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Akero (AKRO) Up on Upbeat Week 96 Data From Liver Disease Study
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Akero Therapeutics, Inc. (AKRO - Free Report) announced a statistically significant histological improvement in the primary endpoint of its mid-stage study, evaluating the efficacy and safety of efruxifermin (EFX) in patients with pre-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH), fibrosis stage 2 or 3, at week 96.
EFX, the company’s lead product candidate, is being developed for a serious liver disease caused by metabolic dysregulation that does not have any approved therapies.
We remind the investors that in 2022, Akero reported that the phase IIb HARMONY study met its primary endpoint of ≥1 stage improvement in fibrosis with no worsening of MASH after 24 weeks of treatment for both the 50mg EFX (41%) and 28mg EFX (39%) dose groups compared with 20% for the placebo arm.
However, in the recent data readout, it was observed that the response rates on the same primary endpoint of the HARMONY study increased to 75% for 50mg EFX and 46% for 28mg EFX compared with 24% for placebo at week 96.
Furthermore, the mid-stage study also met additional histology endpoints at week 96 and 36% and 31% of patients treated with 50mg EFX and 28mg EFX, respectively, experienced a two-stage improvement in fibrosis without worsening of MASH compared with the placebo rate of 3%.
Akero’s stock gained 11.7% on Mar 4, in response to the encouraging news. In the past year, shares of AKRO have plunged 34.4% compared with the industry’s 4.7% decline.
Image Source: Zacks Investment Research
It was also observed that the 50 mg EFX group demonstrated a superior efficacy profile compared with the 28mg EFX group at week 96.
Further analysis of the evolution of responses between week 24 and 96 also indicated sustained fibrosis improvement upon longer exposure to EFX, particularly at the 50mg dose.
The HARMONY study also evaluated a subset of patients with advanced stage 3 fibrosis. In this patient population, 68% and 40% of the 50mg and 28mg EFX groups, respectively, experienced at least a one-stage improvement in fibrosis without worsening of MASH compared with 14% for placebo. This demonstrates EFX’s potential to treat patients with more advanced fibrosis, who are generally considered to be at higher risk of progression to cirrhosis.
Akero is also currently evaluating EFX in patients with pre-cirrhotic MASH and cirrhosis due to MASH in its ongoing phase III SYNCHRONY program, in which two out of three late-stage studies are actively enrolling patients.
In its fourth-quarter earnings release, the company announced that it expects to initiate the third phase III study in the SYNCHRONY program in the first half of 2024 to evaluate the safety and efficacy of EFX in patients with compensated cirrhosis due to MASH.
Interestingly, the positive results from AKRO’s MASH study also boosted the shares of rival company, 89bio, Inc. (ETNB - Free Report) , which rose about 9.1% in the last trading session. ETNB is currently developing a similar treatment for MASH.
89Bio is developing its only pipeline candidate, pegozafermin, an investigational FGF21 analog, to treat MASH and another cardiometabolic indication. In fourth-quarter earnings release, ETNB reported that it has met with the FDA and European Medicines Agency (EMA) to discuss the next steps for the candidate. Per the company, both the FDA and EMA have supported the advancement of pegozafermin into phase III studies for MASH.
89Bio anticipates its phase III ENLIGHTEN program for pegozafermin to include two late-stage studies evaluating patients with MASH.
The late-stage ENLIGHTEN-Fibrosis study is expected to enroll non-cirrhotic patients with fibrosis stage 2 or 3, while on the other hand, the late-stage ENLIGHTEN-Cirrhosis is likely to enroll MASH patients with compensated cirrhosis.
89Bio is currently gearing up to initiate the phase III ENLIGHTEN-Fibrosis and ENLIGHTEN-Cirrhosis studies in the first and second quarters of 2024, respectively.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2024 earnings per share (EPS) has increased from 22 cents to 30 cents. During the same period, the estimate for ADMA’s 2025 EPS has increased from 32 cents to 50 cents. Over the past year, shares of ADMA have surged 70.7%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 85%.
In the past 30 days, the Zacks Consensus Estimate for Adicet Bio’s 2023 loss per share has remained constant at $3.39. During the same period, the consensus estimate for Adicet’s 2024 loss per share has narrowed from $1.97 to $1.81. In the past year, shares of ACET have plunged 68.9%.
ACET’s earnings beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, delivering an average negative surprise of 8.36%.
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Akero (AKRO) Up on Upbeat Week 96 Data From Liver Disease Study
Akero Therapeutics, Inc. (AKRO - Free Report) announced a statistically significant histological improvement in the primary endpoint of its mid-stage study, evaluating the efficacy and safety of efruxifermin (EFX) in patients with pre-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH), fibrosis stage 2 or 3, at week 96.
