Gainey McKenna & Egleston Announces A Class Action Lawsuit Has Been Filed Against Zynex, Inc. (ZYXIQ)

NEW YORK, April 10, 2026 (GLOBE NEWSWIRE) — Gainey McKenna & Egleston announces that it has filed a securities class action lawsuit on February 20, 2026 in the United States District Court for the District of Colorado on behalf of all persons or entities who purchased or otherwise acquired Zynex, Inc. (“Zynex” or the “Company”) (NYSE: ZYXIQ) securities between February 25, 2021 to December 15, 2025, inclusive (the “Class Period”).

The Complaint alleges that throughout the Class Period, Defendants made materially false and/or misleading statements and failed to disclose material adverse facts about the Company’s business, operations, and prospects.  Specifically, the Complaint alleges that Defendants failed to disclose to investors that: (a) Zynex shipped products, including electrodes, in excess of need; (b) as a result of this practice, the Company inflated its revenue; (c) the Company’s practice of filing false claims drew scrutiny from insurers, including Tricare; (d) on August 21, 2023, Travelers commenced an action against Zynex, Sandgaard, Lucsok and Fox in the Superior Court of California alleging that Zynex and the defendants had embarked on a fraudulent overbilling scheme and sought more than $23 million in damages and civil penalties relating to hundreds of fraudulent claims between 2018 and 2023; (e) management had prioritized aggressive sales strategies to drive orders over compliance with industry laws, rules and regulations; (f) the Company was not committed to maintaining a strong internal control environment; (g) the Company’s order growth was a result of illegal overbilling; (h) as a result, it was reasonably likely that Zynex would face adverse consequences, including removal from insurer networks and penalties from the federal government; and (i) as a result of the foregoing, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

Investors who purchased or otherwise acquired shares of Zynex should contact the Firm prior to the April 21, 2026 lead plaintiff motion deadline. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. If you wish to discuss your rights or interests regarding this class action, please contact Thomas J. McKenna, Esq. or Gregory M. Egleston, Esq. of Gainey McKenna & Egleston at (212) 983-1300, or via e-mail at [email protected] or [email protected].

Please visit our website at http://www.gme-law.com for more information about the firm.



Sandisk Corporation to Join the Nasdaq-100 Index® Beginning April 20, 2026

NEW YORK, April 10, 2026 (GLOBE NEWSWIRE) — Nasdaq (Nasdaq: NDAQ) today announced that Sandisk Corporation (Nasdaq: SNDK) will become a component of the Nasdaq-100 Index® (NDX®) replacing Atlassian Corporation (Nasdaq: TEAM) prior to market open on Monday, April 20, 2026.

These updates are consistent with the current Nasdaq-100 Index® methodology, in effect through April 30, 2026. For additional information, including notifications on changes to any Nasdaq Indexes, please go to https://indexes.nasdaq.com/

About Nasdaq Global Indexes

Nasdaq Global Indexes is one of the world’s leading index providers, offering a comprehensive suite of rules-based benchmarks and indexes. The Nasdaq-100 Index® — which measures the performance of 100 of the largest Nasdaq-listed non-financial companies — is tracked by more than 200 investment products with over $600 billion in assets under management globally. Nasdaq Global Indexes publishes and maintains more than 35,000 indexes across asset classes and geographies.

About Nasdaq

Nasdaq (Nasdaq: NDAQ) is a leading technology platform that powers the world’s economies. We architect the world’s most modern markets, power the innovation economy, and build trust in the financial system. We empower economic opportunity by designing and deploying markets, technology, data, and advanced analytics that enable our clients to capture opportunities, navigate risk, and strengthen resilience. To learn more about the company, technology solutions and career opportunities, visit us on LinkedIn, on X @Nasdaq, or at www.nasdaq.com.

Nasdaq®, Nasdaq
-100 Index®
and NDX®
a
re
registered trademark
s
of Nasdaq, Inc.
The information contained above is provided for informational and educational purposes only, and nothing contained herein should be construed as investment advice, either on behalf of a particular financial product or an overall investment strategy.
Neither
Nasdaq
, Inc.
nor any of its affiliates makes any recommendation to buy or sell any financial product or any representation about the financial condition of any company or fund. Statements regarding Nasdaq’s proprietary indexes are not guarantees of future performance. Actual results may differ materially from those expressed or implied. Past performance is not indicative of future results. Investors should undertake their own due diligence and carefully evaluate companies before investing. ADVICE FROM A SECURITIES PROFESSIONAL IS STRONGLY ADVISED.

