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FDA Rejected Utebzi; Now Spero Strikes a $1.1B Innovent Deal

FDA Rejected Utebzi; Now Spero Strikes a $1.1B Innovent Deal

Spero’s $1.1B Innovent Deal Signals a High-Stakes Shift Beyond Antibiotics

Spero Therapeutics is moving beyond antibiotics and into immune and inflammatory diseases through a licensing agreement with Innovent Biologics worth up to $1.1 billion. The company will gain rights to develop SP001 outside China. Meanwhile, a separate $105 million financing deal tied to Utebzi royalties will help fund Spero’s new pipeline strategy.

Inside Spero’s $1.1B Bet on Innovent’s CD40L Antibody

The Spero Therapeutics Innovent deal gives Spero the rights to research, develop and commercialize SP001 outside China. Innovent previously called the CD40L antibody IBI355 and tested it in two phase 1 studies involving healthy volunteers.

The company also evaluated the drug in a phase 1b study of patients with Sjögren’s disease, an autoimmune condition that affects the tear and salivary glands.

In return, Innovent may receive an upfront payment, development and commercial milestones, and tiered royalties on future sales. However, the companies did not disclose the financial breakdown of the agreement.

Why SP001 Could Become the Cornerstone of Spero’s New I&I Pipeline

SP001 targets CD40L, a protein found on activated T cells. This pathway helps regulate cell survival, vascular inflammation and anti-tumor immunity. Therefore, Spero sees an opportunity to study the antibody across several autoimmune and inflammatory conditions.

The company plans to advance SP001 into a phase 2 trial for IgG4-related disease. This rare autoimmune condition causes inflammatory lesions and tissue fibrosis.

Meanwhile, Innovent expects to begin a mid-stage study in China for Sjögren’s disease by early 2027. Spero CEO Esther Rajavelu said the licensing agreement establishes the foundation of the company’s new pipeline.

How a $105M Utebzi Royalty Deal Is Funding Spero’s Next Growth Phase

Spero will finance its new direction through a $105 million agreement with Healthcare Royalty, also known as HCRx. In exchange, HCRx will receive payments linked to the royalties that GSK pays Spero from Utebzi sales.

HCRx will receive quarterly principal and interest payments until Spero repays the loan balance. Afterward, HCRx will receive 65% of the Utebzi profits covered by the arrangement.

As a result, Spero can unlock immediate value from future Utebzi revenue and use the capital to advance SP001 and build its immune-mediated disease pipeline.

Utebzi’s Path From FDA Rejection to a Major Strategic Asset

The FDA approved Utebzi in June 2026 for adults with complicated urinary tract infections. GSK now commercializes the oral treatment, which targets drug-resistant bacteria.

The approval also made Utebzi the first oral carbapenem antibiotic approved in the United States. However, the drug followed a difficult regulatory path.

The FDA rejected tebipenem pivoxil hydrobromide in 2022 because the original phase 3 study did not provide enough evidence for approval. Soon afterward, GSK entered a $66 million agreement with Spero to continue development and conduct a new study.

Spero then cut 75% of its workforce. Later, the company reduced staff again after another antibiotic program failed to outperform placebo and raised toxicity concerns.

From Antibiotic Setbacks to a Billion-Dollar Immunology Reset

GSK and Spero reported successful phase 3 results for Utebzi in 2025. Although two former Spero executives later settled SEC allegations related to earlier efficacy statements, the case did not stop the FDA from approving the drug in 2026.

Now, Spero is turning that approval into a broader corporate reset. The Innovent agreement gives the company a new lead asset, while the HCRx financing provides capital for clinical development.

Together, the two deals mark Spero’s shift from a shrinking antibiotic pipeline to a new strategy focused on immune-mediated diseases.

Major pipeline transitions require more than financial investment; they also demand structured risk management, clear change control and quality-focused project governance. Zamann Pharma Support helps pharmaceutical teams manage these challenges through its Quality Management System services across regulated operations.

Source:  Fiercebiotech.Com