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Pluristem (PSTI) Misses Study Goal to Treat COVID-Related ARDS

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Pluristem Therapeutics (PSTI - Free Report) announced top-line data from two phase II dose escalation studies evaluating the safety and efficacy of its intramuscular injections of PLX-PAD cells in comparison with placebo for the treatment of acute respiratory distress syndrome (ARDS) associated with COVID-19.

Both the studies did not meet the primary endpoint of statistically significant improvement of ventilator free days (VFD) at 28 days.

The data is based on the evaluation of a total of 89 patients enrolled in both the studies. While one study enrolled patients in the United States (the “U.S. Study”), the other one enrolled patients in Europe and Israel (the “EU Study”).

VFD at day 60 and all-cause mortality at days 28 and 60 were part of the secondary efficacy endpoints in both the studies.

Shares of Pluristem tanked 17% following the news. In fact, the stock has declined 77.2% this year so far in comparison with the decline of 20.4% for the industry.

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Based on the efficacy trends observed in both the studies, Pluristem will explore other opportunities for PLX-PAD cells to treat COVID-19.

Pluristem noted that a single administration of 300 million PLX-PAD cells demonstrated overall better results than other treatment groups. In fact, patients dosed with 300 million of PLX-PAD showed an increase in the survival rate at day 60 in both the studies compared to placebo. While the U.S. Study reported an increase in the survival rate by 40%, the E.U. study registered a 27% increase.

In the EU study, patients treated with a single administration of 300 million PLX-PAD cells demonstrated increased VFD for the treated group at both day 28 and day 60 compared to participants in the control group. While VFD at day 28 increased to 3.8 days compared to 0.2 days in the control group, VFD at day 60 rose to 12.5 days compared to 5.9 days in the control group.

Please note that Pluristem planned to initially enroll a total of 180 participants in both the studies. On account of changes in the standards of care for COVID-19, the number was subsequently reduced to 89. Pluristem attributed the decline in participant population as a reason for a significant reduction in the statistical power of both the studies.

Zacks Rank & Other Stocks to Consider

Pluristem Therapeutics currently carries a Zacks Rank #2 (Buy). Other top-ranked stocks in the overall healthcare sector include Endo Pharmaceuticals (ENDP - Free Report) , Repligen (RGEN - Free Report) and Precision BioSciences (DTIL - Free Report) . While Precision BioSciences sports a Zacks Rank #1 (Strong Buy), both Endo Pharmaceuticals and Repligen carry a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Precision BioSciences’ loss per share estimates for 2021 have narrowed from $1.17 to $0.65 in the past 60 days. The same for 2022 has narrowed from $2.39 to $1.91 in the past 60 days.

Earnings of Precision BioSciences beat estimates in all the last four quarters, delivering a surprise of 76.9%, on average.

Repligen’s earnings per share estimates for 2021 have increased from $2.81 to $2.90 in the past 60 days. The same for 2022 has increased from $3.06 to $3.21 in the past 60 days. Shares of Repligen have risen 39.8% in the year so far.

Earnings of Repligen beat estimates in all the last four quarters, with the average being 49.2%.

Endo International’s earnings per share estimates for 2021 have increased from $2.32 to $2.85 in the past 60 days. The same for 2022 has increased from $2.25 to $2.29 in the past 60 days.

Earnings of Endo International beat estimates in all the last four quarters, delivering a surprise of 57.7%, on average.