On April 30, 2026 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company, reported that the U.S. Food and Drug Administration (FDA) has agreed to review its New Drug Application (NDA) for darovasertib in combination with crizotinib (darovasertib combination) for patients with first line (1L) HLA*A2-negative metastatic uveal melanoma (mUM) under the Oncology Center of Excellence (OCE) Real-Time Oncology Review (RTOR) program.

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"We are grateful for the continued partnership with the FDA and being accepted in the Oncology Center of Excellence Real-Time Oncology Review program based on the topline results from the OptimUM-02 trial. This is an important achievement for IDEAYA and the people living with mUM who today have very few treatment options. We believe the topline results from OptimUM-02 provide further evidence to support the potential benefit of the darovasertib combination in patients with first-line HLA*A2-negative mUM, and we look forward to working closely with the FDA through the RTOR process to make this promising new potential treatment available to patients as quickly as possible," said Yujiro S. Hata, President and Chief Executive Officer of IDEAYA Biosciences.

On April 13th, IDEAYA reported positive topline data from the Phase 2/3 OptimUM-02 trial of darovasertib in combination with crizotinib in 1L HLA*A2-negative mUM. The trial met its primary endpoint, with the combination reducing the risk of disease progression by 58% (Hazard Ratio of 0.42; 95% CI: 0.30, 0.59; p-value: <0.0001) and achieving a statistically significant improvement in median progression-free survival (PFS) of 6.9 months versus 3.1 months in the investigator choice of therapy (ICT) arm as assessed by blinded independent central review (BICR). On secondary endpoints, an overall response rate (ORR) of 37.1%, including 5 complete responses, was observed in patients treated with the darovasertib combination versus 5.8% in the ICT arm (p-value: <0.0001) with a median duration of response (DOR) of 6.8 months. Overall survival (OS) data were not yet mature, however the darovasertib combination did show an early trend in OS improvement versus the ICT arm. The combination was generally well-tolerated with a manageable safety profile consistent with previously reported results and known side-effects of each drug.

The FDA’s OCE RTOR program allows an applicant to pre-submit components of its NDA to allow the FDA to review clinical trial data before the complete filing is submitted and aims to provide a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. IDEAYA plans to initiate the RTOR submission process with the first pre-submission targeted for May, with completion of the NDA filing expected in the second half of 2026.

Full results from the OptimUM-02 trial will be presented in a late-breaking oral presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, taking place in Chicago, Illinois. IDEAYA is also conducting clinical trials of darovasertib in HLA*A2-positive mUM as well as in the neoadjuvant and adjuvant settings of primary uveal melanoma.

(Press release, Ideaya Biosciences, APR 30, 2026, View Source [SID1234664981])

On April 30, 2026 Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") reported that the marketing authorization application (MAA) filed in Europe for TLX101-Px (O-(2-[18F]fluoroethyl)-L-tyrosine, 18F-FET), its glioma (brain cancer) imaging candidate[1], has been validated and accepted for review.

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The application, covering commercially significant European markets[2], has now moved into a 210-day active assessment phase[3]. Telix is seeking to expand patient access to advanced brain imaging through a broad clinical label, reflective of current clinical practice guidelines[4]. Assuming a positive outcome from the application at Day 210, national marketing authorizations are expected to follow shortly after.

In Europe, there is currently no generally available commercial product for PET[5] imaging of glioma with 18F-FET ("FET-PET"), resulting in an acute and immediate need for a consistent, high-quality product [6]. Through this MAA, Telix aims to expand patient access to advanced imaging that can distinguish progressive or recurrent glioma from treatment-related changes in both adults and children, with potential for additional future indications. TLX101-Px is also being developed as a patient selection and response assessment tool for Telix’s glioblastoma therapy candidate TLX101-Tx (iodofalan 131I), which has been granted orphan drug designation in Europe and the U.S. The Phase 3 IPAX-BrIGHT[7] trial of TLX101-Tx in patients with recurrent glioblastoma has commenced patient dosing internationally[8] and is launching in multiple European countries.

Sied Kebir, MD, Head of Clinical Neuro-Oncology, University Hospital Essen, said: "In our day-to-day practice, one of the hardest questions we face is whether a change on conventional imaging reflects tumor progression or a treatment-related effect. PET imaging with ¹⁸F-FET can be used to help resolve this dilemma. The acceptance of this application is a welcome step toward broader, standardized patient access across Europe, and more timely and accurate decision-making."

