Telix Gets Second FDA Rejection For Kidney Cancer Drug
1. Telix Pharmaceuticals received a Complete Response Letter from the FDA regarding TLX250-CDx. 2. The CRL highlights deficiencies in the Chemistry, Manufacturing, and Controls package. 3. Remediation is required for third-party manufacturing before resubmission to the FDA. 4. Zircaix's approval is crucial as it would be the first PET scan drug for kidney cancer. 5. Current stock price is down 13.18% following the news.