On February 24, 2026 Aktis Oncology, Inc. (NASDAQ:AKTS), a clinical-stage oncology company focused on expanding the breakthrough potential of targeted radiopharmaceuticals to large patient populations, including those not addressed by existing platform technologies, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to AKY-1189 for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who have progressed on or after prior systemic therapies. Generated using Aktis’ miniprotein radioconjugate platform, AKY-1189 is designed to deliver actinium-225 (225Ac), a highly potent alpha-emitting radioisotope, to Nectin-4 expressing tumors. Approximately 80 – 90% of urothelial cancer patients show positive expression of Nectin-4.

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Fast Track designation is an FDA process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to bring important new drugs to patients earlier. A drug that receives Fast Track designation may be eligible for more frequent interactions and communications with the FDA and the ability to submit a Biologics License Application on a rolling basis.

"Patients with locally advanced or metastatic urothelial cancer who progress on systemic therapies, such as PADCEV, have limited treatment options," said Akos Czibere, MD, PhD, Chief Medical Officer of Aktis Oncology. "The granting of Fast Track designation affords us a unique opportunity to work closely with the FDA to potentially expedite the development and review process of AKY-1189 with the goal of addressing this unmet medical need by bringing a new therapeutic option to patients with locally advanced or metastatic urothelial cancer."

Aktis is currently conducting a multi-site Phase 1b clinical trial (NCT07020117) of AKY-1189 in the United States for the treatment of locally advanced or mUC, breast cancer, non-small cell lung cancer, colorectal cancer, cervical cancer, and head and neck cancer. Aktis expects to present preliminary results from Part 1 of the trial in the first quarter of 2027.

About Aktis’ Radioconjugate Platform
Aktis has developed a proprietary, isotope-agnostic miniprotein radioconjugate platform to selectively deliver the tumor-killing properties of radioisotopes to targeted tumors. Aktis’ therapeutic miniprotein radioconjugates are designed to maximize anti-cancer activity through high penetration, internalization and retention in cancer cells, while quickly clearing from normal organs and tissues. The Aktis platform further enables clinicians to visualize and verify target engagement with imaging isotopes prior to exposure to therapeutic radioisotopes. Leveraging this platform, Aktis is advancing a pipeline of next-generation targeted radiopharmaceuticals to address the unmet needs of patients across a broad spectrum of solid tumors.

(Press release, Aktis Oncology, FEB 24, 2026, View Source [SID1234662967])

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])

On February 19, 2026 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, reported the launch of an underwritten public offering of $100 million of its common stock. Candel also intends to grant the underwriters a 30-day option to purchase up to an additional $15 million shares of its common stock on the same terms and conditions. All shares of common stock to be sold in the offering will be offered by Candel. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering.

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Candel intends to use the net proceeds from the offering to complete critical launch readiness, medical affairs, pre-commercialization, and commercial activities for aglatimagene besadenovec (CAN-2409 or aglatimagene) in early, localized prostate cancer, ongoing development costs related to the phase 3 trial of aglatimagene in non-small cell lung cancer (NSCLC), and for general corporate purposes.

Citigroup, Cantor, and Stifel are acting as joint bookrunning managers for the offering. LifeSci Capital is acting as lead manager for the offering. H.C. Wainwright & Co. and Brookline Capital Markets, a division of Arcadia Securities, LLC, are acting as co-managers for the offering.

A shelf registration statement on Form S-3 relating to the shares of common stock offered in the public offering described above was filed with the Securities and Exchange Commission (the "SEC") on August 14, 2025 and declared effective by the SEC on August 22, 2025. The offering will be made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus, when available, may also be obtained by contacting Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, telephone: 1-800-831-9146; Cantor Fitzgerald & Co., Attention: Equity Capital Markets, 110 E. 59th Street, 6th Floor, New York, New York 10022, or by email at [email protected]; or Stifel, Nicolaus & Company, Incorporated, Attention: Prospectus Department, One Montgomery Street, Suite 3700, San Francisco, California 94104, by telephone at (415) 364-2720 or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

(Press release, Candel Therapeutics, FEB 23, 2026, View Source [SID1234662849])

On February 23, 2026 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported financial results and operational updates for the quarter and year ended December 31, 2025.

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"2025 was a transformational year for ORIC highlighted by clinical data that further demonstrated the potential best-in-class profiles of rinzimetostat in prostate cancer and enozertinib in lung cancer," said Jacob M. Chacko, M.D., president and chief executive officer. "Those data, along with substantially extended cash runway, position us well for 2026 and beyond as we advance our programs towards registrational studies."

