IPSEN, OOO

A post-hoc analysis of the Phase III NAPOLI 3 trial identified characteristics associated with long-term survival in metastatic pancreatic adenocarcinoma patients treated with the NALIRIFOX regimen.

The 15th World ADC San Diego conference (November 4-7, 2024) represents the industry's largest and most comprehensive ADC-focused forum, featuring 120+ speakers across six development tracks.

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.

China's National Medical Products Administration (NMPA) has granted conditional approval to tazemetostat (Tazverik) for adult patients with relapsed or refractory EZH2-mutated follicular lymphoma who have received at least two prior systemic therapies.

China's National Medical Products Administration (NMPA) has conditionally approved Tazverik (tazemetostat) for adult patients with relapsed or refractory follicular lymphoma with EZH2 mutation who have received at least two prior systemic therapies.

Ipsen has successfully completed its first Rated Public Bond of €500 million with a 3.875% coupon maturing in March 2032, following Investment Grade ratings from S&P (BBB-) and Moody's (Baa3).

• 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.

Priority Review Vouchers (PRVs) have surged in value to $150-158 million in recent months, up from the typical $100 million, following Congress's failure to reauthorize the rare pediatric disease program.