Shots:
The US FDA has granted RMAT designation to GLPG5101 for the r/r mantle cell lymphoma (MCL)
Designation was supported by P-I/II (ATALANTA-1) trial assessing GLPG5101 [50×106 (DL1), 110×106 (DL2) & 250×106 (DL3)] in r/r B-cell Non-Hodgkin Lymphoma pts, incl. those with MCL
Trial demonstrated superior ORR & CR rate as well as favorable safety…
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SERB Pharmaceuticals has entered into a definitive merger agreement to acquire Y-mAbs, incl. its asset Danyelza (naxitamab-gqgk), strengthening its rare oncology portfolio
As per the deal, SERB will acquire Y-mAbs for a total equity value of ~$412M, with its shareholders receiving $8.6/share in cash, delisting Y-mAbs from Nasdaq; closing expected in Q4’25
Additionally, Y-mAbs’ pipeline incl.…
Shots:
Ethris has dosed the first pts in a P-IIa trial of ETH47 for asthma symptom reduction after rhinovirus challenge, building on P-I trial data, which showed strong respiratory tract activity, local IFNλ induction, antiviral gene activation, & no systemic exposure
The P-IIa trial will evaluate ETH47 vs PBO in ~50 adults with asthma who…
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The US FDA has approved IND application of IBI3032 to initiate P-I trial for cardiometabolic disorders
The P-I trials will be initiated simultaneously in China & the US, with dosing in healthy & overweight or obese participants anticipated to start in H2’25
IBI3032, an oral GLP-1 receptor agonist biased toward the cAMP pathway, showed…
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The US FDA has approved IND application of ABT-301 to initiate P-I/II trial for pts with metastatic colorectal cancer (mCRC)
Trial will assess ABT-301 + Tevimbra (provided by Beone) + Avastin in ~66 pts across Taiwan & Australia, with proficient mismatch repair (pMMR) or non-microsatellite instability-high (non-MSI-H) mCRC
Additionally, Anbogen is pursuing global licensing,…
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The CHMP has recommended Romvimza (vimseltinib) to treat symptomatic TGCT with physical function deterioration in adults for which surgery may lead to functional impairment or severe morbidity; EC’s decision is expected in Q3'25
Opinion was based on P-I/II trial as well as P-III (MOTION) trial, which evaluated Romvimza vs PBO in surgery-ineligible pts without…
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The US FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to RP-A601 for the treatment of PKP2-arrhythmogenic cardiomyopathy
Designation was supported by ongoing P-I trial, where all 3 adults treated with a single dose of RP-A601 (8x10¹³ GC/kg) showed enhanced PKP2 protein expression, incl. 110% & 398% increase in 2 pts with low…
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FDA has accepted BLA for BAT2506, a biosimilar of Simponi (golimumab) for all approved doses, formulations, & indications of reference product, with a request for interchangeability (BsUFA: May 16, 2026)
BLA was backed by extensive analytical characterization & biosimilarity of BAT2506 in comparison to US & EU Simponi from P-I trial in healthy subjects,…
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Debiopharm has entered into an exclusive global licensing agreement with Repare Therapeutics for lunresertib (PKMYT1 inhibitor) to treat difficult-to-treat solid tumors
As per the deal, Repare will receive $10M upfront, ~$257M in clinical, regulatory, commercial & sales milestones, incl. $5M in near-term payments & net sales-based single-digit royalties
Debiopharm will assume sponsorship of P-I (MYTHIC)…
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Otsuka Pharmaceutical has entered into an agreement with Cantargia for the acquisition of all assets related to its P-I IL-1RAP antagonist program, CAN10
Otsuka Pharmaceutical will handle global development, regulatory approvals, manufacturing, & commercialization of CAN10. Otsuka has also acquired 3G5 as a backup antibody & holds exclusive negotiation right for next-gen IL-1RAP antibodies…

