Lantheus Holdings, Inc.
For the period ended Sep 30, 2026. Filed Nov 5, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2026 · Filed Nov 5, 2026
What changed in Risk Factors?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-08-06.
0001193125-26-336795
Item 1A. Risk FactorsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-05.
0001193125-26-448622
Item 1A. Risk FactorsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 47 previous paragraphs and 57 current paragraphs.
30 unchanged; 16 reworded; 11 added; 0 removed; 1 previous and 0 current paragraphs rearranged.
Tables are not compared: 0 previous and 0 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
The current filing states there were no material changes to risk factors.
This is the filer’s own statement, not a conclusion from the comparison. Read its qualifications and the report it references.
Current filing’s statement
There have been no material changes to the risk factors set forth in our Annual Report on Form 10-K (our “Form 10-K”) for the year ended December 31, 2025, except as set forth below:
Added paragraphs (11)
Current report
On October 21, 2026, we received a request for additional information and documentary materials (a “Second Request”) from the Federal Trade Commission (the “FTC”) in connection with the FTC’s review of the Merger. The effect of a Second Request is to extend the waiting period imposed by the HSR Act until 30 days after we and the Parent each have substantially complied with the Second Request issued to it, unless that period is terminated sooner by the FTC. Completion of the Merger remains subject to the expiration or termination of the waiting period under the HSR Act and the satisfaction or waiver of the other closing conditions specified in the Merger Agreement. Governmental authorities could seek to impose conditions on the Merger, including divestitures or other remedies, or seek to block it.
Current report
Litigation is common in connection with acquisitions of public companies in the United States, regardless of any merits related to the underlying acquisition. Following the filing of our definitive proxy statement relating to the Merger on September 8, 2026, three complaints were filed by purported stockholders against us and certain members of our Board in connection with the Merger (the “Merger Complaints”). The Merger Complaints generally alleged, among other things, that the definitive proxy statement omitted or misrepresented certain material information and asserted claims under state common law. In addition, we have received sixteen demand letters from purported stockholders, two of which attached a draft complaint, making similar allegations to the Merger Complaints. On October 2, 2026, solely to avoid the costs, burden, nuisance and uncertainties inherent in litigation, and without admitting any liability or wrongdoing, we filed supplemental disclosures to the definitive proxy statement. On October 14, 2026, our stockholders adopted the Merger Agreement and approved related proposals at a special meeting of stockholders. We believe the complaints and demand letters are without merit.
Current report
We may not, or may take longer to, realize the expected benefits and opportunities related to investments we have made to develop diagnostic product candidates to be used in diagnosing, staging and monitoring Alzheimer’s disease.
Current report
As part of our acquisition of Lantheus Biosciences (formerly Life Molecular Imaging Limited), we acquired LNTH-2620 (previously referred to as PI-2620), a tau PET imaging agent. On August 14, 2026, we announced that the FDA approved TAUKLARIFY (florquinitau F-18 injection), also referred to as MK-6240. As a result, there is no near-term plan to commercialize the asset.
Current report
During 2024, we acquired Meilleur Technologies, Inc. (which has subsequently merged with and into Cerveau), which holds the rights under a license agreement to develop and commercialize NAV-4694, an investigational late-stage F-18-labeled PET imaging agent that targets beta amyloid in Alzheimer’s disease. NAV-4694 is currently in Phase 3 development and is also being used in academic and industry sponsored clinical trials.
Current report
Previously, we acquired MK-6240, an F-18-labeled PET imaging agent that targets tau tangles. On August 14, 2026, we announced that the FDA approved TAUKLARIFY (florquinitau F-18 injection), also referred to as MK-6240, for PET imaging of the brain in adults with cognitive impairment who are being evaluated for Alzheimer’s disease to identify patients with tau neurofibrillary tangle pathology. We intend to continue supporting the use of TAUKLARIFY in Alzheimer’s disease therapeutic programs through our Pharma Solutions business while assessing the appropriate path and timing toward broader commercial availability, but we can provide no assurance that we will be successful in the broader commercialization of TAUKLARIFY, including obtaining FDA approval for each PMF we select to manufacture TAUKLARIFY, obtaining adequate coding, coverage and payment, including TPT Status, for TAUKLARIFY and having physicians and customers adopt TAUKLARIFY.
Current report
While we believe that TAUKLARIFY, as a tau imaging agent, and NAV-4694, as a beta amyloid imaging agent, have the potential to expand our neurology franchise that also includes Neuraceq and could play an important role in diagnosing, staging and monitoring Alzheimer’s disease, we can give no assurance that we will be successful with continued development, regulatory approval and commercialization of these products and product candidates or that we will be able to resolve any disagreements with the counterparties to our license agreements or the former stockholders of the companies we acquired who could receive future milestone and royalty-based payments, including any disagreements over proprietary rights, contract interpretation or the preferred course of product research, development or marketing that might cause delays or termination of the license agreements, or might result in litigation or arbitration, which could be time-consuming and expensive. In addition, the successful acceptance and use of these diagnostic products and product candidates will depend on the successful development by pharmaceutical companies of disease-modifying treatments for Alzheimer’s disease, as well as the inclusion of our products in the prescribing information or guidelines for such disease-modifying treatments.
