Veracyte to Highlight Extensive Decipher® Data at 2026 ASCO GU Symposium

On February 24, 2026 Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, reported more than 15 abstracts featuring its urology portfolio will be presented at the 2026 ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU). The abstracts span studies across prostate and bladder cancers, featuring real-world data for Decipher Prostate and new insights from phase II clinical trials, including one utilizing the company’s upcoming TrueMRD Muscle-Invasive Bladder Cancer (MIBC) test. Collectively, these studies highlight how Veracyte’s Decipher and TrueMRD genomic tests are increasingly helping to guide clinical decision-making, advance biological understanding, and accelerate innovation in urologic cancer care. The conference will take place February 26-28 in San Francisco.

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"The breadth of data at ASCO (Free ASCO Whitepaper) GU shows how our Veracyte Diagnostics Platform is driving meaningful insight across multiple urologic cancers," said Elai Davicioni, Ph.D., Veracyte’s medical director, Urology. "In bladder cancer, Decipher is increasingly being integrated into studies that aim to help guide treatment decisions. With TrueMRD, our whole-genome sequencing minimal residual disease platform, we are extending the understanding of tumor evolution and treatment resistance, while also providing critical information to ensure the earlier detection of recurrent disease when a cure may still be achievable."

One of the key studies being presented is SURE‑02, a phase II trial examining how genomic subtyping with the Decipher Bladder test can inform treatment approaches in bladder cancer.

"The findings underscore the importance of molecular subtyping in muscle‑invasive bladder cancer and support the integration of genomic classifiers, such as the Decipher Bladder test, into clinical trial design, for the first time suggesting a biologically informed strategy for the use of anti-TROP2 ADCs," said Andrea Necchi, M.D., principal investigator of the SURE‑02 trial. "This approach enables a more rational selection of novel treatment strategies and represents an important step in aligning clinical research with precision‑based care."

Other highlights at the conference include an oral presentation with data on Veracyte’s upcoming TrueMRD MIBC test in the HCRN GU 20-444 response guided bladder-sparing trial and results for Decipher Bladder from NURE-combo and BLASST-01 trials:

Title:

Phase 2 trial of pembrolizumab (P) with response-guided bladder-sparing in patients with muscle-invasive bladder cancer (MIBC; HCRN GU 20-444).

Presenter:

Jonathan Anker, M.D., Ph.D., Mount Sinai Tisch Cancer Center

Format:

Rapid Oral Abstract Session

Abstract #:

737

Date/Time:

Friday, February 27, 2026, 4:00 – 4:45 PM PST

Location:

Level 3, Ballroom

Title:

Neoadjuvant sacituzumab govitecan (SG) plus pembrolizumab (Pembro), followed by response-adapted bladder sparing and adjuvant pembro, in patients with muscle-invasive bladder cancer (MIBC): SURE-02 primary analysis and biomarker results.

Presenter:

Andrea Necchi, M.D., IRCCS San Raffaele Hospital, Comprehensive Cancer Center

Format:

Poster (#H1)

Abstract #:

769

Date/Time:

Friday, February 27, 2026, 11:30 – 12:45 PM PST

Location:

Level 1, West Hall

Title:

Association of non-luminal subtype with overall survival in high-risk non-muscle invasive bladder cancer patients: Biomarker results from the Bladder Cancer Prognosis Programme.

Presenter:

Joep J. de Jong, M.D., Erasmus MC Cancer Institute, Rotterdam, Netherlands

Format:

Poster (#K23)

Abstract #:

843

Date/Time:

Friday, February 27, 2026, 11:30 – 12:45 PM PST

Location:

Level 1, West Hall

Title:

Association between non-luminal molecular subtypes and complete response rates after neoadjuvant chemo-immune therapy for muscle-invasive bladder cancer: Biomarker analyses of NURE-combo and BLASST-01 phase 2 clinical trials.

Presenter:

Joep J. de Jong, M.D., Erasmus MC Cancer Institute, Rotterdam, Netherlands

Format:

Poster (#K25)

Abstract #:

845

Date/Time:

Friday, February 27, 2026, 11:30 – 12:45 PM PST

Location:

Level 1, West Hall

Additionally, Veracyte continues to strengthen the connection of real-world data and outcomes to the Decipher Prostate test and the Decipher Genomics Research for Intelligent Discovery (GRID) platform, with several abstracts being showcased at the conference including:

Title:

Transcriptomic characterization of prostate cancer in patients with HIV infection.

