Thu, Feb. 12, 12:56 PM
- Johnson & Johnson (JNJ -1.6%) slumps on double normal volume after U.S. Patent Office upholds the rejection of its Remicade 2018 patent. Biosimilar makers rally as a result, including thinly-traded nano cap Epirus Biopharmaceuticals (EPRS +15.1%) whose lead product is BOW015, a biosimilar version of Remicade (infliximab).
- Biosimilar-related tickers: (PFE +1.3%)(HSP +0.1%)(AMGN -0.4%)(CHRS +0.2%)(PFNX +14.5%)(NVS -0.2%)
Wed, Jan. 14, 8:25 AM
- Ziopharm (NASDAQ:ZIOP) jumps 50% premarket on robust volume in response to its announcement of an exclusive license deal with partner Intrexon (NYSE:XON) (+12%) with The University of Texas MD Anderson Cancer Center covering technology and intellectual property related to non-viral adoptive cellular cancer immunotherapies. The technologies originate from two researchers who have pioneered the design and clinical investigation of chimeric antigen receptor (CAR) T cell therapies for the potential treatment of cancer using non-viral gene integration platforms.
- The two researchers are Laurence Cooper, M.D., Ph.D, professor of pediatrics at MD Anderson who has expertise in immunotherapies and Perry Hackett, Ph.D., professor within the College of Biological Sciences at Minnesota, who discovered and developed a system called Sleeping Beauty, a non-viral DNA plasmid-based gene transfer system.
- The deal brings the CAR-T technology together Intrexon's technology suite and Ziopharm's clinically tested RheoSwitch Therapeutic System interleukin-12 modules. Up to five CARs are expected to enter the clinic this year and off-the-shelf programming initiating in 2016.
- Under the terms of the agreement, MD Anderson will receive $100M from the companies in the form of $50M of common stock from each firm. In addition, the companies have committed $15M - 20M over each of the next three years for researching and developing the technologies.
- CAR-T therapies are the "next big thing" in cancer treatment.
- Related tickers: (NASDAQ:KITE) (NASDAQ:JUNO) (NASDAQ:AMGN) (NYSE:NVS) (NYSE:JNJ)
Nov. 14, 2014, 12:00 PM| 41 Comments
Oct. 27, 2014, 4:05 PM
Oct. 21, 2014, 1:55 PM
Aug. 13, 2014, 5:54 PM
- Amgen's (AMGN) Kyprolis (carfilzomib) failed to achieve its primary endpoint of improving overall survival (OS) in a 315-patient Phase 3 clinical trial (FOCUS) evaluating the safety and efficacy of the product in patients with relapsed and advanced refractory multiple myeloma compared to an active control regimen of low-dose dexamethasone (or equivalent corticosteroids) plus optional cyclophosphamide.
- Despite the setback, Amgen subsidiary Onyx Pharmaceuticals (ONXX) President Pablo J. Cagnoni says, "While it is unfortunate that the FOCUS study did not meet its primary endpoint, we believe the results from the recent positive ASPIRE Phase 3 clinical trial will be sufficient to support regulatory submissions around the world."
Jul. 29, 2014, 4:19 PM
May. 30, 2014, 5:36 PM
Jan. 22, 2014, 2:51 PM
- Good things could be ahead for Amgen (AMGN +3.8%), RBC analyst Michael Yee writes, believing the company has been laying the groundwork for growth through pipeline renewal, the effects of which should become evident in mid-2014.
- In the near term, the firm says shares could be range-bound as investors await the ASPIRE interim analysis in mid-2014; removal of this overhang should allow AMGN to embark on a ‘new product story” supported by Phase III PCSK-9 data and eventual approval; Phase III readout for AMG-416 (hyperparathyroidism) and Brodalumab (psorasis) and Phase II proof-of-concept data in migraine prevention (AMG-334); and Phase III anti-sclerostin data in 2015.
- AMGN has climbed 48% during the past 12 months, a fine showing but lagging Biogen’s 116% rise, Gilead Sciences' 111% gain, and even the SPDR S&P Biotech ETF’s 67% advance.
Jan. 16, 2014, 8:39 AM
- Illumina (ILMN) +4.8% premarket after reaching an agreement with Amgen (AMGN) to develop an oncology companion diagnostic test.
- The companies will develop and commercialize a multigene, NGS-based test as a companion diagnostic for Vectibix (panitumumab) in the treatment of metastatic colorectal cancer approved in the U.S. and EU.
- The test will be developed for use with ILMN's MiSeqDx instrument, which has received premarket clearance from the FDA and CE-marked for the European Union.
Jan. 13, 2014, 2:03 PM
- Cytokinetics (CYTK -7.9%) is lower on the day after giving an update on the development of omecamtiv mecarbil.
- CYTK says that it and partner Amgen (AMGN) have "agreed to amend the protocol to evaluate a dose titration strategy in the expansion phase of COSMIC-HF [and up] the size of the expansion phase ... with the objective to provide greater statistical power for the planned evaluation of several pharmacodynamic parameters during oral dosing." (PR)
- Here's The Street's Adam Feuerstein, commenting: "Sounds like data release will be pushed back."
Jan. 8, 2014, 10:46 AM
- Nomura's Ian Somaiya (formerly at Piper) is out with a number of healthcare initiations.
- Gilead (GILD +1.7%) is the firm's top biotech pick for 2014 as the company is "set to dominate the HCV market." GILD started at Buy. Price target is $118.
- Neurocrine Biosciences (NBIX -3.2%) started at Buy. Somaiya sees peak sales of $700M for NBI-98854. Price target is $23.
- Celgene (CELG +1.2%) started at Buy. "Revlimid for multiple myeloma, is less than a third of the way to realizing its peak sales potential," Somaiya says. Price target is $236.
- Biogen (BIIB +4.1%) initiated at Buy. Tecfidera, is "a blockbuster ... treatment for MS, with estimated peak sales of $9B," Somaiya notes. Price target is $368.
- Alexion (ALXN +1.5%) initiated at Buy. Price target $150.
- Pharmacyclics (PCYC +1.9%) will "transform the treatment paradigm and disease course of CLL and mantle cell lymphoma MCL." Shares started at Buy. Price target is $137.
- Other initiations: Incyte (INCY +5.9%) started at Buy. Synageva BioPharma (GEVA +3.7%) started at Buy. BioMarin (BMRN +1.2%), Amgen (AMGN), and Infinity Pharmaceuticals (INFI +2.8%) started at Neutral.
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.
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. 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. 4, 2013, 10:02 AM
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