NKTR Investor Alert: Nektar Therapeutics Securities Fraud Lawsuit - Investors With Losses May Seek to Lead the Class Action After Allegedly Concealed Trial Protocol Violations: Levi & Korsinsky
Important Notice Regarding Alleged Clinical Trial Enrollment Misrepresentations
NEW YORK, March 23, 2026 (GLOBE NEWSWIRE) -- Levi & Korsinsky, LLP notifies investors in Nektar Therapeutics (NASDAQ: NKTR) that a class action lawsuit has been filed on behalf of shareholders who purchased securities between February 26, 2025 and December 15, 2025. Find out if you qualify to recover losses. You may also contact Joseph E. Levi, Esq. at jlevi@levikorsinsky.com or (212) 363-7500.
Nektar shares fell $4.14 per share, or 7.77%, after the Company disclosed that four patients with major eligibility violations had been included in its pivotal REZOLVE-AA Phase 2b trial, causing the trial's primary endpoint to miss statistical significance.
How Alleged Protocol Failures Undermined the REZOLVE-AA Trial
The autoimmune disease drug development space demands strict adherence to clinical trial protocols, particularly regarding patient eligibility screening. For Nektar's REZOLVE-AA trial evaluating rezpegaldesleukin in alopecia areata, the complaint contends that the Company repeatedly assured investors that enrollment followed rigorous standards, including SALT score screening at both screening and randomization, exclusion of patients with unstable disease courses under six months, and mandatory eight-week washout periods for prior treatments. The lawsuit alleges these assurances were materially false because the Company had enrolled patients who did not meet these criteria.
Key Clinical Trial Enrollment Allegations for Shareholders
- Two patients allegedly had unstable alopecia areata, with initial diagnoses less than six months prior to randomization, violating the protocol's stability requirement
- Two additional patients allegedly began treatment before completing the prerequisite eight-week washout period for prior alopecia areata medications
- The trial's primary endpoint narrowly missed statistical significance with the ineligible patients included (p=0.186 and p=0.121 for the two dosing arms)
- Both treatment arms allegedly met statistical significance on the primary endpoint when the four ineligible patients were excluded from the analysis
- Management repeatedly described "unique operational features" allegedly "designed to minimize clinical operational risk" while these violations existed
The Alleged Impact on Trial Integrity
As alleged in the lawsuit, the inclusion of ineligible patients was not a minor administrative oversight. Patients with unstable alopecia areata diagnosed within six months are routinely excluded from studies because of unpredictable autoimmune fluctuations that can produce spontaneous periods of hair regrowth, potentially distorting placebo arm results. The action contends that this known scientific reality made proper screening essential to trial integrity, and that management's repeated public assurances about eligibility criteria created a materially misleading impression of the trial's operational soundness.
"This case presents important questions about clinical trial protocol disclosure obligations in the biopharmaceutical sector. When a company's lead product candidate depends on the integrity of a single pivotal trial, investors are entitled to accurate information about whether enrollment standards were properly followed," stated Joseph E. Levi, Esq.
Submit your information to join this case or contact Joseph E. Levi, Esq. at (212) 363-7500.
ABOUT LEVI & KORSINSKY, LLP -- Over the past 20 years, Levi & Korsinsky has secured hundreds of millions of dollars for aggrieved shareholders. The firm has extensive expertise in complex securities litigation and a team of over 70 employees. For seven consecutive years, Levi & Korsinsky has ranked in ISS Securities Class Action Services' Top 50 Report. Applications to serve as lead plaintiff must be filed by May 5, 2026.
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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