Latest news with #MOONRAKER
Yahoo
2 days ago
- Business
- Yahoo
Bayer Gets FDA Nod for Label Expansion of Kerendia in Heart Failure
Bayer AG BAYRY announced that the FDA has approved a label expansion of kidney disease drug Kerendia (finerenone). The regulatory body approved finerenone for the treatment of adult patients with heart failure (HF) and a left ventricular ejection fraction (LVEF) of ≥40%. The approval of finerenone by the FDA for this new indication is based on the positive results of the late-stage FINEARTS-HF study, which is part of the ongoing MOONRAKER program — one of the largest phase III clinical trial programs to date in heart failure. Year to date, shares of Bayer have rallied 64.1% compared with the industry's growth of 1.8%. Image Source: Zacks Investment Research Finerenone is a non-steroidal, selective mineralocorticoid receptor (MR) antagonist that has been shown to block harmful effects of MR overactivation. MR overactivation contributes to chronic kidney disease (CKD) progression and cardiovascular damage caused by metabolic, hemodynamic, or inflammatory and fibrotic factors. Finerenone is marketed as Kerendia (Firialta in some countries) and is already approved for the treatment of adult patients with CKD associated with type 2 diabetes (T2D) in more than 95 countries worldwide, including China, Europe, Japan and the United States. With the latest FDA approval, Kerendia is the only non-steroidal MR antagonist approved in the United States for CKD associated with T2D and for HF with LVEF of ≥40%. Please note the FDA granted Priority Review designation to the supplemental new drug application seeking approval for finerenone for the treatment of adult patients with HF with an LVEF of ≥40%. Per estimates, approximately 3.7 million people in the United States live with HF with an LVEF of ≥40%, which accounts for more than 500,000 hospitalizations per year. Data from the FINEARTS-HF study showed that finerenone achieved a statistically significant and clinically meaningful reduction of the composite of cardiovascular death and total (first and recurrent) HF events, defined as hospitalizations for HF or urgent HF visits. These benefits were demonstrated regardless of background therapy, comorbidities, or hospitalization status. Finerenone has also been submitted for marketing authorization in HF with an LVEF of ≥40% in China, the EU and Japan. Bayer's new products, such as Nubeqa and Kerendia, continue to maintain their impressive momentum in the Pharmaceutical division and offset the negative impact of a decline in Xarelto sales. Labels of these key drugs should boost its top-line growth. Last month, the FDA also expanded Nubeqa's label for a third indication for patients with advanced prostate cancer. The successful development of additional drugs is imperative for Bayer amid multiple challenges. BAYRY expects to launch two new drugs — elinzanetant, a hormone-free treatment for menopause symptoms, and acoramidis, a drug for the treatment of a certain type of heart disease. Elinzanetant was recently approved in the UK for the treatment of moderate to severe vasomotor symptoms (VMS or hot flashes) associated with menopause under the brand name Lynkuet. The company also aims to strengthen its pharmaceutical pipeline. In 2021, Bayer acquired clinical-stage biopharmaceutical company Vividion Therapeutics to expand its presence in precision small-molecule therapeutics, primarily in oncology and immunology. BAYRY has expanded its pipeline in new modalities of cell therapy through the acquisition of BlueRock, and in gene therapy, through the AskBio buyout. BAYRY currently carries a Zacks Rank #1 (Strong). A couple of other top-ranked stocks in the large-cap pharma sector are Novartis NVS and Johnson & Johnson JNJ, both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today's Zacks #1 Rank stocks here. The Zacks Consensus Estimate for Novartis' 2025 earnings per share (EPS) has risen from $8.78 to $8.92 over the past 60 days. EPS estimates for 2026 have jumped 20 cents to $9.27 during the said timeframe. The stock has risen 27.3% so far this year. J&J's EPS estimate for 2025 has risen from $10.60 to $10.64 over the past 60 days, while that for 2026 has increased from $10.98 to $11.07 over the same timeframe. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Novartis AG (NVS) : Free Stock Analysis Report Johnson & Johnson (JNJ) : Free Stock Analysis Report Bayer Aktiengesellschaft (BAYRY) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research
Globe and Mail
2 days ago
- Business
- Globe and Mail
Bayer Gets FDA Nod for Label Expansion of Kerendia in Heart Failure
