Trump Signs Plan to Fire FDA Commissioner Makary
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1 day ago
0mins
Should l Buy MRNA?
President Trump has signed off on a plan to fire Food and Drug Administration Commissioner Marty Makary, following a tumultuous period for the regulator that included clashes over vaping, abortion and drug policy, The Wall Street Journal's Liz Essley Whyte reports, citing people familiar with the matter. Makary is seen by other top administration leaders as struggling to manage his agency, sparring frequently with health department officials and at times the White House, the author notes. Biotech stocks that could be impacted by the news include Moderna (MRNA), Sarepta (SRPT), Xencor (XNCR), PTC Therapeutics (PTCT), Biohaven (BHVN), Edgewise Therapeutics (EWTX), Design Therapeutics (DSGN), Ultragenyx (RARE), Avidity Biosciences (RNA), Dyne Therapeutics (DYN), Wave Life Sciences (WVE), MeiraGTx (MGTX), uniQure (QURE), Regenxbio (RGNX), Novavax (NVAX) and Lexeo Therapeutics (LXEO).
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Analyst Views on MRNA
Wall Street analysts forecast MRNA stock price to fall
20 Analyst Rating
1 Buy
16 Hold
3 Sell
Hold
Current: 48.540
Low
17.00
Averages
32.47
High
63.00
Current: 48.540
Low
17.00
Averages
32.47
High
63.00
About MRNA
Moderna, Inc. is a biotechnology company advancing a new class of medicines made of messenger ribonucleic acid (mRNA). It is engaged in developing medicines across infectious disease vaccines, oncology therapeutics and rare disease therapeutics. Its platform incorporates advances across three components, mRNA, delivery, and the manufacturing process, to advance its medicines. Its products are Spikevax and mNEXSPIKE (its COVID vaccines), and mRESVIA (its vaccine against respiratory syncytial virus (RSV)). It also has a diverse development pipeline that consists of 35 therapeutic and vaccine programs, six of which are in late-stage development. It has regulatory filings under review for its seasonal flu+COVID vaccine (mRNA-1083) in Europe and Canada and for its seasonal flu vaccine (mRNA-1010) in the United States, Europe, Canada and Australia. Its rare disease programs are Propionic acidemia (mRNA-3927); Methylmalonic acidemia (mRNA-3705), and Cystic Fibrosis (mRNA-3692/VX-522).
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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- Positive Market Reaction: Moderna's shares rose approximately 14% in Friday afternoon trading, indicating investor optimism regarding the new vaccine development, which could enhance its market competitiveness.
- Epidemic Context Impact: Hantavirus has gained renewed attention due to an outbreak on the MV Hondius cruise ship, which resulted in three deaths and at least six infections, highlighting the urgency for vaccine development as noted by the World Health Organization.
- Funding Challenges and Outlook: Despite the challenges of insufficient funding for hantavirus vaccine development, experts suggest that without significant government investment, the timeline for vaccine availability could extend to a decade or more, impacting the company's long-term strategic planning.
See More
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- Vaccine Development Progress: Moderna's hantavirus vaccine research is in early stages, with preclinical work conducted in collaboration with the U.S. Army Medical Research Institute, indicating the company's ongoing commitment to vaccine innovation despite no human trials yet.
- Positive Market Reaction: Following the confirmation of its hantavirus vaccine research, Moderna's stock surged 12% on Friday, marking its best performance in over two months, reflecting investor optimism about the company's future potential in the vaccine market.
- Dramatic Sales Decline: Moderna's vaccine sales have plummeted post-pandemic, with total revenue dropping from a record $19.26 billion in 2022 to $6.85 billion in 2023, and further declining to $3.24 billion in 2024, highlighting a significant shift in market demand.
- Public Health Risk Assessment: Despite an increase in hantavirus cases linked to a cruise ship, the WHO has assessed the overall risk to the public as low, primarily due to hantaviruses being rodent-borne with human-to-human transmission being rare.
See More
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- Industry Response: The pharmaceutical industry has expressed dissatisfaction with Makary's drug review policies, citing inconsistencies and overly restrictive processes that hinder innovative drug approvals, suggesting that new leadership could accelerate approval timelines and restore clearer regulatory guidance.
