$154.2 million in total fourth quarter revenues, net, and$502.1 million in full year revenues, net, primarily comprised of net product revenue of$146.0 million and$362.4 million , respectively- BridgeBio reported three positive Phase 3 trial readouts in just over three months, a demonstration of its unique model for sustainable drug development as described in a recent peer-reviewed manuscript
- Attruby continues to demonstrate clinical differentiation as a first-choice therapy in ATTR-CM with the greatest TTR stabilization on the market (=90%) and the most rapid benefit on clinical outcomes observed within 1 month, with 7,804 unique patient prescriptions written by 1,856 unique prescribers as of
February 20, 2026 - PROPEL 3 for oral infigratinib successfully met its primary endpoint (p<0.0001). The change from baseline in AHV was superior to placebo at Week 52, with a mean treatment difference against placebo of +2.10 cm/year; topline results showed the first statistically significant improvements in body proportionality in achondroplasia
- Positive interim Phase 3 FORTIFY results for BBP-418 in LGMD2I/R9 demonstrated a statistically significant and clinically meaningful 2.6-point NSAD improvement versus placebo at 12 months; FDA recommended pursuing traditional approval, supporting a planned 1H 2026 NDA submission and a
U.S. launch anticipated in late 2026/early 2027 - On track for a 1H 2026 NDA submission following positive Phase 3 CALIBRATE results for encaleret in ADH1 and successful completion of a pre-NDA meeting with FDA;
U.S. launch anticipated in late 2026/early 2027 $587.5 million in cash, cash equivalents, and marketable securities as ofDecember 31, 2025 ; additionally, the Company completed issuance of$632.5 million aggregate principal amount of 2033 convertible notes inJanuary 2026 , positioning it to fund planned commercial and pipeline operations
Pipeline Overview:
| Program | Status | Next expected milestone |
| Acoramidis for ATTR-CM | Approved in | New OLE data to be shared at ACC Scientific Sessions |
| BBP-418 for LGMD2I/R9 | FORTIFY, Phase 3 study positive interim analysis topline results released | Submit NDA to FDA in 1H 2026 |
| Encaleret for ADH1 | CALIBRATE, Phase 3 study positive topline results released | Submit NDA to FDA in 1H 2026 |
| Infigratinib for achondroplasia | PROPEL 3, Phase 3 study positive topline results released | Submit NDA to FDA in 2H 2026 |
| Encaleret for chronic hypoparathyroidism | Phase 2 proof-of-principle study and FDA End of Phase 2 interaction completed | Phase 3 study to be initiated in 2H 2026 |
| Infigratinib for hypochondroplasia | ACCEL 2/3, Phase 2 portion enrollment completed | Phase 2 data in 2H 2026 |
| Depleter for ATTR-CM | Development candidate nomination | Submit IND to the FDA in 2027 |
“As we close our first decade at BridgeBio, we’re reflecting on just how far we’ve come – from a bold idea about a new type of biotech rooted in a hub-and-spoke model to a company with incredible commercial strength and multiple late-stage successes. In a little over three months, we’ve delivered three successful Phase 3 readouts, a testament to the rigor of our science, the dedication of our teams, and the trust of the patients and physicians we serve. In all, we hope this leads to 6 approved products as our first decade draws to a close. I am excited not only to live up to our responsibilities against these assets but further to see if we can do even better,” said Co-Founder and CEO,
Corporate Updates:
- BridgeBio published its unique model for sustainable drug development in a peer-reviewed Drug Discovery Today manuscript, highlighting its ability to reduce asset-level risk, improve clinical success rates through genetic validation, and enhance capital efficiency to drive sustainable growth. This builds on the recent case studies at Harvard and
MIT and BridgeBio case study published in 2024 as a peer reviewed manuscript inJournal of Portfolio Management that elucidates the BridgeBio approach. - In
January 2026 , BridgeBio completed issuance of$632.5 million aggregate principal amount Convertible Senior Notes due 2033. This transaction is part of BridgeBio’s strategy to lower interest expense, reduce dilution, and significantly extend debt maturity. - With the reauthorization of the Rare Pediatric Review Voucher (PRV) program, BBP-418, BBP-812, and infigratinib, each of which has received Rare Pediatric Disease designation, may be eligible to receive PRV upon approval. A PRV may be used to shorten the FDA review timeline for a subsequent drug application from 10 months to 6 months or can be sold upon receipt to another company.
