Bristol-Myers Squibb CompanyNYSE
Yesterday, 10:20 AM
- Nano cap Heat Biologics (HTBX -55.7%) gets slammed on double normal volume in response to its announcement that lead product candidate HS-410 (vesigenurtacel-L) failed to beat placebo in a Phase 2 study in non-muscle invasive bladder cancer. The data were presented at the Society of Urologic Oncology Annual Meeting in San Antonio, TX.
- The company says HS-410 generated a robust antigen-specific immune response to multiple tumor-associated peptides (compared to zero for placebo) but the responses did not translate into clinical outcomes. There was no statistically significant difference in the primary endpoint (proportion of recurrence-free survival at year 1) between the treatment and placebo arms.
- CEO Jeff Wolf says, "We are actively pursuing new programs to complement our existing platforms, which we expect to announce in early 2017. Moreover, we look forward to examining the additional top-line data that will be reported next week for our combination trial of HS-110 with Bristol-Myers Squibb's (BMY -1.1%) Opdivo (nivolumab) in lung cancer."
- HS-410, based on the company's proprietary ImPACTimmunotherapy platform, is designed to generate certain immune cells, CD8+ killer T cells, that attack cancer cells.
Mon, Nov. 28, 7:59 AM
- Mylan N.V. (NASDAQ:MYL) signs an agreement with United Nations-backed Medicines Patent Pool that enables it to produce and market a generic version of Bristol-Myers Squibb's (NYSE:BMY) hepatitis C med DAKLINZA (daclatasvir) in 112 low to middle income countries. The license allows Mylan to develop fixed-dose combinations for all six major genotypes of HCV.
- DAKLINZA, in combination with sofosbuvir, with or without ribavirin, is approved in the U.S. for the treatment of HCV genotypes 1 and 3 and in Europe for HCV genotypes 1,3 and 4.
Tue, Nov. 22, 3:31 PM
- As expected, the European Commission approves the use of Bristol-Myers Squibb's (BMY -0.7%) Opdivo (nivolumab) for the treatment of adult patients with relapsed/refractory classical Hodgkin lymphoma after autologous stem cell transplant and treatment with Seattle Genetics' (SGEN -4.1%) ADCETRIS (brentuximab vedotin).
- Advisory committee CHMP adopted a positive opinion backing approval in October.
Tue, Nov. 22, 10:35 AM
- uniQure (QURE -3.2%) Q3 results (€M): Total Revenues: 6.5 (+105.3); Product Sales: 0.3.
- Net Loss: (13.5) (+47.7%); Loss per Share: (1.08) (+100.0%); CF Ops (9 mo.): (51.2) (-279.6%); Quick Assets: 140.3 (-31.1%).
- Pursuant to its just-completed strategic review, the company will focus its development programs in hemophilia B, Huntington's disease and, in collaboration with Bristol-Myers Squibb (BMY +0.1%), in cardiovascular disease.
Tue, Nov. 22, 8:44 AM
- QuintilesIMS (NYSE:Q): will lead a collaborative initiative involving Bristol-Myers Squibb (NYSE:BMY), Eli Lilly (NYSE:LLY), Merck KGaA (OTCPK:MKGAF)(OTCPK:MKGAY) and Pfizer (NYSE:PFE) with the goal of providing clearer and more proactive insight into how anti-cancer treatments are used in actual practice across key European markets. Specifically, the initiative aims to bridge the information gaps and inconsistencies in knowledge related to how oncology products are used, for which types of patients and indications and in what sequences and combinations. The ultimate goal is to improve the quality of care for cancer patients and improve outcomes.
- Financial details are not disclosed.
Mon, Nov. 21, 11:40 AM
- Rosetta Genomics (ROSG +1.4%) enters into a research agreement with Sheba Medical Center in Tel Aviv, Israel to develop a microRNA-based signature to predict response to Bristol-Myers Squibb's (BMY -0.5%) Opdivo (nivolumab).
- The company plans to use its proprietary microarray design and qRT-PCR platform to identify miRNAs associated with response. The primary endpoint of the study is prediction of Objective Response Rate as measured by tumor radiologic response. The secondary endpoint is to predict survival benefit (overall survival) in patients with advanced non-small cell lung cancer treated with nivolumab.
Thu, Nov. 17, 12:11 PM
- Prompted by political pressure related to its over-stretched healthcare budget, Japanese authorities have cut the price of Bristol-Myers Squibb's (BMY +1.3%) blockbuster cancer med Opdivo by 50% more than a year ahead of its regularly scheduled once-every-other year price review. The annual cost per patient will be ~$160K compared to the current cost of $320K.
