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Sold @ $42.60. Don't know the stock that well and took small profit. Look to re-enter.
MTZ
In @ $41.50. Infra-structure company which has been trending down. Dropped today at "news" of quarterly report date.
"MasTec, Inc. is an infrastructure construction company. The Company operates primarily across North America through a range of industries. The Company operates through five segments: Communications, Oil and Gas, Electrical Transmission, Power Generation and Industrial, and Other. Its primary activities include the engineering, building, installation, maintenance and upgrade of communications, energy and utility infrastructure, such as wireless, wireline/fiber, satellite communications and customer fulfillment activities; petroleum and natural gas pipeline infrastructure; electrical utility transmission and distribution; conventional and renewable power generation, and industrial infrastructure. The Company offered its services primarily under the MasTec service mark and had operations across 510 locations as of December 31, 2016. It provides services under master service and other service agreements, which are generally multi-year agreements."
MTZ
BREAKING: Senators Reach Deal to Fund Subsidies to Health Insurers ---@thomaskaplan
Senators Reach Deal to Fund Subsidies to Health Insurers
By THOMAS KAPLANOCT. 17, 2017
WASHINGTON — Two leading senators have reached a bipartisan deal to provide funding for critical subsidies to health insurers that President Trump said last week that he would cut off, Senator Lamar Alexander, Republican of Tennessee, said Tuesday.
The plan agreed to by Mr. Alexander and Senator Patty Murray of Washington, a Democrat, is intended to stabilize health insurance markets under the Affordable Care Act.
As one part of the deal, the subsidies would be funded for two years, a step that would provide at least short-term certainty to insurers. The subsidies, known as cost-sharing reductions, lower out-of-pocket costs for low-income consumers.
The deal between Mr. Alexander, the chairman of the Senate health committee, and Ms. Murray, the panel’s top Democrat, is an important step for lawmakers hoping to shore up insurance markets after Republicans’ failed efforts to repeal the health law.
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Mr. Alexander told reporters on Monday that Mr. Trump had encouraged him to reach a deal with Ms. Murray.
But it remains to be seen whether conservative-leaning Republicans will get on board with the agreement, and whether the House will entertain it. Some Republicans have said they do not wish to provide what they describe as a bailout to insurers.
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THC
Thanks for the sentiment. It sure moved fast out of the gate. Don't doubt the $10 once there is some movement on infra-structure.
Could have been worse as I hadn't intended to hold through earnings in any case.
CLF
Never underestimate Trump's influence on a stock and in a perverse way. Everyone seemed to think he wouldn't do away with subsidies!
THC
Out CLF @ $7.35, sorta unintentionally as had my limit taken out while focusing on another stock. Moves fast!
Gotta be more upside if can get back in at a good price.
CLF
Wrong day to initiate a position, the whole sector down -3.16%
https://finance.google.com/finance?catid=us-TRBC%3A5610201010&ei=gCPdWZnuLJTlmAHw7rbIDA
THC
Continues the crazy trend of up/down. Currently up 5% today. Market Makers making lots of money on this stock.
RUBI
Anybody with RUBI insights? Last week has been crazy. 7 days with no consecutive days up or down:
Trading at great discount to both book and cash, as well as target price:
Book/sh 5.80 Target Price 5.14
Cash/sh 6.47
https://finviz.com/quote.ashx?t=rubi&ty=c&ta=1&p=d
RUBI
Sold @ $24.78. Had set this limit just below 50 DMA and got distracted. No homerun but at least a triple.
Will be back in if it stalls.
X
Don't use pattern very much. Rather other TA. You are correct that the chart is not great and could go to the 20's but would be more due to fundamentals.
My chart setup (you need paid StockCharts to see the indicators)
The positives I see is the stock is oversold (RSI, Wm%R(14) and CCI). The Full STO has turned up and the MACD seems close to the bottom. Otherwise not so great. Looks as if there stock doesn't trade down much more than 4 successive days and there has been 2
As stated this is a short term play for me and depending on world events over the weekend hope to sell on Monday or Tuesday.
Good luck.
X
In @ $23.45. Not sure for how long, but thinking Cowen's $20.00 is over reaction.
X
Watching also for a technical play since haven't followed anything about the fundamentals. We missed a good chance about 2 weeks ago but may retrace back down.
CORN
Out @ $88.50 for a small profit after buying down from a too high entry. Probably a multi-day runner, but changing brokers (leaving Ally Invest which has been terrible) and had to sell.
Could be back in tomorrow if transfer proceeds well.
BMRN
Actually switching everything to the E-Trade account that I have always had. Been paying $100 each month for the E-Trade Pro platform which I couldn't do without. Trade enuff that it would be free with my volume of trades. Suffered through the old TradeKing outages, etc. but can't tolerate the current problems with Ally Invest and especially the lack of customer support and respect.
I've always found E-Trade to be a good broker.
Sold OHI @ $31.24 for small profit. Meant to be in longer but changing brokers and need to sell (leaving Ally Invest which was TradeKing because of poor service). Will be back in by next week.
OHI
Out of BMY @ $58.99. No reflection on the company but changing brokers which will freeze funds for a few days. Leaving Ally (formerly TradeKing) due to poor service. ~$59 seems a good exit assuming there is no blockbuster news.
No more posts until re-enter in the future.
BMY
Bristol-Myers Squibb and Pfizer Alliance Announce Real-World Observational Analysis of the Effectiveness and Safety of Direct Oral Anticoagulants Compared to Warfarin in Elderly Patients with Non-Valvular Atrial Fibrillation
By Business Wire, August 29, 2017, 08:21:00 AM EDT
Eliquis®(apixaban) associated with lower risk of stroke and lower rates of major bleeding compared to warfarin in U.S. Humana database analysis
PRINCETON, N.J. & NEW YORK--(BUSINESS WIRE)--
Bristol-Myers Squibb Company (NYSE:BMY) and Pfizer Inc. (NYSE:PFE) today announced findings from a real-world data analysis of the U.S. Humana database, in which treatment with Eliquis®(apixaban) was associated with asignificantly lower risk of stroke/systemic embolism and lower ratesof major bleeding compared to warfarin in patients aged 65 years and older with non-valvular atrial fibrillation (NVAF). The Humana database includes managed care medical and pharmacy claims from greater than 20 million persons primarily residing in the Southern and Midwestern regions of the U.S. This analysis was published today in the journal Current Medical Research and Opinion, with data from select cohorts also presented today in a poster session at the ESC Congress 2017, organized by the European Society of Cardiology, in Barcelona, Spain (please see indications and important safety information for Eliquis later in this press release).
