Time-Sensitive: Allegations Focus on Overstated REZOLVE-AA Trial Integrity and Prospects

Levi & Korsinsky, LLP alerts investors in Nektar Therapeutics (NASDAQ: NKTR) of a pending securities class action. Class Period: February 26, 2025 through December 15, 2025. Check if you can recover your investment losses or contact Joseph E. Levi, Esq. at jlevi@levikorsinsky.com | (212) 363-7500.

Nektar shares fell $4.14 per share, or 7.77%, closing at $49.16 on December 16, 2025, after the Company disclosed that its Phase 2b REZOLVE-AA trial narrowly missed statistical significance on its primary endpoint. The Court has set May 5, 2026 as the deadline to apply for lead plaintiff appointment.

How Alleged Protocol Failures Undermined the Trial's Stated Prospects

The lawsuit asserts that throughout the Class Period, management repeatedly portrayed the REZOLVE-AA trial as rigorously conducted, with enrollment criteria carefully designed to screen out ineligible patients. Statements emphasized that only patients with severe-to-very-severe alopecia areata confirmed by SALT scores at both screening and randomization were included, and that patients with unstable disease courses or inadequate washout periods were excluded.

As alleged, these representations painted a misleading picture of the trial's overall integrity and commercial prospects. The action claims that management knew or recklessly disregarded that enrollment had not followed the stated protocol standards, meaning the trial's prospects for achieving statistical significance were overstated.

Why Trial Integrity Allegedly Matters to Investors

For a clinical-stage biopharmaceutical company like Nektar, the perceived integrity of a pivotal trial is directly tied to the company's valuation. The lawsuit contends that by overstating the REZOLVE-AA trial's prospects, management artificially inflated NKTR's stock price during the Class Period. Key allegations include:

• Management described "unique operational features" designed to "minimize clinical operational risk" while four patients with major eligibility violations had been randomized into the trial
• The Company raised approximately $115 million in a July 2025 public offering while the trial's integrity was allegedly compromised
• Two patients had unstable alopecia areata diagnosed less than six months before randomization, a standard exclusion criterion management repeatedly cited as enforced
• Two additional patients began treatment before completing the prerequisite 8-week washout period for prior medications
• When the four ineligible patients were excluded from analysis, both treatment arms achieved statistical significance, underscoring how their inclusion skewed the reported results
• Annual bonuses for senior leadership were tied in part to maintaining REZOLVE-AA enrollment timelines, creating alleged motive to overlook protocol deviations

Speak with an attorney about recovering damages or call (212) 363-7500.

"Investors deserve transparency about material risks that could affect their investments. When a company's lead clinical trial is the primary driver of shareholder value, the integrity of that trial's enrollment process is not a minor operational detail — it is material information." -- Joseph E. Levi, Esq.

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