Acceleron Pharma Slides on Missed Mid-Stage Results

By Chris Lange Updated Jan 12, 11:06AM EST · Published Jun 13, 9:10AM EDT

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Acceleron Pharma Slides on Missed Mid-Stage Results — © Thinkstock

Acceleron Pharma Inc. (NASDAQ: XLRN) saw its shares droop early on Tuesday after the firm offered an update from its mid-stage trial in advanced renal cell carcinoma (RCC). Specifically, Acceleron said that its DART Phase 2 study of dalantercept plus axitinib did not achieve its primary endpoint of demonstrating a statistically significant increase in progression-free survival (PFS) versus the placebo.

The median PFS for dalantercept plus axitinib was 6.8 months versus 5.6 months for placebo plus axitinib. Unfortunately, dalantercept plus axitinib did not decrease the rate of disease progression or death. The confirmed objective response rate for dalantercept plus axitinib was 19% versus 25% for placebo plus axitinib.

The safety data are based on the 119 ATS patients. The frequency of Grade 3 or higher adverse events regardless of causality were similar overall in the dalantercept plus axitinib (59%) and the placebo plus axitinib (64%) study arms.

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Habib Dable, president and CEO of Acceleron, commented:

We designed a robust Phase 2 study to evaluate the efficacy of dalantercept in combination with anti-VEGF therapy in advanced renal cell carcinoma patients whose disease has progressed on prior anti-VEGF therapy. We are disappointed by the results given the need for new agents that improve outcomes for patients with advanced RCC. We would like to thank the patients, caregivers, investigators, and our team who made the DART study possible. Based on the lack of efficacy, we are discontinuing the development of dalantercept. We remain focused on the development of luspatercept across multiple Phase 3 and Phase 2 studies and ACE-083 across two neuromuscular diseases, and will continue to pursue additional candidates in areas of high unmet medical need.

Shares of Acceleron closed Monday down 2.8% at $28.23, with a consensus analyst price target of $41.93 and a 52-week trading range of $23.07 to $41.69. Following the announcement, the stock was down close to 7% at $26.30 in early trading indications Tuesday.

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About the Author Chris Lange →

Chris Lange is a writer for 24/7 Wall St., based in Houston. He has covered financial markets over the past decade with an emphasis on healthcare, tech, and IPOs. During this time, he has published thousands of articles with insightful analysis across these complex fields. Currently, Lange's focus is on military and geopolitical topics.

Lange's work has been quoted or mentioned in Forbes, The New York Times, Business Insider, USA Today, MSN, Yahoo, The Verge, Vice, The Intelligencer, Quartz, Nasdaq, The Motley Fool, Fox Business, International Business Times, The Street, Seeking Alpha, Barron’s, Benzinga, and many other major publications.

A graduate of Southwestern University in Georgetown, Texas, Lange majored in business with a particular focus on investments. He has previous experience in the banking industry and startups.