This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170829005667/en/
In this observational, real-world data analysis, NVAF patients with U.S. Medicare Advantage insurance were identified in the Humana database by age (65 years and older), and having a pharmacy claim of Eliquis or warfarin between January 1, 2013, and September 30, 2015. The analysis evaluated rates of stroke/systemic embolism (including ischemic stroke, hemorrhagic stroke and systemic embolism) and major bleeding (including intracranial hemorrhage, gastrointestinal bleeding, and other major bleeding). Rates of stroke/systemic embolism and major bleeding were evaluated in the follow-up, based on hospitalization claims with the corresponding ICD-9-CM codes at the first position among the diagnosis codes associated with any of the inpatient claims. Real-world data analyses cannot be used as stand-alone evidence to validate the efficacy and/or safety of a treatment. Observational real-world studies can only evaluate association and not causality.i,ii Please see full methodology and additional limitations below.
"NVAF has long been identified as a significant risk for stroke, and its prevalence increases with age," said Steven Deitelzweig, M.D., lead author of the publication and System Department Chair of Hospital Medicine, Ochsner Medical Center, New Orleans. "Real-world data such as this Humana database analysis provide further information to inform treatment decisions for select patient sub-populations, such as the elderly, in our everyday clinical practice."
Eliquis, in this analysis, was associated with a lower risk of stroke/systemic embolism (hazard ratio [HR]:0.65, 95% confidence interval [CI]: 0.51 to 0.83, p=0.001) and lower rates of major bleeding (HR:0.53, 95% CI: 0.45 to 0.63, p=0.001) compared to warfarin. The mean duration of follow-up was 6.3 months for Eliquis and 8.3 months for warfarin. These findings supplement results from the landmark Phase 3 ARISTOTLE (Apixaban for Reduction In STroke and Other ThromboemboLic Events in Atrial Fibrillation) clinical trial. Eliquis increases the risk of bleeding and can cause serious, potentially fatal, bleeding.
This analysis is part of the BMS-Pfizer Alliance global real-world data analysis program, ACROPOLIS™ (Apixaban ExperienCe Through Real-WOrld POpuLatIon Studies). Data sources for ACROPOLIS include de-identified medical records, medical and pharmacy health insurance claims data, and national health data systems, representing patient records across various populations and geographies.
"People aged 65 and older with non-valvular atrial fibrillation are approximately three to five times more likely to have a stroke than those without this disorder,"iii,iv,v said Christoph Koenen, M.D., MBA, VP, Development Lead, Eliquis, Bristol-Myers Squibb (BMS). "Despite treatment advances over the past decade, a significant number of people in this age group with NVAF remain under-treated."vi
"Through these real-world analyses, we continue to add to the growing body of evidence around the effects of Eliquis in commonly seen patient groups such as the elderly," said Rory O'Connor, M.D., Chief Medical Officer, Pfizer Innovative Health. "The analyses from the ACROPOLIS program aim to supplement Eliquis' randomized clinical trial results with insights gleaned from data collected across large patient populations and diverse clinical settings."
Methodology
In addition to the Eliquis cohort, this observational, retrospective analysis of the Humana database included two other direct oral anticoagulants (rivaroxaban and dabigatran). The analysis was conducted in patients aged 65 and older with NVAF who had not received an oral anticoagulant for at least one year. Patients had to have continuous health plan enrollment with medical and pharmacy benefits for at least 12 months pre-index date. Patients with claims indicative of diagnoses of valvular heart disease, venous thromboembolism, transient atrial fibrillation, cardiac surgery, hyperthyroidism and thyrotoxicity, or pregnancy during the baseline period were excluded. For more information, please refer to the full journal article published in Current Medical Research and Opinion.
In this analysis, 7,107 matched pair patients were identified as treated with Eliquis and warfarin respectively (n=14,214) after balancing patient characteristics with propensity score matching (PSM). Multivariate logistic regression was used in this analysis to generate propensity scores with covariates to balance select demographic and clinical characteristics. Separate one-to-one PSM was conducted among patients treated with Eliquis vs. warfarin to verify cohorts were well balanced with key patient characteristics not statistically different (p>0.05). Cox proportional hazards models were used to estimate the hazard ratio (HR) - the rates at which events occurred - of stroke/systemic embolism and major bleeding using primary ICD-9 codes of inpatient claims.
Limitations of Real-World Data Analyses and of the Humana Database Analysis
Real-world data have the potential to supplement randomized clinical trial data by providing additional information about how a medicine performs in routine medical practice. Real-world data analyses have several limitations. For example, the source and type of data used may limit the generalizability of the results and of the endpoints. Observational real-world studies can only evaluate association and not causality. Due to these limitations, real-world data analyses cannot be used as stand-alone evidence to validate the efficacy and/or safety of a treatment. It is important to note that, at this time, there are no head-to-head clinical trials comparing direct oral anticoagulants.
In this analysis, although PSM was used to control for multiple confounders, there is still potential for residual bias. Claims for a filled prescription do not indicate that the medication was consumed or taken as prescribed. Also, medications filled over-the-counter or provided as samples are not captured in the claims data. Lastly, the Humana insurance claims database is comprised of claims of persons primarily residing in the Southern and Midwestern regions of the U.S. and the results of this study may not be generalizable to the entire U.S. elderly population.
About Eliquis
Eliquis (apixaban) is an oral selective Factor Xa inhibitor. By inhibiting Factor Xa, a key blood clotting protein, Eliquis decreases thrombin generation and blood clot formation. Eliquis is approved for multiple indications in the U.S. based on efficacy and safety data from multiple Phase 3 clinical trials. Eliquis is a prescription medicineindicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF); for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery; for the treatment of DVT and PE; and to reduce the risk of recurrent DVT and PE, following initial therapy.
