BridgeBio Shares Second Positive Late-Stage Study Result In A Week – Calcium Disorder Drug Trial Yields Positive Results

• The study was designed to study the efficacy and safety of Encaleret and enrolled 70 adults with ADH1.
• 76% of the 67 participants administered Encaleret in the trial achieved both serum and urine calcium within the respective target ranges after 24 weeks of treatment.
• The company now plans to submit a new drug application to the U.S. Food and Drug Administration in the first half of 2026.
   

Shares of BridgeBio Pharma, Inc. (BBIO) rose 4% on Wednesday afternoon after the company announced that its late-stage study of Encaleret in patients with autosomal dominant hypocalcemia type 1 met all primary and key secondary endpoints.

This marks the company’s second positive trial result announcement this week. The Encaleret study was designed to study the efficacy and safety of the drug and enrolled 70 adults with ADH1– autosomal dominant hypocalcemia type 1 – a genetic disorder that causes low blood calcium levels, a condition known as hypocalcemia. Symptoms, which can range from none to severe, include muscle spasms, cramps, tingling sensations, and, in severe cases, seizures.

Trial Outcomes

76% of the 67 participants administered Encaleret in the trial achieved both serum and urine calcium within the respective target ranges after 24 weeks of treatment compared to 4% when on conventional therapy, the company said. Furthermore, the drug was well-tolerated, the company noted.

The company now plans to submit a new drug application to the U.S. Food and Drug Administration (FDA) in the first half of 2026, followed by an application to the European Medicines Agency.

The company also intends to initiate registrational studies of Encaleret in chronic hypoparathyroidism and pediatric ADH1 in 2026. The trial in pediatric ADH1 is slated for the first quarter of 2026.

How Did Stocktwits Users React?

On Stocktwits, retail sentiment around BBIO stock stayed within the ‘extremely bullish’ territory over the past 24 hours, while message volume remained at ‘extremely high’ levels.

A Stocktwits user termed the news great but expressed disappointment that the stock didn't rally further.

Wednesday’s results come after the company announced on Monday that limb-girdle muscular dystrophy type 2I/R9 patients treated with BBP-418 in a late-stage study demonstrated improvements in motor and pulmonary function at 12 months.

BBIO stock is up by 145% this year and by about 175% over the past 12 months. 

Read also: Akebia Therapeutics Stock Slumps After FDA Meeting Ends Without Path Forward for Vafseo Label Expansion

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