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BridgeBio Files NDA for LGMD2I/R9 Oral Therapy

Story Highlights
  • BridgeBio filed an FDA NDA for BBP-418 in LGMD2I/R9 on March 30, 2026, based on positive Phase 3 data.
  • If approved, BBP-418 could become the first therapy for LGMD2I/R9 and any limb-girdle muscular dystrophy, supported by multiple regulatory designations.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
BridgeBio Files NDA for LGMD2I/R9 Oral Therapy

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BridgeBio Pharma ( (BBIO) ) has shared an announcement.

On March 30, 2026, BridgeBio Pharma announced that it had submitted a New Drug Application to the FDA for its oral therapy BBP-418 to treat limb-girdle muscular dystrophy type 2I/R9, a severe, progressive neuromuscular disease caused by FKRP gene mutations. The filing is backed by interim 12-month Phase 3 FORTIFY data showing statistically significant and clinically meaningful improvements in ambulation and pulmonary function, along with a favorable safety profile, and BBP-418 has already secured multiple U.S. and European regulatory designations, positioning it as a potential first approved therapy for LGMD2I/R9 and any form of limb-girdle muscular dystrophy, with broader clinical development planned in younger patients and additional LGMD subtypes.

The most recent analyst rating on (BBIO) stock is a Buy with a $69.00 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.

The score is held down primarily by weak financials (large losses, heavy cash burn, and negative equity) and bearish technical momentum. These are partially offset by a constructive earnings-call outlook driven by strong Atruby growth and multiple positive late-stage pipeline readouts, while valuation support is limited given ongoing losses and no dividend.

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

More about BridgeBio Pharma

BridgeBio Pharma, Inc. is a biopharmaceutical company focused on developing transformative medicines for genetic conditions, targeting small and underserved patient populations where traditional drug development is often commercially challenging. The company operates a decentralized hub-and-spoke model, with autonomous teams dedicated to specific diseases supported by a central clinical, regulatory, and commercial infrastructure to accelerate bringing therapies to market.

Average Trading Volume: 2,874,573

Technical Sentiment Signal: Buy

Current Market Cap: $13.51B

See more insights into BBIO stock on TipRanks’ Stock Analysis page.

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