Fri, Oct. 2, 11:44 AM
- House Democrats' keen interest in certain drug firms' pricing strategies prompted Morgan Stanley's David Risinger to downgrade Valeant Pharmaceuticals (VRX -3.2%) to Equal Weight from Overweight with a price target of $200 (14% upside) citing the large contribution (14%) that price increases have to its top-line growth.
- He also downgraded Regeneron Pharmaceuticals (REGN -0.2%) to Equal Weight with a price target of $593 (26% upside) citing potential headwinds created by competitors, including an anticipated tough fight with Amgen (Praluent vs. Repatha). Gilead Sciences (GILD -1.3%) got a haircut to Equal Weight with a price target of $127 (31% upside) citing slowing Hep C volume growth.
- Mr. Risinger also slapped AmerisourceBergen (ABC -1.3%) with an Underweight (Sell) rating due to its reliance on branded drug price inflation. He cut his price target to $93 (0% upside) from $120.
Thu, Oct. 1, 4:38 PM
- Regeneron Pharmaceuticals (NASDAQ:REGN) grants exclusive development and commercial rights to its Nerve Growth Factor (NGF) antibody, fasinumab, to Mitsubishi Tanabe Pharma for the territory of Japan, Korea and nine other Asian countries, excluding China. Fasinumab is in late-stage development for the treatment of musculoskeletal pain.
- Under the terms of the agreement, Regeneron will receive an upfront payment of $55M as well as other near-term payments. It will also be eligible to receive up to $170M in R&D reimbursement payments and development milestones, a portion of the profits and additional one-time purchase price adjustment payments of up to $100M upon the achievement of certain annual sales targets.
Wed, Sep. 30, 12:49 PM
- Bruised and battered biotech investors get some welcome buying today as bargain hunters open their wallets. The iShares Nasdaq Biotech Index Fund (IBB +2%) is up nicely, albeit on average volume.
- Key tickers: (AMGN +1.6%)(BIIB +2.5%)(GILD +1%)(CELG +0.7%)(DEPO +12.4%)(HZNP +8.6%)(NVO +0.7%)(AGN +4.9%)(VRX +6.4%)(REGN +0.9%)(TEVA +2%)(SHPG +2.6%)
Mon, Sep. 28, 7:03 AM
- As expected, the European Commission (EC) approves Praluent (alirocumab) for lowering low-density lipoprotein (LDL) cholesterol in certain adults with hypercholesterolemia. The approval follows CHMP's positive opinion in July. Praluent, co-developed by Sanofi (NYSE:SNY) and Regeneron Pharmaceuticals (NASDAQ:REGN), will be available in a single-dose (75 mg or 150 mg) pre-filled pen that patients can self-administer.
- The EC approved Amgen's (NASDAQ:AMGN) Repatha (evolocumab) in July.
- Previously: Amgen's Repatha cleared in Europe (July 21)
- Previously: Europe's CHMP give thumbs up to Regeneron and Sanofi's Praluent (July 24)
Sun, Sep. 27, 8:59 AM
- The $8B iShares Nasdaq Biotechnology ETF (NASDAQ:IBB) fell 4.9% on Friday and 13% for the week - its worst weekly performance since the height of the financial panic seven years ago. Many biotech ETFs eat the same cooking - Gilead (NASDAQ:GILD), Amgen (NASDAQ:AMGN), Biogen (NASDAQ:BIIB), and Regeneron (NASDAQ:REGN) among the popular names - and FBT, XBI, and BBP fell in amounts similar to IBB.
- The news flow was relatively quiet late in the week, but Hilary Clinton's promise Monday to clamp down on drug prices set things in negative motion for the momo sector.
- Barron's Chris Dieterich reminds that a flood of biotech IPOs in recent years has filled the small cap universe with these highly speculative names, and biotech now makes up 7% of the iShares Russell 2000 Index (NYSEARCA:IWM). Indeed. The IWM fell 3.7% for the week, nearly tripling the decline of the S&P 500.
- ETFs: IWM, TZA, TNA, UWM, VB, VBK, URTY, SCHA, TWM, IWO, RWM, SRTY, VTWO, RCG, JKJ, VTWG, TWOK, FYX, JKK, EWRS, ZSML, FYC, SMLL, RYRSX
Mon, Sep. 21, 6:52 PM
- Wynn Resorts (NASDAQ:WYNN), Viacom (NASDAQ:VIAB) and Dollar Tree (NASDAQ:DLTR) headline Goldman Sachs' list of 25 companies that could post outsized returns even as more and more stocks are moving in lock-step.
- Goldman’s picks come as return dispersion - the performance gap among stocks - has sunk lately amid turmoil in China and concerns about when the Fed will raise interest rates that has pushed stock correlations to their highest level since 2011.