Media Contacts:

Maximilian Leitenberger
[email protected]

Issuer & Investor Contact

Index Client Services
[email protected]

-NDAQG-



Pilgrim’s Pride Corporation Announces Early Tender Results for up to $250 Million Aggregate Principal Amount of Its Outstanding 6.250% Senior Notes Due 2033

GREELEY, Colorado, April 10, 2026 (GLOBE NEWSWIRE) — Pilgrim’s Pride Corporation (NASDAQ: PPC) (the “Company”) announced today the early tender results for its cash tender offer (the “Tender Offer”) for up to $250 million aggregate principal amount (the “Maximum Tender Amount”) of its 6.250% Senior Notes due 2033 (the “Notes”).

The Company has been advised that as of 5:00 p.m., New York City time, on April 10, 2026 (such date and time, the “Early Tender Date”), $471,546,000 aggregate principal amount of Notes had been validly tendered and not validly withdrawn in the Tender Offer. Withdrawal rights for the Notes expired on the Early Tender Date.

The Tender Offer is being made upon the terms, and subject to the conditions, previously described in the offer to purchase dated March 30, 2026 (the “Offer to Purchase”). The Company refers investors to the Offer to Purchase for the complete terms and conditions of the Tender Offer.

The Company expects to elect to exercise its right to make payment on April 14, 2026 (the “Early Settlement Date”) for Notes that were validly tendered prior to or at the Early Tender Date and that are accepted for purchase.

Because the aggregate principal amount of Notes that have been validly tendered and not validly withdrawn prior to or at the Early Tender Date exceeds the Maximum Tender Amount, the Company does not expect to accept for purchase all Notes that have been validly tendered and not validly withdrawn prior to or at the Early Tender Date. Rather, the Company expects to accept for purchase $250,000,000 aggregate principal amount of the Notes validly tendered and not validly withdrawn prior to or at the Early Tender Date on a prorated basis using a proration factor to be announced following the determination of the Total Consideration (as defined herein). As described further in the Offer to Purchase, Notes tendered and not accepted for purchase will be promptly credited to the tendering holder’s account. Additionally, because the Notes validly tendered and not validly withdrawn prior to or at the Early Tender Date have an aggregate principal amount that exceeds the Maximum Tender Amount, the Company does not expect to accept for purchase any Notes tendered after the Early Tender Date on a subsequent settlement date.

The consideration (the “Total Consideration”) offered per $1,000 principal amount of the Notes validly tendered and accepted for purchase pursuant to the Tender Offer will be determined in the manner described in the Offer to Purchase by reference to the fixed spread for the Notes (the “Fixed Spread”) plus the yield based on the bid-side price of the U.S. Treasury Reference Security at 10:00 a.m., New York City time, on April 13, 2026 (the “Price Determination Date”). Only holders of Notes who validly tendered and did not validly withdraw their Notes prior to or at the Early Tender Date are eligible to receive the Total Consideration for Notes accepted for purchase. Holders will also receive accrued and unpaid interest on Notes validly tendered and accepted for purchase from the last interest payment date up to, but not including, the Early Settlement Date.

Promptly after the Price Determination Date, the Company will issue a news release specifying, among other things, (i) the aggregate principal amount of Notes validly tendered and not validly withdrawn as of the Early Tender Date and expected to be accepted for purchase in the Tender Offer, (ii) the proration factor for the Notes and (iii) the Total Consideration for the Notes expected to be accepted for purchase.

The Company’s obligation to purchase, and to pay for, Notes validly tendered in the Tender Offer and not validly withdrawn pursuant to the Tender Offer is conditioned upon the satisfaction or, when applicable, waiver of certain conditions, which are more fully described in the Offer to Purchase. The Tender Offer is not conditioned upon the tender of any minimum principal amount of Notes. However, the Tender Offer is subject to the Maximum Tender Amount. The Company reserves the right, but is under no obligation, to increase the Maximum Tender Amount at any time, subject to compliance with applicable law. In the event of a termination of the Tender Offer, neither the applicable consideration will be paid or become payable to the holders of the Notes, and the Notes tendered pursuant to the Tender Offer will be promptly returned to the tendering holders. The Company has the right, in its sole discretion, to not accept any tenders of Notes for any reason and to amend or terminate the Tender Offer at any time.

