BridgeBio Announces Commercial Progress, Program Updates, and 2025 Milestones
BridgeBio Pharma (NASDAQ: BBIO) reported significant commercial progress for its recently FDA-approved drug Attruby, with 430 prescriptions written by 248 unique physicians for ATTR-CM treatment. The company announced the completion of enrollment in three major Phase 3 clinical trials: FORTIFY (112 patients for LGMD2I/R9), CALIBRATE (70 patients for ADH1), and PROPEL 3 (114 participants for achondroplasia).
The company's financial position is strong with $406 million in cash as of last quarter, plus $500 million received upon Attruby's FDA approval from a royalty facility. BridgeBio anticipates an additional $105 million in regulatory milestones in the first half of 2025 from expected European and Japanese approvals of acoramidis. All three Phase 3 trials are expected to reach significant milestones in the second half of 2025.
BridgeBio Pharma (NASDAQ: BBIO) ha riportato progressi commerciali significativi per il suo recente farmaco approvato dalla FDA, Attruby, con 430 prescrizioni scritte da 248 medici unici per il trattamento dell'ATTR-CM. L'azienda ha annunciato il completamento dell'arruolamento in tre importanti studi clinici di Fase 3: FORTIFY (112 pazienti per LGMD2I/R9), CALIBRATE (70 pazienti per ADH1) e PROPEL 3 (114 partecipanti per l'achondroplasia).
La posizione finanziaria dell'azienda è solida, con 406 milioni di dollari in contante al termine dell'ultimo trimestre, più 500 milioni di dollari ricevuti al momento dell'approvazione di Attruby dalla FDA attraverso un impianto di royalties. BridgeBio prevede ulteriori 105 milioni di dollari in traguardi normativi nella prima metà del 2025, in seguito alle previste approvazioni europee e giapponesi di acoramidis. Tutti e tre gli studi di Fase 3 dovrebbero raggiungere traguardi significativi nella seconda metà del 2025.
BridgeBio Pharma (NASDAQ: BBIO) reportó avances comerciales significativos para su reciente medicamento aprobado por la FDA, Attruby, con 430 recetas escritas por 248 médicos únicos para el tratamiento de ATTR-CM. La compañía anunció la finalización de la inscripción en tres importantes ensayos clínicos de Fase 3: FORTIFY (112 pacientes para LGMD2I/R9), CALIBRATE (70 pacientes para ADH1) y PROPEL 3 (114 participantes para la acondroplasia).
La posición financiera de la empresa es sólida, con 406 millones de dólares en efectivo al final del último trimestre, además de 500 millones de dólares recibidos al aprobar Attruby por la FDA a través de una instalación de regalías. BridgeBio anticipa 105 millones de dólares adicionales en hitos regulatorios en la primera mitad de 2025, debido a las esperadas aprobaciones europeas y japonesas de acoramidis. Se espera que todos los ensayos de Fase 3 alcancen hitos significativos en la segunda mitad de 2025.
브릿지바이오 제약 (NASDAQ: BBIO)는 최근 FDA 승인을 받은 약물 Attruby의 상업적 진전을 보고하며, ATTR-CM 치료를 위해 248명의 고유 의사에 의해 작성된 430건의 처방전을 기록했습니다. 회사는 세 개의 주요 3상 임상 시험에서의 등록 완료를 발표했습니다: FORTIFY (LGMD2I/R9을 위한 112명), CALIBRATE (ADH1을 위한 70명), 그리고 PROPEL 3 (왜소증을 위한 114명 참여자).
회사의 재정 상태는 견고하며, 지난 분기 말 기준으로 4억 6백만 달러의 현금을 보유하고 있으며, Attruby가 FDA 승인을 받을 때 5억 달러의 로열티 시설에서 수령했습니다. 브릿지바이오는 아코라미딘의 유럽과 일본 승인을 예상하여 2025년 상반기에 추가로 1억 5백만 달러의 규제 이정표를 예상하고 있습니다. 모든 3상 시험은 2025년 하반기에 중요한 이정표에 도달할 것으로 예상됩니다.
BridgeBio Pharma (NASDAQ: BBIO) a signalé des progrès commerciaux significatifs pour son médicament récemment approuvé par la FDA, Attruby, avec 430 prescriptions écrites par 248 médecins uniques pour le traitement de l'ATTR-CM. L'entreprise a annoncé l'achèvement de l'inscription dans trois importants essais cliniques de phase 3 : FORTIFY (112 patients pour LGMD2I/R9), CALIBRATE (70 patients pour ADH1) et PROPEL 3 (114 participants pour l'achondroplasie).
