BridgeBio Soars to 52-Week High on Positive Drug Trial Results
Phase 3 study for its rare calcium disorder drug, Encaleret, met all primary and secondary endpoints, prompting a surge in the company's shares.
Shares of BridgeBio Pharma (NASDAQ: BBIO) surged to a new 52-week high on Tuesday, following the announcement of successful results from a late-stage trial of its experimental drug, Encaleret. The therapy, designed to treat a rare genetic calcium disorder, demonstrated significant efficacy, fueling investor optimism and sending the company's stock up over 7% in after-hours trading.
The Palo Alto-based biopharmaceutical company reported that its Phase 3 CALIBRATE study for Encaleret in treating autosomal dominant hypocalcemia type 1 (ADH1) met all of its primary and key secondary endpoints. The results were stark: 76% of patients treated with Encaleret achieved normal blood and urine calcium levels at the 24-week mark, compared to just 4% of those receiving standard therapy.
This outcome represents a significant potential advancement for patients with ADH1, a condition characterized by low levels of parathyroid hormone, leading to low blood calcium and high urine calcium. The current standard of care often involves a difficult balancing act of managing symptoms without causing long-term kidney damage. BridgeBio's drug, a calcium-sensing receptor antagonist, aims to address the underlying cause of the disease by restoring the body's natural mineral regulation.
"These results are not just statistically significant; they represent a potential paradigm shift for patients who have long struggled with the debilitating effects of this chronic disease," said Dr. Neil Kumar, CEO of BridgeBio, in a conference call discussing the results. The company noted that Encaleret was well-tolerated among trial participants, with no discontinuations related to the treatment itself.
The market's reaction was swift and decisive. BridgeBio's shares, which closed the regular session at $67.46, continued to climb in after-hours trading, reflecting the significance of the clinical milestone. The positive data adds to a recent string of successes for the company, which specializes in developing therapies for genetic diseases and cancers with clear genetic drivers.
Analysts were quick to weigh in on the news, with H.C. Wainwright raising its price target for BridgeBio to $90 from $80 while maintaining a "Buy" rating on the stock. This reflects a broader Wall Street consensus that sees significant upside potential for the company's diverse pipeline, with 18 out of 19 analysts covering the stock rating it as a "Buy" or "Strong Buy."
The successful trial is a critical step for BridgeBio as it prepares for regulatory submission. The company announced its intention to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) in the first half of 2026. If approved, Encaleret could become the first targeted therapy for ADH1, a market with a significant unmet medical need.
Looking ahead, investors will be closely watching for further details from the CALIBRATE study, which are expected to be presented at an upcoming medical conference. The company's ability to navigate the regulatory process and successfully commercialize Encaleret will be a key determinant of its future growth trajectory. For now, the strong Phase 3 data provides a major de-risking event for the program and a powerful validation of BridgeBio's focused approach to genetic medicine.