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Acceleron (XLRN) Up on Success of PAH Drug in Phase II Study

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Shares of Acceleron Pharma Inc. XLRN 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 ALXN and Clovis Oncology CLVS. 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.

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