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Deciphera Pharmaceuticals Announces U.S. Food and Drug Administration Acceptance for Filing of New Drug Application for Tirabrutinib in Patients with Relapsed or Refractory PCNSL

On February 17, 2026 Deciphera Pharmaceuticals, a member of Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; "Ono"), reported that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) under the accelerated approval pathway for tirabrutinib, a highly selective irreversible, second generation Bruton tyrosine kinase inhibitor, for the treatment of relapsed or refractory primary central nervous system lymphoma (R/R PCNSL). The FDA has set an action date of December 18, 2026, under the Prescription Drug User Fee Act (PDUFA).

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"R/R PCNSL is a rare and aggressive form of non-Hodgkin lymphoma with particularly poor clinical outcomes. Patients often experience difficulty and delay in diagnosis, and once they are diagnosed, there is a high unmet need for a treatment with a favorable safety profile," said Matthew L. Sherman, M.D., Chief Medical Officer of Deciphera. "The FDA’s acceptance of tirabrutinib’s NDA for filing is an exciting milestone as it brings us one step closer to our goal of providing patients with R/R PCNSL an important new treatment option."

"We are very pleased that the NDA for tirabrutinib has been accepted for filing," said Toichi Takino, President and COO of Ono Pharmaceutical Co., Ltd. "This is an important milestone on the way to expanding our commercial pipeline and achieving our goal of becoming a global specialty pharma. Tirabrutinib’s potential to address unmet patient needs embodies our corporate philosophy and we will continue to focus on developing and delivering innovative medicines to benefit patients worldwide."

The NDA is supported by the positive results from the Phase 2 PROSPECT study, presented at the 2025 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, in which tirabrutinib demonstrated an overall response rate of 67%, a complete response rate of 44%, and a manageable safety profile. If approved, tirabrutinib will be the first BTK inhibitor therapy commercially available in the U.S. for the treatment of patients with R/R PCNSL, and the third commercial therapy for Ono group available in the U.S. The study is currently recruiting patients with R/R PCNSL in a global Phase 3 randomized trial, which will serve as a confirmatory study for this indication (ClinicalTrials.gov NCT07104032.)

About Tirabrutinib

Tirabrutinib, discovered and developed by Ono Pharmaceutical Co., Ltd., is a highly potent selective BTK inhibitor. Signaling through the B-cell receptor (BCR) regulates cellular proliferation and activation, and promotes survival, differentiation, and clonal expansion of B-cells. The BCR signaling pathway plays an important role in a number of B-cell malignancies. In Japan, tirabrutinib was approved in March 2020 for the treatment of R/R PCNSL and launched under the tradename of Velexbru in May 2020. It was subsequently approved for the treatment of Waldenstrom macroglobulinemia and lymphoplasmacytic lymphoma in August 2020. Tirabrutinib was approved for the treatment of R/R PCNSL in South Korea in November 2021 and in Taiwan in February 2022.

About PCNSL

PCNSL is a rare and aggressive extra-nodal non-Hodgkin lymphoma (NHL) that is confined to the brain parenchyma, spinal cord, eye, or leptomeninges without systemic involvement. The annual incidence rate of PCNSL is approximately five cases per 1,000,000 people in the U.S. The rate can further increase among immuno-compromised people aged 65 years and older. The signs and symptoms presented in patients with PCNSL vary depending on the neuroanatomical site of the lesion, and include cranial neuropathy, neuropsychiatric symptoms, symptoms associated with increased intracranial pressure, seizures, ocular symptoms, headache, dysmotility, cranial neuropathy, and radiculopathy. There is a high unmet need for a treatment with a favorable safety profile, and data guiding therapeutic approaches are very limited. Despite recent progress resulting in the improvement of clinical outcomes in newly diagnosed patients with PCNSL after an induction treatment, approximately 20 to 30 percent of patients are refractory to the initial treatment, and up to 60 percent of patients will eventually relapse. To learn more about R/R PCNSL, please visit navigatingpcnsl.com.

(Press release, Deciphera Pharmaceuticals, FEB 17, 2026, View Source [SID1234662740])

Incyte to Present at Upcoming Investor Conferences

On February 17, 2026 Incyte (Nasdaq:INCY) reported that it will present at the following investor conferences during the month of March:

TD Cowen 46th Annual Health Care Conference on Monday, March 2, 2026 at 10:30 am (EST)

Leerink Partners 2026 Global Healthcare Conference on Tuesday, March 10, 2026 at 9:20 am (EDT) and

Barclays 28th Annual Global Healthcare Conference on Wednesday, March 11, 2026 at 8:30 am (EDT)
The presentations will be webcast live and can be accessed at Investor.Incyte.com and will be available for replay for 30 days.

(Press release, Incyte, FEB 17, 2026, View Source [SID1234662739])

Personalis to Participate in the TD Cowen 46th Annual Healthcare Conference

On February 17, 2026 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported that its management team will be attending the TD Cowen 46th Annual Healthcare Conference on Tuesday, March 3, 2026 at the Boston Marriott Copley Place in Boston, MA.

(Press release, Personalis, FEB 17, 2026, View Source [SID1234662738])

Flashpoint Therapeutics Announces Major Publication on Novel HPV Cancer Vaccine

On February 17, 2026 Flashpoint Therapeutics, a biotechnology company pioneering a new class of structural nanomedicines, reported a major, peer-reviewed publication demonstrating the power of its Spherical Nucleic Acid (SNA) platform in immuno-oncology. The study, led by Flashpoint’s scientific co-founder Professor Chad A. Mirkin at the International Institute for Nanotechnology at Northwestern University, describes a novel therapeutic vaccine that generates a potent and targeted immune response against established human papillomavirus (HPV)-driven cancers in a preclinical animal model.

