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Bristol-Myers Squibb: Analysis Of Earnings Beat, Missed Revenues
- Bristol-Myers Squibb Company (NYSE:BMY) earnings beat estimates, up 4.19% on a year-ago basis and up almost 117% from last quarter.
- However, overall revenues missed expectations with the virology unit and their schizophrenia drug reporting below par numbers.
- Sales of Eliquis, their DVT drug though, have grown on the back on additional approvals. The oncology division has performed well too.
- Earnings growth due to the contribution of unusual items.
Bristol-Myers Squibb Strategy Could Boost Share Price
- BMY has risen less than 1%.
- DRG is up almost 15%.
- What needs to happen to get BMY moving?
Called Strike 3 For Bristol-Myers Squibb: What This Says For Gilead And Its Competitors In The Hep C Market
- Bristol-Myers Squibb halts NDA for its NS3/4A protease inhibitor, asunaprevir.
- BMY shows weakness that its current regimen of daclatasvir and asunaprevir is inferior to Gilead's Harvoni in HCV genotype 1b patients.
- Gilead's Harvoni is leading the show in HCV. Can anyone catch them?
Impact Of Bristol-Myers Squibb Getting Approval For HCV Drug Daklinza
- Gilead Sciences did not agree to collaborate with Bristol-Myers Squibb during the clinical trial for Daklinza.
- The drug is under review of the EC for being approved as a Medical Product for Human Use (CHMP).
- Gilead Sciences has some plans of its own, while Bristol-Myers Squibb revels on the success of being approved in Europe.
Why Bristol-Myers Squibb Loses Out Against This Rival
- We pitch two companies from the GICS sector ‘health care distributors and services’, Bristol-Myers Squibb and Express Scripts, against one another in the latest instalment of our Head-To-Head series.
- The article focuses on the relative strengths and weaknesses of Bristol-Myers Squibb and Express Scripts based on business performance and sustainability/dividends/forecasts.
- It ends with discussion of the current valuations of the two companies, and details whether Bristol-Myers Squibb represents good relative value at current price levels.
Whisper Number Impact: What Will Bristol-Myers' Shares Do Post Earnings?WhisperNumber • Wed, Jul. 23
- The whisper number is $0.47, three cents ahead of the analysts' estimate.
- Bristol-Myers has a 48% positive surprise history (having topped the whisper in 14 of the 29 earnings reports for which we have data).
- The overall average post earnings price move is "as expected" (beat the whisper number and see strength, miss and see weakness) when the company reports earnings.
- Bristol-Myers’s stock price has been lowered by analysts but they still expect the future price to be above the current price of the stock.
- The company received approval for its HCV combo drug in Japan and has been recommended by the European regulators.
- The cancer drug completed its clinical trials ahead of schedule and it is considered the most promising drug for the company.
- A brighter full year 2014 outlook is expected on the back of healthy and expanding portfolio and improving margins.
- The company is overvalued on the basis of price multiples.
Bristol-Myers Squibb May Be Fast-Tracking Its Promising Cancer Drug
- Bristol-Myers Squibb appears to be fast-tracking the development of its breakthrough immuno-oncology drug, Nivolumab.
- The Phase 3 clinical trials were earlier expected to run into the second half of 2015.
- However, with the recent release of promising data and the early termination of the first batch of Phase 3 trials, the drug may hit the market sooner than expected.
Bristol-Myers Squibb: Expect Accelerated Dividend Growth In The Near Term
- Healthy free cash flow and EPS growth trends create room for higher dividend growth.
- With conservative assumptions, BMY can sustain a 5% dividend growth in foreseeable future.
- Current share valuation reasonably reflects the higher dividend growth potential.
Hepatitis C May Give A Big Boost To These Drug Stocks - If The FDA Approves
- Hepatitis C is a liver virus affecting roughly 3.2 million people in the US.
- The virus is particularly prevalent among baby boomers, with over 2 million sufferers.
- If Bristol-Myers wins approval for 2 hep-C drugs, the company could see a huge uptick in sales, since the drugs are used in tandem.
Bristol-Myers Squibb Should Be In Your Retirement Portfolio
- Solid history of growth and value creation.
- Stable dividend, though the growth rate has been mediocre.
- Should offer both stock price appreciation and dividend growth going forward.
- EPS is expected to show negative growth in 2014 and 2015.
- BMY trades at a significant premium to JNJ and MRK.
- The current payout ratio is 80% and earnings are projected to decline; BMY's dividend may not be safe.