ELIQUIS Important Safety Information
WARNING: (A) PREMATURE DISCONTINUATION OF ELIQUIS INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA
(A) Premature discontinuation of any oral anticoagulant, including ELIQUIS, increases the risk of thrombotic events. If anticoagulation with ELIQUIS is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant.
(B) Epidural or spinal hematomas may occur in patients treated with ELIQUIS who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:
use of indwelling epidural catheters
concomitant use of other drugs that affect hemostasis, such as nonsteroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants
a history of traumatic or repeated epidural or spinal punctures
a history of spinal deformity or spinal surgery
optimal timing between the administration of ELIQUIS and neuraxial procedures is not known
Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary.
Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated.
CONTRAINDICATIONS
Active pathological bleeding
Severe hypersensitivity reaction to ELIQUIS (e.g., anaphylactic reactions)
WARNINGS AND PRECAUTIONS
Increased Risk of Thrombotic Events after Premature Discontinuation: Premature discontinuation of any oral anticoagulant, including ELIQUIS, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. An increased rate of stroke was observed during the transition from ELIQUIS to warfarin in clinical trials in atrial fibrillation patients. If ELIQUIS is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant.
Bleeding Risk: ELIQUIS increases the risk of bleeding and can cause serious, potentially fatal, bleeding.
Concomitant use of drugs affecting hemostasis increases the risk of bleeding, including aspirin and other antiplatelet agents, other anticoagulants, heparin, thrombolytic agents, SSRIs, SNRIs, and NSAIDs.
Advise patients of signs and symptoms of blood loss and to report them immediately or go to an emergency room. Discontinue ELIQUIS in patients with active pathological hemorrhage.
There is no established way to reverse the anticoagulant effect of apixaban, which can be expected to persist for at least 24 hours after the last dose (i.e., about two half-lives). A specific antidote for ELIQUIS is not available.
Spinal/Epidural Anesthesia or Puncture: Patients treated with ELIQUIS undergoing spinal/epidural anesthesia or puncture may develop an epidural or spinal hematoma which can result in long-term or permanent paralysis.
The risk of these events may be increased by the postoperative use of indwelling epidural catheters or the concomitant use of medicinal products affecting hemostasis. Indwelling epidural or intrathecal catheters should not be removed earlier than 24 hours after the last administration of ELIQUIS. The next dose of ELIQUIS should not be administered earlier than 5 hours after the removal of the catheter. The risk may also be increased by traumatic or repeated epidural or spinal puncture. If traumatic puncture occurs, delay the administration of ELIQUIS for 48 hours.
Monitor patients frequently and if neurological compromise is noted, urgent diagnosis and treatment is necessary. Physicians should consider the potential benefit versus the risk of neuraxial intervention in ELIQUIS patients.
Prosthetic Heart Valves: The safety and efficacy of ELIQUIS have not been studied in patients with prosthetic heart valves and is not recommended in these patients.
Acute PE in Hemodynamically Unstable Patients or Patients who Require Thrombolysis or Pulmonary Embolectomy: Initiation of ELIQUIS is not recommended as an alternative to unfractionated heparin for the initial treatment of patients with PE who present with hemodynamic instability or who may receive thrombolysis or pulmonary embolectomy.
ADVERSE REACTIONS
The most common and most serious adverse reactions reported with ELIQUIS were related to bleeding.
TEMPORARY INTERRUPTION FOR SURGERY AND OTHER INTERVENTIONS
ELIQUIS should be discontinued at least 48 hours prior to elective surgery or invasive procedures with a moderate or high risk of unacceptable or clinically significant bleeding. ELIQUIS should be discontinued at least 24 hours prior to elective surgery or invasive procedures with a low risk of bleeding or where the bleeding would be noncritical in location and easily controlled. Bridging anticoagulation during the 24 to 48 hours after stopping ELIQUIS and prior to the intervention is not generally required. ELIQUIS should be restarted after the surgical or other procedures as soon as adequate hemostasis has been established.
DRUG INTERACTIONS
Strong Dual Inhibitors of CYP3A4 and P-gp: Inhibitors of cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp) increase exposure to apixaban and increase the risk of bleeding. For patients receiving ELIQUIS doses of 5 mg or 10 mg twice daily, reduce the dose of ELIQUIS by 50% when ELIQUIS is coadministered with drugs that are strong dual inhibitors of CYP3A4 and P-gp (e.g., ketoconazole, itraconazole, ritonavir, or clarithromycin). In patients already taking 2.5 mg twice daily, avoid coadministration of ELIQUIS with strong dual inhibitors of CYP3A4 and P-gp.
Strong Dual Inducers of CYP3A4 and P-gp: Avoid concomitant use of ELIQUIS with strong dual inducers of CYP3A4 and P-gp (e.g., rifampin, carbamazepine, phenytoin, St. John's wort) because such drugs will decrease exposure to apixaban and increase the risk of stroke and other thromboembolic events.
Anticoagulants and Antiplatelet Agents: Coadministration of antiplatelet agents, fibrinolytics, heparin, aspirin, and chronic NSAID use increases the risk of bleeding. APPRAISE-2, a placebo-controlled clinical trial of apixaban in high-risk post-acute coronary syndrome patients treated with aspirin or the combination of aspirin and clopidogrel, was terminated early due to a higher rate of bleeding with apixaban compared to placebo.
PREGNANCY CATEGORY B
There are no adequate and well-controlled studies of ELIQUIS in pregnant women. Treatment is likely to increase the risk of hemorrhage during pregnancy and delivery. ELIQUIS should be used during pregnancy only if the potential benefit outweighs the potential risk to the mother and fetus.
Please see full U.S. Prescribing Information, including BOXED WARNINGS and Medication Guide, available at www.bms.com.
Local prescribing information may vary between countries. Please refer to your local Prescribing Information, including details on indications, dosage, and safety.
About ACROPOLIS™
ACROPOLIS™ (Apixaban ExperienCe Through Real-WOrld POpuLatIon Studies) is the Eliquis (apixaban) global real-world data program designed to generate additional evidence from routine clinical practice settings to further inform healthcare decision makers, including healthcare providers and payers. The ACROPOLIS program will include retrospective, outcomes-based analyses from over 10 databases around the world, including medical records, medical and pharmacy health insurance claims data, and national health data systems.
