We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
PhaseBio (PHAS) Dips on Mixed Data From Antiplatelet Drug Study
Read MoreHide Full Article
PhaseBio Pharmaceuticals, Inc. reported interim data from the ongoing phase III REVERSE-IT study evaluating its lead product candidate bentracimab to reverse the antiplatelet effects of blood thinner drug ticagrelor in surgical and bleeding populations.
Ticagrelor is a blockbuster drug developed by AstraZeneca (AZN - Free Report) and marketed under the brand name Brilinta/Brilique for cardiovascular treatment.
For the third quarter, AstraZeneca reported Brilinta/Brilique sales of $375 million, down 18% year over year primarily due to the impact of the COVID-19 pandemic (reflecting fewer elective procedures) and pricing pressure from the volume-based procurement program in China. AstraZeneca reported that the drug has already generated sales of $1.12 billion from the beginning of the year till September-end 2021.
The REVERSE-IT study evaluated bentracimab in 150 patients with the need for urgent surgery or an invasive procedure or experiencing uncontrolled major or life-threatening bleeding.
The study achieved its primary endpoint of immediate and sustained reversal of the antiplatelet effects of ticagrelor, with patients showing a 135% reduction in platelet inhibition within 5-10 minutes after initiation of the bentracimab infusion and sustaining the effects of the drug through all timepoints over 24 hours. Further, 90% of the eligible patients achieved effective hemostasis, the study’s co-primary endpoint of clinical hemostasis, within 24 hours of initiation of bentracimab infusion.
Yet, PhaseBio reported that 91% of enrolled patients administered the drug experienced treatment-emergent side effects. While the most common side effect was pain associated with surgical procedures, cardiac and metabolic disorders such as atrial fibrillation, sinus tachycardia as well as electrolyte abnormalities were also reported. Four patients enrolled in the study died, which the company said were not related to treatment with the drug. Eight patients experienced thrombotic events, though none of the cases were related to treatment with bentracimab.
Shares of PhaseBio were down 18.4% yesterday, most likely due to the large patient population experiencing the side effects of bentracimab. In fact, shares have declined 10.1% so far this year in comparison with the industry’s 14.6% decline.
Image Source: Zacks Investment Research
The phase III study was initiated on the basis of data from phase I and phase II studies on bentracimab, which have also demonstrated immediate and sustained reversal of the antiplatelet effects of ticagrelor. PhaseBio expects to submit a biologics license application with the FDA seeking approval for bentracimab in mid-2022.
In the meantime, PhaseBio is focused on enrolling more patients with an uncontrolled major or life-threatening bleeding event in the REVERSE-IT study and aims to complete enrolment faster by increasing clinical sites for the study.
Per the company, ticagrelor is the only orally-administered P2Y12 inhibitor whose antiplatelet activity can be reversed.
PhaseBio currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include Endo International and Sarepta Therapeutics (SRPT - Free Report) . While Endo sports a Zacks Rank #1 (Strong Buy), Sarepta carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Endo’s earnings per share estimates for 2021 have increased from $2.29 to $2.84 in the past 30 days. The same for 2022 has risen from $2.24 to $2.47 over the same period.
Endo’s earnings beat estimates in the last four quarters, delivering an average surprise of 57.7%.
Sarepta’s loss estimates per share estimates for 2021 have narrowed from $7.06 to $4.99 in the past 30 days. The same for 2022 has narrowed from $4.82 to $3.61 in the past 30 days.
Sarepta’s earnings beat estimates in two of the last four quarters and missed on the other two occasions, delivering an average surprise of 11.1%.
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Bigstock
PhaseBio (PHAS) Dips on Mixed Data From Antiplatelet Drug Study
PhaseBio Pharmaceuticals, Inc. reported interim data from the ongoing phase III REVERSE-IT study evaluating its lead product candidate bentracimab to reverse the antiplatelet effects of blood thinner drug ticagrelor in surgical and bleeding populations.
Ticagrelor is a blockbuster drug developed by AstraZeneca (AZN - Free Report) and marketed under the brand name Brilinta/Brilique for cardiovascular treatment.
For the third quarter, AstraZeneca reported Brilinta/Brilique sales of $375 million, down 18% year over year primarily due to the impact of the COVID-19 pandemic (reflecting fewer elective procedures) and pricing pressure from the volume-based procurement program in China. AstraZeneca reported that the drug has already generated sales of $1.12 billion from the beginning of the year till September-end 2021.
The REVERSE-IT study evaluated bentracimab in 150 patients with the need for urgent surgery or an invasive procedure or experiencing uncontrolled major or life-threatening bleeding.
The study achieved its primary endpoint of immediate and sustained reversal of the antiplatelet effects of ticagrelor, with patients showing a 135% reduction in platelet inhibition within 5-10 minutes after initiation of the bentracimab infusion and sustaining the effects of the drug through all timepoints over 24 hours. Further, 90% of the eligible patients achieved effective hemostasis, the study’s co-primary endpoint of clinical hemostasis, within 24 hours of initiation of bentracimab infusion.
Yet, PhaseBio reported that 91% of enrolled patients administered the drug experienced treatment-emergent side effects. While the most common side effect was pain associated with surgical procedures, cardiac and metabolic disorders such as atrial fibrillation, sinus tachycardia as well as electrolyte abnormalities were also reported. Four patients enrolled in the study died, which the company said were not related to treatment with the drug. Eight patients experienced thrombotic events, though none of the cases were related to treatment with bentracimab.
Shares of PhaseBio were down 18.4% yesterday, most likely due to the large patient population experiencing the side effects of bentracimab. In fact, shares have declined 10.1% so far this year in comparison with the industry’s 14.6% decline.
The phase III study was initiated on the basis of data from phase I and phase II studies on bentracimab, which have also demonstrated immediate and sustained reversal of the antiplatelet effects of ticagrelor. PhaseBio expects to submit a biologics license application with the FDA seeking approval for bentracimab in mid-2022.
In the meantime, PhaseBio is focused on enrolling more patients with an uncontrolled major or life-threatening bleeding event in the REVERSE-IT study and aims to complete enrolment faster by increasing clinical sites for the study.
Per the company, ticagrelor is the only orally-administered P2Y12 inhibitor whose antiplatelet activity can be reversed.
Catalyst Pharmaceuticals, Inc. Price
Catalyst Pharmaceuticals, Inc. price | Catalyst Pharmaceuticals, Inc. Quote
Zacks Rank & Stocks to Consider
PhaseBio currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include Endo International and Sarepta Therapeutics (SRPT - Free Report) . While Endo sports a Zacks Rank #1 (Strong Buy), Sarepta carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Endo’s earnings per share estimates for 2021 have increased from $2.29 to $2.84 in the past 30 days. The same for 2022 has risen from $2.24 to $2.47 over the same period.
Endo’s earnings beat estimates in the last four quarters, delivering an average surprise of 57.7%.
Sarepta’s loss estimates per share estimates for 2021 have narrowed from $7.06 to $4.99 in the past 30 days. The same for 2022 has narrowed from $4.82 to $3.61 in the past 30 days.
Sarepta’s earnings beat estimates in two of the last four quarters and missed on the other two occasions, delivering an average surprise of 11.1%.