- Potential Beneficiaries: Companies like Replimune and uniQure, which have publicly clashed with the FDA, are seen as potential beneficiaries of new leadership, with Replimune's melanoma therapy RP1 being rejected and uniQure's Huntington's disease gene therapy AMT-130 facing significant shifts in review policy.
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- Vaccine Development Update: Moderna's partnership with Korea University to develop an mRNA hantavirus vaccine has gained attention, receiving a $176 million government award in 2024, highlighting its critical role in pandemic response and potential to accelerate vaccine development timelines.
- Market Reaction: Vaccine manufacturers and biodefense companies saw stock rallies on Friday night, with Emergent BioSolutions up 3%, Inovio and Novavax each gaining 2%, and Moderna rising 1%, reflecting investor optimism regarding vaccine development amid the outbreak.
- Investor Sentiment: On Stocktwits, retail sentiment for Inovio and Novavax was extremely bullish, while Moderna showed positive sentiment, indicating high market interest in hantavirus-related companies, with Moderna's stock surging 102% over the past year.
See More
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- Increased Vaccine Preference: Data revealed that patients receiving Nuvaxovid were twice as likely to choose the same vaccine again next year compared to those who received Moderna's vaccine, providing Novavax with a significant competitive edge in the crowded vaccine market.
- 2026 Revenue Outlook: The company maintained its adjusted revenue forecast for 2026 at $230 million to $270 million, with expectations that existing cash and partner reimbursements will fund operations through 2028, even without additional milestone or royalty revenue.
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- New Product Approvals: The company secured approvals for mCOMBRIAX and mNEXSPIKE in the EU, which are expected to be key growth drivers in 2027, further solidifying Moderna's position in the $1.8 billion annual European respiratory vaccines market.
- Rising Cost Expectations: Due to litigation and settlement costs, Moderna has raised its sales cost projection from $900 million to $1.8 billion, which includes a $900 million litigation settlement charge, potentially impacting future profitability.
- Flu Vaccine Progress: Management expressed optimism regarding the regulatory status of its U.S. flu vaccine, with a PDUFA date of August 5 for mRNA-1010, marking a strategic shift from previous disappointment to clearer expectations for future market entry.
See More
Moderna Initiates Hantavirus Vaccine Development
- Vaccine Development Progress: Moderna is collaborating with the U.S. Army Medical Research Institute of Infectious Diseases to develop a hantavirus vaccine in early stages, although availability may take years, reflecting the company's commitment to addressing emerging infectious diseases.
- Positive Market Reaction: Moderna's shares rose approximately 14% in Friday afternoon trading, indicating investor optimism regarding the new vaccine development, which could enhance its market competitiveness.
- Epidemic Context Impact: Hantavirus has gained renewed attention due to an outbreak on the MV Hondius cruise ship, which resulted in three deaths and at least six infections, highlighting the urgency for vaccine development as noted by the World Health Organization.
- Funding Challenges and Outlook: Despite the challenges of insufficient funding for hantavirus vaccine development, experts suggest that without significant government investment, the timeline for vaccine availability could extend to a decade or more, impacting the company's long-term strategic planning.
See More
Moderna Initiates Hantavirus Vaccine Research Amid Outbreak
- Vaccine Development Progress: Moderna's hantavirus vaccine research is in early stages, with preclinical work conducted in collaboration with the U.S. Army Medical Research Institute, indicating the company's ongoing commitment to vaccine innovation despite no human trials yet.
- Positive Market Reaction: Following the confirmation of its hantavirus vaccine research, Moderna's stock surged 12% on Friday, marking its best performance in over two months, reflecting investor optimism about the company's future potential in the vaccine market.
- Dramatic Sales Decline: Moderna's vaccine sales have plummeted post-pandemic, with total revenue dropping from a record $19.26 billion in 2022 to $6.85 billion in 2023, and further declining to $3.24 billion in 2024, highlighting a significant shift in market demand.
- Public Health Risk Assessment: Despite an increase in hantavirus cases linked to a cruise ship, the WHO has assessed the overall risk to the public as low, primarily due to hantaviruses being rodent-borne with human-to-human transmission being rare.
