62.61 0.00 (0.00%)
After hours: 5:02PM EDT
|Bid||62.66 x 100|
|Ask||63.13 x 500|
|Day's Range||61.61 - 63.47|
|52 Week Range||61.30 - 140.11|
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rheumatoid arthritis drug baricitinib, Eli Lilly chairman and CEO David Ricks on an earnings call Tuesday expressed confidence in the benefit-risk profile of both doses of the treatment. The advisory panel recommended that the FDA approve the 2-mg dose of baricitinib, but not the 4-mg dose for the proposed indication based on the adequacy of the safety and benefit-risk profiles. "While we are pleased that the FDA's arthritis advisory committee supported the efficacy of both 2 mg and 4 mg of baricitinib in RA and 2 mg overall, we are disappointed that the committee did not recommend approval of the 4-mg dose," Ricks said.
Eli Lilly & Co. shares dropped nearly 3% in premarket trade Tuesday after the company's rheumatoid arthritis therapy baricitinib was recommended for Food and Drug Administration approval at the 2-mg dose, but not the 4-mg dose. Incyte Corp. , a partner on the drug, had its shares drop nearly 5% premarket. The recommendation, made by the FDA's arthritis advisory committee late Monday, was based on concerns about the 4-mg dose's safety and risks relative to its benefits.
An arthritis drug developed by Eli Lilly & Co and Incyte Corp should not be approved at a 4-milligram dose, advisers to the U.S. FDA voted on Monday, in a setback to the drugmakers that were counting on the treatment as a future blockbuster.
Gilead Sciences Inc. shares dropped 2.1% in moderate Thursday trade after a Food and Drug Administration briefing document raised safety questions about a similar Eli Lilly & Co. and Incyte Corp. drug. ...
Eli Lilly & Co. shares fell 1.8% premarket and Incyte Corp. shares dropped 4.5% premarket on Thursday after a Food and Drug Administration briefing document raised issues with their rheumatoid arthritis drug baricitinib. The drug will go up before a FDA arthritis advisory committee meeting on Monday. The FDA often follows an advisory committee's recommendation, though there are exceptions.
The U.S. Food and Drug Administration staff on Thursday flagged concerns about potentially fatal blood clots from higher doses of Eli Lilly and Co and Incyte Corp's rheumatoid arthritis drug. An independent ...
NewLink toppled Monday after it scrapped a late-stage study of its immuno-oncology drug in combination with drugs from Merck and Bristol.
NewLink Genetics Corp. shares fell as much as 15% in premarket trade Monday after the company said it won't proceed as planned with a late-stage trial of its indoximod for advanced melanoma. The company ...
The Zacks Analyst Blog Highlights: Agios Pharmaceuticals, BioMarin Pharmaceutical, Vertex Pharmaceuticals and Incyte
Novartis and Alexion announce respective acquisitions of AveXis and Wilson Therapeutics for a pipeline boost. We suggest four stocks as hot acquisition picks this year.
The S&P 500’s top gainers on April 12 were: Incyte (INCY) gained 5.3%. Micron Technology (MU) gained 4.2%. Host Marriott Financial Trust (HST) gained 4.1%. Deere & Company (DE) gained 4.1%. Discovery (DISCK) gained 3.9%. Incyte
Incyte (INCY) popped to the top of among S&P 500 stock performers, helped by an analyst upgrade. Incyte added $3.54, or 5.3%, to $69.83. The S&P 500 gained 21.80 points, or 0.83%, to 2663.99. UBS's Carter ...
In January 2015, Incyte (INCY) entered an antibody discovery collaboration with Agenus (AGEN), which was later amended in February 2017. As per the amended agreement, the ongoing research programs for the development of checkpoint modulator antibodies targeted at GITR and OX40 have been converted from co-funded ones to being fully funded by Incyte. Additionally, the profit-sharing arrangement for these research programs has been converted into royalty-bearing programs.
On April 6, 2018, Incyte (INCY) stock fell nearly 20%, triggered by news of the failure of the clinical trial for its skin cancer drug. The trial is for the assessment of the combo-therapy approach of Incyte’s epacadostat and Merck’s (MRK) Keytruda for the treatment of skin cancer. The Phase 3 trial results were unexpectedly found to yield unsuccessful results since it did not achieve the main goal of the study.
In February 2017, Eli Lilly (LLY) secured approval for Olumiant (baricitinib) from the European Medicines Agency (or EMA) for patients suffering from moderate-to-severe rheumatoid arthritis (or RA) and who did not respond sufficiently or could not tolerate disease-modifying antirheumatic drugs (or DMARDs). In July 2017, the drug was approved by the Japan Ministry of Health, Labor, and Welfare for RA patients who don’t respond sufficiently to standard-of-care treatment options. The drug is also approved in Switzerland for the RA indication.