- Common valuation metrics show the fair value of the stock to be around $27, a little over half of what the stock is trading at.
- Besides the weak top line performance, another reason for the drop in the stock price is the delay in submission of clinical trial data of cancer drug Nivolumab.
- Bristol-Myers has recently invested in a private biotechnology company, iPierian Inc., with the intention of strengthening its research unit in relation to neurodegenerative diseases.
- Nivolumab is expected to contribute to revenues by the first quarter of FY2015.
- Since Nivolumab's efficacy is enhanced when combined with Yervoy, the latter drug's sale is expected to increase as well.
- Despite expiring patents, Bristol-Myers Squibb remains a top-notch performer in big pharma.
- Bristol-Myers continues to invest in their product pipeline, which helped the company achieve 6% revenue growth in the January quarter, beating estimates by 3%.
- Trading at a P/E of 32 compared to Johnson & Johnson's multiple of 19, the majority of analysts still has a median target of $60.
Bristol-Myers Squibb: Great Dividend Stocks From The Bond Refugee Screen - High Yields And Low Volatility Part VI
- BMY among stocks selected as an alternative for bond investors.
- BMY stock is expensive,on a relative basis, to the S&P 500 and healthcare sector earnings multiples and projected five year growth rates.
- BMY transformation to focus on bio pharmaceuticals is undesirable for bond refugee investors.
Yesterday, 11:51 AM
- The FDA issues a Complete Response Letter (CRL) to Bristol-Myers Squibb (BMY +0.2%) in response to its NDA for HCV drug daclatasvir in combination with other agents.
- The company's initial daclatasvir NDA focused on its use in combination with asunaprevir. Considering BMY's withdrawal of asunaprevir in October, the FDA requests additional data for daclatasvir in combination with other antiviral agents for the treatment of HCV infection. BMY is in discussions with the agency about the scope of these data.
- Previously: Bristol-Myers pulls hep C NDA
- Previously: Bristol-Myers presents data on HCV Trio regimen
Tue, Nov. 25, 8:18 AM
- Pharmacy benefits manager Express Scripts (NASDAQ:ESRX) is at the forefront of an increasing wave of resistance to the high prices of new drugs from pharma and biotech firms, some which cost as much as $50K per month. Pharmaceutical spending in the U.S. is $270B and may breach $500B in five years. ESRX's method of controlling costs is to refuse to pay for them. For 2015, for example, it is excluding 66 branded drugs from its main formulary, an increase of 18 from 2014's 48. On the list is Johnson & Johnson's (NYSE:JNJ) rheumatoid arthritis drug Simponi (golimumab) which costs $3K per month.
- Other prescription benefits managers are employing similar tactics. CVS Health (NYSE:CVS) will exclude 95 drugs from its 2015 formulary including Pfizer's (NYSE:PFE) multiple sclerosis med Rebif (interferon beta-1a) which costs $5K for a four-week supply.
- Governments are pushing back as well. Among 42 state Medicaid programs, 27 pay for Gilead Sciences' HCV med Sovaldi (sofosbuvir) only for patients with severe liver damage while others impose coverage limitations for patients with recent substance-abuse problems. In the U.S., the full regimen cost is $84K. Recently, Britain's National Institute for Health and Care Excellence (NICE) balked at recommending reimbursement for Roche's (OTCQX:RHHBY) blood cancer drug Gazyvaro (obinutuzumab).
- Ninety percent of commercial health plans require pre-approval of specialty drugs, up from 82% in 2011.
- Previously: Roche's Gazyvaro not NICE in the UK
- Previously: Global drug tab will breach trillion dollar mark this year
- ETFs: IBB, BIB, IRY, BIS, IXJ, DRGS
- Related tickers: (NYSE:NVS) (NYSE:AZN) (NASDAQ:AMGN) (NASDAQ:BIIB) (NASDAQ:CELG) (NYSE:LLY) (NYSE:SNY) (NYSE:ABT) (NYSE:ABBV) (NYSE:BMY) (NYSE:MRK) (NYSE:GSK)
Mon, Nov. 24, 9:29 AM
- Bristol-Myers Squibb (NYSE:BMY) and Five Prime Therapeutics (NASDAQ:FPRX) enter into an exclusive clinical collaboration agreement to evaluate the immunotherapy combination of BMY's investigational PD-1 inhibitor Opdivo (nivolumab) and Five Prime's monoclonal antibody, FPA008, that inhibits colony stimulating factor-1 receptor (CSF1R) as a potential treatment for various cancers.
