Lantheus Holdings, Inc. LNTH
Lantheus Holdings, Inc. (Nasdaq: LNTH) is a CNS/neurology/psychiatry drug developer. Its lead program, MK-6240 (F-18 tau PET imaging agent), is in Phase 3 for PET detection of tau neurofibrillary tangle pathology in patients with cognitive impairment evaluated for Alzheimer's disease. Its next catalyst on record is PYLARIFY TruVu: Commercial availability (rolling geographic launch) (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 (rolling geographic launch) (Q4 2026). 2 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| MK-6240 (tau PET agent) | Alzheimer's disease tau imaging | radiopharmaceutical | Phase 3 |
| LNTH-2501 (Ga-68 edotreotide kit) | PET staging/localization of neuroendocrine tumors | radiopharmaceutical | Phase 3 |
| PNT2003 (generic Lu-177 dotatate, ANDA) | Neuroendocrine tumors | radiopharmaceutical | Phase 3 |
| PNT2002 (Lu-177 PSMA I&T, SPLASH Ph3) | Metastatic castration-resistant prostate cancer | radiopharmaceutical | Phase 3 |
| NAV-4694 (flutafuranol, amyloid PET) | Alzheimer's disease amyloid imaging | radiopharmaceutical | Phase 3 |
| LNTH-2401 (68Ga-RM2, GRPR PET) | Prostate cancer imaging | radiopharmaceutical | Phase 2 |
| LNTH-2515 (florbetaben, cardiac amyloidosis new indication) | AL and ATTR cardiac amyloidosis imaging | radiopharmaceutical | Phase 2 |
| LNTH-1363S | Sarcoma; fibrosis imaging | radiopharmaceutical | Phase 1 |
| LNTH-2403 (LRRC15 radiotherapeutic) | Relapsed/refractory osteosarcoma | radiopharmaceutical | Phase 1 |
| LNTH-2402 (177Lu-RM2) | Prostate cancer (GRPR) radiotherapy | radiopharmaceutical | Phase 1 |
| LNTH-2404 (TROP2 nanobody) | Solid tumors | biologic-other | Pre-clinical |
Recent results and decisions
- Oct 21, 2026n/a FTC issued Second Request for Lantheus merger with Curium, extending review period with completion still expected in first half 2027.
The Company and Parent continue to expect to consummate the Merger in the first half of 2027.
Filing - May 7, 2026approval FDA approved PYLARIFY TruVu, a new formulation of PYLARIFY; phased geographic launch to begin in Q4 2026.
Received FDA approval for PYLARIFY TruVuTM (piflufolastat F18), a new formulation of PYLARIFY®, the Company’s market‑leading PSMA PET imaging agent
Filing - May 7, 2026n/a FDA granted tentative (not final) approval to PNT2003, which would be the first radioequivalent to Lutetium Lu 177 Dotatate for GEP-NETs.
Achieved FDA tentative approval for PNT2003, which upon full approval would be the first radioequivalent to Lutetium Lu 177 Dotatate for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP‑NETs)
Filing
3 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 CNS/neurology/psychiatry companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.