Commercial Updates:
As of
“2025 reflected strong commercial momentum for Attruby and an important step forward as we advance three additional medicines toward potential commercialization,” said
Pipeline Updates:
Attruby (acoramidis) – First and only near-complete (=90%) transthyretin (TTR) stabilizer for treatment of transthyretin amyloid cardiomyopathy (ATTR-CM):
- At the
American Heart Association (AHA) Scientific Sessions 2025, data from the ATTRibute-CM study showed that acoramidis significantly reduces all-cause mortality through Month 42 in the overall variant ATTR-CM population, and specifically in the p.Val142Ile (V142I, V122I) subpopulation. The V142I variant disproportionately affects individuals of Western African ancestry, with a carrier frequency of 3-4% in theU.S. Black population. These data were simultaneously published in JAMA Cardiology.1 - More data on Attruby will be shared at the
American College of Cardiology (ACC) AnnualScientific Sessions & Expo inMarch 2026 and in additional medical congresses throughout 2026.
________________
1 https://jamanetwork.com/journals/jamacardiology/fullarticle/2841140
BBP-418 – Glycosylation substrate for limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9):
- FORTIFY, the Phase 3 clinical trial of BBP-418, successfully achieved all primary and secondary endpoints of its interim analysis. The topline results can be found here.
- Based on the statistically significant and clinically meaningful interim analysis results, BridgeBio intends to submit an NDA to the FDA for traditional approval in the first half of 2026 with a
U.S. launch anticipated in late 2026/early 2027. Claudia Bujold, RN , MBA, joined the Company as Senior Vice President of Sales and Marketing to lead theU.S. commercial launch of BBP-418. Claudia brings more than 25 years of global commercialization experience and led the strategy and execution for multiple launches in both broad markets (Kisqali for early breast cancer) and rare conditions (Skyclarys for Friedreich’s Ataxia).- Based on the FORTIFY interim analysis results, BridgeBio is also engaging regulatory agencies to identify an expedited path to approval for BBP-418 in
Europe . - If successful, BBP-418 could be the first approved therapy for individuals living with LGMD2I/R9, potentially representing the first approval of a therapy for any form of LGMD.
- The Company intends to initiate clinical studies of BBP-418 in LGMD2I/R9 for individuals less than 12 years of age and in LGMD2M/2U in the near future.
Encaleret – Calcium-sensing receptor (CaSR) antagonist for autosomal dominant hypocalcemia type 1 (ADH1) and chronic hypoparathyroidism:
- CALIBRATE, the Phase 3 clinical trial of encaleret in ADH1, successfully achieved all pre-specified primary and key secondary efficacy endpoints. The topline results can be found here.
- BridgeBio has successfully completed a pre-NDA interaction and intends to submit an NDA to the FDA in the first half of 2026, and a Marketing Authorization Application (MAA) to the
European Medicines Agency (EMA) to follow. - The Company anticipates a
U.S. launch in late 2026/early 2027. If approved, encaleret would be the first therapy indicated specifically for individuals living with ADH1. Jeron Evans joined the Company as Senior Vice President of Sales and Marketing to lead theU.S. commercial launch of encaleret. Jeron brings more than 30 years of global commercialization experience across biopharma, medtech, and diagnostics.- Diagnosis of ADH1 in the
U.S. has accelerated with >1,700 unique patients claimed under the dedicated ICD-10 code (E20.810) during the 24-month period from October 2023-2025. - The Company initiated CALIBRATE-PEDS, a registrational Phase 2/3 study of encaleret in pediatric ADH1.
