Shares of Alexion Pharmaceuticals Inc. (ALXN) rose 5.3% to $142.37 in premarket trading on Tuesday, Oct. 24, after the New Haven, Conn.-based firm clinched approval from the U.S. Food and Drug Administration for Soliris (eculizumab) as a treatment for adults with generalized myasthenia gravis (gMG) that are anti-acetylcholine receptor (AChR) antibody-positive.
The announcement on Monday was "largely anticipated by the Street," wrote SunTrust Robinson Humphrey Inc. analyst Yatin Suneja in a note, adding that he nonetheless thinks that the approval "represents a significant de-risking event that should provide a significant growth driver for Soliris."
In addition, "we believe the drug's broad label across all generalized myasthenia gravis patients was a pleasant surprise," Suneja added.
The approval came after the European Commission in August greenlighted the extension of the indication for Soliris to include the treatment of refractory gMG in adults who are anti-AChR antibody-positive. In March, Alexion submitted an application to Japan's Ministry of Labour and Welfare to extend the indication for Soliris as a potential treatment for patients with anti-AchR antibody-positive refractory gMG.
Meanwhile, shares of Catalyst Biosciences Inc. (CBIO) were up 6.1% to $5.20 after the South San Francisco firm entered into a collaboration with privately held Mosaic Biosciences Inc. to develop Catalyst's anti-C3 protease assets for dry age-related macular degeneration (dAMD) and other serious inflammatory retinal disorders.
Among the other biotech movers was DBV Technologies SA (DBVT) . The Montrouge, France-based firm's American depository shares were down 7.2% to $26.28 after closing at $28.32 on Monday, down 41.1%.
DBV on Friday unveiled top-line results from its Phase 3 study of a peanut allergy treatment. The company said that the primary endpoint, which assesses the 95% confidence interval (CI) in the difference in response rates between the active and placebo arms, "did not reach the 15% lower bound of the CI that was proposed in the study's Statistical Analysis Plan (SAP) submitted to the U.S Food and Drug Administration (FDA)."
Shares of DBV competitor Aimmune Therapeutics Inc. (AIMT) were down 4.4% to $31.50 in premarket trading on Tuesday after closing at $32.94 on Monday, up 28.4%.
