LNTH — what changed in the latest 10-Q
A section-by-section comparison of LNTH's newest periodic SEC filing (10-K/10-Q) against the prior same-form filing: paragraphs added and removed per section, with verbatim excerpts. Purely a deterministic text diff — no similarity scores, no directional read, not investment advice.
Comparing 10-Q · 2026-05-07 vs the prior 10-Q · 2025-11-06
| Section | Outcome | Added | Removed | Minor | Unchanged |
|---|---|---|---|---|---|
| MD&A | Text added/removed | +75 | −83 | ~33 | 28 |
| Market risk (Item 3) | Text added/removed | 0 | 0 | ~2 | 0 |
| Controls & procedures | Text added/removed | 0 | 0 | ~2 | 0 |
| Legal proceedings | Text added/removed | 0 | 0 | ~1 | 0 |
| Risk factors | Some risk factors updated | +16 | −76 | ~1 | 1 |
| Other information | Text added/removed | +4 | −1 | 0 | 0 |
Counts are paragraphs; added/removed means text added or removed vs the prior filing — no direction or judgement implied.
Representative excerpts
Up to 5 excerpts of about 300 characters per section, quoted verbatim from the two SEC filings.
MD&A
Text added vs the prior filing · source: 10-Q · 2026-05-07
We are the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Prior to January 1, 2026, we classified our revenues into three product categories: Radiopharmaceutical Oncology, Precision Diagnostics, and S…
In February 2026, we announced an updated strategic focus on innovative PET radiodiagnostics, informed by our capabilities and customer relationships. Over the past year, we took purposeful, disciplined actions to optimize our portfolio and continue to strengthen our commercial and development capab…
On March 17, 2026, we announced that the FDA has extended its review of the NDA for LNTH-2501, moving the Prescription Drug User Fee Act (“PDUFA”) target action date from March 29, 2026 to June 29, 2026. LNTH-2501 is a diagnostic kit for the preparation of Gallium-68 (“Ga-68”) edotreotide injection,…
consider further manufacturing-related information we submitted. This standard review extension is not related to the efficacy or safety data of LNTH-2501.
On March 6, 2026, we announced that the FDA approved PYLARIFY TruVu (piflufolastat F18), a new formulation of our F-18 PSMA PET imaging agent. PYLARIFY TruVu is indicated for PET imaging of PSMA-positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial def…
Text removed vs the prior filing · source: 10-Q · 2025-11-06
We are the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes. We classify our revenues into three product categories: Radiopharmaceutical Oncology, Precision Diagnostics, and Strategic Partnerships and Ot…
We continue to execute on our strategy to evolve into a fully integrated radiopharmaceutical company, supported by our increasingly diversified portfolio and our targeted initiatives to expand our pipeline, commercial, development and manufacturing capabilities. Over the past year, we announced mult…
On November 6, 2025, we announced that Brian Markison, our Chief Executive Officer (“CEO”), notified us that he will retire from the Company effective December 31, 2025 (the “Effective Date”). In connection with his retirement, Mr. Markison will also resign from our Board of Directors (“Board”) on t…
time as the Board completes the comprehensive search process that it initiated to identify and appoint the Company’s next CEO. Mr. Markison has agreed to serve as a strategic advisor to the Company through at least March 31, 2026.
Separately, we announced that Paul Blanchfield, our President, has accepted a role at another company and is leaving the Company. In addition, Amanda Morgan will return from leave and continue in her role as Chief Commercial Officer, reporting directly to Ms. Heino.
Risk factors
Text added vs the prior filing · source: 10-Q · 2026-05-07
Risks Related to Our and our Strategic Partners’ Portfolios of Clinical Development Candidates
We may not, or may take longer to, realize the expected benefits and opportunities related to PYLARIFY TruVu, our recently-approved new formulation of our prostate-specific membrane antigen (“PSMA”) positron emission tomography (“PET”) Imaging Agent.
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…
We may not, or may take longer to, realize the expected benefits and opportunities related to our acquisition of the rights to LNTH-2501.
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 …
Text removed vs the prior filing · source: 10-Q · 2025-11-06
Our ability to grow PYLARIFY as a commercial product is dependent on (A) the ability of positron emission tomography (“PET”) manufacturing facilities (“PMFs”) to manufacture PYLARIFY to meet product demand, including ensuring that PYLARIFY is available at the specific time of day preferred by the en…
To manufacture PYLARIFY, we assembled and qualified a nationwide network of PMFs with radioisotope-producing cyclotrons that make F-18, which has a 110-minute half-life, so PYLARIFY is manufactured and distributed rapidly to end-users. Because each of the PMFs manufacturing these products is deemed …
Obtaining adequate coding, coverage, and payment for PYLARIFY is critical, including not only coverage from Medicare, Medicaid and other government payors, as well as private payors, but also appropriate payment levels to adequately cover our customers’ costs of using PYLARIFY in PET/computed tomogr…
reporting. We have reported and continue to report ASP for PYLARIFY, have engaged with CMS on the methodology for reporting ASP, and we will continue to work with coalition partners and CMS to support using ASP to calculate payment for diagnostic radiopharmaceuticals in future years similar to the w…
Growth of PYLARIFY is also dependent on our ability to promote PYLARIFY to customers, to clinically and commercially differentiate PYLARIFY from other products on the market, to enter into and realize the benefits of strategic contracts with customers and to maintain PYLARIFY as the most utilized PS…
Other information
Text added vs the prior filing · source: 10-Q · 2026-05-07
On March 2, 2026, Julie McHugh, a member of our Board, entered into a trading plan intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act (a “10b5-1 Plan”). The 10b5-1 Plan provides for the potential sale of up to 2,033 shares of our common stock on June 1, 2…
On March 9 , 2026, Mary Anne Heino, our Executive Chairperson and Chief Executive Officer, entered into a 10b5-1 Plan providing for the potential sale of shares of our common stock in an amount necessary to attain approximately $2,000,000 of net sale proceeds between each of June 8, 2026, and June 1…
On March 11, 2026, Samuel R. Leno, a member of our Board, entered into a 10b5-1 Plan providing for the potential sale of 7,154 shares of our common stock on June 11, 2026, and for the potential sale of 7,153 shares of our common stock on June 12, 2026.
On March 12, 2026, Daniel Niedzwiecki, our Chief Administrative Officer, General Counsel and Corporate Secretary, entered into a 10b5-1 Plan providing for the potential sale of 7,029 shares of our common stock on June 15, 2026, and the potential sale of 4,798 shares of our common stock on September …
Text removed vs the prior filing · source: 10-Q · 2025-11-06
During the third quarter of 2025, none of our directors or officers (as defined in Rule 16a-1(f) of the Securities Exchange Act of 1934, as amended) adopted, modified, or terminated a Rule 10b5-1 trading arrangement.
How to read Risk Factors (Item 1A) in a 10-Q
A 10-Q risk-factor section usually takes one of three forms; this page classifies it as one of:
- Pointer — the filer states there have been no material changes and points back to the annual 10-K risk factors; there is no own risk text to compare this quarter.
- Partial update — the filer carves out specific updated risks ("except as set forth below"); the excerpts show exactly what is new this quarter.
- Restated in full — the quarter carries the complete risk-factor text. When the prior quarter was only a pointer there is no prior full text to diff against, so the page flags the section as restated instead.
This describes the filing structure only — it is never a judgement on whether risk went up or down.
Source: text-level diff of the two SEC EDGAR filings · deterministic (no AI-generated content) · for reference only · not investment advice