BridgeBio Pharma, Inc. (BBIO)
US FDA approves BridgeBio's drug for rare heart condition
The U.S. Food and Drug Administration has approved BridgeBio's drug for a rare and deadly heart condition, the company said on Friday, making it the first new treatment in a market dominated by Pfizer's blockbuster Vyndaqel.
BridgeBio: 2 Weeks Until Major Drug Approval Catalyst - A Buy, With Caveats
BridgeBio Pharma, Inc.'s acoramidis is awaiting FDA's approval decision for transthyretin amyloidosis, with strong clinical data suggesting a likely approval and potential “blockbuster” status. The PDUFA date is 29th Nov. Despite past setbacks, including a Phase 3 failure, recent data shows significant improvements in survival rates and cardiovascular-related hospitalizations, bolstering the approval case. BridgeBio has secured substantial funding and partnerships, indicating confidence in acoramidis' market potential, but commercial success remains uncertain due to competition from Pfizer and Alnylam.
BridgeBio Pharma (BBIO) Reports Q3 Loss, Lags Revenue Estimates
BridgeBio Pharma (BBIO) came out with a quarterly loss of $0.86 per share versus the Zacks Consensus Estimate of a loss of $1.03. This compares to loss of $1.08 per share a year ago.
BridgeBio Pharma (BBIO) Expected to Beat Earnings Estimates: What to Know Ahead of Q3 Release
BridgeBio Pharma (BBIO) possesses the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.
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BridgeBio Pharma's Lead Candidate Cuts Mortality, Related Hospitalizations In Patients With Certain Type Of Heart Disease
On Friday, BridgeBio Pharma, Inc. BBIO presented a post-hoc analysis evaluating the effect of acoramidis on the composite endpoint of all-cause mortality (ACM) and recurrent cardiovascular-related hospitalizations (CVH) events in its Phase 3 ATTRibute-CM study in ATTR-CM.
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BridgeBio to stop development of therapy for genetic disorder
BridgeBio Pharma said on Tuesday it will stop development of its experimental therapy for a genetic disease that affects the adrenaline-producing gland.
BridgeBio: With HELIOS-B Overhang Removed, Focus To Turn To Approval And Launch Of Acoramidis
BridgeBio's stock is underperforming this year despite the progress the company made in recent quarters. HELIOS-B trial of Alnylam's Amvuttra (vutrisiran) was keeping investors away from BridgeBio, but the data presentation this week should lift this overhang on the stock. Investor focus should turn to the potential FDA approval and launch of acoramidis for the treatment of ATTR CM, followed by three late-stage clinical readouts in 2025.
BridgeBio: PDUFA Date Expected In November 2024 Could Shift Momentum
The FDA accepted BridgeBio Pharma, Inc.'s NDA regulatory submission of Acoramidis for the treatment of patients with ATTR-CM and set a PDUFA date of November 29th of 2024. Partnership established with Bayer to commercialize Acoramidis for the treatment of patients with ATTR-CM in European territories; Regulatory approval for Europe expected in 2025. The transthyretin amyloidosis treatment market size is expected to reach $11.2 billion by 2032.
BridgeBio Pharma's Acoramidis Leads Promising Pipeline With FDA Approval On Horizon
BridgeBio Pharma focuses on developing therapies for genetic diseases with a threefold approach to managing costs and timelines effectively. The company employs a threefold R&D strategy: streamlined discovery, decentralized teams, and efficient development processes. BBIO's pipeline includes late-stage drug candidates like Acoramidis for ATTR-CM and Phase 3 candidates for Achondroplasia, ADH1, and LGMD2I.
BridgeBio Pharma (BBIO) Reports Q2 Loss, Misses Revenue Estimates
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.
