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Knight Therapeutics has amended its agreement with Incyte Biosciences to gain exclusive distribution rights for retifanlimab (Brand name: Zynyz in the US and EU) and axatilimab (Brand name: Niktimvo in the US) in LATAM
Under the amended deal, Incyte will develop, manufacture, and supply retifanlimab and axatilimab, while Knight will handle regulatory approvals and…

Knight Therapeutics and Incyte Expand Latin America Agreement to Include Retifanlimab and Axatilimab

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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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TransMedics received US FDA conditional IDE approval to initiate its two-part Next‑Gen OCS ENHANCE Heart study evaluating prolonged heart perfusion (Part A) and superiority of OCS Heart in donation after brain death (DBD) cases vs static cold storage (Part B)
The study will enroll >650 pts; Part B aims to expand OCS Heart indications…

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The FDA has granted accelerated approval for Jazz Pharmaceuticals’ Modeyso (dordaviprone) to treat diffuse midline glioma with an H3 K27M mutation in pts (aged≥ 1 yrs.) with progressive disease after prior therapy. Continued approval depends on results from the P-III (ACTION) trial
Approval was based on data from 50 pts across 5 studies, showing…

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Intas Pharmaceuticals, through its Accord subsidiaries, has completed the acquisition of Coherus BioSciences’ Udenyca (pegfilgrastim-cbqv), a biosimilar of Neulasta
With the acquisition, Accord BioPharma, Intas’ U.S. specialty arm, continues Udenyca commercialization, offering patient-friendly administration options autoinjector (AI), on-body injector (OBI), and prefilled syringe (PFS)
Udenyca is a leukocyte growth factor used to reduce infection risk in…

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UroGen Pharma has reported P-III (ENVISION) trial data of Zusduri (mitomycin; QW, intravesical) as a chemoablative therapy for adults (n=240) with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC)
Trial showed a 24mos. DoR of 72.2% (Kaplan-Meier) in pts with CR at 3mos., with a mFU of 23.7mos. after 3mos. CR; the mDoR was…

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Kashiv BioSciences and MS Pharma have signed a license & supply agreement for ADL-018, a Xolair (omalizumab) biosimilar, across the Middle East and North Africa (MENA) region, with anticipated regulatory submissions in Q4’25
Under the agreement, Kashiv BioSciences will develop ADL-018, while MS Pharma will handle licensing, distribution, and commercialization in MENA, with local…

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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.…