Mon, May 11, 8:29 AM
- The European Medicines Agency gives Can-Fite BioPharma (NYSEMKT:CANF) the go-ahead to commence a Phase 2 trial assessing CF102 in patients with hepatocellular carcinoma (HCC), the most common form of liver cancer. The randomized, double-blind study, also being conducted in the U.S. and Israel, will enroll 78 HCC patients with Child-Pugh Class B cirrhosis who failed treatment with Nexavar (sorafenib), the only FDA-approved drug for HCC. Nexavar was co-developed by Bayer (OTCPK:BAYRY) and Onyx Pharmaceuticals (NASDAQ:AMGN).
- CF102 is a small molecule drug that binds to the A3 adenosine receptor which is highly expressed in tumor cells. It has demonstrated a robust anti-tumor effect (apoptosis of liver cells) via its deregulation of the Wnt signaling pathway.
- The FDA designated CF102 an Orphan Drug for the treatment of HCC in 2012. It is approved for compassionate use in Israel.
- Shares are up 13% premarket on increased volume.
Wed, Apr. 29, 7:34 PM
- Members of the FDA's Cellular, Tissue and Gene Therapies Advisory Committee and the Oncologic Drugs Advisory Committee voted 22 - 1 in favor of approval for Amgen's (NASDAQ:AMGN) talimogene laherparepvec for the treatment of patients with injectable regionally or distantly metastatic melanoma.
- Previously: Ad Comm review approaches for Amgen's cancer immunotherapy (April 27)
Wed, Apr. 29, 10:05 AM
- The FDA's Endocrinologic and Metabolic Drugs Advisory Committee will meet on June 10 to discuss Amgen's (AMGN +0.2%) Biologics License Application (BLA) for Repatha (evolocumab) for the treatment of high cholesterol. The FDA's PDUFA date is August 27.
- Evolocumab is an inhibitor of proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove low-density lipoprotein cholesterol (LDL-C) (the "bad" cholesterol) from the blood. It, along with Regeneron's (REGN +0.8%) Praluent (alirocumab), are the front-runners to dominate the post-statin cholesterol-lowering market. Praluent's PDUFA date is July 24. Both drugs should be blockbusters.
- Previously: Evolocumab successful in two Phase 3 studies (Oct. 2, 2014)
- Previously: Regeneron's alirocumab shows durable effect in lowering "bad" cholesterol in high risk patients (March 16)
Mon, Apr. 27, 4:53 PM
- A joint meeting of the FDA's Cellular, Tissue and Gene Therapies Advisory Committee and the Oncologic Drugs Advisory Committee is on tap for this Wednesday. The two groups will discuss and make recommendations regarding regulatory approval of Amgen's (NASDAQ:AMGN) Biologics License Application (BLA) for talimogene laherparepvec for the treatment of patients with injectable regionally or distantly metastatic melanoma.
- Briefing doc
- Amgen's briefing doc
Fri, Apr. 24, 3:52 PM
- Burlington, MA-based CoLucid Pharmaceuticals (Pending:CLCD) is set for its IPO of 5.36M shares of common stock at $13 - 15.
- The clinical stage biopharmaceutical firm is developing a small molecule for the acute treatment of migraine headaches. Lasmiditan, currently in Phase 3 development in an oral tablet form, is a 5-HT1F receptor agonist that blocks the pain transmission without the side effects of the class of migraine therapies called triptans. The 5-HT1F receptor is a serotonin subtype that lacks the vasoconstrictive properties of other serotonin receptors, which can cause adverse cardiac events in patients with cardiovascular or cerebrovascular disease. Top-line data from a Phase 3 study, called SAMURAI, is expected in Q3 2016. A second Phase 3 evaluating an IV formulation of lasmiditan should commence in H1 2016.
- The company licensed lasmiditan from Eli Lilly.
- 2014 financials ($M): Operating expenses: 2.3 (+43.8%); Net Loss: (3.0) (-34.6%); CF Ops: (0.8) (+49.3%).
- Migraine-related tickers: (OFIX +0.4%)(TEVA +1.8%)(AVNR)(RDHL +0.5%)(PTX -3%)(ALDR -0.8%)(ENDP -0.8%)(JNJ +0.6%)(AMGN -0.7%)(DEPO +1.2%)(AGN)
Tue, Apr. 21, 4:26 PM
- Amgen (NASDAQ:AMGN) Q1 results ($M): Total Revenues: 5,033 (+11.3%); Product Revenues: 4,874 (+11.9%); U.S.: 3,771 (+14.7%); Intl: 1,103 (+3.4%).
- Net Income: 1,623 (+51.3%); GAAP EPS: 2.11 (50.7%); CF Ops: 1,329 (+16.4%); Quick Assets: 27,118 (+36.9%); Operating Earnings: 2,080 (+50.6%); Operating Earnings Yield: 41.3% (+35.3%); Net Earnings Yield: 32.2% (+35.9%).
- Product Sales Leaders: Neulasta/Neupogen: 1,380 (+0.1%); Neulasta: 1,134 (+4.0%); Enbrel: 1,116 (+13.0%); Xgeva/Prolia: 612 (+28.8%); Epogen: 534 (+15.6%); Aranesp: 480 (+4.3%); Xgeva: 340 (+21.9%); Sensipar/Mimpara: 334 (+23.7%); Prolia: 272 (+38.8%); Kyprolis: 108 (+58.8%).
- Neupogen: 246 (-14.9%).
- U.S. product sales growth has accelerated the past two quarters: 1.6%, 8.6%, 14.7% as has EPS growth: -10.1%, 26.3%, 50.7%.
