|Over a week ago|
Akero Therapeutics appoints Yuan Xu to board of directors » 08:2404/2604/26/21
Akero Therapeutics (AKRO)…
Akero Therapeutics (AKRO) announced the appointment of Yuan Xu, Ph.D., to its board of directors as an independent director. "Dr. Xu's extensive experience in establishing and leading biopharmaceutical development and manufacturing capabilities brings a complementary perspective to our Board," said Andrew Cheng, M.D., Ph.D., president and CEO of Akero Therapeutics. "The Akero leadership team looks forward to working with Dr. Xu as we enter late-stage development of our lead NASH candidate efruxifermin." Yuan Xu, Ph.D., most recently served as a board member and CEO for Legend Biotech (LEGN).
Akero Therapeutics participates in a conference call with JPMorgan » 11:1604/1304/13/21
SMid Cap Biotech Analyst…
SMid Cap Biotech Analyst Joseph holds a conference call with CEO Cheng, CSO Rolph and CDO Yale on April 13 at 1 pm hosted by JPMorgan.
|Over a month ago|
Akero says1st patient randomized for dosing in EFX study in F2/F3 NASH patients » 08:1303/2303/23/21
Akero Therapeutics announced the first patient has been randomized for dosing in its Phase 2b clinical study of Efruxifermin in the treatment of patients with F2/F3 NASH. "Randomization of the first patient in our Phase 2b HARMONY study in F2/F3 patients is yet another key milestone for Akero, which builds on our recent data in cirrhotic patients (F4) and last year's data in patients with F1-F3 fibrosis," said Kitty Yale, chief development officer of Akero. "Screening and enrollment in HARMONY are ahead of schedule and we remain on track to report topline preliminary results in the second half of 2022. We are excited about the potential benefits that EFX may offer to patients with NASH, a serious metabolic disease for which there is no FDA-approved treatment option." The Phase 2b HARMONY study is a multicenter, randomized, double-blind, placebo-controlled, clinical trial in biopsy-confirmed NASH patients with fibrosis stage 2 or 3. Patients will be randomized to receive once-weekly subcutaneous dosing of 28 or 50mg EFX, or placebo. The primary endpoint for the trial is fibrosis regression at 24 weeks. Patients will continue to receive EFX or placebo after 24 weeks during a long-term follow-up period to provide additional safety data.
Akero Therapeutics price target raised to $68 from $61 at H.C. Wainwright » 06:2003/2303/23/21
H.C. Wainwright analyst…
H.C. Wainwright analyst Ed Arce raised the firm's price target on Akero Therapeutics to $68 from $61 and reiterates a Buy rating on the shares after the company announced results from the Cohort C of its 16-week Phase 2a BALANCED trial of efruxifermin for the treatment of adult patients with cirrhotic nonalcoholic steatohepatitis. The rapid fibrosis improvement in cirrhotic NASH patients is unprecedented, Arce tells investors in a research note. The data are "strongly suggestive" not only of direct anti-fibrotic effects, but also of a positive read-through for the HARMONY study in F2-F3 patients, says the analyst.
Akero NASH data 'very exciting outcome,' says Chardan » 05:3803/2303/23/21
Chardan analyst Michael…
Chardan analyst Michael Morabito reiterates a Buy rating on Akero Therapeutics with an $81 price target after the company announced results from Cohort C of the BALANCED trial, a 16-week comparison of efruxifermin versus placebo in patients with compensated F4 nonalcoholic steatohepatitis. Though the trial enrolled 30 patients, only 17 volunteered for an end of study biopsy. Of the 12 patients on efruxifermin, seven exhibited a histological response while none of the five placebo patients demonstrated a histological response, Morabito tells investors in a research note. Though the early stage trial was not powered for statistical analysis, this result still represents a "very exciting outcome" as efruxifermin is now the first NASH therapeutic to have a substantial impact on cirrhotic patients, says the analyst. Morabito believes the ability to reverse fibrosis in cirrhotic patients represents a "significant milestone" in NASH therapy, but he adds that a "long road remains" for efruxifermin.
Akero Therapeutics histological improvements in cirrhotic NASH post cohort C » 16:0803/2203/22/21
Akero Therapeutics announced results of an expansion cohort of a 16-week Phase 2a clinical trial, Cohort C, evaluating efruxiferminin the treatment of adult patients with cirrhotic nonalcoholic steatohepatitis. Of the 17 confirmed compensated cirrhosis study subjects who volunteered to have end-of-treatment biopsies, 4 of 12 patients, or 33%, treated with EFX achieved a one-stage improvement in fibrosis without worsening of NASH. Another 3 of 12 EFX patients achieved NASH resolution. In total, 7 of 12 EFX patient sshowed histological improvements. None of the 5 placebo patients achieved either one-stage improvement in fibrosis without worsening of NASH, or resolution of NASH. In addition, statistically significant improvements in glycemic control and lipoprotein profile, and a trend toward weight loss, were also observed. "I believe these data are unprecedented," said Stephen Harrison, M.D., medical director of Pinnacle Clinical Research. "Today's data in cirrhotic patients, who have the highest unmet need, show clear signals of fibrosis improvement without worsening of NASH and NASH resolution, supported by compelling, statistically significant results for non-invasive fibrosis measures. These results set EFX apart."
Akero Therapeutics price target raised to $81 from $79 at Chardan » 05:3703/1703/17/21
Chardan analyst Michael…
Chardan analyst Michael Morabito raised the firm's price target on Akero Therapeutics to $81 from $79 and reiterates a Buy rating on the shares following the company's 2020 results. Akero announced that patient visits for Cohort C of the Phase IIa BALANCED trial concluded in February and that it expects to report preliminary results "by April 2021," Morabito tells investors in a research note. A positive trend in fibrosis improvement for the efruxifermin-treated patients would represent an "unprecedented milestone" in nonalcoholic steatohepatitis therapy, says the analyst. Morabito believes Akero is in position for an "upside move" with the Cohort C data.
Fly Intel: Pre-market Movers » 08:5803/1603/16/21
FTCV, AZRX, ICAD, JBL, DFH, DBI, CRH, AKRO, FCEL, CLSK
Check out this morning's…
Akero Therapeutics reports Q4 EPS (86c), consensus (59c) » 08:0303/1603/16/21
"In 2020 we reported…
"In 2020 we reported strong results from our Phase 2a BALANCED study in biopsy-confirmed NASH patients suggesting that our lead asset, efruxifermin, has the potential to be a foundational monotherapy for treatment of NASH," said Andrew Cheng, M.D., Ph.D., president and chief executive officer of Akero. "We have been particularly pleased with biopsy data that showed rapid improvements in both fibrosis and NASH resolution and look forward to reporting additional biopsy data among cirrhotic patients by April of this year."
Akero Therapeutics initiated with a Buy at Guggenheim » 07:5102/2602/26/21
Guggenheim analyst Etzer…
Guggenheim analyst Etzer Darout initiated coverage of Akero Therapeutics with a Buy rating and $54 price target.