Invivyd Earns Fast Track Designation for VYD2311, a Vaccine-Alternative Antibody to Prevent COVID

Rhea-AI Summary

Invivyd (Nasdaq: IVVD) announced the U.S. FDA granted Fast Track designation for VYD2311, an investigational vaccine-alternative monoclonal antibody to prevent COVID in individuals with underlying risk factors for severe disease. Fast Track can enable priority review and rolling BLA submission if criteria are met.

Invivyd is conducting DECLARATION, a Phase 3, randomized, triple-blind, placebo-controlled, BLA‑enabling trial of VYD2311 with planned total enrollment of 1,770 participants. Participants receive a single or monthly intramuscular dose versus placebo. Top-line data are expected mid-2026.

Positive

• FDA Fast Track designation for VYD2311
• Phase 3 DECLARATION is randomized, triple-blind, placebo-controlled
• Top-line data expected mid-2026
• Planned enrollment of 1,770 participants

Negative

• No efficacy or safety data reported yet
• BLA priority/rolling review eligibility is contingent on meeting FDA criteria
• Top-line readout not expected until mid-2026, delaying near-term clarity

Key Figures

DECLARATION sample size 1,770 participants Phase 3 DECLARATION trial of VYD2311 for COVID prevention

Endpoint timeframe 3 months Prevention of symptomatic COVID assessment window in DECLARATION

Top-line data timing Mid-2026 Expected top-line results from DECLARATION Phase 3 trial

Dosing regimen Single or monthly dose VYD2311 IM dosing arms vs placebo in DECLARATION

Price move 25.22% Share price change over the last 24 hours pre-news

52-week range $0.3546–$3.0699 IVVD 52-week low and high before this news

Form S-3 date 2025-10-02 Shelf registration statement filing date

Shelf usage count 2 offerings Recent 424B5 prospectus supplements under S-3 shelf

Market Reality Check

$2.88 Last Close

Volume Volume 11,592,101 is 2.32x the 20-day average of 5,001,886, signaling elevated interest ahead of Fast Track news. high

Technical Price $2.88 is trading above the 200-day moving average of $1.15, reflecting a pre-existing upward trend.

Peers on Argus 1 Up

IVVD is up 25.22%, while peers show mixed, mostly modest moves: CADL +6.64%, LYEL +10.59%, NMRA +2.26%, AVIR +0.63%, TNXP -0.12%. The magnitude favors a stock-specific reaction.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Nov 25	Conference participation	Neutral	-5.4%	Announcement of participation in Evercore healthcare conference and webcast details.
Nov 24	Pipeline update	Positive	-4.0%	Selection of RSV antibody VBY329 with stronger in vitro potency vs comparators.
Nov 17	Equity offering priced	Negative	+20.9%	Pricing of <b>$125M</b> public offering of stock and pre-funded warrants.
Nov 17	Equity offering proposed	Negative	+20.9%	Announcement of proposed underwritten public offering for VYD2311 and pipeline funding.
Nov 06	Earnings and pipeline	Positive	+1.3%	Q3 2025 results with higher PEMGARDA revenue, lower R&D, and VYD2311 Phase 3 plans.

Pattern Detected

Material pipeline and financing updates often triggered sizable, sometimes contrary, price moves, while routine or conference news saw smaller reactions.

Recent Company History

Over recent months, Invivyd reported Q3 2025 revenue growth and narrowed losses, advanced VYD2311 toward pivotal trials, and strengthened its balance sheet via a $125M equity offering. The company also highlighted RSV candidate VBY329 and participated in an investor conference. Today’s Fast Track designation for VYD2311 and the ongoing DECLARATION Phase 3 trial build directly on prior FDA IND clearance and earlier plans for pivotal studies disclosed in earnings and financing updates.

Regulatory & Risk Context

Active S-3 Shelf Registration 2025-10-02

Invivyd has an active Form S-3 shelf filed on 2025-10-02, later utilized via 424B5 offerings on 2025-11-17 and 2025-11-18. This structure provides flexibility to raise additional capital, as seen with the recent equity and pre-funded warrant offerings that boosted liquidity for VYD2311 commercialization and broader R&D.

Market Pulse Summary

This announcement highlights FDA Fast Track status for VYD2311 and the pivotal DECLARATION Phase 3 trial, targeting 1,770 participants with top-line data expected in mid-2026. It extends a series of positive COVID-19 monoclonal antibody updates and follows earlier financing under an active S-3 shelf to support development and potential commercialization. Investors may watch Phase 3 enrollment progress, regulatory interactions, and any further use of the shelf or equity offerings.

Key Terms

fast track designation regulatory

"FDA has granted Fast Track designation for VYD2311, an investigational..."

