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.