October 2nd Week, 2025 Regulatory Events 🎯 The US FDA approved Regeneron's cemiplimab (PD-1 inhibitor) as an adjuvant Tx for adult patients with cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation. (Ref 1) ❓ How is this approval expected to impact the Tx paradigm of this indication? 🎯 The US FDA accepted for Priority Review Orca Bio's BLA seeking approval of Orca-T (allogeneic T-cell immunotherapy) as a Tx of hematological malignancies i

09/10/2025 Adcendo's ADCE-D01 received the FDA fast track designation for the treatment of STS (Ref) The US FDA granted the fast track designation to Adcendo's ADCE-D01 (uPARAP-targeting ADC) for the treatment of soft tissue sarcoma (STS). Preclinically, ADCE-D01 shows strong anti-tumor activity in a range of mesenchymal tumor models including STS and is well tolerated in non-human primate toxicology studies with a favorable safety profile and no evidence of target-specific t

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