43.08 -0.79 (-1.79%)
After hours: 4:11PM EDT
|Bid||40.00 x 800|
|Ask||43.85 x 800|
|Day's Range||41.81 - 43.97|
|52 Week Range||40.25 - 136.90|
|Beta (3Y Monthly)||1.01|
|PE Ratio (TTM)||N/A|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||N/A|
Puma Biotech (PBYI) gains EU approval for Nerlynx as an extended adjuvant treatment in adult patients with early stage HER2-positive breast cancer.
The Zacks Analyst Blog Highlights: Amgen, Puma Biotechnology, MannKind, United Therapeutics and Vertex Pharmaceuticals
Drug approvals in Europe and other pipeline updates comprise some of the key developments in the biotech sector this week.
On September 4, the European Commission approved the marketing authorization of Puma Biotechnology’s Nerlynx as extended adjuvant therapy for the treatment of adults with early-stage HER2-positive (hormone receptor-2 positive) breast cancer who completed previous adjuvant trastuzumab-containing therapy less than a year ago.
Roche’s (RHHBY) Herceptin reported revenues of 3.6 billion Swiss francs in the first half compared to 3.5 billion Swiss francs in the first half of 2017, reflecting ~2.0% YoY year-over-year growth at CER (constant exchange rates).
In June, the Committee for Medicinal Products for Human Use recommended a favorable opinion on the approval of Puma Biotechnology’s (PBYI) Nerlynx for its commercialization in the European Union for the prolonged adjuvant therapy of adults with early-stage HER2+ (hormone-receptor-positive) breast cancer whose prior adjuvant trastuzumab-based therapy is less than one year from completion.
Puma Biotechnology (PBYI) released its second-quarter earnings results on August 9. It reported net revenue of $117.3 million in the first half of 2018. Puma Biotechnology’s revenue came primarily from its sales of Nerlynx.
Puma Biotech (PBYI) posts narrower-than-estimated loss in Q2. Also, rapid growth of its only marketed drug, Nerlynx, boosts sales.
Puma Biotech (PBYI) delivered earnings and revenue surprises of 53.17% and 0.77%, respectively, for the quarter ended June 2018. Do the numbers hold clues to what lies ahead for the stock?
The Los Angeles-based company said it had a loss of $1.17 per share. Losses, adjusted for stock option expense, came to 59 cents per share. The biopharmaceutical company posted revenue of $50.8 million ...
Shares of Puma Biotechnology Inc. (pbyi) rose more than 19% in the extended session Thursday after the company reported a narrower-than-expected quarterly loss and sales came in above forecasts. Puma said it lost $44.3 million, or $1.17 a share, in the second quarter, compared with a net loss of $77.8 million, or $2.10 a share, in the year-ago period. Puma in July got approval from the U.S. Food and Drug Administration for Nerlynx, used in the treatment of breast cancer, and the company began shipment to wholesalers at the end of that month.
On Puma Biotechnology's (PBYI) second-quarter 2018 earnings call, investor focus will be on the sales figures of its only marketed drug Nerlynx.
Puma Biotechnology (PBYI) generated revenues of $66.5 million in the first quarter, including revenues of $36 million and $30.5 million from product sales and licenses, respectively.
The positive recommendation from CHMP comes after a reexamination of negative recommendations at the meeting for the MAA on February 23. On July 5, the company had a consensus 12-month target price of $94.17, which represents a 60.29% return on investment over the next 12 months. On July 5, Incyte had a consensus 12-month target price of $83.71, which represents an 18.65% return on investment over the next 12 months.
Puma Biotechnology's (PBYI) marketing application seeking approval for neratinib in breast cancer gets positive CHMP trend vote, following a negative opinion in February.
The biotech sector was in the news with a few hits and misses. Gilead's Biktarvy got approval in Europe while Puma Biotechology is also closer to breast cancer drug approval in Europe.
Puma shares were up 27.5 percent at $65.15 in premarket trading. The decision followed a reexamination of the negative opinion announced by the Committee for Medicinal Products for Human Use in February, the company said. The committee will hold a final vote at its next meeting, Puma said.
A former Puma Biotechnology Inc (PBYI.O) executive was sentenced on Wednesday to 2-1/4 years in prison for trading on inside information ahead of announcements by the biopharmaceutical company about a breast cancer drug it was developing. Robert Gadimian, 48, was sentenced by U.S. District Judge William Young in Boston after pleading guilty in November to seven counts of securities fraud for carrying out illicit trades that prosecutors said allowed him to earn about $1 million. Prosecutors said that from 2013 to 2014, Gadimian twice secretly traded Puma stock and options based on information he learned about positive developments regarding clinical trials involving neratinib before the company announced the news.