Viatris' NDA for Fast-Acting Meloxicam Accepted by FDA
Written by Emily J. Thompson, Senior Investment Analyst
Updated: May 18 2026
0mins
Source: Newsfilter
- FDA Review Progress: Viatris announced that the FDA has accepted its New Drug Application for MR-107A-02 (fast-acting meloxicam), with a PDUFA goal date set for December 27, 2026, marking a significant advancement in the non-opioid treatment of acute pain.
- Clinical Trial Results: The NDA is supported by data from Phase 3 trials involving 579 herniorrhaphy and 410 bunionectomy patients, demonstrating efficacy and safety while meeting primary and secondary endpoints, potentially reducing opioid usage significantly.
- Market Demand Response: Acute pain affects over 80 million individuals in the U.S. annually, and Viatris' fast-acting meloxicam aims to address this critical public health need by providing an effective non-opioid first-line treatment option, potentially improving patients' quality of life.
- Strategic Product Line Expansion: Viatris is actively pursuing several value-added medicines, including fast-acting meloxicam, to enhance product value through lifecycle optimization and new formulation development, addressing the market's demand for effective and safe treatment options.
Trade with 70% Backtested Accuracy
Stop guessing "Should I Buy VTRS?" and start using high-conviction signals backed by rigorous historical data.
Sign up today to access powerful investing tools and make smarter, data-driven decisions.
Analyst Views on VTRS
Wall Street analysts forecast VTRS stock price to fall
4 Analyst Rating
2 Buy
1 Hold
1 Sell
Hold
Current: 16.110
Low
10.00
Averages
13.25
High
16.00
Current: 16.110
Low
10.00
Averages
13.25
High
16.00
About VTRS
Viatris Inc. is a global healthcare company. The Company markets branded and generic drugs, including complex drugs. The Company's segments include Developed Markets, Greater China, JANZ, and Emerging Markets. Its Developed Markets segment comprises its operations primarily in North America and Europe. The Company's Greater China segment includes its operations in mainland China, Taiwan and Hong Kong. The Company's JANZ segment consists of its operations in Japan, Australia and New Zealand. Its Emerging Markets segment encompasses its presence in more than 125 countries with developing markets and emerging economies including in Asia, Africa, Eastern Europe, Latin America and the Middle East as well as the Company's ARV franchise. It produces medicines for patients across a broad range of major therapeutic areas. From cardiovascular health to oncology, it offers treatment options across more than 10 major therapeutic areas covering a variety of noncommunicable and infectious diseases.
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.
Viatris Receives Overweight Rating and Price Target
- Rating Upgrade: Viatris (VTRS) has received an overweight rating from analysts, indicating a positive outlook on its future performance, which is likely to attract more investor attention.
- Price Target Set: The average price target set by analysts is $18.25, reflecting confidence in the company's growth potential, which may drive the stock price towards this target.
- Market Reaction Anticipation: With the upgrade in rating and price target, Viatris's stock price is expected to experience a positive impact, enhancing investor confidence and potentially attracting more capital inflow.
- Strategic Implications: This upgrade and price target not only help improve the company's image among investors but may also strengthen its position in the highly competitive pharmaceutical market.
See More
Mark Cuban to Join Trump for Generic Drug Announcement
- Pharmacy Collaboration: Mark Cuban's Cost Plus Drugs online pharmacy is set to collaborate with Trump's TrumpRx website to offer a wide range of generic medicines, which is expected to significantly reduce drug costs for consumers, particularly those without insurance.
- Significant Price Advantage: Cost Plus Drugs sells both branded and generic drugs at discounts below insurance-covered prices, with Cuban stating that a 30-day supply of the generic drug Eliquis costs $345, showcasing its competitive edge in the pharmaceutical market.
- Positive Market Response: This initiative may generate widespread attention in the pharmaceutical industry, especially regarding drug price transparency and affordability, potentially driving increased consumer demand for generics.
- Industry-Wide Impact: Cuban's involvement not only enhances the visibility of Cost Plus Drugs but may also compel other pharmaceutical companies to reconsider their pricing strategies, thereby triggering price competition across the industry.
See More
Viatris' NDA for Fast-Acting Meloxicam Accepted by FDA
- FDA Review Progress: Viatris announced that the FDA has accepted its New Drug Application for MR-107A-02 (fast-acting meloxicam), with a PDUFA goal date set for December 27, 2026, marking a significant advancement in the non-opioid treatment of acute pain.
- Clinical Trial Results: The NDA is supported by data from Phase 3 trials involving 579 herniorrhaphy and 410 bunionectomy patients, demonstrating efficacy and safety while meeting primary and secondary endpoints, potentially reducing opioid usage significantly.
