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BridgeBio Pharma, Inc. (Nasdaq: BBIO) is a pioneering commercial-stage biopharmaceutical company that specializes in the discovery, creation, and delivery of transformative medicines for patients suffering from genetic diseases and cancers with clear genetic drivers. Established in 2015, the company is headquartered in Palo Alto, California. BridgeBio's mission is to address significant unmet medical needs through genetic medicine by leveraging a comprehensive pipeline of development programs that span from early-stage scientific research to late-stage clinical trials.
The company's core focus areas include Mendelian diseases, Genetic Dermatology, Oncology, and Gene Therapy. BridgeBio’s innovative approach involves systematically mapping the genetic disease landscape to identify promising therapeutic assets. Their proprietary platform and management expertise are harnessed to accelerate the development of these early-stage assets into clinically impactful treatments.
BridgeBio’s robust pipeline boasts several notable programs:
- Acoramidis (AG10): Aiming to treat transthyretin amyloid cardiomyopathy (ATTR-CM), this next-generation, orally-administered TTR stabilizer has shown positive results in the Phase 3 ATTRibute-CM trial. The New Drug Application (NDA) for acoramidis has been accepted by the FDA, with a target decision date set for November 29, 2024.
- Infigratinib: Targeting achondroplasia and hypochondroplasia, this FGFR1-3 inhibitor aims to address skeletal dysplasias. The PROPEL 2 Phase 2 trial has demonstrated significant and sustained increases in growth velocity.
- BBP-418: Designed for limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9), this glycosylation substrate is under Phase 3 trials, with the potential for accelerated approval based on recent interactions with the FDA.
BridgeBio's track record includes successful capital raises, strategic partnerships, and a series of public offerings that have strengthened its financial positioning. The company recently completed a $200 million private financing for its oncology subsidiary, BridgeBio Oncology Therapeutics, to accelerate the development of its precision oncology pipeline.
Key recent developments include:
- The initiation of a comprehensive equity grants program to attract top talent in the biopharmaceutical industry.
- Positive results from multiple clinical trials, including significant improvements in health-related quality of life measures for patients with ATTR-CM treated with acoramidis.
- Ongoing collaborations with global pharmaceutical leaders like Bayer for the commercial development and distribution of key assets in international markets.
BridgeBio remains committed to advancing genetic medicine and delivering groundbreaking therapies to improve patient lives. For more information, visit bridgebio.com and follow them on LinkedIn and Twitter.
BridgeBio Pharma (Nasdaq: BBIO), a commercial-stage biopharmaceutical company focusing on genetic diseases, has announced the approval of equity grants for 17 new employees. The grants, approved by the compensation committee on August 6, 2024, consist of restricted stock units totaling 71,859 shares of the company's common stock. The vesting schedule includes one-fourth of the shares vesting on August 16, 2025, followed by quarterly vesting of one-twelfth of the remaining shares, subject to continued employment. These grants were made under BridgeBio's Amended and Restated 2019 Inducement Equity Plan, in accordance with Nasdaq Listing Rule 5635(c)(4), as inducements for the new employees joining the company.
BridgeBio Pharma reported its Q2 2024 financial results, focusing on significant clinical trial progress and financial updates. Acoramidis demonstrated a 42% reduction in composite CVH and ACM events by Month 30, with improvements starting by Month 3. Infigratinib showed +2.50 cm/yr annualized height velocity at Month 18 in Cohort 5 of the PROPEL 2 study. The company exceeded its enrollment target for the Phase 3 FORTIFY study of BBP-418 in LGMD2I/R9. Financially, BridgeBio ended the quarter with $587M in cash, driven by various financing activities. Revenue for the quarter was $2.2M, up from $1.6M in the same period last year, primarily due to collaborations with Bayer and Kyowa Kirin. Operating costs increased to $177.7M, leading to a net loss per share of $0.39, an improvement from $0.98 in Q2 2023.
BridgeBio Pharma (Nasdaq: BBIO) has appointed Thomas Trimarchi, Ph.D., as President and Chief Operating Officer (COO), effective immediately. In this newly created role, Dr. Trimarchi will drive operational excellence, strategic planning, and overall business success, reporting directly to CEO Neil Kumar, Ph.D. He will lead cross-functional activities to develop a centralized operation across the late-stage pipeline, focusing on efficiency, rigor, and scale.