Raphaël Ortiz, Chief Executive Officer, Telix International, commented, "The acceptance of our European MAA represents a significant regulatory milestone for Telix and for TLX101‑Px. It supports a critical unmet need for widely accessible glioma imaging for both diagnostic evaluation and therapeutic decision‑making. Subject to regulatory approval, we are preparing to bring this powerful precision medicine product to market in both Europe and the United States, where our new drug application has recently been accepted[9]."

About glioma in Europe

In Europe, approximately 67,500 brain and central nervous system tumors are diagnosed every year[10], with gliomas accounting for approximately 30% of these, and up to 80% of all malignant brain tumors[11]. There is a critical unmet need to improve the diagnosis and management of gliomas, which are the most common primary brain tumors of the central nervous system, particularly in the post-treatment setting4. Conventional MRI imaging techniques have several limitations, including a lack of biological specificity, dependency on blood-brain barrier disruption, and an inherent inability to differentiate between tumor progression or treatment-related causes. This can yield inconclusive results and delay time-sensitive treatment decisions[12]. With low survival rates and the need to make rapid decisions, precision imaging is paramount6. Subject to regulatory approval, TLX101-Px has the potential to address this need, enabling patients in Europe and worldwide to receive greater clarity in their diagnosis and treatment decision making.

About TLX101-Px

TLX101-Px (O-(2-[18F]fluoroethyl)-L-tyrosine) is Telix’s PET imaging candidate for the characterization of glioma. TLX101-Px targets membrane transport proteins known as L-type amino acid transporters 1 and 2 (LAT1 and LAT2). This enables TLX101-Px to be potentially utilized as a patient selection and response assessment tool for TLX101-Tx (iodofalan 131I), Telix’s LAT1-targeting glioblastoma (GBM) therapy candidate, currently under investigation in Telix’s IPAX-2[13] and IPAX-BrIGHT studies. TLX101-Px and TLX101-Tx have not received marketing authorizations in any jurisdiction. In relevant European markets, the proposed brand name for TLX101-Px is "Pixlumi". Brand name and commercial launch are subject to final regulatory approval.

(Press release, Telix Pharmaceuticals, APR 30, 2026, View Source [SID1234664980])

On April 30, 2026 Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") reported that the marketing authorization application (MAA) filed in Europe for TLX101-Px (O-(2-[18F]fluoroethyl)-L-tyrosine, 18F-FET), its glioma (brain cancer) imaging candidate[1], has been validated and accepted for review.

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The application, covering commercially significant European markets[2], has now moved into a 210-day active assessment phase[3]. Telix is seeking to expand patient access to advanced brain imaging through a broad clinical label, reflective of current clinical practice guidelines[4]. Assuming a positive outcome from the application at Day 210, national marketing authorizations are expected to follow shortly after.

In Europe, there is currently no generally available commercial product for PET[5] imaging of glioma with 18F-FET ("FET-PET"), resulting in an acute and immediate need for a consistent, high-quality product [6]. Through this MAA, Telix aims to expand patient access to advanced imaging that can distinguish progressive or recurrent glioma from treatment-related changes in both adults and children, with potential for additional future indications. TLX101-Px is also being developed as a patient selection and response assessment tool for Telix’s glioblastoma therapy candidate TLX101-Tx (iodofalan 131I), which has been granted orphan drug designation in Europe and the U.S. The Phase 3 IPAX-BrIGHT[7] trial of TLX101-Tx in patients with recurrent glioblastoma has commenced patient dosing internationally[8] and is launching in multiple European countries.

Sied Kebir, MD, Head of Clinical Neuro-Oncology, University Hospital Essen, said: "In our day-to-day practice, one of the hardest questions we face is whether a change on conventional imaging reflects tumor progression or a treatment-related effect. PET imaging with ¹⁸F-FET can be used to help resolve this dilemma. The acceptance of this application is a welcome step toward broader, standardized patient access across Europe, and more timely and accurate decision-making."

