On February 24, 2026 BridgeBio Pharma, Inc. (Nasdaq: BBIO) ("BridgeBio" or the "Company"), a commercial-stage, multi-product biopharmaceutical company focused on developing medicines for genetic conditions, reported its financial results for the fourth quarter and full year ended December 31, 2025, and provided an update on Attruby’s commercial progress.

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Pipeline Overview:
Program Status Next expected milestone
Acoramidis for ATTR-CM
Approved in U.S., E.U., Japan, Switzerland, and U.K.
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, Neil Kumar, Ph.D.

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 in Journal 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 February 20, 2026, 7,804 unique patient prescriptions have been written by 1,856 unique prescribers since FDA approval in November 2024. The fourth quarter total revenues, net totaled $154.2 million, comprised of $146.0 million of U.S. Attruby net product revenue, $5.3 million from royalty revenue, and $2.9 million in license and services revenue. The full year 2025 net product revenue was $362.4 million.
"2025 reflected strong commercial momentum for Attruby and an important step forward as we advance three additional medicines toward potential commercialization," said Matt Outten, Chief Commercial Officer of BridgeBio. "Attruby delivered 35% quarter-over-quarter growth in net product revenue in Q4, driven by its differentiated profile as the only near-complete stabilizer on the market, continued prescribing growth, repeat use, and patient persistence that has exceeded our expectations. As we prepare for the potential launches of BBP-418, encaleret, and infigratinib, we are intentionally applying the learnings established with Attruby. When successful, these approvals will bring BridgeBio to achieving six approved medicines, which marks a significant milestone for our platform and positions us to extend our impact to even more patients with genetic conditions."
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 the U.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) Annual Scientific Sessions & Expo in March 2026 and in additional medical congresses throughout 2026.
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 the U.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 the U.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 the U.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 from Turning Point Therapeutics, Gilead, and Genentech.
•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 Equivalents and Marketable Securities
Cash, cash equivalents and marketable securities totaled $587.5 million as of December 31, 2025, compared to cash and cash equivalents of $681.1 million as of December 31, 2024. The $93.6 million decrease is primarily attributable to net cash used in operating activities of $445.9 million for the year ended December 31, 2025, the repayment of the Company’s previous term loan under its credit facility (including prepayment fees) of $459.0 million in February 2025, the repurchase of common stock of $48.3 million using proceeds from the 2031 Notes in February 2025, and payments for deferred royalty obligations of $15.5 million. These outflows were partially offset by net proceeds of $563.0 million from the issuance of the 2031 Notes in February 2025, net proceeds of $297.0 million from the execution of the Royalty Interest Purchase and Sale Agreement with HealthCare Royalty, a related party, and Blue Owl Capital in June 2025, and $19.9 million in net proceeds from equity incentive plan activities.
Total Revenues, Net
Three Months Ended December 31, Years Ended December 31,
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 December 31, 2025 were $154.2 million compared to $5.9 million for the same period in the prior year. The $148.3 million increase was primarily driven by a $143.1 million increase in net product revenue from Attruby, a $5.1 million increase in royalty revenue primarily earned on net product sales of BEYONTTRA in the EU and Japan, and a $0.1 million increase in license and services revenue.
Total revenues, net for the year ended December 31, 2025 was $502.1 million compared to $221.9 million in the prior year. The $280.2 million increase was primarily driven by a $359.5 million increase in net product revenue from Attruby and an $11.2 million increase in royalty revenue primarily earned on net product sales of BEYONTTRA in the EU and Japan. These increases were partially offset by a $90.5 million decrease in license and services revenue, reflecting the timing of recognition of upfront payments from the Company’s exclusive license agreements with collaboration partners as well as regulatory-related milestones recognized upon the approval of BEYONTTRA in the EU and pricing approval in Japan.

