Core Insights - Acoramidis has shown a significant impact on mortality, hospitalizations, and quality of life in patients with transthyretin amyloid cardiomyopathy (ATTR-CM), demonstrating a 42% reduction in composite cardiovascular hospitalization (CVH) and all-cause mortality (ACM) events relative to placebo by Month 30 [1][4][5] - The company reported a net loss attributable to common stockholders of $73.5 million for the three months ended June 30, 2024, compared to $157.9 million for the same period in 2023, indicating improved financial performance [14] - The company ended the quarter with $587 million in cash, cash equivalents, marketable securities, and short-term restricted cash, a significant increase from $392.6 million at the end of 2023 [6] Pipeline Overview - Acoramidis for ATTR-CM has an NDA filed with the FDA, with a PDUFA date set for November 29, 2024 [2] - Encaleret for autosomal dominant hypocalcemia type 1 (ADH1) is currently enrolling in the CALIBRATE Phase 3 study, with enrollment completion expected in 2024 [2] - BBP-418 for limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9) is also enrolling in the FORTIFY Phase 3 study, with completion anticipated in 2024 [2] - Low-dose infigratinib for achondroplasia and hypochondroplasia is enrolling in the PROPEL 3 Phase 3 study, with completion expected in 2024 [2] Financial Performance - Revenue for the three months ended June 30, 2024, was $2.2 million, an increase from $1.6 million in the same period in 2023, primarily due to recognition of services revenue under collaboration agreements [7] - Operating costs and expenses for the three months ended June 30, 2024, were $177.7 million, compared to $147.7 million for the same period in 2023, driven by increased selling, general, and administrative expenses [8][9] - Total other income for the three months ended June 30, 2024, was $100 million, a significant increase from a loss of $14.6 million in the same period in 2023, mainly due to a gain on deconsolidation of a subsidiary [12][13] Clinical Developments - Acoramidis treatment resulted in a statistically significant reduction in ACM in the intention-to-treat population at Month 30, with no safety signals of concern [1][5] - The company shared positive analyses at various conferences, including a significant improvement in health-related quality of life as assessed by the EuroQoL Health Outcomes Assessment tool [5] - Infigratinib for achondroplasia showed a statistically significant increase in annualized height velocity, with a mean change of +2.50 cm/year at Month 18 [1][4]

PALO ALTO, Calif., July 23, 2024 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) ("BridgeBio" or the "Company"), a commercial-stage biopharmaceutical company focused on genetic diseases, announced that Thomas Trimarchi, Ph.D., has been appointed President and Chief Operating Officer (COO) of the company. Dr. Trimarchi will assume his new responsibilities effective immediately and will continue to report directly to CEO and founder, Neil Kumar, Ph.D. In this newly created position, Dr. Trimarchi wil ...

- BridgeBio has surpassed its interim analysis enrollment target for its Phase 3 FORTIFY study of BBP-418 in individuals living with LGMD2I/R9, with top-line results from the interim analysis expected in 2025 - Recent Type C interactions with U.S. Food and Drug Administration (FDA) focused on the validated glycosylated alpha-dystroglycan (αDG) bioassay and our interim analysis plans reinforce BridgeBio's belief that there is potential to pursue Accelerated Approval for BBP-418 - Rare Pediatric Disease Desig ...

NEW YORK, June 13, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of BridgeBio Pharma, Inc. (“BridgeBio” or the “Company”) (NASDAQ: BBIO).   Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. The investigation concerns whether BridgeBio and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. [Click here for information about joining the class action] On Ju ...

NEW YORK, June 05, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of BridgeBio Pharma, Inc. (“BridgeBio” or the “Company”) (NASDAQ: BBIO). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980.    The investigation concerns whether BridgeBio and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.  [Click here for information about joining the class action] On ...

The biotech sector, under the life sciences umbrella, exited 2023 with 41 bankruptcies. This was not surprising given the disparity between biotech’s high-capital requirements and rising interest rates set by the Fed. Despite these challenges, some of the best biotech stocks show promise and resilience in a volatile market environment.At the same time, smaller biotech deals became prevalent, accounting for $17 billion during 2023, per JP Morgan data. Another noticeable trend was the uptick in mergers and ac ...

- In Cohort 5 of PROPEL 2 (0.25 mg/kg/day), oral treatment with infigratinib resulted in a statistically significant and sustained increase in annualized height velocity (AHV), with a mean change from baseline of +2.51cm/yr at Month 12, and +2.50 cm/yr at Month 18 (p=0.0015) - At Month 18, there was a statistically significant improvement in body proportionality (p-value of 0.001). The mean upper to lower body segment ratio was 1.88 at Month 18, as compared to 2.02 at baseline - Infigratinib continues to b ...

- In Cohort 5 of PROPEL 2 (0.25 mg/kg/day), oral treatment with infigratinib resulted in a statistically significant and sustained increase in annualized height velocity (AHV), with a mean change from baseline of +2.51cm/yr at Month 12, and +2.50 cm/yr at Month 18 (p=0.0015) - At Month 18, there was a statistically significant improvement in body proportionality (p-value of 0.001). The mean upper to lower body segment ratio was 1.88 at Month 18, as compared to 2.02 at baseline - Infigratinib continues to b ...

PALO ALTO, Calif., June 03, 2024 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) (BridgeBio), a commercial-stage biopharmaceutical company focused on genetic diseases, today announced that members of its management team, along with Ravi Savarirayan, M.D., Ph.D., of Murdoch Children's Research Institute in Melbourne, Australia, and the global lead investigator for PROPEL 2, will host a call on June 4, 2024, at 8:00 am ET to share results from Month 12 and Month 18 from Cohort 5 of PROPEL 2, a Phase ...

PALO ALTO, Calif., June 03, 2024 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio), a commercial-stage biopharmaceutical company focused on genetic diseases, today announced that members of its management team, along with Ravi Savarirayan, M.D., Ph.D., of Murdoch Children’s Research Institute in Melbourne, Australia, and the global lead investigator for PROPEL 2, will host a call on June 4, 2024, at 8:00 am ET to share results from Month 12 and Month 18 from Cohort 5 of PROPEL 2, a Phase ...