Oppenheimer & Co. Inc. acquired a new position in BridgeBio Pharma, Inc. (NASDAQ:BBIO – Free Report) in the third quarter, according to its most recent Form 13F filing with the SEC. The institutional investor acquired 7,845 shares of the company’s stock, valued at approximately $407,000. Get BridgeBio Pharma alerts: Several other large investors have also recently added to or reduced their stakes in the business. Jones Financial Companies Lllp bought a new position in shares of BridgeBio Pharma in the firs ...

Core Insights - Sharp Therapeutics Corp. has appointed Dr. Robin Ely, a prominent figure in Gaucher disease advocacy and research, to its Advisory Board, enhancing its expertise in orphan diseases [1][3]. Company Overview - Sharp Therapeutics is a preclinical-stage biotechnology company focused on developing small-molecule therapeutics for genetic diseases, aiming to restore function in mutated proteins through conventional pill-based medicines [4]. Advisory Board Composition - Dr. Ely's appointment is part of a broader strategy to strengthen the Advisory Board, which includes other distinguished experts in the field of rare diseases and therapeutic development [3][6]. Clinical Development Plans - The company is preparing to initiate clinical studies later in the year, with a focus on its lead program '901' for Gaucher disease and a growing pipeline for other genetically defined indications [3].

Core Insights - BridgeBio Pharma reported preliminary unaudited Q4 and Full Year 2025 net product revenue of $146.0 million and $362.4 million respectively, indicating strong commercial performance for its product Attruby (acoramidis) [1] - Attruby is becoming the preferred therapy for newly diagnosed ATTR-CM patients, with 6,629 unique patient prescriptions written by 1,632 prescribers as of December 31, 2025, driven by its differentiated clinical data and increasing real-world confidence [1] - The company announced a new TTR amyloid depleter antibody program aimed at exploring the potential for ATTR-CM disease reversal, with clinical advancement expected between 2027 and 2028 [1] - Interim analysis from the FORTIFY Phase 3 study of BBP-418 in LGMD2I/R9 showed significant benefits, leading the FDA to recommend a traditional full approval pathway, with an NDA submission planned for the first half of 2026 [1] - A rapid increase in the diagnosis of ADH1 has been noted, with over 1,700 unique patients identified since October 2023, and an NDA submission for encaleret based on CALIBRATE trial results is anticipated in the first half of 2026 [1] - The initiation of the RECLAIM-HP Phase 3 trial for encaleret in chronic hypoparathyroidism is scheduled for summer 2026 following a successful End of Phase 2 interaction with the FDA [1] - The PROPEL 3 Phase 3 study of infigratinib for children with achondroplasia has achieved LPLV, with topline results expected by the end of Q1 2026 [1] - As of December 31, 2025, the company had approximately $587.5 million in cash, cash equivalents, and marketable securities, positioning it well to support the acceleration of Attruby and potentially launch three additional medicines globally [1] Company Overview - BridgeBio Pharma is a biopharmaceutical company focused on genetic diseases, founded in 2015, with a commitment to delivering transformative medicines quickly and effectively [2][7] - The company operates on a decentralized model, aiming to double the number of patients served by the end of 2026 [2]

Core Insights - BridgeBio Pharma reported preliminary unaudited Q4 and Full Year 2025 net product revenue of $146.0 million and $362.4 million, respectively, indicating strong commercial performance for its product Attruby (acoramidis) [1] - Attruby is becoming the preferred therapy for newly diagnosed ATTR-CM patients, with 6,629 unique patient prescriptions written by 1,632 prescribers as of December 31, 2025, driven by its differentiated clinical data [1] - The company announced a new TTR amyloid depleter antibody program aimed at exploring the potential for ATTR-CM disease reversal, with clinical advancement expected between 2027 and 2028 [1] - The interim analysis from the FORTIFY Phase 3 study of BBP-418 in LGMD2I/R9 showed a statistically significant 2.6 point benefit on NSAD relative to placebo at 12 months, leading the FDA to recommend a traditional full approval pathway [1] - A rapid increase in the diagnosis of ADH1 has been observed, with over 1,700 unique patients identified since October 2023, prompting the company to plan an NDA submission based on CALIBRATE trial results in the first half of 2026 [1] - The initiation of the RECLAIM-HP Phase 3 trial of encaleret in chronic hypoparathyroidism is scheduled for summer 2026 following a completed End of Phase 2 interaction with the FDA [1] - The company achieved LPLV for PROPEL 3, with topline results expected by the end of Q1 2026, and LPI for the Phase 2 portion of ACCEL 2/3 [1] - As of December 31, 2025, the company had approximately $587.5 million in cash, cash equivalents, and marketable securities, positioning it well to support the acceleration of Attruby and potentially launch three additional medicines globally [1] Company Overview - BridgeBio Pharma is a biopharmaceutical company focused on discovering, creating, testing, and delivering transformative medicines for genetic diseases, founded in 2015 [6] - The company emphasizes a decentralized model to drive impact across various communities, aiming to double the number of patients served by the end of 2026 [2]