Current report
We have recognized, and may in the future recognize, impairment charges on our acquired intangible assets, which could adversely affect our results of operations.
Current report
We have significant goodwill and intangible assets from our acquisitions, including the LMI Acquisition and the Evergreen Acquisition. During the third quarter of 2026, we recognized impairment charges of $21.0 million and $10.0 million on the LNTH-2620 and LNTH-2515 in-process research and development intangible assets, respectively, which we acquired with Lantheus Biosciences in July 2025. On August 14, 2026, we announced that the FDA approved TAUKLARIFY (florquinitau F-18 injection), also referred to as MK-6240. As a result, we reassessed the existing development plan for LNTH-2620 and because there is no near-term plan to commercialize the asset, we determined that based on the updated analysis of the future cash flow, the value of the asset that remained was immaterial and therefore we recorded the full impairment in an amount equal to $21.0 million for the three and nine months ended September 30, 2026.
Current report
Our impairment assessments rely on estimates of future cash flows that involve significant management judgment and uncertainties beyond our control, and actual cash flows could differ materially from our estimates. Clinical, regulatory or commercial setbacks, competition, lower-than-expected sales or changes in our development priorities could result in additional impairment charges. Those charges could be material and could adversely affect our results of operations in the period in which they are recorded.
Current report
In addition, purported stockholders have filed complaints and sent demand letters in connection with the Merger. See “Lawsuits relating to the Merger have been, and additional lawsuits may be, filed against us, including by our stockholders.” above.
Reworded paragraphs (16)
Previous wording
There have been no material changes to the risk factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2025 (our “Form 10-K”), except as set forth below:
Current wording
There have been no material changes to the risk factors set forth in our Annual Report on Form 10-K (our “Form 10-K”) for the year ended December 31, 2025, except as set forth below:
Previous wording
The completion of the Merger is subject to the fulfillment or waiver of certain customary mutual closing conditions, including, among other things, (i) the adoption of the Merger Agreement by the affirmative vote of the holders of a majority of the outstanding shares of our common stock entitled to vote at our shareholders meeting, (ii) the absence of any law or order by a governmental authority of competent jurisdiction prohibiting or otherwise making illegal the consummation of the Merger, (iii) the expiration or termination of the applicable waiting period (or any extensions thereof) under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, (iv) that no voluntary agreement between the parties and a governmental entity not to consummate the Merger shall be in effect and (v) that certain other specified approvals, filings, notifications, clearances or expirations or terminations of waiting periods shall have occurred or been obtained, made or waived, as applicable. The obligation of each party to consummate the Merger is also conditioned upon (i) the accuracy of the other party’s representations and warranties, (subject, in certain cases, to certain customary materiality qualifications) and (ii) the other party’s performance or compliance in all material respects with its obligations under the Merger Agreement. In addition, the obligation of Parent and Merger Sub to consummate the Merger is also conditioned up on there being no continuing Material Adverse Effect (as defined in the Merger Agreement) having occurred that is continuing at the Effective Time. In addition, we have certain customary termination rights pursuant to the Merger Agreement, including our right to terminate the Merger Agreement to accept a “Superior Proposal” (as defined in the Merger Agreement) subject to compliance with certain procedures specified in the Merger Agreement. As a result, we cannot assure you that all of the various closing conditions will be satisfied and that the Merger with the Parent will be completed, or that, if completed, it will be exactly on the terms set forth in the Merger Agreement or within the expected time frame.
Current wording
The completion of the Merger is subject to the fulfillment or waiver of certain customary mutual closing conditions, including, among other things, (i) the absence of any law or order by a governmental authority of competent jurisdiction prohibiting or otherwise making illegal the consummation of the Merger, (ii) the expiration or termination of the applicable waiting period (or any extensions thereof) under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the “HSR Act”), (iii) that no voluntary agreement between the parties and a governmental entity not to consummate the Merger shall be in effect and (iv) that certain other specified approvals, filings, notifications, clearances or expirations or terminations of waiting periods shall have occurred or been obtained, made or waived, as applicable. The obligation of each party to consummate the Merger is also conditioned upon (i) the accuracy of the other party’s representations and warranties, (subject, in certain cases, to certain customary materiality qualifications) and (ii) the other party’s performance or compliance in all material respects with its obligations under the Merger Agreement. In addition, the obligation of the Parent and Merger Sub to consummate the Merger is also conditioned upon no Company Material Adverse Effect (as defined in the Merger Agreement) having occurred that is continuing at the effective time of the Merger. In addition, we have certain customary termination rights pursuant to the Merger Agreement, including our right to terminate the Merger Agreement to accept a “Superior Proposal” (as defined in the Merger Agreement) subject to compliance with certain procedures specified in the Merger Agreement. As a result, we cannot assure you that all of the various closing conditions will be satisfied and that the Merger with the Parent will be completed, or that, if completed, it will be exactly on the terms set forth in the Merger Agreement or within the expected time frame.
