Invivyd Advances VYD2311 With Key Phase 3 Alignments

Invivyd ( (IVVD) ) has provided an announcement.

Invivyd reported fourth-quarter 2025 PEMGARDA net product revenue of $17.2 million, marking 25% year-over-year and 31% sequential growth, and ended 2025 with $226.7 million in cash and equivalents after raising more than $200 million in the second half of the year. Management highlighted that revenues more than doubled year over year while operating expenses were cut nearly in half, underscoring improved financial discipline and funding capacity for late-stage programs.

Operationally, the company initiated the DECLARATION Phase 3 pivotal trial of VYD2311 in December 2025 to prevent COVID-19, rapidly achieved full enrollment, and received FDA Fast Track designation for the candidate in the same month. An independent data monitoring committee’s favorable safety review allowed enrollment of pregnant and breastfeeding women and relaxed other safety requirements, suggesting a supportive safety profile as the trial progresses toward top-line data expected in mid-2026.

Invivyd also advanced its broader REVOLUTION clinical program, aligning with the U.S. Food and Drug Administration in February 2026 on the LIBERTY Phase 3 trial comparing VYD2311’s safety and immunologic profile with mRNA COVID vaccines and exploring co-administration. In January 2026, the company and the SPEAR Study Group unveiled plans for a Phase 2 trial of VYD2311 in Long COVID or COVID vaccine injury, reinforcing Invivyd’s strategy to position monoclonal antibodies as complementary or alternative prophylaxis options across multiple COVID-related indications.

The DECLARATION trial, which evaluates single and monthly intramuscular dosing regimens of VYD2311 versus placebo with a primary endpoint of reducing PCR-confirmed symptomatic COVID, is on track with early blinded pooled event data indicating adequate trial progress. Earlier Phase 1/2 results showed intramuscular VYD2311 at four times the planned Phase 3 dose was well tolerated with only mild to moderate adverse events deemed unrelated to the drug, supporting continued development as Invivyd seeks to create medical value for patients and shareholders through antibody-based COVID prevention.

The most recent analyst rating on (IVVD) stock is a Buy with a $10.00 price target. To see the full list of analyst forecasts on Invivyd stock, see the IVVD Stock Forecast page.

Spark’s Take on IVVD Stock

According to Spark, TipRanks’ AI Analyst, IVVD is a Neutral.

The score is held back primarily by ongoing large losses and significant free-cash-flow burn, alongside weak technical momentum. Offsetting factors include very strong gross margins, low leverage, and a more positive forward outlook from the earnings call tied to funding and advancement of the VYD2311 pivotal program.

To see Spark’s full report on IVVD stock, click here.

More about Invivyd

Invivyd, Inc. is a biopharmaceutical company focused on developing monoclonal antibody therapies for the prevention of infectious diseases, with an initial emphasis on COVID-19. Its lead marketed product is PEMGARDA (pemivibart), a monoclonal antibody for COVID-19 prophylaxis, and its pipeline centers on VYD2311, a vaccine-alternative antibody being advanced through late-stage clinical programs targeting vulnerable patient populations.

Average Trading Volume: 3,460,735

Technical Sentiment Signal: Sell

Current Market Cap: $448.9M

Find detailed analytics on IVVD stock on TipRanks’ Stock Analysis page.