- The Company also plans to initiate RECLAIM-HP, a Phase 3 study of encaleret in chronic hypoparathyroidism in the second half of 2026.
Infigratinib – FGFR3 inhibitor:
- PROPEL 3, the Phase 3 clinical trial of infigratinib in achondroplasia, successfully achieved its pre-specified primary efficacy endpoint of change from baseline in absolute height velocity (AHV) at Week 52 (p<0.0001). In addition, infigratinib showed the first statistically significant improvement in body proportionality against placebo in achondroplasia in children 3 to younger than 8 years old in a pre-specified exploratory analysis. The topline results can be found here.
- Based on the statistically significant data, BridgeBio intends to submit an NDA to the FDA and a MAA to the EMA in the second half of 2026. If approved, the Company plans to launch in early to mid 2027.
Aaron McIlwain joined the Company as Senior Vice President, Sales and Marketing to lead theU.S. commercial launch of infigratinib for achondroplasia. Previously, Aaron was the global ATTR brand lead for Ionis Pharmaceuticals. He also brings over 20 years of commercial rare disease launch experience fromTurning Point Therapeutics , Gilead, andGenentech .- The Company also intends to accelerate the development of infigratinib for hypochondroplasia and is enrolling participants in the observational run-in study for the Phase 3 trial. The Phase 2 data is expected in the second half of 2026.
- If successful, infigratinib would be the first approved oral therapy option for children living with achondroplasia or with hypochondroplasia.
Financial Updates:
Cash,
Cash, cash equivalents and marketable securities totaled
Total Revenues, Net
| Three Months Ended | Years Ended | ||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||
| (in thousands) | |||||||||||
| Net product revenue | $ | 146,017 | $ | 2,884 | $ | 362,368 | $ | 2,884 | |||
| License and services revenue | 2,881 | 2,829 | 128,322 | 218,849 | |||||||
| Royalty revenue | 5,280 | 169 | 11,386 | 169 | |||||||
| Total revenues, net | $ | 154,178 | $ | 5,882 | $ | 502,076 | $ | 221,902 | |||
Total revenues, net for the three months ended
Total revenues, net for the year ended
Operating Costs and Expenses
| Three Months Ended | Years Ended | ||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||
| (in thousands) | |||||||||||
| Total cost of revenues | $ | 8,107 | $ | 2,084 | $ | 20,962 | $ | 3,878 | |||
| Research and development | 116,417 | 130,350 | 451,953 | 506,461 | |||||||
| Selling, general and administrative | 158,085 | 94,782 | 531,225 | 288,931 | |||||||
| Restructuring, impairment, and related charges | 11,131 | 4,693 | 21,347 | 15,605 | |||||||
| Total operating costs and expenses | $ | 293,740 | $ | 231,909 | $ | 1,025,487 | $ | 814,875 | |||
Operating costs and expenses for the three months ended
Operating costs and expenses for the year ended
Stock-based compensation expenses included in operating costs and expenses for the three months ended
Stock-based compensation expenses included in operating costs and expenses for the year ended
Total Other Income (Expense), Net
Total other income (expense), net for the three months and year ended
The change in total other income (expense), net of
The change in total other income (expense), net of
Net Loss Attributable to Common Stockholders of BridgeBio and Net Loss per Share
For the three months and year ended
For the three months and year ended
Condensed Consolidated Statements of Operations (in thousands, except shares and per share amounts) | |||||||||||||||
| Three Months Ended | Years Ended | ||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||
| (Unaudited) | (1) | (Unaudited) | (1) | ||||||||||||
| Revenues: | |||||||||||||||