Previous wording
If the Merger is not completed within the expected time frame or at all, we may be subject to a number of material risks. The price of our common stock may decline to the extent that the current market price of our common stock reflects a market assumption that the Merger will be completed. We could also be required to pay the Parent a termination fee if the Merger Agreement is terminated under specific circumstances set forth in the Merger Agreement. The failure to complete the Merger also may result in negative publicity, a decline in investor confidence, stockholder litigation being brought against us, adverse impacts to our relationships with our existing and prospective employees, collaborators, customers, regulators, suppliers and other business partners, us being unable to recruit prospective employees or to retain and motivate existing employees, and adverse financial impacts due to costs incurred in connection with the Merger. We may also be required to devote significant time and resources to litigation related to any failure to complete the Merger or related to any enforcement proceeding commenced against us to perform our obligations under the Merger Agreement.
Current wording
If the Merger is not completed within the expected time frame or at all, we may be subject to a number of material risks. The price of our common stock may decline for a number of reasons, including because the market price may reflect expectations regarding completion of the Merger. We could also be required to pay the Parent a termination fee if the Merger Agreement is terminated under specific circumstances set forth in the Merger Agreement. The failure to complete the Merger also may result in negative publicity, a decline in investor confidence, stockholder litigation being brought against us, adverse impacts to our relationships with our existing and prospective employees, collaborators, customers, regulators, suppliers and other business partners, us being unable to recruit prospective employees or to retain and motivate existing employees, and adverse financial impacts due to costs incurred in connection with the Merger. We may also be required to devote significant time and resources to litigation related to any failure to complete the Merger or related to any enforcement proceeding commenced against us to perform our obligations under the Merger Agreement.
Previous wording
Our efforts to complete the Merger could cause substantial disruptions in, and create uncertainty surrounding, our business, which may materially adversely affect our results of operation and our business. Uncertainty as to whether the Merger will be completed may affect our ability to recruit prospective employees or to retain and motivate existing employees. Employee retention may be particularly challenging while the Merger is pending because employees may experience uncertainty about their roles following consummation of the Merger. Our management’s and certain of our employees’ attention is being directed toward the completion of the Merger and thus is being diverted to some extent from our day-to-day operations.
Current wording
Our efforts to complete the Merger could cause substantial disruptions in, and create uncertainty surrounding, our business, which may materially adversely affect our results of operations and our business. Uncertainty as to whether the Merger will be completed may affect our ability to recruit prospective employees or to retain and motivate existing employees. Employee retention may be particularly challenging while the Merger is pending because employees may experience uncertainty about their roles following consummation of the Merger. Our management’s and certain of our employees’ attention is being directed toward the completion of the Merger and thus is being diverted to some extent from our day-to-day operations or other strategic initiatives we might pursue. In addition, to the extent the FTC requires us to divest assets as a condition to completing the Merger, some of our management’s and certain of our employees’ attention would be directed towards negotiation and completion of such divestitures and the terms and conditions of such divestitures could be on terms less favorable to us than they might otherwise be if not done as a condition to completing the Merger.
Previous wording
Under the terms of the Merger Agreement, we have agreed to certain restrictions (unless approved by the Parent) on the operations of our business that could harm our business relationships, financial condition, operating results, cash flows and business, including restrictions with respect to our ability to, among other things, subject to certain specified exceptions: incur capital expenditures in excess of a specified aggregate amount for an applicable calendar year, incur or assume any long-term or short-term indebtedness for borrowed money or materially modify the terms of any indebtedness for borrowed money other than revolver borrowings or letters of credit in the ordinary course of business, commence any clinical study except for select studies or discontinue, terminate or suspend any ongoing clinical study other than (i) for efficacy or safety reasons, (ii) as mandated by any health regulatory authority or (iii) pursuant to any discontinuation, termination or suspension, for bona fide business reasons. Because of these restrictions, we may be prevented from undertaking certain actions with respect to the conduct of our business that we might otherwise have taken if not for the Merger Agreement. Such restrictions could prevent us from pursuing certain business opportunities that arise prior to the effective time of the Merger and are outside the ordinary course of business and could otherwise adversely affect our business and operations prior to completion of the Merger.
Current wording
Under the terms of the Merger Agreement, we have agreed to certain restrictions (unless approved by the Parent) on the operations of our business that could harm our business relationships, financial condition, operating results, cash flows and business, including restrictions with respect to our ability to, among other things, subject to certain specified exceptions: incur capital expenditures in excess of a specified aggregate amount for an applicable calendar year, incur or assume any long-term or short-term indebtedness for borrowed money or materially modify the terms of any indebtedness for borrowed money other than revolver borrowings or letters of credit in the ordinary course of business, commence any clinical study, except for select studies or discontinue, terminate or suspend any ongoing clinical study other than (i) for efficacy or safety reasons, (ii) as mandated by any health regulatory authority or (iii) pursuant to any discontinuation, termination or suspension, for bona fide business reasons. Because of these restrictions, we may be prevented or delayed from undertaking certain actions with respect to the conduct of our business that we might otherwise have taken if not for the Merger Agreement. Such restrictions could prevent or delay us from pursuing certain business opportunities that arise prior to the effective time of the Merger and are outside the ordinary course of business and could otherwise adversely affect our business and operations prior to completion of the Merger or could prevent or delay actions that could otherwise enable future growth.
