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.
Acceleron (XLRN) Up on Success of PAH Drug in Phase II Study
Read MoreHide Full Article
Shares of Acceleron Pharma Inc. soared more than 66% in after-market trading after it announced that the mid-stage study on pipeline candidate, sotatercept, in patients with pulmonary arterial hypertension (PAH) was successful.
The phase II study, PULSAR, is a randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of sotatercept in PAH patients. The primary endpoint of the trial is the change from baseline in pulmonary vascular resistance (PVR) over a 24-week treatment period.
In the study, 106 patients were randomized to receive placebo, 0.3 mg/kg of sotatercept, or 0.7 mg/kg of sotatercept subcutaneously, every 21 days, in combination with stable background PAH-specific therapies over a 24-week treatment period.
The study results showed that the candidate demonstrated a statistically significant reduction in PVR, the trial’s primary endpoint, at week 24 versus placebo. PVR, as measured by right heart catheterization, is the resistance that the heart must overcome to pump blood through the pulmonary circulatory system.
The study also achieved statistically significant improvements in the key secondary endpoint of six-minute walk distance (6MWD) and other secondary endpoints, including amino-terminal brain natriuretic propeptide (NT-proBNP) and World Health Organization (WHO) functional class.
The candidate was generally well tolerated.
Moreover, 97 out of the 106 patients are currently participating in the 18-month extension period of the study.
Additional results will be presented later in the year.
Meanwhile, sotatercept is also being evaluated in another phase II study, SPECTRA, in patients with PAH.
Acceleron’s stock has rallied 33.6% in the past year against the industry’s decline of 5.6%.
The company received a major boost with the FDA approval of Reblozyl (luspatercept-aamt) for the treatment of anemia in adult patients with beta thalassemia, who require regular red blood cell (RBC) transfusions, in 2019. The drug is being developed in collaboration with pharma major Bristol-Myers Squibb (BMY - Free Report) .
Both companies are also developing luspatercept for the treatment of chronic anemia in myelodysplastic syndromes and myelofibrosis. Acceleron is also advancing its neuromuscular program with ACE-083, a locally-acting Myostatin+ agent in phase II development in Charcot-Marie-Tooth disease.
Zacks Rank & Stocks to Consider
Acceleron currently carries a Zacks Rank #4 (Sell). A couple of better-ranked biotech stocks include Alexion Pharmaceuticals and Clovis Oncology . Both stocks carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Alexion’s earnings per share estimates have increased from $10.35 to $10.43 for 2019 and from $11.10 to $11.36 for 2020 in the past 90 days.
Clovis’ loss per share estimates have narrowed to $4.82 from $6 for 2020 in the past 90 days.
5 Stocks Set to Double
Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor. Today, See These 5 Potential Home Runs >>
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Bigstock
Acceleron (XLRN) Up on Success of PAH Drug in Phase II Study
Shares of Acceleron Pharma Inc. soared more than 66% in after-market trading after it announced that the mid-stage study on pipeline candidate, sotatercept, in patients with pulmonary arterial hypertension (PAH) was successful.
The phase II study, PULSAR, is a randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of sotatercept in PAH patients. The primary endpoint of the trial is the change from baseline in pulmonary vascular resistance (PVR) over a 24-week treatment period.
In the study, 106 patients were randomized to receive placebo, 0.3 mg/kg of sotatercept, or 0.7 mg/kg of sotatercept subcutaneously, every 21 days, in combination with stable background PAH-specific therapies over a 24-week treatment period.
The study results showed that the candidate demonstrated a statistically significant reduction in PVR, the trial’s primary endpoint, at week 24 versus placebo. PVR, as measured by right heart catheterization, is the resistance that the heart must overcome to pump blood through the pulmonary circulatory system.
The study also achieved statistically significant improvements in the key secondary endpoint of six-minute walk distance (6MWD) and other secondary endpoints, including amino-terminal brain natriuretic propeptide (NT-proBNP) and World Health Organization (WHO) functional class.
The candidate was generally well tolerated.
Moreover, 97 out of the 106 patients are currently participating in the 18-month extension period of the study.
Additional results will be presented later in the year.
Meanwhile, sotatercept is also being evaluated in another phase II study, SPECTRA, in patients with PAH.
Acceleron’s stock has rallied 33.6% in the past year against the industry’s decline of 5.6%.
The company received a major boost with the FDA approval of Reblozyl (luspatercept-aamt) for the treatment of anemia in adult patients with beta thalassemia, who require regular red blood cell (RBC) transfusions, in 2019. The drug is being developed in collaboration with pharma major Bristol-Myers Squibb (BMY - Free Report) .
Both companies are also developing luspatercept for the treatment of chronic anemia in myelodysplastic syndromes and myelofibrosis. Acceleron is also advancing its neuromuscular program with ACE-083, a locally-acting Myostatin+ agent in phase II development in Charcot-Marie-Tooth disease.
Zacks Rank & Stocks to Consider
Acceleron currently carries a Zacks Rank #4 (Sell). A couple of better-ranked biotech stocks include Alexion Pharmaceuticals and Clovis Oncology . Both stocks carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Alexion’s earnings per share estimates have increased from $10.35 to $10.43 for 2019 and from $11.10 to $11.36 for 2020 in the past 90 days.
Clovis’ loss per share estimates have narrowed to $4.82 from $6 for 2020 in the past 90 days.
5 Stocks Set to Double
Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
Today, See These 5 Potential Home Runs >>