| Net product revenue | $ | 146,017 | $ | 2,884 | $ | 362,368 | $ | 2,884 | |||||||
| License and services revenue | 2,881 | 2,829 | 128,322 | 218,849 | |||||||||||
| Royalty revenue | 5,280 | 169 | 11,386 | 169 | |||||||||||
| Total revenues, net | 154,178 | 5,882 | 502,076 | 221,902 | |||||||||||
| Operating costs and expenses: | |||||||||||||||
| Cost of revenues: | |||||||||||||||
| Cost of goods sold | 6,777 | 1,442 | 15,687 | 1,442 | |||||||||||
| Cost of license, services, and royalty revenue | 1,330 | 642 | 5,275 | 2,436 | |||||||||||
| Total cost of revenues | 8,107 | 2,084 | 20,962 | 3,878 | |||||||||||
| Research and development | 116,417 | 130,350 | 451,953 | 506,461 | |||||||||||
| Selling, general and administrative | 158,085 | 94,782 | 531,225 | 288,931 | |||||||||||
| Restructuring, impairment, and related charges | 11,131 | 4,693 | 21,347 | 15,605 | |||||||||||
| Total operating costs and expenses | 293,740 | 231,909 | 1,025,487 | 814,875 | |||||||||||
| Loss from operations | (139,562 | ) | (226,027 | ) | (523,411 | ) | (592,973 | ) | |||||||
| Other income (expense), net: | |||||||||||||||
| Interest income | 4,332 | 4,683 | 19,854 | 17,249 | |||||||||||
| Interest expense | (11,636 | ) | (21,522 | ) | (53,103 | ) | (90,991 | ) | |||||||
| Noncash interest expense on deferred royalty obligations (2) | (38,678 | ) | (8,299 | ) | (125,138 | ) | (8,299 | ) | |||||||
| Gain on deconsolidation of subsidiaries | — | — | — | 178,321 | |||||||||||
| Loss on extinguishments of debt | — | — | (21,155 | ) | (26,590 | ) | |||||||||
| Net loss from equity method investments | (21,029 | ) | (16,695 | ) | (72,608 | ) | (31,183 | ) | |||||||
| Other income, net | 11,818 | 1,624 | 43,058 | 12,272 | |||||||||||
| Total other income (expense), net | (55,193 | ) | (40,209 | ) | (209,092 | ) | 50,779 | ||||||||
| Loss before income taxes | (194,755 | ) | (266,236 | ) | (732,503 | ) | (542,194 | ) | |||||||
| Provision for (benefit from) income taxes | (120 | ) | 1,153 | 435 | 1,153 | ||||||||||
| Net loss | (194,635 | ) | (267,389 | ) | (732,938 | ) | (543,347 | ) | |||||||
| Net loss attributable to redeemable convertible noncontrolling interests and noncontrolling interests | 1,772 | 2,339 | 8,007 | 7,585 | |||||||||||
| Net loss attributable to common stockholders of BridgeBio | $ | (192,863 | ) | $ | (265,050 | ) | $ | (724,931 | ) | $ | (535,762 | ) | |||
| Net loss per share attributable to common stockholders of BridgeBio, basic and diluted | $ | (1.00 | ) | $ | (1.40 | ) | $ | (3.78 | ) | $ | (2.88 | ) | |||
| Weighted-average shares used in computing net loss per share attributable to common stockholders of BridgeBio, basic and diluted | 193,552,280 | 189,437,438 | 191,527,482 | 186,075,873 | |||||||||||
(1) The condensed consolidated financial statements as of and for the year ended
(2) Including related party amounts of
| Three Months Ended | Years Ended | ||||||||||
| Stock-based Compensation | 2025 | 2024 | 2025 | 2024 | |||||||
| (Unaudited) | (1) | (Unaudited) | (1) | ||||||||
| Cost of goods sold | $ | 687 | $ | — | $ | 1,265 | $ | — | |||
| Research and development | 11,685 | 20,004 | 49,267 | 49,844 | |||||||
| Selling, general and administrative | 21,579 | 16,351 | 84,656 | 63,862 | |||||||
| Restructuring, impairment and related charges | 939 | 79 | 1,694 | 160 | |||||||
| Total stock-based compensation | $ | 34,890 | $ | 36,434 | $ | 136,882 | $ | 113,866 | |||
(1) The condensed consolidated financial statements as of and for the year ended
Condensed Consolidated Balance Sheets (In thousands) | |||||||
2025 | 2024 | ||||||
| (Unaudited) | (1) | ||||||
| Assets | |||||||
| Cash, cash equivalents and marketable securities | $ | 587,482 | $ | 681,101 | |||
