Lancet publication 'strong validation' Genfit's NIS4, says H.C. Wainwright » 12:1008/0508/05/20
H.C. Wainwright analyst…
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Genfit announces publication of NIS4 technology in Lancet » 12:0708/0508/05/20
Genfit earlier today…
Genfit earlier today announced that pivotal data describing the derivation and validation of NIS4 has been accepted for publication by The Lancet Gastroenterology & Hepatology. NIS4 is the company's non-invasive, blood-based diagnostic technology, developed to identify patients with nonalcoholic steatohepatitis and significant to advanced fibrosis. Suneil Hosmane, Head of Global Diagnostics at Genfit commented: "This publication represents a milestone achievement for our NIS4(TM) technology. The data presented in The Lancet Gastroenterology and Hepatology showcases not only the robust and consistent performance of NIS4 to identify at-risk NASH, but also the improved performance of NIS4 relative to other technologies including commonly used liver fibrosis tests." Genfit intends to license NIS4 technology to a diagnostic partner to enable the development and projected launch of a clinical diagnostic test powered by NIS4 in the second half of 2020. Genfit added that it continues to explore opportunities to obtain formal marketing authorization of an in vitro diagnostic version of NIS4 in both the U.S. and European markets.
|Over a week ago|
Genfit price target lowered to $8 from $11 at H.C. Wainwright » 10:5107/2307/23/20
H.C. Wainwright analyst…
H.C. Wainwright analyst Ed Arce lowered the firm's price target on Genfit to $8 from $11 and keeps a Neutral rating on the shares after the company announced its decision to discontinue the Phase 3 RESOLVE-IT trial of elafibranor for the treatment of nonalcoholic steatohepatitis. Though not guided by management, the analyst anticipates Genfit to initiate a Phase 3 pivotal trial of elafibranor for primary biliary cholangitis by year-end, noting elafibranor previously met the primary endpoint of serum alkaline phosphatase. He maintains a Neutral rating on Genfit pending a complete picture of its new clinical strategy.
Fly Intel: Top five analyst upgrades » 10:1407/2307/23/20
TSLA, TXN, APA, MRO, GNFT, SUM
Catch up on today's…
Catch up on today's top five analyst upgrades with this list compiled by The Fly: 1. Tesla (TSLA) upgraded to Market Perform from Underperform at Cowen. 2. Texas Instruments (TXN) upgraded to Buy from Hold at DZ Bank. 3. Apache (APA) and Marathon Oil (MRO) upgraded to Overweight from Neutral at JPMorgan. 4. Genfit (GNFT) upgraded to Buy from Hold at Stifel with analyst Derek Archila saying the move to discontinue its nonalcoholic steatohepatitis program to focus on elafibranor's Phase 3 in primary biliary cholangitis where it has "solid proof-of-concept data and can benefit from orphan pricing would be a positive." 5. Summit Materials (SUM) upgraded to Buy from Hold at Loop Capital with analyst Garik Shmois saying he thinks the pullback yesterday disconnected with what was an exceptionally strong quarter and very solid Q3 outlook and sees the risk/reward as too favorable to ignore. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.
Genfit upgraded to Buy from Hold at Stifel » 04:5107/2307/23/20
Stifel analyst Derek…
Stifel analyst Derek Archila upgraded Genfit to Buy from Hold with an unchanged price target of EUR 11. The move to discontinue its nonalcoholic steatohepatitis program to focus on elafibranor's Phase 3 in primary biliary cholangitis where it has "solid proof-of-concept data and can benefit from orphan pricing would be a positive," Archila tells investors in a research note. With shares trading below cash of EUR 7 per share, the analyst thinks the risk/reward is favorable, and he believes the company should have enough cash runway to get to a Phase 3 PBC read out.
