29/09/2025 In an ~$8B deal, Genmab will acquire Merus in an all-cash transaction (Ref) Genmab and Merus announced a transaction agreement pursuant to which Genmab will acquire all the shares of Merus for $97.00 per share in an all-cash transaction representing a transaction value of ~$8.0 billion. The transaction has been unanimously approved by the Boards of Directors of both companies A wholly owned subsidiary of Genmab will commence a tender offer for 100% of Merus’ common

19/09/2025 Merck & Co/MSD received positive EU CHMP Opinions for perioperative pembrolizumab regimen in SCCHN, and for subcutaneous administration (Ref) The EMA's CHMP adopted a positive opinion recommending the approval of Merck & Co./MSD's pembro (anti-PD-1) mono as a neoadjuvant Tx followed by adjuvant pembro + RT ± cisplatin after surgery, then pembro mono for resectable locally advanced SCCHN with PD-L1 CPS ≥1. The recommendation is based on results from the Ph3 KEYNOTE

15/09/2025 Daiichi and Merck's raludotatug deruxtecan received the Breakthrough Therapy Designation for Ovarian, Primary Peritoneal, or Fallopian Tube Cancers (Ref) The US FDA granted the Breakthrough Therapy Designation to Daiichi Sankyo and Merck & Co./MSD's raludotatug deruxtecan (R-DXd; CDH6-directed ADC) for the treatment of adult patients with platinum-resistant epithelial ovarian, primary peritoneal or fallopian tube cancers expressing CDH6 who have received prior trea

10/09/2025 Greenwich LifeSciences' GLSI-100 received the FDA fast track designation for HER2+ve breast cancer (Ref) The US FDA granted the Fast Track Designation to Greenwich LifeSciences' GLSI-100 (GP2 + GM-CSF) for the treatment of patients with HLA-A*02 genotype and HER2+ve breast cancer who have completed treatment with standard of care HER2/neu targeted therapy. Dr. Jaye Thompson, VP Clinical and Regulatory Affairs, Greenwich: "Greenwich is pleased that the FDA sees the

18/08/2025 Izalontamab brengitecan received the Breakthrough Therapy Designation by the US FDA for EGFR-mutated NSCLC (Ref) The US FDA granted the Breakthrough Therapy Designation to SystImmune and Bristol Myers Squibb's izalontamab brengitecan (EGFR x HER3 bispecific ADC) for the treatment of locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with an EGFR TKI and platinum

31/07/2025 MaxCyte and Anocca AB signed a Strategic Platform Licensing Agreement to advance TCR-T cell therapies (Ref) MaxCyte signed a Strategic Platform License Agreement (SPL) with Anocca AB in which Anocca AB will deploy MaxCyte’s Flow Electroporation® technology and ExPERT™ platform to support the scalable development and manufacturing of its TCR-T cell therapy pipeline. Anocca AB obtained non-exclusive research, clinical and commercial rights to use MaxCyte’s Flow Elect

30/07/2025 Phase 3 COSTAR Lung trial of dostarlimab + docetaxel ± cobolimab failed to meet the OS endpoint in previously treated NSCLC (Ref) GSK's Phase 3 COSTAR Lung/NCT04655976 trial of dostarlimab (anti-PD-1) + docetaxel ± cobolimab (anti-TIM-3) combinations did not meet the primary endpoint of improving OS vs docetaxel alone in advanced NSCLC that has progressed on prior PD-(L)1 therapy and chemotherapy. All regimens were well tolerated and toxicities were consistent with

28/07/2025 sNDA for Akeso and Summit's ivonescimab (PD-1 x VEGF bispecific antibody) + chemotherapy for sqNSCLC accepted by China's NMPA (Ref) The National Medical Products Administration (NMPA) has accepted the sNDA for Akeso and Summit's ivonescimab (PD-1 x VEGF bispecific antibody) + chemotherapy as a first-line treatment for advanced squamous NSCLC. The filing is based on the results from the Phase 3 AK112-306/HARMONi-6 trial, which showed that ivonescimab + chemotherapy

22/07/2025 Replimune's BLA for vusolimogene oderparepvec + nivo received a CRL from the US FDA (Ref) The US FDA issued a Complete Response Letter (CRL) regarding the BLA for Replimune's vusolimogene oderparepvec (RP1; herpes simplex virus engineered with a fusogenic protein (GALV-GP R-) and GM-CSF) + nivolumab for the treatment of advanced melanoma. The CRL highlighted that the FDA was unable to approve the application in its present form due to the following reasons: The Ph1