A "fast track designation" is a process that speeds up the review and approval of a product or project, allowing it to reach the market or be completed more quickly than usual. For investors, it can signal that a product may become available sooner, potentially leading to earlier revenue or benefits, and indicating a priority status that might influence company performance and market opportunities.

monoclonal antibody medical

"an investigational vaccine-alternative monoclonal antibody candidate for the prevention..."

A monoclonal antibody is a laboratory-made protein designed to recognize and attach to a specific target in the body, such as a disease-causing substance or cell. It functions like a highly precise lock-and-key tool, helping to treat or detect illnesses. For investors, companies developing monoclonal antibodies can represent promising opportunities in the healthcare sector, especially as these treatments often address unmet medical needs.

biologics license application (bla) regulatory

"eligible for priority review and rolling Biologics License Application (BLA) submission..."

A biologics license application (BLA) is a formal request to a government agency seeking approval to sell a biological medicine, such as vaccines or gene therapies, in the market. It is similar to a detailed report that proves the product is safe, effective, and manufactured properly. For investors, a BLA signifies a critical step toward commercial availability, often impacting a company's valuation and market prospects.

placebo-controlled medical

"we move forward with our placebo-controlled, pivotal clinical trial DECLARATION."

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

phase 3 medical

"DECLARATION is a Phase 3, randomized, triple-blind, placebo-controlled trial..."

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

randomized medical

"DECLARATION is a Phase 3, randomized, triple-blind, placebo-controlled trial..."

Randomized means participants or units in a study are assigned to different groups by chance rather than by choice, like flipping a coin to decide who gets a new treatment and who gets a comparison. For investors, randomized designs matter because they reduce bias and make results more trustworthy, so outcomes from randomized studies carry more weight when assessing regulatory approval, commercial prospects, and the risk that trial results will change a company’s valuation.

AI-generated analysis. Not financial advice.

NEW HAVEN, Conn., Dec. 23, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for VYD2311, an investigational vaccine-alternative monoclonal antibody candidate for the prevention of COVID.

Fast Track is a process that enables the FDA to expedite the development and review of new drugs that address a serious or life-threatening condition and fill an unmet medical need. If relevant criteria are met, programs with Fast Track designation can become eligible for priority review and rolling Biologics License Application (BLA) submission, which can reduce the timelines associated with regulatory action. VYD2311 was granted Fast Track designation by the FDA for the prevention of COVID in individuals with underlying risk factors for severe COVID.

“COVID is a critical ongoing endemic and chronic health challenge, and Americans need more options to prevent themselves from getting sick,” said Marc Elia, Chairman of Invivyd’s Board of Directors. “We are thrilled that the FDA recognizes the need to move quickly to prevent COVID as we move forward with our placebo-controlled, pivotal clinical trial DECLARATION.”

Invivyd previously announced initiation of DECLARATION, the company’s BLA-enabling clinical trial of VYD2311. Top-line data from the trial are expected mid-2026.

DECLARATION is a Phase 3, randomized, triple-blind, placebo-controlled trial to evaluate VYD2311 safety and efficacy in prevention of symptomatic COVID in a broad population of participants including adults and adolescents both with and without underlying risk factors for progression to severe COVID-19, at three months. Participants will receive either a single dose or a monthly dose of VYD2311, each administered via intramuscular (IM) injection, compared to placebo. Total enrollment of the trial is expected to be 1770 participants.

About VYD2311

VYD2311 is a novel monoclonal antibody (mAb) candidate being developed for COVID-19 to continue to address the urgent need for new prophylactic and therapeutic options. The pharmacokinetic profile and antiviral potency of VYD2311 may offer the ability to deliver clinically meaningful titer levels through more patient-friendly means such as an intramuscular route of administration.

VYD2311 was engineered using Invivyd’s proprietary integrated technology platform and is the product of serial molecular evolution designed to generate an antibody optimized for neutralizing contemporary virus lineages. VYD2311 leverages the same antibody backbone as pemivibart, Invivyd’s investigational mAb granted emergency use authorization in the U.S. for the pre-exposure prophylaxis (PrEP) of symptomatic COVID-19 in certain immunocompromised patients, and adintrevimab, Invivyd’s investigational mAb that has a robust safety data package and demonstrated clinically meaningful results in global Phase 2/3 clinical trials for the prevention and treatment of COVID-19.

About DECLARATION

DECLARATION is a Phase 3, randomized, triple-blind, placebo-controlled trial to evaluate VYD2311 efficacy and safety in prevention of symptomatic COVID in a broad population of participants including adults and adolescents both with and without risk factors for progression to severe COVID-19, at three months. Participants will receive either a single dose or a monthly dose of VYD2311, each administered via intramuscular (IM) injection, compared to placebo. Total enrollment of the trial is expected to be 1770 participants.