Information Relating to the Tender Offer

BMO Capital Markets Corp. is the dealer manager for the Tender Offer. Investors with questions regarding the terms and conditions of the Tender Offer may contact BMO Capital Markets Corp. at +1 (833) 418-0762 (toll-free) or +1 (212) 702-1840 (collect) or by email at [email protected].

D.F. King & Co., Inc. is the tender and information agent for the Tender Offer. The full details of the Tender Offer, including complete instructions on how to tender Notes, are included in the Offer to Purchase. Investors with questions regarding the procedures for tendering Notes and/or that want to obtain the Offer to Purchase may contact the tender and information agent by email at [email protected], or by phone at +1 (646) 981-1284 (for banks and brokers only) or + 1 (877) 283-0318 (for all others, toll-free). Beneficial owners may also contact their broker, dealer, commercial bank, trust company or other nominee for assistance.

Neither the Offer to Purchase nor any related documents have been filed with the U.S. Securities and Exchange Commission, nor have any such documents been filed with or reviewed by any federal or state securities commission or regulatory authority of any country. No authority has passed upon the accuracy or adequacy of the Offer to Purchase or any related documents, and it is unlawful and may be a criminal offense to make any representation to the contrary.

The Tender Offer is being made solely on the terms and conditions set forth in the Offer to Purchase. Under no circumstances shall this news release constitute an offer to buy or the solicitation of an offer to sell the Notes or any other securities of the Company or any of its subsidiaries. The Tender Offer is not being made to, nor will the Company accept tenders of Notes from, holders in any jurisdiction in which the Tender Offer or the acceptance thereof would not be in compliance with the securities or blue sky laws of such jurisdiction. No recommendation is made as to whether holders should tender their Notes. Holders should (i) carefully read the Offer to Purchase because it contains important information, including the various terms and conditions of the Tender Offer, (ii) consult their own investment and tax advisors and (iii) make their own decisions whether to tender Notes in the Tender Offer, and, if so, the principal amount of Notes to tender.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are subject to certain risks, uncertainties and assumptions and typically can be identified by the use of words such as “expect,” “estimate,” “should,” “anticipate,” “forecast,” “plan,” “guidance,” “outlook,” “believe” and similar terms. Although the Company believes that the expectations are reasonable, it can give no assurance that these expectations will prove to be correct, and actual results may vary materially.

The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. The foregoing review of factors that could cause the Company’s actual results to differ materially from those contemplated in the forward-looking statements included in this news release should be considered in connection with information regarding risks and uncertainties that may affect the Company’s future results included in the Company’s filings with the SEC at www.sec.gov.

About Pilgrim’s Pride Corporation

The Company employs approximately 63,000 people and operates protein processing plants and prepared-foods facilities in 14 states, Puerto Rico, Mexico, the United Kingdom, the Republic of Ireland and continental Europe. The Company’s primary distribution is through retailers and foodservice distributors.

Contacts:

Andy Rojeski
Investor Relations
Phone: (970) 506 7783
[email protected]

Diego Pirani
Treasurer
Phone: +1 (970) 506-8117
e-mail: [email protected]

Nikki Richardson
Pilgrim’s Pride Corporation Communications
[email protected]



Innovator Announces Results of Special Meeting of Shareholders Relating to the Reorganizations of Innovator IBD® Breakout Opportunities ETF and Innovator IBD® 50 ETF

WHEATON, Ill., April 10, 2026 (GLOBE NEWSWIRE) — Innovator Capital Management, LLC (“Innovator”) announced today the results of the joint special meeting of shareholders of Innovator IBD® Breakout Opportunities ETF (NYSE Arca: BOUT) and Innovator IBD® 50 ETF (NYSE Arca: FFTY) (each a “Target Fund” and collectively, the “Target Funds”) held of April 10, 2026.

