Lantheus Gets FDA CRL for LNTH-2501; No Safety or Efficacy Concerns Raised
The delay is due to manufacturing issues at a third-party facility, with no safety or clinical data concerns.
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Ardelyx Suffers Legal Setback as Appeals Court Confirms XPHOZAH in Medicare Bundle
Ardelyx shares fell after losing a court case on Xphozah Medicare coverage, moving drug into bundled payments, hurting revenue outlook.
Moderna Shares Surge as Oncology Pipeline Ignites Investor Optimism
Piper Sandler raised its price target on Moderna from $69 to $77, maintaining an Overweight rating. Strong momentum in the oncology pipeline is fueling the rally.
Capricor Shares Fall as FDA Schedules Advisory Committee for Deramiocel
Capricor Therapeutics stock fell after the Food and Drug Administration set a July 29 review of its DMD therapy; a decision is due Aug. 22.
JPMorgan Upgrades Replimune to Overweight as FDA Sets Late-July Advisory Committee for RP1
Replimune receives FDA priority review for RP1 in advanced melanoma with August 2, 2026 PDUFA date.
Omeros Shares Plunge After CHMP Rejects Narsoplimab for TA-TMA
Omeros shares fell sharply after the CHMP gave a negative opinion on its drug narsoplimab for transplant-associated thrombotic microangiopathy. Company plans re-examination.