Previous wording
Lawsuits relating to the Merger could be filed against us, including by our stockholders.
Current wording
Lawsuits relating to the Merger have been, and additional lawsuits may be, filed against us, including by our stockholders.
Previous wording
Although litigation is common in connection with acquisitions of public companies in the United States, regardless of any merits related to the underlying acquisition, the outcome of any lawsuits filed against us is uncertain and could delay or prevent completion of the Merger. We may not be successful in defending against any such claims. Additionally, the costs of defense of such litigation, including costs associated with the indemnification of directors and officers, and other effects, such as negative publicity or damage to our relationships with business partners, suppliers and customers, could have an adverse effect on our business, financial condition and operating results.
Current wording
Additional demand letters may be received, and additional lawsuits may be filed, against us, members of our Board, the Parent and/or the Merger Sub in connection with the Merger, and we will not necessarily announce such additional demands or filings. The outcome of any pending or future lawsuits is uncertain and could delay or prevent completion of the Merger. We may not be successful in defending against any such claims. Additionally, the costs of defense of such litigation, including costs associated with the indemnification of directors and officers, and other effects, such as negative publicity or damage to our relationships with business partners, suppliers and customers, could have an adverse effect on our business, financial condition and operating results.
Previous wording
At the time the Merger is completed, each issued and outstanding share of our common stock will be automatically cancelled and converted into the right to receive $102.50 per share in cash, without interest, plus a non-transferable CVR to receive up to $12.00 in cash, for total potential consideration of $114.50 per share in cash. The non-transferable CVR will be issued to our stockholders at closing and paid, in whole or in part, following achievement of certain specified milestones. There can be no assurance that any payment will be made under the CVR, or regarding the amount or timing of any such payment. As mentioned above, any amounts to be received in connection with the CVR are contingent upon achievement of certain specified milestones, which may or may not occur.
Current wording
At the time the Merger is completed, each issued and outstanding share of our common stock (other than certain excluded shares and shares for which appraisal rights have been properly exercised) will be automatically cancelled and converted into the right to receive $102.50 per share in cash, without interest, plus one non-transferable CVR representing the right to receive up to $12.00 in cash, for total potential consideration of up to $114.50 per share in cash. The non-transferable CVR will be issued to our stockholders at closing and paid, in whole or in part, following achievement of certain specified milestones. There can be no assurance that any payment will be made under the CVR, or regarding the amount or timing of any such payment. As mentioned above, any amounts to be received in connection with the CVR are contingent upon the achievement of certain specified milestones, which may or may not occur.
Previous wording
On March 6, 2026, the U.S. Food and Drug Administration (the “FDA”) approved PYLARIFY TruVu (piflufolastat F18), a new formulation of our F-18 PSMA PET imaging agent. PYLARIFY TruVu is designed to enhance product stability at higher radioactive concentrations, supporting more efficient manufacturing and distribution, including the potential to increase batch sizes and serve broader geographic markets. PYLARIFY TruVu is expected to become commercially available beginning in the fourth quarter of 2026 and will be introduced on a rolling geographic basis, with the intent to transition customers from PYLARIFY to PYLARIFY TruVu. It is anticipated that once a PMF site receives FDA approval to manufacture PYLARIFY TruVu and begins to supply PYLARIFY TruVu commercially, it will no longer supply PYLARIFY. We plan to work closely with clinicians and PET manufacturing facility (“PMF”) sites to support a smooth transition, including providing guidance on ordering, handling, and clinical use to support continuity of care. We are also pursuing reimbursement for PYLARIFY TruVu from the Centers for Medicare and Medicaid Services (“CMS”), including seeking three years of transitional pass-through payment status (“TPT Status”). In the second quarter of 2026, we submitted applications for both Healthcare Common Procedure Coding System (“HCPCS”) coding and TPT Status, with a targeted October 1, 2026 effective date for both. On July 24, 2026, CMS granted a HCPCS code for PYLARIFY TruVu, with an effective date of October 1, 2026. However, we can provide no assurance that we will be able to complete the technology transfer across our PMF network for PYLARIFY TruVu or obtain FDA approval for each PMF site to manufacture PYLARIFY TruVu on our expected timeline or at all. Additionally, we may be unable to obtain adequate coverage and payment, including TPT Status, for PYLARIFY TruVu on our expected timeline or at all, and payers may not add the HCPCS code to their systems on our expected timeline. Furthermore, there is no assurance that any customer transition will occur on our expected timeline or that our customers will adopt PYLARIFY TruVu at all. If customers do not adopt PYLARIFY TruVu we may not be able to reintroduce PYLARIFY and we would then lose customers to competitors which would have an adverse effect on our business, results of operations, financial condition and cash flows. All of the risks as described in Part I, Item 1A, “Risk Factors”in our Form 10-K with respect to our ability to continue to generate substantial revenue from PYLARIFY, as well as the risks associated with launching a product, also apply to PYLARIFY TruVu, and we can provide no assurances that the anticipated increase in batch size or other expected improvements associated with the design of the new formulation will be realized or be viewed in the market as differentiating factors.