2025 Key Accomplishments

Rinzimetostat: a potent and selective allosteric inhibitor of PRC2

Completed Phase 1b dose exploration in prostate cancer and selected provisional recommended Phase 2 doses (RP2Ds) of rinzimetostat to be tested in combination with the approved doses of darolutamide and apalutamide in dose optimization.
Reported potential best-in-class efficacy and safety dose exploration data in combination with darolutamide and with apalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC). Data demonstrated:
PSA responses and ctDNA reductions across all rinzimetostat dose levels and at comparable rates in combination with apalutamide or with darolutamide.
Broad and deep PSA responses that compare favorably to competitor PRC2 inhibitors, with 55% of patients (11/20) achieving a PSA50 response (confirmed in 40%), and 20% of patients (4/20) achieving a PSA90 response (all confirmed).
Rapid and deep ctDNA responses across a breadth of AR mutations and other gene alterations, with 76% (13/17) achieving > 50% ctDNA reduction, and 59% (10/17) achieving ctDNA clearance, which is greater than clearance rates observed in precedent trials with standard of care agents in comparable mCRPC patient populations.
Both combination regimens demonstrated a clearly differentiated safety profile compatible with long-term dosing, with the vast majority of treatment-related adverse events (TRAEs) Grade 1 or 2 in severity and consistent with PRC2 and AR inhibition.
Presented preclinical data at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics demonstrating potential utility of rinzimetostat combined with AR inhibition in castration-sensitive prostate cancer and combined with KRAS inhibition in KRAS G12C-mutant NSCLC and colorectal cancer models.
Enozertinib: a brain-penetrant inhibitor that selectively targets EGFR exon 20 and EGFR PACC mutations

Reported potential best-in-class efficacy and safety data from a Phase 1b trial of enozertinib at the ESMO (Free ESMO Whitepaper) Asia Congress 2025 in NSCLC patients with EGFR exon 20 and EGFR PACC mutations. Data demonstrated:
Systemic activity in 2L EGFR exon 20 and pretreated EGFR PACC exceeding competitor benchmarks.
Highly competitive preliminary 1L systemic activity, with 67% ORR in EGFR exon 20 and 80% ORR in EGFR PACC.
Convincing 1L CNS activity, with 100% intracranial ORR in EGFR exon 20 and 100% intracranial ORR in EGFR PACC in patients with measurable CNS disease, including in patients with active brain metastases.
Competitive safety profile, with no significant off-target toxicity, resulting in low rate of treatment discontinuations.
Announced a clinical trial collaboration and supply agreement with Johnson & Johnson to evaluate enozertinib in combination with amivantamab and hyaluronidase-lpuj subcutaneous injection (SC amivantamab) for the 1L treatment of NSCLC patients with EGFR exon 20 mutations.
Announced publication in Cancer Research of preclinical data demonstrating enozertinib’s exquisite selectivity, strong potency, brain penetrance, and antitumor activity across a broad range of EGFR exon 20 and PACC mutant models.
Anticipated Program Milestones:

ORIC anticipates the following upcoming milestones:

Rinzimetostat in mCRPC:
1Q 2026: Combination dose optimization data with AR inhibitor
1H 2026: Initiate first global Phase 3 registrational trial in mCRPC
2H 2026: Program update
Enozertinib in NSCLC:
2H 2026: 1L EGFR exon 20 monotherapy data and combination data with SC amivantamab
2H 2026: 1L EGFR PACC monotherapy data
Fourth Quarter and Full Year 2025 Financial Results

Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments totaled $392.3 million as of December 31, 2025, which includes net proceeds of $124.4 million from a private placement financing in May 2025 and $117.6 million from the company’s ATM program in 2025. Subsequent to the quarter ended December 31, 2025, the company raised an additional $20.0 million in net proceeds from a healthcare specialist fund under the ATM program resulting in proforma cash and investments of $412.3 million as of December 31, 2025. The company expects its cash and investments to fund the current operating plan into 2H 2028.

R&D Expenses: Research and development (R&D) expenses were $25.9 million for the three months ended December 31, 2025, compared to $32.0 million for the three months ended December 31, 2024, a decrease of $6.1 million. For the year ended December 31, 2025, R&D expenses were $109.8 million compared to $114.1 million for the same period in 2024, a decrease of $4.3 million. The decreases were due to lower rinzimetostat drug manufacturing costs and lower costs from discontinued programs, offset by higher personnel costs, including additional non-cash stock-based compensation, and costs related to the advancement of enozertinib.

G&A Expenses: General and administrative (G&A) expenses were $8.7 million for the three months ended December 31, 2025, compared to $7.6 million for the three months ended December 31, 2024, an increase of $1.1 million. For the year ended December 31, 2025, G&A expenses were $33.2 million compared to $28.8 million for the same period in 2024, an increase of $4.4 million. The increases were primarily due to higher personnel costs and professional services, including additional non-cash stock-based compensation.

(Press release, ORIC Pharmaceuticals, FEB 23, 2026, View Source [SID1234662865])

On February 23, 2026 Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a fully integrated, late-stage biotechnology company advancing a sustainable pipeline of genetic therapies for rare disorders with high unmet need, reported that the Company will participate in the TD Cowen 46th Annual Health Care Conference and Leerink Partners Global Healthcare Conference in Boston and Miami, respectively.

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Gaurav Shah, M.D., Chief Executive Officer, will take part in a fireside chat and management will host investor meetings at each conference. Participation details are as follows:

TD Cowen 46th Annual Health Care Conference
Date: March 2, 2026
Time: 11:10 AM ET

Leerink Partners Global Healthcare Conference
Date: March 10, 2026
Time: 9:20 AM ET

Webcasts of the presentations will be available here on the Investors section of the Company’s website.

(Press release, Rocket Pharmaceuticals, FEB 23, 2026, View Source [SID1234662882])