- The in-country price was bullish to begin with, running twice as much as the U.S. and five times more than the UK.
- Distributor Ono Pharmaceutical (OTC:OPHLF)(OTCPK:OPHLY) is down 2% on the news since Opdivo accounts for $1.2B in annual sales in Japan.
Thu, Nov. 17, 6:59 AM
- Britain's advisor to its National Health Service (NHS), the National Institute for Health and Care Excellence (NICE) continues its success with corralling prices from drug makers. Roche (OTCQX:RHHBY) and Bristol-Myers Squibb (NYSE:BMY) are the latest to extend discounts for access to the NHS.
- Roche cut the price to breast cancer drug Perjeta earlier this year as did BMY with leukemia med Sprycel.
- Novartis (NYSE:NVS) and Pfizer (NYSE:PFE) have also offered increased discounts of late. The specific amounts are confidential, however.
Wed, Nov. 16, 7:18 AM
- Bristol-Myers Squibb (NYSE:BMY) and Paris, France-based Enterome SA ink a collaboration agreement to discover and develop microbiome-derived biomarkers, drug targets and bioactive molecules as potential companion diagnostics and therapeutics for cancer. The partnership will also attempt to identify microbiome-derived biomarkers to improve clinical outcomes for patients treated with BMY's immuno-oncology products.
- The collaboration will leverage BMY's know-how in the discovery and development of immunotherapies with Enterome's proprietary metagenomic technology platform and leadership in the science of the gut microbiome.
- Under the terms of the deal, Enterome will receive an upfront payment of $15M for R&D funding and access to its technology, milestones for each licensed therapeutic candidate and royalties on net sales. It is also eligible for milestones related to new diagnostic products. BMY will have exclusive rights to the intellectual property and therapeutics generated under the collaboration.
Tue, Nov. 15, 8:27 AM
- With the aim of improving its execution to stoke shareholder value, uniQure (NASDAQ:QURE) refocuses its pipeline and consolidates manufacturing.
- It will prioritize its development programs on hemophilia B, Huntington's disease and those under its collaboration with Bristol-Myers Squibb (NYSE:BMY) in cardiovascular disease.
- It will restructure its R&D group in the Netherlands and consolidate its manufacturing in the U.S at its Lexington, MA facility. The company has also initiated discussions with collaborators about backing away from licensing deals for AMT-110 for the treatment of Sanfilippo B, but will pursue partnering opportunities for its academic-sponsored Parkinson's disease program.
- The company expects to save €5M - 6M in annual operating expenses by cutting 50 - 60 positions (20 - 25% of its headcount) by the end of next year. It expects to save another €11M - 15M over the next two years by refocusing its pipeline. Management believes that its current cash resources will be sufficient to fund operations into 2019.
- Deya Corzo, M.D., SVP of the liver and metabolic area and Charles Richard, M.D., Ph.D, SVP of the central nervous area will leave the company by year end.
Sat, Nov. 12, 4:29 PM
- An early-stage trial combining drugs from Bristol-Myers (NYSE:BMY) and Innate Pharma (OTC:INNTY, OTCPK:INNMF), showed promise in treating patients with advanced head and neck cancer.
- A trial looked at 29 patients whose cancer had returned after previous treatment, and also at a 17-person subset whose tumors have a marker that’s thought to predict response to Bristol-Myers’s drug, Opdivo. Innate’s drug is known as lirilumab; both are designed to help the immune system attack tumors.
- In the 17 patients in whom at least 1% of their cancer cells expressed the PD-L1 biomarker, 41% had their tumors shrink. Among the wider group, 24% of patients saw their tumors shrink.
- An earlier study of Opdivo alone in a similar group of patients showed that 13% of people with advanced head and neck cancer saw their tumors shrink.
- On Thursday, the FDA approved Opdivo for the treatment of recurrent or metastatic squamous cell head and neck cancer in patients who had been treated previously with chemotherapy.
- Source: press release
Thu, Nov. 10, 8:15 AM
- Bristol-Myers Squibb (NYSE:BMY) inks a worldwide licensing agreement with Osaka, Japan-based Nitto Denko (OTCPK:NDEKF)(OTCPK:NDEKY) for the development and commercialization of Nitto's siRNA molecules targeting heat shock protein 47 (HSP47) formulations containing vitamin A. The deal includes Nitto's lead product candidate, Phase 1b-stage ND-L02-s0201, for the treatment of advanced liver fibrosis and grants BMY the option for secure exclusive licenses for HSP47 sirRNAs in vitamin A formulations for the treatment of lung fibrosis and other organ fibrosis.