Genfit discontinues Phase 3 elafibranor trial in steatohepatitis, fibrosis » 04:4807/2307/23/20
Genfit announced the…
Genfit announced the discontinuation of the RESOLVE-IT Phase 3 clinical trial of elafibranor in adults with non-alcoholic steatohepatitis and fibrosis. On May 11, the company announced the results from the interim analysis of the RESOLVE-IT Phase 3 trial, which did not meet the predefined primary surrogate efficacy endpoint of NASH resolution without worsening of fibrosis in the ITT population of 1,070 patients. Following the detailed review of the full RESOLVE-IT interim efficacy dataset, Genfit "determined that the investment needed to continue the trial was not justified, as it was unlikely to provide results that would be sufficient to support elafibranor for registration in NASH in the USA and Europe." Genfit will now engage with the RESOLVE-IT investigators to expedite the trial termination process. The company will also meet with regulatory agencies "to share key learnings, including upcoming results from the second reading of liver biopsies that will help better understand inter- reader variability and its impact." Genfit added that it is "committed to finalizing this process, considering that insights gained from such a large international Phase 3 trial will provide valuable and beneficial information for the whole of the NASH community." This decision is the first step of the new corporate strategy and allows GENFIT to accelerate its cost-saving plan, and to focus its efforts on developing its two major programs: elafibranor development in PBC, and the commercial growth of NIS4 , for NASH diagnostics.
Gamida Cell names Michele Korfin Chief Operating and Chief Commercial Officer » 08:1807/2107/21/20
Gamida Cell announced the…
Gamida Cell announced the appointment of Michele Korfin as chief operating and chief commercial officer. Gamida Cell said in a release, "Ms. Korfin brings over 20 years of experience in oncology, focused on business operations and commercialization of novel therapies. In this role, she will have oversight of manufacturing and commercialization as Gamida Cell advances its clinical development candidates: omidubicel, an advanced cell therapy in Phase 3 clinical development as a potentially life-saving treatment option for patients in need of bone marrow transplant, and GDA-201, an investigational, natural killer cell-based cancer immunotherapy in Phase 1 development in patients with non-Hodgkin lymphoma. Prior to joining Gamida Cell, Ms. Korfin served as COO at TYME Technologies."
|Over a month ago|
Fly Intel: Top five analyst initiations » 10:0507/0107/01/20
PZZA, DKNG, WSC, GMDA, IHG
Catch up on today's…
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. Papa John's (PZZA) initiated with an Outperform at Wedbush. 2. DraftKings (DKNG) initiated with an Overweight at Stephens. 3. WillScot (WSC) initiated with a Buy at Stifel. 4. Gamida Cell (GMDA) initiated with an Outperform at Evercore ISI. 5. InterContinental (IHG) initiated with a Neutral at Credit Suisse. This list is just a portion of The Fly's analyst coverage. To see The Fly's full Street Research coverage, click here.
Gamida Cell initiated with an Outperform at Evercore ISI » 16:2906/3006/30/20
Evercore ISI analyst…
Evercore ISI analyst Jonathan Miller initiated coverage of Gamida Cell with an Outperform rating.
Intercept selloff yesterday overdone, says B. Riley FBR » 08:4506/3006/30/20
ICPT, GNFT, CBAY
B. Riley FBR analyst…
B. Riley FBR analyst Mayank Mamtani lowered the firm's price target on Intercept Pharmaceuticals (ICPT) to $97 from $158 and keeps a Buy rating on the shares. The selloff yesterday on the unexpected receipt of a Complete Response Letter for obeticholic acid is overdone, Mamtani tells investors in a research note. With a large share of the FDA's infrastructure diverted towards COVID-19 drug development, it is reasonable for the agency to take more time in gaining comfort with obeticholic acid's clinical profile as well as histology-based surrogate endpoint that has recently been "muddled" by Genfit's (GNFT) Phase III unusually high placebo response and CymaBay's (CBAY) Phase II study challenged by errors in biopsy reads, says the analyst. Mamtani's long-term view remains favorable on approvability of obeticholic acid in nonalcoholic steatohepatitis.