Operating Costs and Expenses
Three Months Ended December 31, Years Ended December 31,
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 December 31, 2025 were $293.7 million compared to $231.9 million for the same period in the prior year. The $61.8 million increase was primarily driven by a $63.3 million increase in selling, general and administrative ("SG&A") expenses largely reflecting the Company’s investments in support of the commercial launch and ongoing activities of Attruby, a $6.4 million increase in restructuring, impairment, and related charges as a result of the Company’s reprioritization of its research and development ("R&D") programs, and a $6.0 million increase in total cost of revenues, primarily due to the product costs of Attruby and royalty and license costs associated with BEYONTTRA net sales. These increases were partially offset by a $13.9 million decrease in R&D expenses primarily due to decreased R&D activities related to the Attruby and BEYONTTRA program following regulatory approval, the Company’s reprioritization of its R&D programs, and license fees incurred in 2024 related to program advancements.
Operating costs and expenses for the year ended December 31, 2025 were $1.0 billion compared to $814.9 million in the prior year. The $210.6 million increase was primarily driven by a $242.3 million increase in SG&A largely reflecting the Company’s investments to support the commercial launch and ongoing activities of Attruby, a $17.1 million increase in total cost of revenues primarily due to the product costs of Attruby and royalty and license costs associated with BEYONTTRA net sales, and a $5.7 million increase in restructuring, impairment, and related charges as a result of the Company’s reprioritization of its R&D programs. The increases were partially offset by a $54.5 million decrease in R&D expenses primarily due to decreased R&D activities related to the Attruby and BEYONTTRA program following regulatory approval, the Company’s reprioritization of its R&D programs, and license fees incurred in 2024 related to program advancements.
Stock-based compensation expenses included in operating costs and expenses for the three months ended December 31, 2025 were $34.9 million, of which $21.6 million was included in SG&A expenses, $11.7 million was included in R&D expenses, $0.9 million was included in restructuring impairment and related charges, and $0.7 million was included in cost of goods sold. Stock-based compensation expenses included in operating costs and expenses for the same period in 2024 were $36.4 million, of which $16.4 million was included in SG&A expenses and $20.0 million was included in R&D expenses.
Stock-based compensation expenses included in operating costs and expenses for the year ended December 31, 2025 were $136.9 million, of which $84.6 million was included in SG&A expenses, $49.3 million was included in R&D expenses, $1.7 million was included in restructuring impairment and related charges, and $1.3 million was included in cost of goods sold. Stock-based compensation expenses included in operating costs and expenses for the prior year were $113.9 million, of which $63.9 million was included in SG&A expenses, $49.8 million was included in R&D expenses, and $0.2 million was included in restructuring, impairment and related charges.

Total Other Income (Expense), Net
Total other income (expense), net for the three months and year ended December 31, 2025, was $(55.2) million and $(209.1) million, respectively, compared to $(40.2) million and $50.8 million, respectively, for the same periods in the prior year.
The change in total other income (expense), net of $(15.0) million for the three months ended December 31, 2025, compared to the same period in the prior year was primarily due to a $30.4 million increase in noncash interest expense on deferred royalty obligations and a $4.3 million increase in net loss from equity method investments; partially offset by a $9.9 million decrease in interest expense and a $10.2 million increase in other income primarily related to the change in fair value of our derivative liability.
The change in total other income (expense), net of $259.9 million for the year ended December 31, 2025, compared to the prior year was primarily due to a $178.3 million decrease in gain on deconsolidation of subsidiaries, a $116.8 million increase in noncash interest expense on deferred royalty obligations, and a $41.4 million increase in net loss from equity method investments. These increases were partially offset by a $37.9 million decrease in interest expense, a $19.7 million increase in other income for the change in fair value of our derivative liability, a $11.1 million increase in other income primarily due to gains related to our equity method and equity security investments, and a $5.4 million decrease in loss on extinguishments of debt.
Net Loss Attributable to Common Stockholders of BridgeBio and Net Loss per Share
For the three months and year ended December 31, 2025, the Company recorded a net loss attributable to common stockholders of BridgeBio of $192.9 million and $724.9 million, respectively, compared to $265.1 million and $535.8 million, respectively, for the same periods in the prior year.
For the three months and year ended December 31, 2025, the Company reported a net loss per share of $1.00 and $3.78, respectively, compared to $1.40 and $2.88, respectively, for the same periods in the prior year.

(Press release, BridgeBio, FEB 24, 2026, View Source [SID1234662985])

On February 24, 2026 Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW ("Alpha Tau"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported that Japan’s Ministry of Health, Labour and Welfare ("MHLW") has granted regulatory (Shonin) marketing approval for Alpha DaRT for the treatment of unresectable locally advanced or locally recurrent head and neck cancer.

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In Japan, the Shonin approval process is the most rigorous pathway for medical devices, conducted after a review and recommendation by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). This marks the first regulatory approval of the Alpha DaRT platform outside Israel. As part of the approval, Alpha Tau will need to conduct a post-market surveillance (PMS) study enrolling 66 patients in total at five selected leading clinical centers in Japan. The PMS study is intended to further evaluate the safety and clinical performance of Alpha DaRT in real-world clinical settings and to generate additional real-world clinical evidence in collaboration with Japanese physicians and treatment centers.

"Receiving Shonin approval in Japan is a significant milestone for Alpha Tau and for the Alpha DaRT platform," said Uzi Sofer, Chief Executive Officer of Alpha Tau. "Japan has granted our first marketing approval outside of Israel, and is a country with deep clinical expertise in head and neck oncology. We are grateful to HekaBio for their leadership during this process, and to the six medical societies in Japan who have continually provided their support for the approval and future launch of Alpha DaRT in Japan. Our immediate focus is on working closely with Japanese clinicians to complete the PMS study and to generate high-quality clinical data in patients with unresectable locally advanced or locally recurrent disease. In parallel we anticipate initiating discussions shortly with the MHLW regarding potential reimbursement approaches for Alpha DaRT in Japan. We believe this approval represents an important first step toward broader clinical evaluation of Alpha DaRT, and look forward to discussing with the PMDA further potential clinical studies in Japan evaluating the use of Alpha DaRT in additional tumor types."