| Accounts receivable, net | 139,444 | 4,722 | |||||
| Inventories | 26,753 | — | |||||
| Prepaid expenses and other current assets | 44,070 | 34,869 | |||||
| Equity method investments | 79,972 | 143,747 | |||||
| Property and equipment, net | 5,366 | 7,011 | |||||
| Operating lease right-of-use assets | 8,149 | 5,767 | |||||
| Intangible assets, net | 28,077 | 23,926 | |||||
| Other assets | 16,712 | 18,195 | |||||
| Total assets | $ | 936,025 | $ | 919,338 | |||
| Liabilities, Redeemable Convertible Noncontrolling Interests and Stockholders' Deficit | |||||||
| Accounts payable | $ | 36,228 | $ | 9,618 | |||
| Accrued and other current liabilities (2) | 238,361 | 125,672 | |||||
| Operating lease liabilities | 10,003 | 9,202 | |||||
| Deferred revenue | 20,270 | 31,699 | |||||
| 2031 Notes, net | 564,565 | — | |||||
| 2029 Notes, net | 740,890 | 738,872 | |||||
| 2027 Notes, net | 547,015 | 545,173 | |||||
| Term loan, net | — | 437,337 | |||||
| Deferred royalty obligations, net (3) | 855,030 | 479,091 | |||||
| Other long-term liabilities | 244 | 286 | |||||
| Redeemable convertible noncontrolling interests | (570 | ) | 142 | ||||
| Total BridgeBio stockholders' deficit | (2,086,610 | ) | (1,467,904 | ) | |||
| Noncontrolling interests | 10,599 | 10,150 | |||||
| Total liabilities, redeemable convertible noncontrolling interests and stockholders' deficit | $ | 936,025 | $ | 919,338 | |||
(1) The condensed consolidated financial statements as of and for the year ended
(2) Including a related party amount of
(3) Including a related party amount of
Condensed Consolidated Statements of Cash Flows (In thousands) | |||||||
| Years Ended | |||||||
| 2025 | 2024 | ||||||
| (Unaudited) | (1) | ||||||
| Operating activities: | |||||||
| Net loss | $ | (732,938 | ) | $ | (543,347 | ) | |
| Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
| Stock-based compensation | 133,024 | 95,800 | |||||
| Loss on extinguishments of debt | 21,155 | 26,590 | |||||
| Noncash interest expense on deferred royalty obligations (2) | 125,138 | 8,299 | |||||
| Amortization of debt discount and issuance costs | 5,967 | 7,464 | |||||
| Depreciation and amortization | 5,434 | 6,075 | |||||
| Noncash lease expense | 4,902 | 4,110 | |||||
| Net loss from equity method investments | 72,608 | 31,183 | |||||
| Change in fair value of the embedded derivative associated with the deferred royalty obligation | (19,652 | ) | (1,550 | ) | |||
| Noncash income from equity method investments | (8,833 | ) | — | ||||
| Gain on deconsolidation of subsidiaries | — | (178,321 | ) | ||||
| Gain from investment in equity securities, net | — | (8,136 | ) | ||||
| Other noncash adjustments, net | (1,651 | ) | (935 | ) | |||
| Changes in operating assets and liabilities: | |||||||
| Accounts receivable, net | (134,722 | ) | (2,971 | ) | |||
| Inventories | (25,307 | ) | — | ||||
| Prepaid expenses and other current assets | (8,777 | ) | (13,918 | ) | |||
| Other assets | 1,113 | 1,542 | |||||
| Accounts payable | 26,609 | 1,512 | |||||
| Accrued compensation and benefits | 23,022 | 16,986 | |||||
| Accrued research and development liabilities | 7,163 | 8,729 | |||||
| Operating lease liabilities | (6,547 | ) | (5,902 | ) | |||
| Deferred revenue | (11,428 | ) | 21,875 | ||||
| Other liabilities (3) | 77,810 | 4,189 | |||||
| Net cash used in operating activities | (445,910 | ) | (520,726 | ) | |||
| Investing activities: | |||||||
| Purchases of marketable securities | (28,197 | ) | (93,811 | ) | |||
| Maturities of marketable securities | 11,000 | 95,000 | |||||
| Purchases of investments in equity securities | — | (20,271 | ) | ||||
| Proceeds from sales of investments in equity securities | — | 63,229 | |||||
