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UPDATE: Revance stock surges and Allergan drops on positive results for wrinkle injection
Revance Therapeutics Inc. shares surged nearly 38% in extremely heavy morning trade Tuesday after the company reported positive results for its wrinkle-relaxing injection in two late-stage clinical trials. If approved, the product, DaxibotulinumtoxinA for Injection (RT002), would be the first of its kind to last six months. Products currently on the market, including Allergan's market-leading Botox, last three to four months. Allergan shares dropped 3.2% in extremely heavy morning trade on Tuesday. In two trials, Revance's product showed highly statistically significant improvement relative to the placebo in reducing frown lines or wrinkles between eyebrows. The product is also being tested in a long-term safety trial, with results expected in the second half of next year; if the trial is successfully completed, Revance expects to file for approval in the first half of 2019 and, if it's approved, launch the product in the U.S. in 2020. Botox has been a wildly profitable product for Allergan, since patients largely pay out-of-pocket for it, and analysts have noted that new rivals could pose a long-term risk for the company. Revance's latest data are "better than their Ph 2 on several metrics," said EvercoreISI analyst Umer Raffat. But, with regard to being able to claim six months of effectiveness, Raffat said, "I think there's a case to be made for that, but that's not a layup." Raffat also noted that the product would likely be priced higher than Botox. In a statement to MarketWatch, Allergan called the Revance results "underwhelming." "Allergan does not expect Revance's toxin to enter the market until mid-2020, and we do not believe this data will support a longer duration claim," a company spokesperson said, adding that "based on the profile demonstrated in this data, Allergan does not view this toxin as being differentiated from Botox." Revance shares have surged 45.5% over the last three months to $35.80, compared with a 7.4% rise in the S&P 500 and a 11.7% rise in the Dow Jones Industrial Average .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.
Allergan wins FDA approval for use of Vraylar in maintenance treatment of schizophrenia
Allergan plc said Monday it has won U.S. Food and Drug Administration approval for use of Vraylar in the maintenance treatment of schizophrenia. The FDA approved the company's supplemental new drug application for the substance, an antipsychotic that is already approved for the acute treatment of adult patients with manic or mixed episodes stemming from bipolar I disorder and for the treatment of schizophrenia. "Schizophrenia is one of the most challenging mental health disorders to manage -- particularly due to the complexity of patient symptoms, varying response to treatment and high rates of relapse," said Dr. Herbert Meltzer, professor of psychiatry and behavioral sciences at Northwestern Feinberg School of Medicine. "The goal of clinicians is to minimize relapses, which can cause significant personal distress, and can often have serious implications for a patient's health." Up to 70% of patients can experience relapse within one year of treatment without maintenance treatment, he said. Schizophrenia affects about 2.4 million American adults and symptoms include hallucinations, delusions, thought disorders and movement disorders. Allergan shares were flat premarket, but have fallen 18% in 2017, while the S&P 500 has gained 15%. 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.
U.S. senators press Allergan for details on patent deal with tribe
A group of U.S. senators on Tuesday asked drugmaker Allergan Plc (AGN) to produce documents relating to its agreement to transfer patents to a Native American tribe to shield them from review by an administrative court. Democratic Senators Sherrod Brown, Maggie Hassan, Amy Klobuchar, Al Franken and Patty Murray made the request for documents in a letter to Allergan Chief Executive Brent Saunders.
Allergan: That $15 Billion Sure Went Fast
Last year Allergan PLC (AGN) did one of the best deals in drug industry history. The drug company has been busily squandering the benefits ever since. Shares are down nearly 25% over the past three months and more than 40% from the all-time high set in 2015. The latest blow came last week after a federal judge invalidated a key patent on the dry-eye drug Restasis.
BRIEF-U.S. Court issues adverse decision concerning Allergan's Restasis
Allergan Plc(AGN). * U.S. District Court for the Eastern District of Texas issues adverse trial decision concerning Restasis 0.05% patents. * Says company will appeal court's ruling regarding Restasis. * Says "we are disappointed" by Federal District Court's decision on Restasis patents Source text for Eikon: Further company coverage:
Allergan stock drops 5% after judge decides against company on key dry eye product
Allergan PLC shares dropped 5% in extremely heavy afternoon trade Monday after a Texas district court judge ruled against the company in a patent lawsuit regarding the company's key billion-dollar dry eye medication Restasis. "There is no doubt that Allergan has invented a useful and successful pharmaceutical product. It has been richly rewarded for that invention," Judge William Bryson said, adding, "the Court has concluded that Allergan is not entitled to renewed patent rights for Restasis in the form of a second wave of patent protection." Allergan had previously made an unorthodox agreement with a New York state-based American Indian tribe in order to protect Restasis patents from challenges made through the U.S. Patent and Trade Office's inter partes review process, which is separate from any court decisions. The company, which has been widely criticized for the move, including by lawmakers, has said that an district court ruling against it would allow a generic Restasis to "enter the market many years in advance of the listed patent expiry dates," or 2024. Restasis, which is used for eye inflammation, brought in $1.4 billion in revenue last year, second only to Allergan's top-selling Botox. Allergan shares have dropped 20.7% over the last three months, compared with a 3.9% rise in the S&P 500 .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.
BRIEF-U.S. House committee launches probe into Allergan patent deal
* House Oversight Committee Says Launches Probe Into Allergan Patent deal with native american tribe. * House oversight committee asks Allergan (AGN) to provide documents regarding deal with saint regis mohawk tribe, restasis patents Source text for Eikon: Further company coverage:
Shire sues Allergan in U.S. over dry eye drug
Oct 2 (Reuters) - Allergan Plc was sued on Monday by
Shire Plc for allegedly scheming to block doctors from
prescribing its new treatment for dry eye disease.
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