Bristol Myers Squibb (BMY) has announced that Opdivo (nivolumab) plus Yervoy (ipilimumab) demonstrated a significant improvement in overall survival (OS) in patients with previously untreated, unresectable malignant pleural mesothelioma (MPM). This is a rare but aggressive form of cancer that forms in the lining of the lungs, and is frequently caused by asbestos exposure.With a minimum follow-up of 22 months, treatment with Opdivo plus Yervoy reduced the risk of death by 26%, demonstrating a median OS of 18.1 months vs. 14.1 months for chemotherapy. At two years, 41% of patients treated with the Opdivo plus Yervoy combination were alive, compared to 27% of patients treated with chemotherapy.The safety profile of Opdivo plus Yervoy in the Phase 3 CheckMate -743 clinical trial was consistent with previously reported studies, and no new safety signals were observed.The primary endpoint of the randomized Phase 3 trial, which involved 605 patients, was OS in all randomized patients. Key secondary endpoints included objective response rate (ORR), disease control rate (DCR) and progression-free survival (PFS).“An aggressive cancer with a five-year survival rate of less than 10%, malignant pleural mesothelioma has shown resistance to many clinical treatments,” said Paul Baas, M.D., Ph.D., Department of Thoracic Oncology, Netherlands Cancer Institute.“Now, for the first time, we have evidence that a dual immunotherapy combination showed a superior, sustained overall survival benefit compared to chemotherapy in the first-line treatment of all types of malignant pleural mesothelioma” he stated, adding that the data supports the potential for nivolumab plus ipilimumab to become a new standard of care.Indeed, in CheckMate -743, Opdivo plus Yervoy showed improvements in survival across both non-epithelioid and epithelioid MPM, with a larger magnitude of benefit observed in the non-epithelioid subgroup. This is striking because non-epithelioid patients generally experience poorer outcomes.With the dual immunotherapy combination, median OS was 18.7 months for epithelioid patients and 18.1 months for non-epithelioid patients, compared to 16.5 months and 8.8 months, respectively, with chemotherapy.Opdivo plus Yervoy is a combination of two immune checkpoint inhibitors, targeting two different checkpoints to help destroy tumor cells: Yervoy helps activate and proliferate T cells, while Opdivo helps existing T cells discover the tumor.Shares in BMY are down 5% year-to-date, but the stock scores a bullish Strong Buy consensus from the Street. That’s with an average analyst price target of $69 (13% upside potential).On August 6 JP Morgan’s Chris Schott reiterated his buy rating on the stock, writing 2Q sales were negatively impacted due to unwinding of COVID-19-related stocking in 1Q, reduced new patient starts, and fewer patient visits to physicians.However the analyst noted that management expects an accelerated resumption of clinical trials in 2H20. “We found the commentary to be comparable to other large-cap biopharma companies this earnings season” Schott wrote. He has a $74 price target on BMY for upside potential of 21%.(See BMY stock analysis on TipRanks).Related News: Amarin’s Vascepa To Take Part In Covid-19 Study In Adults With Heart Disease Moderna Secures $400M In Deposits For Supply Of Covid-19 Vaccine Candidate Eli Lilly, Innovent Deliver Encouraging Lung Cancer Data For Sintilimab More recent articles from Smarter Analyst: * AstraZeneca Strikes First China Manufacturing Deal For Covid-19 Candidate * Regeneron Prices $1.25B Public Offering; Analyst Cautious On Valuation * Cisco Completes ThousandEyes Deal; Analyst Warns Of Growth Headwinds * Roper Looking To Snap Up Vertafore For $5.5 Billion- Report
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First Majestic Silver (AG) has now executed a definitive option agreement granting Silver Dollar Resources a potential 100% interest in First Majestic’s La Joya silver-copper-gold property.Located in the south-eastern portion of the State of Durango in the Mexican Silver Belt, La Joya consists of 15 mineral concessions totalling 4,646 hectares and hosts the Main Mineralized Trend (MMT), Santo Nino and Coloradito deposits.Silver Dollar now has an exclusive option to acquire an initial 80% interest in the property, and if exercised, a second option to acquire an additional 20% interest.For the 80% interest, Silver Dollar will pay First Majestic a total of $1.3M plus annual holding costs for the property and will issue 19.9% of its shares to First Majestic, as well as incurring exploration expenditure of $1M on the project in the next few years.Within 30 days after exercising its first option, Silver Dollar may exercise its second option and acquire the remaining 20% interest by issuing a further 5% its shares to First Majestic. In addition, First Majestic will reserve a 2% net smelter returns royalty interest in all minerals produced from La Joya.