Lantheus Holdings, Inc. LNTH
Lantheus Holdings, Inc. (Nasdaq: LNTH) is an oncology drug developer. Its lead program, PYLARIFY TruVu (piflufolastat F-18), is in Phase 3 for Prostate cancer imaging (PSMA-positive lesions). Its next catalyst on record is PYLARIFY TruVu: Commercial availability beginning (Q4 2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: PYLARIFY TruVu — Commercial availability beginning (Q4 2026). 3 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| PYLARIFY TruVu (piflufolastat F-18) | Prostate cancer imaging (PSMA-positive lesions) | small molecule | Approved |
| BRAVNETSA (lutetium Lu 177 dotatate) | Somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors | radiopharmaceutical | Approved |
| TAUKLARIFY (florquinitau F-18 injection, MK-6240) | Alzheimer's disease tau imaging | small molecule | Approved |
| DEFINITY | Echocardiography ultrasound enhancement | device-combination | Approved |
| Neuraceq | Alzheimer's disease beta-amyloid imaging | small molecule | Approved |
| LNTH-2401 (68Ga-DOTA-RM2) | Prostate cancer imaging (GRPR-targeted) | radiopharmaceutical | Phase 3 |
| LNTH-2501 (Ga-68 edotreotide injection kit) | Neuroendocrine tumor imaging | radiopharmaceutical | Phase 3 |
| LNTH-2402 (177Lu-DOTA-RM2) | Prostate cancer therapy (GRPR-targeted) | radiopharmaceutical | Phase 1 |
| LNTH-2403 (LRRC15-targeted monoclonal antibody) | Multiple malignancies (head and neck, breast, lung, pancreatic) | antibody | Pre-clinical |
| NAV-4694 | Alzheimer's disease beta-amyloid imaging | small molecule | Pre-clinical |
Recent results and decisions
- Nov 5, 2026started First patient dosed in SPARROW Phase 2/3 registrational trial of LNTH-2401, a GRPR-targeted PET imaging agent for prostate cancer.
Dosed the first patient in the SPARROW study, a Phase 2/3 registrational trial evaluating LNTH-2401, the Company's investigational GRPR-targeted PET imaging agent for prostate cancer; the Phase 3 portion is expected to enroll approximately 400 participants.
Filing - Sep 22, 2026approval FDA grants final approval for BRAVNETSA, the only radiopharmaceutical determined bioequivalent and therapeutically equivalent to LUTATHERA for GEP-NETs.
FDA grants final approval for BRAVNETSA™ (lutetium Lu 177 dotatate); the only radiopharmaceutical the FDA has determined to be bioequivalent and therapeutically equivalent to LUTATHERA® for the treatment of adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-
Filing - Aug 14, 2026approval FDA approves TAUKLARIFY, an F-18-labeled tau PET imaging agent for evaluation of adults with cognitive impairment being assessed for Alzheimer's disease.
Received FDA approval for TAUKLARIFY (florquinitau F-18 injection), an F-18-labeled tau PET imaging agent for the evaluation of adults with cognitive impairment being assessed for Alzheimer's disease.
Filing
5 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 oncology companies
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- Moderna, Inc. MRNA
- Revolution Medicines, Inc. RVMD
- Genmab A/S GMAB
- BioNTech SE BNTX
- Guardant Health, Inc. GH
- Exelixis, Inc. EXEL
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.