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BridgeBio Pharma's Acoramidis Leads Promising Pipeline With FDA Approval On Horizon
Seeking Alpha· 2024-08-17 06:57
byakkaya BridgeBio Pharma Inc. (NASDAQ:BBIO) is a biopharmaceutical company that focuses on developing innovative therapies for genetic diseases. The company’s research and development platform uses a threefold approach to managing costs and timelines effectively: streamlined discovery, decentralized teams, and efficient development processes. BBIO’s pipeline includes late-stage drug candidates like Acoramidis for transthyretin amyloid cardiomyopathy (ATTR-CM). The company also has other Phase 3 drug ca ...
BridgeBio(BBIO) - 2024 Q2 - Quarterly Report
2024-08-01 20:24
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, par value $0.001 per share BBIO The Nasdaq Global Select Market FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from t ...
BridgeBio Pharma (BBIO) Reports Q2 Loss, Misses Revenue Estimates
ZACKS· 2024-08-01 13:40
BridgeBio Pharma (BBIO) came out with a quarterly loss of $1.02 per share versus the Zacks Consensus Estimate of a loss of $1.09. This compares to loss of $0.98 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 6.42%. A quarter ago, it was expected that this rare disease drug developer would post a loss of $0.40 per share when it actually produced a loss of $0.05, delivering a surprise of 87.50%.Over the last four quarters, the ...
BridgeBio(BBIO) - 2024 Q2 - Quarterly Results
2024-08-01 11:31
Exhibit 99.1 BridgeBio Pharma Reports Second Quarter 2024 Financial Results and Business Update - Acoramidis demonstrated a significant impact on mortality, hospitalizations, and quality of life - Starting at Month 3, patients taking acoramidis showed meaningful and sustained improvement in time to first event (CVH or ACM) - Acoramidis demonstrated a 42% reduction in composite CVH and ACM events relative to placebo by Month 30 - Increased serum TTR levels by Day 28 were correlated with a reduced risk of eve ...
BridgeBio Pharma Reports Second Quarter 2024 Financial Results and Business Update
Newsfilter· 2024-08-01 11:30
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]
BridgeBio Announces Appointment of Thomas Trimarchi, Ph.D., as President and Chief Operating Officer
Newsfilter· 2024-07-23 11:30
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 Pharma Surpasses Interim Analysis Enrollment Target and Receives U.S. FDA Rare Pediatric Disease Designation for BBP-418, a Potential Treatment for Limb-girdle Muscular Dystrophy Type 2I/R9 (LGMD2I/R9)
Newsfilter· 2024-06-18 11:30
- 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 ...
SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of BridgeBio Pharma, Inc. - BBIO
GlobeNewswire News Room· 2024-06-13 18:38
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 ...
SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of BridgeBio Pharma, Inc. - BBIO
GlobeNewswire News Room· 2024-06-05 18:08
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 3 Best Biotech Stocks to Buy in June 2024
Investor Place· 2024-06-05 17:35
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 ...