Thu, Jul. 30, 4:21 PM
- Amgen (NASDAQ:AMGN) Q2 results ($M): Total Revenues: 5,370 (+3.7%); Product Sales: 5,225 (+5.6%).
- Key Product Sales: Enbrel: 1,348 (+8.4%); Neulasta: 1,158 (+2.2%); Epogen: 491 (-4.1%); Aranesp: 479 (-7.4%); Sensipar/Mimpara: 344 (+15.4%); Prolia: 340 (+28.8%); Xgeva: 331 (+10.7%); Neupogen: 256 (-13.5%); Vectibix: 160 (+21.2%); Kyprolis: 119 (+52.6%).
- Net Income: 1,653 (+6.9%); EPS: 2.15 (+7.0%); CF Ops: 2,814 (+26.4%).
- 2015 Guidance: Total Revenues: $21.1B - 21.4B from $20.9B - 21.3B; EPS: $8.06 - 8.35 from $7.48 - 7.87; Non-GAAP EPS: $9.55 - 9.80 from $9.05 - 9.40.
- Shares are up 2% after hours on increased volume.
Thu, Jul. 30, 4:03 PM
Wed, Jul. 29, 5:35 PM
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Wed, Jul. 29, 12:44 PM
Tue, Jul. 28, 5:47 PM
Tue, Jul. 28, 12:57 PM
- Privately-held Boehringer Ingelheim (BI) enters into an exclusive license and collaboration agreement with Seoul, Korea-based Hanmi Pharmaceutical to develop and commercialize HM61713, a third generation epidermal growth factor receptor (EGFR)-targeted therapy for the treatment of EGFR mutation-positive lung cancer.
- Under the terms of the agreement, Hanmi will receive an upfront payment of $50M, milestones up to $680M and tiered double-digit royalties on net sales. BI will have exclusive global commercialization rights to HM61713 except South Korea, China and Hong Kong.
- HM61713 is an orally active, irreversible EGFR mutation-selective tyrosine kinase inhibitor (TKI). It is currently in Phase 2 development for the treatment of patients with non-small cell lung cancer with T790M mutations who have developed resistance to other EGFR-targeting agents. A Phase 3 study will commence next year.
- EGFR-related tickers: (AZN +0.3%)(OTCQX:RHHBY +1.3%)(OTCPK:ALPMY) (OTCPK:ALPMF) (BMY +0.1%)(LLY +1.4%)(GSK -0.1%)(AMGN +4.3%)
Tue, Jul. 28, 10:08 AM
- The European Medicines Agency validates Teva Pharmaceutical Industries' (TEVA -1.6%) Marketing Authorization Application (MAA) for reslizumab for the treatment of inadequately controlled asthma in adult patients with elevated blood eosinophils despite an inhaled corticosteroid-based regimen. A final decision by the European Commission is anticipated in H2 2016.
- Reslizumab is an investigational humanized monoclonal antibody that binds to interleukin-5 (IL-5), a cytokine that plays a key role in the activation and growth of eosinophils, a type of white blood cell that is elevated in the lungs and blood of many asthmatics. High levels of eosinophils correlate with disease severity so binding to IL-5 inhibits its ability to stoke eosinophil levels.
- Teva's Biologics License Application (BLA) is currently under review by the FDA. A decision is expected in March 2016.
- Asthma-related tickers: (SNY -0.1%)(GSK -0.4%)(AZN -0.7%)(OTCQX:RHHBY)(AMGN +2.2%)(MRK -1.1%)(NVS +0.7%)(THRX +1.5%)
Tue, Jul. 28, 2:38 AM
- So what's Allergan (NYSE:AGN) doing with all that cash from the Teva deal? CEO Brent Saunders plans to use the money to increase the size of the firm's existing drug business, expand into new therapy areas and pursue larger deals.
- When asked if Allergan planned to spend the cash within 18 months, Saunders replied that he would, as long as the company could maintain its investment-grade credit rating.
- Possible targets: Biogen (NASDAQ:BIIB), AbbVie (NYSE:ABBV) and Amgen (NASDAQ:AMGN).
- Previously: Teva to buy Allergan Generics for $40.5B (Jul. 27 2015)
Fri, Jul. 24, 12:53 PM
- The FDA approves Amgen's (AMGN -0.8%) sNDA for Kyprolis (carfilzomib) for patients with relapsed multiple myeloma who have received at least one prior line of therapy. The approval was based on results from the ASPIRE Phase 3 study.
- Kyprolis was originally approved for the treatment of MM patients who have received at least two prior lines of therapy.
Thu, Jul. 23, 1:47 PM
- Tomorrow is the FDA's action (PDUFA) date for its review of regulatory filings submitted by Amgen and Sanofi.
- Sanofi's (SNY +1.2%) NDA for cholesterol-lowering Praluent (alirocumab), co-developed with Regeneron Pharmaceuticals (REGN -0.2%). On June 9, the Ad Comm voted 13 - 3 supporting approval.
