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 猫 solida, con 406 milioni di dollari in contante al termine dell'ultimo trimestre, pi霉 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 met脿 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 met脿 del 2025.
BridgeBio Pharma (NASDAQ: BBIO) report贸 avances comerciales significativos para su reciente medicamento aprobado por la FDA, Attruby, con 430 recetas escritas por 248 m茅dicos 煤nicos para el tratamiento de ATTR-CM. La compa帽铆a anunci贸 la finalizaci贸n de la inscripci贸n en tres importantes ensayos cl铆nicos de Fase 3: FORTIFY (112 pacientes para LGMD2I/R9), CALIBRATE (70 pacientes para ADH1) y PROPEL 3 (114 participantes para la acondroplasia).
La posici贸n financiera de la empresa es s贸lida, con 406 millones de d贸lares en efectivo al final del 煤ltimo trimestre, adem谩s de 500 millones de d贸lares recibidos al aprobar Attruby por la FDA a trav茅s de una instalaci贸n de regal铆as. BridgeBio anticipa 105 millones de d贸lares 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.
敫岆歆氚旍澊鞓 鞝滌暯 (NASDAQ: BBIO)電 斓滉芳 FDA 鞀轨澑鞚 氚涭潃 鞎诫 Attruby鞚 靸侅梾鞝 歆勳爠鞚 氤搓碃頃橂┌, ATTR-CM 旃橂毳 鞙勴暣 248氇呾潣 瓿犾湢 鞚橃偓鞐 鞚橅暣 鞛戩劚霅 430瓯挫潣 觳橂癌鞝勳潉 旮半頄堨姷雼堧嫟. 須岇偓電 靹 臧滌潣 欤检殧 3靸 鞛勳儊 鞁滍棙鞐愳劀鞚 霌彪 鞕勲毳 氚滍憸頄堨姷雼堧嫟: FORTIFY (LGMD2I/R9鞚 鞙勴暅 112氇), CALIBRATE (ADH1鞚 鞙勴暅 70氇), 攴鸽Μ瓿 PROPEL 3 (鞕滌唽歃濎潉 鞙勴暅 114氇 彀胳棳鞛).
須岇偓鞚 鞛爼 靸來儨電 瓴碃頃橂┌, 歆雮 攵勱赴 毵 旮办鞙茧 4鞏 6氚彪 雼煬鞚 順勱笀鞚 氤挫湢頃橁碃 鞛堨溂氅, Attruby臧 FDA 鞀轨澑鞚 氚涭潉 霑 5鞏 雼煬鞚 搿滌棿韹 鞁滌劋鞐愳劀 靾橂牴頄堨姷雼堧嫟. 敫岆歆氚旍澊鞓る姅 鞎勳綌霛茧霐橃潣 鞙犽熃瓿 鞚茧掣 鞀轨澑鞚 鞓堨儊頃橃棳 2025雲 靸侂皹旮办棎 於旉皜搿 1鞏 5氚彪 雼煬鞚 攴滌牅 鞚挫爼響滊ゼ 鞓堨儊頃橁碃 鞛堨姷雼堧嫟. 氇摖 3靸 鞁滍棙鞚 2025雲 頃橂皹旮办棎 欷戩殧頃 鞚挫爼響滌棎 霃勲嫭頃 瓴冹溂搿 鞓堨儊霅╇媹雼.
BridgeBio Pharma (NASDAQ: BBIO) a signal茅 des progr猫s commerciaux significatifs pour son m茅dicament r茅cemment approuv茅 par la FDA, Attruby, avec 430 prescriptions 茅crites par 248 m茅decins uniques pour le traitement de l'ATTR-CM. L'entreprise a annonc茅 l'ach猫vement 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 financi猫re de l'entreprise est solide, avec 406 millions de dollars en esp猫ces 脿 la fin du dernier trimestre, plus 500 millions de dollars re莽us lors de l'approbation d'Attruby par la FDA gr芒ce 脿 un dispositif de redevances. BridgeBio pr茅voit 105 millions de dollars suppl茅mentaires en jalons r茅glementaires au cours de la premi猫re moiti茅 de 2025, en raison des approbations europ茅ennes et japonaises d'acoramidis attendues. Tous les trois essais de phase 3 devraient atteindre des jalons significatifs dans la seconde moiti茅 de 2025.
