Categories Analysis, Health Care, Research Summary

What is NASH and which biotech firms are vying for the first-mover status

NASH, or Nonalcoholic steatohepatitis, is undeniably a golden goose in the pharma space. The biggest corporate attraction towards this liver disorder is the fact that there are currently no treatments available in the market, and therefore, whoever manages a breakthrough in the clinical trials would grab the first-mover advantage.

It also nullifies the requirement during phase 3 trials to prove that the investigational drug is more effective than the one that is currently available in the market.

Image for representation (Photo by Drew Hays on Unsplash)

According to ResearchAndMarkets.com, NASH’s market value is set to increase to $21.5 billion by 2025, compared to just over $1.1 billion in 2017.

What is NASH?

NASH is a type of Nonalcoholic fatty liver disease (NAFLD), usually caused by an unhealthy lifestyle, heavy alcohol intake or obesity, which damages the liver and causes inflammation due to a high buildup of fat. It can also lead to liver cell damage or cirrhosis.

Though the disorder shows no symptoms initially, in the later stages, a patient may experience fatigue and belly ache.

READ: THE CANNABIS-BEVERAGE INDUSTRY IS SOMETHING YOU WON’T WANT TO MISS THIS YEAR

Clinical trials and drug candidates

Though the testing conducted by different laboratories follow various designs and methods, the US Food and Drug Administration (FDA) has set the primary endpoint for Phase 2b or Phase 3 treatments as reversion of NASH fibrosis, according to NASH Biotechs.

Allergan (AGN), Gilead Sciences (GILD), French biopharmaceutical company GENFIT and Intercept Pharmaceuticals (ICPT) were among the first companies to gain a breakthrough in the clinical trials, to reach Phase 3.

With Gilead taking a hit in early February by failing to meet the primary endpoint of its most advanced NASH candidate, selonsertib, in a Phase 3 trial, it may be said that Intercept is leading the race at the moment. A week after Gilead’s failed trial, Intercept announced positive topline results from the phase 3 study of its NASH candidate Ocaliva, sending the stock up 25%. The company added that it intends to file for approval in the U.S. and Europe in the latter half of 2019.

READ: NOVAVAX MISSES Q4 ESTIMATES, SHARES SLIP

However, investors continue to be brutal towards biopharma companies. The stock tumbled the next day on investor concerns over any troubling side-effects, besides the failure to meet one trial endpoint.

Meanwhile, French company Genfit has been studying the scope for combos to treat NASH and is expected to deliver top-line data from the Phase 3 trial for its elafibrano late this year. Genfit could be the next-in-line for the first-mover status if Intercept fails to please the FDA. Genfit last week launched a global offering of its American Depository Shares and ordinary shares to raise around $132 million. The company intends to list as “GNFT” on the Nasdaq Global Market.

Allergan’s immune modulator drug candidate Cenicriviroc, which is currently in phase 3, is also showing a lot of prospects for its anti-fibrotic effects. But the top line data is now expected to be out only by the fourth quarter of 2020, which gives adequate time for rival firms to catch up.

READ: AMARIN SHARES JUMP ON RUMORS OVER NOVARTIS INTEREST

Norcross, Georgia-based small cap clinical-stage biopharma firm Galectin Therapeutics (GALT) had recently announced rights offering to fund the Phase 3 trials for its candidate belapectin. The fallout of bigger firm Gilead has now opened up lots of growth opportunities to smaller firms like Galectin.

Besides these, over 30 companies are in the fray in phase 2, hoping to beat the rivals who have already gained a head start. The companies that are most advanced in Phase 2 trials include Madrigal Pharmaceuticals (MDGL), Australian firm Immuron and Galmed Pharmaceuticals (GLMD).

 

Earnings Call: Listen to on-demand earnings calls and hear how management responds to analysts’ questions

Most Popular

After mixed Q4, Darden Restaurants stays focused on profitable sales growth

Darden Restaurants, Inc. (NYSE: DRI), which owns popular restaurant brands Olive Garden and LongHorn Steakhouse, has reported stronger-than-expected fourth-quarter results, sending the stock higher soon after the announcement. Contributions from

What to expect when McCormick & Company (MKC) reports Q2 2024 earnings results

Shares of McCormick & Company, Incorporated (NYSE: MKC) stayed green on Friday. The stock has dropped 4% over the past one month. The spices and condiments maker is scheduled to report