- Market Demand Response: Acute pain affects over 80 million individuals in the U.S. annually, and Viatris' fast-acting meloxicam aims to address this critical public health need by providing an effective non-opioid first-line treatment option, potentially improving patients' quality of life.
- Strategic Product Line Expansion: Viatris is actively pursuing several value-added medicines, including fast-acting meloxicam, to enhance product value through lifecycle optimization and new formulation development, addressing the market's demand for effective and safe treatment options.
See More
HHS Considers Restrictions on Antidepressant Use Amid Mental Health Crisis
- Mental Health Crisis Response: HHS announced the launch of the 'MAHA Action Plan' at the Mental Health and Overmedicalization Summit, aimed at addressing the overprescription of psychiatric medications, particularly among children, highlighting a commitment to improving mental health.
- Current Medication Usage: A 2026 study revealed that 16.6% of Americans are taking antidepressants, indicating the prevalence of these medications and their significant impact on public health.
- Shift in Policy Direction: HHS Secretary RFK Jr. emphasized a future shift in treatment standards towards prevention, transparency, and a more holistic approach, supporting patient autonomy and informed consent, reflecting a reevaluation of mental health treatment methods.
- SSRIs Ban Discussion: Despite discussions about potentially banning selective serotonin reuptake inhibitors (SSRIs), an HHS spokesperson clarified that no such discussions have taken place, indicating uncertainty in the policy-making process.
See More
Viatris to Present at Bank of America Healthcare Conference
- Conference Schedule: Viatris Inc. will present at the Bank of America Securities 2026 Healthcare Conference on May 12, 2026, at 8 a.m. PT / 11 a.m. ET, providing updates to investors and the public about the company's latest developments.
- Live and Archived Access: The event will feature a live webcast accessible via viatris.com, and an archived version will be available post-event, ensuring that investors who cannot attend live can still access important information.
- Company Mission and Vision: Viatris aims to empower people worldwide to live healthier at every stage of life, demonstrating its commitment to meeting global patient needs through innovation and resolve, thereby showcasing its impact in the healthcare sector.
- Global Presence: Headquartered in the U.S., Viatris has global centers in Shanghai, China, and Hyderabad, India, highlighting its business expansion and focus on diverse markets around the world.
See More
Viatris Reports Strong Q1 2026 Earnings with $3.5 Billion Revenue
- Strong Financial Performance: Viatris reported total revenues of $3.5 billion in Q1 2026, reflecting a 3% year-over-year increase, with adjusted EBITDA of $1 billion and adjusted EPS of $0.59, indicating robust growth and profitability in the market.
- Regional Growth Drivers: The cardiovascular portfolio in Greater China drove an 18% year-over-year growth, while e-commerce sales more than doubled, enhancing the company's competitive position in the rapidly growing Asia-Pacific market and laying a foundation for future revenue growth.
- Pipeline Progress: The NDA for fast-acting meloxicam has been accepted for FDA review, with regulatory decisions expected in the second half of 2026, while the PDUFA goal dates for XULANE LO and presbyopia treatment are set for July 30 and October 17, 2026, respectively, showcasing the company's ongoing commitment to innovative drug development.
- Leadership Change and Outlook: Interim CFO Paul Campbell has taken over from former CFO Doretta Mistras, with management reaffirming confidence in their 2026 financial guidance, expecting mid- to high-single-digit growth in Greater China despite policy risks and competitive pressures in the market.
See More
Viatris Receives Overweight Rating and Price Target
- Rating Upgrade: Viatris (VTRS) has received an overweight rating from analysts, indicating a positive outlook on its future performance, which is likely to attract more investor attention.
- Price Target Set: The average price target set by analysts is $18.25, reflecting confidence in the company's growth potential, which may drive the stock price towards this target.
- Market Reaction Anticipation: With the upgrade in rating and price target, Viatris's stock price is expected to experience a positive impact, enhancing investor confidence and potentially attracting more capital inflow.
- Strategic Implications: This upgrade and price target not only help improve the company's image among investors but may also strengthen its position in the highly competitive pharmaceutical market.
See More
Mark Cuban to Join Trump for Generic Drug Announcement
- Pharmacy Collaboration: Mark Cuban's Cost Plus Drugs online pharmacy is set to collaborate with Trump's TrumpRx website to offer a wide range of generic medicines, which is expected to significantly reduce drug costs for consumers, particularly those without insurance.
