4 big pharmaceutical giants are bumping into a $40 billion market into an "sky house"?

TextEvaIntercept Pharmaceuticals, a longtime leader in non-alcoholic fatty hepatitis (NASH), is working to win the first new DRUG, but its OCA has been delayed in the FDA filing processYesterday, the company received a full response letter from the FDA (CRL)THE FDA rejected the OCA application for THE treatment of NASH on the grounds that the FDA believes the benefits of OCA at the mid-term histopathological endpoint are still uncertain, and recommended that Intercept submit additional interim analysis validity and safety data from the ongoing REGENERATE study to support the potential accelerated approval of OCA, noting that the long-term results of the study should continue, Intercept's shares fell about 39 percent on Monday as a result of the newsShares of other drugmakers, which also develop NASH, also fell, with Madrigal down about 6 percent and Viking, Akero and GenFit down about 1 percent eachFebruary 19, 2019, Intercept announced positive results from the mid-term analysis of obeycholic acid (OCA) in critical phase III REGENERATE studies in patients with non-alcoholic fatty hepatitis 2-3 hepatitis fibrosis (NASH)OCA reached the primary endpoint, liver fibrosis improved significantly, and after 18 months NASH did not deteriorate (p s 0.0002)Obechochoricic acid is the first new NASH drug to succeed in Phase III studiesSeptember 27, 2019, Intercept filed a listing application with the U.SFDA for a new drug for the use of its innovative drug, obecholic acid, for fibrosis caused by NASHNovember 25, 2019, Intercept announced that the FDA had accepted the company's NDA application and had been granted priority review status, with a PDUFA date of March 26, 2020on January 13, 2020, Intercept issued "Intercept Provides Regulatory Update", indicating that experts would review Intercept's NDA application on 22 April 2020June 29, 2020, Intercept announced that the FDA rejected applications for new drugs for the use of obelcholic acid for NASH-induced fibrosisNEW DRUG NASH, Phase III Black Hole?non-alcoholic fatty hepatitis (NASH) is a chronic progressive liver disease caused by the accumulation of fat in the liver, which can lead to cirrhosis, liver failure and hepatocellular carcinoma No drugs for non-alcoholic fatty hepatitis have been approved, and there is plenty of market space , Evaluate Pharma, predicts that the global MARKET for NASH drugs could reach $40 billion by 2025 The huge market size has attracted many pharmaceutical companies, but most of them are in a very early stage International is the first of eight pharmaceutical companies to be successful in the key Phase III study The rest of the leading layout of NASH companies, have encountered obstacles, the industry has even called NASH after Alzheimer's disease, another Phase III black hole Company: Genfit Drug Name: Elafibranor Mechanism: PPAR alpha and diagonist stage: Phase 3 May 11, 2020, the interim results of Genfit's Elafibranor RESOLVE-IT Phase III clinical trial indicate that the trial did not reach its intended primary endpoint The news sent Genfit's shares down 68 per cent and the market value evaporated by half : Gilead drug names: selonsertib, firsocostand, and cilofexor
mechanisms: ASK1 inhibitors, ACC inhibitors, FXR agonists stages: Phase 2 February 2019 Selonsertib failed to improve fibrosis in two phase 3 trials involving more than 1,600 patients December 2019, Gilead's NASH Phase II clinical failure, the study recruited 392 PATIENTs with severe fibrosis, comparing ACC2 inhibitor firsocostat, FXR receptor agonists, the two combinations, and the combination of ask1sel inhibitors onsertibons, and the effects of placebo on improving fibrosis, without reaching the primary endpoint of the study : Novartis drug names: Tropifexor and licogliflozin mechanisms: FXR agonists and SGLT1 / 2 inhibitors phases: Phase 2 and 2a Subsequent Steps: Two prospects are tested in combination with drugs that work through different mechanisms to determine the NASH method suitable for each drug June 25, 2019, Novartis' Phase II study of non-alcoholic fatty hepatitis (NASH) failed to reach the primary endpoint At present, Novartis tropifexor and licogliflozin are jointly used in the treatment of non-alcoholic fatty hepatitis, and have been undertheed in four clinical trials in China : AstraZeneca Drug Name: Cotadutide Mechanism: GLP-1 /Glucagon Receptor Dagomic
Phase: Phase 2 Next Data: Potential Clinical Trials in NASH
Company: Allergan Drug Name: Ceniciroc
Mechanism: 2/5 CCR Double Atagcant Phase: Phase 3 Next Data: AURORA Data expected for Q4 2020 Company: NGM Biopharmaceuticals Drug Name: Aldafermin Mechanism: FGF19 Similarity Phase: Phase 2b
Next Reading: Preliminary data from Phase 2b 2/3 Study by the end of 2020 Company: Zydus Cadilla drug name: Saroglitazar mechanism: PPAR alpha and gamma double agonists stage: Phase 2 next data: NASH potential 3 research the world's leading pharmaceutical companies, have hit the wall, its NASH drug trials either do not reach Phase III, or Phase III trials frequently fail, the only successful phase III trial OF THE new NASH oxen pyreic acid application is rejected, which also means that the development of the new drug at present, there are nearly 20 enterprises in the layout of NASH new drugs These include Clarion Pharmaceuticals, Tuo-Tai, Jun Shengtai, Micro-Core Biology, Zhengda Sunny, Paige Bio and so on Ofaly's FASN inhibitor TVB-2640 will present its latest clinical and preclinical data at the European Society for The Study of The Liver (EASL) International Liver Congress 2020 (ILC) in London early May, Junsanti also announced that its original new drug HTD1801 had reached the primary and several major secondary endpoints in phase IIA clinical trials in patients with non-alcoholic fatty hepatitis (NASH) combined type 2 diabetes (T2DM) Detailed results will be published at international academic conferences and professional journals.