IPSEN SA S/ADR - IPSEY STOCK NEWS

Ipsen (Euronext: IPN; ADR: IPSEY) has announced its decision to request a re-examination of the CHMP's unfavorable opinion regarding the marketing authorization for palovarotene, intended for treating the ultra-rare bone disease fibrodysplasia ossificans progressiva (FOP) in the E.U. Currently, there are no disease-modifying treatments available for FOP in this region. The CHMP's decision was based on data from the MOVE trial, which assessed palovarotene's efficacy and safety. Ipsen remains committed to addressing the concerns raised and to providing innovative treatment options for the FOP community.

Ipsen announced promising results from the Phase III NAPOLI 3 trial for its investigational Onivyde regimen, aimed at treating previously untreated metastatic pancreatic ductal adenocarcinoma. The trial demonstrated a significant improvement in overall survival (11.1 months for Onivyde versus 9.2 months for nab-paclitaxel plus gemcitabine) and progression-free survival (7.4 months compared to 5.6 months). Ipsen plans to file a supplemental New Drug Application with the FDA. Despite a manageable safety profile, common adverse events included diarrhea and low blood cell counts.

Ipsen has announced a definitive merger agreement to acquire Albireo for $42.00 per share, plus a contingent value right of $10.00 pertaining to potential FDA approval for Bylvay in biliary atresia. This acquisition aims to enhance Ipsen's Rare Disease portfolio, particularly through the inclusion of Bylvay®, the first approved treatment for progressive familial intrahepatic cholestasis (PFIC). The total consideration for the acquisition amounts to approximately $952 million. The transaction is expected to close by the end of Q1 2023.

Ipsen has provided an update regarding its liquidity agreement with NATIXIS ODDO BHF. As of December 31, 2022, the dedicated liquidity account held 24,069 shares and €2,483,094.99. Initially, 12,751 shares and €3,137,934.80 were allocated to the account. From July 1 to December 31, 2022, 2,466 buy and 2,235 sell transactions were executed, resulting in trading volumes of 296,190 shares worth €29,245,027.80 purchased and 299,127 shares worth €29,692,331.70 sold.

Ipsen announced the U.S. FDA issued a Complete Response Letter (CRL) regarding the New Drug Application for palovarotene, an investigational treatment for fibrodysplasia ossificans progressiva (FOP). The CRL requests additional clinical trial data previously sought in October 2022, not new efficacy or safety data. Ipsen plans to respond in Q1 2023, leading to a six-month review cycle. FOP affects fewer than 400 people in the U.S., and without approved treatments, life expectancy is limited. Palovarotene is already authorized in Canada and UAE as Sohonos™.

Ipsen has reported updated share capital details as of 30 November 2022. The total number of shares stands at 83,814,526. The gross total of voting rights is 132,091,596, while the net total is 130,922,364. The report complies with French regulatory requirements, highlighting the presence of statutory clauses that require declaration of threshold crossings. This information is crucial for shareholders and potential investors monitoring voting rights.

Ipsen announced that the CONTACT-01 study, evaluating Cabometyx® (cabozantinib) with atezolizumab for treating non-small cell lung cancer (NSCLC), did not achieve its primary endpoint of overall survival. The trial involved 366 patients who previously received anti-PD-1 treatment and chemotherapy. Despite the disappointing results, the safety profile of the treatment was consistent with known safety profiles and no new safety signals were identified. Detailed findings will be presented at a future medical meeting.