July 3rd Week, 2025 Regulatory Updates 🎯 Corcept Therapeutics submitted an NDA to the US FDA for relacorilant (selective cortisol modulator) to treat patients with platinum-resistant ovarian cancer. (Ref 1) ❓ What are the clinical outcomes that support the NDA submission? Special Designations ⭐ The US FDA granted the Priority Review to Johnson & Johnson Innovative Medicine’s TAR-200 (intravesical gemcitabine releasing system) for the Tx of BCG unresponsive high-risk non-

14/07/2025 Henlius’ Ph3 trial of HLX22 combo has dosed the first HER2+ GC patient in the US (Ref) Shanghai Henlius Biotech announced the dosing of the first patient in the US in Phase 3 HLX22-GC-301 international, multicentre trial of HLX22 (anti-HER2) + trastuzumab + chemotherapy vs trastuzumab + chemotherapy ± pembrolizumab as a first-line Tx for HER2+ve, locally advanced or metastatic gastroesophageal junction cancer and gastric cancer The primary endpoints of this study a

May 3rd Week, 2025 Regulatory Events 🎯 Incyte and MacroGenics, Inc.’s retifanlimab (anti-PD-1) + carboplatin + paclitaxel has been approved by the US FDA for the first-line Tx of inoperable, locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). Retifanlimab has also been approved as a single agent for the Tx of locally recurrent or metastatic SCAC with disease progression on or intolerance to platinum-based chemo. (Ref 1) ❓ What is the status of

February 3rd Week, 2025 📝 BMS’ Breyanzi (liso-cel; an autologous, anti-CD19 CAR-T) received NICE recommendation as an option for treating Relapsed or Refractory Large B-cell Lymphoma after first-line chemoimmunotherapy when a stem cell transplant is suitable (Ref 1) ❓ What new evidence led NICE to overturn its initial rejection of Breyanzi in Oct 2024? 📝 Anixa Biosciences received the approval to amend Ovarian Cancer Phase 1/NCT05316129 trial, allowing a second dose of FS