Bayer AG BAYRY announced that the FDA has approved a label expansion of kidney disease drug Kerendia (finerenone). The regulatory body approved finerenone for the treatment of adult patients with heart failure (HF) and a left ventricular ejection fraction (LVEF) of ≥40%. The approval of finerenone by the FDA for this new indication is based on the positive results of the late-stage FINEARTS-HF study, which is part of the ongoing MOONRAKER program — one of the largest phase III clinical trial programs to date in heart failure. Year to date, shares of Bayer have rallied 64.1% compared with the industry 's growth of 1.8%. More on Bayer's Kerendia Finerenone is a non-steroidal, selective mineralocorticoid receptor (MR) antagonist that has been shown to block harmful effects of MR overactivation. MR overactivation contributes to chronic kidney disease (CKD) progression and cardiovascular damage caused by metabolic, hemodynamic, or inflammatory and fibrotic factors. Finerenone is marketed as Kerendia (Firialta in some countries) and is already approved for the treatment of adult patients with CKD associated with type 2 diabetes (T2D) in more than 95 countries worldwide, including China, Europe, Japan and the United States. With the latest FDA approval, Kerendia is the only non-steroidal MR antagonist approved in the United States for CKD associated with T2D and for HF with LVEF of ≥40%. Please note the FDA granted Priority Review designation to the supplemental new drug application seeking approval for finerenone for the treatment of adult patients with HF with an LVEF of ≥40%. Per estimates, approximately 3.7 million people in the United States live with HF with an LVEF of ≥40%, which accounts for more than 500,000 hospitalizations per year. Data from the FINEARTS-HF study showed that finerenone achieved a statistically significant and clinically meaningful reduction of the composite of cardiovascular death and total (first and recurrent) HF events, defined as hospitalizations for HF or urgent HF visits. These benefits were demonstrated regardless of background therapy, comorbidities, or hospitalization status. Finerenone has also been submitted for marketing authorization in HF with an LVEF of ≥40% in China, the EU and Japan. BAYRY's Efforts to Strengthen Pharma Business Bayer's new products, such as Nubeqa and Kerendia, continue to maintain their impressive momentum in the Pharmaceutical division and offset the negative impact of a decline in Xarelto sales. Labels of these key drugs should boost its top-line growth. Last month, the FDA also expanded Nubeqa's label for a third indication for patients with advanced prostate cancer. The successful development of additional drugs is imperative for Bayer amid multiple challenges. BAYRY expects to launch two new drugs — elinzanetant, a hormone-free treatment for menopause symptoms, and acoramidis, a drug for the treatment of a certain type of heart disease. Elinzanetant was recently approved in the UK for the treatment of moderate to severe vasomotor symptoms (VMS or hot flashes) associated with menopause under the brand name Lynkuet. The company also aims to strengthen its pharmaceutical pipeline. In 2021, Bayer acquired clinical-stage biopharmaceutical company Vividion Therapeutics to expand its presence in precision small-molecule therapeutics, primarily in oncology and immunology. BAYRY has expanded its pipeline in new modalities of cell therapy through the acquisition of BlueRock, and in gene therapy, through the AskBio buyout. Bayer's Zacks Rank & Other Key Picks BAYRY currently carries a Zacks Rank #1 (Strong). A couple of other top-ranked stocks in the large-cap pharma sector are Novartis NVS and Johnson & Johnson JNJ, both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today's Zacks #1 Rank stocks here. The Zacks Consensus Estimate for Novartis' 2025 earnings per share (EPS) has risen from $8.78 to $8.92 over the past 60 days. EPS estimates for 2026 have jumped 20 cents to $9.27 during the said timeframe. The stock has risen 27.3% so far this year. J&J's EPS estimate for 2025 has risen from $10.60 to $10.64 over the past 60 days, while that for 2026 has increased from $10.98 to $11.07 over the same timeframe. 5 Stocks Set to Double Each was handpicked by a Zacks expert as the favorite stock to gain +100% or more in the months ahead. They include Stock #1: A Disruptive Force with Notable Growth and Resilience Stock #2: Bullish Signs Signaling to Buy the Dip Stock #3: One of the Most Compelling Investments in the Market Stock #4: Leader In a Red-Hot Industry Poised for Growth Stock #5: Modern Omni-Channel Platform Coiled to Spring Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor. While not all picks can be winners, previous recommendations have soared +171%, +209% and +232%. Download Atomic Opportunity: Nuclear Energy's Comeback free today. Novartis AG (NVS): Free Stock Analysis Report Johnson & Johnson (JNJ): Free Stock Analysis Report Bayer Aktiengesellschaft (BAYRY): Free Stock Analysis Report
