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Biopharma dealmaking in 2025 continued to face significant headwinds, with collaborations frequently collapsing due to strategic reprioritization, fierce competitive pressures, unfavorable clinical readouts, and failure to meet key closing conditions highlighting the inherent uncertainty and capital risk embedded in innovation-driven partnerships
The year underscored a clear dominance of R&D-focused collaborations and licensing agreements,…
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The EC has granted conditional approval to Ipsen's Ojemda as a monotx. for the treatment of pts (≥6mos.) with pLGG harbouring a BRAF fusion or rearrangement or BRAF V600 mutation, who have progressed after ≥1 prior systemic therapy, across all 30 EEA states
Approval was based on the P-II (FIREFLY-1) trial assessing Ojemda (QW, PO)…
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The European Commission approved multiple innovative therapies across vaccines, oncology, cardiology, immunology, and rare diseases, including products from Moderna, Hansoh Pharmaceutical, Cytokinetics, ImmunityBio, and GSK
The Committee for Medicinal Products for Human Use also issued positive opinions for late-stage assets from Ipsen, X4 Pharmaceuticals, Novartis, and Moderna, alongside additional recommendations for therapies targeting chronic spontaneous urticaria, WHIM syndrome, pediatric…
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The CHMP has recommended conditional approval of Ojemda monotx. for the treatment of pts (≥6mos.) with pLGG harbouring a BRAF fusion or rearrangement or BRAF V600 mutation, who have progressed after ≥1 prior systemic therapy
Opinion was based on the ongoing P-II (FIREFLY-1) trial assessing Ojemda (QW, PO) in 137 relapsed or refractory BRAF-altered pLGG…
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Origami Therapeutics has entered into a global collaboration & option agreement with Ipsen to develop a small-molecule protein degrader, using Origami’s Oricision platform, for a rare inherited neurodegenerative disorder
Under the deal, Ipsen will secure an exclusive option to license the program globally after drug candidate nomination &, upon exercise, would take over worldwide…
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The US FDA has granted Breakthrough Therapy Designation (BTD) to Ipsen’s investigational therapy IPN60340 (ICT01) in combination with venetoclax and azacitidine for the treatment of 1L unfit acute myeloid leukemia (AML)
The designation was supported by data from the P-I/II (EVICTION) study (n=57), where IPN60340 + Ven-Aza showed encouraging response rates, including a near…
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Ipsen has entered into an exclusive licensing agreement with Simcere Zaiming for SIM0613 to treat solid tumors with the highest unmet needs
Ipsen will secure global rights to SIM0613 outside Greater China, gain manufacturing rights after technology transfer, & assume responsibility for all development activities beyond Greater China, incl. P-I preparation & IND/CTA submissions
As…
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Health Canada has approved Bylvay (odevixibat) for the treatment of cholestatic pruritus in pts (≥12mos.) with Alagille Syndrome (ALGS)
Approval was based on P-III (ASSERT) trial assessing Bylvay (120µg/kg, QD) vs PBO in ALGS pts for 24wks. across North America, EU, Middle East, & Asia Pacific regions
Trial met its 1EP of improved pruritus…
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The EC has approved Cabometyx for inoperable, locally advanced or metastatic, well-differentiated pancreatic NET (pNET) & extra-pancreatic NET (epNET) pts, who progressed on ≥1 prior systemic therapy other than somatostatin analogues in all 30 EEA states
Approval was based on P-III (CABINET) study assessing Cabometyx (60mg) vs PBO among 298 US pts, which were…
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Ipsen has reported P-II (ELMWOOD) trial data assessing elafibranor (80 or 120mg) vs PBO in 68 PSC pts for 12wks.; 96wks. OLE study evaluating elafibranor (120mg) is ongoing
Trial demonstrated favorable safety & tolerability (1EP) at Wk. 12, with elafibranor 80 or 120mg vs PBO showing TRAEs 68.2%, 78.3% vs 69.6% pts, respectively
Elafibranor…