Raphaël Ortiz, Chief Executive Officer, Telix International, commented, "The acceptance of our European MAA represents a significant regulatory milestone for Telix and for TLX101‑Px. It supports a critical unmet need for widely accessible glioma imaging for both diagnostic evaluation and therapeutic decision‑making. Subject to regulatory approval, we are preparing to bring this powerful precision medicine product to market in both Europe and the United States, where our new drug application has recently been accepted[9]."

About glioma in Europe

In Europe, approximately 67,500 brain and central nervous system tumors are diagnosed every year[10], with gliomas accounting for approximately 30% of these, and up to 80% of all malignant brain tumors[11]. There is a critical unmet need to improve the diagnosis and management of gliomas, which are the most common primary brain tumors of the central nervous system, particularly in the post-treatment setting4. Conventional MRI imaging techniques have several limitations, including a lack of biological specificity, dependency on blood-brain barrier disruption, and an inherent inability to differentiate between tumor progression or treatment-related causes. This can yield inconclusive results and delay time-sensitive treatment decisions[12]. With low survival rates and the need to make rapid decisions, precision imaging is paramount6. Subject to regulatory approval, TLX101-Px has the potential to address this need, enabling patients in Europe and worldwide to receive greater clarity in their diagnosis and treatment decision making.

About TLX101-Px

TLX101-Px (O-(2-[18F]fluoroethyl)-L-tyrosine) is Telix’s PET imaging candidate for the characterization of glioma. TLX101-Px targets membrane transport proteins known as L-type amino acid transporters 1 and 2 (LAT1 and LAT2). This enables TLX101-Px to be potentially utilized as a patient selection and response assessment tool for TLX101-Tx (iodofalan 131I), Telix’s LAT1-targeting glioblastoma (GBM) therapy candidate, currently under investigation in Telix’s IPAX-2[13] and IPAX-BrIGHT studies. TLX101-Px and TLX101-Tx have not received marketing authorizations in any jurisdiction. In relevant European markets, the proposed brand name for TLX101-Px is "Pixlumi". Brand name and commercial launch are subject to final regulatory approval.

(Press release, Telix Pharmaceuticals, APR 30, 2026, View Source [SID1234664980])

On April 30, 2026 Krystal Biotech, Inc. (the "Company") (NASDAQ: KRYS) reported that the Company will be presenting on multiple programs at upcoming scientific conferences being held in May and June.

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Presentation details are outlined below.

American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 2026 Annual Meeting
Poster Presentation

Title: Evaluation of KB409 and KB410, two HSV-1-based gene therapy vectors for the treatment of primary ciliary dyskinesia (PCD)
Presenter: Bruce Nmezi, PhD
Date and Time: May 12, 2026 from 5:00PM to 6:30PM ET

American Thoracic Society (ATS) International Conference 2026
Oral Presentation

Title: Interim results of the CORAL-1 trial of KB407 for the treatment of cystic fibrosis
Presenter: Jorge Lascano, MD, Professor of Medicine, Associate Director of the Adult Cystic Fibrosis Program, and Director of the Cystic Fibrosis Therapeutics Development Center at the University of Florida
Date and Time: May 20, 2026 at 10:03AM ET

2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting
Poster Presentation

Title: Inhaled delivery of KB707, a novel HSV-based immunotherapy, in combination with pembrolizumab in advanced non-small cell lung cancer: a phase 1/2 study
Presenter: Wen Wee Ma, MBBS, Enterprise Vice Chair for Research and Director of the Novel Cancer Therapeutics Center at Cleveland Clinic Cancer Institute
Date and Time: May 31, 2026 from 9:00AM to 12:00PM CT

Additional presentation details will be available to conference attendees. Following completion of each conference, presentation slides or posters, as applicable, will also be available to view online on the Investor section of the Company’s website.

(Press release, Krystal Biotech, APR 30, 2026, View Source [SID1234664979])

On April 30, 2026 Rakovina Therapeutics Inc. ("Rakovina" or the "Company") (TSX-V: RKV) (FSE: 7J0), a biopharmaceutical company advancing next-generation cancer therapies through artificial intelligence (AI)-powered drug discovery, reported its financial results for the fourth quarter and fiscal year ended December 31, 2025, and provided a corporate update.