- 2015 Guidance: Total Revenues: $20.9B - 21.3B from $20.8B - 21.3B; Non-GAAP EPS: $9.35 - 9.65 from $9.05 - 9.40; CAPEX: ~$800M (unch).
Tue, Apr. 21, 4:01 PM
Tue, Apr. 21, 1:37 PM
Mon, Apr. 20, 5:35 PM
Wed, Apr. 15, 4:50 PM
- The FDA approves Amgen's (NASDAQ:AMGN) Corlanor (ivabradine) to reduce hospitalization resulting from chronic heart failure that is worsening. The review of the New Drug Application (NDA) was done under Priority Review and Fast Track designations.
- Ivabradine lowers the heart rate by inhibiting the funny channel (lf current) in the heart's sinoatrial node, the body's cardiac pacemaker.
- AMGN is up a fraction after hours on higher-than-average volume.
Wed, Apr. 15, 10:14 AM
- Coherus BioSciences (CHRS -3%) and Baxter International (BAX +0.4%) amend their August 2013 collaboration agreement pertaining to the development and commercialization of CHS-0214, a biosimilar to Amgen's (AMGN +1%) Enbrel (etanercept). Certain milestones and funding obligations have been revised and the partnership has been expanded to include select pre-commercialization activities. The revised milestone payments may increase Baxter's funding obligations by ~$12M. It also has agreed to buy Coherus common stock in a private transaction.
Mon, Apr. 6, 7:20 AM
- The European Commission approves Amgen's (NASDAQ:AMGN) Vectibix (panitumumab) as first-line treatment, in combination with the chemo regimen FOLFIRI, for patients with wild-type (WT) RAS metastatic colorectal cancer (mCRC). About half of mCRC patients are classified as WT RAS. FOLFIRI is an irinotecan-based chemotherapy frequently used as first-line treatment for CRC in Europe.
- In the EU, Vectibix is also cleared for use in patients with WT RAS mCRC as first-line therapy in combination with FOLFOX (another chem regimen), as second-line therapy in combination with FOLFIRI in patients who have received first-line fluoropyrimidine-based chemo excluding irinotecan and as monotherapy after failure of fluoropyrimidine-, oxaliplatin- and irinotecan-containing chemo regimens.
- Europe has the highest incidence of CRC in the world, with ~470K new cases each year. It is the second most common cancer in Europe following lung cancer.
Mon, Mar. 30, 12:30 PM
- Last night on CBS' 60 Minutes news show, two segments were dedicated to an experimental treatment for brain cancer being developed at Duke University. The therapy, based on a genetically modified form of the polio virus, was injected directly into the brains of patients with glioblastoma, a type of brain cancer with a poor prognosis. Of the 22 patients treated in a Phase 1 study, 11 died. In the group of 11 survivors, though, all experienced a shrinkage in their tumors with three being cancer-free.
- The polio virus, engineered to render it incapable of harming normal cells, replicates in cancer cells, killing them. Other viruses under investigation as cancer killers are herpes simplex, vaccinia and respiratory viruses.
- Companies working on genetically engineered viruses include Amgen (AMGN +0.6%) and Oncolytics Biotech (ONCY -0.4%). Amgen got into the business via its acquisition of Biovex in 2011. On April 29, a joint meeting of the Cellular, Tissue and Gene Therapies Advisory Committee and the Oncologic Drugs Advisory Committee will review Amgen's Biologics License Application (BLA) for talimogene laherparepvec (T-VEC), based on the herpes virus, for the treatment of metastatic melanoma.
- The unique feature of engineered viruses is that they are designed as a single treatment, rather than a multi-dose regimen. Another benefit is their scalability, a potential problem with personalized CAR-T therapies.
Mon, Mar. 30, 10:18 AM
- The FDA accepts under Priority Review Amgen's (AMGN +1.2%) supplemental New Drug Application (sNDA) for Kyprolis (carfilzomib) for the treatment of patients with relapse multiple myeloma who have received at least one prior therapy. The PDUFA date is July 26.
- Kyprois is currently cleared for the treatment of patients with multiple myeloma who have received as least two prior therapies.
- Multiple myeloma is the second most common blood cancer with ~230K people living with the disorder worldwide and ~114K new cases diagnosed each year.
- Kyprolis has generated $331M in sales the past four quarters.
Mon, Mar. 30, 8:00 AM
- The European Medicines Agency (EMA) validates (accepts for review) the Marketing Authorization Application (MAA) for SB2, Biogen's (NASDAQ:BIIB) biosimilar to Janssen's (NYSE:JNJ) Remicade (infliximab). The MAA was submitted by the firm's joint venture partner, Samsung Bioepis. This is the second MAA accepted for review by the European regulator. It validated the MAA for SB4, a biosimilar to Amgen's (NASDAQ:AMGN) Enbrel (etanercept), earlier this year.
- Both SB2 and SB4 will be manufactured at Biogen's Hillerod, Denmark facility, once approved.
Tue, Mar. 24, 10:30 AM
- Cancer diagnostics firm Dako expands its collaboration with Amgen (AMGN +0.4%) in the field of personalized medicine, specifically companion diagnostics. Agilent Diagnostics and Genomics Group President Jacob Thayson says, "We are proud to both continue and broaden our multi-year partnership with Amgen. Together, we will continue our work in the development of high quality companion diagnostic products to enable physicians and pathologists to identify cancer patients who are more likely to respond to a specific therapy."
- Specific terms of the collaboration are not disclosed.
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