Thu, Jul. 30, 4:03 PM
Tue, Jun. 9, 6:51 PM
- Regeneron (NASDAQ:REGN) has reopened for trading, up 1.1% to $532, after an FDA Ad Comm ruling in favor of its and Sanofi's Praluent (alirocumab) cholesterol-lowering drug.
- Shares had been halted since just before 7 a.m.
- The vote was 13-3. On Wednesday, the committee turns its attention to Amgen's (NASDAQ:AMGN) drug evolocumab.
- Sanofi estimates that 11M Americans might qualify for the drugs, which could run up to $10K/year in cost. Amgen estimates that 8M Americans might qualify.
Tue, Jun. 2, 9:44 AM
- Aveo Pharmaceuticals (AVEO +11.4%) is set for a gap up this morning stoked by positive data on its lead product candidate, tivozanib, that was presented yesterday at ASCO (abstract #4557).
- In a Phase 3 study, TIVO-1, patients with metastatic renal cell carcinoma were randomized to receive either tivozanib or sorafenib (Bayer (OTCPK:BAYRY) and Amgen's (AMGN -1.1%) Nexavar). Progression-free survival (PFS) and overall survival (OS) in the tivozanib arm were 14.6 months and 29.0 months, respectively. For the sorafenib arm, PFS and OS were 9.7 months and 34.1 months, respectively.
- In the 163 patients that crossed over from sorafenib to tivozanib, median PFS and median OS were 11.0 months and 21.6 months, respectively, from the start of tivozanib therapy.
Tue, May 26, 4:56 AM
- AstraZeneca's (NYSE:AZN) goal of topping $45B in revenue by 2023 has been dealt a severe blow by a problem with an experimental psoriasis drug that the company had viewed as a potential billion-dollar plus seller.
- Amgen (NASDAQ:AMGN), its partner on the project, announced late on Friday it was ending a collaboration to develop brodalumab after suicidal thoughts were observed in patients taking the medicine.
- AZN -1.6%; AMGN -0.8% premarket
Thu, Mar. 5, 8:52 AM
- AbbVie's (NYSE:ABBV) extraordinarily generous buyout of Pharmacyclics (NASDAQ:PCYC) is a crystal clear example of how keen big pharma is to boost its prospects with biotech drugs with blockbuster potential. The transaction's $20B tab, backing out PCYC's $1B cash balance, values Imbruvica (ibrutinib) at $40B since Pharmacyclics' commercial partner Johnson & Johnson (NYSE:JNJ) gets 50% of Imbruvica's revenue. This implies a multiple of almost 7x Imbruvica's projected peak sales of $6B. By comparison, Amgen's (NASDAQ:AMGN) takeout of Onyx Pharma and Sanofi's (NYSE:SNY) takeout of Genzyme were both at 5x premiums.
- The looming patent expiration for Humira ($12.5B in sales the past four quarters) undoubtedly provided AbbVie extra incentive to get the deal done.
- Adding 50% of Imbruvica's sales to AbbVie's top line should increase its revenue growth 3 - 7% and EPS growth 8 - 11% through 2020.
- According to RBC analyst Michael Yee, other biotechs on the big ticket acquisition radar are: BioMarin Pharmaceuticals (NASDAQ:BMRN), Dyax (NASDAQ:DYAX), Esperion Therapeutics (NASDAQ:ESPR), United Therapeutics (NASDAQ:UTHR), Vertex Pharmaceuticals (NASDAQ:VRTX), Intercept Pharmaceuticals (NASDAQ:ICPT), Juno Therapeutics (NASDAQ:JUNO), Kite Pharma (NASDAQ:KITE), PTC Therapeutics (NASDAQ:PTCT) and Receptos (NASDAQ:RCPT).
Mon, Mar. 2, 4:05 PM
- Thinly-traded Ligand Pharmaceuticals (LGND +15.5%) jumps on a 5x surge in volume in response to the positive news on Amgen's (AMGN +1.1%) Kyprolis (carfilzomib) study. Ligand is eligible to receive milestone and royalty payments on sales of Captisol, which carfilzomib's IV formulation utilizes. Ligand and Proteolix entered into a collaboration in 2005 to explore the use to Captisol. Onyx Pharmaceuticals acquired Proteolix in 2009 and Amgen acquired Onyx in 2013.
- Captisol is a formulation technology. It is a uniquely modified cyclodextrin, which improves the solubility, stability, bioavailability and dosing of active pharmaceutical ingredients.
- Previously: Amgen's Kyprolis beats Takeda's Velcade in head-to-head study (March 1)
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
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.
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