Invivyd Receives FDA Termination Notice for Pemgarda EUA
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1 day ago
0mins
Invivyd announced that the FDA has sent Invivyd a notice of termination for the Pemgarda Emergency Use Authorization, or EUA, following the U.S. Department of Health and Human Services', or HHS, announcement of advanced notice of termination of the COVID-19 EUA declaration on June 30, with an effective date of June 29, 2027. Consequently, the EUA for Pemgarda is set to terminate on June 29, 2027. Pemgarda is Invivyd's investigational monoclonal antibody authorized by the FDA under an EUA since March 2024 for the pre-exposure prophylaxis of COVID-19 in certain adults and adolescents who have moderate-to-severe immune compromise due to certain medical conditions or receipt of certain immunosuppressive medications or treatments and are unlikely to mount an adequate immune response to COVID-19 vaccination.
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Analyst Views on IVVD
Wall Street analysts forecast IVVD stock price to rise
4 Analyst Rating
3 Buy
1 Hold
0 Sell
Strong Buy
Current: 0.834
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10.00
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10.00
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Current: 0.834
Low
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Averages
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About IVVD
Invivyd, Inc. is a biopharmaceutical company. The Company’s proprietary INVYMAB platform approach combines state-of-the-art viral surveillance and predictive modeling with advanced antibody engineering. INVYMAB is designed to facilitate the rapid, serial generation of new monoclonal antibodies (mAbs) to keep pace with evolving viral threats. The Company delivers antibody-based therapies that protect vulnerable people from the devastating consequences of circulating viral threats, such as SARS-CoV-2. Its PEMGARDA (pemivibart) is the Company's first mAb to receive regulatory authorization and is designed to keep pace with SARS-CoV-2 viral evolution. PEMGARDA is used for the pre-exposure prophylaxis (prevention) of COVID-19 in adults and adolescents. Its VYD2311 is optimized for neutralization potency against SARS-CoV-2 lineages such as BA.2.86 and JN.1. The Company also has additional anti-SARS-CoV-2 mAb candidates in discovery and pre-clinical characterization.
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.
Invivyd Faces Expiration of PEMGARDA Emergency Authorization
- Emergency Authorization Expiry: Invivyd's PEMGARDA treatment is set to expire on June 29, 2027, unless the company secures full FDA approval beforehand, which could significantly impact its market position and revenue stream.
- Significant Revenue Growth: In 2025, PEMGARDA generated $53.4 million in net product revenue for Invivyd, more than doubling the $25.4 million recorded in its partial sales year of 2024, indicating strong market demand.
- Proactive FDA Communication: Invivyd is actively engaging with the FDA and plans to pursue every available path to ensure PEMGARDA remains accessible for immunocompromised patients, reflecting the company's commitment to patient needs.
- Market Sentiment Dismal: Despite all analysts rating IVVD as a 'Buy', retail sentiment around the stock has remained in the 'bearish' territory over the past 24 hours, indicating investor uncertainty about the future.
See More
Invivyd's COVID-19 Monoclonal Antibody Authorization Terminated
- Emergency Use Authorization Termination: The FDA has terminated Invivyd's emergency use authorization for PEMGARDA, effective June 29, 2027, following the Department of Health and Human Services' advanced notice of termination on June 30, 2026, indicating a significant shift in COVID-19 treatment strategies.
- Market Reaction Volatility: Following the announcement, IVVD shares initially fell approximately 6% in premarket trading before rebounding to a 1.8% increase, reflecting the market's mixed response and investor caution regarding the company's future prospects.
- Drug Background Information: PEMGARDA received FDA emergency use authorization in March 2024 for COVID-19 prevention in immunocompromised patients, and the termination of this authorization could impact treatment options for this vulnerable group, potentially affecting Invivyd's market share.
- Ongoing Dialogue: Invivyd has stated it is in discussions with the FDA regarding next steps, indicating that the company is actively seeking solutions, which may influence its future research directions and market strategies.
See More
Invivyd Receives Notice of Termination for COVID-19 EUA
- EUA Termination Notice: The U.S. Department of Health and Human Services (HHS) announced the termination of the COVID-19 Emergency Use Authorization (EUA) effective June 29, 2027, which directly impacts Invivyd's PEMGARDA, leading to its EUA termination on the same date, potentially affecting the company's future revenue and market position.
- Clinical Trial Results: PEMGARDA has demonstrated strong COVID-19 protection in randomized clinical trials and has been in clinical use for over two years, serving as a critical non-vaccine option for immune-compromised and other vulnerable populations; however, the termination of the EUA may lead to decreased market acceptance.
- Ongoing Regulatory Dialogue: Invivyd is in dialogue with the FDA to seek a regulatory approval pathway for PEMGARDA, although no explicit written advice has been received to date, creating uncertainty that may impact the company's strategic planning and investor confidence.