The research, published in the journal Science Advances, details a structurally novel vaccine design where an HPV antigen and a powerful immune-stimulating adjuvant are co-engineered onto a single SNA scaffold. This architecture is the key to the vaccine’s success, ensuring both components are delivered to the same immune cells in the lymph nodes, resulting in a highly coordinated and robust anti-tumor response. In humanized mouse models of HPV-positive cancer, the therapeutic vaccine significantly slowed tumor growth and extended survival.

Key findings from the study highlight the unique advantages of Flashpoint’s structural nanomedicine approach:

Potent Immune Activation: The SNA vaccine elicited a strong T-cell response specifically directed at cancer cells expressing the HPV E7 antigen.
Superior Efficacy Through Co-delivery: The SNA structure, which guarantees co-delivery of the antigen and adjuvant, was critical for generating a powerful therapeutic effect.
Therapeutic, Not Just Prophylactic: Unlike existing HPV vaccines to prevent infection, this SNA-based approach is designed to treat active, established cancers caused by the virus.
A key insight from the publication is the mechanism behind the SNA vaccine’s enhanced potency. The research demonstrates that the specific placement and orientation of the antigen within the SNA is critical for its therapeutic effect. Unlike simple mixtures where the tumor antigen and the adjuvant can be taken up by different cells, the SNA platform ensures that both components are delivered as a single unit to the same antigen-presenting cells. This simultaneous co-delivery within the lymph nodes generates a more powerful and coordinated T-cell response, effectively training the immune system to seek out and destroy cancer cells.

"This publication highlights the fundamental advantage of structural nanomedicine," said Venkat Krishnamurthy, Ph.D., Chief Scientific Officer of Flashpoint Therapeutics. "By precisely engineering how therapeutic components are arranged and presented at the nanoscale, we can generate biological responses that exceed what is achieved when the same components are delivered conventionally. In this study, that architectural control translated into coordinated immune activation, tumor growth suppression, and improved survival. It is an important validation of our SNA platform and supports our strategy to advance therapeutic cancer vaccines and other immuno-oncology applications."

Barry Labinger, Chief Executive Officer of Flashpoint Therapeutics, added, "These results strengthen our conviction that structural design is a powerful lever in medicine. We are focused on translating this platform into clinically meaningful therapies and building a pipeline that leverages this differentiated approach."

HPV is the leading cause of cervical, anal, and head and neck cancers. While prophylactic vaccines against HPV are effective, there remains a significant unmet need for better treatments for patients who are unvaccinated and develop advanced HPV-related malignancies.

(Press release, Flashpoint Therapeutics, FEB 17, 2026, View Source [SID1234662737])

TuHURA Files Investigational New Drug Application for TBS-2025 in the Treatment of Blood-Related Cancers

On February 17, 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 it has filed an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration’s (FDA) Division of Hematologic Malignancies 1 (DHM1) for the study of TBS-2025, a novel VISTA inhibiting antibody, for the treatment of mutNPM1 relapsed/refractory (r/r) Acute Myeloid Leukemia (AML) in combination with a menin inhibitor.

The Company plans on initiating a Phase 2 study in menin inhibitor naïve patients with mutNPM1 r/r AML utilizing a Simon 2 stage design. Pending completion of FDA review and clearance, the Company currently targets initiating the Phase 2 study in early Q2 2026 with preliminary Stage 1 results in Q3 2026.

"There is a broad body of scientific evidence showing that leukemogenic mutations common in AML, such as mutNPM1, may drive the expression of VISTA on the surface of leukemic cells, which contribute to low response rates to therapy and markedly reduced overall survival," said Dr. James Bianco, President and Chief Executive Officer of TuHURA Biosciences.

"While the introduction of menin inhibitors for the treatment of mutNPM1 r/r AML has provided these patients with the first approved therapy, CR/CRh rates across the class are generally <25% and of short duration, underscoring the continued unmet medical need." Dr. Bianco continued, "Given the strong scientific rationale, we believe adding TBS-2025 to a menin inhibitor may markedly increase both the CR/CRh rate and its duration, potentially addressing this unmet medical need. If successful, the Company would seek FDA guidance on the potential for developing TBS-2025 under FDA’s accelerated approval pathway."

About TBS-2025
TBS-2025 is a unique VISTA-inhibiting monoclonal antibody acquired by the Company in its acquisition by merger with Kineta Inc. on June 30, 2025. VISTA is a novel checkpoint expressed on quiescent (resting) T cells and highly expressed on myeloid cells. Unlike the expression of VISTA on solid tumor cancers, its role is well established in hematological malignancies. Scientific evidence demonstrates that mutNPM1 and mutDNM3TA, two of the most common mutations in AML and other myeloid (blood related) malignancies, may drive the expression of VISTA on leukemic blasts and are reported to be the primary mechanisms by which AML has a poor response to and high relapse rate following current therapies. VISTA expression is linked to high relapse rates in AML due to its ability to allow leukemic blasts to evade immune recognition and attack by the patient’s immune system. When VSIR, the gene that encodes for VISTA, is removed in murine models of mutNPM1 AML, an immune response is observed and survival is enhanced.

TBS-2025 was initially investigated by Kineta in a large Phase 1 trial either as monotherapy (n=24) or in combination with pembrolizumab (n=15) among patients with advanced, therapy refractory cancers, including breast, lung, colorectal, and ovarian cancer. The purpose of the study was to investigate its safety profile and determine the recommended Phase 2 dose. The drug demonstrated a favorable safety profile even at the highest dose level of 1,000mg administered every two weeks. Based on pharmacokinetics and pharmacodynamics, the Company believes the optimal Phase 2 dose is 750mg every three weeks.

(Press release, TuHURA Biosciences, FEB 17, 2026, View Source [SID1234662736])