The shareholders of each Target Fund have approved the reorganization of each Target Fund into a corresponding newly-created series of Capital-Force ETF Trust (each, an “Acquiring Fund”), as detailed in the table below (each, a “Reorganization” and collectively, the “Reorganizations”):

Target Funds Acquiring Funds
Innovator IBD® Breakout Opportunities ETF CapForce IBD® Breakout Opportunities ETF

Innovator IBD® 50 ETF CapForce IBD® 50 ETF
     

As previously announced, the Reorganizations were approved by the Board of Trustees of the Innovator ETFs® Trust at a meeting held on January 21, 2026. Subject to the satisfaction of certain customary closing conditions, the Reorganizations are expected to close by the end of April 2026. No assurance can be given as to the exact closing date of the Reorganizations. Upon the completion of the Reorganization, which is expected to be tax-free, the assets of each Target Fund will be transferred to, and the liabilities of each Target Fund will be assumed by, the respective Acquiring Fund. The shareholders of each Target Fund will receive shares of the respective Acquiring Fund with a value equal to the aggregate net asset value of the shares of the respective Target Fund held by them.

Innovator Capital Management is a leading active ETF sponsor and is the pioneer of outcome-based ETFs. Most notably the inaugural and largest lineup of Buffer ETFs™. The firm is committed to delivering innovative risk-managed strategies and managed 171 ETFs with approximately $31 billion in assets under management as of February 28, 2026.1

M2 Financial LLC, is a limited liability company organized in the State of California and is an SEC registered investment adviser.

Additional
Information
/
Forward-Looking
Statements

This press release is not intended to, and shall not, constitute an offer to purchase or sell shares of any Acquiring Fund. An investor should carefully consider the investment objectives, risks, charges and expenses of an Acquiring Fund before investing.

Certain statements made in this news release that are not historical facts are referred to as “forward-looking statements” under the U.S. federal securities laws. Actual future results or occurrences may differ significantly from those anticipated in any forward-looking statements due to numerous factors. Generally, the words “believe,” “expect,” “intend,” “estimate,” “anticipate,” “project,” “will” and similar expressions identify forward-looking statements, which generally are not historical in nature. Forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ from the historical experience of Innovator and the funds managed by Innovator and its present expectations or projections. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Innovator, the Target Funds and the Acquiring Funds undertake no responsibility to update publicly or revise any forward-looking statements.

Media Contact

Frank Taylor / Stephanie Dressler

(646) 808-3647 / (949) 269-2535
[email protected]

SOURCE: Innovator Capital Management, LLC

¹ AUS as of February 28, 2026. Innovator Capital Management AUS represents fee-based client assets managed on a discretionary basis.



FCPT to Report First Quarter 2026 Financial Results

FCPT to Report First Quarter 2026 Financial Results

Conference Call and Webcast Scheduled for Thursday, April 30, 2026 at 12:00 p.m. Eastern Time

MILL VALLEY, Calif.–(BUSINESS WIRE)–
Four Corners Property Trust (NYSE: FCPT), a real estate investment trust (REIT) primarily engaged in the ownership and acquisition of high-quality, net-leased restaurant and retail properties (“FCPT” or the “Company”), announced today that it will release financial results for the three months ended March 31, 2026, after the market close on Wednesday, April 29, 2026. A conference call and audio webcast with analysts and investors will be held on Thursday, April 30 at 12:00 p.m. Eastern Time, to discuss the results. Details for the call are listed below.

First Quarter Conference Call Details:

To access the live webcast (listen only), please visit https://events.q4inc.com/attendee/865913566. To access via the phone, please dial 1 833 461 5787 (domestic toll free) or 1 626 884 3620 (local) and reference the FCPT First Quarter 2026 Financial Results Conference Call. A conference call replay will be available for one year via the webcast.

About FCPT:

FCPT, headquartered in Mill Valley, CA, is a real estate investment trust primarily engaged in the ownership, acquisition and leasing of restaurant and retail properties. The Company seeks to grow its portfolio by acquiring additional real estate to lease, on a net basis, for use in the restaurant and retail industries. Additional information about FCPT can be found on the website at www.fcpt.com.