Presenter:

Michael Leapman, M.D., Department of Urology, Yale School of Medicine

Format:

Poster (#M24)

Abstract #:

396

Date/Time:

Thursday, February 26, 2026, 11:30 – 12:45 PM PST

Location:

Level 1, West Hall

Title:

Comprehensive analysis of androgen production, uptake, and conversion (APUC) genes to highlight SRD5 family diversity in a large localized prostate cancer cohort.

Presenter:

Xiaolei Shi, M.D., University of Maryland School of Medicine

Format:

Poster (#M10)

Abstract #:

382

Date/Time:

Thursday, February 26, 2026, 11:30 – 12:45 PM PST

Location:

Level 1, West Hall

Veracyte’s Decipher team will be at Booth #48 at the 2026 ASCO (Free ASCO Whitepaper) GU Symposium. More information, including a full list of Decipher-focused abstracts being presented, can be found here.

About Decipher Prostate

The Decipher Prostate Genomic Classifier is a 22-gene test, developed using RNA whole-transcriptome analysis and machine learning, that helps inform treatment decisions for patients with prostate cancer. The test is performed on biopsy or surgically resected samples and provides an accurate risk of developing metastasis with standard treatment. Armed with this information, physicians can better personalize their patients’ care and may recommend less-intensive options for those at lower risk or earlier, more-intensive treatment for those at higher risk of metastasis. The Decipher Prostate test has been validated in many dozens of published studies involving more than 100,000 patients. It is the only gene expression test to achieve "Level 1B" evidence status and inclusion in the risk-stratification table in the most recent NCCN Guidelines* for prostate cancer. More information about the Decipher Prostate test can be found here.

About Decipher Bladder

The Decipher Bladder Genomic Classifier is a 219-gene test, developed using RNA whole-transcriptome analysis and machine learning, that is designed for use in patients following bladder cancer diagnosis who face questions regarding treatment intensity. The test classifies bladder tumors into five molecular subtypes, each having distinct tumor biology and potential clinical implications. This information can help physicians and their patients better understand the degree of benefit that would likely be gained from neoadjuvant chemotherapy and/or the likelihood of harboring non-organ-confined disease at time of surgery, respectively. More information about the Decipher Bladder test can be found here.

About Decipher GRID

The Decipher GRID database includes more than 200,000 whole-transcriptome profiles from patients with urologic cancers and is used by Veracyte and its partners to contribute to continued research and help advance understanding of prostate and other urologic cancers. GRID-derived information is available on a Research Use Only basis. More information about Decipher GRID can be found here.

About TrueMRD

Veracyte’s TrueMRD testing approach uniquely gives clinicians a comprehensive picture of their patient’s cancer status at every step, enabling them to personalize post-treatment care. From a small blood sample, we use AI and whole-genome sequencing to create a custom, molecular "fingerprint" for each patient’s tumor and then track the cancer’s recurrence and evolution over time. We plan to begin making our first TrueMRD test—for muscle-invasive bladder cancer—available to clinicians in the first half of 2026 and then expand to other cancers. More information about Veracyte’s TrueMRD testing approach can be found here.

(Press release, Veracyte, FEB 24, 2026, View Source [SID1234662933])

UroGen Pharma to Present at the TD Cowen 46th Annual Health Care Conference

On February 24, 2026 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported that management will present at the TD Cowen 46th Annual Health Care Conference to take place March 2-4, 2026.

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TD Cowen 46th Annual Health Care Conference

Date / Time: March 3, 2026, at 1:50 PM ET
Format: Presentation and 1×1 investor meetings
Location: Boston, MA
Webcast Link: here
The webcast from the conference will also be available on UroGen’s corporate website, under Events & Presentations. A replay will be available for approximately 30 days.

(Press release, UroGen Pharma, FEB 24, 2026, View Source [SID1234662932])

Supernus Announces Record Fourth Quarter and Full Year 2025 Financial Results

On February 24, 2026 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported financial results for the fourth quarter and full year 2025 and associated Company developments.

