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Acceleron (XLRN) Kidney Cancer Candidate Fails in Phase II


Acceleron Pharma Inc.’s XLRN stock had gone down earlier and then regained ground by almost 5% after the company announced disappointing top-line results from a phase II DART study evaluating its pipeline candidate dalantercept in combination with Pfizer’s PFE Inlyta (axitinib) for treatment of advanced renal cell carcinoma (RCC).

Following the disappointing phase II results, the company decided to discontinue further development of the said kidney cancer candidate.

The increase in share price despite failing the phase II study reveals that dalantercept had become a secondary priority for Acceleron, while the company’s primary focus is on the late-stage anemia candidate luspatercept. Shares of Acceleron have outperformed the Zacks classified Medical-Biomed/Genetics industry so far this year. The stock has soared 16% compared with the broader industry’s increase of 2.6%.

We remind investors that Acceleron has a collaboration, license and option agreement with Celgene Corp. CELG for luspatercept.

Presently, Celgene is conducting two phase III study (MEDALIST and BELIEVE) for luspatercept: one for treating patients with lower risk Myelodysplastic syndromes (MDS) and another for the treatment of patients with beta-thalassemia. Results from the studies are expected in mid-2018.

The phase II study was designed to evaluate the safety and tolerability of the combination therapy of dalantercept. The study did not meet the primary end points and was unable to demonstrate a statistically significant increase in progression-free survival (PFS), when treated with dalantercept compared with placebo plus axitinib in advanced RCC patients.

The median PFS for the combination therapy was 6.8 months, versus 5.6 months for placebo. Moreover, dalantercept plus axitinib did not decrease the rate of disease progression or death.

Apart from luspatercept, the company has two other internally discovered therapeutic candidates, currently in clinical trials: sotatercept and ACE-083.

Acceleron expects to initiate a phase II study with ACE-083 in Charcot-Marie-Tooth disease. Previously, the company reported positive data from a phase I study for ACE-083, demonstrating marked increases in muscle-volume, treated with ACE-083.

We expect the investors’ focus to remain on the company’s updates relating to the development of pipeline candidates.

Acceleron Pharma Inc. Price

Acceleron Pharma Inc. Price | Acceleron Pharma Inc. Quote

Zacks Rank & Key Picks

Acceleron currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the healthcare sector includes VIVUS, Inc. VVUS, which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

VIVUS’s loss per share estimates narrowed down from 50 cents to 39 cents for 2017 in the last 60 days. The company posted positive earnings surprises in all four trailing quarters with an average beat of 233.69%.

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