Thursday was a breakout day for a few biotech companies. Some made absolutely massive runs, while others fell off a cliff. The biotechnology sector is pushing near all-time highs, and a few standouts are giving credence to these highs.
24/7 Wall St. has picked a few of those standouts from Thursday to highlight. We have included information about each company, as well as recent trading activity and the consensus analyst price target.
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) announced positive efficacy and safety results from its pivotal Aurora Phase 3 trial of voclosporin, in combination with mycophenolate and low-dose corticosteroids, in the treatment of lupus nephritis.
This global study, in which 357 patients with active lupus nephritis were enrolled, met its primary endpoint of renal response rates of 40.8% for voclosporin, versus 22.5% for the control group. Additionally, all prespecified hierarchical secondary endpoints achieved statistical significance in favor of voclosporin.
Neil Solomons, M.D., chief medical officer of Aurinia, commented:
This extraordinary pivotal data confirms voclosporin’s ability to achieve statistically significant improvements in clinically meaningful endpoints for this complex disease, with a comparable safety profile to the current standard of care. This data represents a significant advance for people living with [lupus nephritis], which can lead to irreversible kidney damage, eventual kidney failure and death.
Shares of Aurinia traded up about 105% to $17.21 on Thursday, in a 52-week range of $3.52 to $17.48. The consensus price target is $11.92.
Acadia Pharmaceuticals Inc. (NASDAQ: ACAD) presented positive topline results from its Phase 3 Harmony study at the Clinical Trials on Alzheimer’s Disease (CTAD) Meeting in San Diego. Harmony was a study in 392 patients evaluating pimavanserin for the treatment of dementia-related psychosis.
Pimavanserin met the primary endpoint of the study and was stopped at the preplanned interim analysis by significantly reducing risk of relapse of psychosis by 2.8 fold compared to placebo. In addition, pimavanserin met the key secondary endpoint by significantly reducing risk of discontinuation for any reason by 2.2 fold.
Jeffrey Cummings, M.D., Sc.D., director emeritus of Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas, commented:
The results presented today are an important advance for patients and caregivers who struggle with the burden of dementia-related psychosis where no FDA-approved treatment is currently available,” “Reducing the risk of relapse of psychotic symptoms by this magnitude is an important and meaningful outcome as these are serious events which could lead to poor patient outcomes and a significant increase in caregiver burden and distress.
Acadia shares traded up about 16% at $51.43. The 52-week range is $14.01 to $53.70, and the consensus price target is $54.86.
Sage Therapeutics Inc. (NASDAQ: SAGE) reported topline results from the pivotal Phase 3 Mountain Study evaluating the effect of SAGE-217 on depressive symptoms in adults with major depressive disorder.
Unfortunately, the Mountain study did not meet its primary endpoint of a statistically significant reduction from baseline compared to placebo in the 17-item Hamilton Rating Scale for Depression total score at day 15.
The SAGE-217 development program includes five other pivotal studies, two of which have reported positive data, one in major depressive disorder and one in postpartum depression and three of which are ongoing.
Jeff Jonas, M.D., CEO at Sage, commented:
This study did not meet the primary endpoint. With that, the data are supportive of the activity of SAGE-217 in [major depressive disorder] given the statistical significance at the majority of timepoints, and in relevant populations. Notwithstanding the finding on the primary endpoint, the drug displays good activity on most measures. We understand that drug development is an iterative process. In this study, we’ve gathered new data on SAGE-217, data we believe support our hypothesis that SAGE-217 has a unique profile with the potential for rapid and robust onset with durable effect.
Sage traded down about 55% to $66.50 a share, in a 52-week range of $56.50 to $193.56. The consensus price target is $201.84.
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