About Invivyd

Invivyd, Inc. (Nasdaq: IVVD) is a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2. Invivyd deploys a proprietary integrated technology platform unique in the industry designed to assess, monitor, develop, and adapt to create best in class antibodies. In March 2024, Invivyd received emergency use authorization (EUA) from the U.S. FDA for a monoclonal antibody (mAb) in its pipeline of innovative antibody candidates. Visit https://invivyd.com/ to learn more.

Trademarks are the property of their respective owners.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “believes,” “could,” “expects,” “estimates,” “intends,” “plans,” “potential,” “predicts,” “projects,” and “future” or similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements include statements concerning, among other things, plans related to the company’s research and development activities, and the timing and potential results thereof; expectations regarding the company’s clinical trial designs and enrollment, regulatory pathway, product profile, indication and administration paradigm for VYD2311; the potential of VYD2311 as a novel mAb candidate that may be able to deliver clinically meaningful titer levels through more patient-friendly means; the potential benefits of Fast Track designation; expectations regarding the COVID landscape, and beliefs about the need for more options to prevent Americans from getting sick; the company’s devotion to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2; and other statements that are not historical fact. The company may not actually achieve the plans, intentions or expectations disclosed in the company’s forward-looking statements and you should not place undue reliance on the company’s forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause the company’s actual results to differ materially from the results described in or implied by the forward-looking statements, including, without limitation: the timing, progress and results of the company’s discovery, preclinical and clinical development activities, including advancement of the DECLARATION clinical trial, and finalization and initiation of other aspects of the REVOLUTION clinical program, such as the LIBERTY clinical trial, subject to final alignment with the U.S. FDA; clinical trial site activation or enrollment rates; the risk that results of nonclinical studies or clinical trials may not be predictive of future results, and interim data are subject to further analysis; unexpected safety or efficacy data observed during preclinical studies or clinical trials; the predictability of clinical success of the company’s product candidates based on neutralizing activity in nonclinical studies; potential variability in neutralizing activity of product candidates tested in different assays, such as pseudovirus assays and authentic assays; variability of results in models and methods used to predict activity against SARS-CoV-2 variants; whether the epitope that VYD2311 targets remains structurally intact; whether the company’s product candidates are able to demonstrate and sustain neutralizing activity against major SARS-CoV-2 variants, particularly in the face of viral evolution; changes in the regulatory environment; the outcome of the company’s engagement with regulators; uncertainties related to the regulatory approval process, and available development and regulatory pathways; the company’s ability to generate the data needed to support a potential BLA submission for VYD2311; whether the company is able to realize the potential benefits of Fast Track designation for VYD2311; how long the EUA granted by the FDA for a mAb in the company’s pipeline will remain in effect and whether the EUA is revised or revoked by the FDA; the ability to maintain a continued acceptable safety, tolerability and efficacy profile of any product candidate following regulatory authorization or approval; changes in expected or existing competition; the company’s reliance on third parties; complexities of manufacturing mAb therapies, and availability of quantities of commercial launch product in the future; macroeconomic and political uncertainties; the company’s ability to continue as a going concern; and whether the company has adequate funding to meet future operating expenses and capital expenditure requirements. Other factors that may cause the company’s actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading “Risk Factors” in the company’s Annual Report on Form 10-K for the year ended December 31, 2024 and its Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, each filed with the Securities and Exchange Commission (SEC), and in the company’s other filings with the SEC, and in its future reports to be filed with the SEC and available at www.sec.gov. Forward-looking statements contained in this press release are made as of this date, and Invivyd undertakes no duty to update such information whether as a result of new information, future events or otherwise, except as required under applicable law.

This press release contains hyperlinks to information that is not deemed to be incorporated by reference in this press release.

Contacts:

Media Relations
(781) 208-0160
media@invivyd.com

Investor Relations
(781) 208-1747
investors@invivyd.com

FAQ

What did Invivyd (IVVD) announce about VYD2311 on December 23, 2025?

The company said the FDA granted Fast Track designation for VYD2311 to prevent COVID in individuals with risk factors for severe disease.

What is the design of Invivyd's Phase 3 DECLARATION trial for VYD2311 (IVVD)?

DECLARATION is a Phase 3, randomized, triple-blind, placebo-controlled trial evaluating single or monthly IM doses versus placebo.

How many participants will Invivyd enroll in the DECLARATION trial (IVVD)?

Total enrollment is planned at 1,770 participants.

When does Invivyd expect top-line results for VYD2311 (IVVD)?

Top-line data from the DECLARATION trial are expected mid-2026.

What regulatory benefits can Fast Track give VYD2311 for Invivyd (IVVD)?

Fast Track can enable expedited development, potential priority review, and rolling BLA submission if criteria are met.

Who is the target population for VYD2311 in Invivyd's (IVVD) Fast Track designation?

The designation covers prevention of COVID in individuals with underlying risk factors for progression to severe COVID.