5, 2021. "While we are disappointed by the extension of the review period by FDA, we look forward to continuing discussions with the FDA during the review process," said Kenneth Galbraith, Chief Executive Officer of Liminal BioSciences. "We remain committed to bringing this much needed treatment forward to help patients with this serious disease." The BLA resubmission for Ryplazim was originally accepted by FDA in September 2020 as a Class 2 response to the prior complete response letter issued by FDA in 2018, with a six-month review period, and the FDA set a PDUFA target action date of March 5, 2021.
PHG

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16:09 EST Patient-level meta-analysis results show safety profile of Philips Stellarex DCB - Royal Philips announced the results of a patient-level meta-analysis that confirms the safety profile of its Stellarex drug-coated balloon at four years. Including data from two major randomized controlled trials, the results show no difference in mortality between patients treated with the Stellarex DCB and those treated with percutaneous angioplasty, the current standard of care. The meta-analysis, which represents the highest level of the evidence pyramid, was presented at the virtual 2020 Vascular Interventional Advances conference. The meta-analysis found that over four years, there was no significant difference in survival among patients treated with the Stellarex DCB. The data includes two Stellarex RCTs: the ILLUMENATE EU RCT and the ILLUMENATE Pivotal RCT, comprised of 589 patients in the U.S. and Europe followed up to four years with a high compliance on vital status data. In addition to demonstrating no significant difference in all-cause mortality between patients treated with the Stellarex DCB and those treated with PTA, the results of the meta-analysis also show no difference in cardiovascular mortality and non-cardiovascular mortality.
SWAV

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16:05 EST ShockWave announces unveiling of data from Disrupt PAD III study - Shockwave Medical, a pioneer in the development and commercialization of Intravascular Lithotripsy to treat severely calcified cardiovascular disease, reported that investigators unveiled data from the Disrupt PAD III study, which "showed IVL to be superior to percutaneous transluminal angioplasty on the primary endpoint of procedural success," the company said. The largest randomized trial of severely calcified peripheral lesions, Disrupt PAD III found that IVL was also associated with a "statistically significant" reduction in diameter stenosis, arterial dissections and bail-out stenting versus PTA. The results were presented earlier in a late-breaking clinical trial session at VIVA20. Disrupt PAD III is a prospective, multicenter, randomized study designed to demonstrate the safety and effectiveness of IVL as a vessel preparation procedure in moderate to severely calcified superficial femoral and popliteal lesions, followed by a drug-coated balloon or stent. The study enrolled 306 patients randomized between IVL and PTA at 45 sites in the United States, Germany, Austria and New Zealand. In the IVL arm, 83% of patients were classified by the angiographic core lab as having severe calcification, with an average calcified lesion length of 129 millimeters. IVL demonstrated superiority over PTA in the primary endpoint analysis, defined as procedural success with a residual stenosis less than or equal to 30% without flow-limiting dissection, prior to DCB or stenting, with a rate of 65.8% versus 50.4% as determined by an independent angiographic core lab. Additionally, PAD III showed that IVL achieved more atraumatic treatment based on the following findings: Reduction in frequency and severity of major arterial dissections; Reduction in the need for bail-out stenting and stent implantation rate; Lower balloon maximum inflation pressure; Reduction in categorical percent diameter stenosis after treatment with IVL versus PTA.