STOCK TITAN
  1. Home
  2. Sec-filings
  3. BBIO
  4. [8-K] BridgeBio Pharma, Inc. Reports Material Event

BridgeBio (NASDAQ: BBIO) to widen Medicaid access with support that can cut eligible patients’ drug bills to $0

Filing Impact
(High)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

BridgeBio Pharma, Inc. (BBIO) announced a voluntary agreement with the U.S. government intended to expand access to its medicines and lower costs for American patients, particularly those with rare genetic diseases. As part of the agreement, BridgeBio plans to expand state Medicaid access to its currently marketed medicine via the GENEROUS Model, building on existing patient support programs such as ForgingBridges®, which can reduce qualifying patients’ out-of-pocket costs to as little as $0 per month.

BridgeBio states that it does not expect to be subject to future pricing mandates and that its pricing commitment for future medicines is expected to exclude products approved exclusively for orphan indications. The agreement does not affect coverage of Attruby through Medicare Part D or the ForgingBridges copay assistance program. The company also highlights three additional medicines under FDA review for rare genetic conditions, with priority review PDUFA dates in late 2026 and 2027.

Positive

  • None.

Negative

  • None.

Filing Explained

BridgeBio entered the agreement, but confidential terms leave its financial and completed-access effects unquantified as of August 31, 2026.

As of August 31, 2026, BridgeBio reports that it has entered a voluntary agreement with the U.S. government. The disclosed structural consequence is prospective change to medicine-access and pricing arrangements, while the filing does not establish a completed or quantified operating effect.

The company says the agreement’s specific terms remain confidential and describes its implementation, scope, and effects as forward-looking. Thus, the filing establishes the agreement’s existence, but not the amount, timing, or final commercial effect of the associated commitments.

The principal watch item is later disclosure of the agreement’s terms or implementation, because the company warns that it could be implemented, interpreted, or applied differently from its current expectations.

Item 8.01 Other Events Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, or exhibit attachments filed with this report.
PDUFA date for BBP-418 (LGMD2I/R9) November 27, 2026 Priority Review PDUFA date for BBP-418 for limb-girdle muscular dystrophy type 2I/R9
PDUFA date for encaleret (ADH1) May 7, 2027 Priority Review PDUFA date for encaleret for autosomal dominant hypocalcemia type 1
Diarrhea incidence with Attruby 11.6% Adverse reaction rate in patients treated with Attruby
Diarrhea incidence with placebo 7.6% Adverse reaction rate in patients receiving placebo
Upper abdominal pain with Attruby 5.5% Adverse reaction rate in patients treated with Attruby
Upper abdominal pain with placebo 1.4% Adverse reaction rate in patients receiving placebo
Attruby discontinuation due to adverse events 9.3% Discontinuation rate for patients treated with Attruby
Placebo discontinuation due to adverse events 8.5% Discontinuation rate for patients receiving placebo
GENEROUS Model financial
"expand state Medicaid access to its currently marketed medicine via the GENEROUS Model"
PDUFA date regulatory
"BBP-418 for limb-girdle muscular dystrophy type 2I/R9 (PDUFA date with Priority Review: November 27, 2026)"
PDUFA date is the deadline the U.S. Food and Drug Administration sets to complete its review of a drug or biologic application and decide whether to approve it. Investors watch it like a court verdict date: the decision can unlock sales and growth if approved or sharply reduce expected value if denied, so markets often move significantly as the date approaches or when the outcome is announced.
transthyretin-mediated amyloidosis medical
"treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM)"
A progressive disease in which a normally helpful blood protein called transthyretin misfolds and forms sticky clumps (amyloid) that build up in organs, most often the heart and peripheral nerves, impairing their function. It matters to investors because treatments that slow, stop, or reverse those deposits can command significant pricing and long-term demand, so clinical trial results, regulatory decisions, or new competitor drugs can quickly change the commercial outlook—think of it like fixing a widespread plumbing clog that restores flow to critical systems.
orphan indications regulatory
"exclude medicines approved exclusively for orphan indications"
Treating an "orphan indication" means developing a medicine or medical device for a rare disease that affects a very small number of people. Investors care because regulators often offer incentives—such as faster reviews, fee breaks, or market protections—making the opportunity like a specialized niche product: smaller patient pools but often higher prices, less competition, and distinct regulatory and commercial risks that can sharply affect returns.
autosomal dominant hypocalcemia type 1 medical
"encaleret for autosomal dominant hypocalcemia type 1, or ADH1"
A genetic disorder in which a commonly used calcium sensor in the body is overactive, causing chronically low blood calcium levels and symptoms like muscle cramps, tingling or fatigue. Because it is inherited in a dominant pattern, one altered copy of the gene can cause the condition. Investors should care because this straightforward biological cause creates a defined patient group for diagnostics, long‑term treatments, or drugs that modulate the calcium sensor, affecting market size and regulatory planning.
Priority Review regulatory
"BBP-418 for limb-girdle muscular dystrophy type 2I/R9 (PDUFA date with Priority Review: November 27, 2026)"
Priority review is a regulatory fast-track that shortens the time an agency spends evaluating a drug, vaccine or medical device application so a decision comes sooner than normal. For investors, it matters because a faster review is like an express lane to market: it can speed revenue potential and reduce regulatory uncertainty, but it does not guarantee approval and still requires the product to meet safety and effectiveness standards.

