US FDA Grants Additional Six Fast-Track Vouchers to Accelerate Drug Review Process
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Nov 07 2025
0mins
Should l Buy VRTX?
Source: Reuters
FDA Awards Special Vouchers: The U.S. FDA has granted special vouchers to six additional companies, including Eli Lilly and Novo Nordisk, to expedite the review of their medicines, increasing the total recipients to 15. These vouchers are aimed at treatments for cancer, obesity, tuberculosis, and sickle cell disease.
Accelerated Review Process: The vouchers are part of a pilot program designed to accelerate FDA decisions for drugs addressing significant public health needs, allowing companies to receive decisions within one to two months instead of the usual 10 to 12 months.
Pricing Agreements and Market Impact: The announcement coincided with the Trump administration's pricing agreements with Eli Lilly and Novo Nordisk for their weight-loss treatments, which included commitments to lower prices for Medicare and Medicaid in exchange for priority review vouchers.
Analyst Insights and Company Reactions: Analysts suggest that the benefits of the vouchers may be limited for Novo Nordisk, as approval for its oral Wegovy is expected soon. Following the announcement, shares of Lilly rose slightly, while Novo Nordisk's shares fell.
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Analyst Views on VRTX
Wall Street analysts forecast VRTX stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for VRTX is 515.88 USD with a low forecast of 414.00 USD and a high forecast of 604.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
22 Analyst Rating
17 Buy
5 Hold
0 Sell
Strong Buy
Current: 477.920
Low
414.00
Averages
515.88
High
604.00
Current: 477.920
Low
414.00
Averages
515.88
High
604.00
About VRTX
Vertex Pharmaceuticals Incorporated is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases, with a focus on specialty markets. It has seven approved medicines: five that treat the underlying cause of cystic fibrosis (CF), one that treats severe sickle cell disease (SCD) and transfusion dependent beta thalassemia (TDT), and one that treats moderate-to-severe acute pain. Its pipeline includes clinical-stage programs in CF, SCD, beta thalassemia, acute and peripheral neuropathic pain, APOL1-mediated kidney disease, IgA nephropathy and other autoimmune renal diseases and cytopenias, type 1 diabetes, myotonic dystrophy type 1, and autosomal dominant polycystic kidney disease. Its marketed medicines are TRIKAFTA/KAFTRIO (elexacaftor/tezacaftor/ivacaftor and ivacaftor), SYMDEKO/SYMKEVI (elexacaftor/tezacaftor/ivacaftor and ivacaftor), ORKAMBI (lumacaftor/ivacaftor), and KALYDECO (ivacaftor).
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Clinical Trial Developments: Vertex is advancing potential new drugs such as zimislecel, inaxaplin, and povetacicept, with relevant updates expected in the next earnings report, which could significantly impact stock price.
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- Financial Performance Expectations: Vertex Pharmaceuticals projects revenue for fiscal year 2025 to be between $11.9 billion and $12 billion, indicating at least 8% year-over-year growth, which underscores its continued leadership in the cystic fibrosis drug market driving stable revenue growth.
- New Product Progress: The upcoming earnings report may highlight advancements for Casgevy and Journavx, particularly the latter, which has gained third-party insurance coverage for over 170 million U.S. patients, indicating increasing market acceptance.
- Clinical Trial Developments: Vertex is advancing potential new drugs such as zimislecel, inaxaplin, and povetacicept, with relevant updates expected in the next earnings report, which could significantly impact stock price.
- Long-term Investment Value: While short-term stock price movements are hard to predict, Vertex's core business remains strong, and new products are gradually contributing to financial results, making its long-term prospects attractive and suggesting investors consider buying before the earnings release.
See More
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- Earnings Schedule: This week features a high volume of earnings reports from technology, consumer discretionary, and energy sectors, with RIVN stock showing notable movement ahead of its earnings release, indicating investor sentiment.
- Monday.com and Pagaya Reports: On Monday, work management SaaS provider Monday.com and fintech company Pagaya released their earnings before the market opened, with expectations that their results will reflect broader industry trends.
- Coinbase Earnings Expectations: On Thursday, Coinbase is expected to report earnings of 68 cents per share and quarterly revenue of $1.86 billion, despite facing a projected 33% drop in transaction revenue, raising investor interest in its growing stablecoin and subscription services.
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See More
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- Cisco's AI Focus: Cisco anticipates earnings of $1.02 per share and revenue of $15.1 billion for Q2 FY2026, with CEO highlighting a major multi-year campus networking refresh, making AI infrastructure demand a critical growth driver.
- Importance of Employment Report: The January employment report is expected to show an addition of 80,000 nonfarm payrolls and an unchanged unemployment rate of 4.4%, directly impacting private consumption and U.S. GDP, making it crucial for investors to monitor.
- Consumer Price Index Insights: The January CPI is projected to increase by 2.5% year-over-year, with core CPI rising by 2.6%, providing essential inflation details despite not being the Fed's preferred measure, particularly regarding persistent shelter cost inflation.
See More
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- Market Performance: The Dow Jones Industrial Average rose by 2.5% and closed above 50,000 for the first time.
- Nasdaq Struggles: In contrast, the Nasdaq Composite ended the week down 1.8%, despite a strong rally on Friday.
See More
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- Bond Market Signals: Following Trump's nomination of Warsh as Fed chair, shorter-duration U.S. Treasury yields have fallen while longer-term yields have risen, creating a bear steepening yield curve that signals the market's warning of likely rising inflation, which could influence investor strategies.
- Berkshire Hathaway's Advantage: With expected increased market volatility under Warsh's leadership, Berkshire Hathaway, holding approximately $382 billion in cash and short-term Treasury investments, is well-positioned to buy undervalued stocks during downturns, enhancing its financial resilience.
- Vertex Pharmaceuticals' Resilience: While rising long-term bond yields typically hurt growth stocks, Vertex Pharmaceuticals stands out with its $12 billion cash flow and unique drug offerings, allowing it to remain stable amid market fluctuations, with upcoming drug submissions potentially serving as catalysts for share price increases.
- Walmart's Market Adaptability: As a major discount retailer, Walmart has historically performed well during market volatility, and in an environment of rising inflation and tightening consumer spending, it is likely to attract more customers, further solidifying its market position.
See More
Investment Outlook for Intuitive Surgical and Vertex Pharmaceuticals
- Market Challenges for Intuitive Surgical: Despite being a leader in the robotic-assisted surgery market, Intuitive Surgical faces financial impacts from high tariffs and increased competition, with its fiscal 2026 guidance falling short of market expectations; however, its long-term outlook remains optimistic.
- Growth in Installed Base: Intuitive Surgical ended Q4 with an installed base of 11,106 devices, a 12% increase year-over-year, which is expected to drive an increase in procedure volume, serving as a crucial growth driver for the medical device specialist.
- Vertex Pharmaceuticals' Drug Development: Vertex plans to submit regulatory applications for its investigational therapy zimislecel for type 1 diabetes this year and will release clinical trial data for therapies targeting APOL-1 mediated kidney disease and IgA nephropathy; if any prove effective, it will significantly expand its product lineup.
- Increased Investment Appeal: Although Intuitive Surgical was not included in The Motley Fool Stock Advisor's top stock picks, its strong competitive advantage in the medical device sector, combined with Vertex Pharmaceuticals' potential new products, makes both companies attractive for investment over the next five years.
See More
