|Bid||0.0000 x 0|
|Ask||0.0000 x 0|
|Day's Range||4.7120 - 5.0200|
|52 Week Range||4.6600 - 22.2600|
|Beta (5Y Monthly)||0.99|
|PE Ratio (TTM)||N/A|
|Earnings Date||Apr 08, 2020|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||63.89|
Lille (France), Cambridge (Massachusetts, United States), May 27, 2020 – GENFIT (Euronext: GNFT - ISIN: FR0004163111), a late-stage biopharmaceutical company dedicated to.
The FDA defers advisory committee meeting date pertaining to Intercept's (ICPT) NDA for obeticholic acid to treat liver fibrosis due to nonalcoholic steatohepatitis.
GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with metabolic and liver diseases, today announced its cash position as of March 31, 2020 and revenues for the first three months of 2020. As of March 31, 2020, the Company’s cash and cash equivalents amounted to €252.0 million compared with €314.1 million as of March 31, 2019 and €276.7 million as of December 31, 2019.
Shares of Durect (NASDAQ: DRRX) were up 23% at 1:53 p.m. EDT on Tuesday. The gains followed the release of first-quarter results after the closing bell Monday and disappointing trial results for Genfit (NASDAQ: GNFT), a fellow biotech developing a potential competitor to Durect's nonalcoholic steatohepatitis (NASH) drug. It certainly wasn't Durect's financial report from the first quarter that has investors excited.
Genfit (NASDAQ: GNFT), a late-stage biopharmaceutical company, reported some disappointing news on Monday regarding one of its leading pipeline candidates, Elafibranor. Genfit's shares are down by 65.2% as of 12:46 p.m. EDT on Tuesday. Interim analysis of RESOLVE-IT -- a phase 3 clinical trial evaluating Elafibranor in NASH patients -- showed that the treatment failed to achieve statistically significant NASH resolution without worsening of fibrosis (scarring in the lungs) at week 72, which was the primary endpoint of the study.
Shares in Genfit (GNFT) crashed 49% in after-hours trading on Monday after the late-stage biopharma announced disappointing results from an interim analysis of the RESOLVE-IT Phase 3 trial evaluating once-daily, 120mg of elafibranor in adults with non-alcoholic steatohepatitis (NASH).The trial did not meet the predefined primary endpoint of NASH resolution without worsening of fibrosis in the ITT population of 1,070 patients.The response rate in the 717 patients enrolled on study drug was 19.2% for patients who received elafibranor 120mg compared to 14.7% for patients in the placebo arm. On the fibrosis key secondary endpoint, 24.5% of patients who received elafibranor 120mg achieved fibrosis improvement of at least one stage compared to 22.4% in the placebo arm. The other key secondary endpoint related to metabolic parameters did not achieve statistical significance.“These results are highly disappointing, not only for the GENFIT team, but also for patients and healthcare providers as there continues to be considerable unmet medical need in the NASH space” commented Pascal Prigent, CEO of Genfit.The GENFIT team is actively reviewing the full interim dataset, said Prigent, and will conduct additional analyses to gain a clearer understanding of the higher than anticipated response rates in the placebo arm.“We plan to share these detailed findings with the regulatory authorities in the coming months and with their guidance, determine a final decision regarding the continuation of the RESOLVE-IT trial” the CEO said.The full dataset will be presented at one of the international hepatology meetings in the second half of 2020. Safety and tolerability of elafibranor was similar to previously conducted trials.Prigent revealed that the company will continue as planned with the NIS4TM and Phase 3 PBC (primary biliary cholangitis) programs, which are independent of the NASH elafibranor program.“We are not terribly surprised elafibranor failed in the RESOLVE-IT Phase 3 study in NASH as we were pretty skeptical ahead of results based on our diligence into elafibranor’s Phase 2 data and its mechanism” says Stifel Nicolaus analyst Derek Archila.He has a hold rating on GNFT, arguing that the stock is now likely to remain range bound until management provides an update in the fall for elafibranor in NASH.However, there is a glimmer of hope- elafibranor’s program in primary biliary cholangitis (PBC). Archila thinks here GNFT has solid proof-of-concept data from both an efficacy and safety perspective, and that this could provide a floor for shares.“Until it is certain management plans terminate NASH and move forward with PBC as the lead indication, where it can benefit from orphan pricing, we remain on the sidelines” he explains.Overall the stock has a Moderate Buy consensus from the Street and a $40 average analyst price target (82% upside potential). (See Genfit stock analysis on TipRanks).Related News: CymaBay Doubles After-Hours On Positive NASH Trial Update Seres Therapeutics Reports Weak Earnings, But Significant Upside Lies Ahead Inovio’s COVID-19 Vaccine Candidate Has the Edge Over Moderna’s, Says 5-Star Analyst More recent articles from Smarter Analyst: * Halliburton Wipes 75% Off Dividend; Board Takes Pay Cut * AstraZeneca-Merck Lynparza Prostate Cancer Treatment Gets FDA Approval * Zoom Suspends Free China Service As Trade Tensions Intensify * Unclear If President Trump Will Wear Mask At Ford’s Repurposed Factory Tour