- Amgen's (AMGN -0.4%) sNDA for Kyprolis (carfilzomib) for the second-line treatment of relapsed multiple myeloma. Filing accepted for review on March 30.
Tue, Jul. 21, 12:36 PM
- The U.S. Court of Appeals for the Federal Circuit rejects Amgen's (AMGN -0.5%) attempt to block Novartis' (NVS -1.7%) Sandoz unit from launching Zarxio (filgrastim - sndz), a biosimilar to Neupogen (filgrastim), in the U.S. The current injunction will remain in place until September 2.
- A district court rebuffed Amgen in March. The FDA approved Zarxio on March 6.
- Previously: Court rejects Amgen's bid to block Neupogen biosimilar (March 20)
- Previously: FDA clears first biosimilar (March 6)
Tue, Jul. 21, 8:03 AM
- As expected, the European Commission approves Amgen's (NASDAQ:AMGN) Repatha (evolocumab) for the treatment of adults with primary hypercholesterolemia or mixed dyslipidemia, as an adjunct to diet, in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach their LDL-C goals with the maximum tolerated dose of a statin or alone or in combination with other lipid-lowering therapies in patients who are statin intolerant or for whom a statin is contraindicated. It is also approved to the treatment of adults and adolescents at least 12 years old with homozygous familial hypercholesterolemia in combination with other lipid-lowering therapies.
- Repatha is the first proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor approved in the world. Regulatory clearance for Regeneron (NASDAQ:REGN) and Sanofi's (NYSE:SNY) Praluent (alirocumab) should happen shortly, however. PCSK9 inhibitors are poised to dominate the post-statin cholesterol-lowering market.
- Previously: Amgen gets EU backing for Repatha (May 22)
- Previously: Regeneron up 1.1% as trading reopens after Ad Comm approval (June 9)
Thu, Jul. 16, 4:20 PM
- Top-line results from a Phase 2 clinical trial evaluating Amgen's (NASDAQ:AMGN) Blincyto (blinatumomab) in adult patients with relapsed/refractory Philadelphia chromosome-positive B-cell precursor acute lymphoblastic leukemia (ALL) show a clinically meaningful number of patients achieved complete remission or complete remission with partial hematologic recovery within two cycles of treatment. The data will be submitted for publication and for presentation at a future medical meeting.
- About 25% of adult ALL patients express the oncogenic protein BCR-ABL1 that results from the mutation known as the Philadelphia chromosome.
- The FDA cleared Blincyto in December 2014 for the treatment of adults with Philadelphia chromosome-negative ALL.
- Previously: FDA clears Amgen blood cancer immunotherapy (Dec. 3, 2014)
Fri, Jul. 10, 7:05 AM
- Ultragenyx (NASDAQ:RARE) initiated with Market Outperform rating with a $119 (6% upside) price target by JMP Securities.
- Regeneron Pharmaceuticals (NASDAQ:REGN) downgraded to Sell from Neutral by UBS. Price target maintained at $500 (2% downside risk).
- Amgen (NASDAQ:AMGN) downgraded to Neutral from Buy by UBS. Price target lowered to $165 (9% upside) from $185.
Fri, Jun. 19, 9:02 AM
- A Phase 3 study, called REACH, evaluating Eli Lilly's (NYSE:LLY) Cyramza (ramucirumab) as second-line treatment [after Nexavar (sorafenib)] in patients with hepatocellular carcinoma (HCC) failed to achieve its primary endpoint of a statistically significant improvement in overall survival (OS). Median OS in the Cyramza plus best supportive care (BSC) arm was 9.2 months versus 7.6 months in the placebo plus BSC arm (p=0.1391). The results were published in The Lancet Oncology.
- A prespecified subgroup of HCC patients with elevated baseline alpha-fetoprotein (AFP), a liver enzyme, did show a statistically valid improvement in survival after receiving ramucirumab. Median OS was 7.8 months compared to 4.2 months for placebo (p=0.0059).
- The company plans to conduct an new Phase 3 study, called REACH-2, to assess Cyramza in a second-line setting in patients with elevated AFP. Enrollment will begin shortly.
- Cyramza is currently approved for the treatment of certain colorectal, gastric and lung cancers and gastroesophageal junction adenocarcinoma.
- Related tickers: (NASDAQ:AMGN) (OTCPK:BAYRY)
Thu, Jun. 18, 4:23 PM
- A Phase 3 clinical trial comparing the efficacy of Amgen's (NASDAQ:AMGN) Vectibix (panitumumab) and best supportive care (BSC) versus BSC alone in patients with chemorefractory wild-type KRAS (exon 2) metastatic colorectal cancer (mCRC) met its primary endpoint of a statistically significant improvement in overall survival (OS) in the Vectibix cohort. All key secondary endpoints were met as well.
- Complete results will be presented at a future medical conference and will be submitted for publication.
- The FDA approved Vectibix in May 2014 as a first-line treatment, in combination with the chemo regimen FOLFOX, in patients with wild-type KRAS (exon 2) mCRC.
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