Dr. Trimarchi, who joined BridgeBio in 2018, previously served as Chief Product Officer and is a board member of ML Bio Solutions, a BridgeBio affiliate. His prior experience includes roles at Regeneron Pharmaceuticals and Goldman Sachs. CEO Kumar praised Trimarchi's patient-first approach and data-driven decision-making, expressing excitement about the continued growth and impact on patients under his leadership.
BridgeBio Pharma (Nasdaq: BBIO), a biopharmaceutical company specializing in genetic diseases, announced that on July 2, 2024, its compensation committee approved equity grants to 25 new employees. These grants, totaling 123,070 restricted stock units, are part of the Amended and Restated 2019 Inducement Equity Plan.
Each employee will see one-fourth of their restricted stock units vest on August 16, 2025. The remaining shares will vest quarterly thereafter, contingent upon continuous employment with BridgeBio or its subsidiaries. These grants were made as an inducement for employment under Nasdaq Listing Rule 5635(c)(4).
BridgeBio Pharma has exceeded its targeted enrollment for the interim analysis in its Phase 3 FORTIFY study of BBP-418, aimed at treating LGMD2I/R9. The company expects top-line results in 2025. The study is randomized, double-blind, and placebo-controlled, evaluating the safety and efficacy of BBP-418. The study includes an interim analysis at 12 months, focusing on glycosylated αDG levels, which may be used as a surrogate endpoint for accelerated approval.
Recent FDA interactions affirm the potential for accelerated approval based on these surrogate endpoints. Additionally, the FDA has granted Rare Pediatric Disease Designation for BBP-418, which could qualify BridgeBio for a Priority Review Voucher if BBP-418 is approved. This designation highlights the seriousness of LGMD2I/R9, a disease primarily affecting children. The study continues to enroll participants in the U.S., UK, Europe, and Australia.
On June 6, 2024, BridgeBio Pharma announced that its board's compensation committee approved equity grants to 18 new employees. These grants consist of restricted stock units totaling 90,591 shares of common stock. Under the vesting schedule, one-fourth of the shares will vest on May 16, 2025, with the remaining shares vesting quarterly over the subsequent three years, contingent on continued employment. The grants were made under BridgeBio’s Amended and Restated 2019 Inducement Equity Plan as part of an inducement to join the company, following Nasdaq Listing Rule 5635(c)(4).
BridgeBio Pharma (Nasdaq: BBIO), a commercial-stage biopharmaceutical company, will participate in the 45th Annual Goldman Sachs Global Healthcare Conference. Founder and CEO Neil Kumar, Ph.D., is scheduled to present on June 12 at 3:20 pm EDT in Miami, FL. The presentation will be available via live webcast on the Investor section of BridgeBio's website, with a replay accessible for 90 days thereafter.
BridgeBio announced promising results from the Phase 2 PROPEL 2 trial of infigratinib for achondroplasia. At 12 and 18 months, Cohort 5 participants showed a statistically significant and sustained increase in annualized height velocity (AHV) of +2.51 cm/year and +2.50 cm/year, respectively (p=0.0015). Additionally, there was a significant improvement in body proportionality, with the mean upper to lower body segment ratio improving from 2.02 at baseline to 1.88 at Month 18 (p=0.001). Infigratinib was well-tolerated with no treatment-related adverse events reported. BridgeBio also initiated the ACCEL study for infigratinib in hypochondroplasia, starting with the first participant's consent in May 2024. The company intends to continue enrolling for the global Phase 3 PROPEL 3 study, expecting completion by end of 2024.
BridgeBio Pharma (Nasdaq: BBIO) will host a call on June 4, 2024, at 8:00 am ET to present results from Month 12 and Month 18 of Cohort 5 in the Phase 2 PROPEL 2 trial. This trial evaluates the efficacy of the investigational oral therapy infigratinib in children with achondroplasia. Dr. Ravi Savarirayan from Murdoch Children’s Research Institute in Melbourne will join the call. The live webcast can be accessed via the 'Events' page in the Investors section of BridgeBio's website, with a replay available for 90 days post-event.
BridgeBio Pharma announced positive results from its Phase 3 ATTRibute-CM study regarding acoramidis treatment for ATTR-CM. The study noted significant increases in serum transthyretin (TTR) levels by Day 28, sustained through Month 30. These increases correlated with reduced all-cause mortality (ACM), cardiovascular mortality (CVM), and cardiovascular-related hospitalization (CVH). Notable improvements were also observed in the composite endpoint of CVM and CVH, with benefits evident as early as Month 3. The company shared plans for the ACT-EARLY trial to prevent ATTR amyloidosis and announced an upcoming investor call on May 29, 2024, to discuss these results.
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