FAQ

What agreement did BridgeBio Pharma (BBIO) enter into with the U.S. government?
BridgeBio entered into a voluntary agreement with the U.S. government to expand access to its medicines and lower costs for American patients, particularly those with rare genetic diseases, while aiming to sustain innovation and investment in this therapeutic area.

How will the BridgeBio (BBIO) agreement affect Medicaid patients?
Under the agreement, BridgeBio will expand state Medicaid access to its currently marketed medicine via the GENEROUS Model, building on its existing patient access work to improve availability and affordability for Medicaid patients.

Does BridgeBio (BBIO) expect future drug pricing mandates under this agreement?
BridgeBio states that it does not expect to be subject to future pricing mandates under the agreement with the U.S. government, while noting that the specific terms of the agreement remain confidential.

Are orphan-only medicines included in BridgeBio’s pricing commitments?
BridgeBio expects its pricing commitment for future medicines under the agreement to exclude medicines approved exclusively for orphan indications, meaning those products are expected to fall outside the agreement’s pricing scope.

What is the impact of the agreement on Attruby and the ForgingBridges program?
BridgeBio states that the agreement has no impact on ForgingBridges®, which can reduce out-of-pocket costs to as little as $0 per month for qualifying patients, and that it will continue to offer Attruby via Medicare Part D without future pricing mandates.

Which BridgeBio (BBIO) drugs are currently under FDA review and what are their PDUFA dates?
Three medicines are under FDA review: BBP-418 for LGMD2I/R9 with a PDUFA date of November 27, 2026; encaleret for ADH1 with a PDUFA date of May 7, 2027; and infigratinib for achondroplasia.

What adverse reactions were reported for Attruby in clinical data cited by BridgeBio (BBIO)?
For Attruby, diarrhea was reported in 11.6% of patients versus 7.6% with placebo, and upper abdominal pain in 5.5% versus 1.4% with placebo. Discontinuation rates due to adverse events were 9.3% for Attruby and 8.5% for placebo.

AI-generated analysis. How Rhea-AI works. Not financial advice.

Understanding 8-K Material Events →
See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google
Add on Google
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549


FORM 8-K


CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
 
Date of Report (Date of earliest event reported): August 31, 2026 (August 31, 2026)


BridgeBio Pharma, Inc.
(Exact name of registrant as specified in its charter)

 
Delaware
001-38959
84-1850815
(State or other jurisdiction of incorporation)
(Commission File Number)
(IRS Employer Identification No.)