Associated Press
20-03-2025
- Business
- Associated Press
The outstanding, design-driven 47M Bilgin Yachts MOONRAKER New For Sale
47 m Bilgin Yachts MOONRAKER has been announced for Sale on the Global Market exclusively by Ikonic Yachts ABOUT MOONRAKER Built in 2019 in Turkey by Bilgin Yachts, the 47m/155' superyacht MOONRAKER boasts incredible naval architecture and exterior styling by Unique Yacht Design, with interiors by İlkay Dovan. A masterpiece of design, MOONRAKER is for sale exclusively through Ikonic Yachts with a listing price of 26,500,000 EUR. As the first yachting family office advisory firm, Ikonic Yachts is redefining the yachting experience as a fully integrated yachting ecosystem with a focus on extraordinary service, paired with investment-level advice, and industry-leading asset management and valuation. CEO and Founder of Ikonic Yachts, AJ Blackmon comments, 'Over $7 million has been invested into upgrades and maintenance over the last 24 months, finding MOONRAKER in the best condition she has ever been in. Following a 5-year class survey which was completed in the summer of 2024, any potential buyer can be confident in the outstanding quality and condition of the vessel. This is a purchase opportunity not to be missed.' The entire interior design of the boat consists of natural elements including beautiful stone and rare woods as well as soft, entirely custom soft goods and warm-toned lighting to incite a connection with nature. The interior design elements throughout were imagined through a kaleidoscope, bringing beautiful, radial designs throughout the entirety of MOONRAKER. One of the most unique areas on board MOONRAKER is the on-deck Master Stateroom which features a lovely skylight directly above the bed for maximum natural light, as well as an incredible fold-down balcony to connect you to the sea from the very moment you wake up. The main foyer has a staircase where the light streams down from the sundeck Jacuzzi above, and the 'Caviar lights' inspired by nature have accents in gold and silver that, just like the marble in the en-suite bathrooms, break with the pristine white appearance to be found everywhere else on board. This outstanding yacht offers generous outdoor spaces across all decks, rivalling that of a 60m yacht. The exterior spaces on board are well-designed for maximizing guest enjoyment - from the lounging area on the aft deck perfect for evening conversations to the lovely al fresco dining area on the bridge deck complemented by a bar and oversized sun pads for afternoon enjoyment, all the way up to the spacious sun deck which features an oversized jacuzzi, full wet bar, and multiple seating and lounging areas and finally, a second jacuzzi can be found on the Portuguese bridge on the bow, surrounded by a lovely seating area to enjoy all views as you enter or leave any port – a guest favorite area! MOONRAKER's spacious beach club has been reimagined to be a well-appointed wellness area fully equipped with top-of-the-line fitness equipment, just a few feet away from the water for a quick dip as soon as your workout is completed! Built with a steel hull and aluminum superstructure, she offers greater on-board space and incredible stability when at anchor, thanks to her full-displacement hull. Powered by twin MTU engines, she reaches a maximum speed of 16 knots. The advanced stabilization system on board reduces the side-to-side roll of the yacht and promises guests exceptional comfort levels at anchor or when underway. MOONRAKER is found in brand-new condition and ready to offer its next owner an exceptional cruising experience. KEY SPECIFICATIONS AND FEATURES Length: 47.4 m / 155' 7" Builder: Bilgin Yachts Year: 2019 Accommodation: 10 guests in 5 staterooms Top Speed: 16 knots Range: 3,500 nautical miles at 11 knots cruising MINI WEBSITE Visit the mini website for more details: PHOTOS Please click the link here to view or download imagery: ABOUT IKONIC YACHTS Ikonic Yachts is changing the traditional yachting model and setting itself apart with a commitment to excellence, service, and personalized approach. Ikonic Yachts' expert team crafts tailored solutions for buying, selling, luxury yacht chartering, and management, guaranteeing your unique yachting needs are met with precision. With Ikonic Yachts, every yacht journey becomes an extraordinary adventure, guided by our dedication to surpassing expectations. Each client of Ikonic Yachts enjoys the confidence of partnering with dedicated, value-driven advisors who are with them through every step of their journey to deliver outstanding results.
