Over the month leading up to mid-September, shares of Nektar Therapeutics (NASDAQ: NKTR) and Mineralys Therapeutics (NASDAQ: MLYS) surged by more than 100% each. Clinical trial progress and potential blockbuster drug prospects drove the rally, yet significant risks remain behind these high returns.
Nektar’s stock rose 108% over the month ending September 18, fueled by promising Phase 2b trial data for its lead drug candidate, rezpegaldesleukin, an IL-2 pathway agonist. In the Rezolve-AD trial targeting moderate-to-severe eczema patients, 42% of the high-dose group achieved 75% skin clearance—compared to 17% in the placebo group—performing on par with early data for Dupixent, a blockbuster eczema drug with $14.2 billion in annual sales.
Notably, among patients treated for 24 weeks, the rate of 75% skin clearance rose to 62%, indicating sustained efficacy potential. With a current market cap of approximately $989 million, Nektar is valued lower than many peers—but the stock has historically been volatile. The company, founded in 1990, has no commercialized products to date. Success in Phase 3 trials could push the stock higher, but investors should tread carefully given the high risks.
From August 18 to September 19, Mineralys shares skyrocketed 155%, largely driven by positive Phase 3 results from a potential competitor, AstraZeneca. Mineralys’ lead candidate, lorundrostat, an aldosterone-targeting therapy for hypertension, achieved a placebo-adjusted reduction of 9.1 mmHg in systolic blood pressure in its Phase 3 trial—comparable to AstraZeneca’s baxdrostat (9.8 mmHg reduction).
The company plans to submit a New Drug Application (NDA) to the FDA around late 2025 or early 2026. With a current market cap of $3 billion, and $325 million in cash as of June 30—plus an additional $288 million raised in a recent secondary offering—Mineralys is well-funded through the FDA review process. However, any delays in development or intensified competition could lead to a sharp pullback.
Both companies are in critical R&D stages with no commercial products generating revenue. Nektar must confirm efficacy in Phase 3 trials, while Mineralys faces fierce competition from large pharma players. Although target markets are large (e.g., millions with treatment-resistant hypertension), biotech stocks are inherently volatile. These investments are suitable only for investors with a higher risk tolerance.
