Vaxcyte Shares Soar on Promising Pneumococcal Vaccine Trial Results

Vaxcyte's shares surged by 36% following the successful results of its Phase 3 trial for the pneumococcal vaccine VAX-31. The trial, known as OPUS-1, achieved all primary goals in testing the vaccine on adults aged 50 and older. VAX-31 outperformed Pfizer’s Prevnar 20 on all 20 shared strains and met the criteria on 17 of 19 strains compared to Merck’s Capvaxive.

CEO Grant Pickering highlighted that VAX-31 'sets a new benchmark for the class,' indicating strong potential for FDA approval. The trial also demonstrated that VAX-31's safety profile is similar to its competitors. However, the company's Chief Scientific Officer James Wassil noted that the FDA will likely focus on the comparison with Capvaxive, given its relevance to current U.S. epidemiology.

Looking ahead, Vaxcyte plans to release results from the OPUS-2 and OPUS-3 trials in the first half of 2027 and aims to file with the FDA in the first half of 2028. Despite the positive trial results, the company is burning through cash, with free cash flow reaching -$713 million in 2025. This financial strain suggests a potential capital raise in the near future.

The company projects significant growth in the pneumococcal vaccine market, expecting it to expand from $8.5 billion in 2023 to about $12 billion by 2030. VAX-31 could cover around 95% of invasive pneumococcal disease in U.S. adults 50 and older, positioning Vaxcyte as a strong competitor to established drugs from Pfizer and Merck.