- Given the low-dispersion setting, Goldman says investors should focus on these 25 stocks that have high “dispersion scores” and 15%-plus upside to the firm’s targets: WYNN, VIAB, DLTR, UAL, LUV, URBN, CBG, JNPR, MPC, NFLX, HBI, SIG, CRM, CERN, VLO, KMX, ENDP, CTSH, ISRG, ETFC, TSN, CCE, CI, REGN, GT
Mon, Sep. 21, 8:27 AM
- The U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) will provide $17M in initial funding to Regeneron Pharmaceuticals (NASDAQ:REGN) to develop, test and manufacture a treatment for Ebola infection including an IND filing with the FDA. An option in the agreement provides for an additional $21M to fund a Phase 1 study in health volunteers, planned for January 2016, and further manufacturing and development studies.
- The product candidate is a monoclonal antibody developed with the company's VolociGene and VelocImmune technologies. Sanofi (NYSE:SNY) has opt-in rights pursuant to its 2009 antibody discovery and development agreement with Regeneron.
Fri, Sep. 11, 9:39 AM
- Amgen (AMGN -0.8%) files an application with the FDA seeking clearance for a single once-per-month 420 mg injection of its cholesterol fighter Repatha (evolocumab). Presently, Repatha is available in a single-use 140 mg/mL prefilled autoinjector which requires three subcutaneous injections for a dose of 420 mg. One injection, obviously, would be much more patient-friendly for those patients requiring/preferring a once-per-month regimen.
- The FDA cleared Repatha, a PCSK9 inhibitor, on August 27, for lowering LDL-C (bad cholesterol).
- Sanofi (SNY -0.2%) and Regeneron's (REGN -0.4%) Praluent (alirocumab), Reptha's competitor, requires a subcutaneous injection every two weeks via a pre-filled syringe/pen.
Tue, Sep. 1, 11:11 AM
- In a presentation today at the European Society of Cardiology Congress in London, pooled data from the ODYSSEY clinical trial program show Praluent (alirocumab) significantly lowered bad cholesterol (LDL-C). The analysis included 1,257 patients with heterozygous familial hypercholesterolemia (HeFH), a genetic predisposition for high cholesterol.
- At week 24, patients receiving Praluent experienced an average 56% greater reduction in LDL-C versus placebo (p<0.0001). Reductions were observed as early as week 4 and were maintained until week 78, the duration of therapy.
- Only ~20% of HeFH patients are able to reduce their LDL-C level below 100 mg/dL with statins. In this analysis, 75% of HeFH patients who added Praluent to their standard-of-care treatment (which included statins) were able to lower their LDL-C below 100 mg/dL.
- Praluent, approved by the FDA in July, was co-developed by Regeneron Pharmaceuticals (REGN -2%) and Sanofi (SNY -1.9%).
Mon, Aug. 31, 7:53 AM
- The Medicines Company (NASDAQ:MDCO) jumps 20% premarket on average volume in response to development partner Alnylam's (NASDAQ:ALNY) announcement that its investigational RNAi therapeutic, ALN-PCSsc, lowered LDL-C (bad cholesterol) up to 83% with a mean maximum reduction of up to 64% (+-5%) in an early stage study, results comparable to Amgen's (NASDAQ:AMGN) Repatha (evolocumab) and Sanofi (NYSE:SNY) and Regeneron's (NASDAQ:REGN) Praluent (alirocumab). The data were presented at the ESC Congress in London.
- What's notable in this case is the difference in dosing regimens. ALN-PCSsc was administered in one subcutaneous dose that was effective for over 140 days, giving it the potential for once per quarter or twice per year administration. Praluent is dosed once every two weeks and Repatha once every two weeks or once per month at a higher dose.
- ALN-PCSsc turns off PCSK9 synthesis in the liver. This is a different mechanism of action compared to Praluent and Repatha, both of which bind to PCSK9 in the blood.
- The Medicines Company will take the lead in developing ALN-PCSsc under the ORION Program. A Phase 2 study will commence by the end of the year and a Phase 3 trial is planned for 2017. The clinical development will include comparisons to the anti-PCSK9 monoclonal antibodies.
- The companies will host a conference call this morning at 9:30 am ET to discuss the results and their development plan.
Thu, Aug. 27, 5:56 PM
- The FDA approves Amgen's (NASDAQ:AMGN) Repatha drug for patients with hereditary forms of high cholesterol and those at high risk of cardiovascular disease.
- The scope of the approval was similar to the recent approval given to Regeneron's (NASDAQ:REGN) Praluent, which was approved for patients with cardiovascular disease and those with heterozygous familial hypercholesterolemia.
- Each of the drugs are expected to generate more than $2B/year in sales by 2020.
Tue, Aug. 25, 5:35 PM
- investors should stick with "market darlings" - the 25 stocks that had performed the best during the six months before a market pullback - according to the analyst team at RBC.
