Latest news with #Ohtuvayre
Yahoo
3 days ago
- Business
- Yahoo
Jim Cramer Notes Verona Pharma plc (VRNA) 'Loses a Lot of Money'
We recently published a list of . In this article, we are going to take a look at where Verona Pharma plc (NASDAQ:VRNA) stands against other stocks that Jim Cramer discusses. Answering a caller's query about Verona Pharma plc (NASDAQ:VRNA), Cramer stated: 'That stock is a rocket ship. Again, very very speculative, because it loses a lot of money. Does have a couple things in the pipe that people like, but also has a huge amount of insider selling, frankly.' A patient in a clinic, taking a medication dose from a nebulizer to treat a respiratory disease. Verona Pharma (NASDAQ:VRNA) is a biopharmaceutical company developing treatments for respiratory diseases with limited treatment options. The company's lead therapy, Ohtuvayre, is designed to provide bronchodilation and anti-inflammatory benefits for conditions like COPD, cystic fibrosis, and asthma. Buckley Capital Advisors stated the following regarding Verona Pharma plc (NASDAQ:VRNA) in its Q1 2025 investor letter: 'Verona Pharma plc (NASDAQ:VRNA) has developed a product called ensifentrine (Ohtuvayre), a bronchodilator and anti-inflammatory agent for maintenance treatment of COPD. COPD, more commonly known as smoker's lung, is caused by pollution or smoking. Diagnosis of COPD lowers life expectancy by approximately 6 years. Symptoms of COPD are shortness of breath, cough, wheezing, and sputum. COPD affects approximately 400 million people worldwide, with 8.6m people treated in the United States. Overall, VRNA ranks 7th on our list of stocks that Jim Cramer discusses. While we acknowledge the potential of VRNA as an investment, our conviction lies in the belief that AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than VRNA and that has 100x upside potential, check out our report about this cheapest AI stock. READ NEXT: 20 Best AI Stocks To Buy Now and 30 Best Stocks to Buy Now According to Billionaires. Disclosure: None. This article is originally published at Insider Monkey.
Yahoo
4 days ago
- Business
- Yahoo
Regeneron, Sanofi Stock Falls After Uneven Smoker's Lung Drug Data
Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) and Sanofi SA (NASDAQ:SNY) on Friday announced results from two Phase 3 trials of itepekimab in chronic obstructive pulmonary disease (COPD) patients. Phase 3 AERIFY-1 trial evaluating itepekimab in adults who were former smokers with inadequately controlled COPD met the primary endpoint of significantly reducing moderate or severe acute exacerbations by 27% compared to placebo at week 52, a clinically meaningful benefit. A second Phase 3 trial, AERIFY-2, did not meet the same primary endpoint. Despite showing some benefit earlier in the trial (at week 24), itepekimab did not achieve a statistically significant reduction in moderate or severe exacerbations at week 52 in the second the trials, patients were randomized to receive itepekimab every two weeks (AERIFY-1: n=375; AERIFY-2: n=326), every four weeks (AERIFY-1: n=377; AERIFY-2: n=303), or placebo (AERIFY-1: n=375; AERIFY-2: n=324), which was added to inhaled triple or double standard-of-care therapy. The primary endpoint for AERIFY-1 and AERIFY-2 was the reduction in the annualized rate of acute moderate or severe COPD exacerbations with itepekimab treatment. The total number of exacerbations was lower than prospectively anticipated, decreasing the power of both trials. Enrollment largely occurred during the global COVID-19 pandemic, which could have contributed to the lower overall exacerbation rates. The safety profile of itepekimab was consistent across dosing regimens, and adverse events (AEs) were generally comparable between treatment and placebo groups. Regeneron and Sanofi will review the data and discuss it with regulatory authorities to evaluate the next steps. Itepekimab is also being evaluated in other respiratory conditions, including chronic rhinosinusitis without nasal polyps, chronic rhinosinusitis with nasal polyps, and non-cystic fibrosis bronchiectasis. In November 2024, Regeneron and Sanofi's Dupixent gained FDA approval for COPD, marking its sixth U.S. indication since its first use for atopic dermatitis seven years ago. This expansion positions Dupixent as the first targeted therapy for COPD, a significant leap in treating this progressive lung condition that impedes breathing due to obstructed airflow. Last Thursday, the U.S. Food and Drug Administration (FDA) approved GSK Plc's (NYSE:GSK) Nucala (mepolizumab) as an add-on maintenance treatment for adult patients with inadequately controlled COPD and an eosinophilic phenotype. Last