FCPT

Bill Lenehan, 415-965-8031

CEO

Patrick Wernig, 415-965-8038

CFO

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: REIT Restaurant/Bar Retail Commercial Building & Real Estate Construction & Property

MEDIA:

Lamb Weston Announces Inducement Award Under NYSE Listing Rule 303A.08

Lamb Weston Announces Inducement Award Under NYSE Listing Rule 303A.08

EAGLE, Idaho–(BUSINESS WIRE)–
Lamb Weston Holdings, Inc. (NYSE: LW) announced today that on April 10, 2026, the company granted 37,923 restricted stock units (the “Inducement Awards”) to James D. Gray. The company’s Compensation and Human Capital Committee approved the grant of Inducement Awards, made under the Lamb Weston Holdings, Inc. 2026 Inducement Stock Plan, to Mr. Gray as a material inducement to Mr. Gray’s hiring as Chief Financial Officer on April 2, 2026. The restricted stock units vest 50% on each of April 13, 2027 and April 11, 2028.

The Inducement Awards were granted in reliance on the employment inducement exemption under the NYSE’s Listed Company Manual Rule 303A.08, which requires public announcement of inducement awards. The company is issuing this press release pursuant to Rule 303A.08.

About Lamb Weston

Lamb Weston is a leading supplier of frozen potato products to restaurants and retailers around the world. For more than 75 years, Lamb Weston has led the industry in innovation, introducing inventive products that simplify back-of-house management for its customers and make things more delicious for their customers. From the fields where Lamb Weston potatoes are grown to proactive customer partnerships, Lamb Weston always strives for more and never settles. Because, when we look at a potato, we see possibilities. Learn more about us at lambweston.com.

Investors:

Debbie Hancock

208-202-7259

[email protected]

Media:

Erin Gardiner

208-202-7257

[email protected]

KEYWORDS: Idaho New York United States North America

INDUSTRY KEYWORDS: Retail Restaurant/Bar Supermarket Agriculture Natural Resources Food/Beverage

MEDIA:

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FCPT Announces Acquisition of a National Veterinary Associates Property for $4.4 Million

FCPT Announces Acquisition of a National Veterinary Associates Property for $4.4 Million

MILL VALLEY, Calif.–(BUSINESS WIRE)–
Four Corners Property Trust (NYSE:FCPT), a real estate investment trust primarily engaged in the ownership and acquisition of high-quality, net-leased restaurant and retail properties (“FCPT” or the “Company”), is pleased to announce the acquisition of a National Veterinary Associates property for $4.4 million. The property is located in a strong retail corridor in California and is corporate-operated under a long term, net lease. The transaction was priced at a 7.1% cap rate on rent as of the closing date and exclusive of transaction costs.

About FCPT

FCPT, headquartered in Mill Valley, CA, is a real estate investment trust primarily engaged in the ownership, acquisition and leasing of restaurant and retail properties. The Company seeks to grow its portfolio by acquiring additional real estate to lease, on a net basis, for use in the restaurant and retail industries. Additional information about FCPT can be found on the website at www.fcpt.com.

Category: Acquisition

Four Corners Property Trust:

Bill Lenehan, 415-965-8031

CEO

Patrick Wernig, 415-965-8038

CFO

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Retail Restaurant/Bar Other Retail Commercial Building & Real Estate Construction & Property REIT

MEDIA:

Quantum-Si Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Quantum-Si Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

BRANFORD, Conn.–(BUSINESS WIRE)–Quantum-Si Incorporated (Nasdaq: QSI) (“Quantum-Si,” “QSI” or the “Company”), a proteomics company redefining protein analysis through single-molecule protein sequencing, today announced that the Compensation Committee of Quantum-Si’s Board of Directors has granted 61,439 restricted stock units (“RSUs”) to new employees under the Company’s previously adopted Quantum-Si Incorporated 2023 Inducement Equity Incentive Plan, as amended (the “2023 Inducement Plan”). The RSUs were granted as an inducement material to the new employees becoming an employee of Quantum-Si in accordance with Nasdaq Listing Rule 5635(c)(4).

The 2023 Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously employees of Quantum-Si (or following a bona fide period of non-employment), as an inducement material to such individuals entering into employment with Quantum-Si, pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules.

The RSUs will vest 25% on June 20, 2027, with the remainder vesting in 12 equal quarterly installments thereafter, subject to the employee’s continued employment with Quantum-Si on such vesting dates. The RSUs are subject to the terms and conditions of the 2023 Inducement Plan and a RSU agreement covering the grant.