421 Kipling Street
Palo Alto, CA
  
94301
(Address of principal executive offices)
  
(Zip Code)
 
(650) 391-9740
(Registrant’s telephone number, including area code)
 
Not Applicable
(Former name or former address, if changed since last report)


Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

  ☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class
  
Trading
Symbol(s)
  
Name of each exchange
on which registered
Common stock
  
BBIO
  
The Nasdaq Global Select Market
 
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
 
Emerging growth company ☐
 
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 8.01.
Other Events.
 
On August 31, 2026, BridgeBio Pharma, Inc. (the “Company”) issued a press release titled, “BridgeBio Announces Agreement with U.S. Government to Improve Affordability and Access to Critical Medicines for Americans.” A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
 
The Company expects its pricing commitment for its future medicines under its agreement with the U.S. government to exclude medicines approved exclusively for orphan indications.
 
Forward-Looking Statements

This Current Report on Form 8-K and certain of the materials filed herewith contain forward-looking statements. Such statements 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. The Company 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 include statements regarding the anticipated implementation, scope and effects of the Company’s agreement with the U.S. government, including the Company’s plans to expand Medicaid access to AttrubyTM through the GENEROUS Model; the Company’s expectation that it will not be subject to future pricing mandates; the Company’s expectations regarding the scope of the pricing commitments under its agreement with the U.S. government; and the anticipated impact of the agreement on patient access, affordability and the Company’s ability to continue developing and providing medicines for rare genetic diseases.

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, the risk that the agreement may be implemented, interpreted or applied differently than the Company currently expects; that federal or state laws, regulations, policies, reimbursement frameworks or government pricing programs may change or be implemented in a manner that adversely affects the Company or its products; that the Company may become subject to additional pricing mandates, requirements or restrictions notwithstanding its current expectations; that the scope or application of the Company’s pricing commitments, including the exclusion for medicines approved exclusively for orphan indications, may differ from the Company’s current expectations; that the agreement may not result in the anticipated improvements in access, affordability or other expected benefits; that the agreement or future changes in government pricing or reimbursement policies may adversely affect the Company’s business, results of operations or ability to continue investing in the development and commercialization of medicines for rare genetic diseases; the impacts of current macroeconomic and geopolitical events, including changing conditions from hostilities in Ukraine and in Israel and the Middle East, increasing rates of inflation and changing interest rates, on business operations and expectations, as well as those risks set forth in the Risk Factors section of the Company’s most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K and the Company’s other filings with the U.S. Securities and Exchange Commission.

Item 9.01.
Financial Statements and Exhibits.
 
(d) Exhibits.

Exhibit
No.
Description
   
99.1
Press release titled, “BridgeBio Announces Agreement with U.S. Government to Improve Affordability and Access to Critical Medicines for Americans.”
   
104
 Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURE
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 
BridgeBio Pharma, Inc.
   
Date: August 31, 2026
/s/ Thomas Trimarchi
 
Thomas Trimarchi
 
President and Chief Financial Officer


Exhibit 99.1

BridgeBio Announces Agreement with U.S. Government to Improve Affordability and Access to Critical Medicines for Americans

- This voluntary agreement expands access for Medicaid patients to BridgeBio’s currently marketed medicine and lowers drug costs for Americans without jeopardizing innovation and sustainability in rare diseases

- BridgeBio will continue to offer Attruby via Medicare Part D without any future pricing mandates

- The agreement has no impact on ForgingBridges®, a copay assistance program that helps reduce out-of-pocket costs to as little as $0 per month for qualifying patients

PALO ALTO, Calif., Aug. 31, 2026 (GLOBE NEWSWIRE) — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage, multi-product biopharmaceutical company focused on developing medicines for genetic conditions, today announced that it has entered into a voluntary agreement with the U.S. government to expand access to its medicines and lower costs for American patients. Neil Kumar, Ph.D., Co-Founder and CEO of BridgeBio, joined President Donald J. Trump and members of his Administration at the White House to discuss the new agreement, which improves access to treatments for rare genetic diseases without jeopardizing innovation or sustained investment. 

