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FDA sets May 8, 2027 action date for BridgeBio (NASDAQ: BBIO) drug

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

Rhea-AI Filing Summary

BridgeBio Pharma, Inc. announced that the FDA has accepted for filing its New Drug Application for encaleret to treat autosomal dominant hypocalcemia type 1 (ADH1), assigning a PDUFA target action date of May 8, 2027 and indicating it is not currently planning an advisory committee meeting.

The Phase 3 CALIBRATE trial of encaleret in ADH1 achieved all pre-specified primary and key secondary endpoints, and BridgeBio is enrolling the CALIBRATE-PEDS Phase 2/3 pediatric study and preparing a Phase 3 trial in chronic hypoparathyroidism. As of April 2026, over 2,100 individuals in the U.S. have been diagnosed with autosomal dominant hypocalcemia since October 2023 based on claims data, and the company plans to submit a European MAA for encaleret in the second half of 2026.

Positive

  • The FDA accepted BridgeBio’s NDA for encaleret for ADH1 and set a PDUFA target action date of May 8, 2027, establishing a clear late-stage regulatory timeline for this program.

Negative

  • None.

Filing Explained

The July 22 Form 8-K reports that the FDA accepted BridgeBio’s NDA for encaleret for filing, a regulatory-review milestone rather than an approval; the filing identifies encaleret as investigational and gives May 8, 2027 as the PDUFA target action date.

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, and exhibit attachments filed with this report.
PDUFA target action date May 8, 2027 FDA’s target action date for the encaleret NDA for ADH1
NDA acceptance announcement date July 22, 2026 Date BridgeBio announced FDA acceptance of the encaleret NDA
Diagnosed ADH1 individuals in U.S. over 2,100 As of April 2026, based on claims data since October 2023
CALIBRATE trial phase Phase 3 CALIBRATE Phase 3 trial in ADH1 met all primary and key secondary endpoints
CALIBRATE-PEDS trial phase Phase 2/3 Global registrational Phase 2/3 study of encaleret in pediatric ADH1
Planned EMA MAA timing second half of 2026 Targeted timing for encaleret MAA submission for ADH1 to the EMA
New Drug Application (NDA) regulatory
"FDA has accepted for filing its New Drug Application (NDA) for encaleret"
A new drug application (NDA) is a formal request submitted to regulatory authorities to gain approval for a new medication to be sold and used by the public. It is a comprehensive review process that examines the drug’s safety, effectiveness, and manufacturing quality. For investors, an NDA approval can signal a potential breakthrough product and influence a company's stock value.
PDUFA target action date regulatory
"The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of May 8, 2027"
The PDUFA target action date is the deadline set by the U.S. Food and Drug Administration (FDA) by which it aims to decide whether to approve or reject a new drug application. This date helps investors gauge when a company’s new medication might reach the market, potentially influencing sales and revenue expectations. It acts as a key milestone signaling progress in the drug approval process.
autosomal dominant hypocalcemia type 1 (ADH1) medical
"for the treatment of individuals living with autosomal dominant hypocalcemia type 1 (ADH1)"
Orphan Drug Designation regulatory
"Encaleret has been granted Fast Track Designation and Orphan Drug Designation in the U.S., European Union, and Japan"
Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.
chronic hypoparathyroidism medical
"plans to initiate -HP, a global Phase 3 study of encaleret in chronic hypoparathyroidism"

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FAQ

What FDA milestone did BridgeBio (BBIO) reach for encaleret and when is the PDUFA date?
The FDA accepted BridgeBio’s NDA for encaleret in ADH1 and assigned a PDUFA target action date of May 8, 2027. The agency also indicated it is not currently planning to hold an advisory committee meeting on the application.

What is encaleret and which conditions is BridgeBio (BBIO) targeting?
Encaleret is an investigational, orally administered small molecule designed to negatively modulate the calcium-sensing receptor. BridgeBio is developing it for autosomal dominant hypocalcemia type 1 (ADH1) and plans a global Phase 3 study in chronic hypoparathyroidism in addition to pediatric ADH1.

