Streetbeat News

IPSEY

Ipsen

https://www.ipsen.com/

CEO

David Loew

Industry

Medicinal and Botanical Manufacturing

Open

31.17

Mkt cap

9.4B

Volume

300

High

31.17

P/E Ratio

13.45

52-wk high

34.06

Low

28.39

Div yield

0.01

52-wk low

26.97

Ipsen and GENFIT announced the FDA has accepted the NDA for elafibranor, a potential treatment for PBC, a rare liver disease. The FDA granted priority review with a target PDUFA date of June 10, 2024.

Portfolio Pulse from Charles Gross

December 07, 2023 | 10:17 am

The U.S. FDA has granted priority review for Ipsen's new drug application for elafibranor, aimed at treating the rare cholestatic liver disease PBC. The PDUFA date is set for June 10, 2024. Additionally, the EMA has validated the MAA for elafibranor, marking it as the first novel second-line treatment for PBC filed in the E.U. and U.S. in nearly a decade.

Portfolio Pulse from Benzinga Newsdesk

December 07, 2023 | 6:45 am

Exelixis Inc, Roche Holdings AG, and Ipsen announced that their Phase 3 CONTACT-02 pivotal trial evaluating Cabometyx in combination with Tecentriq has met one of the primary endpoints, showing a significant improvement in progression-free survival. The trial is for patients with metastatic castration-resistant prostate cancer. The estimated total U.S. market value is approximately $1.9 billion. Analysts from William Blair maintain the Outperform rating on Exelixis' stock.

Portfolio Pulse from Vandana Singh

August 21, 2023 | 6:57 pm

Exelixis and Ipsen have announced results from their Phase 3 CONTACT-02 trial, which evaluated the combination of Cabozantinib and Atezolizumab in treating metastatic castration-resistant prostate cancer.

Portfolio Pulse from Benzinga Newsdesk

August 21, 2023 | 5:27 am

Genfit SA and Ipsen SA announced topline results from the Phase III ELATIVE trial of elafibranor in primary biliary cholangitis (PBC), meeting its primary composite endpoint. However, CymaBay Therapeutics' ongoing Phase 3 RESPONSE study is expected to show a statistically significant reduction in itch with its drug, seladelpar. This has led to optimism for CymaBay's stock, with an Outperform rating maintained by a William Blair analyst.

Portfolio Pulse from Vandana Singh

June 30, 2023 | 6:51 pm

Ipsen SA and Genfit SA announced positive topline data from the Phase 3 ELATIVE trial evaluating the efficacy and safety of elafibranor for primary biliary cholangitis (PBC). The trial met its primary composite endpoint, with 51% of patients on elafibranor 80mg exhibiting a cholestasis response compared to 4% on placebo. Ipsen plans to discuss these results with regulatory bodies and aims to move forward with regulatory submissions to the FDA and the European Medicines Agency. Genfit shares are down 14.30% at $3.47 on the last check Friday.

Portfolio Pulse from Vandana Singh

June 30, 2023 | 6:03 pm

Ipsen and Genfit have announced topline data from the pivotal ELATIVE Phase 3 trial of Elafibrano for Primary Biliary Cholangitis. The trial met its primary composite endpoint, with 51% of patients achieving cholestasis response compared with 4% on placebo.

Portfolio Pulse from Benzinga Newsdesk

June 30, 2023 | 10:18 am

FDA's Gastrointestinal Drugs Advisory Committee voted against the benefits of Intercept Pharmaceutical's Ocaliva 25 mg for NASH patients with stage 2 or 3 fibrosis. HC Wainwright downgraded the stock to Sell from Neutral, citing potential commercial failure and competition from other drugs.

Portfolio Pulse from Vandana Singh

May 22, 2023 | 8:20 pm

All corporate logos and prices are for illustrative purposes only and are not a recommendation, an offer to sell, or a solicitation of an offer to buy any security.