- The initial Phase 1a/1b study will assess the combination in non-small cell lung cancer, melanoma, head and neck cancer, pancreatic cancer, colorectal cancer and malignant glioma.
- Opdivo is currently approved in Japan for the treatment of patients with unresectable melanoma.
- Under the terms of the agreement, BMY will make a one-time payment of $30M to FPRX and will be responsible to study costs. FPRX will conduct the clinical trial, which should commence in 2015.The contract provides for exclusivity with respect to the development, with a collaboration partner, of combination regimens of anti-PD-1/PDL1 antagonists together with an anti-CSF1R antagonist. BMY has a time-limited right of first refusal subject to certain conditions if FPRX wishes to seek a partner for FPA008.
- Previously: Bristo-Myers plans a Q3 BLA submission for Opdivo
- Previously: EMA accepts Opdivo MAA
- Previously: Bristol-Myers' Opdivo delivers in Phase 2 NSCLC trial
Fri, Nov. 21, 8:48 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion supporting approval of AbbVie's (NYSE:ABBV) Viekirax (a combination of ombitasvir, paritaprevir and ritonavir) plus Exviera (dasabuvir), with or without ribavirin, for patients with chronic HCV genotype 1 infection and Viekirax only, with ribavirin, for patients with HCV genotype 4 infection. A final decision by the European Commission usually takes about 60 days.
- The FDA tagged Viekirax a Breakthrough Therapy and granted priority review of AbbVie's NDA in June.
- Related tickers: (NASDAQ:ENTA) (NASDAQ:GILD) (NYSE:MRK) (NYSE:BMY) (NASDAQ:RGLS) (NASDAQ:CNAT) (NASDAQ:ACHN)
- Previously: Enanta declines HCV drug co-development option with AbbVie
- Previously: AbbVie presents HCV/HIV and liver transplant HCV data
Mon, Nov. 17, 9:57 AM
- In the first part of the ANNEXA-A Phase 3 study, andexanet alfa produced a rapid and almost complete reversal (94%) (p<0.0001) compared to placebo of the anticoagulant effect of Eliquis (apixaban) in healthy volunteers ages 50 - 75 as measured by anti-Factor Xa activity. The results will be presented today at the American Heart Association meeting in Chicago.
- Eliquis is indicated for the treatment of blood clots due to nonvalvular atrial fibrillation and venous thromboembolism. Currently, there is no antidote to Eliquis despite the need for a method to reverse its anticoagulation effects in certain clinical situations such as a major bleeding event or emergency surgery.
- In the first part of the study, healthy volunteers were given Eliquis 5 mg daily for four days and then randomized in a 3:1 ratio to andexanet alfa administered as a 400 mg IV bolus or placebo. In the second part, healthy volunteers will be given Eliquis 5 mg twice daily for four days and then randomized in a 3:1 ratio to andexanet alfa administered as a 400 mg IV bolus followed by a continuous infusion on 4 mg/minute for 120 minutes or to placebo.
- Portola Pharmaceuticals (PTLA +0.1%) is collaborating with Pfizer (PFE -1.3%) and Bristol-Myers Squibb (BMY +0.4%) on the product's development.
- Previously: Portola Pharma anticoagulant antidote Phase 3 trial successful
Sun, Nov. 16, 5:08 PM
- FDA says it's evaluating preliminary data from a clinical trial showing that 30-month treatment with dual antiplatelet blood-thinning therapy decreased the risk of heart attacks and clot formation in stents, but there was an increased overall risk of death compared to 12 months of treatment.
- The clinical trial compared 30 months vs. 12 months of treatment with dual antiplatelet therapy consisting of aspirin plus either clopidogrel (Plavix (NYSE:BMY)) or prasugrel (Effient (NYSE:LLY)), following implantation of drug-eluting coronary stents.
- The higher rate of death was largely explained by an increase in deaths from non-cardiovascular causes, primarily cancer and trauma deaths. The increased risk of death with longer treatment was seen in the patients given clopidogrel, but not those given prasugrel.
- Increases in non-cardiovascular death have not been reported in previous clopidogrel trials for other cardiovascular diseases.
- FDA still sees benefits of Plavix and Effient outweighing their potential risks, and recommends doctors "should not change the way they prescribe these drugs at this time."