About Quantum-Si Incorporated

Quantum-Si is transforming proteomics with a benchtop platform that brings single-molecule protein analysis to every lab, everywhere. The Company’s platform enables real-time kinetic-based detection and allows researchers to move beyond traditional, multistep workflows and directly access dynamic, functional protein insights with unparalleled resolution. By making protein analysis simpler, faster, and more informative, Quantum-Si is accelerating proteomic discoveries to improve the way we live. Learn more at quantum-si.com or follow us on LinkedIn or X.

Investor and Media

Jeff Keyes

Chief Financial Officer

[email protected]

KEYWORDS: Connecticut United States North America

INDUSTRY KEYWORDS: Research Technology Other Health Biotechnology Hardware Pharmaceutical Health Science Oncology Other Science

MEDIA:

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Tenaris Convenes the Annual General Meeting of Shareholders and an Extraordinary General Meeting of Shareholders

LUXEMBOURG, April 10, 2026 (GLOBE NEWSWIRE) — Tenaris S.A. (NYSE and Mexico: TS and EXM Italy: TEN) announced today that has convened its Annual General Meeting of Shareholders to be held on May 12, 2026, at 10:00 (Central European time), and an Extraordinary General Meeting of Shareholders to be held immediately after the adjournment of the Annual General Meeting of Shareholders. The convening notice (which includes the agendas for the meetings and the procedure for attending and/or voting at the meetings) was published in such newspapers and filed with the regulators, as required by applicable law, and is available on the Luxembourg Stock Exchange’s website at www.bourse.lu/regulated-information-oam, the SEC’s website at www.sec.gov, and Tenaris’s website at ir.tenaris.com.

The following documents are also available on Tenaris’s website at ir.tenaris.com upon publication of the convening notice:

  • information on Tenaris’s total number of shares and voting rights as of the date of the convening notice;
  • the Shareholder Meeting Brochure and Proxy Statement (which contains the procedure for attending and/or voting at the meetings, and reports on each item of the meetings’ agendas and draft resolutions proposed to be adopted at the meetings);
  • the 2025 Annual Report (which contains the consolidated management report, the consolidated financial statements and the annual accounts);
  • the 2025 Compensation Report;
  • the proposed amendments to the articles of association; and
  • the forms and certificates required for purposes of attending and/or voting at the meetings.

Copies of these documents are also available, free of charge, at Tenaris’s registered office in Luxembourg, between 10:00 and 17:00 (Central European time). In addition, shareholders registered in the share register may request electronic copies of such documents, free of charge, to [email protected].

Tenaris is a leading global supplier of steel tubes and related services for the world’s energy industry and certain other industrial applications. 

Giovanni Sardagna        
Tenaris
1-888-300-5432
www.tenaris.com



Replimune Receives Complete Response Letter from the FDA for RP1 Biologics License Application for the Treatment of Advanced Melanoma

WOBURN, Mass., April 10, 2026 (GLOBE NEWSWIRE) — Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that the company received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) for the Company’s Biologics License Application (BLA) for RP1 in combination with nivolumab for the treatment of advanced melanoma.

Replimune disagrees with the FDA about whether the data set, upon which breakthrough therapy designation was awarded, is sufficient to allow this promising medicine to be made available to advanced cancer patients. In the IGNYTE trial, patients with confirmed progression on an anti-PD-1 based regimen who received RP1 plus nivolumab had a 34% response rate with a median duration of 24.8 months with a favorable safety profile.

“It is deeply disappointing that the FDA has not exercised regulatory flexibility to meet patients’ needs given the data supporting strong efficacy and the favorable safety profile. Approximately 8,500 Americans with advanced melanoma die every year. The country’s foremost melanoma specialists stood behind the RP1 data. Patients and caregivers pleaded for urgency. All of it was met with inconsistent communication and a fragmented and slow-moving regulatory process which clearly puts U.S. innovation at risk,” said Sushil Patel, Ph.D., CEO of Replimune. “As we previously communicated, without timely accelerated approval, the development of RP1 will not be viable. We are devastated for our committed employees who have worked tirelessly for patients but at this point we have no choice but to eliminate jobs, including substantially scaling back our U.S. based manufacturing operations. A treatment desperately needed by patients will not be available. Not because the medicine failed. Because the system did.”

