AstraZeneca plc AZN shares, which have gained about 9 percent year-to-date, were seeing incremental upside Monday in the wake of a company announcement.
The shares also received a shot in the arm from a Cowen upgrade from Market Perform to Outperform.
What Happened
U.K.-based AstraZeneca and U.S. pharma giant Merck & Co., Inc. MRK announced the FDA has granted Breakthrough Therapy Designation for their investigational MEK1/2 inhibitor selumetinib.
Selumetinib, a potentially new medicine, is being evaluated in pediatric patients ages 3 and older for neurofibromatosis type 1 symptomatic and/or progressive, inoperable plexiform neurofibroma — a rare incurable genetic condition.
Why It's Important
NF1-related plexiform neurofibromas have no approved medications.
The BTD, according to AstraZeneca, is an acknowledgment of the significant unmet need and the potential benefit of selumetinib in this setting, supporting a potential expedited review.
AstraZeneca shares were trading up 2.18 percent at $41.31 at the time of publication Monday, while Merck shares were higher by 0.14 percent at $83.32.
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