- Also see: NEJM
Thu, Nov. 13, 11:56 AM
- The FDA's Anesthetic and Analgesic Drug Products Advisory Committee meets on November 24, 25 to discuss the risk of serious neurologic adverse reactions associated with epidural steroid injections (ESI) administered to reduce inflammation for pain management. The committee will also review the efficacy of ESI and the overall risk benefit profile of injecting steroids in the epidural space to treat pain. Regulatory options will also be discussed which could include changes to product labeling.
- Briefing doc
- Related tickers: (MRK +0.7%)(PFE +0.2%)(BMY -1.3%)(NVS +2%)
Tue, Nov. 11, 11:03 AM
- At The Liver Meeting in Boston, Gilead Sciences (GILD +1.1%) presented results from several Phase 2 and Phase 3 trials evaluating Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg) for the treatment of chronic HCV infection in patients with limited or no treatment options, including decompensated cirrhosis, HCV recurrence following liver transplantation and patients refractory to other direct-acting antivirals.
- In a pooled analysis of Phase 2 and Phase 3 open-label studies involving more than 500 HCV-1 patients with compensated cirrhosis who received Harvoni alone or with ribavirin (RBV) for 12 or 24 weeks, 96% achieved SVR12.
- In a Phase 2 open-label study evaluating patients with decompensated cirrhosis and those with HCV recurrence after a liver transplant, 87% of those receiving Harvoni + RBV for 12 weeks achieved SVR12 compared to 89% of the treatment arm receiving a 24-week regimen (subgroup analysis of 108 HCV genotype 1 and 4 patients).
- In another subgroup analysis from the same Phase 2 trial, response rates for patients who developed HCV (genotypes 1 and 4) recurrence following liver transplantation who were treated with Harvoni + RBV were analyzed. SVR12 rates for non-cirrhotic patients were 96% and 98%, respectively, for the 12- and 24-week regimens. For patients with compensated cirrhosis, the SVR12 rate was 96% for both regimens. For patients with decompensated cirrhosis, the SVR12 rate was 81% for both regimens.
- In two studies of HCV patients who failed prior therapy, those receiving Harvoni + RBV for 12 weeks achieved SVR12 rates of 96% and 98%. Those receiving Harvoni alone for 24 weeks (Study GS-US-337-0121) achieved an SVR12 rate of 97%.
- HCV-related tickers: (BMY -0.1%)(MRK +1.4%)(ABBV +0.3%)(JNJ +0.2%)(ACHN -0.6%)(RGLS -2.7%)(CNAT -1.1%)(ENTA -0.4%)
Tue, Nov. 11, 10:07 AM
- At The Liver Meeting in Boston, AbbVie (ABBV -0.1%) presented results from studies in HCV patients co-infected with HIV and liver transplant recipients who received its all-oral, interferon-free investigational treatment combining three antivirals (ombitasvir/ABT-450/ritonavir and dasabuvir)
- SVR12 rates for patients co-infected with HCV/HIV that received the company's investigational treatment plus ribavirin were 93.5% for the 12-week regimen and 90.6% for the 24-week regimen.
- In non-cirrhotic liver transplant recipients with recurrent HCV-1 new to treatment, SVR12 and SVR24 rates were each 97.1%.
- HCV-related tickers: (GILD +0.5%)(MRK +1%)(JNJ -0.1%)(BMY -0.2%)(ENTA +0.2%)(RGLS +0.2%)(CNAT -0.5%)(ACHN -1.7%)
Tue, Nov. 11, 9:37 AM
- At The Liver Meeting in Boston, Merck (NYSE:MRK) presented data from a Phase 2 clinical trial evaluating the combination of the company's investigational NS3/4A inhibitor, grazoprevir, and its investigational NS5A inhibitor, elbasvir, with and without ribavirin, in treatment-naive and treatment-experienced HCV-1 patients. The length of treatment was either eight,12 or 18 weeks.
- SVR12 rates in treatment-naive non-cirrhotic patients were: 8-week regimen with RBV: 80%; 12-week regiment with and without RBV: 93% and 98%.
- SVR12 rates in treatment-naive patients with cirrhosis were: 12-week regimen with and without RBV: 90% and 97%; 18-week regimen with and without RBV: 97% and 94%.
- SVR12 rates for treatment-experienced patients with and without cirrhosis: 12-week regimen with and without RBV: 94% and 91%; 18-week regimen with and without RBV: 100% and 97%.
- SVR12 rates for HCV-1 patients co-infected with HIV: 12-week regimen with and without RBV: 97% and 87%.