Current wording
On March 6, 2026, the U.S. Food and Drug Administration (the “FDA”) approved PYLARIFY TruVu (piflufolastat F-18), a new formulation of our F-18 PSMA PET imaging agent. PYLARIFY TruVu is designed to enhance product stability at higher radioactive concentrations, supporting more efficient manufacturing and distribution, including the potential to increase batch sizes and serve broader geographic markets. PYLARIFY TruVu is expected to become commercially available beginning in the fourth quarter of 2026 and will be introduced on a rolling geographic basis, with the intent to transition customers from PYLARIFY to PYLARIFY TruVu. It is anticipated that once a PET manufacturing facility (“PMF”) site receives FDA approval to manufacture PYLARIFY TruVu and begins to supply PYLARIFY TruVu commercially, it will no longer supply PYLARIFY. We plan to work closely with clinicians and PMF sites to support a smooth transition, including providing guidance on ordering, handling, and clinical use to support continuity of care. On July 24, 2026, the Centers for Medicare and Medicaid Services (“CMS”) granted a Healthcare Common Procedure Coding System (“HCPCS”) code for PYLARIFY TruVu, with an effective date of October 1, 2026. On September 30, 2026, we announced that CMS granted TPT Status for PYLARIFY TruVu, effective October 1, 2026. TPT Status is temporary, and there can be no assurance that PYLARIFY TruVu will continue to receive adequate coding, coverage and payment after TPT Status expires. We can provide no assurance that we will be able to complete the technology transfer across our PMF network for PYLARIFY TruVu or obtain FDA approval for each PMF site to manufacture PYLARIFY TruVu on our expected timeline or at all. Additionally, payers may not add the HCPCS code to their systems on our expected timeline. Furthermore, there is no assurance that any customer transition will occur on our expected timeline or that our customers will adopt PYLARIFY TruVu at all. If customers do not adopt PYLARIFY TruVu we may not be able to reintroduce PYLARIFY and we would then lose customers to competitors which would have an adverse effect on our business, results of operations, financial condition and cash flows. All of the risks as described in Part I, Item 1A, “Risk Factors”in our Form 10-K with respect to our ability to continue to generate substantial revenue from PYLARIFY, as well as the risks associated with launching a product, also apply to PYLARIFY TruVu, and we can provide no assurances that the anticipated increase in batch size or other expected improvements associated with the design of the new formulation will be realized or be viewed in the market as differentiating factors.
Previous wording
In April 2025, we acquired Evergreen, including the rights to LNTH-2501. On October 30, 2025, we announced that the FDA had accepted our New Drug Application (“NDA”) for LNTH-2501 and set a PDUFA target action date of March 29, 2026. On March 17, 2026, the FDA extended its review of the NDA, moving the PDUFA target action date to June 29, 2026, which would allow the FDA additional time to review and consider further manufacturing-related information. On June 26, 2026, we announced that the FDA issued a Complete Response Letter (“CRL”) regarding the NDA, stating that the agency could not approve the NDA by the June 29, 2026 extended PDUFA target action date due to unresolved third-party facility manufacturing-related conditions. The third-party facility is responsible for drug product manufacturing. Satisfactory resolution of the unresolved facility inspection-related conditions is required before the LNTH-2501 NDA may be approved. The CRL did not identify any concerns regarding the data we submitted in support of the application, nor did it identify any issues related to the safety or efficacy of LNTH-2501. We can provide no assurance that the third-party facility manufacturing-related conditions identified in the CRL will be resolved in a manner satisfactory to the FDA, that LNTH-2501 will be approved by the FDA in a timely manner or at all. If LNTH-2501 is approved, there is no guarantee that we will be successful in gaining post-approval market acceptance and adequate coding, coverage, and payment for LNTH-2501 or that our manufacturer will be able to successfully develop and scale the manufacturing capabilities to support the launch of LNTH-2501. Even if we do receive NDA approval, all of the risks as described in Part I, Item 1A, “Risk Factors” in our Form 10-K with respect to launching a product would apply to LNTH-2501. Additionally, LNTH-2501 is a kit product with a supply chain that differs from that of our other commercial products, which may introduce additional operational complexity, coordination requirements, and sourcing and supply risks, and we can provide no assurance that we will be able to successfully or timely launch LNTH-2501, achieve anticipated adoption, or realize expected commercial results.
