In conjunction with the company’s first quarter earnings, Novo Nordisk (NVO) released Phase 2b nonalcoholic steatohepatitis data for semaglutide on Wednesday. Commenting on the announcement, Stifel analyst Derek Archila said he thinks the data has some important read through for many of the stand-alone NASH companies and would view it positive for NGM Biopharmaceuticals (NGM), neutral to incrementally positive for Intercept (ICPT), and negative for Genfit (GNFT). Meanwhile, his peer at Roth Capital added that the questions left unanswered from the dataset are "exactly the strategic areas" where Altimmune's (ALT) '801 can demonstrate substantial improvement compared to solo GLP-1 drugs.
'SLIGHT POSITIVE' FOR NGM: Stifel analyst Derek Archila noted that Novo Nordisk indicated in conjunction with its earnings report that semaglutide demonstrated statistically significant results at all doses on the primary endpoint of NASH resolution without worsening of fibrosis in a phase 2 study in biopsy confirmed non-alcoholic steatohepatitis, or NASH, patients. However, management noted that the study did not the "important" secondary endpoint of fibrosis improvement without worsening of NASH, Archila added.
The analyst thinks this data has some important read through for many of the stand-alone NASH companies. For NGM Biopharmaceuticals, the results probably have little impact or are a slight positive, he contended. While he acknowledged the challenge in comparing the datasets, the fact NGM's aldafermin has demonstrated a fibrosis improvement in only 24-weeks "still remains a clear differentiator." For Genfit, Archilla believes the high response rate seen for semaglutide does set a high bar for elafibranor in Phase 3, particularly given the similar trial design, and views the results as an incremental negative for the company. For the FGF21 class – being explored by Akero Therapeutics (AKRO) and Bristol-Myers Squibb (BMY) - and TR-beta class - being explored by Madrigal Pharmaceuticals (MDGL) and Vertex Pharmaceuticals (VKTX) - the analyst believes the semaglutide results on NASH resolution are competitive but leave the door open for both the FGF21 and TR-beta classes to demonstrate fibrosis improvement. For Intercept, he views the lack of fibrosis improvement for semaglutide as "an incremental positive," though he remains cautious on OCA's uptake given its modest efficacy on fibrosis and "less than ideal safety profile."
DATA 'SETS UP THE RUNWAY' FOR ALTIMMUNE: With the release of Novo Nordisk's Phase 2b nonalcoholic steatohepatitis data for semaglutide on Wednesday, all eyes are on what this means for other compounds utilizing GLP-1 and the broader NASH space, Roth Capital analyst Yasmeen Rahimi said in a research note. The analyst sees the semaglutide readout as "strong validation" of GLP-1 agonism as a NASH mechanism of action. Further, questions left unanswered from the dataset are "exactly the strategic areas" where Altimmune's dual GLP-1:glucagon agonist, ALT-801, can demonstrate substantial improvement on sole GLP-1 drugs, Rahimi contended, adding that the GLP-1 data "sets up the runway for ALT-801 to take off in the near-term." The analyst has a Buy rating and a $13 price target on Altimmune shares.
PRICE ACTION: In afternoon trading, shares of Novo Nordisk have dropped over 1% to $62.44. Meanwhile, Intercept shares are up 11% to $89.46 and NGM Biopharmaceuticals has jumped nearly 12% to $19.97.
Novo Nordisk
-0.81 (-1.28%)
Intercept
+9.16 (+11.37%)
NGM Biopharmaceuticals
+2.06 (+11.49%)
Genfit
-0.85 (-3.87%)
Altimmune
-0.11 (-3.51%)
Akero Therapeutics
+0.27 (+1.31%)
Bristol Myers
+0.13 (+0.21%)
Madrigal Pharmaceuticals
-0.01 (-0.01%)
Viking Therapeutics
-0.05 (-0.75%)