Nov. 21, 2013, 3:20 PM
- After opening higher, shares of Amgen (AMGN -2.9%) moved into negative territory this morning and have since traded notably lower on above average volume.
- The weakness looks to be attributable to BofA/ Merrill Lynch. Here's what the firm had to say regarding a meeting with Celgene's (CELG +1.8%) management: "The most notable derivative commentary was around AMGN's Kyprolis. CELG is hearing increasing concerns from big myeloma centers on CV events."
- They continue: CELG "has access to the event rate in ASPIRE and believes the full story has yet to fully play out." While BofA says CELG "was not tossing away Kyprolis" they did seem to suggest that "it could be reserved with Revlimid/Dexamethasone for high risk myeloma." ASPIRE combines Kyrpolis, Revlimid, and Dexamethasone.
- Now, Cowen is apparently out defending AMGN, saying any CELG commentary might have been taken out of context.
- Also down sharply are shares of Ligand Pharmaceuticals (LGND -5.7%) which receives tiered royalties tied to the use of Captisol technology in the drug.
Nov. 20, 2013, 2:13 PM
- Amgen (AMGN) announces results from an open-label extension study of evolocumab in patients with high cholesterol.
- The company's executive VP of R&D calls the results "encouraging" and says the data "suggest evolocumab may be a promising option to treat hyperlipidemia in a range of at-risk patients."
- The company says the PCSK9 inhibitor "was not associated with a major increase in AEs versus SOC and produced mean LDL-C reductions of 52% in combination with SOC in patients with high cholesterol." (PR)
Nov. 18, 2013, 11:33 AM
- Teva (TEVA -0.6%) is out with an oncology portfolio update.
- Highlights: Lonquex was launched in Germany on November 4, Granix was launched in the U.S. on November 11, and the BLA for balugrastim has been withdrawn "pending the provision of additional confirmatory data." (PR)
- Although Goldman's Terence Flynn didn't "see balugrastim as a significant competitive threat to [Neulasta]," the analyst notes that "many investors did," and therefore, TEVA's move to pull the leukocyte growth factor from the FDA review process "removes a near-term competitive threat" for an Amgen (AMGN +1.9%) and also lifts "an overhang on shares heading into 2014."
- Goldman maintains a CL-Buy on AMGN.
- Price target is $140.
Oct. 22, 2013, 4:10 PM
- Amgen (AMGN) is up 1% AH following its Q3 report.
- Revenues of $4.75B are up 11% Y/Y.
- Adjusted EPS growth comes in at 16%.
- Sales by product: Neulasta/ Neupogen, +18%; Enbrel, +7%; Aranesp, -10%; Epogen, flat; Sensi[ar/Mimpara, +7%; Vectibix and Nplate, +19%; XGEVA, +30%; Prolia, +62%.
- FY 13 outlook: Adjusted EPS of $7.35-7.45 on sales of $18.3-18.5B against consensus of $7.32/share on $18.33B in sales. (PR)
Oct. 22, 2013, 4:05 PM
Oct. 22, 2013, 12:10 AM
Oct. 21, 2013, 5:35 PM
Oct. 16, 2013, 4:56 PM
Oct. 16, 2013, 3:15 AM
- A drug developed by Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) cut levels of the "bad" LDL cholesterol by 47% in a Phase III trial of 103 patients. No major side effects were experienced.
- The treatment, called Alirocumab, is part of a new class of injectable cholesterol medicines that block a protein called PCSK9. Amgen (AMGN) and Pfizer (PFE) are among those developing such drugs, which could each generate sales of $3B or more.
- Regeneron and Sanofi hope to file for authorization of Alirocumab by late 2015 after the results of another 11 studies are released. (PR)
Oct. 14, 2013, 10:01 AM
- Leerink starts Acceleron Pharma (XLRN -0.3%) at Outperform.
- The company is "pushing innovation boundaries with lead compounds for anemia (Sotatercept, ACE-536) and oncology (Dalantercept)," analyst Marko Kozul says.
- Leerink thinks Sotatercept and ACE-536 "have potential to compete directly with ESAs" such as Aranesp and Epogen (AMGN) and Procrit (JNJ).
