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BridgeBio to Present Phase 2 Proof-of-Concept Data for Encaleret in Post-Surgical Hypoparathyroidism
Globenewswire· 2025-09-02 11:30
Core Insights - BridgeBio Pharma, Inc. is set to present Phase 2 data on post-surgical hypoparathyroidism and skeletal dysplasia at the ASBMR Annual Meeting 2025 in Seattle from September 5-8, 2025 [1] Group 1: Post-Surgical Hypoparathyroidism Presentation - An oral presentation titled "The Oral Calcilytic Encaleret Reduced Urinary Calcium While Maintaining Blood Calcium in Individuals with Post-Surgical Hypoparathyroidism" will be presented by Dr. Iris Hartley on September 6 at 11:30 am PT [2] Group 2: Skeletal Dysplasia Poster Sessions - A poster session on "Infigratinib Low Dose Therapy Is an Effective Strategy in Improving Bone Growth in a Hypochondroplasia Mouse Model" will be presented by Dr. Bhavik Shah on September 5 at 5:00 pm PT and September 7 at 2:00 pm PT [2] - Another poster session titled "Infigratinib Improves Skull Measures in a Mouse Model of Crouzon/Pfeiffer Syndromes" will also be presented by Dr. Bhavik Shah on September 6 at 2:00 pm PT [3] Group 3: Company Overview - BridgeBio Pharma, Inc. focuses on discovering, creating, testing, and delivering transformative medicines for genetic diseases, with a pipeline that includes early science to advanced clinical trials [3] - Founded in 2015, the company aims to leverage advances in genetic medicine to expedite patient care [3]
BridgeBio Reports Second Quarter 2025 Financial Results and Business Updates
GlobeNewswire News Room· 2025-08-05 20:01
Core Insights - BridgeBio Pharma reported strong commercial progress with 3,751 unique patient prescriptions for Attruby as of August 1, 2025, indicating robust month-over-month growth in treatment-naïve patients [1][3] - The company achieved total second-quarter revenue of $110.6 million, driven by $71.5 million in U.S. Attruby net product revenue, $1.6 million in royalty revenue, and $37.5 million in license and services revenue [1][12] - Attruby's clinical profile was reinforced by new analyses from the ATTRibute-CM study, showing significant benefits for patients, including a 59% relative risk reduction in mortality and a 43% reduction in annual frequency of cardiovascular hospitalization due to atrial fibrillation [1][8] Commercial Progress - The launch of Attruby has accelerated, with nearly double the product revenue this quarter, attributed to growing adoption among healthcare providers [4] - The company ended the quarter with $756.9 million in cash and marketable securities, positioning it well for ongoing commercial activities and upcoming clinical trials [2][9] Pipeline Overview - Key upcoming milestones include topline results from the CALIBRATE study for encaleret in ADH1 expected in fall 2025, and from the PROPEL 3 study for infigratinib in achondroplasia expected in early 2026 [2][11] - The FORTIFY Phase 3 study of BBP-418 for LGMD2I/R9 has completed enrollment, with topline results anticipated in fall 2025 [1][6] Financial Performance - Total revenues for the three months ended June 30, 2025, were $110.6 million, a significant increase from $2.2 million in the same period last year, primarily due to the success of Attruby [12][13] - Operating costs for the quarter were $244.8 million, up from $177.7 million year-over-year, largely driven by increased selling, general, and administrative expenses related to the commercial launch of Attruby [14][15] Key Program Updates - Attruby is positioned as a near-complete transthyretin stabilizer for treating transthyretin amyloid cardiomyopathy (ATTR-CM), with ongoing studies to further validate its efficacy [7][31] - The company is also advancing its pipeline with BBP-418 and encaleret, aiming to address significant unmet needs in genetic diseases [9][11]
BridgeBio Reports First Quarter 2025 Financial Results and Business Updates
GlobeNewswire News Room· 2025-04-29 20:01
Core Insights - BridgeBio Pharma reported $36.7 million in net product revenue for Attruby in its first full quarter, with 2,072 unique patient prescriptions written by 756 prescribers as of April 25, 2025 [1][2] - The company has made significant progress in its clinical trials, including the full enrollment of the observational run-in study for hypochondroplasia Phase 2 trial ahead of schedule [1][6] - BridgeBio ended the quarter with $540.6 million in cash and cash equivalents, excluding anticipated regulatory milestone payments of $105 million for ex-U.S. approvals of BEYONTTRA [1][9] Commercial Progress - The first full quarter of Attruby net product revenue was $36.7 million, with 2,072 unique patient prescriptions written by 756 healthcare providers since FDA approval in November 2024 [2][13] - The Chief Commercial Officer highlighted a 42% reduction in all-cause mortality and a 50% decrease in cardiovascular hospitalizations at 30 months for patients treated with Attruby [3] Pipeline Overview - Acoramidis for ATTR-CM is approved in the U.S., EU, Japan, and UK, with the first participant in the ACT-EARLY Phase 3 trial expected to be dosed in 2025 [4] - BBP-418 for LGMD2I/R9 and encaleret for ADH1 have completed enrollment in their Phase 3 studies, with topline results expected in the second half of 2025 [4][6] - Infigratinib for achondroplasia is fully enrolled, with topline results anticipated in early 2026 [4][6] Key Program Updates - Attruby has shown strong clinical efficacy and safety, contributing to its growth in the ATTR-CM treatment paradigm [5][6] - The Phase 2 proof-of-principle study of encaleret in hypoparathyroidism showed 78% of participants achieving normal calcium levels within 5 days, with plans to advance to a registrational study in 2026 [6][7] Financial Updates - Cash and cash equivalents decreased to $540.6 million as of March 31, 2025, primarily due to operating activities and loan repayments [9][10] - Total revenues for the three months ended March 31, 2025, were $116.6 million, down from $211.1 million in the same period the previous year, mainly due to a decrease in license and services revenue [10][11] - The company recorded a net loss attributable to common stockholders of $167.4 million for the quarter, compared to a loss of $35.2 million for the same period in 2024 [20]