Nov. 23, 2015, 3:28 PM
- The FDA accepted Bristol-Myers Squibb's (BMY +0.5%) application for priority review one week ago, and today announces its approval.
- Previously: FDA accepts for review Bristol-Myers' sBLA for Opdivo in advanced kidney cancer (Nov. 16)
Nov. 23, 2015, 11:09 AM
- The FDA approves privately held Boehringer Ingelheim's anticoagulant Pradaxa (dubigatran etexilate mesylate) for the prevention of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have undergone hip replacement surgery. Without preventive anticoagulant therapy, as many as 60% of hip replacement patients would be at risk for blood clots.
- The FDA initially cleared Pradaxa in 2010 to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. In 2014, it approved the indications of DVT and PE in patients who have been treated with a parenteral anticoagulant for up to 10 days and to reduce the risk of recurrent DVT and PE in patients who have been previously treated.
- Related tickers: (BMY +0.2%)(JNJ +0.4%)
Nov. 23, 2015, 10:33 AM
- Bristol-Myers Squibb (BMY +0.3%) licenses HCV med daclatasvir to The Medicines Patent Pool (MPP), a United Nations-backed public health organization that aims to increase access to HIV and HCV medicines in developing countries. The royalty-free license will enable the generic manufacture of daclatasvir for sale in 112 low- and middle-income countries, home to almost 67% of all HCV-positive people. Manufacturers can be based anywhere in the world as long as the products are sold only in the specified countries.
- MPP and the company have a history. In December 2013, they negotiated a license for HIV med atazanavir.
Nov. 16, 2015, 5:41 PM
- The FDA accepts for review the supplemental Biologics License Application (sBLA) from Bristol-Myers Squibb (NYSE:BMY) seeking clearance for the use of Opdivo (nivolumab) in patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy. The PDUFA date for the Breakthrough Therapy-tagged indication is March 16.
- The data supporting the application was generated in a Phase 3 study called CheckMate-025 which showed a significant increase in overall survival in this patient population compared to standard-of-care therapy. The trial was stopped early (in July) after the independent Data Monitoring Committee determined that the study met its primary endpoint of overall survival.
- The company's application in Europe, called a type II variation, is currently under review.
- Opdivo is currently cleared in the U.S. for the treatment of certain types of melanoma and lung cancer.
- Previously: Bristol-Myers' Opdivo a Breakthrough Therapy for advanced kidney cancer (Sept. 16)
Nov. 16, 2015, 11:21 AM
- Results from a Phase 3 clinical trial, ALLY-3+, evaluating the combination of Bristol-Myers Squibb's (BMY +0.3%) Daklinza (daclatasvir), Gilead's (GILD -0.5%) Sovaldi (sofosbuvir) and ribavirin (RBV) in HCV-3 patients with advanced fibrosis or cirrhosis show cure rates as high as 100% after 12 - 16 weeks. The data will be presented today at The Liver Meeting in San Francisco.
- 100% of the patients in the advanced fibrosis cohort achieved SVR12 in both the 12- and 16-week arms. In the cirrhosis cohort, the cure rates in the 12- and 16-week arms were 83% and 89%, respectively.
- Daklinza, approved by the FDA in July, is an NS5A inhibitor indicated for the treatment of HCV-3-positive adults (in combination with Sovaldi).
Nov. 16, 2015, 10:07 AM
- Data from two mid-stage clinical trials, SURVEYOR-I and SURVEYOR-II, show AbbVie's (ABBV +1.3%) investigational HCV regimen, ABT-493 and ABT-530, produced cure rates as high as 100% after 12 weeks of treatment. The results are being presented at The Liver Meeting in San Francisco.
- Results from the two ongoing studies include genotypes 1, 2 and 3. Data from genotypes 4 - 6 will be presented at future meetings.
- SURVEYOR-I is assessing ABT-493 and ABT-530, with and without ribavirin, in cirrhotic and non-cirrhotic adult HCV-1 patients and non-cirrhotic HCV-4,-5 and -6 treatment-naive or treatment-resistant adults. The cure rates range from 97 - 100% in HCV-1.
