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NKTR Investor Alert: Nektar Therapeutics Securities Fraud Lawsuit - Investors With Losses May Seek to Lead the Class Action After Allegedly Misrepresenting Enrollment Protocol Compliance: Levi & Korsinsky
Promise vs. Reality: The Nektar Therapeutics REZOLVE-AA Performance Gap
NEW YORK, May 04, 2026 (GLOBE NEWSWIRE) -- Nektar Therapeutics (NASDAQ: NKTR) promised investors a rigorously controlled Phase 2b clinical trial. The results told a different story. Find out if you can recover your investment losses or contact Joseph E. Levi, Esq. at jlevi@levikorsinsky.com or (212) 363-7500.
On December 16, 2025, Nektar disclosed that four patients included in the REZOLVE-AA trial had "major study eligibility violations that should have disqualified them for randomization." NKTR shares fell $4.14 per share, or 7.77%, closing at $49.16. The lead plaintiff deadline is May 5, 2026.
The Promise
From February through November 2025, the company made specific, repeated representations to shareholders about the REZOLVE-AA trial's enrollment standards:
- Patients had to present with severe-to-very-severe disease at SALT 50 to SALT 100 "for at least six months" to be eligible
- Patients with "unstable" alopecia areata over the prior six months were excluded
- Patients with diffuse alopecia and other forms of alopecia were excluded
- An eight-week washout period for prior alopecia areata medications was required before randomization
- Management touted "unique operational features" designed to "minimize clinical operational risk"
- SEC filings claimed Nektar used its "drug development expertise to advance [its] molecules through ... clinical development"
These assurances were delivered across press releases, quarterly earnings calls, SEC filings, and the July 2025 Fast Track designation announcement.
The Reality
The December 16, 2025 disclosure revealed a starkly different picture. Two of the four ineligible patients had unstable alopecia areata diagnosed less than six months before randomization, directly violating the exclusion criteria the company had repeatedly emphasized. Two additional patients began treatment before completing the prerequisite eight-week washout period for prior medications.
The trial's primary endpoint narrowly missed statistical significance with the ineligible patients included. When those four patients were excluded, both treatment arms met statistical significance, underscoring how directly these enrollment failures affected the outcome investors had been anticipating for months.
The Numbers: Promised vs. Actual
| What Was Promised | What Happened |
| Only patients with 6+ months stable disease enrolled | 2 patients diagnosed less than 6 months prior were included |
| 8-week medication washout completed before randomization | 2 patients started treatment before completing washout |
| Trial designed to "minimize clinical operational risk" | 4 patients with major eligibility violations randomized |
| Primary endpoint expected to demonstrate efficacy | Primary endpoint missed statistical significance (p=0.186 and p=0.121) |
| Enrollment followed "applicable instructions and protocol standards" | Enrollment violated the company's own stated criteria |
What the Lawsuit Alleges About the Gap
A securities class action filed in the U.S. District Court for the Northern District of California contends that the gap between Nektar's promises and the trial's reality was not a surprise to management. The action alleges that defendants knew or recklessly disregarded that enrollment had not followed protocol standards, and that this failure was likely to negatively impact trial results. During the Class Period (February 26, 2025 through December 15, 2025), the company raised approximately $115 million through a public stock offering and CEO Howard W. Robin sold nearly $1 million in personal shares, the complaint asserts.
"Companies that make specific promises to investors about future performance have an obligation to disclose known risks to those projections. The repeated, detailed enrollment representations here make the gap between what was said and what occurred particularly significant for shareholders." -- Joseph E. Levi, Esq.
Evaluate whether you qualify to recover losses from NKTR or call (212) 363-7500.
LEAD PLAINTIFF DEADLINE: May 5, 2026
Levi & Korsinsky, LLP is a nationally recognized shareholder rights firm. Over the past 20 years, the firm has secured hundreds of millions of dollars for aggrieved shareholders. Ranked in ISS Top 50 for seven consecutive years.
CONTACT:
Levi & Korsinsky, LLP
Joseph E. Levi, Esq.
Ed Korsinsky, Esq.
33 Whitehall Street, 27th Floor
New York, NY 10004
Tel: (212) 363-7500
Fax: (212) 363-7171
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