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89bio, Inc. (Nasdaq: NASDAQ:ETNB) shares gained 25% today after the company announced positive topline data from the Phase 2b ENLIVEN trial evaluating treatment with pegozafermin in patients with nonalcoholic steatohepatitis (NASH).
The study demonstrated that both the 44mg every-two-week (Q2W) and 30mg weekly (QW) doses achieved the primary histology endpoints as defined by the U.S. Food and Drug Administration (FDA) guidance on endpoints and statistical analysis, with high statistical significance.
Following the announcement, Oppenheimer raised its price target on the stock to $33.00 from $18.00 while maintaining an Outperform rating.
“We see best-in-class potential for pegozafermin as an FGF21 analog as 44mg (Q2W) dose appears competitive to efruxifermin 50mg-QW on FI and NR efficacy but with more convenient dosing which we view as critical for NASH patients,” said Oppenheimer, noting that the company now plans Ph3 trial with FDA, and it views the company as well-positioned following recent Q4/22 update.
H.C. Wainwright raised its price target to $30.00 from $25.00 while maintaining a Buy rating.
According to the firm, management plans to meet with the FDA and EMA in the next few months to discuss ENLIVEN results and develop a Phase 3 plan and protocol for PGZ in NASH. This may involve using safety data from SHTG patients and pursuing the FDA’s alternative pathway, which includes a Phase 3 trial in F2-F3 NASH patients and an outcomes study in cirrhotic (F4) NASH patients for full approval in both indications.
Raymond James raised the price target on the stock to $50.00 from $25.00 while maintaining a Strong Buy rating. The firm increased its probability of success in NASH to 95% and raised estimates slightly. Their NASH revenue estimate by 2030 is ~$2 billion (plus ~$450 million in SHTG).
According to RBC Capital, the study looked successful across the board, and though differences in placebo rates make comparing across studies (most notably vs. FGF21 competitor AKRO) difficult, they believe the drug’s activity generally looks similar and that the results provide considerable de-risking for the drug’s next steps in the indication.
The firm reiterated its Outperform rating and $27.00 price target on the stock.