Current wording
In April 2025, we acquired Evergreen, including the rights to LNTH-2501. On October 30, 2025, we announced that the FDA had accepted our New Drug Application (“NDA”) for LNTH-2501 and set a PDUFA target action date of March 29, 2026. On March 17, 2026, the FDA extended its review of the NDA, moving the PDUFA target action date to June 29, 2026, which would allow the FDA additional time to review and consider further manufacturing-related information. On June 26, 2026, we announced that the FDA issued a Complete Response Letter (“CRL”) regarding the NDA, stating that the agency could not approve the NDA by the June 29, 2026 extended PDUFA target action date due to unresolved third-party facility manufacturing-related conditions. The third-party facility is responsible for drug product manufacturing. Satisfactory resolution of the unresolved facility inspection-related conditions and approval of a resubmitted NDA is required before the LNTH-2501 NDA may be approved. The CRL did not identify any concerns regarding the data we submitted in support of the application, nor did it identify any issues related to the safety or efficacy of LNTH-2501. We can provide no assurance that the third-party facility manufacturing-related conditions identified in the CRL will be resolved in a manner satisfactory to the FDA, that LNTH-2501 will be approved by the FDA in a timely manner or at all. If LNTH-2501 is approved, there is no guarantee that we will be successful in gaining post-approval market acceptance and adequate coding, coverage, and payment for LNTH-2501 or that our manufacturer will be able to successfully develop and scale the manufacturing capabilities to support the launch of LNTH-2501. Even if we do receive NDA approval, all of the risks as described in Part I, Item 1A, “Risk Factors” in our Form 10-K with respect to launching a product would apply to LNTH-2501. Additionally, LNTH-2501 is a kit product with a supply chain that differs from that of our other commercial products, which may introduce additional operational complexity, coordination requirements, and sourcing and supply risks, and we can provide no assurance that we will be able to successfully or timely launch LNTH-2501, achieve anticipated adoption, or realize expected commercial results.
Previous wording
We may not, or may take longer to, realize the expected benefits and opportunities related to, the POINT Biopharma Global Inc. (“POINT”) License Agreements, including PNT2003.
Current wording
We may not, or may take longer to, realize the expected benefits and opportunities related to, the POINT Biopharma Global Inc. (“POINT”) License Agreements, including BRAVNETSA (previously known as PNT2003).
Previous wording
On December 20, 2022, we announced the closing of a set of strategic collaborations with an affiliate of POINT, in which we were granted a license to exclusive worldwide rights (excluding Japan, South Korea, China (including Hong Kong, Macau and Taiwan), Singapore and Indonesia) to co-develop and commercialize POINT’s PNT2003 and PNT2002 product candidates (the “POINT License Agreements”). The expected benefits and opportunities related to the POINT License Agreements and related agreements for the supply of PNT2003 by POINT may not be realized or may take longer to realize than expected due to, for example, challenges and uncertainties inherent in product research, development, manufacturing, regulatory approval, marketing and competition. In particular, activities under the POINT License Agreements may not result in viable products suitable for commercialization in a timely manner or at all, due to a variety of reasons, including any inability of the relevant parties to perform their commitments and obligations under the POINT License Agreements, our ability to obtain final FDA approval for PNT2003, to successfully defend the favorable U.S. District Court ruling invalidating all patents asserted by Advanced Accelerator Applications USA, Inc. and Advanced Accelerator Applications SA as part of the PNT2003 Hatch-Waxman litigation through any appeals, and, if approved by the FDA, the timing, execution and success of launching and commercializing PNT2003. The POINT License Agreements impose various development, regulatory filing, commercialization and other obligations on us, and require us to meet development timelines or to exercise commercially reasonable efforts to develop and commercialize licensed products.
Current wording
On December 20, 2022, we announced the closing of a set of strategic collaborations with an affiliate of POINT, in which we were granted a license to exclusive worldwide rights (excluding Japan, South Korea, China (including Hong Kong, Macau and Taiwan), Singapore and Indonesia) to co-develop and commercialize POINT’s PNT2003 and PNT2002 product candidates (the “POINT License Agreements”). The expected benefits and opportunities related to the POINT License Agreements and related agreements for the supply of PNT2003 by POINT may not be realized or may take longer to realize than expected due to, for example, challenges and uncertainties inherent in product research, development, manufacturing, regulatory approval, marketing and competition. In particular, activities under the POINT License Agreements may not result in viable products suitable for commercialization in a timely manner or at all, due to a variety of reasons, including any inability of the relevant parties to perform their commitments and obligations under the POINT License Agreements, our ability to successfully defend the favorable U.S. District Court ruling invalidating all patents asserted by Advanced Accelerator Applications USA, Inc. and Advanced Accelerator Applications SA as part of the PNT2003 Hatch-Waxman litigation through any appeals, including the appeal currently pending before the U.S. Court of Appeals for the Federal Circuit, and the timing, execution and success of launching and commercializing BRAVNETSA (lutetium Lu 177 dotatate), previously known as PNT2003. The POINT License Agreements impose various development, regulatory filing, commercialization and other obligations on us, and require us to meet development timelines or to exercise commercially reasonable efforts to develop and commercialize licensed products.
