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Avadel Pharma shares soar 22% premarket after FDA cuts sample size in trial of narcolepsy treatmentExternal Link

Avadel Pharmaceuticals PLC shares soared about 22% in premarket trade Monday, after the company said the U.S. Food and Drug Administration has agreed to reduce the sample size in a phase 3 trial of a treatment for narcolepsy. The company said it now expects full enrollment for the trial of once-nightly sodium oxybate, or FT218, to be completed by year-end. The lower sample size needed to demonstrate significance for excessive daytime sleepiness and cataplexy in narcolepsy patients will reduce the estimated time for the trial by up to 12 months. The study will now target 205 patients, down from 264 previously. Topline data is expected in the second quarter of 2020, up to a year ahead of earlier expectations. FT218 has been granted orphan drug designation by the FDA, meaning its path to approval has been accelerated. Shares have gained 31% in 2019, while the S&P 500 has gained 19%.

Market Pulse Stories are Rapid-fire, short news bursts on stocks and markets as they move. Visit MarketWatch.com for more information on this news.


Mon, 23 Sep 2019 11:55:58 GMT
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Dow to be paid $1.1 billion by Nova Chemicals as part of Canadian court judgmentExternal Link

Dow Inc. disclosed Monday that a Canadian court has ordered Nova Chemicals Corp. to pay Dow C$1.43 billion ($1.08 billion) for damages through 2012 related to the jointly-owned ethylene asset in Joffre, Alberta. The payment was ordered to be made on Oct. 11, but the judgment is subject to appeal. Dow said it expects to record a gain related to the judgment in the third quarter. Dow's stock, which was still inactive in premarket trading, has slipped 0.3% over the past three months, while the SPDR Materials Select Sector ETF has gained 1.2% and the Dow Jones Industrial Average has tacked on 0.8%.

Market Pulse Stories are Rapid-fire, short news bursts on stocks and markets as they move. Visit MarketWatch.com for more information on this news.


Mon, 23 Sep 2019 11:41:09 GMT
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UPDATE: GW Pharma gets EU approval for cannabis-based drug as treatment for severe childhood epilepsyExternal Link

GW Pharmaceuticals PLC shares rose 3.9% in premarket trade Monday, after the company said it has received European Commission approval for its cannabis-based drug Epidyolex for the treatment of seizures in patients with Lennox-Gastaut syndrome or Dravet syndrome, in conjunction with clobazam, two severe types of childhood epilepsy. The drug, which is already approved in the U.S. under the brand name Epidiolex, will now be available to children of 2 years of age and older across Europe. The news "marks a significant milestone, offering patients and their families the first in a new class of epilepsy medicines and the first and only EMA-approved CBD medicine to treat two severe and life-threatening forms of childhood-onset epilepsy," Chief Executive Justin Gover said in a statement. The approval is based on the results from four randomised, controlled phase 3 trials, involving more than 714 patients. GW Pharma shares have gained 32% in 2019, while the S&P 500 has gained 19%.

Market Pulse Stories are Rapid-fire, short news bursts on stocks and markets as they move. Visit MarketWatch.com for more information on this news.


Mon, 23 Sep 2019 11:36:14 GMT
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ADC Therapeutics to offer 8.1 million shares in planned IPO, priced at $23 to $26 eachExternal Link

ADC Therapeutics SA set terms for its planned initial public offering on Monday, saying in a regulatory filing that it expects to offer 8.1 million shares priced at $23 to $26 each. The clinical-stage, oncology-focused biotech has applied to list on the New York Stock Exchange, under the ticker symbol "ADCT." Morgan Stanley, BofA Merrill Lynch and Cowen are underwriters on the deal, proceeds of which will be used to advance clinical trials and for R&D.

Market Pulse Stories are Rapid-fire, short news bursts on stocks and markets as they move. Visit MarketWatch.com for more information on this news.


Mon, 23 Sep 2019 11:17:59 GMT
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Snapchat parent kept Project Voldemort dossier on how Facebook thwarted competition--WSJExternal Link

Snapchat parent Snap Inc. is talking to federal regulators about the ways Facebook Inc. tried to thwart competition from the rival social media company, including discouraging popular account holders from referencing Snap, according to a report in The Wall Street Journal. Snap's legal team had been keeping a dossier named "Project Voldemort" about Facebook's anti-competitive tactics, the WSJ report said, citing people familiar with the project. Snap's talks with the Federal Trade Commission are part of a larger probe into Facebook's business tactics, in which the FTC has made contact with dozens of tech executives and app developers. The report cited Gene Kimmelman, a senior advisor at consumer group Public Knowledge, who said the FTC is putting together a picture of what might be a pattern of behavior to prevent competition to the core Facebook business. Facebook's stock slipped 0.1% in premarket trading while Snap shares fell 0.7%. Over the past three months, shares of Facebook slipped 0.6%, Snap rallied 17.0% and the S&P 500 has gained 1.4%.

Market Pulse Stories are Rapid-fire, short news bursts on stocks and markets as they move. Visit MarketWatch.com for more information on this news.


Mon, 23 Sep 2019 11:17:04 GMT
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