La position financière de l'entreprise est solide, avec 406 millions de dollars en espèces à la fin du dernier trimestre, plus 500 millions de dollars reçus lors de l'approbation d'Attruby par la FDA grâce à un dispositif de redevances. BridgeBio prévoit 105 millions de dollars supplémentaires en jalons réglementaires au cours de la première moitié de 2025, en raison des approbations européennes et japonaises d'acoramidis attendues. Tous les trois essais de phase 3 devraient atteindre des jalons significatifs dans la seconde moitié de 2025.
BridgeBio Pharma (NASDAQ: BBIO) berichtete von signifikanten kommerziellen Fortschritten mit seinem kürzlich von der FDA zugelassenen Medikament Attruby, mit 430 Rezepten, die von 248 einzigartigen Ärzten für die Behandlung von ATTR-CM ausgestellt wurden. Das Unternehmen gab den Abschluss der Rekrutierung in drei wichtigen Phase-3-Studien bekannt: FORTIFY (112 Patienten für LGMD2I/R9), CALIBRATE (70 Patienten für ADH1) und PROPEL 3 (114 Teilnehmer für Achondroplasie).
Die finanzielle Lage des Unternehmens ist stark, mit 406 Millionen Dollar an Bargeld zum Ende des letzten Quartals, plus 500 Millionen Dollar, die nach der FDA-Zulassung von Attruby aus einer Lizenzgebühr-Einrichtung erhalten wurden. BridgeBio erwartet zusätzlich 105 Millionen Dollar an regulatorischen Meilensteinen in der ersten Hälfte von 2025 durch die erwarteten europäischen und japanischen Genehmigungen von Acoramidis. Alle drei Phase-3-Studien sollen in der zweiten Hälfte von 2025 bedeutende Meilensteine erreichen.
- Strong early commercial traction with 430 Attruby prescriptions from 248 physicians
- Solid cash position of $406M plus $500M from royalty facility
- Expected $105M in regulatory milestones from EU and Japan approvals in 1H 2025
- Completed enrollment in three major Phase 3 clinical trials
- None.
Insights
The commercial launch of Attruby shows remarkable early traction with 430 prescriptions from 248 unique physicians, indicating strong initial market penetration. This rapid adoption across both academic and community centers suggests potential for significant revenue generation. The company's robust cash position of
Three fully enrolled Phase 3 trials represent major value drivers: FORTIFY (112 patients), CALIBRATE (70 patients) and PROPEL 3 (114 patients). Each addresses rare diseases with no current approved treatments, potentially leading to monopolistic market positions. The H2 2025 readouts could trigger significant stock catalysts, particularly if positive results emerge.
For everyday investors: Think of BridgeBio like a specialized car manufacturer that just launched its first successful model (Attruby) and has three more potentially groundbreaking vehicles in final testing. The strong early sales and healthy bank account suggest they're well-positioned to handle both production and future launches.
The initial Attruby launch metrics demonstrate strong market acceptance, particularly noteworthy given the drug's recent approval in November 2024. The geographic diversity of prescriptions and physician adoption across both academic and community settings suggests effective market penetration strategy and potential for sustained growth trajectory.
The company's pipeline diversity across three distinct rare disease markets - muscular dystrophy, hypocalcemia and achondroplasia - provides multiple shots on goal and risk mitigation. Each indication represents an untapped market opportunity with potential first-mover advantages. The timing alignment of three major trial readouts in H2 2025 could create significant momentum if positive results materialize.
Simple explanation: BridgeBio has successfully started selling their first approved medicine and doctors are quickly adopting it. They also have three more potential medicines in final testing, each targeting diseases that currently have no treatments. This gives them multiple opportunities for success, rather than relying on just one product.
- Remarkable early Attruby demand: 430 scripts written by 248 unique HCPs since FDA approval with broad uptake across academic centers and community centers in all patient types
- Fully enrolled three major market Phase 3 clinical trials: FORTIFY (BBP-418 for LGMD2I/R9); CALIBRATE (encaleret for ADH1); and PROPEL 3 (infigratinib for Achondroplasia)
- Well-financed to launch Attruby and read out major market Phase 3 trials:
PALO ALTO, Calif., Jan. 13, 2025 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a new type of biopharmaceutical company focused on genetic diseases, today provided updates on its commercial progress for Attruby (acoramidis), status of late-stage pipeline programs, and anticipated 2025 milestones.
