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Akero Therapeutics (AKRO) Up on Positive NASH Study Data
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Akero Therapeutics (AKRO - Free Report) was up 9.38% on Aug 24, after the company announced positive results from cohort C of its phase IIa BALANCED study, evaluating efruxifermin (EFX) in non-alcoholic steatohepatitis (NASH). The results have been published in JHEP reports.
The company’s lead candidate, EFX, is an analog of fibroblast growth factor 21 (FGF21), which is an endogenously expressed hormone providing protection against cellular stress. It also helps in regulating the metabolism of lipids, carbohydrates and proteins throughout the body.
EFX has also been granted Fast Track and PRIority MEdicines (PRIME) designations by both the FDA and the European Medicine Agency (EMA) for the treatment of NASH.
NASH is a progressive liver disease which causes liver cirrhosis and can even lead to liver failure and liver cancer. It can also increase the risk of cardiac events.
The phase III study conducted in patients with compensated cirrhosis demonstrated that EFX, at a dosage of once-weekly subcutaneous injection of 50 mg, is well tolerated in subjects.
The study exhibited improvements in 33% of the patients, by one fibrosis stage, without deterioration of NASH. 25% of patients treated with EFX witnessed a resolution of NASH in the mid-stage study.
Shares of Akero have lost 37.7% compared to the industry’s decline of 21.6%, in the year-to-date period.
Image Source: Zacks Investment Research
Presently, EFX is also being evaluated in two phase IIb studied in patients with biopsy-confirmed NASH, namely—the HARMONY study being conducted in patients with pre-cirrhotic NASH (F2-F3 fibrosis) and the SYMMETRY study in cirrhotic patients (F4 fibrosis, compensated).
Earlier this year, the company completed enrollment of the HARMONY study of EFX for NASH. Akero intends to report data from its HARMONY study in September 2022, providing further evidence that EFX has the potential to reverse fibrosis while addressing the underlying causes of the disease.
The company expects to report data from its SYMMETRY study in the second half of 2023.
In June, Akero announced that Pfizer (PFE - Free Report) made an equity investment of $25 million in the company, following an agreement to purchase approximately 2.5 million of the Akero shares at $9.90 per share.
Post the transaction, Pfizer owned 6.7% of Akero’s outstanding common stock.
Akero also received a term loan of $100 million from the business development company Hercules Capital (HTGC - Free Report) , out of which $10 million will be drawn at the closing of the transaction.
With Akero’s existing cash profile, and the funding from both Pfizer and Hercules Capital, Akero will have enough financial stability to support the development of EFX till the third quarter of 2024.
Till date, there is no approved therapy for NASH. If EFX gets approved, it will be an immense boost to Akero’s top line.
Rhythm’s loss per share estimates for 2022 have widened from $3.74 to $3.82 in the past 30 days. The same for 2023 has narrowed from $3.40 to $3.08 in the same time frame.
Earnings of Rhythm missed estimates in two of the trailing four quarters and beat the same on the remaining two occasions. The average earnings surprise for RYTM is 2.97%.
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Akero Therapeutics (AKRO) Up on Positive NASH Study Data
Akero Therapeutics (AKRO - Free Report) was up 9.38% on Aug 24, after the company announced positive results from cohort C of its phase IIa BALANCED study, evaluating efruxifermin (EFX) in non-alcoholic steatohepatitis (NASH). The results have been published in JHEP reports.
The company’s lead candidate, EFX, is an analog of fibroblast growth factor 21 (FGF21), which is an endogenously expressed hormone providing protection against cellular stress. It also helps in regulating the metabolism of lipids, carbohydrates and proteins throughout the body.
EFX has also been granted Fast Track and PRIority MEdicines (PRIME) designations by both the FDA and the European Medicine Agency (EMA) for the treatment of NASH.
NASH is a progressive liver disease which causes liver cirrhosis and can even lead to liver failure and liver cancer. It can also increase the risk of cardiac events.
The phase III study conducted in patients with compensated cirrhosis demonstrated that EFX, at a dosage of once-weekly subcutaneous injection of 50 mg, is well tolerated in subjects.
The study exhibited improvements in 33% of the patients, by one fibrosis stage, without deterioration of NASH. 25% of patients treated with EFX witnessed a resolution of NASH in the mid-stage study.
Shares of Akero have lost 37.7% compared to the industry’s decline of 21.6%, in the year-to-date period.
Image Source: Zacks Investment Research
Presently, EFX is also being evaluated in two phase IIb studied in patients with biopsy-confirmed NASH, namely—the HARMONY study being conducted in patients with pre-cirrhotic NASH (F2-F3 fibrosis) and the SYMMETRY study in cirrhotic patients (F4 fibrosis, compensated).
Earlier this year, the company completed enrollment of the HARMONY study of EFX for NASH. Akero intends to report data from its HARMONY study in September 2022, providing further evidence that EFX has the potential to reverse fibrosis while addressing the underlying causes of the disease.
The company expects to report data from its SYMMETRY study in the second half of 2023.
In June, Akero announced that Pfizer (PFE - Free Report) made an equity investment of $25 million in the company, following an agreement to purchase approximately 2.5 million of the Akero shares at $9.90 per share.
Post the transaction, Pfizer owned 6.7% of Akero’s outstanding common stock.
Akero also received a term loan of $100 million from the business development company Hercules Capital (HTGC - Free Report) , out of which $10 million will be drawn at the closing of the transaction.
With Akero’s existing cash profile, and the funding from both Pfizer and Hercules Capital, Akero will have enough financial stability to support the development of EFX till the third quarter of 2024.
Till date, there is no approved therapy for NASH. If EFX gets approved, it will be an immense boost to Akero’s top line.
Akero Therapeutics, Inc. Price
Akero Therapeutics, Inc. price | Akero Therapeutics, Inc. Quote
Zacks Rank and A Key Pick
Akero currently has a Zacks Rank #3 (Hold).
A better-ranked stock in the same sector is Rhythm Pharmaceuticals (RYTM - Free Report) , carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.
Rhythm’s loss per share estimates for 2022 have widened from $3.74 to $3.82 in the past 30 days. The same for 2023 has narrowed from $3.40 to $3.08 in the same time frame.
Earnings of Rhythm missed estimates in two of the trailing four quarters and beat the same on the remaining two occasions. The average earnings surprise for RYTM is 2.97%.