How did encaleret perform in BridgeBio (BBIO)’s CALIBRATE Phase 3 trial?
In CALIBRATE, the Phase 3 trial in ADH1, encaleret achieved all pre-specified primary and key secondary efficacy endpoints. Data showed normalization of key markers of CaSR-driven disease biology without the need for calcium and vitamin D supplements, with a favorable safety and tolerability profile.

What ADH1 patient population size did BridgeBio (BBIO) reference?
BridgeBio cited that, as of April 2026, over 2,100 individuals in the U.S. have been diagnosed with autosomal dominant hypocalcemia since October 2023, based on claims data. This suggests a growing diagnosed population and rising diagnostic recognition of the condition.

What additional encaleret studies is BridgeBio (BBIO) running or planning?
BridgeBio is enrolling CALIBRATE-PEDS, a global registrational Phase 2/3 study in pediatric ADH1, and plans to initiate -HP, a global Phase 3 trial in chronic hypoparathyroidism. These programs aim to extend encaleret’s potential use beyond adult ADH1.

What international regulatory plans does BridgeBio (BBIO) have for encaleret?
BridgeBio intends to submit a Marketing Authorization Application (MAA) to the European Medicines Agency for encaleret in ADH1 in the second half of 2026. Encaleret also holds Orphan Drug Designation in the U.S., European Union, and Japan.
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): July 22, 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.)
 
3160 Porter Dr., Suite 250
 
Palo Alto, CA
94304
(Address of Principal Executive Offices)
(Zip Code)
 
Registrant’s Telephone Number, Including Area Code: (650) 391-9740
 
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:
 
☐
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, par value $0.001 per share
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 July 22, 2026, BridgeBio Pharma, Inc. issued a press release titled “BridgeBio Announces FDA Acceptance of NDA for Encaleret for ADH1.” 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.
 
Item 9.01
Financial Statements and Exhibits.
 
(d)
Exhibits.
 
Exhibit Description
   
99.1 Press Release titled “BridgeBio Announces FDA Acceptance of NDA for Encaleret for ADH1”
   
104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
 
 
SIGNATURES
 
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:
July 22, 2026
By:
/s/ Thomas Trimarchi
 
 
 
Thomas Trimarchi, Ph.D.
 
 
 
President and Chief Financial Officer
 
 
0001743881 false 0001743881 2026-07-22 2026-07-22
Exhibit 99.1
 
BridgeBio Announces FDA Acceptance of NDA for Encaleret for ADH1
 
- PDUFA target action date of May 8, 2027
 
- If approved, encaleret will be the first and only approved therapy specifically indicated for individuals living with ADH1, representing a potential blockbuster opportunity for BridgeBio
 
- Encaleret demonstrated consistent efficacy across all pre-specified primary and key secondary efficacy endpoints normalizing key markers of CaSR-driven disease biology without the need for calcium and vitamin D supplements, with a favorable safety and tolerability profile
 
- BridgeBio is also currently enrolling CALIBRATE-PEDS, a registrational Phase 2/3 trial to study encaleret in pediatric ADH1 and intends to initiate the RECLAIM-HP Phase 3 registrational study of encaleret in chronic hypoparathyroidism later this summer; successful development could extend encaleret’s utility to a broader patient population
 
PALO ALTO, Calif., July 22, 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 the FDA has accepted for filing its New Drug Application (NDA) for encaleret for the treatment of individuals living with autosomal dominant hypocalcemia type 1 (ADH1). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of May 8, 2027, and BridgeBio is prepared to launch encaleret upon approval, representing a potential blockbuster opportunity for the Company. The FDA also notified the Company that it is not currently planning to hold an advisory committee meeting to discuss the application.
 
"The FDA's acceptance of our NDA is a powerful validation of encaleret’s differentiated clinical profile and enables a major step forward for the ADH1 community. We believe encaleret has the potential to transform care for patients who currently have no indicated treatment options, and we're moving with urgency to bring it to them,” said Ananth Sridhar, Chief Executive Officer of BridgeBio Endocrinology.
 
CALIBRATE, the Phase 3 clinical trial of encaleret in ADH1, successfully achieved all pre-specified primary and key secondary efficacy endpoints, supporting encaleret’s potential as a disease-modifying therapy by targeting the underlying genetic cause of ADH1. The topline results can be found here. Additional results were presented at the European Congress of Endocrinology (ECE) 2026 and the Endocrine Society 2026 annual meeting (ENDO) in oral presentations, with data showing simultaneous restoration of blood and urine calcium, as well as restoration of physiologic parathyroid hormone (PTH) production.
 