(Bloomberg) -- French biotech Genfit plunged after falling short in the race to develop a drug for a disease lurking undetected in tens of millions of people struggling with obesity and diabetes.Preliminary data reported on Monday pointed to a failure of Genfit’s elafibranor drug in a crucial late-stage trial. The stock fell as much as 75% in Paris trading, reaching its lowest level in almost seven years and giving the company a market value of 246 million euros ($266 million).For years, Genfit was seen as a top contender to find a treatment for a fatty liver disease known as nonalcoholic steatohepatitis, or NASH, which has no existing cure on the market.“This leaves a big question mark for us and for the entire field,” said Chief Executive Officer Pascal Prigent in an interview. “The odds are not great for us,” he said, “but we still see this space as really attractive.”NASH is marked by a build-up of fat and scarring in the liver. The mildest patients can be fairly asymptomatic, while the disease can progress to deadly liver cancer in others.Genfit’s elafibranor belongs to a class of drugs that targets proteins that control how the body stores and distributes fat known as peroxisome proliferator-activated receptors, or PPARs. PPARs like GlaxoSmithKline’s diabetes medicine Avandia have been used to treat inflammation as well to improve blood sugar.The first interim results from Genfit’s late-stage clinical trial of elafibranor in 1,070 patients found that the study did not meet the primary endpoint of NASH resolution without worsening of fibrosis. It showed that 19% of patients who received elafibranor saw the disease resolved, versus roughly 15% of patients in the placebo arm. The difference between those two groups wasn’t statistically significant.Placebo ShockThe trial also evaluated improvement to scarring in liver tissue. The preliminary data showed that about 25% of patients who got elafibranor saw their fibrosis improve by at least one stage, compared with 22% of patients on a placebo. That result wasn’t statistically significant. Safety and tolerability were consistent with prior studies.CEO Prigent said he was both surprised and disappointed by the results. He said he had expected elafibranor to show these rates of efficacy, but what came as a shock was the sheer level of benefit patients saw on placebo.“Why the heck do we have a placebo response that is almost twice what we’d seen in the last trial?” Prigent asked. “We believe that the question about how we measure endpoints, and how we use biopsy, that’s probably going to continue to be a challenge for the space.”Experts in general say NASH studies can be hindered by the fact that patients often see immediate benefit merely by consulting with doctors about their health conditions, and making lifestyle changes that include diet and exercise. That can confound the ability to assess the benefit of a treatment.Prigent believes that a medicine is necessary to treat the condition despite the benefit patients can see through lifestyle changes. “I’m 100% convinced you need a drug,” he said. “We could give up medicine for lung cancer if people quit smoking, but we don’t. In this case, it’s simplistic to think that everyone could lose weight, and problem solved. Some cannot afford to make lifestyle changes.”Genfit will conduct additional analysis to better understand why the placebo arm saw a greater benefit than expected and plans to share those details with regulators. Though the preliminary data serve as a proxy for the ultimate clinical outcomes, Prigent said the company will weigh the costs and benefits of moving forward before discontinuing the overarching trial. A more complete look at the results is expected at one of the international hepatology meetings that will take place in the second half of this year.Genfit holders may have gotten an inkling that the drug wasn’t likely to work last June when another PPAR from CymaBay Therapeutics Inc. failed to beat a placebo at showing an improvement on liver fat levels. Some investors likely remained optimistic as each drug targeted a different one of the three types of PPARs.Previous FailuresThe path to developing new NASH therapies is littered with failures for once high-flying names like Conatus Pharmaceuticals Inc. and Galectin Therapeutics Inc. Novo Nordisk A/S reported mixed results from a mid-stage study of semaglutide last week.While Intercept Pharmaceuticals Inc. is widely expected to get regulatory approval of the first drug to treat NASH in June, expectations around potentially better follow-on treatments from other small-cap drugmakers like Madrigal Pharmaceuticals Inc. and Viking Therapeutics Inc. have led to volatility in NASH-related stocks.Prigent still sees a major value creator lurking within Genfit’s portfolio. Its non-invasive blood diagnostic test, known as NIS4, would potentially compete with experimental tests from the likes of Siemens AG. One study showed it outperformed other non-invasive diagnostics tools in identifying NASH in people with Type 2 diabetes.“Sometimes as a biotech, your program fails, and it’s game over,” said Prigent. “Today, I think, unfortunately, is going to be about the disappointment of the Phase 3 trial. That was the immediate value proposition. But the diagnostic will be the cornerstone of out value proposition in the future. That’s the most important question: Which patients do you treat, and at what point do you treat them?”For more articles like this, please visit us at bloomberg.comSubscribe now to stay ahead with the most trusted business news source.©2020 Bloomberg L.P.