Analyses of real-world data allow for a broader understanding of patient outcomes associated with Eliquis outside of the clinical trial setting, as well as insight into other measures of healthcare delivery, such as hospitalization and costs.
About ARISTOTLE
ARISTOTLE (Apixaban for Reduction In STroke and Other ThromboemboLic Events in Atrial Fibrillation) was designed to evaluate the efficacy and safety of Eliquis versus warfarin for the prevention of stroke or systemic embolism. In ARISTOTLE, 18,201 patients were randomized (9,120 patients to Eliquis and 9,081 to warfarin). ARISTOTLE was an active-controlled, randomized, double-blind, multi-national trial in patients with non-valvular atrial fibrillation or atrial flutter, and at least one additional risk factor for stroke. Patients were randomized to treatment with Eliquis 5 mg orally twice daily (or 2.5 mg twice daily in selected patients, representing 4.7 percent of all patients) or warfarin (target INR range 2.0-3.0), and followed for a median of 1.8 years.
About the Bristol-Myers Squibb/Pfizer Collaboration
In 2007, Pfizer and Bristol-Myers Squibb entered into a worldwide collaboration to develop and commercialize apixaban, an oral anticoagulant discovered by Bristol-Myers Squibb. This global alliance combines Bristol-Myers Squibb's long-standing strengths in cardiovascular drug development and commercialization with Pfizer's global scale and expertise in this field.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube and Facebook.
About Pfizer Inc.: Working together for a healthier world®
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.pfizer.com. In addition, to learn more, please visit us on www.pfizer.com and follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding product development. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2016, in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
Pfizer Disclosure Notice
The information contained in this release is as of August 29, 2017. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about Eliquis (apixaban), including its potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including, without limitation, the ability to meet anticipated clinical trial commencement and completion dates as well as the possibility of unfavorable clinical trial results, including unfavorable new clinical data and additional analyses of existing clinical data; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of Eliquis; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2016 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 8-K, all of which are filed with the SEC and available at www.sec.gov and www.pfizer.com.
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i Garrison LP, Neumann PJ, Erickson P, Marshall D, Mullins CD. Using real-world data for coverage and payment decisions: the ISPOR real-world data task force report. Value Health. 2007;10:326-335.
ii Hannan EL. Randomized clinical trials and observational studies. J Am Coll Cardiol Intv. 2008;1:211-217.
iii January, C. T. ACC/AHA/HRS Guideline for the Management of Patients With Atrial Fibrillation. Circulation. 2014;130:E212-E212.
iv Eagle, K. A. Management of Atrial Fibrillation: Translating Clinical Trial Data into Clinical Practice. The American Journal of Medicine. 2011;124:4-14.
v Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham study. Stroke. 1991;22: 983-8.
vi Hsu JC, Maddox TM, Kennedy K, et al. Aspirin instead of oral anticoagulant prescription in atrial fibrillation patients at risk for stroke. J Am Coll Cardiol. 2016;67:2913-23.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170829005667/en/
Source: Pfizer Inc.
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BMY
Bristol-Myers Squibb's (BMY) Nivolumab Receives FDA Orphan Designation for Treatment of Mesothelioma
August 18, 2017 6:24 AM EDT
Bristol-Myers Squibb (NYSE: BMY) Nivolumab received FDA orphan designation for treatment of mesothelioma.
-
Generic Name: nivolumab
Trade Name: N/A
Date Designated: 08/16/2017
Orphan Designation: Treatment of mesothelioma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Marketing Approval Date: N/A
Approved Labeled Indication:
Exclusivity End Date: N/A
Sponsor: Bristol-Myers Squibb Company
5 Research Parkway
Wallingford, Connecticut 06492
USA
The sponsor address listed is the last reported by the sponsor to OOPD.
___________________________________________________
https://www.streetinsider.com/Corporate+News/Bristol-Myers+Squibbs+%28BMY%29+Nivolumab+Receives+FDA+Orphan+Designation+for+Treatment+of+Mesothelioma/13219235.html
BMY
Bristol-Myers shares sink after another setback for its immuno-oncology franchise drugs
by john carroll — on August 15, 2017 05:22 PM EDT
Updated: August 16, 2017 08:13 AM
Once again undermining confidence in its all-important immuno-oncology pipeline, Bristol-Myers Squibb conceded Tuesday evening that a combination of Opdivo and Yervoy failed to hit a key co-primary endpoint in a Phase III study for frontline renal cell carcinoma.
Comparing the combo against sunitinib (Sutent) in CHECKMATE-214, researchers said that Opdivo/Yervoy failed to significantly improve progression-free survival for patients. They did note, though, that the combo hit a co-primary endpoint on the objective response rate, achieving a 41.6% ORR versus 26.5% for sunitinib. In their words: “The median PFS was 11.56 months (95% CI 8.71 – 15.51) for the Opdivo and Yervoy combination versus 8.38 months (95% CI 7.03-10.81) for sunitinib.”
Coming fast on the heels of AstraZeneca’s woeful failure on PFS for its PD-L1/CTLA4 combo in lung cancer, investors clearly didn’t like the latest setback for Bristol-Myers, driving shares $BMY down 3.5% in pre-market trading. Investigators will continue to follow patients to see how the combo works on overall survival.
Analysts offered two key opinions on the results. A few noted that the PFS numbers only narrowly missed their target on statistical significance, meaning the combo isn’t out for the count. And Michael Schmidt at Leerink noted that Exelixis $EXEL investors are likely to be relieved as one near-term threat to cabo’s franchise for Exelixis at least got delayed by the late-stage miss.
Underscoring that point, Exelixis reported this morning that it had filed a supplemental NDA for cabo in frontline RCC. Exelixis’ shares jumped 3.5% overnight.
Bristol-Myers has been working hard to overcome suspicions about the future of Opdivo and I/O in general after a major blow was leveled by a failure in frontline lung cancer. This latest flop won’t help, but it also won’t deter the company from its comeback mission.
“We are encouraged by the totality of the CHECKMATE-214 data. The overall response rate and durability of response favored the combination of Opdivo and Yervoy, and the trend for PFS supports the potential of the combination in intermediate and poor-risk advanced renal cell carcinoma, the most common type of kidney cancer. This is an important study in first-line renal cancer as these patients need new options,” said Vicki Goodman, development lead, melanoma and genitourinary cancers, Bristol-Myers Squibb. “We look forward to presenting the full results from this study at an upcoming medical meeting.”