Inconsistent agency process and communication thwarts innovation

With the CRL, the company learned that a different review team was appointed for the resubmission and replaced the prior team who had interacted with the company. A senior member of the prior review team stated publicly that the “BLA clinical team thought the applicant had provided adequate evidence to support contribution of effect of RP1 plus nivolumab but leadership did not agree.” The new team did not meet with the company during the review process despite the company offering.

In the CRL, the agency appears to have contradicted their positions expressed at the September 2025 Type A meeting, including on the following points:

  • After testimony from melanoma experts, the agency did not raise further concerns about the heterogeneity of the patient population in IGNYTE and acknowledged that randomizing patients to an anti-PD1 only arm in the confirmatory study was not feasible.
  • Following an agency suggestion, the company submitted a proposal for a descriptive analysis from IGNYTE-3 supporting contribution of components. The company also included data from IGNYTE showing median progression free survival on RP1 plus nivolumab was 30.6 months compared to 4.4 months on their prior PD-1 based regimen. The company requested feedback, however, the FDA did not respond and subsequently accepted the resubmission as a complete response to the July 2025 CRL.
  • The FDA raised several points related to tumor assessment methodology. As requested by the FDA, responses in IGNYTE were assessed using RECIST 1.1 without modifications. In addition, the company provided detailed analyses showing no material difference in response rates between injected and non-injected lesions. The company also provided a comprehensive analysis which showed that biopsies and surgical interventions did not impact tumor response.

Prior to the original BLA submission, standard regulatory meetings were conducted to discuss trial design, patient population, and the BLA package requirements. While a randomized controlled trial was preferred, the FDA suggested in the March 2021 Type B minutes that if the data was sufficiently compelling, a single arm trial could be acceptable for consideration under accelerated approval. At the subsequent pre-BLA meeting, the FDA stated “we do not object to your proposal to submit a BLA based primarily on data from the cohort of patients (n=140) in the Phase 2 IGNYTE trial who had advanced melanoma and progressed while being treated with prior anti-PD-1 based therapy.” The company subsequently submitted a BLA which was accepted with breakthrough therapy designation and granted priority review. Based on feedback from the FDA, the company initiated a resource-intensive global Phase 3 trial, IGNYTE-3, to satisfy the regulatory requirement that a confirmatory study be underway for an accelerated approval. 

About Melanoma
Melanoma is the fifth most common cancer, with approximately 112,000 new cases estimated in the U.S. in 2026, and the most lethal form of skin cancer, accounting for nearly 8,500 deaths annually. Standard of care therapy includes treatment with immune checkpoint blockade, to which approximately half of patients will not respond or will progress after treatment. Melanoma is considered advanced when the cancer spreads beyond the primary tumor to other parts of the body.

About RP1

RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

About Replimune

Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of novel oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is intended to ignite local activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to then activate a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com.

Forward Looking Statements

This press release contains forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding our interactions with the FDA and other statements identified by words such as “could,” “expects,” “intends,” “hope,” “may,” “plans,” “potential,” “should,” “will,” “would,” or similar expressions and the negatives of those terms. Forward-looking statements are not promises or guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in such forward-looking statements. These factors include risks related to our limited operating history, our ability to generate positive clinical trial results for our product candidates, the costs and timing of operating our in-house manufacturing facility, the timing and scope of regulatory approvals, if any, our ability to resolve the issues identified in the CRL in a manner satisfactory to the FDA and to us and the timing thereof, the availability of combination therapies needed to conduct our clinical trials, changes in laws and regulations to which we are subject, competitive pressures, our ability to identify additional product candidates, political and global macro factors including the impact of a global pandemic and related public health issues and the ongoing political and military conflicts, including trade conflicts, and other risks as may be detailed from time to time in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other reports we file with the Securities and Exchange Commission. Our actual results could differ materially from the results described in or implied by such forward-looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake no obligation to update or revise these forward-looking statements.

Investor Inquiries

Chris Brinzey
ICR Healthcare
339.970.2843
[email protected]

Media Inquiries

Arleen Goldenberg
Replimune
917.548.1582
[email protected]