Robert E. Claar, CEO of HekaBio K.K., said, "The Alpha DaRT program has been the primary focus for our team for 7 years, and we’re delighted to reach this Shonin milestone with Alpha Tau Medical for the benefit of patients in Japan. Along the way, we got strong and continuous support from medical professionals, regulators and the government of Japan to enable approval for this breakthrough therapy. An approval in Japan in advance of the US and Europe for a foreign-originated new category medical device is an extremely rare event, and we’re grateful to all of our partners who made this possible. Our team is enthusiastically preparing to launch Alpha DaRT to deliver hope and clinical benefit to patients in Japan."

Dr. Jun Itami, Director, High-Precision Radiation Therapy Center, Shin-Matsudo Central General Hospital, said, "Through this domestic clinical trial, Alpha DaRT has demonstrated promise, representing a major advance in the fight against cancer. Demonstrating the efficacy of intratumoral alpha-particle radiation therapy, a modality long considered difficult to implement, for patients who have not responded to conventional therapies is a highly meaningful achievement, offering a new treatment option.

By confirming both safety and efficacy in this study, we have opened the door to delivering this therapy in real-world clinical practice, thereby expanding the range of treatment options available to patients. This outcome also provides important insights for future clinical research aimed at broadening indications.

Bringing hope to patients and their families by offering ‘a new treatment option’ is not only clinically valuable but also provides psychological support in the care setting. Alpha DaRT holds the potential to turn that hope into reality.

Further validation and long-term safety evaluation will be necessary, but we are confident that these results represent a major step forward in advancing discussions toward broader clinical application."

(Press release, Alpha Tau Medical, FEB 24, 2026, View Source [SID1234662897])

On February 24, 2026 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, reported positive early data from a pilot clinical trial led by Memorial Sloan Kettering Cancer Center (MSKCC) and supported by Iovance of lifileucel in patients with advanced (metastatic or unresectable) undifferentiated pleomorphic sarcoma (UPS) or dedifferentiated liposarcoma (DDLPS) who were refractory to at least one prior line of systemic therapy.

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Among the first six evaluable patients treated with lifileucel monotherapy, physician-assessed confirmed ORR by RECIST v1.1 was 50%. All evaluable patients had advanced disease, were refractory to prior therapy, and had significant disease burden, with a mean sum of diameters of 117 millimeters at baseline and a mean of more than two prior lines of therapy. Patients experienced deep responses that improved over time, consistent with lifileucel in melanoma, non-small-cell lung cancer, and other solid tumors. The safety profile was favorable and consistent with lifileucel therapy in other indications. Based on these results, Iovance plans to commence a single arm registrational trial in second-line advanced UPS and DDLPS in the second quarter of 2026 and will engage with the U.S. Food and Drug Administration (FDA) on an accelerated path to expedite approval. Iovance also plans to explore lifileucel in other high grade soft tissue sarcoma subtypes with high unmet need as part of its clinical development program.

UPS and DDLPS are high grade, aggressive soft tissue sarcomas associated with poor prognosis that impact more than 3,000 patients in the U.S. and more than 5,000 patients in Europe annually, including more than 3,500 patients with advanced disease.1-3 There is a high unmet medical need for new treatment options for second-line patients with recent clinical studies reporting ORRs of less than 5%, median progression-free survival (mPFS) of ~2-3 months, and median overall survival (mOS) of ~9-10 months.4-6

Lauren Baker Banks, MD, PhD, Sarcoma Medical Oncologist, MSKCC, stated, "In the first clinical trial of a TIL cell therapy in UPS and DDLPS, one-time treatment with lifileucel demonstrated compelling and unprecedented response rates with the potential to address a significant unmet need in patients who are refractory to frontline standard of care. Patients with UPS and DDLPS suffer from high disease burden, poor quality of life, and a lack of effective treatments, including no approved immunotherapy options. In the second-line setting, mPFS for many patients is only a few months with mOS less than a year. We look forward to presenting these results at a medical conference in 2026."

Dr. Brian Gastman, EVP Translational Medicine and Research at Iovance, stated, "The exciting clinical results show that lifileucel could offer a new, highly efficacious, and durable immunotherapy option in two aggressive forms of advanced sarcoma and further illustrate the promise of our TIL cell therapy platform to offer meaningful clinical benefit in multiple solid tumor cancers. Chemotherapy with extremely poor efficacy remains the second-line standard of care for these patients after progression on front-line chemotherapy. We look forward to bringing lifileucel to UPS and DDPLS patients as quickly as possible."