“The signing of the definitive agreement to have an option to acquire the La Joya project is a very important milestone for us,” said Mike Romanik President of Silver Dollar. “We engaged some expert help to assist in our due diligence review of the historical data on the project and the unanimous feedback is that La Joya has incredible exploration and development potential, particularly in light of the significant move in metals prices since we signed the letter of intent.”Shares in First Majestic are trading up 6% year-to-date, and analysts have a cautiously optimistic Moderate Buy consensus on the stock’s outlook. That’s alongside a $13 average analyst price target indicating upside is limited from the current share price.HC Wainwright analyst Heiko Ihle has just ramped up his AG price target from $11.50 to $16.50 after revising his gold and silver price estimates.“We feel macroeconomic improvements related to precious metals are increasingly evident in the market… While we note a variety of potential headwinds to continued strength in pricing, including less fear related to COVID-19, we nonetheless believe that longer-term economic impact from the recent pandemic has paved the way for strong pricing in the future” he explained.As a result the analyst raised his long-term gold price forecast to $1,900/oz from $1,700/oz and his silver price estimate to $25.00/ oz from $18.00/oz.(See AG stock analysis on TipRanks)Related News: Roper Looking To Snap Up Vertafore For $5.5 Billion- Report Barclays Lifts Uber’s PT On Recovery Bet Tilray Plunges 10% As Canadian Cannabis Market Remains Under Pressure More recent articles from Smarter Analyst: * Royal Caribbean Rises In Pre-Market On Higher Demand For 2021 Cruises * Pfenex Pops 59% On Ligand $513M Buy-Out Deal; Analyst Sees 93% Upside * American Airlines Shares Lifted By Air Travel Demand Data * Walmart vs Target: Which Retailer is the Better Buy?
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Gilead Sciences, Inc (NASDAQ: GILD) announced Monday it was seeking complete Food and Drug Administration approval for its drug Remdesivir, which is being used in the treatment of COVID-19.What Happened The drugmaker said it has filed a New Drug Application with the FDA on the basis of two randomized, open-label, multi-center Phase 3 clinical studies conducted by itself, and one other study by Anthony Fauci-led National Institute of Allergy and Infectious Diseases.The company claims the drug led to faster recovery from COVID-19 compared to placebo, and a 5-to-10-day treatment led to clinical improvements. Gilead noted that the drug was well-tolerated with no "new safety signals identified.""Today's filing is an important milestone as we continue to partner with the U.S. government and healthcare authorities around the globe to address the treatment needs of patients with COVID-19," Gilead Chief Medical Officer Merdad Parsey said.Why It Matters Remdesivir has received regulatory approvals in the European Union and Japan, according to Gilead. The drug is approved for emergency use in COVID-19 patients in the United States by the FDA.In July, the drugmaker provided additional data on the efficacy of Remdesivir, which associated the drug with an improvement in clinical recovery, and a 62% reduction in risk of mortality compared with standard of care.Pfizer Inc (NYSE: PFE) announced a multiyear agreement with Gilead this month to manufacture and supply Remdesivir, in order to combat the coronavirus crisis.Raymond James analyst Steven Seedhouse expressed a lack of confidence in Remdesivir, citing 2020 revenue guidance, which is upwards of $3 billion, and is predicated on the company selling 1 to 1.5 million courses at $2500 per course. The analyst said the company is uniquely tied to COVID-19.Price Action Gilead shares closed nearly 1.2% lower at $68.51 on Monday.See more from Benzinga * Inovio Coronavirus Vaccine To Enter Mid-To-Late Stage Testing In September * Facebook Forms New Group To Rationalize Payments Across Apps * Uber, Lyft Must Classify Drivers As Employees, In Compliance With California Law, Judge Rules(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.