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Ipsen Pharmaceuticals
NEWS

Ipsen Reports the CHMP Positive Opinion for Ojemda (Tovorafenib) for R/R BRAF-Altered Pediatric Low-Grade Glioma (pLGG)

Shots: 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…
March 2, 2026

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NEWS

Origami Therapeutics Collaborates with Ipsen to Develop Protein Degrader Program for Neurodegenerative Disorder

Shots: 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…
February 2, 2026

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Ipsen Pharmaceuticals
NEWS

Ipsen Receives US FDA Breakthrough Therapy Designation for IPN60340 in Unfit Acute Myeloid Leukemia

Shots: 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…
January 14, 2026

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NEWS

Ipsen Signs ~$1.06B Deal with Simcere Zaiming for SIM0613

Shots: 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…
December 24, 2025

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NEWS

Ipsen Acquires ImCheck Therapeutics, Enhancing its Oncology Leadership and Strengthening its Pipeline

Shots: Ipsen enters into a definitive share purchase agreement with ImCheck Therapeutics to acquire later's all issued and outstanding shares, including lead candidate ICT01, a P-I/II therapy for 1L AML pts ineligible for intensive CT As per the deal, shareholders of ImCheck Therapeutics will receive €350M ($406.62M) in closing purchase price, with additional deferred payments…
October 23, 2025

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NEWS

Medison and Ipsen’s Bylvay Receives the Health Canada’s Approval to Treat Cholestatic Pruritus in Alagille Syndrome Patients

Shots: 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…
September 10, 2025

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Exelixis & Ipsen
NEWS

Exelixis and Ipsen Report the EC’s Approval of Cabometyx (Cabozantinib) to Treat Advanced Neuroendocrine Tumors (NETs)

Shots: 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…
July 25, 2025

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Ipsen
NEWS

Ipsen’s Kayfanda (Odevixibat) Gains the CHMP’s Positive Opinion to Treat Cholestatic Pruritus in Alagille Syndrome (ALGS) 

        Shots:    The CHMP’s positive opinion of Kayfanda to treat cholestatic pruritus in ALGS individuals (≥6mos.) was based on P-III (ASSERT) study. EC’s decision is anticipated in Q3’24  The P-III (ASSERT) study assessed the safety & efficacy of Kayfanda (120µg/kg/day) vs PBO for 24wks.to relieve itch in ALGS patients (n=52; 0-17yrs.) across North America, EU,…
July 27, 2024

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Ipsen
NEWS

Ipsen’s Iqirvo (Elafibranor) Gains the CHMP’s Positive Opinion for Treating Primary Biliary Cholangitis (PBC) 

Shots:    The CHMP’s positive opinion of Iqirvo (PPAR agonist) + ursodeoxycholic acid (UDCA) for PBC adults having inadequate UDCA response or Iqirvo alone for UDCA intolerant patients was based on P-III (ELATIVE) study. EC’s decision is anticipated in Q3’24. The company has submitted Iqirvo for PBC to the MHRA    The P-III (ELATIVE) study assessed Iqirvo…
July 26, 2024

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