BridgeBio Pharma (NASDAQ: BBIO) berichtete von signifikanten kommerziellen Fortschritten mit seinem k眉rzlich von der FDA zugelassenen Medikament Attruby, mit 430 Rezepten, die von 248 einzigartigen 脛rzten f眉r die Behandlung von ATTR-CM ausgestellt wurden. Das Unternehmen gab den Abschluss der Rekrutierung in drei wichtigen Phase-3-Studien bekannt: FORTIFY (112 Patienten f眉r LGMD2I/R9), CALIBRATE (70 Patienten f眉r ADH1) und PROPEL 3 (114 Teilnehmer f眉r 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 Lizenzgeb眉hr-Einrichtung erhalten wurden. BridgeBio erwartet zus盲tzlich 105 Millionen Dollar an regulatorischen Meilensteinen in der ersten H盲lfte von 2025 durch die erwarteten europ盲ischen und japanischen Genehmigungen von Acoramidis. Alle drei Phase-3-Studien sollen in der zweiten H盲lfte 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聽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) (鈥淏ridgeBio鈥 or the 鈥淐ompany鈥), 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.
鈥淲ith the FDA鈥檚 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鈥檙e 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,鈥 said Neil Kumar, Ph.D., Founder and CEO of BridgeBio. 鈥淎dditionally, 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.鈥
Business Update
On November 22, 2024, the U.S. Food and Drug Administration (FDA) approved Attruby (acoramidis), a near-complete TTR stabilizer (鈮
Since the approval, BridgeBio has seen remarkable momentum with 430 patient prescriptions written by 248 physicians.
Pipeline Updates
BBP-418 鈥 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鈥憆elated 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 鈥 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 鈥 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 鈥 Last Visit and topline readout in second half 2025.
- If successful, encaleret would be the first approved therapy for individuals living with ADH1.
Infigratinib 鈥 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 鈥 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 鈥 Last Visit and Topline readout in 2H 2025 |
| Encaleret for ADH1 | CALIBRATE, Phase 3 study enrollment completed | Last Patient 鈥 Last Visit and Topline readout in 2H 2025 |
| Infigratinib for achondroplasia | PROPEL 3, Phase 3 study enrollment completed | Last Participant 鈥 Last Visit in 2H 2025 |
About Attruby鈩 (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鈥檚 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聽聽and follow us on聽,听听补苍诲听.
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 鈥渁nticipates,鈥 鈥渂elieves,鈥 鈥渃ontinues,鈥 鈥渆stimates,鈥 鈥渆xpects,鈥 鈥渉opes,鈥 鈥渋ntends,鈥 鈥渕ay,鈥 鈥減lans,鈥 鈥減rojects,鈥 鈥渞emains,鈥 鈥渟eeks,鈥 鈥渟hould,鈥 鈥渨ill,鈥 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鈥檚 expectations regarding the commercial success of Attruby; the Company鈥檚 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鈥檚 preliminary and unaudited estimate of cash and the Company鈥檚 anticipated funding of its current operations and related timelines; and the Company鈥檚 expectations regarding reaching regulatory milestones and receipt of milestone payments, among others, reflect the Company鈥檚 current views about the Company鈥檚 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鈥檚 preclinical studies and clinical trials not being indicative of final data, the potential size of the target patient populations the Company鈥檚 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鈥檚 product candidates, the FDA or such other regulatory agencies not agreeing with the Company鈥檚 regulatory approval strategies, components of the Company鈥檚 filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted, the continuing success of the Company鈥檚 collaborations, the Company鈥檚 ability to obtain additional funding, including through less dilutive sources of capital than equity financings, potential volatility in the Company鈥檚 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鈥檚 most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K and the Company鈥檚 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鈥檚 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
(650)-789-8220
FAQ
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