- As for Dalantercept (ACE-041), Kozul says it "could be used synergistically with any VEGF-inhibitor."
- Finally, Kozul says XLRN "has important catalysts for almost every quarter through YE14."
- Price target is set at $33.
- Leerink starts Acceleron Pharma (XLRN -0.3%) at Outperform.
Oct. 13, 2013, 2:59 AM
- California Governor Jerry Brown has vetoed a bill that would have limited the use of biosimilar pharmaceuticals in the state.
- Brown explained that the legislation was premature, as the FDA hasn't yet set the rules governing such drugs.
- Biosimilars are the copycat versions of biotech drugs - also known as biologics - which are complex proteins developed in living cells. Biosimilars are not called generics, as it's difficult to prove that they're exactly the same as the biologic original.
- The campaign to limit the use of biosimilars has been led by Amgen (AMGN) and Genentech (RHHBY.OB); so far, 10 states have blocked such efforts this year, including Illinois and Texas.
- Companies developing biosimilars include Hospira (HSP), Novartis (NVS), Momenta Pharmaceuticals (MNTA), Baxter (BAX) and Teva (TEVA).
- Healthcare ETFs: XLV, XHE, VHT, FXH, IHF, IHI, IYH, PTH, RYH, PSCH, RXL, RXD, XHS
Oct. 11, 2013, 10:25 AM
- Cytokinetics (CYTK +7.6%) rallies after Needham's Chad Messer reminds investors that despite a misread by the media, last month's ATOMIC-AHF readout was actually in line with expectations.
- "Significant increases in systolic injection and reduction in worsening of heart failure while actually lowering heart rate, distinguish omecamtiv from older inotropic agents [and] are more than positive enough for Amgen (AMGN) to proceed with a Phase 3 study next year, triggering a milestone payment to CYTK shareholders," Messer notes, downplaying the overall dypsnea response miss.
- Price target raised to $25 from $20.
- While today's vote of confidence is good for morale, the rationale here was discussed at length in early September after the presentation at the ESC Congress.
Oct. 9, 2013, 12:44 PM
- Biotech stocks suffer a third straight day of heavy losses after recording their worst selloff in two years yesterday, but Bernstein’s Geoffrey Porges says it's not time to panic.
- Stocks with major uncertain events looming, such as MDVN, or with significant revenue upside already built into valuation, such as PCYC, were among the most severely affected, Porges says, but "nothing changed in the environment to suggest that those events were any more or less likely to have positive outcomes yesterday, or to suggest that revenue potential was any more or less likely to be achieved than was previously expected."
- Still, investors shouldn’t buy the sector willy-nilly; Porges recommends Celgene (CELG) and Gilead (GILD) among large caps, and notes that less-pricey stocks such as Amgen (AMGN) should hold up better, as should midcaps with earnings and products, such as Alexion (ALXN).
- ETFs: IBB, XBI, FBT, PBE, BBH, BIB, BIS.
Oct. 4, 2013, 10:02 AM
Oct. 3, 2013, 9:51 AM
- Novartis' (NVS +0.1%) IL-17A inhibitor secukinumab cleared skin faster and for longer than Enbrel (AMGN -0.9%) in a Phase 3 plaque psoriasis study.
- FIXTURE met all primary and secondary endpoints.
- Here's NVS' head of pharmaceuticals with the no-frills take: "These exciting data suggest that with secukinumab, we have the potential to help more patients achieve clear skin, which is the ultimate treatment goal."
- Expect regulatory submissions later this year in both the U.S. and Europe. (PR)
Oct. 2, 2013, 1:39 PM
- Leerink is out reiterating a Market Perform rating and a $128 price target on Amgen (AMGN -1%) on the heels of new AMG386 TRINOVA-1 data.
- New data included interim OS results "which showed a relatively modest positive trend with half of the events," analyst Howard Liang notes, adding that the regulatory fate of the angiopoietin inhibitor will likely rest on final survival data due H2 2014.
- Back in June, investors got top-line PFS data which showed a Hazard Ratio of 0.66. More on this here.
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