CarMax (KMX) Q1 2025 Earnings: Key financials and quarterly highlights

CarMax, Inc. (NYSE: KMX) reported its first quarter 2025 earnings results today. Net sales and operating revenues decreased 7.5% year-over-year to $7.1 billion. Net earnings decreased 33% to $152.4 million,

Comments

  1. Pingback: Arie Baisch
  2. Pingback: exams system
  3. Pingback: fue
  4. Pingback: MBA tuition fees
  5. Pingback: Pharmacognos
  6. Pingback: MBA tuition fees
  7. Pingback: Academic Advising
  8. Pingback: grandpashabet
  9. Pingback: meritking giriş
  10. Pingback: madridbet giriş
  11. Pingback: meritking
  12. Pingback: meritking
  13. Pingback: meritking
  14. Pingback: meritking
  15. Pingback: grandpashabet
  16. Pingback: fuck google
  17. Pingback: arm extension
  18. Pingback: cortexi
  19. Pingback: fuck google
  20. Pingback: Fiverr Earn
  21. Pingback: Fiverr Earn
  22. Pingback: fiverrearn.com
  23. Pingback: fiverrearn.com
  24. Pingback: fiverrearn.com
  25. Pingback: TLI
  26. Pingback: Freight Broker
  27. Pingback: clima hoy
  28. Pingback: weather
  29. Pingback: fiverrearn.com
  30. Pingback: grey frenchie
  31. Pingback: chocolate frenchie
  32. Pingback: frenchton
  33. Pingback: jute vs sisal rug
  34. Pingback: crypto news
  35. Pingback: vietravel tour
  36. Pingback: sorority jewelry
  37. Pingback: jewelry
  38. Pingback: multisbobet
  39. Pingback: porn
  40. Pingback: french bulldogs
  41. Pingback: FiverrEarn
  42. Pingback: Fiverr
  43. Pingback: grey bulldog
  44. Pingback: Warranty
  45. Pingback: FUE
  46. Pingback: Office packing
  47. Pingback: Classic Books 500
  48. Pingback: FiverrEarn
  49. Pingback: FiverrEarn
  50. Pingback: FiverrEarn
  51. Pingback: FiverrEarn
  52. Pingback: FiverrEarn
  53. Pingback: Sefton Play Club
  54. Pingback: pupuk
  55. Pingback: partners
  56. Pingback: duotrim reviews
  57. Pingback: Betting
  58. Pingback: FiverrEarn
  59. Pingback: FiverrEarn
  60. Pingback: FiverrEarn
  61. Pingback: FiverrEarn
  62. Pingback: FiverrEarn
  63. Pingback: FiverrEarn
  64. Pingback: FiverrEarn
  65. Pingback: FiverrEarn
  66. Pingback: FiverrEarn
  67. Pingback: FiverrEarn
  68. Pingback: FiverrEarn
  69. Pingback: FiverrEarn
  70. Pingback: FiverrEarn
  71. Pingback: seo company texas
  72. Pingback: education
  73. Pingback: gifts
  74. Pingback: Slot Thailand
  75. Pingback: FiverrEarn
  76. Pingback: FiverrEarn
  77. Pingback: FiverrEarn
  78. Pingback: FiverrEarn
  79. Pingback: sikiş
  80. Pingback: cheap sex cams
  81. Pingback: fullersears.com
  82. Pingback: fullersears.com
  83. Pingback: french bulldog buy
  84. Pingback: grandpashabet
  85. Pingback: live sex cams
  86. Pingback: live sex cams
  87. Pingback: grandpashabet
  88. Pingback: frt trigger
  89. Pingback: grandpashabet
  90. Pingback: 늑대닷컴
  91. Pingback: Slot Asia
  92. Pingback: allgame
  93. Pingback: 918kiss
  94. Pingback: หวย24
  95. Pingback: Dior makeup
  96. Pingback: pg slot
  97. Pingback: child porn
  98. Pingback: AI Lawyer
  99. Pingback: upstate hotels
  100. Pingback: cratosroyalbet
  101. Pingback: megagame
  102. Pingback: itsMasum.Com
  103. Pingback: Skywhip tanks
  104. Pingback: chat a stranger
  105. Pingback: itsmasum.com
  106. Pingback: child porn
  107. Pingback: rome jobs
  108. Pingback: itsmasum.com
  109. Pingback: child porn
  110. Pingback: child porn
  111. Pingback: child porn
Add Comment
Loading...
Cancel
Viewing Highlight
Loading...
Highlight
Close
Top