June, the FDA approved Verona Pharma plc's (NASDAQ:VRNA) Ohtuvayre (ensifentrine) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. Ohtuvayre is the first inhaled product with a novel mechanism of action available for the maintenance treatment of COPD in more than 20 years. In May, Sanofi announced it will invest at least $20 billion in the U.S. through 2030. Research and development, plus U.S. manufacturing, will receive the bulk of the spending. The company also expects higher job creation within the communities where Sanofi and its partners are located, which will help enhance the U.S. supply chain. Earlier in May, Regeneron secured the winning bid in the bankruptcy auction for key assets of 23andMe Holding Co. in a $256 million deal to boost its genetics-based drug discovery efforts. Price Action: REGN stock is down 9.98% at $545, and SNY stock is down 4.57% at $49.96 during the premarket session at last check Friday. Read Next:Photo by Marianne Campolongo via Shutterstock Up Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market. Get the latest stock analysis from Benzinga? REGENERON PHARMACEUTICALS (REGN): Free Stock Analysis Report SANOFI (SNY): Free Stock Analysis Report This article Regeneron, Sanofi Stock Falls After Uneven Smoker's Lung Drug Data originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved. Sign in to access your portfolio
Yahoo
22-05-2025
- Health
- Yahoo
GSK's asthma drug wins FDA approval to treat 'smoker's lung'
By Siddhi Mahatole and Sriparna Roy (Reuters) -The U.S. Food and Drug Administration has approved British drugmaker GSK's asthma drug to treat some patients with a chronic lung disease commonly known as "smoker's lung", the company said on Thursday. The approval expands the use of the drug, Nucala, as an add-on treatment for patients with a type of chronic obstructive pulmonary disease. Sanofi and Regeneron's blockbuster drug Dupixent and Verona Pharma's inhaled therapy Ohtuvayre are also approved for the condition, which affects the lungs, causing restricted airflow and breathing problems. GSK's Nucala is a monoclonal antibody that inhibits interleukin-5, which helps regulate eosinophils, a type of white blood cell that causes inflammation in the lungs when overproduced. The regulator had set a target action date of May 7 for its decision on the drug. The approval, however, came two weeks later. This is the latest instance where the drug regulator has missed its deadline after mass layoffs as part of a major overhaul of federal health agencies under Secretary of Health and Human Services Robert F. Kennedy Jr. The approval was based on a late-stage trial, in which patients treated with Nucala and an inhaled maintenance therapy for up to 104 weeks had significantly reduced exacerbations by 21% compared to placebo. "There's a very high burden when you have severe exacerbations and end up being hospitalized. The aim is to keep patients out of the hospital, keep them stable, and keep them at home," GSK's Chief Commercial Officer Luke Miels said ahead of the approval. Nucala recorded 1.78 billion pounds ($2.38 billion) in total sales last year. The disease commonly affects cigarette smokers but can also be caused by air pollution and related occupational hazards. It is the fourth leading cause of death worldwide, according to the World Health Organization.
Yahoo
16-05-2025
- Business
- Yahoo
Nuance seeks China approval for Ohtuvayre following Phase III trial success
Nuance Pharma's Ohtuvayre (ensifentrine) has met the primary endpoint in a Phase III chronic obstructive pulmonary disease (COPD) study in China. The medication was developed as part of a partnership with UK company Verona Pharma. In the ENHANCE-CHINA trial (NCT05743075), nebulised Ohtuvayre showed a statistically significant and clinically meaningful improvement in change in forced expiratory volume (FEV) of 110ml after 12 weeks. The trial also showed improvement in lung function, including a peak FEV of 174mL, a morning trough FEV increase of 36ml and an evening trough FEV increase of 65ml. Patients also receiving saw a 28% reduction in the rate of moderate/severe COPD exacerbations over 24 weeks, and there was a decrease in the risk of a moderate/severe exacerbation, measured by time to first exacerbation of 25%. There was also improvement in secondary endpoints, including dyspnea as measured by the Transition Dyspnea Index (TDI) of 0.8 compared to placebo over 24 weeks. Quality of Life (QoL), as measured by the St George's Respiratory Questionnaire (SGRQ) Total Score in the Ohtuvayre arm, also improved by -2.9, higher than the Minimal Clinically Important Difference (MCID) of -4. The therapy remained