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Acceleron Receives Thumbs Up From Street On FDA Reblozyl Label Expansion

Acceleron (XLRN) has received U.S. Food and Drug Administration (FDA) approval for Reblozyl’s label expansion to include second-line treatment of anemia in patients with lower-risk myelodysplastic syndromes (MDS).

“We view XLRN as a core biotech holding, and we raise our price target to $112 (from $108)” cheers Oppenheimer analyst Leland Gershell.

The approval comes as expected given the strong trial results says Gershell, but adds “Nonetheless, this sizably increases Reblozyl’s indicated US population, from ~1.5K (transfusion-dependent βthalassemia) to 20K-plus.”

In the trial, a significantly greater proportion of patients receiving Reblozyl achieved independence from red blood cell transfusions for at least eight weeks during the first 24 weeks of the trial compared with those receiving placebo, meeting the study’s primary endpoint.

Gershell believes sales will begin to reflect uptake in MDS starting in 2Q, with EU approvals for both indications in 2H. “We anticipate Reblozyl US/EU sales in 2L (second-line) MDS alone to generate ~$200M in royalty revenue by 2025” the Oppenheimer analyst concludes.

Indeed, Acceleron has a rare bullish outlook according to the Street. TipRanks reveals that in the last three months, XLRN has received 9 buy ratings and just 2 hold ratings- giving it a Strong Buy analyst consensus. (See XLRN’s stock analysis on TipRanks)

The $109 average analyst price target translates into 35% upside potential from the current share price. Shares have surged over 50% year-to-date.

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