PV FIT LIMITED

GENFIT reported a net profit of €1.5 million for 2024, driven by €67.0 million in revenues including a €48.7 million milestone payment and royalties from Iqirvo® (elafibranor) sales in PBC.

Elafibranor demonstrated a favorable safety profile and significant dose-dependent efficacy in the Phase II ELMWOOD trial for primary sclerosing cholangitis (PSC), a rare liver disease with no currently approved treatments.

Ipsen received CHMP approval for odevixibat under the new brand name Kayfanda for Alagille syndrome, marking the second approval for the same drug after rebranding due to orphan status complications.

Madrigal Pharmaceuticals' resmetirom demonstrated significant efficacy in the Phase 3 MAESTRO-NASH trial, achieving both primary endpoints of NASH resolution and liver fibrosis improvement.

• GENFIT has successfully completed a non-dilutive royalty financing agreement with HCRx worth up to €185 million, receiving an immediate €130 million upfront payment with potential for an additional €55 million upon achieving near-term milestones. • The biopharmaceutical company will use €61.66 million to repurchase 99% of its outstanding 2025 OCEANEs convertible bonds, significantly reducing its debt burden from approximately €62 million to just €586,000. • This strategic financing extends GENFIT's cash runway beyond 2027, providing crucial support for its Acute-on-Chronic Liver Failure (ACLF) pipeline development and other rare liver disease programs without diluting shareholder value.

Isomorphic Labs raised $600 million in its first external funding round in March 2025, representing the largest private biotech investment of the month.

NorthSea Therapeutics appoints Melissa Bradford-Klug as CFO/CBO, bringing over 20 years of experience and $6 billion in financing track record to advance metabolic disease therapies.

Ipsen's Iqirvo (elafibranor) receives FDA accelerated approval as the first dual PPAR alpha/delta agonist and first new therapy in over a decade for primary biliary cholangitis treatment.

The advanced liver cancer market is projected to grow from $2.31 billion in 2024 to $11.13 billion by 2035, exhibiting a CAGR of 15.38%, according to IMARC Group research.

Interim data from the open-label extension of the Phase III ELATIVE trial demonstrate Iqirvo's sustained efficacy and safety profile for up to three years in patients with primary biliary cholangitis (PBC).