- SURVEYOR-II is assessing ABT-493 and ABT-530, with and without ribavirin, in cirrhotic and non-cirrhotic adults with HCV-2 or -3 who were new to therapy or had failed earlier treatment with interferon/ribavirin. The cure rates range from 96 - 100% in HCV-2 and 83 - 94% in HCV-3.
- ABT-493, an NS3/4A protease inhibitor, and ABT-530, an NS5A inhibitor, are being developed for the pan-genotypic (genotypes 1-6) treatment of HCV infection. ABT-493 was discovered under the company's collaboration with Enanta Pharmaceuticals (ENTA -1.2%). A Phase 3 trial in genotypes 1-6 was initiated this month.
- Related tickers: (MRK +0.4%)(GILD +0.1%)(BMY +0.2%)(JNJ +0.8%)
Nov. 5, 2015, 11:34 AM
- The European Medicines Agency (EMA) validates Bristol-Myers Squibb's (BMY +0.1%) type II variation application seeking approval for the use of Opdivo (nivolumab) for the treatment of adults with advanced renal cell carcinoma (RCC) after prior therapy. Validation confirms that the application is complete and the review process is underway.
- The application for Opdivo's expanded label is based on data from the Phase 3 Checkmate-025 study which showed superior overall survival in patients with metastatic kidney cancer compared to Novartis' (NVS +0.4%) Afinitor (everolimus).
- The European Commission approved Opdivo for the treatment of advanced melanoma in June.
- Previously: Late-stage kidney cancer study comparing Bristol-Myers' Opdivo and Novartis' Afinitor stopped early after Opdivo shows superior overall survival (July 20)
- Previously: Bristol-Myers' Opdivo cleared in Europe (June 19)
Nov. 4, 2015, 12:48 PM
- Johnson & Johnson (JNJ) acquires privately held Novira Therapeutics, a clinical stage biopharmaceutical firm developing therapies to cure chronic hepatitis B infection within one year of treatment, for an undisclosed sum. The transaction should close this quarter.
- Novira's lead product candidate is NVR 3-778, a orally available, small molecule, direct-acting antiviral that inhibits the HBV core or capsid protein. HBV core is an attractive drug target since it is plays a key role in viral replication and survival. NVR 3-778 disrupts the HBV life cycle by inducing the assembly of defective capsids. According to the company, its inhibitors, when used in combination with current standard-of-care drugs (nucleosides and interferon), should deliver greater and faster suppression of viral DNA and new virus production.
- Selected HBV-related tickers: (ARWR +2.1%)(GILD -1%)(CTRV -3.2%)(ABUS +2.6%)(DVAX -1.8%)(MRK +0.7%)(SNY -0.8%)(GSK +0.1%)(ISIS +2.1%)(ALNY +3.1%)(BMY -0.6%)
Nov. 2, 2015, 7:50 AM
- Bristol-Myers Squibb (NYSE:BMY) acquires privately held Cardioxyl Pharmaceuticals for up to $2.08B. The Chapel Hill, NC-based firm develops nitroxyl therapeutics for the treatment of cardiovascular disease. Its lead product candidate is the second generation nitroxyl donor (prodrug) CXL-1427, currently in Phase 2 development for the treatment of acute decompensated heart failure. CXL-1427, administered as an IV infusion, releases nitroxyl, a molecule that has shown beneficial effects on heart muscle and vascular function.
- Under the terms of the transaction, Cardioxyl will receive upfront and near-term payments of up to $300M and up to $1.775B in development, regulatory and sales milestones. The deal will be dilutive to BMY's 2015 GAAP EPS by ~$0.12 per share, but minimally dilutive to non-GAAP earnings. The deal should close this quarter.
Oct. 28, 2015, 5:16 PM
- The FDA approves the use of Bristol-Myers Squibb's (NYSE:BMY) Yervoy (ipilimumab) for the adjuvant treatment of patients with stage 3 melanoma, an advanced phase of the disease where the cancer has reached one or more lymph nodes.
- Yervoy was originally cleared for the treatment of late-stage (stage 4) melanoma. It is one of the company's top sellers, generating over $1.2B in annual sales.
