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Dec. 12, 2014, 9:16 AM
Nov. 28, 2014, 9:23 AM
- The European Commission approves Boehringer Ingelheim's Vargatef (nintedanib), in combination with docetaxel, for the treatment of adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumor histology, after first-line chemotherapy. Adenocarcinoma is the most common form of lung cancer.
- Nintedanib is an oral angiokinase inhibitor which simultaneously inhibits endothelial growth factor receptors (VEGFR), platelet-derived growth factor receptors (PDGFR) and fibroblast growth factor receptors (FGFR) signalling pathways. It is currently being investigated in various other cancers.
- Earlier this month, Europe's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion supporting approval of nintedanib, branded as Ofev, for the treatment of ideopathic pulmonary fibrosis (IPF). The FDA approved it for IPF in October.
- Previously: Europe Ad Comm supports approval for BI pulmonary fibrosis drug
- Previously: BI begins enrollment in Phase 3 CRC trial
- ETFs: IBB, BIB, IRY, BIS, IXJ, DRGS
- Lung cancer-related tickers: (NYSE:BMY) (NYSE:MRK) (NASDAQ:CLVS) (NASDAQ:FPRX) (NASDAQ:BIND) (NYSE:GSK) (NASDAQ:ARIA) (NASDAQ:ECYT) (NYSE:AZN) (OTC:MKGAF) (OTCPK:MKGAY) (NASDAQ:ONTY) (NYSE:PFE) (NASDAQ:HTBX) (OTCQX:RHHBY) (NASDAQ:INCY)
Nov. 6, 2014, 4:49 PM
- Oncothyreon (NASDAQ:ONTY): Q3 EPS of -$0.09 beats by $0.02.
Sep. 18, 2014, 9:07 AM
- Oncothyreon (NASDAQ:ONTY) prices its public offering of 10M shares of common stock at $2 per share and a concurrent offering of 10K shares of Series A Convertible Preferred Stock at $2,000 per share for total expected gross proceeds of $40M.
- Underwriters over-allotment is 1.5M shares of common stock. Closing date is September 23, 2014.
Sep. 12, 2014, 9:12 AM
Sep. 12, 2014, 8:18 AM
- Merck KGaA's (OTC:MKGAF) (OTCPK:MKGAY) Serono division discontinues its clinical development of tecemotide for non-small cell lung cancer (NSCLC) based on its analysis of a Phase 1/2 study in Japanese patients.
- Merck Serono licensed tecemotide, a MUC1 antigen-specific cancer immunotherapy, from Oncothyreon (NASDAQ:ONTY). It decided to continue its development efforts in NSCLC a year ago despite missing its primary endpoint of Overall Survival (OS) in an earlier trial.
Aug. 19, 2014, 12:49 PM
Aug. 19, 2014, 9:15 AM
Aug. 19, 2014, 8:39 AM
Aug. 18, 2014, 6:22 PM
- Merck has informed Oncothyreon (NASDAQ:ONTY) a randomized Phase 1/2 study of its tecemotide immunotherapy in Japanese Stage III non-small cell lung cancer patients "did not meet its primary endpoint of an improvement in overall survival, and no treatment effect was seen in any of the secondary endpoints (progression free survival, time to progression or time to failure)."
- Merck has advised Oncothyreon it will "recommend that the investigational treatment in the study be discontinued and that no recruitment of Japanese patients into the Phase 3 program of tecemotide will take place."
Aug. 11, 2014, 4:10 PM
- Oncothyreon (NASDAQ:ONTY): Q2 EPS of -$0.09 beats by $0.04.
- Shares +0.99%.
Aug. 10, 2014, 5:35 PM
Jul. 23, 2014, 12:54 PM
- Shares of Oncothyreon (ONTY +16.1%) jump on 7x surge in volume today. The cancer therapeutics firm also has a HER2 inhibitor (ONT-380) in development.
- Investors are falling all over themselves to buy into Puma Biotechnology (PBYI +292.5%) after it announced positive results from a Phase 3 clinical trial evaluating its HER2 inhibitor PB272 (neratinib) as a treatment for breast cancer.
Jul. 23, 2014, 12:47 PM
Jun. 24, 2014, 5:38 PM
May 29, 2014, 8:34 AM
- Oncothyreon (ONTY) and Celldex Therapeutics (CLDX) collaborate on a combined Phase 1b open label study of the therapeutic vaccine ONT-10 and varlilumab in 42 patients with advanced breast or ovarian cancer.
- Under the terms of the agreement, ONTY will supply ONT-10 and CLDX will supply varlilumab while ONTY will submit the IND and conduct and fund the trial. Both firms will jointly own the data and will collaborate on the combination therapy's future development. Neither firm grants the other a license for its product candidate.
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