| Proceeds from special cash dividends received from an investment in equity securities | 2,302 | 25,682 | |||||
| Payment for intangible assets | (8,495 | ) | (7,975 | ) | |||
| Purchases of property and equipment | (1,097 | ) | (933 | ) | |||
| Decrease in cash and cash equivalents resulting from deconsolidation of subsidiaries | — | (140 | ) | ||||
| Net cash provided by (used in) investing activities | (24,487 | ) | 60,781 | ||||
| Financing activities: | |||||||
| Proceeds from issuance of 2031 Notes | 575,000 | — | |||||
| Issuance costs and discounts associated with 2031 Notes | (12,034 | ) | — | ||||
| Repurchase of common stock | (48,276 | ) | — | ||||
| Proceeds from a royalty obligation under the Royalty Purchase Agreement | 300,000 | — | |||||
| Issuance costs associated with a royalty obligation under the Royalty Purchase Agreement | (3,010 | ) | — | ||||
| Proceeds from royalty obligation under Funding Agreement | — | 500,000 | |||||
| Issuance costs and discounts associated with royalty obligation under Funding Agreement | — | (27,513 | ) | ||||
| Proceeds from term loan under the Amended Financing Agreement | — | 450,000 | |||||
| Issuance costs and discounts associated with term loan under the Amended Financing Agreement | — | (15,986 | ) | ||||
| Repayment of term loans | (459,000 | ) | (473,417 | ) | |||
| Repayments of deferred royalty obligations (4) | (15,460 | ) | — | ||||
| Proceeds from issuance of common stock through public offerings, net | — | 314,741 | |||||
| Proceeds from common stock issuances under ESPP | 6,414 | 4,502 | |||||
| Proceeds from stock option exercises, net of repurchases | 27,735 | 3,656 | |||||
| Transactions with noncontrolling interests | 2,150 | — | |||||
| Repurchase of RSU shares to satisfy tax withholding | (14,226 | ) | (7,526 | ) | |||
| Net cash provided by financing activities | 359,293 | 748,457 | |||||
| Net increase (decrease) in cash, cash equivalents, and restricted cash | (111,104 | ) | 288,512 | ||||
| Cash, cash equivalents, and restricted cash at beginning of year | 683,244 | 394,732 | |||||
| Cash, cash equivalents, and restricted cash at end of year | $ | 572,140 | $ | 683,244 | |||
(1) The condensed consolidated financial statements as of and for the year ended
(2) Including a related party amount of
(3) Including a related party amount of
(4) Including a related party amount of
| Years Ended | |||||||
| 2025 | 2024 | ||||||
| (Unaudited) | (1) | ||||||
| Supplemental Disclosure of Cash Flow Information: | |||||||
| Cash paid for interest | $ | 43,670 | $ | 91,342 | |||
| Cash paid for income taxes | $ | 1,198 | $ | — | |||
| Supplemental Disclosures of Noncash Investing and Financing Information: | |||||||
| Unpaid property and equipment | $ | 43 | $ | 279 | |||
| Transfers to noncontrolling interests | $ | (5,594 | ) | $ | (5,819 | ) | |
| Reconciliation of Cash, Cash Equivalents and Restricted Cash: | |||||||
| Cash and cash equivalents | $ | 570,119 | $ | 681,101 | |||
| Restricted cash — Included in “Prepaid expenses and other current assets” | 550 | 126 | |||||
| Restricted cash — Included in “Other assets” | 1,471 | 2,017 | |||||
| Total cash, cash equivalents and restricted cash at end of years shown in the consolidated statements of cash flows | $ | 572,140 | $ | 683,244 | |||
(1) The condensed consolidated financial statements as of and for the year ended
Webcast Information
BridgeBio will host a conference call and webcast to discuss fourth quarter and full year 2025 financial results today,
About Attruby® (acoramidis)
INDICATION
Attruby is a transthyretin stabilizer indicated for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular death and cardiovascular-related hospitalization.
