Achieve, Disc, and Revolution Among Recipients of First FDA National Priority Vouchers
FDA Priority Review Vouchers: Achieve Life Sciences, Disc Medicine, and Revolution Medicines are among the first recipients of the FDA's National Priority Review vouchers, aimed at expediting the review process for important medicines, reducing timelines from 10-12 months to 1-2 months.
Market Reactions: Following the announcement, Achieve Life Sciences and Disc Medicine saw significant premarket gains of approximately 25% and 20%, respectively, while Revolution Medicines increased by about 9% due to its pancreatic cancer therapy receiving a voucher.
Other Recipients: Other pharmaceutical companies, including Regeneron, Sanofi, and EMD Serono, also received priority review vouchers, with EMD Serono's fertility treatment Pergoveris highlighted by President Trump for its potential to lower costs in the market.
Program Goals: The FDA's pilot program is designed to encourage the development of drugs that address significant national priorities, such as unmet medical needs and domestic drug manufacturing.
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- Revenue Growth: Casgevy gene-editing therapy generated $54 million in Q4 2025 and $116 million for the full year, indicating strong market demand and significant business growth potential.
- Increased Patient Treatments: A total of 147 patients initiated treatment in 2025, nearly tripling from 2024, with 30 infusions occurring in Q4, reflecting heightened acceptance and confidence in the therapy.
- Pipeline Advancement: The company continues to advance its in vivo liver editing programs, with CTX310 in Phase 1b trials for lipid disorders and CTX321 progressing through enabling studies, with updates expected in the second half of 2026.
- Financial Position: CRISPR Therapeutics ended 2025 with $1.98 billion in cash and marketable securities, despite R&D expenses rising to $83.5 million in Q4 and net loss widening to $130.6 million, market confidence in its future growth remains strong.
- Leadership Transition: Sanofi announced that CEO Paul Hudson will depart on February 17, with Belén Garijo succeeding him, reflecting ongoing challenges in the company's drug pipeline and market performance, which may impact investor confidence.
- Sales Performance Fluctuations: While Sanofi's top drug Dupixent saw a 32.2% sales increase in Q4 2025, totaling €4.2 billion, vaccine sales declined by 2.5% to €2 billion, highlighting vulnerabilities in its product portfolio.
- Weak Stock Performance: Sanofi shares fell 0.68% in premarket trading to $46.71, trading 1.1% below the 20-day and 4% below the 100-day simple moving averages, indicating a bearish sentiment in the short term.
- Analyst Rating Changes: Despite an average price target of $61.50 and a “Buy” rating, recent downgrades from multiple firms suggest growing concerns about the company's future growth potential.
- New Drug Development Progress: Regeneron will present Phase 3 clinical trial data for two first-in-class antibodies targeting cat and birch allergies at the 2026 AAAAI Annual Meeting, marking a significant innovation potential in allergy treatment that could change existing therapeutic paradigms.
- Dupixent® New Data Release: Newly released data on Dupixent (dupilumab) highlights its clinical and real-world impact across dermatological, respiratory, and gastrointestinal diseases, particularly in analyzing food allergy sensitization in children with atopic dermatitis, showcasing its broad indications and market potential.
- Registration Trial Plans: Based on Phase 3 trial results, Regeneron plans to initiate additional registration trials this year to further validate the efficacy of treatments for cat and birch allergies, which not only strengthens the company's R&D pipeline but also paves the way for future market launches.
- Long-term Efficacy Analysis: Long-term efficacy analyses of Dupixent show that early sustained treatment significantly reduces IgE levels in children, and in adult asthma patients, early use of Dupixent may decrease exacerbations and corticosteroid use, further solidifying its position in treatment regimens.
- Significant Revenue Growth: Regeneron achieved a 10% revenue growth in Q4 2024, reaching $3.8 billion, primarily driven by strong performances from Dupixent, Libtayo, and EYLEA, demonstrating the company's sustained competitiveness in the biopharmaceutical sector.
- Expansion of Dupixent Patient Base: Over 1 million patients are currently on Dupixent treatment globally, with significant future growth potential anticipated from new indications like COPD, further solidifying its market leadership.
- EYLEA HD Market Performance: EYLEA HD reported net sales of $305 million in Q4, and despite competitive pressures, upcoming launches of a prefilled syringe and label expansions are expected to position it as the new standard in the anti-VEGF category.
- Capital Return Strategy: Regeneron announced the initiation of a quarterly cash dividend program at $0.88 per share and an additional $3 billion share repurchase authorization, reflecting confidence in future cash flows while maintaining ongoing investments in R&D.
- Revenue Growth Highlight: Regeneron reported total revenues of $3.72 billion for Q3, reflecting an 11% year-over-year increase, primarily driven by higher collaboration revenues with Sanofi, showcasing the company's robust performance in the biopharmaceutical sector.
- Dupixent Sales Milestone: Dupixent achieved global sales of $3.8 billion, a 24% increase, with over 1 million patients currently on treatment, and is expected to continue driving revenue growth, particularly with new indications like COPD.
- EYLEA HD Market Performance: Combined net sales for EYLEA HD and EYLEA reached $1.54 billion, up 3% year-over-year, maintaining a 44% market share despite competitive pressures, indicating strong trust from physicians and patients.
- Pipeline Outlook: Regeneron has approximately 40 programs in clinical development, with several pivotal data readouts anticipated in the next 12 to 18 months, further enhancing the company's potential for medium- to long-term shareholder value growth.

- Fiscal-Year Outlook Increase: Cardinal Health has raised its fiscal-year outlook for the second time in less than a month.
- Positive Financial Performance: The company’s recent adjustments indicate strong financial performance and confidence in future growth.