- The firm notes that although many recent winners are leading the market lower, the extent of the underperformance is just 1%; it also says investing in the group following sharp market pullbacks is a winning strategy over the ensuing week, month and six months.
- RBC's 25 market darlings are AET, ALTR, AMZN, AIZ, CVC, CI, CAG, EA, EQIX, EXPE, GME, GOOGL, HAS, HCA, MNST, NFLX, NKE, PRGO, REGN, SBUX, TSO, TWC, TSS, UA, UHS
Thu, Aug. 20, 2:35 AM
- Yesterday was the 11th anniversary since Google's (GOOG, GOOGL) initial public offering, and there's no doubt the company has had a remarkable run (Class A shares +1,277%).
- Although the online advertising giant has given a massive return to investors, there are still 13 stocks that outperformed Google since 8/19/2004:
- Alexion Pharmaceuticals (NASDAQ:ALXN); Amazon (NASDAQ:AMZN); Apple (NASDAQ:AAPL); Celgene (NASDAQ:CELG); Gilead Sciences (NASDAQ:GILD); Intuitive Surgical (NASDAQ:ISRG); Keurig Green Mountain (NASDAQ:GMCR); Monster Beverage (NASDAQ:MNST); Netflix (NASDAQ:NFLX); Priceline (NASDAQ:PCLN); Regeneron Pharmaceuticals (NASDAQ:REGN); salesforce.com (NYSE:CRM); Vertex Pharmaceuticals (NASDAQ:VRTX).
Fri, Aug. 14, 7:16 AM
- Based on additional analyses of the data from a Phase 2a clinical trial in wet age-related macular degeneration, Avalanche Biotechnologies (NASDAQ:AAVL) decides not to proceed to Phase 2b with its lead product candidate AVA-101. Instead, it will conduct further preclinical studies to clarify the optimal dose and delivery of AVA-101 and AVA-201 compared to standard-of-care anti-VEGF protein therapy before advancing the best candidate back into the clinic. The process should be completed by the end of the year.
- The company's decision shouldn't be a surprise. The stock plummeted 40% in June after the company reported less-than-expected results from the Phase 2a study.
- The value proposition of AVA-101, a gene therapy that contains a gene that encodes a naturally occurring anti-VEGF protein, is a single subretinal injection compared intravitreal (inside the eye) injections as frequent as once per month for Regeneron's (NASDAQ:REGN) Eylea and Roche's (OTCQX:RHHBY) Lucentis.
- Shares are down 14% premarket on light volume.
- Previously: Avalanche Bio plummets 40% after hours on less-than-expected AVA-101 data; chances dim for pick up by Regeneron (June 15)
Tue, Aug. 11, 10:15 AM
- In a letter published in the Journal of the American Medical Association (AMA), CVS Health (CVS -0.5%) urges heart specialists to revamp guidelines for treating patients with high cholesterol to provide clarity on how best to choose the best and most cost effective therapy now that expensive new drugs called PCSK9 inhibitors are now on (or will soon be on) the market.
- PCSK9 inhibitors, led by recently-approved Praluent (alirocumab) (SNY -0.4%)(REGN -0.8%) and soon-to-be-approved Repatha (evolocumab), are, at least initially, more than 20 times more expensive than statins. Pharmacy benefit managers, like CVS, aim to control costs by extracting significant discounts from manufacturers and controlling patient access to the pricier drugs.
- CVS wants the guidelines to include specific LDL targets, which older guidelines did before new ones issued in 2013 did away with them. The emphasis now is on a patient's risk of developing heart disease as the main determinant for more intensive treatment. Unsurprisingly, the American College of Cardiology and the AMA have shown scant enthusiasm for revisiting the issue.
- CVS Chief Medical Officer Dr. Troyen Brennan says that if the guidelines are not changed, then CVS will use its own targets, which will vary depending on each patent's medical history. "We expect patients to first use statins. If they can't use statins or can't make (NYSE:LDL) targets, then they would use PCSK9 inhibitors."
- The PDUFA date for Amgen's (AMGN -1%) Repatha is August 27.
Mon, Aug. 10, 12:25 PM
- CVS Health (CVS +0.8%), the number two pharmacy benefit manager (PBM), says it will wait until a second PCSK9 inhibitor is approved before adding either one to its list of covered drugs and negotiating price discounts, clearly an effective strategy if its hopes to win significant price reductions, which is likely if one firm secures exclusive coverage.
- Last month, the FDA cleared Praluent (alirocumab), co-developed by Sanofi (SNY +1.6%) and Regeneron Pharmaceuticals (REGN +0.9%). The PDUFA date for a second PCSK9 inhibitor, Amgen's (AMGN -0.8%) Repatha (evolocumab), is August 27.
- PCSK9 inhibitors are the "next big thing" in lowering bad cholesterol. They ain't cheap, though. Generic statins cost ~$50 per month while Praluent costs ~$1,200 before discounts.
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