Millions of people worldwide live with rare genetic conditions that have no approved treatment options because developing medicines for rare diseases has never been commercially straightforward. Today’s agreement with the Administration is intended to ensure that BridgeBio will be able to continue bringing medicines to people living with rare genetic diseases. As part of the agreement, BridgeBio will expand state Medicaid access to its currently marketed medicine via the GENEROUS Model.

This builds on the Company’s existing patient access work, including ForgingBridges, BridgeBio’s patient support program, which provides reimbursement navigation and financial assistance to qualifying patients, potentially minimizing out-of-pocket costs to as little as $0 per month.

BridgeBio does not expect to be subject to future pricing mandates. The specific terms of the agreement remain confidential.

“As an American biotech, it’s a privilege to be working alongside the Administration to ensure the broadest possible access for Americans to the medicines that we make. Thirty million Americans suffer from rare genetic disorders, and our intent is to reliably innovate new medicines and bring them to as many communities as possible,” said Dr. Kumar. “Within the field of ATTR-CM, we’ve already launched the lowest-priced product with the best data at 30 months, and we continue to look forward to working with anyone who wants to help improve access to treatment for the patients who need it.”

BridgeBio’s model was built to make drug development and innovation economically viable for genetic conditions that affect small patient populations. The Company’s approved medicine, Attruby, is available to people with transthyretin amyloid cardiomyopathy, and the Company has three additional medicines under FDA review, each for a genetic condition with limited or no approved treatment options: BBP-418 for limb-girdle muscular dystrophy type 2I/R9, or LGMD2I/R9 (PDUFA date with Priority Review: November 27, 2026); encaleret for autosomal dominant hypocalcemia type 1, or ADH1 (PDUFA date with Priority Review: May 7, 2027); and infigratinib for achondroplasia.

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 inpatients 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
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.

BridgeBio Forward-Looking Statements
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 include statements regarding the anticipated implementation, scope and effects of BridgeBio’s agreement with the U.S. government, including BridgeBio’s plans to expand Medicaid access to Attruby through the GENEROUS Model; BridgeBio’s expectation that it will not be subject to future pricing mandates; and the anticipated impact of the agreement on patient access, affordability and BridgeBio’s ability to continue developing and providing medicines for rare genetic diseases.

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, the risk that the agreement may be implemented, interpreted or applied differently than BridgeBio currently expects; that federal or state laws, regulations, policies, reimbursement frameworks or government pricing programs may change or be implemented in a manner that adversely affects BridgeBio or its products; that BridgeBio may become subject to additional pricing mandates, requirements or restrictions notwithstanding its current expectations; that the agreement may not result in the anticipated improvements in access, affordability or other expected benefits; that the agreement or future changes in government pricing or reimbursement policies may adversely affect BridgeBio’s business, results of operations or ability to continue investing in the development and commercialization of medicines for rare genetic diseases; the impacts of current macroeconomic and geopolitical events, including changing conditions from hostilities in Ukraine and in Israel and the Middle East, increasing rates of inflation and changing interest rates, on business operations and expectations, as well as those risks set forth in the Risk Factors section of the Company’s most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K and the Company’s other filings with the U.S. Securities and Exchange Commission.

Moreover, the Company operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of the Company’s management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, BridgeBio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

BridgeBio Media Contact:
Kaitlyn Reilly, Director, Communications
contact@bridgebio.com
(650) 789-8220

BridgeBio Investor Contact:
Kristen Kelleher, Director, Investor Relations
ir@bridgebio.com


Source: View Original Filing on SEC EDGAR

Filing Exhibits & Attachments

4 documents

Press Releases

Other Documents