Lantheus Holdings, Inc.

Lantheus Announces CMS Grants Transitional Pass-Through Status for PYLARIFY® TruVu (piflufolastat F 18)

CMS granted Transitional Pass-Through payment status for Lantheus' PYLARIFY TruVu (piflufolastat F 18), effective October 1, 2026, enabling separate reimbursement in the hospital outpatient setting. PYLARIFY TruVu, a new formulation of Lantheus' PSMA-targeted PET imaging agent, also received a permanent HCPCS code, easing billing for providers ahead of a phased geographic rollout. The milestone supports commercial launch of the next phase of the PSMA PET franchise, which has already been used in more than 900,000 scans since its May 2021 FDA approval.

•1mo ago

Lantheus Announces First Patient Dosed in SPARROW Phase 2/3 Registrational Trial in Prostate Cancer

Lantheus dosed the first patient in SPARROW, a Phase 2/3 registrational trial evaluating LNTH-2401, an investigational GRPR-targeted PET imaging agent for prostate cancer. The trial includes an initial Phase 2 dose-optimization period with up to 12 participants, followed by a Phase 3 diagnostic performance period enrolling approximately 400 patients, with co-primary endpoints of sensitivity and specificity versus histopathology. The milestone advances Lantheus' pipeline beyond its PSMA PET franchise toward a complementary imaging target; no clinical data were reported.

•1mo ago

Lantheus Receives Final FDA Approval for BRAVNETSA™ (Lutetium Lu 177 Dotatate), the Only Radiopharmaceutical FDA has Determined to be Bioequivalent and Therapeutically Equivalent to LUTATHERA® for the Treatment of GEP-NETs

The FDA granted final approval for BRAVNETSA (lutetium Lu 177 dotatate), Lantheus' radioligand therapy for adult patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors, making it the only radiopharmaceutical the FDA has determined to be bioequivalent and therapeutically equivalent to Novartis' LUTATHERA. BRAVNETSA, previously referred to as PNT2003, is the first radioligand therapy approved through the FDA's Abbreviated New Drug Application (ANDA) pathway, opening a new regulatory route for follow-on radiopharmaceuticals; U.S. GEP-NET prevalence is estimated at approximately 200,000 patients. CEO Mary Anne Heino framed the approval as an important milestone in expanding Lantheus' radiopharmaceutical portfolio, though launch timing and commercial availability have not yet been detailed. As the sole FDA-determined LUTATHERA-equivalent, BRAVNETSA positions Lantheus to compete for share of Novartis' established lutetium therapy franchise, though ANDA entrants typically face pricing pressure and potential patent litigation with the reference product holder.

•1mo ago

Lantheus Announces FDA Approval of TAUKLARIFY™ (Florquinitau F 18 Injection), an F18-Labeled Tau PET Imaging Agent for Alzheimer’s Disease

Lantheus received FDA approval for TAUKLARIFY, an F18-labeled tau PET imaging agent for adults with cognitive impairment being evaluated for Alzheimer's disease. The approval is backed by two blinded read studies analyzing images from over 500 subjects, demonstrating high agreement rates among independent readers and a safety profile evaluated in 1,734 subjects. The company intends to support therapeutic programs through its Pharma Solutions business while assessing the path to broader commercial availability for the new diagnostic.

•2mo ago

Lantheus Reports Second Quarter 2026 Financial Results

Lantheus reported Q2 revenue of $388.2 million, up 2.7% year-over-year, with GAAP EPS of $1.11 and adjusted EPS of $1.55. The company simultaneously announced a definitive agreement to be acquired by Curium in an all-cash transaction valued at up to $114.50 per share, representing a total enterprise value of approximately $8.0 billion. Pending the transaction close, the Board has suspended full-year 2026 financial guidance and will not host a conference call.

•2mo ago

Curium Announces Definitive Agreement to Merge with Lantheus

Curium has agreed to acquire Lantheus for $102.50 per share in cash plus CVRs worth up to $12.00 per share, valuing the transaction at up to $8.0 billion. The offer represents a 38% premium to Lantheus' unaffected 60-day VWAP; the Lantheus Board has unanimously approved the deal, which is expected to close in the first half of 2027. Pending the transaction, Lantheus suspended its FY 2026 guidance and will cease to be a publicly traded company upon completion.

•2mo ago

Lantheus' LNTH-2513 (18F-GP1) PET/CT Awarded SNMMI’s Image of the Year

Lantheus announced that an image generated using its investigational agent LNTH-2513 (18F-GP1) was awarded SNMMI’s Image of the Year at the 2026 Annual Meeting. The award recognizes investigator-initiated trial results evaluating LNTH-2513 PET/CT for detecting acute lower-extremity deep vein thrombosis (DVT) in 46 symptomatic patients. The study demonstrated high diagnostic accuracy for proximal DVT, with 95% sensitivity and 92% specificity, and identified concomitant pulmonary embolism in 22 of the 46 patients. Lead investigator Dr. Sangwon Han noted the approach showed high accuracy and detected thrombi in areas difficult to assess with conventional venous ultrasonography.

•4mo ago

Lantheus Highlights New Radiodiagnostic Data at the 2026 SNMMI Annual Meeting

Lantheus will present new radiodiagnostic data at the 2026 SNMMI Annual Meeting in Los Angeles, featuring two distinct studies. An oral presentation on June 2 will cover the diagnostic performance of 18F-GP1 PET/CT for acute deep vein thrombosis, based on a Phase 2, open-label, non-randomized study led by researchers at Asan Medical Center. A poster presentation on June 1 will examine the impact of PSMA-PET with Piflufolastat F18 on prostate cancer management for patients with low or ultra-low PSA levels after definitive treatment.

•5mo ago