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PYLARIFY TruVu (piflufolastat F-18)

Lantheus Holdings · $LNTH
Standard Review sNDA
PDUFA Date
March 6, 2026
Date Status
38d ago (past)
Review Type
Standard (10 mo)
92%
Baseline PoA
sNDA/sBLA historical approval rate
Based on FDA historical approval rates by submission type (2015–2025)
Dynamic PoA
Coming soon
xAI Sentiment

FDA Decision

✅
✓ FDA Approved
Decision issued: March 6, 2026
FDA APPROVED March 6, 2026 — on PDUFA target date. Approved as PYLARIFY TruVu, a new higher-radioactivity-concentration formulation of piflufolastat F-18 enabling larger batches (~50% bigger) and broader geographic distribution. 505(b)(2) pathway using OSPREY and CONDOR data. Commercial launch planned Q4 2026 with phased geographic rollout.
Source: https://www.globenewswire.com/news-release/2026/03/06/3251298/0/en/Lantheus-Announces-FDA-Approval-of-PYLARIFY-TruVu-piflufolastat-F-18-Injection.html

Live Company Data NGM

Updated 13m ago · Data: FMP
Current Price
$80.47 -21.11%
$-21.53 today
Day: $79.64 – $81.21
Market Cap
N/A
Shares out: 65.10M
Float: 57.81M
52-Week Range
$47.25
$108.91
Current price is at 54% of 52-week range
Avg Volume
940K
Beta
-0.13
vs. S&P 500
Sector
Healthcare
Drug Manufacturers - Specialty & Generic
⚠️ Financial data is for informational purposes only. Not investment advice. Prices may be delayed.
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Indication

PSMA PET imaging — new higher-concentration formulation for prostate cancer

Key Notes

FDA APPROVED March 6, 2026 — on PDUFA target date. Approved as PYLARIFY TruVu (piflufolastat F 18) injection via 505(b)(2) pathway using OSPREY and CONDOR trial data. Higher-radioactivity-concentration formulation enables ~50% larger batch sizes and broader geographic distribution. Improves access to PSMA PET imaging in underserved regions. Commercial launch planned Q4 2026 with phased geographic rollout to transition from original PYLARIFY to TruVu.
⚠️ Not Investment Advice: This information is provided for educational purposes only. PDUFA dates are FDA target action dates, not guaranteed approval dates. The FDA may extend the review period, issue Complete Response Letters, or take unexpected actions. Probability of approval scores are based on historical base rates and do not account for drug-specific factors. Always consult a financial advisor before making investment decisions.

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