IMPORTANT SAFETY INFORMATION
Adverse Reactions
Diarrhea (11.6% vs 7.6%) and upper abdominal pain (5.5% vs 1.4%) were reported in patients treated with Attruby versus placebo, respectively. The majority of these adverse reactions were mild and resolved without drug discontinuation. Discontinuation rates due to adverse events were similar between patients treated with Attruby versus placebo (9.3% and 8.5%, respectively).
About
BridgeBio exists to develop transformative medicines for genetic conditions. Millions of people worldwide living with genetic conditions lack treatment options, often because drug development for small patient populations can be commercially challenging. We aim to bridge the gap between advancements in genetic science and meaningful medicines for underserved patient populations. Our decentralized, hub-and-spoke model is designed for speed, precision, and scalability. Autonomous and empowered teams focus on individual conditions, while a central hub provides the clinical, regulatory, and commercial capabilities needed to bring innovation to market. For more information, visit bridgebio.com and follow us on LinkedIn, X, Facebook, Instagram, YouTube, and TikTok.
This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “estimates,” “expects,” “hopes,” “intends,” “may,” “plans,” “projects,” “remains,” “seeks,” “should,” “will,” and variations of such words or similar expressions. BridgeBio intends these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements, including express and implied statements relating to the Company’s expectations regarding timing of regulatory submissions, approvals and launches, including for BBP-418 in LGMD2I/R9, encaleret in ADH1, infigratinib in achondroplasia; the timing of the Company’s clinical trials and milestones for its various programs, including RECLAIM-HP; the eligibility of BBP-418, BBP-812 and infigratinib under the Rare Pediatric Priority Review Voucher (PRV) program and related FDA review timeline; and the Company’s anticipated funding to finance its operations. Such statements reflect the Company’s current views about the Company’s plans, intentions, expectations and strategies, which are based on the information currently available to it and on assumptions the Company has made. Although the Company believes that its plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, the Company can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, initial and ongoing data from the Company’s preclinical studies and clinical trials not being indicative of final data, the potential size of the target patient populations the Company’s product candidates are designed to treat not being as large as anticipated, the design and success of ongoing and planned clinical trials, future regulatory filings, approvals and/or sales, despite having ongoing and future interactions with the FDA or other regulatory agencies to discuss potential paths to registration for the Company’s product candidates, the FDA or such other regulatory agencies not agreeing with the Company’s regulatory approval strategies, components of the Company’s filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted, the continuing success of the Company’s collaborations, the Company’s ability to obtain additional funding, including through less dilutive sources of capital than equity financings, potential volatility in the Company’s share price, the impacts of current macroeconomic and geopolitical events, including changing conditions from hostilities in
BridgeBio Media Contact:
contact@bridgebio.com
(650)-789-8220
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