December 2nd Week, 2025 Regulatory Events 🎯 The US FDA granted approval to Johnson & Johnson Innovative Medicine's sNDA for niraparib and abiraterone acetate dual-action tablet (PARB inhibition and novel hormonal therapy) + prednisone for the treatment of patients with BRCA2-mutated metastatic castration-sensitive prostate cancer. (Ref 1) ❓ How is this approval expected to impact the treatment algorithm of the indication? Clinical Events 🔬 The Phase 3 STAR-221 trial of A

November 4th Week, 2025 Regulatory Events 🎯 The EC granted approval to Bristol Myers Squibb's lisocabtagene maraleucel (anti-CD19 CAR-T) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy including a BTK inhibitor. (Ref 1) ❓ How is this approval expected to impact the treatment algorithm of the indication? 🎯 The US FDA granted approval to AstraZeneca’s neoadjuvant durvalumab (anti-PD-L1) + chemot

November 3rd Week, 2025 Regulatory Events 🎯 The EC granted approval to Merck & Co./MSD's subcutaneous formulation of pembrolizumab (KEYTRUDA SC, anti-PD-1) for use across all 33 KEYTRUDA indications for adult patients in Europe. (Ref 1) ❓ What are the key pros and cons of this SC formulation? 🎯 The EC granted approval to Regeneron's cemiplimab (anti-PD-1) as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma at high risk of recurrence after surg

July 1st Week, 2025 Regulatory Updates 🎯 The US FDA granted accelerated approved for Dizal Pharmaceutical’s sunvozertinib (EGFR TKI) for the Tx of adult patients with LA/M NSCLC with EGFR exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemo. (Ref 1) ❓ How does sunvozertinib compare with Johnson & Johnson’s previously approved Rybrevant (amivantamab)? 🎯 The US FDA granted accelerated approval for Regeneron's linvoseltamab-gcpt (BCMA

March 1st Week, 2025 Regulatory Events 🎯 Bristol Myers Squibb’ nivolumab (anti-PD-1) + ipilimumab (anti-CTLA-4) has been approved by the EC as a first-line Tx for unresectable or advanced HCC. (Ref 1) ❓ How do the outcomes of nivolumab + ipilimumab compare against the previously approved Tx options for the first-line HCC? 🎯 Johnson & Johnson's amivantamab (EGFR x MET BsAb) + lazertinib (EGFR TKI) has been approved by the UK's MHRA for EGFR mutant, metastatic NSCLC. (Ref 2)

May 5th & June 1st Week ⭐ Regulatory Updates 🎯 China’s NMPA granted Priority Review to CARsgen Therapeutics’ satri-cel (CT041; an autologous, anti-CLDN18.2 CAR-T) for ≥3L aGC/GEJA pts (Ref 1) ❓ What is the current landscape of cell therapies in GC? 🎯 Autolus Therapeutics’ obe-cel (an autologous, anti-CD-19 CAR-T) received a positive CHMP opinion in the EU for the treatment of R/R B-ALL in adults, based upon Ph1/2 FELIX/NCT04404660 study results (Ref 2) ❓ What are the ap

Welcome to the May edition of our CGT Watch newsletter! CARsgen’s satri-cel priority review & Ph2 results; Autolus’ obe-cel positive CHMP opinion; BrainChild Bio’s BCB-276 RMAT; Gilead & Arcellx’s anito-cel Ph2 updated results; Senti Bio’s SENTI-202 updated Ph1 results; CARsgen’s CT0596 first-time Ph0 results; Artiva Bio’s AlloNK long-term Ph1/2 results; NeoImmuneTech’s NT-17 + CAR-T Ph1 topline results; Nkure and CRISPR Therapeutics partnership; Chong Kun Dang & AbClon part

Dear Readers, Welcome to our inaugural CGT Watch newsletter! We’re excited to bring you monthly highlights on novel targets, innovative therapeutic approaches, and emerging companies in the cell and gene therapy space. Since we’re keen to keep things concise and focused, this issue will exclusively cover cell therapies. We’re using a 45-day window for these highlights; from our next issue onward, we’ll transition to a monthly update schedule. Section 1: Key Monthly Updates 🎯