- Board Commentary: Invivyd's Board Chairman Marc Elia stated that while the EUA has provided an important COVID-19 prevention option for vulnerable populations, it does not equate to product approval, emphasizing the company's confidence that PEMGARDA's clinical data is sufficient to support a Biologics License Application (BLA) and expressing optimism for the future.
See More
Invivyd Grants Stock Options to New Employees
- Stock Option Grant: On July 1, 2026, Invivyd granted stock options for a total of 493,000 shares to 14 newly hired non-executive employees as a significant inducement for their employment, reflecting the company's commitment to attracting talent.
- Exercise Price: The options have an exercise price of $0.8544 per share, which matches the closing price of Invivyd's common stock on the grant date, thereby aligning employee incentives with company performance.
- Vesting Schedule: The options vest over four years, with 25% vesting on the first anniversary and the remainder vesting in equal monthly installments, which enhances employee loyalty and stability as they remain with the company.
- Long-Term Incentive: With a 10-year term, the options are subject to the terms of the Invivyd 2026 Inducement Plan, aiming to boost employee motivation and overall company performance through a long-term incentive structure.
See More
Invivyd Completes Enrollment in LIBERTY Clinical Trial for VYD2311
- Trial Enrollment Complete: Invivyd has announced the completion of participant enrollment in its LIBERTY clinical trial, which will compare the safety and tolerability of the monoclonal antibody VYD2311 with an mRNA COVID-19 vaccine, with initial results expected in Q3 2026, potentially released alongside DECLARATION trial data.
- Significant Clinical Comparison: The LIBERTY trial will evaluate the safety and immune response when VYD2311 is administered alongside the vaccine, and if VYD2311 demonstrates improved side effects and tolerability, it could provide a crucial alternative for COVID-19 prevention, potentially enhancing public health outcomes.
- REVOLUTION Program: The LIBERTY trial is part of Invivyd's broader REVOLUTION clinical program, aimed at establishing VYD2311 as the preferred option for COVID-19 prevention, which, if approved, would offer more choices for Americans and address vaccine hesitancy.
- Participant Scale: The LIBERTY trial involves approximately 210 healthy adults and will last for seven days, focusing on assessing the side effects and tolerability of COVID antibodies versus vaccines, providing critical data for future clinical applications.
See More
Invivyd Initiates Phase 3 Trial for VYD2311 Monoclonal Antibody
- Trial Launch: Invivyd announced that the first participant in its Phase 3 LIBERTY trial has been dosed with VYD2311, an investigational monoclonal antibody for COVID-19, marking a significant advancement in the company's antiviral treatment efforts.
- Trial Design Details: The LIBERTY trial is a randomized, double-blind study aiming to enroll approximately 210 participants aged 18 to 49, focusing on evaluating the safety of VYD2311 and its co-administration with an mRNA COVID-19 vaccine, highlighting the company's commitment to innovative therapies.
- Fast-Track Designation: VYD2311 has received fast-track designation from the U.S. FDA, indicating its potential importance in COVID-19 treatment and possibly accelerating its market entry, which could enhance the company's competitive position in the biopharmaceutical sector.
- Market Performance: Invivyd's stock has traded between $0.4830 and $3.070 over the past year, closing at $0.99, and despite recent declines, the clinical progress may positively influence future stock performance.
See More
Invivyd Faces Expiration of PEMGARDA Emergency Authorization
- Emergency Authorization Expiry: Invivyd's PEMGARDA treatment is set to expire on June 29, 2027, unless the company secures full FDA approval beforehand, which could significantly impact its market position and revenue stream.
- Significant Revenue Growth: In 2025, PEMGARDA generated $53.4 million in net product revenue for Invivyd, more than doubling the $25.4 million recorded in its partial sales year of 2024, indicating strong market demand.
- Proactive FDA Communication: Invivyd is actively engaging with the FDA and plans to pursue every available path to ensure PEMGARDA remains accessible for immunocompromised patients, reflecting the company's commitment to patient needs.
- Market Sentiment Dismal: Despite all analysts rating IVVD as a 'Buy', retail sentiment around the stock has remained in the 'bearish' territory over the past 24 hours, indicating investor uncertainty about the future.
See More
Invivyd's COVID-19 Monoclonal Antibody Authorization Terminated
- Emergency Use Authorization Termination: The FDA has terminated Invivyd's emergency use authorization for PEMGARDA, effective June 29, 2027, following the Department of Health and Human Services' advanced notice of termination on June 30, 2026, indicating a significant shift in COVID-19 treatment strategies.
