Welcome to our dedicated page for IPSEN SA news (Ticker: IPSEY), a resource for investors and traders seeking the latest updates and insights on IPSEN SA stock.
Ipsen SA (ADR: IPSEY) generates a steady flow of news centered on its activities as a global, mid-sized biopharmaceutical company focused on Oncology, Rare Disease and Neuroscience. This news page aggregates company announcements, partner releases and regulatory updates that mention Ipsen and its ADR program, giving readers a focused view of developments that can influence perceptions of IPSEY.
Recent news highlights Ipsen’s role in advancing specialty care medicines. In oncology, the company has reported Phase III NAPOLI 3 trial results for an investigational Onivyde-based regimen (NALIRIFOX) in previously untreated metastatic pancreatic ductal adenocarcinoma, with statistically significant improvements in overall and progression-free survival compared to a nab-paclitaxel plus gemcitabine regimen. Ipsen has also nominated a first clinical drug candidate from its multi-year oncology collaboration with Marengo Therapeutics, based on Marengo’s STAR T cell activator platform for solid tumors.
In rare diseases, news items cover Ipsen’s work in pediatric cholestatic liver diseases and ultra-rare conditions. Examples include Health Canada’s approval of Bylvay (odevixibat) for pruritus due to Progressive Familial Intrahepatic Cholestasis, under a partnership with Medison Pharma, and regulatory interactions for palovarotene in fibrodysplasia ossificans progressiva, including a CHMP negative opinion and a U.S. FDA Complete Response Letter. Corporate news also details Ipsen’s agreement to acquire Albireo, adding Bylvay and other bile acid modulators to its rare disease portfolio.
Neuroscience and rare neurological disease updates feature Ipsen’s collaboration with Skyhawk Therapeutics to discover RNA-targeting small molecules for rare neurological diseases. Partner announcements describe Ipsen’s option to obtain exclusive global rights to development candidates and its responsibility for later-stage development and commercialization.
Investors and observers can use this news feed to follow Ipsen’s clinical trial readouts, regulatory decisions, licensing deals, acquisitions and capital markets disclosures that reference IPSEY. Regularly reviewing these updates can help contextualize the company’s therapeutic focus and strategic direction as reflected in public announcements.
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.
Ipsen has released an update regarding its share capital and voting rights as of October 31, 2022. The total number of shares is 83,814,526, leading to a gross total of 132,102,918 voting rights and a net total of 130,928,526 voting rights. This announcement complies with the French Commercial Code and is essential for shareholders to understand changes in voting power.
Ipsen announced that its Phase III NAPOLI 3 trial of Onivyde (irinotecan liposome injection) has successfully met its primary endpoint. The trial demonstrated a statistically significant improvement in overall survival for patients with metastatic pancreatic ductal adenocarcinoma compared to the nab-paclitaxel plus gemcitabine regimen. Key secondary endpoints, including progression-free survival, also showed significant results. Ipsen plans to file a supplemental New Drug Application with the FDA following these promising results.
Ipsen (IPSEY) reported robust sales performance for YTD 2022, with total sales reaching €2,208.5m, marking a 15.5% increase year-over-year, and growth of 9.5% at constant exchange rates (CER). Key drivers included Oncology sales rising by 12.9%, Neuroscience by 31.7%, and total sales in Q3 up 16.0%. However, Rare Disease sales decreased by 9.8%, and Somatuline sales suffered a 2.8% decline due to increased competition. Ipsen confirmed its FY 2022 guidance, expecting total-sales growth greater than 7% at CER. The recent acquisition of Epizyme enhances Ipsen’s Oncology portfolio.