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https://endpts.com/bristol-myers-shares-sink-after-another-setback-for-its-immuno-oncology-franchise-drugs/?utm_medium=email&utm_campaign=286%20Wednesday%2081617%20JJ%20stands%20by%20Trump%20as%20controversy%20rips%20president%20Bristol-Myers%20stumbles%20again%20on%20PhIII&utm_content=286%20Wednesday%2081617%20JJ%20stands%20by%20Trump%20as%20controversy%20rips%20president%20Bristol-Myers%20stumbles%20again%20on%20PhIII+CID_8ada3eb0a2a796459aade1bd883aec12&utm_source=ENDPOINTS%20emails&utm_term=Bristol-Myers%20shares%20sink%20after%20another%20setback%20for%20its%20immuno-oncology%20franchise%20drugs
BMY
Glad the pps is recovering pre-market. While disappointing the initial response (-4%) seemed overdone for mixed results.
BMY
So much for $58.
BMY
According to WhaleWisdom, BMRN is Baker Bro 6th largest holding with 22% increase in shares as of the last filing:
BMRN HEALTH CARE 5,905,673 $ 536,353,000 2.59% 3.45% 6 1,099,190 22% 3.4163% Q2 2012 13F 2017-06-30 2017-08-14
https://whalewisdom.com/filer/baker-bros-advisors-llc#/tabholdings_tab_link
BMRN
Consensus Ratings for Bristol-Myers Squibb Company (NYSE:BMY) (How are Consensus Ratings Calculated?)
Ratings Breakdown: 1 Sell Rating, 10 Hold Ratings, 10 Buy Ratings
Consensus Rating: Hold (Score: 2.43)
Consensus Price Target: $62.25 (8.45% upside)
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https://www.marketbeat.com/stocks/NYSE/BMY/?RegistrationCode=SocialMedia-direct&utm_source=GeneralSocialMedia&utm_medium=Social
BMY
Out @ $5.43 just before close for a couple hundred loss after several dip buys. Intended to sell before ER -- INO got caught up in a negative Seeking Alpha article today.
INO
Buy out rumors/analyst comment:
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Bristol-Myers Squibb (BMY) Could Be Worth $59-$75 In Takeout W/O CM-227 - Goldman
Goldman Sachs maintained a Buy rating on Bristol-Myers Squibb Co. (NYSE: BMY) with a price target of $63.00.
Analyst Jami Rubin says the stock could be worth $64-$74 per share depending on the varying degrees of success of CM-227. The analyst also notes that in a takeout scenario the stock could be worth $59-$75 per share with no value for CM-277.
Rubin further comments that while it is fair to assume a lower probability of success for IO-IO arm of CM-277 there is one change worth noting which is that if the trial is successful then BMY would be the only CTLA-4 IO combo on the market and that would translate in something particularly meaningful were the company to show superior OS data relative to the chemo combos.
FY 2017 EPS estimate remains at $2.95, FY 2018 EPS estimate remains at $3.21 and FY 2019 EPS estimate remains at $3.85.
For an analyst ratings summary and ratings history on Bristol-Myers Squibb Co. click here. For more ratings news on Bristol-Myers Squibb Co. click here.
Shares of Bristol-Myers Squibb Co. closed at $56.30 yesterday.
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https://www.streetinsider.com/Analyst+Comments/Bristol-Myers+Squibb+%28BMY%29+Could+Be+Worth+%2459-%2475+In+Takeout+WO+CM-227+-+Goldman/13179305.htm
BMY
Bullish SA article:
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Bristol-Myers Squibb: A Combined Value And Growth Story
Aug. 6, 2017 11:36 PM ET|14 comments| About: Bristol-Myers Squibb Company (BMY)
DoctoRx
(13,404 followers)
Summary
Bristol-Myers Squibb has tumbled from about $75 last year to $56 as of Friday largely due to one failed Phase 3 study in lung cancer.
Sometimes this large a price drop in a bull market provides a reason to look for undervaluation.
This article suggests that the company's substantial Phase 1-2 pipeline could be a "freebie", given the potential value of its marketed products and other assets.
Background
Bristol-Myers Squibb (NYSE:BMY) was formed from a merger of two old-line pharma companies more than a quarter century ago. At the time, it was a powerhouse. It began to hit much harder times in the late '90s and was forced to reinvent itself in the '00s. Unusually, in a compliment to management, it has been able to do so via its "string of pearls" acquisition strategy. This turned BMY into what is largely a biotech.
Probably the most important deal was to acquire Medarex. The shrunken BMY launched the novel oral anticoagulant Eliquis a few years ago in competition with Bayer's (OTCPK:BAYRY) Xarelto, which is marketed in the US by Johnson & Johnson (NYSE:JNJ). As a smaller player lacking much of the marketing clout and know-how, BMY turned to Pfizer (NYSE:PFE) to assist with marketing the product. PFE took the ball and did what it knows best - which is devise a brilliant marketing strategy that took Eliquis to first place, with worldwide revenues up 50% yoy to $2.3 billion in the first half of 2017.
While BMY is moving ahead with certain anticoagulant and cardiovascular R&D, its future - without a marketing partner - is planned to be in oncology first and what it calls immunoscience (a related field) second. Here, the company has a certain dominance with two market-leading therapies for cancer, Opdivo and Yervoy; two other less important cancer drugs, Sprycel and Empliciti; and a drug for certain autoimmune diseases, Orencia. It needs no co-marketing partner here, and has Opdivo and Yervoy largely to itself, unlike Eliquis.
The company also has a huge pipeline, which is a drag on current earnings.
Because of that, it makes sense to think of BMY as two companies - one an existing marketing company, and the other a pipeline company, in concept valued as a junior biotech would be. There is one big complication, though, because nearly 100% of the Phase 3 studies involve marketed products, largely Opdivo and Yervoy. I'll therefore include Phase 3 in this analysis and try to account for its cost later.
Overview of BMY's earning assets
To begin with, BMY has a favorable mix of sales. Per its Q2 earnings press release, the growth is attributed largely to these five drugs, with yoy growth rates as follows:
Eliquis - 51%
Opdivo - 42%
Yervoy - 34%
Sprycel 12%
Orencia 10%
The other important young brand is the myeloma antibody Empliciti, which only had sales of $55 million, but they were up 62% yoy.
