LNTH-2501 (Ga 68 edotreotide)
Lantheus HoldingsLNTH
- Indication
- Neuroendocrine tumors (NETs)
- Stage
- PDUFA
- Event
- PDUFA Approval decision
- Details
May 07, 2026 — Lantheus Holdings, Inc. (NASDAQ: LNTH) reported first-quarter 2026 results (quarter ended March 31, 2026) and provided a business update. Worldwide revenue rose 1.2% year-over-year to $377.3 million; GAAP net income increased to $118.4 million (from $72.9 million) and GAAP diluted EPS to $1.80 (from $1.02). Adjusted net income declined to $95.8 million (from $109.5 million) and adjusted diluted EPS to $1.46 (from $1.53). Product sales: PYLARIFY $240.9 million (-6.5%), Neuraceq $35.4 million, and DEFINITY $84.6 million (+6.8%). Operating cash flow was $125.1 million and free cash flow $121.9 million. Cash and equivalents were $498.6 million, including $31.4 million proceeds from selling its SPECT business to SHINE (effective Jan 1, 2026); Lantheus also has access to a $750 million revolving credit line. Operationally, FDA approved PYLARIFY TruVu (piflufolastat F18) with a phased launch planned for Q4 2026, and granted tentative approval for PNT2003 (Lutetium Lu 177 Dotatate) as a potential first “radioequivalent” for GEP-NETs. FDA extended LNTH-2501’s PDUFA date to June 29, 2026 for manufacturing-review reasons. Lantheus reaffirmed full-year 2026 guidance: revenue $1.4–$1.45 billion and adjusted diluted EPS $5.00–$5.25.
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Financial Snapshot
Market Cap
$6.5B
Price
$99.98