Core Insights - BridgeBio Pharma, Inc. is set to release topline results from the CALIBRATE Phase 3 trial for autosomal dominant hypocalcemia type 1 (ADH1) on October 28, 2025, before market opening [1] - A conference call will be held by management at 8:00 a.m. ET on the same day to discuss the trial data [1] Company Overview - BridgeBio Pharma, Inc. is a biopharmaceutical company focused on discovering, creating, testing, and delivering transformative medicines for genetic diseases [3] - Founded in 2015, the company has a pipeline that includes programs from early science to advanced clinical trials [3] - The team consists of experienced professionals dedicated to applying advances in genetic medicine to benefit patients quickly [3]

Core Insights - Encaleret demonstrated significant efficacy in normalizing blood and urine calcium levels in post-surgical hypoparathyroidism patients, with 80% achieving normal levels within 5 days of treatment initiation compared to 0% on conventional therapy at baseline [1][6] - The treatment was well-tolerated, with no serious adverse events reported during the study [1] - BridgeBio plans to initiate a registrational clinical study for encaleret in chronic hypoparathyroidism in 2026 based on the promising Phase 2 results [1][3] Company Overview - BridgeBio Pharma, Inc. is focused on developing transformative medicines for genetic diseases, with a pipeline that includes early science to advanced clinical trials [5] - The company was founded in 2015 and aims to leverage advances in genetic medicine to expedite patient care [5] Study Details - The Phase 2 proof-of-concept study evaluated the PTH-independent effects of encaleret on renal calcium handling in ten participants with post-surgical hypoparathyroidism, administered at 162 mg twice daily for up to 5 days [2] - Calcitriol was stopped one day prior to the first dose, and calcium levels were titrated based on blood calcium after starting encaleret [2] Additional Findings - Encaleret treatment resulted in a rapid and sustained reduction in fractional excretion of calcium in nine participants, supporting its potential as an orally-administered treatment option for chronic hypoparathyroidism [6] - Data from preclinical studies of infigratinib were also presented, showing significant improvements in bone growth and skull development in relevant mouse models, indicating broad potential for treating skeletal conditions [4]

Core Insights - BridgeBio Pharma, Inc. is hosting an investor webinar on September 10, 2025, focusing on its Phase 3 clinical trial for autosomal dominant hypocalcemia type 1 (ADH1) [1][2] - Dr. Rachel Gafni will discuss the pathophysiology of ADH1, the unmet medical needs, and the rationale for evaluating encaleret as a treatment [2] - The ongoing CALIBRATE study is expected to provide topline results in fall 2025 [2] Company Overview - BridgeBio Pharma is a biopharmaceutical company established to develop transformative medicines for genetic diseases, with a pipeline that includes early science to advanced clinical trials [4] - Founded in 2015, the company aims to leverage advances in genetic medicine to expedite patient treatment [4] Webinar Access - The investor webinar can be accessed via the "Events & Presentations" section on BridgeBio's website, with a replay available for 30 days post-event [3]

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]

Pipeline and Approvals - Attruby (acoramidis) is now FDA approved in the US for Transthyretin Amyloidosis (ATTR-CM)[8, 40, 42] - Beyonttra (acoramidis) is approved in the EU, Japan, and UK[11, 32] - Three Phase 3 trials are fully enrolled: BBP-418 for Limb-Girdle Muscular Dystrophy 2I/R9 (112 patients), encaleret for Autosomal Dominant Hypocalcemia Type 1 (71 patients), and infigratinib for Achondroplasia (114 participants)[12] Attruby (acoramidis) Clinical and Commercial Performance - Attruby demonstrated a 42% reduction in the composite of all-cause mortality and recurrent cardiovascular-related hospitalization events at Month 30[44] - Attruby showed a 50% reduction in the cumulative frequency of cardiovascular-related hospitalization events at Month 30[44] - In Q1 2025, Attruby generated $36.7 million in total U S revenue[51] - Attruby has achieved 77% Medicare lives in equal formulary position to tafamidis[51] Market and Financial Outlook - The global annual ATTR market is projected to reach $15-$20 billion at its peak[30, 66] - BridgeBio envisions a vision for 2030 with >$8 billion in revenue[35] - The company estimates the market opportunity for Infigratinib in Achondroplasia and Hypochondroplasia to be $2B+ each[30] - The company estimates the market opportunity for BBP-418 in Limb-Girdle Muscular Dystrophy Type 2I/R9 (LGMD2I/R9) to be $1B+[30, 146] - The company estimates the market opportunity for Encaleret in Autosomal Dominant Hypocalcemia Type 1 (ADH1) to be $1B+[30, 121]

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]