Stock of the Day

July 12, 2019

BridgeBio Pharma (BBIO)

$67.13
+$2.19 (+3.4%)
Market Cap: $12.69B

About BridgeBio Pharma

BridgeBio Pharma, Inc., a commercial-stage biopharmaceutical company, discovers, creates, tests, and delivers transformative medicines to treat patients who suffer from genetic diseases and cancers. Its products in development programs include AG10, a next-generation oral small molecule near-complete TTR stabilizer that is in Phase 3 clinical trial for the treatment of TTR amyloidosis, or transthyretin amyloid cardiomyopathy (ATTR-CM); low-dose infigratinib, an oral FGFR1-3 selective tyrosine kinase inhibitor, which is in Phase 3 double-blinded, placebo-controlled pivotal study for the treatment option for children with achondroplasia; and BBP-631, an AAV5 gene transfer product candidate that is in Phase 1/2 clinical trial for the treatment of congenital adrenal hyperplasia, or CAH, driven by 21-hydroxylase deficiency, or 21OHD. The company also develops Encaleret, a small molecule antagonist of the calcium sensing receptor, or CaSR, which is in phase 3 clinical trial for treating autosomal dominant hypocalcemia type 1, or ADH1; and BBP-418, a glycosylation substrate pro-drug that is in Phase 3 clinical trial for treating limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9). In addition, it engages in developing products for mendelian, oncology, and gene therapy diseases. BridgeBio Pharma, Inc. has license and collaboration agreements with the Leland Stanford Junior University; and Leidos Biomedical Research, Inc. The company was founded in 2015 and is headquartered in Palo Alto, California.

Today's Trend

BridgeBio Pharma, Inc. (NASDAQ: BBIO) shares moved higher as investors responded to multiple favorable regulatory and clinical updates across the company’s pipeline.

  • The FDA accepted BridgeBio’s new drug application for oral infigratinib for children with achondroplasia and granted it Priority Review. The agency set a PDUFA target action date of February 4, 2027, accelerating a potential regulatory decision for an oral treatment addressing a significant unmet need. BridgeBio Announces FDA Acceptance and Priority Review of NDA for Oral Infigratinib
  • New exploratory data from the Phase 3 FORTIFY trial showed potentially meaningful cardiac benefits for BBP-418 in LGMD2I/R9. Among treated patients with elevated baseline troponin I, 100% reached normal levels by Month 12 versus 40% on placebo, while 54% of treated patients had stable or improved left-ventricular ejection fraction compared with 25% for placebo. BBP-418 is under Priority Review, with an FDA decision targeted for November 27, 2026. BridgeBio BBP-418 FORTIFY Trial Update
  • BridgeBio will present additional Phase 3 CALIBRATE data for encaleret in autosomal dominant hypocalcemia type 1, potentially providing another catalyst for the company’s rare-disease pipeline. BridgeBio Encaleret CALIBRATE Trial Presentation
  • BridgeBio also plans to present new acoramidis data in ATTR-CM at the HFSA annual meeting. The presentations could support the commercial profile of its marketed portfolio, but the announcement does not include new approval or financial results. BridgeBio Acoramidis HFSA Presentation
  • The BBP-418 cardiac findings are exploratory, based on relatively small subgroups, and may not establish long-term clinical benefit. Regulatory approval is not guaranteed, leaving material clinical and regulatory risk.
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