April 28 Quick Takes: Brukinsa data buoy BeiGene; plus Adverum, Dynamk, Pfizer-Amplyx, Boundless Bio and Clarus
Positive Phase III data for Brukinsa zanubrutinib lifted shares of BeiGene Ltd. (NASDAQ:BGNE; HKEX:6160) 9% on NASDAQ, leaving the company with a market cap of $32 billion. The Btk inhibitor showed non-inferiority in ORR by both investigator and independent review committee assessments compared with Imbruvica ibrutinib in an interim analysis of its Phase III ALPINE trial. BeiGene will present data from the trial, which included 415 patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), at an upcoming medical conference. Brukinsa also showed lower risk of atrial fibrillation or flutter than ibrutinib.
Look for shares of Adverum Biotechnologies Inc. (NASDAQ:ADVM) to move Thursday after a diabetic macular edema patient experienced a Suspected Unexpected Serious Adverse Reaction (SUSAR) in the Phase II INFINITY of ADVM-022. The therapy is an intravitreally delivered AAV.7m8 vector encoding the VEGF-A-inhibiting fusion protein aflibercept. Thirty weeks after randomization, one patient treated with a single intravitreal injection of the high dose (6 x 10^11 vg/eye) of ADVM-022 developed hypotony, panuveitis and loss of vision in the treated eye. The company’s shares tumbled 52% to $4.88 after hours...