- Previously: FDA decision expected today on expanded label for Bristol-Myers' Yervoy (Oct. 28)
Oct. 28, 2015, 9:50 AM
- Today is the PDUFA date for the FDA's review of Bristol-Myers Squibb's (BMY +0.1%) supplemental Biologics License Application (sBLA) seeking clearance for the use of Yervoy (ipilimumab) for the treatment of patients with stage 3 melanoma, an advanced stage of the disease, but not as advanced as stage 4. The FDA approved Yervoy on March 25, 2011 for the treatment of late-stage (4) melanoma.
Oct. 27, 2015, 9:13 AM
- Bristol-Myers Squibb (NYSE:BMY) Q3 results ($M): Total Revenues: 4,069 (+3.8%); Alliance & Other: 517 (-52.0%).
- Net Income: 706 (-2.1%); EPS: 0.42 (-2.3%).
- Key Product Sales: Orencia: 484 (+9.0%); Eliquis: 466 (+115.7%); Sprycel: 411 (+6.8%); Hep C Franchise: 402 (down 16% from Q2); Sustiva Franchise: 333 (-6.7%); Baraclude: 320 (-1.5%).
- 2015 Guidance: Total Revenues: $16.0B - 16.4B from $15.5B - 15.9B; EPS: $1.02 - 1.07 from $1.02 - 1.12; Non-GAAP EPS: $1.85 - 1.90 from $1.70 - 1.80.
Oct. 27, 2015, 7:01 AM
- Bristol-Myers Squibb (NYSE:BMY): Q3 EPS of $0.39 beats by $0.04.
- Revenue of $4.07B (+3.8% Y/Y) beats by $210M.
Oct. 26, 2015, 5:30 PM
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Oct. 26, 2015, 4:05 PM
- Bristol-Myers Squibb (NYSE:BMY) will report Q3 results tomorrow before the open. Consensus view is EPS of $0.35 (-22.2%) on revenues of $3.86B (-1.5%).
Oct. 23, 2015, 11:38 AM
- Results from a three-part Phase 2a proof-of-concept study assessing Bristol-Myers Squibb's (BMY +1.8%) second-generation HIV maturation inhibitor, BMS-955176, demonstrated encouraging antiviral activity and a favorable safety profile. The data were presented at the 15th European AIDS Conference in Barcelona.
- BMS-955176 is designed to inhibit one of the last steps of the HIV-1 viral life cycle when the virus breaks connections between structural proteins, which then undergo changes that produce fully mature infectious virus particles. This late-state disruption, which results in the release of immature HIV-1 particles that are unable to complete their life cycle, is a unique mechanism of action.
- The study results demonstrated BMS-955176's antiviral activity against HIV-1 both as monotherapy and in combination with other antiretrovirals and across patient subtypes (B,C), including those infected with the HIV-1 virus with changes to a key protein (Gag polymorphisms) that enabled it to fend off the effects of a first-generation maturation inhibitor.
- Part A of the randomized trial assessed one of four once-daily doses (5, 10,20, 40 mg) of BMS-955176 as monotherapy or placebo in 40 HIV-1 subtype B patients. 20 additional patients were later randomized to receive 80 mg and 120 mg once daily. All doses showed greater antiviral activity on day 11 than placebo with the 80 and 120 mg doses showing the highest mean knockdown of HIV-1 RNA (~96%).
- Part B assessed BMS-955176 administered with atazanavir (ATV) with or without ritonavir compared to a standard-of-care regimen of atazanavir and ritonavir plus tenofovir disoproxil fumarate/emtricitabine after 28 days of therapy. The median knockdown of HIV-1 RNA of <99% was similar between the 80 mg dose + ATV and the standard-of-care regimen.
- Part C assessed BMS-955176 (40 mg and 120 mg) as monotherapy vs. placebo for 10 days in 19 patients infected with HIV-1 subtype C. On day 11, the median HIV-1 RNA knockdown was highest in the 40 mg arm (~94%).
- The company intends to advance BMS-955176 to Phase 3 development.
- Related tickers: (GILD -1.3%)(MRK +1.3%)(ABBV +4.2%)
Bristol-Myers Squibb Co. is engaged in the discovery, development, licensing, manufacturing, marketing, distribution and sale of biopharmaceutical products. Its pharmaceutical products include chemically-synthesized drugs or small molecules and an increasing portion of products produced from... More
Industry: Drug Manufacturers - Major
Country: United States
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