well-tolerated with adverse event (AE) incidence similar to placebo. Nuance Pharma CEO Mark Lotter said: "These promising results demonstrate Ohtuvayre's strength as a first-in-class bronchodilator and non-steroidal anti-inflammatory therapy for COPD, as an advance to existing treatment options.' Nuance Pharma plans to submit a new drug application to China's National Medical Products Administration (NMPA) in the second half of 2025. Shanghai-based Nuance gained rights to Ohtuvayre in June 2021 after signing a $219m strategic collaboration with Verona Pharma. The collaboration gave Nuance Pharma development and commercial rights in Greater China. Ohtuvayre is a first-in-class selective dual inhibitor of phosphodiesterase 3 and 4 (PDE3 and PDE4) that combines bronchodilator and non-steroidal anti-inflammatory effects delivered through a standard jet nebuliser. The drug was approved by the US Food and Drug Administration (FDA) on 26 June 2024 for use in adult COPD patients. Approval for use in Europe has yet to be granted. Nuance Pharma plans to release additional information from ENHANCE-CHINA at upcoming scientific conferences. According to GlobalData, Ohtuvayre could reach global sales of $1.63bn in 2030. GlobalData is the parent company of Clinical Trials Arena. "Nuance seeks China approval for Ohtuvayre following Phase III trial success" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Yahoo
08-05-2025
- Business
- Yahoo
What Makes Verona Pharma plc (VRNA) a Good Investment?
Buckley Capital Advisors, an investment management company, released its first quarter 2025 investor letter. A copy of the letter can be downloaded here. The fund returned -0.5% (net) in the quarter compared to -7.7% return for iShares Russell 2000 Value Index and -9.5% return for the iShares Russell 2000 Index. In the quarter, Donald Trump's aggressive tariff plans increased economic uncertainty. Although tariffs directly impact less than 5% of the portfolio, the firm was prepared for this situation. However, the widespread selling of stocks affected it significantly. The firm focuses on the fundamentally strong companies regardless of the economic environment. In addition, you can check the fund's top 5 holdings to determine its best picks for 2025. In its first-quarter 2025 investor letter, Buckley Capital Advisors highlighted stocks such as Verona Pharma plc (NASDAQ:VRNA). Verona Pharma plc (NASDAQ:VRNA) is a biopharmaceutical company. The one-month return of Verona Pharma plc (NASDAQ:VRNA) was 23.24%, and its shares gained 350.61% of their value over the last 52 weeks. On May 7, 2025, Verona Pharma plc (NASDAQ:VRNA) stock closed at $69.14 per share with a market capitalization of $8.699 billion. Buckley Capital Advisors stated the following regarding Verona Pharma plc (NASDAQ:VRNA) in its Q1 2025 investor letter: "Verona Pharma plc (NASDAQ:VRNA) has developed a product called ensifentrine (Ohtuvayre), a bronchodilator and anti-inflammatory agent for maintenance treatment of COPD. COPD, more commonly known as smoker's lung, is caused by pollution or smoking. Diagnosis of COPD lowers life expectancy by approximately 6 years. Symptoms of COPD are shortness of breath, cough, wheezing, and sputum. COPD affects approximately 400 million people worldwide, with 8.6m people treated in the United States. A patient in a clinic, taking a medication dose from a nebulizer to treat a respiratory disease. Verona Pharma plc (NASDAQ:VRNA) is not on our list of 30 Most Popular Stocks Among Hedge Funds. As per our database, 42 hedge fund portfolios held Verona Pharma plc (NASDAQ:VRNA) at the end of the fourth quarter, compared to 25 in the third quarter. Verona Pharma plc (NASDAQ:VRNA) reported revenue of $76.3 million in the first quarter, which was in line with prior quarters. While we acknowledge the potential of Verona Pharma plc (NASDAQ:VRNA) as an investment, our conviction lies in the belief that AI stocks hold greater promise for delivering higher returns, and doing so within a shorter timeframe. If you are looking for an AI stock that is as promising as NVIDIA but that trades at less than 5 times its earnings, check out our report about the cheapest AI stock. In another article, we covered Verona Pharma plc (NASDAQ:VRNA) and shared the list of best multibagger stocks to buy according to billionaires. In addition, please check out our hedge fund investor letters Q1 2025 page for more investor letters from hedge funds and other leading investors. READ NEXT: Michael Burry Is Selling These Stocks and A New Dawn Is Coming to US Stocks. Disclosure: None. This article is originally published at Insider Monkey. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