- Significant Price Advantage: Cost Plus Drugs sells both branded and generic drugs at discounts below insurance-covered prices, with Cuban stating that a 30-day supply of the generic drug Eliquis costs $345, showcasing its competitive edge in the pharmaceutical market.
- Positive Market Response: This initiative may generate widespread attention in the pharmaceutical industry, especially regarding drug price transparency and affordability, potentially driving increased consumer demand for generics.
- Industry-Wide Impact: Cuban's involvement not only enhances the visibility of Cost Plus Drugs but may also compel other pharmaceutical companies to reconsider their pricing strategies, thereby triggering price competition across the industry.
See More
Viatris' NDA for Fast-Acting Meloxicam Accepted by FDA
- FDA Review Progress: Viatris announced that the FDA has accepted its New Drug Application for MR-107A-02 (fast-acting meloxicam), with a PDUFA goal date set for December 27, 2026, marking a significant advancement in the non-opioid treatment of acute pain.
- Clinical Trial Results: The NDA is supported by data from Phase 3 trials involving 579 herniorrhaphy and 410 bunionectomy patients, demonstrating efficacy and safety while meeting primary and secondary endpoints, potentially reducing opioid usage significantly.
- Market Demand Response: Acute pain affects over 80 million individuals in the U.S. annually, and Viatris' fast-acting meloxicam aims to address this critical public health need by providing an effective non-opioid first-line treatment option, potentially improving patients' quality of life.
- Strategic Product Line Expansion: Viatris is actively pursuing several value-added medicines, including fast-acting meloxicam, to enhance product value through lifecycle optimization and new formulation development, addressing the market's demand for effective and safe treatment options.
See More
HHS Considers Restrictions on Antidepressant Use Amid Mental Health Crisis
- Mental Health Crisis Response: HHS announced the launch of the 'MAHA Action Plan' at the Mental Health and Overmedicalization Summit, aimed at addressing the overprescription of psychiatric medications, particularly among children, highlighting a commitment to improving mental health.
- Current Medication Usage: A 2026 study revealed that 16.6% of Americans are taking antidepressants, indicating the prevalence of these medications and their significant impact on public health.
- Shift in Policy Direction: HHS Secretary RFK Jr. emphasized a future shift in treatment standards towards prevention, transparency, and a more holistic approach, supporting patient autonomy and informed consent, reflecting a reevaluation of mental health treatment methods.
- SSRIs Ban Discussion: Despite discussions about potentially banning selective serotonin reuptake inhibitors (SSRIs), an HHS spokesperson clarified that no such discussions have taken place, indicating uncertainty in the policy-making process.
See More
Viatris to Present at Bank of America Healthcare Conference
- Conference Schedule: Viatris Inc. will present at the Bank of America Securities 2026 Healthcare Conference on May 12, 2026, at 8 a.m. PT / 11 a.m. ET, providing updates to investors and the public about the company's latest developments.
- Live and Archived Access: The event will feature a live webcast accessible via viatris.com, and an archived version will be available post-event, ensuring that investors who cannot attend live can still access important information.
- Company Mission and Vision: Viatris aims to empower people worldwide to live healthier at every stage of life, demonstrating its commitment to meeting global patient needs through innovation and resolve, thereby showcasing its impact in the healthcare sector.
- Global Presence: Headquartered in the U.S., Viatris has global centers in Shanghai, China, and Hyderabad, India, highlighting its business expansion and focus on diverse markets around the world.
See More
Viatris Reports Strong Q1 2026 Earnings with $3.5 Billion Revenue
- Strong Financial Performance: Viatris reported total revenues of $3.5 billion in Q1 2026, reflecting a 3% year-over-year increase, with adjusted EBITDA of $1 billion and adjusted EPS of $0.59, indicating robust growth and profitability in the market.
- Regional Growth Drivers: The cardiovascular portfolio in Greater China drove an 18% year-over-year growth, while e-commerce sales more than doubled, enhancing the company's competitive position in the rapidly growing Asia-Pacific market and laying a foundation for future revenue growth.
- Pipeline Progress: The NDA for fast-acting meloxicam has been accepted for FDA review, with regulatory decisions expected in the second half of 2026, while the PDUFA goal dates for XULANE LO and presbyopia treatment are set for July 30 and October 17, 2026, respectively, showcasing the company's ongoing commitment to innovative drug development.
- Leadership Change and Outlook: Interim CFO Paul Campbell has taken over from former CFO Doretta Mistras, with management reaffirming confidence in their 2026 financial guidance, expecting mid- to high-single-digit growth in Greater China despite policy risks and competitive pressures in the market.
See More