For the first 6 months of the year, total revenues were $10.1 billion. Of this, only $2.26 billion came from older drugs. And while I won't go into the upside in this article, BMY is launching two hepatitis C drugs in three major provinces in China this quarter - so there may be some surprises if they start selling well.
The above 6 younger, growing brands are unusual amongst biotechs and Big Pharma. That's because, in general, the faster-growing the drug, the later the patent expiration in the US; with the EU generally, but not always, similar though not identical. What I have done is read through the presentation of patent situations in the latest 10-K (pp. 7-8; also see p. 11 regarding alliances) and have used my best guessing as to the approximate year of ultimate patent expiration. Some of the guessing relates to ungranted patent term extensions that have been applied for; other guesses relate to other issues. So, not factual but a working template that I'm using for now as an overview. These are my current estimates of the years that the above 6 BMY growth drugs either go generic (G) or look likely to be open to biosimilars (B):
Eliquis - 2027 G
Opdivo - 2027 or 2028 B
Yervoy - 2025 B
Sprycel - 2024 G
Orencia - 2021 B
Empliciti - 2029 B
What's positive for BMY here is that the fastest-growing drugs look to be without direction competition until perhaps 8-12 years from now. That provides lots of time to grow. It also provides time for new formulations to be developed or new patents to mature that I'm not aware of. This is a common tactic. Amgen (NASDAQ:AMGN) used it to extend the patent life of Enbrel, its lead drug, until the late 2020s rather than falling to biosimilars this decade. Celgene (NASDAQ:CELG) has done something similar with its lead drug, Revlimid.
In addition, Eliquis is given twice daily. A once-daily version might appear and extend exclusivity, as well as helping sales growth.
Finally, it's a positive that 4/6 of the above drugs are biologics. That gives the hope to BMY that it will retain a lot of its sales even when one or more biosimilars come to market.
What are these earning assets worth?
Of course, no one knows, but analysts are guessing at it. My guess is that they are worth, ultimately, close to BMY's current market cap of $92 billion. The way I estimate it is that the company is probably going to see Yervoy and Opdivo sales of some strength into and beyond the 2030 period; and as stated, I assume one or more of the above drugs will either get patent enhancements and/or an improved formulation. So what I've done is take analysts' consensus estimated revenues for 2018 of around $21 billion and extend that for 11 years. Some products will drop out, such as Sprycel and some of the currently-aged drugs, but most of them will keep growing. Given that the fast growers have late patent expiries and are medical breakthroughs, I'm simply guesstimating that the company can achieve $21 billion X 11 = $231 billion in cumulative sales from existing products. Exactly what discount rate to use is difficult. BMY current gets about 55% of its revenues from the US, where there are few truly effective cost controls on breakthrough medications, which almost all the above drugs are.
In any case, the next question is what the fully-costed pre-tax overhead is to achieve those sales. Based on 2016 and 2017 numbers, I hope it is conservative to use 50%. If I recall correctly, somewhere along the line BMY said it hopes to improve on this ratio - but only time will tell. 50% COGS and SG&A, which take partnership payments into account, give a cumulative pre-tax profit of $115 billion by this method.
What tax rate should be used? No one knows. BMY projects 23% for this year, so just for now I'll go with that. That gives $88 billion as after-tax profits projected.
Now, one thing that is not included in these projections is royalties from other companies than Merck (NYSE:MRK), which has settled with BMY regarding the latter's Opdivo-related patents. BMY is going after at least the three other companies marketing PD-L1 I-O drugs, and I expect settlements to be likely. That could add up to billions of dollars over the years.
Finally, BMY has a positive tangible net worth of $6.6 billion as of the end of Q2.
Putting it all together, investors in the company may be getting a mostly early-stage pipeline free. A lot depends on what the actual cost of the Phase 3 program is and will be, but I'm hoping that the numbers work out close when doing all the adding and subtraction.
As a double check to the above, I have worked on what BMY's EPS would be if it dropped all R&D. Doing so would make this a very cheap stock, taking billions out of the cost structure per year on a pre-tax basis. I'm not certain if the tax effects are symmetrical, but a simple calculation that you can do on your own suggests that given what I see as the likely product lives, with several of them rolling on after biosimilar entry, the stock may be cheap here on a fundamental basis if the pipeline comes through even moderately well.
The next section therefore discusses the pipeline, albeit briefly.
BMY's giant pipeline
The 2016 annual report shows the pipeline nicely on PDF slides 12-13.
A slightly more recent version of the oncology pipeline was shown on a presentation related to ASCO; see the crowded slide 12.
I would say that given a Phase 3-ready NASH asset and the proven quality of BMY's R&D department, this company could be a real contender in several ways. It's also important to remember as we think of these stronger companies that the best of them have reinvented their product lines over and over. A question for readers who know some of the history of Bristol-Myers and Squibb: Who remembers Capoten and Monopril? Plavix? Coumadin? Glucophage? Pravachol? Hydrea? Kenalog, Megace, Videx, Zerit?
So, to be very brief, while I'm no longer comfortable thinking about standalone junior biotechs with unproven product lines, processes, technologies and managements, I am comfortable with the successful, mature companies to get a positive return on invested capital over time from their R&D programs. In the case of BMY, the CEO is an M.D. with both product development and commercial experience; and the new head of R&D, Dr. Thomas Lynch, is a superstar oncologist with extensive experience.
If I can think BMY's current assets, mostly marketed products but also tangible net worth and intellectual property that can be monetized further, may be worth somewhere in the range of its market cap, then I'm willing to accept pipeline risk, especially with a reasonable dividend to pacify me if I get antsy over a failed clinical trial along the way (which always happens with large pipelines).
Implications of the above analysis suggest BMY may be perpetually in play
If you look carefully at the Phase 1 assets on the ASCO presentation, and if you are familiar with the I-O field, you will notice that by description, only a small number are novel. The novel ones do include a next-generation Yervoy that's in the clinic and a small number of others. But other acronyms look familiar.
