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BridgeBio Files FDA NDA for Encaleret in ADH1

Story Highlights
  • BridgeBio filed an NDA with the FDA on May 12, 2026, for encaleret to treat autosomal dominant hypocalcemia type 1 after strong Phase 3 data.
  • Encaleret’s Phase 3 results showed robust efficacy, good safety and potential first-in-class status, supporting expansion into pediatric ADH1 and chronic hypoparathyroidism.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
BridgeBio Files FDA NDA for Encaleret in ADH1

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BridgeBio Pharma ( (BBIO) ) just unveiled an announcement.

On May 12, 2026, BridgeBio Pharma announced it had submitted a New Drug Application to the U.S. Food and Drug Administration for encaleret as a targeted treatment for autosomal dominant hypocalcemia type 1, following positive Phase 3 CALIBRATE results. The trial showed rapid, durable normalization of calcium metabolism, with 76% of encaleret-treated participants achieving target serum and urine calcium levels versus low rates on standard care and a favorable safety profile, positioning encaleret to potentially become the first approved therapy for ADH1 and to expand into pediatric ADH1 and chronic hypoparathyroidism through ongoing and planned late-stage studies.

The most recent analyst rating on (BBIO) stock is a Buy with a $101.00 price target. To see the full list of analyst forecasts on BridgeBio Pharma stock, see the BBIO Stock Forecast page.

Spark’s Take on BBIO Stock

According to Spark, TipRanks’ AI Analyst, BBIO is a Neutral.

BBIO’s score is held back primarily by weak financial performance (large losses, significant cash burn, and negative equity) and bearish technicals (trading below key moving averages with negative momentum). Offsetting these risks, the earnings call was notably constructive, citing rapid Atruvio growth, a much stronger cash position, and guidance toward breakeven/cash-flow positivity.

To see Spark’s full report on BBIO stock, click here.

More about BridgeBio Pharma

BridgeBio Pharma, Inc. is a commercial-stage, multi-product biopharmaceutical company focused on developing transformative medicines for genetic conditions. Using a decentralized hub-and-spoke model, it targets underserved patient populations with rare diseases, leveraging a central platform for clinical, regulatory and commercial execution across its portfolio.

Average Trading Volume: 2,533,059

Technical Sentiment Signal: Buy

Current Market Cap: $12.92B

See more data about BBIO stock on TipRanks’ Stock Analysis page.

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