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"We made significant progress in 2025 against our strategic objectives, with record total revenues, including strong growth in combined revenues of our growth products, the successful acquisition of Sage Therapeutics, Inc., and the U.S. Food and Drug Administration’s approval and launch of ONAPGO for Parkinson’s disease," said Jack Khattar, President and CEO of Supernus. "In 2026, we are focused on continued progress of our key growth products, including resumption of new patient initiation for ONAPGO, while advancing our pipeline of promising therapeutic candidates."

Commercial Highlights

The Company has made progress securing additional product supply of ONAPGO from the current supplier and as a result has resumed new patient initiation. In addition, the Company is working with a second supplier, which is expected to begin supplying ONAPGO in 2027.
ONAPGO net product sales were $8.9 million in the fourth quarter of 2025 following the U.S. commercial launch in April 2025. Since launch, more than 1,800 enrollment forms have been submitted by over 540 prescribers.
Collaboration revenue from ZURZUVAE was $32.8 million in the fourth quarter of 2025. Collaboration revenue (ZURZUVAE) represents 50% of the net revenues for ZURZUVAE recorded by Biogen Inc. Fourth quarter 2025 U.S sales of ZURZUVAE, as reported by Biogen Inc., increased approximately 187% compared to the same period in 2024 and approximately 19% compared to the third quarter of 2025. The total number of prescriptions for ZURZUVAE increased by more than 150% in 2025 compared to 2024.
Net sales of Qelbree increased 9% to $81.0 million in the fourth quarter of 2025, compared to the same period in 2024, driven primarily by volume growth and partially offset by an annual gross-to-net deduction that was reflected in fourth quarter 2025. Total IQVIA prescriptions(5) for Qelbree were 253,742 for the fourth quarter 2025, representing an increase of 18% compared to the same period in the prior year.
Net sales of GOCOVRI increased 5% to $38.6 million in the fourth quarter of 2025, compared to the same period in 2024. Total number of prescriptions grew by 14% in 2025 compared to 2024.

Product Pipeline Update

SPN-817 – Novel first-in-class highly selective AChE inhibitor for epilepsy

The Phase 2b randomized, double-blind, placebo-controlled study of 3mg and 4mg twice daily doses is ongoing with a targeted enrollment of approximately 258 adult patients with treatment resistant focal seizures.

SPN-820 – Novel first-in-class molecule that increases mTORC1 mediated synaptic function for depression

The Company initiated a follow-on Phase 2b multi-center, randomized, double-blind, placebo-controlled trial in approximately 200 adults with major depressive disorder (MDD). The study will examine the safety and tolerability of SPN-820 2400 mg given intermittently (twice weekly) as an adjunctive treatment to the current baseline antidepressant therapy, as well as assess the rapid onset of improvement in depressive symptoms.

SPN-443 – Novel stimulant for attention-deficit/hyperactivity disorder (ADHD)

The Company expects to initiate a Phase 1 single-ascending/multiple-ascending dose study in adult healthy volunteers in the second half of 2026.

Financial Highlights

This section includes information on non-GAAP financial measures. See "Non-GAAP Financial Information" section for information on non-GAAP financial measures. In addition, a reconciliation of applicable GAAP to non-GAAP financial information is included at the end of this press release.

Revenues

The following table provides information regarding total revenues (dollars in millions):

Three Months Ended
December 31,
Years Ended
December 31,

2025 2024 Change % 2025 2024 Change %
(unaudited) (unaudited)
Net product sales
Qelbree $ 81.0 $ 74.4 9 % $ 304.7 $ 241.3 26 %
GOCOVRI 38.6 36.9 5 % 146.8 130.8 12 %
APOKYN 9.6 20.1 (52 )% 47.8 73.9 (35 )%
Trokendi XR 8.4 14.8 (43 )% 42.4 63.2 (33 )%
Oxtellar XR 6.8 13.2 (48 )% 40.7 99.5 (59 )%
ONAPGO 8.9 — 100 % 17.3 — 100 %
Other(2) 4.8 7.0 (31 )% 26.9 29.0 (7 )%
Total net product sales 158.1 166.4 (5 )% 626.6 637.7 (2 )%
Collaboration revenue (ZURZUVAE)(3) 32.8 — 100 % 53.0 — 100 %
Royalty, licensing and other revenues(4) 20.7 7.8 165 % 39.4 24.1 63 %
Total revenues $ 211.6 $ 174.2 21 % $ 719.0 $ 661.8 9 %