This suggests to me that there are multiple synergies available if any of the following four companies acquires BMY: PFE, JNJ, Roche (OTCQX:RHHBY) and Novartis (NYSE:NVS). All have the heft to do the deal, and some have overlapping assets. In addition, the usual corporate synergies can be achieved.
One reason to own a stock of a company that's not too large to be acquired is that it makes it difficult to panic and sell on some bad news. The acquirers love to buy the dips.
Risks
As a company that's pushing hard on the pipeline, largely relying on Opdivo and Yervoy, a major risk is that it just gets it wrong. Another risk specific to Opdivo right now is that the majority of its US sales come from lung cancer, where it is not in great competitive shape. A more comprehensive list of risks is found in the 10-K and other communications and regulatory filings from BMY.
The company is aggressive right now, going for growth, and sometimes it just does not work out.
Concluding comments
In a high stock market, with the S&P 500 (NYSEARCA:SPY) trading around 23.7X likely GAAP EPS when Q2 results are finally reported, BMY is trading at a greater than 10% discount to the market. When it was at $70-75 last year, it was at a premium. Given its strong products and long product lives as I estimate them, and significant pipeline potential in a secular growth field of immuno-oncology, I'm comfortable that BMY may be undervalued on its own merits even in a "normal" market, and that it probably is relatively undervalued relative to the SPY. That I can imagine that a mega-cap behemoth might want to acquire it, rationalize the pipelines of the combined companies, and pay for the deal with cash flow from the acquired company, helps me plan for this stock to be a long-term holding.
Thanks for reading and sharing any comments you wish to contribute.
Disclosure: I am/we are long BMY,CELG,RHHBY.
I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
Additional disclosure: Not investment advice. I am not an investment adviser.
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https://seekingalpha.com/article/4095703-bristol-myers-squibb-combined-value-growth-story?app=1&auth_param=udil:1cofo1k:c84b56c4169695770e66e7cf73458aec&uprof=46
BMY
Not sure the range of indications covered by the settlement. Doubt it has been revealed.
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Merck will pay $625 million and royalties to settle Keytruda patent litigation with Bristol-Myers Squibb and Ono Pharma
Published: Jan 20, 2017 4:16 p.m. ET
By
EMMA
COURT
REPORTER
Merck & Co. Inc. MRK, -1.00% will pay $625 million and royalties to Bristol-Myers Squibb Co. BMY, -1.21% and Ono Pharmaceutical Co. Ltd. to settle patent litigation over Merck's cancer drug Keytruda, the companies said Friday afternoon. As part of the settlement all patent litigation will be dismissed, and the companies have granted certain patent rights to each other. Merck will pay royalties on global Keytruda sales of 6.5% between 2017 and the end of 2023 and 2.5% between 2024 and 2026, with the royalties being split 75/25 between Bristol-Myers and Ono. Merck said the $625 million payment would be recorded in its fourth-quarter and full-year 2016 results, but excluded from its non-GAAP results. In their lawsuit against Merck, Bristol-Myers and Ono, which made cancer drug Opdivo, said its Keytruda sales infringed on various of its global patents. Bristol-Myers shares slumped 2.2% over the last three months, compared with a 1.0% rise in Merck shares and a 6.1% rise in the S&P 500 SPX, -0.01%
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http://www.marketwatch.com/story/merck-will-pay-625-million-and-royalties-to-settle-keytruda-patent-litigation-with-bristol-myers-squibb-and-ono-pharma-2017-01-20
DewDiligence is the expert here.
BMY
Opinion: Ignore the Obamacare fight in Congress and buy these 5 health-care stocks
Published: July 29, 2017 8:08 a.m. ET
Plenty of reason to like health care as a long-term investment no matter what Congress does
By
JEFF
REEVES
COLUMNIST
The battle in Congress over the Affordable Care Act continues, with more debate and votes over repealing parts of the law also known as Obamacare.
Of course, it’s anyone’s guess where things will wind up. Hard-line conservatives want to repeal it (they lost one vote to do that on Tuesday night), moderates want to modify it and Democrats want to preserve it.
But that shouldn’t bother investors one whit because the bottom line is that health care is a good investment in general. Several stocks in particular are excellent buys no matter what happens on the Hill.
Consider the following:
•Every health-care company that reported results this earning season through last Friday has beaten expectations, according to the latest FactSet earnings insight, although there have been a few misses since then.
Read: HCA’s weak quarter speaks to a long-term trend: People are going to the doctor less
•For 2017, the Health Care Select Sector SPDR ETF XLV, -0.29% is up over 17% year-to-date in 2017 vs. 11% for the S&P 500 index SPX, -0.07%
•Longer term, that health-care ETF is up over 110% in the last five years vs. about 80% for the S&P in the same period.
These stats show plenty of reason to like health care as a long-term investment regardless of the short-term uncertainty because of Congress. The bottom line is that the sector is mostly recession-proof as patients put their health-care expenses before other discretionary spending, and demographic tailwinds continue to create reliable growth industrywide.
Here's the real reason why U.S. health care is so expensive
So stop sweating the fight over the Affordable Care Act and consider a long-term investment in these five health-care stocks now:
Omega Healthcare
Health-care real estate and senior living properties are as close to a sure thing as you can get right now. Thanks to the unending march of demographics, increasing numbers of older Americans are creating high demand for senior living space and rehab facilities. When you find the right company, structured as a tax-sheltered real estate investment trust REIT, it’s all the better.
That’s what Omega Healthcare Investors Inc. OHI, -0.74% offers. That, and a tremendous 7.7% dividend for investors who buy at current levels.
Amid the current fight over health-care reforms and a chance that Medicare and Medicaid payments will be reduced, some investors may have their doubts. But Omega Healthcare is not a provider itself, just a landlord, and any changes in health-care regulations are the tenants’ problem to work out. Omega operates “triple-net lease” properties, which means it isn’t liable for the three big add-ons that handcuff other REITs — taxes, maintenance and insurance. Omega quite literally just collects the rent from the health-care companies that lease from it, and that’s that.
Yes, some of the tenants’ pain can trickle down. But this company is seeing sustained growth in both the top and bottom lines, and with a juicy dividend, that risk is more than outweighed by the potential rewards.
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http://www.marketwatch.com/story/ignore-the-obamacare-fight-in-congress-and-buy-these-5-health-care-stocks-2017-07-26?siteid=yhoof2&yptr=yahoo
In @ $30.90. See if this thesis works out.