Previous wording
With respect to PNT2003, in March 2026, we announced tentative approval of our Abbreviated New Drug Application (“ANDA”) for PNT2003, which indicates that the FDA has completed its review of the ANDA and determined that it meets the requirements for approval. The timing of our launch will consider the following factors: the timing of final FDA approval and disposition of legal proceedings related to the Hatch-Waxman process, as well as manufacturing and commercial readiness to ensure launch success. Even if we do receive ANDA approval, all of the risks as described in Part I, Item 1A, “Risk Factors” in our Form 10-K with respect to launching and successfully commercializing a radiopharmaceutical product as well as those related to our dependence on third parties for the manufacturing of products would apply to PNT2003.
Current wording
With respect to PNT2003, in March 2026, we announced tentative approval of our Abbreviated New Drug Application (“ANDA”) for PNT2003, and on September 22, 2026, we announced that the FDA granted final approval of the ANDA for BRAVNETSA. The timing and success of our launch will depend on, among other things, the disposition of legal proceedings related to the Hatch-Waxman process, including the pending appeal, as well as manufacturing and commercial readiness to ensure launch success. All of the risks as described in Part I, Item 1A, “Risk Factors” in our Form 10-K with respect to launching and successfully commercializing a radiopharmaceutical product as well as those related to our dependence on third parties for the manufacturing of products apply to BRAVNETSA
Previous wording
SPECT, LLC, SHINE SPECT Medical Products, Ltd., and SHINE SPECT Limited (collectively referred to as “SHINE SPECT”), dated as of May 1, 2025 (the “SHINE SPECT Agreement”), we are entitled to receive future and contingent consideration, including (i) a seller note with a principal amount of $20.0 million (the “Seller Note”), which bears interest at 8.0% per year payable semi-annually (with up to half payable in-kind) and matures on the earlier of January 1, 2029 or completion of an initial public offering by Illuminated (a “SHINE IPO”), and which may be repaid earlier in certain circumstances, including in connection with a change in control or a material financing, as defined in the governing note agreement, and (ii) $20.0 million in cash on the earlier of January 1, 2029 or a SHINE IPO (the “Deferred Cash Purchase Price”), with an additional $5.0 million payable if the Deferred Cash Purchase Price is not paid by January 1, 2029, for a total of $25.0 million in cash to be paid no later than January 1, 2030. In addition, we may earn up to $30.0 million in a combination of cash and capital stock of Illuminated upon exceeding specified annual and cumulative revenue milestones of the SPECT business for each calendar year through December 31, 2027.
Current wording
On January 1, 2026, as a result of the sale of the Company’s SPECT business pursuant to the Equity and Asset Purchase Agreement, by and among Lantheus Medical, Lantheus MI Canada, Inc., Lantheus EU Limited, and Illuminated Holdings, Inc. (“Illuminated”), SHINE SPECT, LLC, SHINE SPECT Medical Products, Ltd., and SHINE SPECT Limited (collectively referred to as “SHINE SPECT”), dated as of May 1, 2025 (the “SHINE SPECT Agreement”), we are entitled to receive future and contingent consideration, including (i) a seller note with a principal amount of $20.0 million (the “Seller Note”), which bears interest at 8.0% per year payable semi-annually (with up to half payable in-kind) and matures on the earlier of January 1, 2029 or completion of an initial public offering by Illuminated (a “SHINE IPO”), and which may be repaid earlier in certain circumstances, including in connection with a change in control or a material financing, as defined in the governing note agreement, and (ii) $20.0 million in cash on the earlier of January 1, 2029 or a SHINE IPO (the “Deferred Cash Purchase Price”), with an additional $5.0 million payable if the Deferred Cash Purchase Price is not paid by January 1, 2029, for a total of $25.0 million in cash to be paid no later than January 1, 2030. In addition, we may earn up to $30.0 million in a combination of cash and capital stock of Illuminated upon exceeding specified annual and cumulative revenue milestones of the SPECT business for each calendar year through December 31, 2027.
Previous wording
As previously announced, we are pursuing value-maximizing alternatives for our radiotherapeutic assets. We are evaluating potential transactions, however, there can be no assurance that this process will result in the identification of a suitable buyer, partner or transaction structure, or that any transaction will be completed on acceptable terms, within this anticipated timeframe, or at all. Market conditions, financing availability, regulatory considerations, due diligence findings, valuation expectations and other factors could adversely affect our ability to consummate such a transaction.
Current wording
As previously announced, we are pursuing value-maximizing alternatives for our radiotherapeutic assets. We are evaluating potential transactions, however, there can be no assurance that this process will result in the identification of a suitable buyer, partner or transaction structure, or that any transaction will be completed on acceptable terms, within any anticipated timeframe, or at all. Market conditions, financing availability, regulatory considerations, due diligence findings, valuation expectations and other factors could adversely affect our ability to consummate such a transaction.
