Lantheus Holdings, Inc.

Lantheus Holdings, Inc. announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for its New Drug Application (NDA) for LNTH-2501. The CRL was due to unresolved third-party facility manufacturing-related conditions and not related to the clinical performance, safety, or efficacy data of the product. Lantheus stated it is working closely with its partner and the FDA to resolve these issues to advance the program.

Lantheus Holdings announced that an image generated using its investigational agent LNTH-2513 (18F-GP1) PET/CT was awarded SNMMI’s Image of the Year. This recognition follows investigator-initiated trial results evaluating LNTH-2513 PET/CT for detecting acute lower-extremity deep vein thrombosis (DVT), showing high diagnostic accuracy and good tolerability. The results highlight the potential of this thrombus-specific imaging approach to improve visualization and understanding of thromboembolic disease.

Lantheus Holdings, Inc. announced that John Wiggins, Vice President, External Manufacturing, will participate in a fireside chat at the William Blair 46th Annual Growth Stock Conference. The event is scheduled for Wednesday, June 3, at 12:10 p.m. ET. A live webcast and replay will be available on the company's investor relations website.

Lantheus Holdings, Inc. announced it will present new radiodiagnostic data at the 2026 Society of Nuclear Medicine and Medical Imaging (SNMMI) Annual Meeting. The presentations include data on the impact of PSMA-PET with Piflufolastat F18 on prostate cancer management and the diagnostic performance of 18F-GP1 PET/CT for acute deep vein thrombosis from a Phase 2 study. These presentations highlight the company's ongoing research and development in radiopharmaceuticals.

Lantheus Holdings, Inc. announced that it will feature data at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, scheduled from May 29 to June 2, 2026, in Chicago, IL. The presentations include a poster session on a Phase 1/2 study of LNTH-2403, a LRRC15-targeted 177lutetium-labeled monoclonal antibody, for patients with relapsed/refractory osteosarcoma. Additionally, a publication-only session will highlight real-world use of piflufolastat F 18 and imaging-associated treatment patterns in early-stage prostate cancer.

Lantheus Holdings, Inc. reported a significant increase in net income and diluted EPS for the first quarter of 2026, primarily driven by a substantial gain from the sale of its SPECT business. Net income rose to $118.4 million, up 62% year-over-year, while diluted EPS reached $1.80. Total revenues saw a modest increase to $377.3 million, despite a decline in PYLARIFY sales, offset by growth in DEFINITY and the inclusion of Neuraceq revenue following a 2025 acquisition. The company also recognized a $59.3 million gain from the divestment of its SPECT business.

Lantheus Holdings, Inc. reported Q1 2026 financial results, with worldwide revenue increasing 1.2% to $377.3 million. GAAP fully diluted earnings per share significantly rose 76.5% to $1.80, while adjusted fully diluted earnings per share decreased 4.6% to $1.46. The company also announced FDA approval for PYLARIFY TruVu, with a phased launch planned for Q4 2026, and tentative FDA approval for Lutetium Lu 177 Dotatate (PNT2003). Lantheus reaffirmed its full-year 2026 financial guidance and completed the divestiture of its SPECT business.

Lantheus Holdings reported strong first-quarter 2026 results with worldwide revenue of $377.3 million, a 1.2% increase year-over-year. GAAP fully diluted EPS rose significantly by 76.5% to $1.80, while adjusted fully diluted EPS decreased by 4.6% to $1.46. The company secured FDA approval for PYLARIFY TruVu and tentative approval for Lutetium Lu 177 Dotatate (PNT2003). Lantheus also reaffirmed its full-year 2026 revenue and adjusted EPS guidance.

Lantheus Holdings, Inc. shareholders approved several key proposals at their Annual Meeting on April 30, 2026. The most significant approvals include an amendment to declassify the Board of Directors over a three-year period, allowing shareholders to remove directors with or without cause once declassified. Additionally, shareholders approved the Amended and Restated 2026 Equity Incentive Plan, which increases the shares reserved for issuance by 2,000,000 and revises non-employee director compensation limits. Shareholders also elected four Class II directors and approved executive compensation on an advisory basis, determining that future "say on pay" votes will occur annually.

Lantheus Holdings, Inc. announced it will host a conference call and webcast on Thursday, May 7, 2026, at 8:00 a.m. ET. The call will cover the company's financial results and provide a business update for the first quarter of 2026. Interested participants are encouraged to register online ahead of time, and a replay will be available for at least 30 days.