- Results from a Phase 3 trial are expected in 1H 2015.
- Previously: Merck triple therapy HCV candidate fails as a four-week regimen
- HCV-related tickers: (GILD +0.4%)(JNJ -0.2%)(BMY -0.1%)(ABBV +0.3%)(ACHN +3%)(ENTA +0.4%)(CNAT)(LGND +0.5%)(RGLS)
Tue, Nov. 11, 9:05 AM
- At The Liver Meeting in Boston, Gilead Sciences (NASDAQ:GILD) presented data from three Phase 2 studies evaluating an all-oral pan-genotypic regimen, Sovaldi (sofosbuvir) + the company's investigational NS5A inhibitor GS-5816, for the treatment of HCV infection. The specific regimens were Sovaldi 400 mg plus GS-5816 25 mg or 100 mg, with and without ribavirin, for eight or 12 weeks.
- The first study, GS-US-342-0109, evaluated Sovaldi + GS5816 with and without ribavirin for 12 weeks in treatment-experienced HCV-1 and HCV-3 patients with and without cirrhosis. SVR12 rates: SOF + GS-5816 100 mg: 100% for GT1 with and without cirrhosis; 100% for GT3 without cirrhosis and 88% for GT3 with cirrhosis. SVR12 rates: SOF + GS-5816 + RBV: 100% for GT1 without cirrhosis and GT3 without cirrhosis; 90% in GT1 with cirrhosis and 96% in GT3 with cirrhosis.
- The second study, ELECTRON 2, evaluated the same regimen as the first study for eight weeks in non-cirrhotic treatment-naive genotype 3 patients. The SVR12 rate inclusive of ribavirin was 100% and 96% for the ribavirin-free approach.
- The third study, GS-US-342-0102, evaluated the same regimen as first study in non-cirrhotic treatment-naive patients. Results from Part A evaluating 12 weeks of treatment were presented at The International Liver Congress in April 2014. The results from Part B, presented this week, evaluated eight weeks of treatment in HCV-1 and HCV-2 patients. SVR12 rates were: G1: 81% and 90% with and without RBV; G2: 88% with and without RBV.
- HCV-related tickers: (NASDAQ:ACHN) (NYSE:BMY) (NYSE:JNJ) (NYSE:ABBV) (NASDAQ:ENTA) (NASDAQ:CNAT) (NASDAQ:LGND) (NASDAQ:RGLS)
Mon, Nov. 10, 7:49 AM
- At The Liver Meeting in Boston, Merck (NYSE:MRK) presented interim data on its triple-therapy regimen for HCV-1 infection. The investigational product combines the company's NS3/4A protease inhibitor, grazoprevir and its NS5A inhibitor, elbasvir, with Sovaldi (sofosbuvir).
- SVR4/8 for the 8-week regimen in treatment-naive cirrhotic patients was 94.7% (18 of 19). SVR4/8 values for other treatment groups, however, appear low. For the six-week regimen in treatment-naive cirrhotic patients, SVR4/8 was only 80% (16 of 20) with four relapses. For treatment-naive non-cirrhotic patients, the six-week regimen SVR4/8 was 86.7% (26/30) with four relapses while the four-week regimen failed to come anywhere close to efficacy at 38.7% (12/31) with 19 relapses.
- Of the 28 total relapses, 25 were genotype 1a and three were genotype 1b.
- The company plans to initiate Phase 2 clinical trials to assess the safety and efficacy of two short-duration triple therapy regimens: MK-3682 in combination with grazoprevir/elbasvir and MK-3682 in combination with grazoprevir and MK-8408 in non-cirrhotic HCV patients. MK-3682 is an investigational oral prodrug HCV nucleotide analogue NS5B polymerase inhibitor. MK-8408 is an investigational early-stage NS5A inhibitor.
- HCV-related tickers: (NASDAQ:GILD) (NYSE:BMY) (NYSE:JNJ) (NYSE:ABBV) (NASDAQ:ENTA) (NASDAQ:CNAT) (NASDAQ:LGND) (NASDAQ:RGLS)
Sun, Nov. 9, 6:04 PM
- At The Liver Meeting in Boston this week, Bristol-Myers Squibb (NYSE:BMY) presented data from its Phase 3 UNITY program investigating a 12-week all-oral TRIO regimen of daclatasvir (DCV) with asunaprevir and beclabuvir for the treatment of HCV-1 infection.
