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AbbVie Inc. shares dropped 11.7% in early trade Thursday after the company said it will not try for accelerated approval of rovalpituzumab tesirine in third-line relapsed/refractory small cell lung cancer based on the drug's results in a phase 2 trial and the "magnitude of effect across multiple parameters." The decision was made after consulting with the Food and Drug Administration,the company said. AbbVie said it does still believe the drug, also called Rova-T, has potential in small cell lung cancer and other cancers expressing the DLL3 protein, and Rova-T continues to be studied in ongoing phase 3 trials for first-line and second-line small cell lung cancer. AbbVie bought Rova-T in a $5.8 billion deal for Stemcentrx in 2016; Rova-T was the company's lead asset. AbbVie shares have surged 14.5% over the last three months but dropped nearly 3% month-to-date. The S&P 500 has surged 1.1% over the last three months and declined 0.1% month-to-date.
AbbVie shares slide 11.7%
AbbVie stock down 9.3% in early trade
AbbVie shares extend losses, now down 6.6% premarket
AbbVie shares slump 4.7% premarket
AbbVie says will not seek accelerated approval for lung cancer drug after mid-stage trial
The Food and Drug Administration is reviewing whether a type of brain inflammation called encephalitis connected to Biogen Inc. and AbbVie Inc.'s multiple sclerosis drug Zinbryta was a result of known side effects of the therapy or have another cause, a FDA spokesperson told MarketWatch. Three U.S. cases of encephalitis related to Zinbryta have been reported in the U.S., though most cases have been reported in Europe, FDA spokesperson Sandy Walsh said. Immune-mediated disorders, which can cause encephalitis, are known side effects of Zinbryta and warned about on the product's U.S. label; the FDA is reviewing whether immune-mediated disorders or something else caused the reports of encephalitis, according to Walsh. Biogen and AbbVie said last week that they are voluntarily withdrawing Zinbryta from global markets, a move that followed the European Medicines Agency's investigation into reports of inflammatory encephalitis and meningioencephalitis, also a type of brain inflammation. The voluntary withdrawal decision was not made because of any FDA action, a spokesperson told MarketWatch last week. Zinbryta, which has been connected with serious liver injury, hypersensitivity reactions and inflammatory and immune toxicity, has been known to have a "complex safety profile" since approval, Walsh said, resulting in use mostly in patients who haven't responded well to two or more multiple sclerosis drugs, a warning on the drug's box and restricted distribution of the product. AbbVie shares declined 1.1% in Wednesday trade and Biogen shares slumped 0.6%. AbbVie shares have surged 20% over the last three months, Biogen shares have dropped 11% and shares of the S&P 500 have risen 2.9%.
FDA is reviewing what caused those encephalitis cases and their causes
Three cases of encephalitis related to Biogen, AbbVie's Zinbryta have been reported in U.S.: FDA
Biogen Inc. and AbbVie Inc. said early Friday that the companies are voluntarily withdrawing their relapsing multiple sclerosis drug, Zinbryta, from global markets. Evaluating the drug's "complex and evolving benefit/risk profile... will not be possible going forward given the limited number of patients being treated," the companies said. The withdrawal is in patients' best interests, said Biogen Chief Medical Officer Alfred Sandrock. Zinbryta, which the companies said is generally used in patients who have tried two or more other multiple sclerosis medications unsuccessfully, is currently sold in the U.S., where it was approved in May 2016, along with Europe, Switzerland, Canada and Australia. Earlier this year, restrictions to minimize risk of serious liver injury with Zinbryta were adopted in Europe. The European Medicines Agency is also investigating reports of inflammatory encephalitis and meningioencephalitis, two kinds of brain inflammation typically caused by infection; those and other safety issues like liver toxicity, hypersensitivity reactions and inflammatory/immune toxicity have limited the drug's profitability "in the context of a number of better options for the disease," said RBC Capital Markets analyst Brian Abrahams. The decision to pull the drug was made by the companies and not because of any Food and Drug Administration action, according to a FDA spokesperson. The spokesperson also said that the FDA believes the drug will stay on the market while a plan is developed. Patients taking Zinbryta should speak with their doctors, and shouldn't stop taking the medication without consulting their doctors, the spokesperson said. Zinbryta has been the least profitable of Biogen's stable of multiple sclerosis drugs, bringing in just $12 million in sales in the fourth quarter, about $53 million in global revenue last year and about $8 million the prior year. AbbVie and Biogen "essentially split profits" on the therapy, according to Abrahams, and Zinbryta revenues aren't broken out in AbbVie's financial results, which list only key product revenues. Company shares initially declined in premarket trade but later rebounded. Biogen shares have dropped 10.8% over the last three months and AbbVie shares have surged 19%, compared with a 1.3% rise in the S&P 500 .