See More
FDA Leadership Shakeup May Impact Biotech Stocks
- Stock Price Surge: Following reports of potential dismissal of FDA Commissioner Marty Makary, shares of Replimune (REPL) and uniQure (QURE) surged by 17% and 15% respectively, indicating market optimism regarding regulatory improvements under new leadership.
- Industry Response: The pharmaceutical industry has expressed dissatisfaction with Makary's drug review policies, citing inconsistencies and overly restrictive processes that hinder innovative drug approvals, suggesting that new leadership could accelerate approval timelines and restore clearer regulatory guidance.
- Potential Beneficiaries: Companies like Replimune and uniQure, which have publicly clashed with the FDA, are seen as potential beneficiaries of new leadership, with Replimune's melanoma therapy RP1 being rejected and uniQure's Huntington's disease gene therapy AMT-130 facing significant shifts in review policy.
- Market Reaction: Despite REPL's stock falling approximately 50% over the past year, QURE's stock has risen by 124%, reflecting investor confidence in the future of the biotech sector and expectations for changes in FDA policies.
See More
Trump Promises Full Report on Hantavirus Outbreak
- Outbreak Overview: The hantavirus outbreak aboard the Dutch-flagged cruise ship Hondius has resulted in three deaths and six confirmed infections among 150 passengers, prompting global attention, with Trump promising a detailed report on Friday, indicating the government's seriousness about the situation.
- Vaccine Development Update: Moderna's partnership with Korea University to develop an mRNA hantavirus vaccine has gained attention, receiving a $176 million government award in 2024, highlighting its critical role in pandemic response and potential to accelerate vaccine development timelines.
- Market Reaction: Vaccine manufacturers and biodefense companies saw stock rallies on Friday night, with Emergent BioSolutions up 3%, Inovio and Novavax each gaining 2%, and Moderna rising 1%, reflecting investor optimism regarding vaccine development amid the outbreak.
- Investor Sentiment: On Stocktwits, retail sentiment for Inovio and Novavax was extremely bullish, while Moderna showed positive sentiment, indicating high market interest in hantavirus-related companies, with Moderna's stock surging 102% over the past year.
See More
Novavax Q1 Revenue Exceeds Expectations with Strong Vaccine Data
- Revenue Beat: Novavax reported Q1 revenue of $139.5 million, surpassing analysts' expectations of $78.3 million, primarily driven by licensing agreements and vaccine supply partnerships, indicating a strategic shift away from reliance on direct COVID vaccine sales.
- Increased Vaccine Preference: Data revealed that patients receiving Nuvaxovid were twice as likely to choose the same vaccine again next year compared to those who received Moderna's vaccine, providing Novavax with a significant competitive edge in the crowded vaccine market.
- 2026 Revenue Outlook: The company maintained its adjusted revenue forecast for 2026 at $230 million to $270 million, with expectations that existing cash and partner reimbursements will fund operations through 2028, even without additional milestone or royalty revenue.
- Optimistic Market Sentiment: Retail sentiment for NVAX on Stocktwits is deemed 'extremely bullish', with a 430% surge in message volume over 24 hours, reflecting strong investor confidence in the company's growth potential, despite a 4% downside from current price targets.
See More
Moderna Reports Strong Q1 2026 Earnings Driven by International Sales
- Significant Revenue Growth: Moderna reported $400 million in revenue for Q1 2026, reflecting a year-over-year increase primarily driven by its long-term strategic partnership with the U.K. government, with expectations of up to 10% growth in 2026 indicating strong international execution.
- New Product Approvals: The company secured approvals for mCOMBRIAX and mNEXSPIKE in the EU, which are expected to be key growth drivers in 2027, further solidifying Moderna's position in the $1.8 billion annual European respiratory vaccines market.
- Rising Cost Expectations: Due to litigation and settlement costs, Moderna has raised its sales cost projection from $900 million to $1.8 billion, which includes a $900 million litigation settlement charge, potentially impacting future profitability.
- Flu Vaccine Progress: Management expressed optimism regarding the regulatory status of its U.S. flu vaccine, with a PDUFA date of August 5 for mRNA-1010, marking a strategic shift from previous disappointment to clearer expectations for future market entry.
See More