OHI
Bristol-Myers: Looking To Maintain Lead In Immunotherapy
Aug. 2.17 | About: Bristol-Myers Squibb (BMY)
BiotechPickList
(1,102 followers)
Summary
Opdivo approval in rare colorectal cancer is a good step forward for the company.
The phase 2 study with accelerated approval shows the true power of Opdivo as an immunotherapy product.
Competition from KEYTRUDA will be fierce in the colorectal cancer space.
On Tuesday, Bristol-Myers (BMY) won approval for microsatellite instability-high (MSI-H) metastatic colorectal cancer. It is a rare tumor that affects only 5% of metastatic colorectal cancer patients. In my opinion, this win is huge for the company in that it will put up a good fight against Merck (MRK) KEYTRUDA. That is because Merck back in May received FDA approval for its own treatment of MSI-H metastatic colorectal cancer. Although, Merck might have the slight upper hand because it targets all tumors in the body as long as the genetic marker is present. Whereas, Opdivo is only approved to treat one location only. Still, this approval was needed for Bristol-Myers. That is because last week AstraZeneca (AZN) failed its combination trial of IMFINZI and tremelimumab in treating lung cancer patients. The combination failed to show that it could improve progression-free survival (PFS) in first-line lung cancer patients. The results from the AstraZeneca trial can be observed in a Seeking Alpha article I wrote named "AstraZeneca: Pipeline Woes" How did that trial failure affect Bristol-Myers? Well, Bristol-Myer's stock tanked as soon as the failed AstraZeneca results were released. That is because Bristol-Myers has its own trial combination study testing Opdivo and Yervoy in first-line lung cancer patients.
Phase 2 Study
Bristol-Myers won approval for Opdivo in MSI-H metastatic colorectal cancer patients with a study known as Checkmate-142. This phase 2 study recruited a total of 74 patients. One thing to note is that this trial was a single-arm study, meaning that patients only received treatment with Opdivo. In addition, patients that were recruited into the trial would have already received treatment with chemotherapy agents such as fluoropyrimidine, oxaliplatin, and irinotecan. This triplet combination is situated as first-line therapy for colorectal cancer patients. The triplet combination works but is cytotoxic, and that's why treatment options like Opdivo and KEYTRUDA are good for patients. The reason for the drug being approved so quickly after a phase 2 trial, was the fact that it was given accelerated approval by the FDA. That is because the primary endpoint of the study was met, and that was an increase in the overall response rate (ORR). The ORR was at 28% achieving the primary endpoint of the study. I feel that Bristol-Myers worked hard to get this indication approved in such a quick manner. Although, Bristol-Myers still has lots of work to do. That is because despite receiving accelerated approval, it will have to run confirmatory trials to keep the drug on the market.
Competition
While Merck may have an upper hand in the MSI-H metastatic colorectal cancer space with KEYTRUDA, Opdivo is performing better overall. Merck's KEYTRUDA sales in Q1 reached up to $585 million, then made $881 million in Q2. Bristol-Myers on the other hand, still maintains the lead in the immunotherapy cancer space. In Q1 sales of Opdivo reached $1.1 billion, and then in Q2 sales reached $1.2 billion. It seems that KEYTRUDA is catching up in sales, but for now Opdivo holds the lead. The truth is that the immunotherapy market for these drugs are enormous. Both these drugs combined have an annualized track record of selling $2 billion or more in sales. Despite the large increase in sales, there are no signs that they are slowing down.
Risks
There are quite a few risks with respect to Bristol-Myers' Opdivo drug. The first risk is that while the drug got FDA approval for patients with MSI-H metastatic colorectal cancer, it will have to run more trials to stay on the market. That means if the confirmatory trials don't come out positive, I believe the FDA could pull the drug off the market. That's not likely to happen after the results observed above, but something to keep in mind just in case. Bristol-Myers faces a risk with respect to the MSI-H population simply because it only targets one portion of the body. Merck's KEYTRUDA can go after other tumors in the body as long as they bare the genetic MSI-H marker as well. That could mean lost sales on Bristol-Myers end. The final risk would be KEYTRUDA itself. As noted above, KEYTRUDA is catching up to Opdivo in sales. If that happens that would put Merck on top in the immunotherapy cancer space. That is a situation that investors should keep in mind.
Conclusion
With the FDA approval it puts Bristol-Myers in the MSI-H colorectal cancer space. While not as good as Merck's approval from May, it does give Bristol-Myers the ability to generate more revenue in the immunotherapy cancer space. The upcoming confirmatory studies should likely be positive, because the overall response rate observed in the Checkmate-142 study was highly positive. This approval is another notch on the belt that Bristol-Myers needed. It won't end with just this approval for Opdivo. The FDA is also expected to review a proposal for approval for Opdivo in liver cancer. Plus there are several other catalysts for Bristol-Myers. Such catalysts include trial results from patients being treated with Opdivo in kidney cancer, melanoma, and many others.
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
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https://seekingalpha.com/article/4093572-bristol-myers-looking-maintain-lead-immunotherapy
BMY
Temporarily out of NEOS @ $6.86. Poor timing as sold minutes before it went to HOD so left some on the table. Looking to re-enter, just assuring profit.
NEOS
Fly Tweet gave us at least some temporary juice:
The Fly? @theflynews 9m9 minutes ago
More
On The Fly: Top five analyst initiations $HAIN $CDEV $NEOS $CLDX $SBOW http://dlvr.it/Pb2Twn
NEOS
Can't answer. You probably have seen their latest corp presentation:
http://investors.neostx.com/phoenix.zhtml?c=254075&p=irol-presentations
No luck in searching Clinical Trials as can't find the Noes complete listing, only one trial. Not sure why can't find.
NEOS
Cantor Fitzgerald Starts Neos Therapeutics (NEOS) at Overweight
July 31, 2017 4:05 PM EDT
Cantor Fitzgerald initiates coverage on Neos Therapeutics (NASDAQ: NEOS) with a Overweight rating and a price target of $20.00.
https://www.streetinsider.com/Analyst+Comments/Cantor+Fitzgerald+Starts+Neos+Therapeutics+(NEOS)+at+Overweight/13148515.html
NEOS