Encaleret

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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
PALO ALTO, Calif., Sept. 02, 2025 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a new type of biopharmaceutical company focused on genetic diseases, announced today that an oral presentation of Phase 2 data in post-surgical hypoparathyroidism and two poster sessions on skeletal dysplasia data will be shared at the American Society for Bone and Mineral Research (ASBMR) Annual Meeting 2025, taking place in Seattle, WA from September 5 - 8, 2025. Post-Surgical Hypopa ...
BridgeBio Reports Second Quarter 2025 Financial Results and Business Updates
GlobeNewswire News Room· 2025-08-05 20:01
- As of August 1, 2025, 3,751 unique patient prescriptions have been written by 1,074 unique prescribers, representing an accelerating launch driven by strong month over month growth in the crucial treatment naïve patient segment - $110.6 million in total second quarter revenue, comprised of $71.5 million of U.S. Attruby® net product revenue, $1.6 million from royalty revenue, and $37.5 million in license and services revenue - Attruby's differentiated clinical profile was further strengthened by new analys ...
Novel Human Genetics Evidence Confirms Estimates of Genetic Prevalence, Underdiagnosis, and Potentially Greater Symptom Burden of Gain-of-Function CASR Variants Associated with ADH1
Globenewswire· 2025-07-23 11:30
Core Insights - The study confirms the genetic prevalence of Autosomal Dominant Hypocalcemia Type 1 (ADH1) and highlights a significant gap in diagnosis and care for affected individuals [1][2][3] Group 1: Genetic Findings - The average frequency of gain-of-function CASR variants is approximately 3.7 per 100,000, equating to around 25,000 carriers in the US and EU [1][6] - Only about 20% of individuals with genetic variants linked to ADH1 have an established diagnosis, indicating a major gap in disease recognition [1][2] - Nine novel gain-of-function CASR variants were identified, associated with symptoms consistent with ADH1 [1] Group 2: Clinical Implications - ADH1 is a common genetic form of hypoparathyroidism, presenting serious symptoms like seizures and irregular heart rhythms due to hypocalcemia [2][5] - The findings emphasize the importance of genetic testing in uncovering the underlying causes of hypoparathyroidism [2][3] Group 3: Clinical Trials and Future Developments - BridgeBio's Phase 3 clinical trial of encaleret for ADH1 is fully enrolled with 71 participants, expected to report topline results in the second half of 2025 [4] - If successful, encaleret would be the first approved therapy for ADH1, with plans to initiate a study in chronic hypoparathyroidism in 2026 [4][8] Group 4: Company Overview - BridgeBio Pharma focuses on discovering and delivering transformative medicines for genetic diseases, with a commitment to applying advances in genetic medicine [9]
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]