(Press release, Iovance Biotherapeutics, FEB 24, 2026, View Source [SID1234662917])

On February 24, 2026 TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA" or the "Company"), a Phase 3 immuno-oncology company developing novel therapeutics to overcome resistance to cancer immunotherapy, reported that Dr. James Bianco, President and Chief Executive Officer, will participate in the following upcoming investor conferences:

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Citizens Life Science Conference
Date: Tuesday, March 10, 2026
Time: 4:00 pm ET
Links: To register and view presentation, click HERE. A live and archived webcast of the presentation will also be available through the investors page of TuHURA’s corporate website at View Source

Leerink Global Healthcare Conference
Date: Wednesday, March 11, 2026
Time: TuHURA will be available to meet 1×1 with investors
Links: To request a meeting, please contact your Leerink representative

(Press release, TuHURA Biosciences, FEB 24, 2026, View Source [SID1234662939])

On February 24, 2026 MiraDx, a molecular diagnostics company focused on genetic testing to personalize cancer treatment, reported the U.S. commercial launch of PROSTOX Standard, a new, clinically validated genetic test that expands access to personalized radiation therapy for patients with localized prostate cancer. The test identifies those at increased risk of developing long-term urinary side effects following conventionally fractionated or moderately hypofractionated radiation therapy (CFRT or MHFRT), and complements the company’s existing PROSTOX Ultra offering, for patients being considered for stereotactic body radiation therapy (SBRT). By offering both tests, MiraDx is expanding access to toxicity risk assessment testing to a broader group of prostate cancer patients at risk for genitourinary (GU) toxicity following external beam radiation therapy (EBRT).

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While EBRT is an effective and widely used treatment for localized prostate cancer, more than 20% of patients treated with radiation therapy experience persistent urinary side effects, referred to as late GU toxicity.1 PROSTOX tests help predict late-onset genitourinary (GU) toxicity—side effects such as urinary urgency, leakage, or discomfort—that can appear months or years after radiation treatment and significantly impact quality of life.

Localized prostate cancer has an excellent prognosis with a five-year survival rate of over 99%.2 Although SBRT, CFRT, and MHFRT have similar efficacy in this population, individual responses to each treatment method can vary due to a patient’s genetics. Until now, clinicians have lacked a biology-driven tool to identify which patients are most at risk for GU toxicity from each EBRT method. PROSTOX tests address this gap by analyzing inherited genetic variants in microRNAs and their pathways that influence how individual patients tolerate radiation. Using a simple cheek swab, PROSTOX delivers actionable results in 5-7 days, enabling physicians and patients to make more personalized radiation treatment decisions based upon each patient’s individual side effect risk profile.

"PROSTOX tests bring precision medicine to radiation oncology by shifting the focus from the tumor alone to determining the most effective treatment approach for each patient based upon their unique biology and resulting treatment risks," said Melissa C. Stoppler, MD, Executive Vice President of Medical Affairs at MiraDx. "Having information about which type of radiation each patient will tolerate best allows clinicians to better tailor radiation treatments to patients, helping them avoid future long-term side effects."

Each PROSTOX test evaluates genetic risk across a different radiation therapy regimen. A result that a patient is at high risk with PROSTOX Standard does not imply a high-risk result for PROSTOX Ultra, and vice versa. In rare cases (less than 2% of patients), PROSTOX tests will identify that a patient has a high risk for late GU side effects with both SBRT and CFRT/MHFRT. For these patients, other interventions may be available.

"Being diagnosed with prostate cancer is life altering and comes with many decisions and so much uncertainty," said Ron Stewart, a patient who received PROSTOX testing. "The PROSTOX test helped me feel more confident about my treatment plan and more optimistic that my cancer treatment would not hamper my quality of life down the road."

PROSTOX Standard and PROSTOX Ultra are commercially available in the U.S. and performed at MiraDx’s CLIA-certified and CAP-accredited molecular diagnostics laboratory in Los Angeles, Calif. Coverage may vary by insurance plan. MiraDx offers a financial assistance program to help ensure patient access to PROSTOX tests.

About PROSTOX Tests

PROSTOX tests are clinically validated diagnostic tests used to predict genitourinary toxicity following external beam radiation therapy (EBRT). The tests analyze inherited genetic variants in microRNAs and their pathways that influence how individual patients tolerate radiation, delivering actionable insights to enable clinicians to make informed therapeutic choices with their families. The PROSTOX Standard test is designed to predict toxicity following CFRT (37-45 fractions over 7-9 weeks) or MHFRT (20-28 fractions over 4-5 weeks). The PROSTOX Ultra test is designed to predict toxicity following SBRT (5–7 fractions over approximately 10 days).

(Press release, MiraDx, FEB 24, 2026, View Source [SID1234662956])