Genfit stock lost half its value late Monday after the biotech company's promising hepatitis treatment failed in a Phase 3 test. The results are a boon for rival Intercept Pharmaceuticals.
Elafibranor did not demonstrate a statistically significant effect on the primary endpoint of NASH resolution without worsening of fibrosis GENFIT will engage with regulatory.
Lille (France); Cambridge (Massachusetts, United States) — May 7, 2020 — GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to the discovery and development of innovative therapeutic and diagnostic solutions in metabolic and liver related diseases, today announced that it published in the May 6, 2020’s French legal announcements bulletin (Bulletin des Annonces Légales Obligatoires) its convening notice that the Annual Shareholders Meeting will be held on Thursday, June 11, 2020, at 10:00 am, at the Company’s headquarters, located at Parc Eurasanté, 885 avenue Eugène Avinée in Loos (59120), France. Due to the ongoing lockdown and prohibition on public gatherings currently imposed by the French government to prevent the spread of Coronavirus (COVID-19), the Board of Directors of the Company decided the Shareholders Meeting will be held behind closed doors, meaning without the physical presence of shareholders and others who are usually entitled to attend, in accordance with the provisions of Article 4 of Ordinance No. 2020-321 of March 25, 2020.
Publication of the Universal Registration Document and Annual Report on Form 20-F are postponed until the end of May 2020All additional dates remain unchanged, including the.
A week ago, Genfit SA (EPA:GNFT) came out with a strong set of full-year numbers that could potentially lead to a...
Topline interim results from Phase 3 clinical trial RESOLVE-IT expected by the end of May 2020Cash position of €277MM as of December 31, 2019 (vs €207MM as of December 31,.
GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to the discovery and development of innovative therapeutic and diagnostic solutions in metabolic and liver related diseases, today reported an update on its regulatory and clinical activities in the context of the COVID-19 pandemic. The unprecedented spread of COVID-19 is impacting the global health and business ecosystem, GENFIT included. During this crisis, our priorities are to ensure the safety and well-being of our employees, of the patients and healthcare professionals involved in our clinical trials, as well as the integrity of our ongoing clinical trials.
Pomerantz LLP is investigating claims on behalf of investors of Genfit SA ("Genfit" or the "Company") (NASDAQ: GNFT). Such investors are advised to contact Robert S. Willoughby at firstname.lastname@example.org or 888-476-6529, ext. 9980.
Attorney Advertising -- Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Genfit SA ("Genfit" or the Company") (NASDAQ: GNFT). Investors who purchased Genfit securities are encouraged to obtain additional information and assist the investigation by visiting the firm's site: www.bgandg.com/gnft.
This release is being issued to correctly state that the Phase 3 RESOLVE-IT trial remains blinded. Lille (France), Cambridge (Massachusetts, United States), February 20, 2020 – GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to the discovery and development of innovative therapeutic and diagnostic solutions in metabolic and liver related diseases, today announced that unblinding of the Phase 3 RESOLVE-IT data will be delayed to incorporate the latest FDA insights expected by the end of March.
GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to the discovery and development of innovative therapeutic and diagnostic solutions in metabolic and liver related diseases, today announced that unblinding of the Phase 3 RESOLVE-IT data will be delayed to incorporate the latest FDA insights expected by the end of March. Topline interim results will be announced in the weeks following receipt of FDA insight.
While not a mind-blowing move, it is good to see that the Genfit SA (EPA:GNFT) share price has gained 23% in the last...
GENFIT: 2020 Financial Calendar Lille (France), Cambridge (Massachusetts, United States), January 21, 2020 – GENFIT (Nasdaq and Euronext: GNFT), a late-stage.
GENFIT: 2019 Half-Year Report of Liquidity Contract with Crédit Industriel et Commercial Lille (France), Cambridge (Massachusetts, United States), January 10, 2020 – GENFIT.
We are still in an overall bull market and many stocks that smart money investors were piling into surged through the end of November. Among them, Facebook and Microsoft ranked among the top 3 picks and these stocks gained 54% and 51% respectively. Hedge funds' top 3 stock picks returned 41.7% this year and beat […]
GENFIT: Outcome of the Ordinary and Extraordinary Shareholders’ Meeting of November 27, 2019 Lille (France), Cambridge (Massachusetts, United States), November 28, 2019 –.