BlondVax Pharmaceuticals Ltd. (NASDAQ: BVXV) was absolutely crushed on Friday after the company reported late-stage results from its flu vaccine study. Needless to say, results obviously didn’t live up to expectations.
In terms of the specifics, the topline data came from the firm’s pivotal, Phase 3 clinical trial of M-001 as a standalone universal flu vaccine candidate.
Results did not demonstrate a statistically significant difference between the vaccinated and placebo groups in reduction of flu illness and severity, and therefore they failed to meet both the primary and secondary efficacy endpoints. However, the study’s primary safety endpoint was met.
The pivotal Phase 3 trial assessed safety and efficacy of the M–001 vaccine candidate alone in reducing flu illness and severity in 12,463 adults aged 50 years and older, including 6,291 (50.5%) aged 65 and older.
The trial commenced in 2018, after the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) reviewed the trial design and provided feedback.
Management noted that the significant need for better, more proactive flu protection is well-understood by clinicians and public health experts around the world. Unfortunately, this study did not have the efficacy outcomes that the firm anticipated for M-001 on a standalone basis. Management has observed in seven previous studies that M-001 safely provoked an immune response to a broad range of flu strains, but ultimately this was not sufficient on a standalone basis to show protection.
BlondVax traded down about 80% to $7.97 on Friday, in a 52-week range of $3.60 to $62.00. The consensus price target is $81.00.