Blockbuster drug
Search documents
Praxis' Epilepsy Drug Too Good To Continue, FDA Meeting Up Next
Benzinga· 2025-12-05 18:10
Core Insights - Praxis Precision Medicines Inc. stock increased following positive results from the EMBOLD study evaluating relutrigine for SCN2A and SCN8A developmental and epileptic encephalopathies [1] - The FDA has scheduled a meeting to review the data and discuss the next steps, with Praxis planning to determine the timing for filing a New Drug Application (NDA) post-meeting [2][4] - Analyst commentary suggests relutrigine is expected to be a blockbuster drug, with increased probability of success and projected peak sales significantly raised [5][7] Study Results - The Data Monitoring Committee recommended stopping the EMBOLD study early due to efficacy [1] - Topline results from the EMBOLD study will be presented at the American Epilepsy Society Annual Meeting [3] Regulatory Developments - Praxis completed its pre-NDA meeting with the FDA, receiving written feedback and conducting an in-person meeting [3] - The company expects to submit its NDA in early 2026 after aligning with the FDA on the content [4] Analyst Insights - HC Wainwright views relutrigine as overlooked but anticipates a shift in perception following EMBOLD data [5] - The analyst increased the probability of success for relutrigine to 80% from 60% and raised projected peak sales to $2.8 billion from $760 million [6][7] - The firm maintains a Buy rating for Praxis Precision and increased the price forecast from $258 to $340 [7] Pipeline Developments - Praxis previously shared positive topline results from its Phase 2 RADIANT study, showing a median seizure reduction of approximately 56.3% in patients with focal onset seizures and generalized epilepsy [8] - The stock price rose by 30.84% to $248.56, reaching a new 52-week high [8]
These Are the 3 Hottest Stocks in the S&P 500 Heading Into the New Year. Should You Invest in Them?
The Motley Fool· 2025-12-05 08:15
Core Viewpoint - The article highlights three stocks in the S&P 500 that have shown significant upward momentum after a period of underperformance, suggesting potential for continued growth in 2026 [1][2][12]. Group 1: Albemarle (ALB) - Albemarle's stock has increased by 39% over the past month, making it the best performer in the S&P 500 during this period [4]. - The company specializes in lithium extraction and refining, which is in high demand for electric vehicle batteries and large-scale power storage systems [4][7]. - Despite sluggish global EV sales, demand for Albemarle's lithium products is rising in other sectors such as battery storage and solar energy [7]. Group 2: Solventum (SOLV) - Solventum's stock has risen nearly 25% over the past month, positioning it as the second-best performer in the S&P 500 [8]. - The company, spun off from 3M in April 2024, produces a variety of medical products and has seen its stock surge following strong third-quarter earnings that exceeded forecasts [10]. - A $1 billion share repurchase program announced by Solventum has further boosted investor confidence in the company's growth potential [11]. Group 3: Merck (MRK) - Merck's stock has increased by nearly 22% over the past month, following a strong quarterly report that surpassed earnings and revenue expectations [12]. - The company's Keytruda cancer drug achieved quarterly sales exceeding $8 billion, marking a 10% increase from the previous year [12]. - Merck's management has successfully reduced costs, leading to an improved earnings outlook for 2025 [12].