Total revenues excluding Trokendi XR and Oxtellar XR net sales (non-GAAP)(1) $ 196.4 $ 146.2 34 % $ 635.9 $ 499.1 27 %

Other Financial Highlights

The Company recognized $15.0 million of licensing revenue in the fourth quarter of 2025 related to the achievement of a regulatory milestone under its collaboration agreement with Shionogi.
Operating loss was $4.0 million and $62.3 million for the three and twelve months ended December 31, 2025, compared to operating earnings of $21.4 million and $81.7 million for the same periods in 2024. The change in both periods was primarily due to higher selling, general and administrative expenses, including approximately $72.9 million of acquisition-related costs associated with the Sage acquisition reported in 2025, change in contingent consideration loss (gain), and incremental intangible asset amortization expense for ZURZUVAE and ONAPGO intangible assets in 2025, partially offset by higher revenues.
Adjusted operating earnings (non-GAAP)(1) were $48.5 million and $158.7 million for the three and twelve months ended December 31, 2025, compared to $48.3 million and $183.7 million for the same periods in 2024.
Net loss and diluted loss per share were $4.1 million and $0.07 for the three months ended December 31, 2025, and $38.6 million and $0.68 for the twelve months December 31, 2025, respectively, compared to net earnings and diluted earnings per share of $15.3 million and $0.27 for the three months ended December 31, 2024, and $73.9 million and $1.32 for the twelve months December 31, 2024, respectively.
Cash, cash equivalents, and current marketable securities were approximately $308.7 million as of December 31, 2025, compared to $453.6 million as of December 31, 2024. This decrease was primarily due to the funding of the Sage acquisition, partially offset by cash generated from operations.

Full Year 2026 Financial Guidance

The Company expects to achieve the following financial objectives in 2026 (dollars in millions):

Full Year 2026 Guidance
(as of February 24, 2026)
Total revenues include the following(6):
◦ ONAPGO net sales of $45 million – $70 million
◦ Trokendi XR and Oxtellar XR net sales of $40 – $50 million $840 – $870
Combined R&D and SG&A expenses $620 – $650
Operating earnings $0 – $30
Adjusted operating earnings (non-GAAP)(1) $140 – $170

Non-GAAP Financial Information

This press release contains financial measures that present financial information which do not comply with United States generally accepted accounting principles (GAAP). The non-GAAP financial measures should be considered in addition to, not as a substitute for or in isolation from, or superior to measures prepared in accordance with GAAP. Non-GAAP adjusted operating earnings on a historical and projected basis adjusts for non-cash share-based compensation expense, depreciation and amortization, intangible asset impairment charges and changes to fair value of contingent consideration, and for factors that are unusual, non-recurring or unpredictable, and excludes those costs, expenses, and other specified items presented in the reconciliation tables in this press release. In addition to non-GAAP adjusted operating earnings, we also present total revenues excluding net sales of Trokendi XR (GAAP) and Oxtellar XR (GAAP), which is a non-GAAP measure and is calculated as total revenues (GAAP) less net product sales of Trokendi XR (GAAP) and Oxtellar XR (GAAP). Beginning in the year a product loses exclusivity due to generic entrants, we generally do not expect net product sales of such products to constitute a significant part of our revenue in the future. We believe that the use of non-GAAP financial measures provides useful supplemental information to management, investors, analysts and others regarding the Company’s revenue and results of operations and assist management, investors, analysts, and others in understanding and evaluating our revenue growth and the performance of the business.

There are limitations associated with the use of non-GAAP financial measures and therefore comparability may be limited. These limitations include: non-GAAP financial measures that may not be entirely comparable to similarly titled measures used by other companies; these may not reflect all items of income and expense, as applicable, that affect our operations; there may be potential differences among calculation methodologies; these may differ from the non-GAAP information used by other companies, including peer companies. We mitigate these limitations by reconciling the non-GAAP financial measure to the most comparable GAAP financial measure. Investors are encouraged to review the reconciliation. The Company’s 2026 financial guidance is also being provided on both a GAAP and a non-GAAP basis.