AbbVie shares drop 1.9%
Biogen shares drop 2.4% premarket
Withdrawing the drug is in best interest of patients, said Biogen executive
Biogen, AbbVie: Drug's benefit/risk profile difficult to evaluate because of small number of patients being treated
Biogen, AbbVie shares drop after 'voluntary worldwide withdrawal' of relapsing multiple sclerosis drug
AbbVie Inc. and Neurocrine Biosciences Inc. shares rose 1.7% and 1.1% respectively in premarket trade Wednesday after the companies announced that their drug met its primary endpoint in a phase 3 trial testing it in women with uterine fibroids. The therapy, elagolix, combined with low-dose hormone therapy reduced heavy menstrual bleeding in 68.5% of women, compared with 8.7% of women on the placebo. The phase 3 trial, ELARIS UF-I, is the first of two late-stage studies, and the Wednesday release was based on topline results from a six-month primary analysis. Uterine fibroids affect an estimated 7.5 million U.S. women, and consist of growths in the uterus that can cause heavy bleeding, pain and bladder problems. Other companies are also developing drugs in this area, includingMyovant , Allergan and the biotech ObsEva . AbbVie and Neurocrine's elagolix is also being developed for endometriosis with associated pain, and is being reviewed by the Food and Drug Administration for that indication. AbbVie shares have surged 24.6% over the last three months, and Neurocrine shares have surged 14%, compared with a 4.5% rise in the S&P 500 .
Among the companies with shares expected to trade actively in Thursday's session are Facebook, Amazon, AbbVie, Accenture, Darden Restaurants and Pandora Media.
More prisoners with hepatitis C are becoming eligible for treatment with effective but costly drugs like Harvoni and Sovaldi from Gilead Sciences Inc., as a result of lawsuits filed by inmates in Massachusetts and Florida.
Drugmakers Biogen and AbbVie said they are pulling their new multiple-sclerosis treatment Zinbryta from all global markets after several European patients suffered serious inflammatory brain disorders.
Among the companies with shares expected to trade actively in Friday's session are Boeing, Apple, U.S. Steel, McDonald's, Microsemi and Nordstrom.
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AbbVie Announces Results from Phase 2 Study Evaluating Rovalpituzumab Tesirine (Rova-T) for Third-Line Treatment of Patients with DLL3-Expressing Relapsed/Refractory Small Cell Lung Cancer
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AbbVie Announces Positive Topline Results from Phase 3 Study Evaluating Investigational Elagolix in Women with Uterine Fibroids
AbbVie, Inc. is a research-based biopharmaceutical company, which engages in the discovery, development, manufacture and sale of a line of proprietary pharmaceutical products. It is focused on treating conditions such as chronic autoimmune diseases in rheumatology, gastroenterology and dermatology; oncology, including blood cancers; virology, including hepatitis C and human immunodeficiency virus; neurological disorders, such as Parkinson's disease; metabolic diseases, including thyroid disease and complications associated with cystic fibrosis; as well as other serious health conditions. The company was founded on January 1, 2013 and is headquartered in North Chicago, IL. (See Full Profile)
Name | Chg % | Market Cap |
---|---|---|
Amgen Inc. | $130.99B | |
Neurocrine Biosciences Inc. | $7.51B | |
Gilead Sciences Inc. | $100.2B | |
Biogen Inc. | $58.66B | |
AstraZeneca PLC ADR | $86.52B |