- In the UNITY-1 trial, a 12-week regimen of DCV-TRIO without ribavirin was evaluated in treatment-naive and treatment-experienced non-cirrhotic HCV patients. SVR12 was 91% overall, 92% for the treatment-naive group and 89% for the treatment-experienced group.
- In UNITY-2, a 12-week regimen of DCV-TRIO was evaluated in cirrhotic patients. SVR12 was 98% in the treatment-naive group and 93% in the treatment-experienced group with ribavirin and 93% and 87%, respectively, without ribavirin.
- In October, the company announced it would not pursue FDA approval for the dual regimen of asunaprevir and daclatasvir for the treatment of HCV-1b infection.
- HCV-related tickers: (NYSE:MRK) (NASDAQ:GILD) (NYSE:ABBV) (NASDAQ:ENTA) (NYSE:JNJ) (NASDAQ:CNAT) (NASDAQ:LGND) (NASDAQ:RGLS)
Sun, Nov. 9, 5:37 PM
- At The Liver Meeting in Boston this week, Bristol-Myers Squibb (NYSE:BMY) presented data from its ALLY Phase 3 clinical trial investigating a 12-week ribavirin-free regimen of daclatasvir in combination with Sovaldi (sofosbuvir) in HCV genotype 3 patients, a population that has emerged as one of the most difficult to treat. The SVR12 in treatment-naive patients was 90% and 86% in treatment-experienced patients. SVR12, sustained viral response 12 weeks after the completion of therapy, is considered cured.
- The results compare favorably with SVR12 in 89% of patients with HCV-1,2 and 3 in an open-label randomized study of a 24-week regimen of the two drugs.
- HCV-related tickers: (NYSE:MRK) (NASDAQ:GILD) (NYSE:ABBV) (NASDAQ:ENTA) (NYSE:JNJ) (NASDAQ:CNAT) (NASDAQ:LGND) (NASDAQ:RGLS)
Sun, Nov. 9, 5:06 PM
- At this week's Annual Meeting for the Study of Liver Diseases in Boston, Achillion Pharmaceuticals (NASDAQ:ACHN) gave poster presentations on two of its HCV product candidates.
- In a Phase 2 pilot study evaluating eight-week treatment of its NS5A inhibitor, ACH-3102, in combination with Sovaldi (sofosbuvir) in treatment-naive HCV genotype 1 patients, the interferon-free, ribavirin-free regimen demonstrated 100% SVR12 in 12 patients. SVR12 or sustained viral response 12 weeks after the completion of therapy, is considered cured. Sovaldi's SVR12 (in combination with peg-interferon alfa and ribavirin) is 90% for HCV-1. Harvoni's (sofosbuvir + ledipasvir) is 94 - 99%.
- The company presented three posters on preclinical results for its uridine analog prodrug, ACH-3422. The data showed improved potency against HCV-3 compared to sofosbuvir. The combination of ACH-3422 with ACH-3102 or sovaprevir (Achillion's Phase 2 NS3/4A inhibitor) displayed additive synergistic activity in vitro. Also, ACH-3422, in combination with other direct-acting antiviral agents, demonstrated the ability to block the appearance of resistant colonies in vitro.
- According to recent research, the global prevalence of HCV genotypes is: type 1: 46%; type 2: 13%; type 3: 22% and type 4: 13%.
- HCV-related tickers: (NASDAQ:GILD) (NYSE:ABBV) (NYSE:JNJ) (NYSE:BMY) (NASDAQ:RGLS) (NASDAQ:ENTA) (NYSE:MRK) (NASDAQ:LGND) (NASDAQ:CNAT)
Wed, Nov. 5, 10:34 AM
- Bristol-Myers Squibb's (BMY -0.3%) PD-1 immune checkpoint inhibitor, Opdivo (nivolumab), demonstrates positive results administered as a single agent in a Phase 2 open-label study in patients with non-small cell lung cancer (NSCLC) who had progressed after at least two prior systemic treatments.
- With a minimum follow up of 11 months, the objective response rate (ORR), the primary endpoint, was 15% as determined by an independent review committee using RECIST 1.1 criteria. The median duration of response was not reached.
- The estimated one-year survival rate was 41% versus the historical range of 5.5 - 18%. The median overall survival was 8.2 months.
- The FDA designated Opdivo Fast Track for NSCLC, melanoma and renal cell carcinoma in 2013. The company began a rolling submission with the FDA for the NSCLC indication in April 2014. It expects to complete the filing by year end.
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