Previous wording
We are, and may become in the future, subject to securities class actions, derivative suits or other securities-related legal actions. For example, on September 9, 2025, an alleged stockholder initiated a putative securities class action against us in the United States District Court for the Southern District of New York, styled Margolis v. Lantheus Holdings, Inc., et al. The operative complaint also asserts claims against certain of our named executives. A related action, styled Indiana Pub. Ret. Sys. v. Lantheus Holdings, Inc., et al., was filed in the same court on November 5, 2025. Those actions are now consolidated into a single putative securities class action (captioned In re Lantheus Holdings, Inc. Secs. Litig.), the theory of which is that the defendants made materially false or misleading statements (or omitted material facts) in violation of the Exchange Act. The lead plaintiff filed an amended complaint on March 13, 2026, we filed a motion to dismiss the amended complaint on May 11, 2026, and under the operative scheduling order that motion will be fully briefed by August 10, 2026. Additionally, on December 17, 2025, another alleged stockholder filed a shareholder derivative action in the same court, styled Lelchuk v. Heino et al., nominally on behalf of the Company and naming as defendants the current directors of our Board and the same officers named in the consolidated securities class action described above (a similar derivative complaint styled Jones v. Markison et al., was previously filed on October 31, 2025 but was voluntarily withdrawn without prejudice). The derivative complaint largely repeats the allegations asserted in the consolidated securities class action, and asserts claims for alleged breaches of fiduciary duties, aiding and abetting breach of fiduciary duty, unjust enrichment, waste of corporate assets, and violations of the Exchange Act. The plaintiff seeks damages and other relief on behalf of the Company. The derivative action is stayed pending one or more of the following events; (i) a public announcement of any settlement of the putative securities class action; (ii) a ruling on the defendants’ motion to dismiss, or (iii) a dismissal with prejudice of the putative securities class action and exhaustion of all related appeals. Because the outcome of litigation is uncertain, we cannot predict how or when these matters will ultimately be resolved. These actions, or any other stockholder litigation against us, could cause us to incur substantial costs defending the lawsuit. Such a lawsuit could also divert the time and attention of our management from our business, which could significantly harm our profitability and reputation. If any of these actions are resolved adversely to us, the amount of any potential loss is difficult to predict, and an adverse resolution could materially and adversely affect our business and financial condition.
Current wording
We are, and may become in the future, subject to securities class actions, derivative suits or other securities-related legal actions. For example, on September 9, 2025, an alleged stockholder initiated a putative securities class action against us in the U.S. District Court for the Southern District of New York, styled Margolis v. Lantheus Holdings, Inc., et al. The operative complaint also asserts claims against certain of our named executives. A related action, styled Indiana Pub. Ret. Sys. v. Lantheus Holdings, Inc., et al., was filed in the same court on November 5, 2025. Those actions are now consolidated into a single putative securities class action (captioned In re Lantheus Holdings, Inc. Secs. Litig.), the theory of which is that the defendants made materially false or misleading statements (or omitted material facts) in violation of the Exchange Act. The lead plaintiff filed an amended complaint on March 13, 2026, we filed a motion to dismiss the amended complaint on May 11, 2026, and under the operative scheduling order that motion was fully briefed by August 10, 2026. Additionally, on December 17, 2025, another alleged stockholder filed a shareholder derivative action in the same court, styled Lelchuk v. Heino et al., nominally on behalf of the Company and naming as defendants the current directors of our Board and the same officers named in the consolidated securities class action described above (a similar derivative complaint styled Jones v. Markison et al., was previously filed on October 31, 2025 but was voluntarily withdrawn without prejudice). The derivative complaint largely repeats the allegations asserted in the consolidated securities class action, and asserts claims for alleged breaches of fiduciary duties, aiding and abetting breach of fiduciary duty, unjust enrichment, waste of corporate assets, and violations of the Exchange Act. The plaintiff seeks damages and other relief on behalf of the Company. The derivative action is stayed pending one or more of the following events; (i) a public announcement of any settlement of the putative securities class action; (ii) a ruling on the defendants’ motion to dismiss, or (iii) a dismissal with prejudice of the putative securities class action and exhaustion of all related appeals. Because the outcome of litigation is uncertain, we cannot predict how or when these matters will ultimately be resolved. These actions, or any other stockholder litigation against us, could cause us to incur substantial costs defending the lawsuit. Such a lawsuit could also divert the time and attention of our management from our business, which could significantly harm our profitability and reputation. If any of these actions are resolved adversely to us, the amount of any potential loss is difficult to predict, and an adverse resolution could materially and adversely affect our business and financial condition.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
On January 1, 2026, as a result of the sale of the Company’s SPECT business pursuant to the Equity and Asset Purchase Agreement, by and among Lantheus Medical, Lantheus MI Canada, Inc., Lantheus EU Limited, and Illuminated Holdings, Inc. (“Illuminated”), SHINE