"For too long, ADH1 has been an invisible condition, that disrupts several systems in the body, from the kidneys to the nervous system to the muscles and often goes unrecognized for years. The path to diagnosis is frequently a long and exhausting one, especially for patients with a genetic disorder. Patients often cycle through specialists before anyone connects the dots to their diagnosis. The FDA's acceptance of this NDA is a moment of real hope for ADH1 patients and a signal that the medical and regulatory community understand the seriousness of this condition and that an orally administered option may finally be on the horizon for those in need," said Patty Keating, Executive Director of the HypoPARAthyroidism Association.
 
As of April 2026, over 2,100 individuals have been diagnosed in the U.S. with autosomal dominant hypocalcemia since October 2023 based on claims data, suggestive of a growing marketplace and elevated diagnostic suspicion. The Company also intends to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the use of encaleret in ADH1 in the second half of 2026.
 
BridgeBio is currently enrolling CALIBRATE-PEDS (NCT07080385), a global registrational Phase 2/3 study of encaleret in pediatric ADH1. The Company also plans to initiate RECLAIM-HP, a global Phase 3 study of encaleret in chronic hypoparathyroidism later this summer, building on the positive Phase 2 proof-of-concept findings of PTH-independent effects of encaleret on renal calcium handling and expanding the potential applications of encaleret beyond ADH1. Successful development could extend encaleret’s utility to a broader patient population.
 
About Autosomal Dominant Hypocalcemia Type 1 (ADH1)
ADH1 is a common form of genetic hypoparathyroidism caused by gain-of-function variants in the calcium-sensing receptor gene (CASR). The calcium-sensing receptor (CaSR) constantly monitors and balances blood calcium levels by regulating parathyroid hormone secretion and calcium reabsorption in the kidneys. Individuals with ADH1 typically experience hypocalcemia, hypercalciuria, and inappropriately low levels of PTH. Symptoms of hypocalcemia may include severe muscle cramps, muscle spasms (tetany), a burning or prickling sensation in the hands or feet (paresthesia), brain fog, fatigue, and seizures. Hypercalciuria may result in kidney calcification (nephrocalcinosis), kidney stones (nephrolithiasis), and kidney failure.
 
About Encaleret
Encaleret is an investigational, orally administered small molecule under investigation to treat ADH1 and chronic hypoparathyroidism, that is designed to selectively negatively modulate the calcium sensing receptor. Encaleret has been granted Fast Track Designation by the U.S. FDA and Orphan Drug Designation in the U.S., European Union, and Japan.
 
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 express and implied statements relating to the Company’s expectations regarding the regulatory review process for encaleret in ADH1, including the FDA’s review of the NDA and the potential for approval; the Company’s preparedness to launch encaleret upon approval; the potential for encaleret to become the first and only approved therapy specifically indicated for individuals living with ADH1 and to transform care for patients with ADH1; the potential for encaleret to be a disease-modifying therapy by targeting the underlying genetic cause of ADH1; the potential commercial opportunity for encaleret in ADH1, including as a potential blockbuster opportunity for the Company; the timing of a potential Marketing Authorization Application submission to the European Medicines Agency for encaleret in ADH1; the Company’s plans to initiate RECLAIM-HP, a global Phase 3 study of encaleret in chronic hypoparathyroidism, and the potential expansion of encaleret beyond ADH1, including the potential for encaleret to become a multi-billion-dollar opportunity for the Company. 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 clinical trials not being indicative of final data, 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, regulatory submissions not being accepted or approved on anticipated timelines or at all, encaleret not becoming the first and only approved therapy specifically indicated for individuals living with ADH1, the Company not being successful in launching encaleret on anticipated timing or at all, the potential commercial opportunity for encaleret not being realized, the Company’s plans for RECLAIM-HP not proceeding as expected, 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 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:
Bubba Murarka, Executive Vice President
contact@bridgebio.com
(650)-789-8220
 
BridgeBio Investor Contact:
Chinmay Shukla, Senior Vice President, Strategic Finance
ir@bridgebio.com
 
 

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