CARVYKTI® (ciltacabtagene autoleucel) Receives Recommendation from the U.S. FDA Oncologic Drugs Advisory Committee for Earlier Treatment of Patients with Relapsed/Refractory Multiple Myelo...
Legend Biotech Corporation - American Depositary Shares (LEGN)
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Source: Yahoo! Finance
SOMERSET, N.J., March 15, 2024 BUSINESS WIRE )--Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, announced today that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended CARVYKTI ® (ciltacabtagene autoleucel, cilta-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) and are refractory to lenalidomide. The positive recommendation follows the committee's evaluation of efficacy and safety data from the Phase 3 CARTITUDE-4 study. The committee voted unanimously in favor of CARVYKTI (11 to 0) finding the risk-benefit assessment of cilta-cel for the proposed indication as favorable. A supplemental Biologics License Application (sBLA) supported by the CARTITUDE-4 study is currently under review by the FDA with a target Prescription Drug User F
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LEGN
News
- Legend Biotech Co. (NASDAQ: LEGN) had its price target raised by analysts at Royal Bank of Canada from $85.00 to $86.00. They now have an "outperform" rating on the stock.MarketBeat
- Legend Biotech GAAP EPS of -$0.16 beats by $0.02, revenue of $93.99M misses by $47.37M [Seeking Alpha]Seeking Alpha
- Legend Biotech Reports First Quarter 2024 Results and Recent HighlightsBusiness Wire
- Legend Biotech Co. (NASDAQ: LEGN) had its "buy" rating re-affirmed by analysts at HC Wainwright. They now have a $87.00 price target on the stock.MarketBeat
- Legend Biotech Co. (NASDAQ: LEGN) had its "buy" rating re-affirmed by analysts at HC Wainwright. They now have a $87.00 price target on the stock.MarketBeat
LEGN
Earnings
- 5/13/24 - Beat
LEGN
Sec Filings
- 5/13/24 - Form 6-K
- 4/22/24 - Form 6-K
- 4/16/24 - Form 6-K
- LEGN's page on the SEC website