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As Rakovina enters 2026, the Company is advancing its three primary drug discovery programs toward key value-creating milestones. For kt-5000, lead optimization continues with Variational AI, with lead candidate selection and IND-enabling studies targeted for the second half of 2026. For kt-3283, in vivo ADME and efficacy testing of the LNP formulation is underway with NanoPalm. For kt-2000, a second round of AI output and in vitro testing is advancing. Across all programs, the Company intends to progress pharmaceutical partnership discussions as preclinical data matures.

"Completing the first phase of our restructuring marks an important inflection point for Rakovina," said Kim Oishi, CEO of Rakovina. "Through the recent debenture restructuring, new financing, and the strengthening of our board and executive team, we are well on our way to repositioning the Company for success. As we continue to put our financial house in order, we are sharpening our focus on execution — advancing our DDR inhibitor pipeline, expanding our strategic partnerships, and unlocking the full potential of our world-class AI-driven drug discovery engine to deliver value for our shareholders."

2025 Highlights and Recent Developments

Leadership and Board

On January 27, 2026, Rakovina appointed Kim Oishi as Chief Executive Officer. Mr. Oishi brings over 25 years of capital markets experience, including as founder of Grand Rock Capital Inc. and partner at First Growth Equity Partners Inc.
On January 27, 2026, Rakovina welcomed Frank Holler to its Board of Directors. Mr. Holler has been directly involved in the founding and development of a number of Canada’s leading biopharma companies, including ID Biomedical Corp., Angiotech Pharmaceuticals Inc. and Xenon Pharmaceuticals Inc.
On May 5, 2025, Rakovina appointed Dr. David Kideckel, PhD, MBA as Chief Financial Officer. Dr. Kideckel brings over 20 years of life sciences and capital markets experience, with prior senior operational and finance positions at both public and private companies, including at Johnson & Johnson, Alexion Pharmaceuticals (acquired by AstraZeneca), and ATB Cormark Capital Markets.
On April 29, 2025, Rakovina appointed Yevgeniy Meshcherekov and Dr. David Kideckel to the Board, with Mr. Meshcherekov assuming Chair of the Audit Committee.
Financing and Capital Structure

On March 5, 2026, Rakovina closed a non-brokered private placement of convertible debenture units for gross proceeds of $1,000,000 and concurrently restructured $1,587,131 in existing debentures through a combination of share settlements (3,265,585 shares at $0.12) and replacement debentures, significantly strengthening the Company’s balance sheet.
On July 15, 2025, Rakovina common shares became eligible for electronic clearing and settlement through the Depository Trust Company (DTC), broadening access for U.S. investors.
On June 24, 2025, Rakovina completed a 10-to-1 share consolidation of its issued and outstanding common shares.
On June 6, 2025, Rakovina closed a non-brokered private placement of equity units for gross proceeds of $3,555,150, concurrent with a $1,350,000 convertible debenture financing.
On January 30, 2025, Rakovina listed its common shares on the Frankfurt Stock Exchange (FSE) under the ticker symbol "7J0", broadening access to European investors.
AI Platform Partnerships

On January 8, 2026, Rakovina expanded its collaboration with Variational AI and its Enki generative AI platform for continued lead optimization of the kt-5000 dual ATR-mTOR inhibitor program.
On August 12, 2025, Rakovina and NanoPalm Ltd. (Riyadh, Saudi Arabia) announced a non-binding Letter of Intent to form a joint venture to co-develop AI-discovered oncology therapies, beginning with kt-3283 delivered via NanoPalm’s patterned lipid nanoparticle (pLNP) system designed using its EnsaliX AI platform.
Scientific and Clinical Milestones