21/07/2025 Bayer and Orion Corporation’s Nubeqa™ received EU approval for mHSPC (Ref) The European Commission granted marketing authorization to Bayer and Orion Corporation’s darolutamide (Nubeqa; oral androgen receptor inhibitor) + androgen deprivation therapy for the treatment of patients with metastatic hormone-sensitive prostate cancer The approval was based on results from the pivotal Phase 3 ARANOTE trial in which darolutamide + ADT significantly reduced the risk of rad

18/07/2025 ImCheck’s ICT01 received the Orphan Drug Designation for Acute Myeloid Leukemia (Ref) The US FDA granted the Orphan Drug Designation to ImCheck Therapeutics' ICT01 (anti-BTN3A) for the treatment of acute myeloid leukemia Stephan Braun, CMO, ImCheck Therapeutics: "Receiving FDA orphan drug designation for ICT01 is a significant recognition of ICT01’s innovative therapeutic potential to meet the urgent unmet medical needs of AML patients. This important regulatory m

15/07/2025 The first patient has been enrolled in the Phase 3 HARMONi-GI6 trial of ivonescimab + chemo in CRC (Ref) The first patient has been successfully enrolled in the registration Phase 3 AK112-312/HARMONi-GI6 trial of Akeso and Summit's ivonescimab (PD-1 x VEGF BsAb) in first-line treatment for advanced metastatic colorectal cancer (mCRC) The trial is evaluating ivonescimab + FOLFOXIRI vs bevacizumab + FOLFOXIRI Primary completion date: Jan'27

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

11/07/2025 Cel-Sci to partner with a leading Saudi Arabian pharma company for Multikine in the Tx of Head & Neck Cancer (Ref) Cel-Sci Corporation announced an agreement with one of Saudi Arabia’s premier pharmaceutical and healthcare companies for a partnership that spans regulatory and commercial activities for Multikine (Leukocyte Interleukin, Injection) in the Kingdom of Saudia Arabia The Saudi pharmaceutical partner which will file a Breakthrough Medicine Designation appl

10/07/2025 TEVIMBRA + chemotherapy has been approved in EU as a first-line treatment for NPC (Ref) The EC approved BeOne Medicines' tislelizumab (TEVIMBRA; anti-PD-1) + gemcitabine + cisplatin for the first-line treatment of adult patients with metastatic or recurrent nasopharyngeal carcinoma (NPC), not amenable to curative surgery or radiotherapy The approval is based on results from the Phase 3 RATIONALE-309 trial which met the primary endpoint of PFS (HR 0.52; p<0.0001)

08/07/2025 Adagene and ConjugateBio sign a partnership agreement to develop novel ADC (Ref) Adagene announced a partnership with ConjugateBio to provide a proprietary antibody for use in partner companies’ bispecific ADC development programs Under the terms of the agreement, Adagene will receive an undisclosed upfront payment, as well as milestone and royalty payments Adagene will provide an internally developed antibody for novel bispecific ADC development Adagene retains al

07/07/2025 SIR-Spheres® Y-90 Resin Microspheres received FDA approval for HCC (Ref) The US FDA approved Sirtex Medical's SIR-Spheres Y-90 resin microspheres for the Tx of unresectable HCC The approval is based on the results from the prospective, multi-center, open-label DOORwaY90 trial DOORwaY90 met its prespecified primary endpoints with a ORR of 98.5%; the median DoR exceeded 300 days Matt Schmidt, CEO, Sirtex: "The expanded indication makes SIR-Spheres® the only Y-90 tr

04/07/2025 Imfinzi has been approved by the EC as a perioperative immunotherapy for muscle-invasive bladder cancer (Ref) AstraZeneca’s neoadjuvant durvalumab (Imfinzi; anti-PD-L1) in combination with gemcitabine and cisplatin followed by adjuvant durvalumab monotherapy after radical cystectomy for adult patients with resectable muscle-invasive bladder cancer (MIBC) has been approved in the EU The approval follows the positive CHMP opinion and is based on results from the Phas

02/07/2025 Lynozyfic received accelerated approval from the US FDA for R/R Multiple Myeloma (Ref) Regeneron Pharmaceuticals announced that the US FDA granted accelerated approval for linvoseltamab-gcpt (Lynozyfic; BCMA x CD3 bispecific antibody) for patients with relapsed or refractory (R/R) multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti‑CD38 monoclonal antibody The accelerated a

24/06/2025 CARsgen Therapeutics submitted a NDA for Satri-cel to China’s NMPA (Ref) CARsgen Therapeutics submitted the New Drug Application (NDA) for satricabtagene autoleucel (satri-cel; an autologous anti-Claudin18.2 CAR-T) to the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for the treatment of Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) in patients who have failed at least two prior