Invivyd Gets Second Nasdaq Warning Amid FDA Product Termination
Distressed
Company Background
Invivyd is a biopharmaceutical company whose entire commercial operation rests on PEMGARDA (pemivibart), a monoclonal antibody authorized under an FDA emergency use authorization since March 2024 for pre-exposure prophylaxis of COVID-19 in immunocompromised adults and adolescents. Revenue from PEMGARDA has grown steadily — from $25.4 million for all of 2024 to $53.4 million in 2025, with Q1 2026 adding another $13.7 million — but the company has never been profitable and carries an accumulated deficit of nearly $996 million as of March 31, 2026.
In the second half of 2025, Invivyd executed two large equity offerings to fund development of VYD2311, a next-generation intramuscular antibody designed to prevent COVID in a broader population. The August 2025 offering raised net proceeds of approximately $53.5 million at $0.52 per share; a November 2025 offering, priced at $2.50 per share as the stock recovered, raised approximately $117.2 million. Year-end 2025 cash stood at $226.7 million, falling to $184.2 million by March 31, 2026 as the company ramped spending on the Phase 3 DECLARATION trial for VYD2311.
Q1 2026 total operating expenses were $56.9 million — more than four times quarterly revenue — driven by $30.7 million in research and development costs, up from $10.6 million a year earlier. The net loss for the quarter was $41.4 million. Management stated as of May 2026 that existing cash, supplemented by approximately $20 million in April 2026 ATM proceeds, was expected to carry the company through the DECLARATION data readout and support a potential VYD2311 launch if approved.
What Was Disclosed
On July 23, 2026, Invivyd received a deficiency letter from Nasdaq's Listing Qualifications Department stating that its common stock had closed below the $1.00 per share minimum bid price for 30 consecutive business days, a violation of Nasdaq Listing Rule 5450(a)(1) required for continued listing on The Nasdaq Global Market. The notice has no immediate effect on trading, and IVVD continues to be listed. Under Nasdaq rules, the company has until January 19, 2027 — the "Initial Compliance Period" — to regain compliance by sustaining a closing bid price at or above $1.00 for at least ten consecutive business days, unless Nasdaq staff exercises discretion to extend that window.
If compliance is not regained by January 19, 2027, the company may qualify for an additional 180-day period by transferring to The Nasdaq Capital Market, provided it meets that market's other listing requirements and Nasdaq staff concludes the deficiency can be cured. There is no assurance that Nasdaq would grant such an extension or that the company could cure the deficiency if one were granted. If Nasdaq ultimately issues a delisting notice, the company would have the right to appeal to a Nasdaq Hearings Panel, though the outcome of any such appeal is also uncertain. The company stated it intends to monitor the stock's closing bid price and consider available options to restore compliance.
Why It Matters
This is the second Nasdaq minimum bid price deficiency Invivyd has faced in approximately 15 months. The first notice arrived on April 21, 2025, when the stock had been below $1.00 for 30 consecutive business days; Nasdaq confirmed compliance was regained on September 22, 2025, following that recovery. The August 2025 equity offering — priced at $0.52 per share, itself a reflection of the stock's distressed level at the time — helped fund the balance sheet rebuild that enabled the stock to recover temporarily. The November 2025 follow-on at $2.50 per share marked what appeared to be a meaningful re-rating. The stock is now back below $1.00 less than ten months after the first compliance letter was closed.
The deficiency notice arrived 17 days after the FDA sent Invivyd formal notice, on July 6, 2026, that PEMGARDA's EUA would terminate on June 29, 2027 — a consequence of HHS announcing on June 30, 2026 the end of the broader COVID-19 EUA declaration. PEMGARDA is Invivyd's sole source of revenue, and its authorization is now on a known 12-month countdown. The stock fell below $1.00 following that regulatory announcement, which directly produced the 30-day threshold required for the Nasdaq deficiency letter. The company stated it believes PEMGARDA has sufficient clinical and post-authorization data for a full Biologics License Application, and management says it is in active dialogue with the FDA about next steps — though as of July 6, neither HHS nor FDA had provided the written regulatory pathway advice that federal statute requires them to give.
The potential counterweight is VYD2311, whose Phase 3 DECLARATION trial completed enrollment in March 2026 and is now expected to deliver top-line data in Q3 2026, modestly delayed from the original mid-2026 guidance due to a pre-specified sample size increase. A positive result and successful BLA filing could replace or succeed PEMGARDA as the company's commercial foundation. The company's cash runway — $184.2 million at the end of Q1 2026 plus approximately $20 million raised via ATM in April — is intended to carry through that readout and support a potential launch. The central risk is that the regulatory and compliance pressures arrive before that data does, and a stock persistently below $1.00 constrains the company's ability to raise additional capital on reasonable terms.