In April 2026, Rakovina presented two posters at the 2026 AACR (Free AACR Whitepaper) Annual Meeting in San Diego. For kt-5000, a prototype lead candidate demonstrated in vivo tumour growth inhibition comparable to ceralasertib in an LNCaP prostate model, with significantly improved tolerability and no signs of hematological toxicity. For kt-3283 LNP, successful characterization of the EnsaliX-designed formulation confirmed uniform particle size, stable colloidal behavior, and surface features predicted to enhance cellular uptake.
On November 24, 2025, Rakovina presented two posters at the Society for Neuro-Oncology (SNO) Annual Meeting, reporting CNS penetrance, metabolic stability, and in vivo tolerability for lead candidates in both the kt-5000 and kt-2000 programs.
On November 18, 2025, Rakovina announced that President & CSO Prof. Mads Daugaard was invited to present and participate as a panelist at the 9th Annual DNA Damage Response (DDR) Inhibitors Summit in January 2026.
On October 27, 2025, Rakovina presented pre-clinical data at the AACR (Free AACR Whitepaper)-NCI-EORTC International Conference confirming potent ATR inhibition and CNS penetration for the kt-5000 series – a milestone differentiator in the DDR inhibitor space.
On August 26, 2025, Rakovina announced that President & CSO Prof. Mads Daugaard was invited to speak at the 13th Tuscany Retreat on Cancer Research & Apoptosis (August 23-30), highlighting Rakovina’s DDR-targeted drug discovery and development accomplishments.
On April 28-29, 2025, Rakovina presented pre-clinical data on the kt-2000 and kt-5000 programs at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.
The Company’s preclinical kt-3283 program continues to demonstrate superior cytotoxicity versus FDA-approved olaparib and vorinostat across multiple tumor types, as reported in a peer-reviewed publication in Clinical Cancer Research.
Pipeline Progress

On July 23, 2025, Rakovina announced that its kt-5000 program had identified potent ATR inhibitor hits during early-stage screening.
On March 12, 2025, Rakovina received the first synthesized batch of AI-generated ATR inhibitor compounds from its Variational AI collaboration.
On January 13, 2025, Rakovina achieved a shortlist of AI-generated CNS-penetrant ATR-targeting molecules, completing the initial AI-driven candidate generation phase for kt-5000.
On January 6, 2025, Rakovina received initial synthesized AI-generated PARP inhibitor compounds for in vitro and in vivo validation in the kt-2000 program.
Summary Financial Results for the Fourth Quarter and Year Ended December 31, 2025

All dollar amounts reflected in Canadian dollars unless otherwise stated.

At December 31, 2025, the Company had a working capital deficit of approximately $2,149,223 and cash and cash equivalents of $298,758. For the three- and twelve-months ended December 31, 2025, the Company reported a net loss of $1,893,159 and $8,680,576, respectively. Research and development expenses were $828,931 and $4,603,002; general and administrative expenses were $972,872 and $3,684,750 for the three- and twelve-months ended December 31, 2025, respectively. Total operating expenses for the three- and twelve-months ended December 31, 2025 were $1,801,803 and $8,287,752, respectively.

Subsequent to year-end, the Company strengthened its balance sheet through approximately $1.0 million in new convertible debenture financing and the restructuring of $1,587,131 in existing debentures, as further described in the Company’s audited financial statements and MD&A for the year ended December 31, 2025, filed on SEDAR+.

Selected Financial Information As at December 31, 2025 ($)
Cash & cash equivalents 298,758
Working capital (deficit) (2,149,223)
Intangible assets 3,439,896
Total Assets 4,240,407
Total liabilities 4,100,682
Deficit (23,678,505)
Total equity 139,725
Three months ended Dec 31, 2025 ($) Three months ended Dec 31, 2024 ($) Year ended Dec 31, 2025 ($) Year ended Dec 31, 2024 ($)
Expenses
Research and development 828,931 744,533 4,603,002 2,341,600
General and administrative 972,872 650,268 3,684,750 1,446,451
Net loss before other items 1,801,803 1,394,801 8,287,752 3,788,051
Other items
Interest income (773) – (797) (5,819)
Interest expense 146,338 45,793 274,596 182,177
Accretion expense (37,860) 23,291 132,100 86,363
Loss (gain) on settlement of debt – 18,815 – 18,815
Loss (gain) on modification of convertible debt (18,623) – (18,623) –
Foreign exchange loss 2,275 1,288 5,548 3,031
Total other expense (income) 91,357 89,187 392,824 284,567
Net loss and comprehensive loss (1,893,159) (1,483,988) (8,680,576) (4,072,618)
Rakovina Therapeutics’ financial statements as filed with SEDAR+ can be accessed from the Company’s website at: View Source

(Press release, Rakovina Therapeutics, APR 30, 2026, View Source;utm_medium=rss&utm_campaign=rakovina-therapeutics-inc-announces-2025-financial-results-and-provides-corporate-update [SID1234664977])