Following on from last week’s rundown of Phase 3 readouts to watch, we continue this week with a look ahead at Phase 1/2 notable events slated for data release this quarter. First, let’s review the week that was, which was notably quieter due to the shortened trading week.
Cortexyme, Inc. (NASDAQ:CRTX) shares closed the week down 32% to $32.47 on news the FDA has placed a partial clinical hold on atuzaginstat (COR388) in patients with Alzheimer's disease. As a result, the open-label extension part of its Phase 2/3 trial has stopped. Patients in the placebo-controlled randomized part of the trial will continue to be dosed, with top-line data still slated for 4Q 2021.
bluebird bio, Inc. (Nasdaq: BLUE) announced its Phase 1/2 (HGB-206) and Phase 3 (HGB-210) trials of LentiGlobin gene therapy for sickle cell disease (SCD) (bb1111) have been placed on a temporary suspension due to a reported Suspected Unexpected Serious Adverse Reaction (SUSAR) of acute myeloid leukemia (AML). A patient that was treated with LentiGlobin more than five years ago has been recently diagnosed with AML. The company is investigating the cause of the patient’s AML in order to determine if there is any relationship with the use of a lentiviral vector in the manufacture of its LentiGlobin gene therapy. Shares slumped to close the week down 42% to $26.68.
AVROBIO, Inc. (Nasdaq: AVRO) shares fell in sympathy to the fall by bluebird, closing the week down 27% to $11.84. The company also has a clinical-stage gene therapy platform, with its most advanced, a lentiviral gene therapy for Fabry disease currently in Phase 2 trials.
GlaxoSmithKline plc (NYSE:GSK) and Vir Biotechnology, Inc. (NASDAQ:VIR) announced they have expanded their existing collaboration to include the research and development of new therapies for influenza and other respiratory viruses. Vir receives $225m upfront and a further equity investment of $120m. Data from the first of their Phase 3 COVID-19 antibody candidates are due this quarter. Vir shares closed Wednesday up 19% to $80.03, before pulling back almost half of its gains to close the week up 10% to $76.58.
Evolus (NASDAQ:EOLS) shares closed Friday up 72% to $12.29 on news of a settlement agreement with AbbVie (NYSE:ABBV) and Medytox to resolve outstanding litigation related to Jeuveau, a treatment for wrinkles approved for Evolus, a competitor of Abbvie’s Botox. AbbVie will grant a license to Evolus to continue to commercialize Jeuveau in return of milestone and royalty payments from Evolus and the issuance of Evolus common stock to Medytox. The litigation was previously initiated on claims Evolus had stolen trade secrets from Abbvie's South Korean partner to manufacture Jeuveau.
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Selection of biotech earnings next week (15) – full list for premium members
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Phase 1/2 data readouts to watch for the remainder of 1Q 2021.