- Market Reaction Volatility: Following the announcement, IVVD shares initially fell approximately 6% in premarket trading before rebounding to a 1.8% increase, reflecting the market's mixed response and investor caution regarding the company's future prospects.
- Drug Background Information: PEMGARDA received FDA emergency use authorization in March 2024 for COVID-19 prevention in immunocompromised patients, and the termination of this authorization could impact treatment options for this vulnerable group, potentially affecting Invivyd's market share.
- Ongoing Dialogue: Invivyd has stated it is in discussions with the FDA regarding next steps, indicating that the company is actively seeking solutions, which may influence its future research directions and market strategies.
See More
Invivyd Receives Notice of Termination for COVID-19 EUA
- EUA Termination Notice: The U.S. Department of Health and Human Services (HHS) announced the termination of the COVID-19 Emergency Use Authorization (EUA) effective June 29, 2027, which directly impacts Invivyd's PEMGARDA, leading to its EUA termination on the same date, potentially affecting the company's future revenue and market position.
- Clinical Trial Results: PEMGARDA has demonstrated strong COVID-19 protection in randomized clinical trials and has been in clinical use for over two years, serving as a critical non-vaccine option for immune-compromised and other vulnerable populations; however, the termination of the EUA may lead to decreased market acceptance.
- Ongoing Regulatory Dialogue: Invivyd is in dialogue with the FDA to seek a regulatory approval pathway for PEMGARDA, although no explicit written advice has been received to date, creating uncertainty that may impact the company's strategic planning and investor confidence.
- Board Commentary: Invivyd's Board Chairman Marc Elia stated that while the EUA has provided an important COVID-19 prevention option for vulnerable populations, it does not equate to product approval, emphasizing the company's confidence that PEMGARDA's clinical data is sufficient to support a Biologics License Application (BLA) and expressing optimism for the future.
See More
Invivyd Grants Stock Options to New Employees
- Stock Option Grant: On July 1, 2026, Invivyd granted stock options for a total of 493,000 shares to 14 newly hired non-executive employees as a significant inducement for their employment, reflecting the company's commitment to attracting talent.
- Exercise Price: The options have an exercise price of $0.8544 per share, which matches the closing price of Invivyd's common stock on the grant date, thereby aligning employee incentives with company performance.
- Vesting Schedule: The options vest over four years, with 25% vesting on the first anniversary and the remainder vesting in equal monthly installments, which enhances employee loyalty and stability as they remain with the company.
- Long-Term Incentive: With a 10-year term, the options are subject to the terms of the Invivyd 2026 Inducement Plan, aiming to boost employee motivation and overall company performance through a long-term incentive structure.
See More
Invivyd Completes Enrollment in LIBERTY Clinical Trial for VYD2311
- Trial Enrollment Complete: Invivyd has announced the completion of participant enrollment in its LIBERTY clinical trial, which will compare the safety and tolerability of the monoclonal antibody VYD2311 with an mRNA COVID-19 vaccine, with initial results expected in Q3 2026, potentially released alongside DECLARATION trial data.
- Significant Clinical Comparison: The LIBERTY trial will evaluate the safety and immune response when VYD2311 is administered alongside the vaccine, and if VYD2311 demonstrates improved side effects and tolerability, it could provide a crucial alternative for COVID-19 prevention, potentially enhancing public health outcomes.
- REVOLUTION Program: The LIBERTY trial is part of Invivyd's broader REVOLUTION clinical program, aimed at establishing VYD2311 as the preferred option for COVID-19 prevention, which, if approved, would offer more choices for Americans and address vaccine hesitancy.
- Participant Scale: The LIBERTY trial involves approximately 210 healthy adults and will last for seven days, focusing on assessing the side effects and tolerability of COVID antibodies versus vaccines, providing critical data for future clinical applications.
See More
Invivyd Initiates Phase 3 Trial for VYD2311 Monoclonal Antibody
- Trial Launch: Invivyd announced that the first participant in its Phase 3 LIBERTY trial has been dosed with VYD2311, an investigational monoclonal antibody for COVID-19, marking a significant advancement in the company's antiviral treatment efforts.
- Trial Design Details: The LIBERTY trial is a randomized, double-blind study aiming to enroll approximately 210 participants aged 18 to 49, focusing on evaluating the safety of VYD2311 and its co-administration with an mRNA COVID-19 vaccine, highlighting the company's commitment to innovative therapies.
- Fast-Track Designation: VYD2311 has received fast-track designation from the U.S. FDA, indicating its potential importance in COVID-19 treatment and possibly accelerating its market entry, which could enhance the company's competitive position in the biopharmaceutical sector.
- Market Performance: Invivyd's stock has traded between $0.4830 and $3.070 over the past year, closing at $0.99, and despite recent declines, the clinical progress may positively influence future stock performance.
See More
