Vaxcyte stock soars 35% on promising VAX-31 vaccine trial results

Vaxcyte Inc (NASDAQ: PCVX) saw a remarkable 35% surge in its stock price during premarket trading today, fueled by positive results from an early study of its pneumococcal conjugate vaccine, VAX-31.

This significant gain highlights growing investor confidence in Vaxcyte’s ability to challenge established competitors in the vaccine market, particularly Pfizer’s Prevnar 20.

In a press release issued on September 2, Vaxcyte revealed that VAX-31 demonstrated a safety profile comparable to Prevnar 20 during a Phase 1/2 clinical trial.

The trial, which involved over 1,000 healthy adults, showed that VAX-31 was well tolerated across all tested doses.

Pneumococcal disease, which the vaccine aims to combat, can lead to severe illnesses such as pneumonia, meningitis, and various ear and sinus infections.

Vaxcyte to proceed with a Phase 3 study of VAX-31

The new data suggest that VAX-31 not only matches but in some cases exceeds the protective efficacy of Pfizer’s Prevnar 20 against pneumococcal strains.

This is a significant milestone for Vaxcyte, considering Prevnar 20’s dominance in the market. Following the encouraging results, Vaxcyte plans to advance VAX-31 to a Phase 3 trial, aiming to confirm its broad-spectrum efficacy and safety.

The Phase 3 study is set to commence in the first half of 2025, with Vaxcyte targeting a Biologics License Application submission by late 2026.

The company will choose a specific dose of VAX-31 before moving forward with the pivotal trial.

The initial results have already positioned VAX-31 as a potential game-changer in the pneumococcal vaccine market, which is projected to exceed $10 billion by 2030.

Is Vaxcyte stock worth owning in September?

Despite the positive trial outcomes, Vaxcyte’s CEO, Grant Pickering, recently sold more than $1.18 million worth of shares.

However, this move has not deterred Wall Street analysts, who currently have a consensus “buy” rating on Vaxcyte stock.

David Risinger of Leerink Partners described the trial results as “stunning” and maintained an “overweight” rating on the stock, citing the strong potential for VAX-31 to capture a significant market share.

Financially, Vaxcyte reported a net loss of $128.7 million for its second quarter, an increase from $68.3 million in the same quarter the previous year.

Nonetheless, the company ended the quarter with $1.85 billion in cash, up from $1.24 billion at the end of Q2 2023.

This strong cash position provides Vaxcyte with the financial stability to continue its development efforts and clinical trials.

Overall, Vaxcyte’s latest vaccine trial results and financial status underscore its potential to become a major player in the pneumococcal vaccine market.

As the company prepares for its next phase of trials, investors and industry observers will be closely watching to see if VAX-31 can live up to its promising start and establish itself as a competitive alternative to existing vaccines.