EFX, the company’s lead product candidate, is being developed for a serious liver disease caused by metabolic dysregulation that does not have any approved therapies.
We remind the investors that in 2022, Akero reported that the phase IIb HARMONY study met its primary endpoint of ≥1 stage improvement in fibrosis with no worsening of MASH after 24 weeks of treatment for both the 50mg EFX (41%) and 28mg EFX (39%) dose groups compared with 20% for the placebo arm.
However, in the recent data readout, it was observed that the response rates on the same primary endpoint of the HARMONY study increased to 75% for 50mg EFX and 46% for 28mg EFX compared with 24% for placebo at week 96.
Furthermore, the mid-stage study also met additional histology endpoints at week 96 and 36% and 31% of patients treated with 50mg EFX and 28mg EFX, respectively, experienced a two-stage improvement in fibrosis without worsening of MASH compared with the placebo rate of 3%.
Akero’s stock gained 11.7% on Mar 4, in response to the encouraging news. In the past year, shares of AKRO have plunged 34.4% compared with the industry’s 4.7% decline.
Image Source: Zacks Investment Research
It was also observed that the 50 mg EFX group demonstrated a superior efficacy profile compared with the 28mg EFX group at week 96.
Further analysis of the evolution of responses between week 24 and 96 also indicated sustained fibrosis improvement upon longer exposure to EFX, particularly at the 50mg dose.
The HARMONY study also evaluated a subset of patients with advanced stage 3 fibrosis. In this patient population, 68% and 40% of the 50mg and 28mg EFX groups, respectively, experienced at least a one-stage improvement in fibrosis without worsening of MASH compared with 14% for placebo. This demonstrates EFX’s potential to treat patients with more advanced fibrosis, who are generally considered to be at higher risk of progression to cirrhosis.
Akero is also currently evaluating EFX in patients with pre-cirrhotic MASH and cirrhosis due to MASH in its ongoing phase III SYNCHRONY program, in which two out of three late-stage studies are actively enrolling patients.
In its fourth-quarter earnings release, the company announced that it expects to initiate the third phase III study in the SYNCHRONY program in the first half of 2024 to evaluate the safety and efficacy of EFX in patients with compensated cirrhosis due to MASH.
Akero Therapeutics, Inc. Price and Consensus
Akero Therapeutics, Inc. price-consensus-chart | Akero Therapeutics, Inc. Quote
Interestingly, the positive results from AKRO’s MASH study also boosted the shares of rival company, 89bio, Inc. (ETNB - Free Report) , which rose about 9.1% in the last trading session. ETNB is currently developing a similar treatment for MASH.
89Bio is developing its only pipeline candidate, pegozafermin, an investigational FGF21 analog, to treat MASH and another cardiometabolic indication. In fourth-quarter earnings release, ETNB reported that it has met with the FDA and European Medicines Agency (EMA) to discuss the next steps for the candidate. Per the company, both the FDA and EMA have supported the advancement of pegozafermin into phase III studies for MASH.
89Bio anticipates its phase III ENLIGHTEN program for pegozafermin to include two late-stage studies evaluating patients with MASH.
The late-stage ENLIGHTEN-Fibrosis study is expected to enroll non-cirrhotic patients with fibrosis stage 2 or 3, while on the other hand, the late-stage ENLIGHTEN-Cirrhosis is likely to enroll MASH patients with compensated cirrhosis.
89Bio is currently gearing up to initiate the phase III ENLIGHTEN-Fibrosis and ENLIGHTEN-Cirrhosis studies in the first and second quarters of 2024, respectively.
Zacks Rank and Stocks to Consider
Akero currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the same industry are ADMA Biologics (ADMA - Free Report) and Adicet Bio, Inc. (ACET - Free Report) . While ADMA sports a Zacks Rank #1 (Strong Buy), ACET carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2024 earnings per share (EPS) has increased from 22 cents to 30 cents. During the same period, the estimate for ADMA’s 2025 EPS has increased from 32 cents to 50 cents. Over the past year, shares of ADMA have surged 70.7%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 85%.
In the past 30 days, the Zacks Consensus Estimate for Adicet Bio’s 2023 loss per share has remained constant at $3.39. During the same period, the consensus estimate for Adicet’s 2024 loss per share has narrowed from $1.97 to $1.81. In the past year, shares of ACET have plunged 68.9%.
ACET’s earnings beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, delivering an average negative surprise of 8.36%.