“With the FDA’s approval of Attruby, we marked an important moment for both our organization and the broader ATTR-CM patient community in need of new treatment options. We’re grateful for the enthusiasm surrounding the product and the associated initial commercial momentum, with 430 prescriptions written by 248 unique physicians, and we look forward to continued progress,” said Neil Kumar, Ph.D., Founder and CEO of BridgeBio. “Additionally, we are excited to share that we have completed enrollment of all three of our major market Phase 3 clinical trials. I look forward to continuing to work with this stellar team to serve patients with genetic disease in 2025.”
Business Update
On November 22, 2024, the U.S. Food and Drug Administration (FDA) approved Attruby (acoramidis), a near-complete TTR stabilizer (≥
Since the approval, BridgeBio has seen remarkable momentum with 430 patient prescriptions written by 248 physicians.
Pipeline Updates
BBP-418 – Glycosylation substrate for limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9):
- FORTIFY is a Phase 3 clinical trial of BBP-418 in LGMD2I/R9, a rare genetic disorder caused by variants in the fukutin‑related protein (FKRP) gene that result in progressive muscle degeneration and damage, and eventual loss of functional independence. The trial is fully enrolled with 112 patients.
- The Company expects Last Patient – Last Visit (LPLV) and topline readout of the interim analysis cohort in second half 2025.
- If successful, BBP-418 would be the first approved therapy for individuals living with LGMD2I/R9.
Encaleret – Calcium-sensing receptor (CaSR) antagonist for autosomal dominant hypocalcemia type 1 (ADH1):
- CALIBRATE, the Phase 3 clinical trial of encaleret in ADH1, a rare, genetic form of hypoparathyroidism, is fully enrolled with 70 patients. The trial is designed to evaluate the efficacy and safety of encaleret compared to standard of care in adult patients with ADH1.
- The Company expects Last Patient – Last Visit and topline readout in second half 2025.
- If successful, encaleret would be the first approved therapy for individuals living with ADH1.
Infigratinib – FGFR1-3 inhibitor for achondroplasia and hypochondroplasia:
- PROPEL 3, the Phase 3 clinical trial of infigratinib in achondroplasia, the most common form of disproportionate short stature, is fully enrolled with 114 participants.
- The Company expects Last Participant – Last Visit in second half 2025.
- If successful, infigratinib would be the first approved oral therapy for children living with achondroplasia.
2025 Milestones
| Program | Status | Anticipated 2025 Milestone |
| Acoramidis for ATTR-CM | US FDA approval on November 22, 2024 | EU and Japan approvals in 1H 2024 |
| BBP-418 for LGMD2I/R9 | FORTIFY, Phase 3 study enrollment completed | Last Patient – Last Visit and Topline readout in 2H 2025 |
| Encaleret for ADH1 | CALIBRATE, Phase 3 study enrollment completed | Last Patient – Last Visit and Topline readout in 2H 2025 |
| Infigratinib for achondroplasia | PROPEL 3, Phase 3 study enrollment completed | Last Participant – Last Visit in 2H 2025 |
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 (
About BridgeBio Pharma, Inc.
BridgeBio Pharma, Inc. (BridgeBio) is a new type of biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases. BridgeBio’s pipeline of development programs ranges from early science to advanced clinical trials. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com and follow us on LinkedIn, Twitter and Facebook.
BridgeBio Pharma, Inc. 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, including express and implied statements relating to the Company’s expectations regarding the commercial success of Attruby; the Company’s clinical trials, including the timing of the last patient-last visit and topline data readouts for each of FORTIFY, CALIBRATE and PROPEL 3; the potential for encaleret to become a new treatment for ADH1; the potential for BBP-418 to become a new treatment for LGMD2I/R9; the potential for infigratinib to become a new treatment for achondroplasia; timing of approval of Attruby for ATTR-CM in the European Union and Japan; and the Company’s preliminary and unaudited estimate of cash and the Company’s anticipated funding of its current operations and related timelines; and the Company’s expectations regarding reaching regulatory milestones and receipt of milestone payments, among others, reflect the Company’s current views about the Company’s plans, intentions, expectations and strategies, which are based on the information currently available to us 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 Ukraine and in Israel and the Gaza Strip, 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:
Bubba Murarka, EVP Communications
contact@bridgebio.com
(650)-789-8220
FAQ
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