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Puma Biotechnology (NASDAQ: PBYI ) surges 13% in after-hours trading after the U.S. Food and Drug Administration approves a labeling supplement for Nerlynx (neratinib) for the extended adjuvant treatment of HER2-positive early stage breast cancer. More news on: Puma Biotechno...
Interim data from the Phase II CONTROL Trial showed that the addition of prophylactic treatment with loperamide plus budesonide reduced the rate of discontinuation due to neratinib-associated diarrhea to 11% versus a discontinuation rate of 18% with loperamide alone. Puma Biotechnology...
Back in August, Puma Biotechnology ( PBYI ) reported their Q2 earnings that revealed NERLYNX net sales were up from the disappointing Q1 report. The Q1 results showed a drop of 25% in revenue from Q4, which forced the management to cut 2019 net sales guidance from $268M to $230M. Obviously, ...
Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder of Puma, will provide an overview of the Company at 2:25 p.m. EDT on Thursday, October 3, at the Cantor Global Healthcare Conference....
Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental New Drug Application (sNDA) for neratinib in combination with capecitabine for the treatment of patients with HER2-positive...
First regulatory approval of NERLYNX in Latin America. NERLYNX is the first approved therapy to reduce the risk of invasive disease recurrence in HER2-positive breast cancer patients following trastuzumab-based adjuvant treatment. Up to 25% of HER2-positive early stage breast ...
OpGen (NASDAQ: OPGN ) +77% to merge with Curetis N.V. More news on: OpGen, Inc., Top Ships Inc., The Michaels Companies, Inc., Stocks on the move, Read more ...
The FDA has designated Puma Biotechnology's (NASDAQ: PBYI ) Nerlynx (neratinib) an Orphan Drug for the treatment of breast cancer patients with brain metastases. More news on: Puma Biotechnology, Inc., Healthcare stocks news, Stocks on the move, Read more ...
Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder of Puma, will provide an overview of the Company at 9:35 a.m. EDT on Tuesday, September 10, at the H.C. Wainwright 21 st Annual Glob...
Puma Biotechnology, Inc. (Nasdaq: PBYI) announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to NERLYNX® (neratinib) for the treatment of breast cancer patients with brain metastases. “Receiving Orphan Drug Designation from the FDA s...
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Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, will host a conference call at 1:30 p.m. PDT/4:30 p.m. EDT on Thursday, August 1, 2024, following the release of its second quarter 2024 financial results. The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-...
Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced the presentation of alisertib for the treatment of patients with advanced osimertinib-resistant epidermal growth factor receptor-mutated (EGFR-mutated) non-small cell lung cancer (NCT04085315) at the 2024 American Soc...
Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced the presentation of biomarker findings from a Phase II randomized clinical trial of alisertib alone vs. alisertib + fulvestrant for the treatment of patients with endocrine and CDK4/6 inhibitor (CDK 4/6i) resistant, h...