Takeda Stock Gains on Promising Phase 3 Psoriasis Drug Data
Oral medication zasocitinib proved superior to Amgen's Otezla, positioning Takeda to challenge Bristol Myers Squibb in the lucrative TYK2 inhibitor market.
Takeda Pharmaceutical Co. (NYSE: TAK) shares climbed Tuesday after the company announced positive topline results from two Phase 3 trials for its oral psoriasis treatment, zasocitinib. The drug not only met all its primary and secondary goals but also demonstrated superiority over Amgen’s established blockbuster, Otezla, signaling a significant potential shift in the competitive landscape for autoimmune disease therapies.
Shares of the Japanese pharmaceutical giant, which has a market capitalization of approximately $48 billion, rose nearly 2.5% to $14.83 in morning trading. The positive data provides a welcome boost to Takeda's late-stage pipeline and positions it to enter the highly competitive multi-billion dollar psoriasis market.
According to the company's official announcement, the two pivotal studies, NCT05792163 and NCT05792176, evaluated the efficacy and safety of the once-daily TYK2 inhibitor in patients with moderate-to-severe plaque psoriasis. Zasocitinib achieved high rates of skin clearance, with more than half of patients reaching at least 90% improvement on the Psoriasis Area and Severity Index (PASI 90) by week 16. Around 30% of patients achieved completely clear skin (PASI 100).
The results position zasocitinib as a potent new contender in oral treatments. The direct demonstration of superiority against Otezla, a widely used PDE4 inhibitor, is a critical differentiating factor. However, the drug's primary competitor will likely be Bristol Myers Squibb’s Sotyktu (deucravacitinib), the first TYK2 inhibitor to gain FDA approval and a drug that has already seen strong market uptake.
TYK2 inhibitors are a newer class of oral medication revered for offering efficacy that approaches injectable biologic drugs while providing the convenience of a daily pill. This has made them a focal point for growth in the immunology sector. While Takeda's trial did not feature a head-to-head comparison with Sotyktu, the strong clearance rates and clean safety profile suggest it will be a formidable competitor.
"The safety and tolerability profile of zasocitinib was consistent with that seen in previous studies," according to an analysis of the data, with the most common adverse events being upper respiratory tract infections and nasopharyngitis. The lack of new safety signals is crucial as Takeda prepares its submission packages for regulatory authorities.
The strategic importance for Takeda is significant. A successful launch of zasocitinib would bolster its immunology franchise and provide a new revenue driver as older products face increasing competition. The company has also indicated that zasocitinib is being investigated for other autoimmune conditions, including psoriatic arthritis and Crohn's disease, highlighting its potential to become a 'pipeline-in-a-product' with multiple blockbuster indications.
Takeda plans to submit these results to the U.S. Food and Drug Administration (FDA) and other global regulatory bodies starting in its 2026 fiscal year, as noted in its regulatory filings. The full detailed results from the Phase 3 program will be presented at an upcoming medical congress. For investors, the focus will now shift to Takeda's execution on the regulatory front and its commercial strategy to carve out market share from established players in a crowded but growing field.