End Notes
(1) See the section titled "Non-GAAP Financial Information" for information about this non-GAAP financial measure. A reconciliation of each non-GAAP financial measure to the most directly comparable GAAP financial measure is included at the end of this press release.
(2) Includes net product sales of MYOBLOC, XADAGO and Osmolex ER.
(3) Represents proportionate share of collaboration revenue from Biogen’s sales of ZURZUVAE to customers in the U.S. from July 31, 2025, the closing of the Sage acquisition.
(4) Royalty, licensing, and other revenues include royalties on generic Trokendi XR, Oxtellar XR, other licensed products and intellectual property.
(5) IQVIA data restatement July 1, 2025.
(6) Includes net product sales, collaboration revenue, and royalty, licensing, and other revenue.

Conference Call Details

Supernus will host a conference call and webcast today, February 24, 2026, at 4:30 p.m. Eastern Time to discuss these results. A live webcast will be available in the Events & Presentations section of the Company’s Investor Relations website www.supernus.com/investors.

Participants may also pre-register any time before the call here. Once registration is completed, participants will be provided a dial-in number with a personalized conference code to access the call. Please dial in 15 minutes prior to the start time.

Following the live call, a replay will be available on the Company’s Investor Relations website www.supernus.com/investors. The webcast will be available on the Company’s website for 60 days following the live call.

(Press release, Supernus, FEB 24, 2026, View Source [SID1234662931])

Soligenix to Present at BIO Investment & Growth Summit

On February 24, 2026 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported that Christopher J. Schaber, Ph.D., President & Chief Executive Officer will deliver a corporate presentation at the BIO Investment & Growth Summit at 3:00 PM on Monday, March 2. The BIO Investment & Growth Summit, held March 2 to 3 at Eden Roc Miami Beach, in Miami Beach, Florida, will include innovative programs, one-on-one meetings, and company presentations. For more information please refer to the conference website at View Source

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Registered conference attendees may schedule a meeting with Soligenix via the conference scheduling platforms. If you are unable to attend the conferences and would like to schedule a meeting with management, please contact [email protected].

(Press release, Soligenix, FEB 24, 2026, View Source [SID1234662930])

Nykode Therapeutics Announces New Interim Data from the VB-C-03 Trial Showing Encouraging Anti-Tumor Activity and Tolerability of Abi-suva (VB10.16)

On February 24, 2026 Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported data from the phase 1 dose-escalation part of the VB-C-03 trial (N=13). The data will be further elaborated at an oral presentation by Dr. Caroline Even, Institut Gustave Roussy, Villejuif (Paris) at the 10th International Congress on Innovative Approaches in Head & Neck Oncology (ICHNO) on March 20, 2026. A full abstract is expected to be published by ICHNO before the congress.

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The VB-C-03 trial is investigating abi-suva in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in 1st line unresectable recurrent or metastatic oropharyngeal head and neck cancer patients (NCT06016920). Nykode is further advancing abi-suva development in 1st line head and neck cancer through the Abili-T phase 2 randomized clinical trial.

The phase 1 VB-C-03 data show that anti-tumor activity was observed with a final confirmed objective response rate (ORR) of 38.5%. The data demonstrates that abi-suva elicits rapid, strong and durable HPV16-specific T cell responses. Robust and durable T cell expansion in the circulation was also confirmed by TCR sequencing. The data also demonstrate that all tested doses of abi-suva in combination with pembrolizumab were well tolerated and showed a favorable safety profile.

Michael Engsig, Chief Executive Officer of Nykode, commented: "The objective response rate of 38.5% for the combination treatment compared to historical 19% of standard of care gives us confidence in abi-suva heading into the Abili-T trial which is investigating the same regiment in a randomized controlled setting. This is the third trial for abi-suva indicating effect across three different patient groups including both head and neck as well as cervical cancer."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. KEYTRUDA has been supplied by MSD for the VB-C-03 trial according to the clinical trial collaboration and supply agreement between Nykode and MSD.

(Press release, Nykode Therapeutics, FEB 24, 2026, View Source [SID1234662929])