- Under the terms of the agreement, Nitto will receive an upfront payment of $100M, milestones, sales-based royalties and option exercise payments for lung and other organ fibrosis. BMY will be responsible for the development, manufacture and commercialization of HSP47 sirRNAs in vitamin A formulations for all liver diseases.
- Fibrotic diseases are characterized by inflammation and subsequent formation of excess collagen (scarring) in the organ or tissue. Nitto's ND-L02-s0201 is a targeted siRNA designed to inhibit HSP47, a collagen-specific chaperone that regulates collagen synthesis and secretion, and prevent further collagen formation while resolving existing fibrosis. It has Fast Track status in the U.S. for the treatment of liver fibrosis and cirrhosis secondary to NASH and liver fibrosis and cirrhosis secondary to HCV infection.
Thu, Nov. 10, 7:52 AM
- A Phase 3 clinical trial, ONO-4538-12, assessing Bristol-Myers Squibb's (NYSE:BMY) Opdivo (nivolumab) for the treatment of patients with unresectable advanced or recurrent gastric cancer resistant to standard therapy met its primary endpoint of overall survival (OS). The company says this is the first immuno-oncology agent to show such a benefit in these patients.
- Bristol-Myers and development partner Ono Pharmaceutical Co. Ltd. are working with investigators on the future presentation of the results.
- Opdivo is currently approved for the treatment of non-small cell lung cancer, melanoma, kidney cancer and classical Hodgkin lymphoma. It is BMY's fastest growing product and is poised to overtake top-selling Eliquis in the near future. Over the past four quarters, Opdivo's sales were $2.929B compared to $2.997B for Eliquis.
Wed, Nov. 9, 8:08 AM
- Biotechs and Big Pharma look like they will jump out of the blocks this morning. Most leading names are up premarket.
- Sampling: (NASDAQ:AMGN) +4%; (NASDAQ:GILD) +2%; (NASDAQ:REGN) +3%; (NASDAQ:BIIB) +4%; (NASDAQ:VRTX) +2%; (NASDAQ:CELG) +3%; (NYSE:BMY) +2%; (NYSE:PFE) +5%; (NYSE:MRK) +2%; (NYSE:AZN) +1%; (NYSE:GSK) +1%; (NYSE:JNJ) +2%; (NYSE:ABBV) +4%; (NYSE:LLY) +3%; (NYSE:NVS) +3%; (NYSE:AGN) +4%; (NASDAQ:TEVA): +6%
Wed, Nov. 9, 7:26 AM
- Bristol-Myers Squibb (NYSE:BMY) and Infinity Pharmaceuticals (NASDAQ:INFI) will collaborate in a clinical program assessing the combination of Opdivo (nivolumab) and Infinity's IPI-549 in patients with advanced solid tumors. The dose escalation phase exploring the combination should begin shortly.
- IPI-549 is an orally available inhibitor of phosphoinositide-3-kinase (PI3K)-gamma. Opdivo is an programmed death receptor-1 (PD-1) immune checkpoint inhibitor that activates the immune system's T cells to detect and attack cancer cells.
- Preclinical data suggest that IPI-549 may enhance the effects of immune checkpoint inhibitors by altering the immune-suppressive microenvironment.
- A Phase 1 dose-escalation study assessing IPI-549 as monotherapy and in combination with Merck's (NYSE:MRK) Keytruda (pembrolizumab) is currently recruiting participants.
Wed, Nov. 9, 3:03 AM
- Healthcare stocks, the weakest sector this year, may become winners, as Obamacare reforms are set to be "repealed and replaced" and major legislation Clinton proposed is unlikely to be imposed on drugmakers.
- While Trump hasn't set out a comprehensive alternative to the Affordable Care Act (which may see 22M Americans lose current coverage), he said he'll encourage competition between markets in different states.
- Insurance stocks: UNH, AET, ANTM, CI, HUM, WCG, CNC, MOH, GTS, HQY
- Drugmakers premarket: MYL +5.8%, NVS +3.4%, SNY +2.9%, AZN +2.4%, GSK +1.9%, PFE +1.8%, CELG +1%, ABBV, MRK, BMY, LLY, JNJ, ABT, ACET, ZTS, BIIB, REGN