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Athersys (ATHX) Down as Ischemic Stroke Study Fails to Meet Goal

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Shares of Athersys (ATHX - Free Report) were down 65.5% on Friday (May 20) after management announced top-line data from the phase II/III TREASURE study, which evaluated its investigational stem cell treatment, MultiStem (invimestrocel), in patients with ischemic stroke. The study was conducted in Japan by ATHX’s partner Healios K.K.

The study failed to achieve its primary endpoint of Excellent Outcome at 90 days, with statistical significance. However, it did demonstrate an overall and consistent improvement in essentially all measured functional outcomes over time through one year, supporting the long-term impact on and continued improvement in the quality of life of participants treated in the study.

We note that the TREASURE study evaluated a single dose of MultiStem cells against placebo, administered via intravenous infusion, in 206 patients with moderate to moderate-severe ischemic stroke. Participants in the study were randomized to receive either of the two within 18-36 hours of their moderate or moderate-severe ischemic stroke.

Shares of Athersys have plunged 71.1% this year so far compared with the industry’s 23.6% fall.

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Athersys is also conducting a phase III MASTERS-2 study in the United States, Europe and the Asia-Pacific, evaluating the MultiStem treatment against placebo in the same patient group. However, compared to the currently enrolling MASTERS-2 study, the TREASURE study evaluated a substantially older study group with a median age of 78 years and moderately greater stroke severity.

One of the reasons for the TREASURE study’s failure to achieve its primary endpoint, as suggested by ATHX, was the presence of the older demographic, which caused slower and less robust recovery in patients enrolled in the TREASURE study.

Athersys expects data from the MASTERS-2 study to have a higher potential to achieve its primary endpoint, i.e. modified Rankin Score (mRS) shift. This main goal is based on the data from the TREASURE study, which enrolled patients representative of the currently recruited participants in the MASTERS-2 study.

Per Athersys, despite not meeting its primary endpoint, the TREASURE study provides new information on the MultiStem treatment in older patients (aged 80 years and above). While the MASTERS-2 study is enrolling this age group as a limited proportion of subjects, the previously conducted phase II MASTERS-1 study did not evaluate the treatment in this particular age bracket.

Zacks Rank & Key Picks

Athersys currently carries a Zacks Rank #4 (Sell).

Some better-ranked stocks in the overall healthcare sector are Abeona Therapeutics (ABEO - Free Report) , Alkermes (ALKS - Free Report) and Angion Biomedica (ANGN - Free Report) . While Alkermes sports a Zacks Rank #1 (Strong Buy), both Abeona Therapeutics and Angion Biomedica carry a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Alkermes’ loss per share estimates for 2022 have narrowed from 13 cents to 3 cents in the past 30 days. Shares of ALKS have risen 29% year to date.

Earnings of Alkermes beat estimates in each of the last four quarters, the average being 350.5%. In the last reported quarter, Alkermes delivered an earnings surprise of 1,100%.

Abeona Therapeutics’ loss per share estimates for 2022 have narrowed from 33 cents to 31 cents in the past 30 days. The same for 2023 has narrowed from 15 cents to 13 cents in the past 30 days. Shares of ABEO have declined 53.7% in the year-to-date period.

Earnings of Abeona Therapeutics missed estimates in two of the trailing four quarters and met the same on the remaining two occasions, the average negative surprise being 8.2%. In the last reported quarter, Abeona Therapeutics missed on earnings by 25%.

Angion Biomedica’s loss per share estimates for 2023 have narrowed from $2.19 to $2.02 in the past 30 days. Shares of ANGN have plunged 55.9% in the year-to-date period.

Earnings of Angion Biomedica beat estimates in three of the last four quarters and missed the mark once, the average surprise being 58.1%. In the last reported quarter, Angion Biomedica missed on earnings by 9.1%.

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