On December 9, 2025, GlaxoSmithKline Intellectual Property (No. 4) Limited ("GSK") delivered written notice to IDEAYA Biosciences, Inc. (the "Company") of its election to terminate the Collaboration, Option and License Agreement, dated June 15, 2020 (as amended, the "Agreement"). This written notice constituted GSK’s formal written follow-up to its December 4 communication to the Company regarding the termination, as referenced in the Company’s Form 8-K filed on December 5, 2025. Pursuant to the terms of the Agreement, such termination will be effective ninety (90) days following the date of GSK’s notice, which is March 9, 2026. During the ninety-day transition period, GSK will transfer the Werner Helicase (IDE275) and Pol Theta (IDE705) clinical programs to the Company in accordance with the applicable provisions of the Agreement. The Company will evaluate its strategic options for these two programs in 2026, and the update does not change its expectation of cash runway into 2030.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Agreement is filed as Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 12, 2020, Exhibit 10.18 to the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 18, 2022 and Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 10, 2022. For a summary of the material terms of the Agreement, please see Note 10, Significant Agreements, to Company’s financial statements for the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission on February 18, 2025, which summary is incorporated by reference herein.

(Filing, 8-K, Ideaya Biosciences, DEC 9, 2025, View Source [SID1234661403])

On December 9, 2025 Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company, reported the planned initiation of an investigator-sponsored study (IST) by City of Hope, a U.S. cancer research and treatment organization, to evaluate PEDMARK (sodium thiosulfate injection) for the prevention of cisplatin-induced ototoxicity (CIO) in adult men with stage II-III metastatic testicular germ cell tumors.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Cisplatin has transformed outcomes for patients with germ cell tumors, turning what was once a highly fatal disease into one of oncology’s true success stories. However, as many as four out of five survivors are left with permanent hearing loss that impacts their quality of life long after treatment ends.i Through this investigator-initiated study, City of Hope aims to better understand how protecting hearing can become an integral part of comprehensive cancer care," said Alexander Chehrazi-Raffle, M.D., City of Hope assistant professor, Department of Medical Oncology & Therapeutics Research, and principal investigator of the study.

PEDMARK is currently approved for pediatric patients one month of age and older with localized, non-metastatic solid tumors, and is also recognized by the National Comprehensive Cancer Network with a 2A recommendation for use in adolescent and young adult patients.

"Initiation of this study by City of Hope reflects the growing clinical interest in addressing the burden of hearing loss among patients receiving cisplatin-based chemotherapy, an indispensable treatment with high survival rates but significant long-term quality-of-life consequences," said Pierre S. Sayad, PhD, M.S., chief medical officer of Fennec Pharmaceuticals. "With cancer rates rising, especially among younger populations, the future of oncological care needs to focus on both survival and survivorship. Fennec is proud to see independent investigators driving important research that not only has the potential to change the standard of care for their patients today but also expand the evidence base for PEDMARK into metastatic disease, where cisplatin is widely used but hearing protection options remain limited."

Study Details:

City of Hope: Duarte, California:

Principal Investigator: Alexander Chehrazi-Raffle, M.D.

Title:

Testing the Addition of PEDMARK to Cisplatin Chemotherapy for Reducing Drug-Induced Ear Damage in Men With Stage II-III Metastatic Testicular Germ Cell Tumors.

Overview:

Phase I study (NCT07218913) to evaluate whether adding PEDMARK to standard of care cisplatin-based chemotherapy reduces drug-induced ear damage (ototoxicity) in men with stage II-III testicular germ cell tumors that have spread from where they first started (primary site) to other places in the body (metastatic).

Multiple other investigator-initiated studies have already been submitted to Fennec and are currently under review, with several others in advanced contracting or evaluation stages. These collaborations are expected to further strengthen Fennec’s clinical and commercial foundation. Additional details will be shared as these programs progress.

About Cisplatin-Induced Ototoxicity

Cisplatin and other platinum-based chemotherapies are widely used to treat solid tumors and have been vital in improving survival rates. Unfortunately, these life-saving treatments often result in permanent, irreversible hearing loss, also known as ototoxicity.ii

Hearing loss from cisplatin treatment is not rare. Studies show that between 60-90% of patients treated with cisplatin may develop hearing loss, depending upon the dose and duration of chemotherapyiii. Many of those treated with cisplatin will require lifelong hearing aids or cochlear implants, which can be helpful for some, but do not reverse the hearing loss and can be costly over time.iv Treatment-induced hearing loss can reduce quality of survivorship as it impacts many aspects of life, such as speech and language skills, academic performance, social-emotional development, career potential and the ability to live independently.v,vi While audiologic monitoring is recommended to help manage ototoxicity, it is currently underutilized in certain cancer patient populations.

PEDMARK (sodium thiosulfate injection)

PEDMARK is the first and only U.S. Food and Drug Administration (FDA) approved therapy indicated to reduce the risk of ototoxicity associated with cisplatin treatment in pediatric patients 1 month of age and older with localized, non-metastatic, solid tumors. It is a unique formulation of sodium thiosulfate in single-dose, ready-to-use vials for intravenous use in pediatric patients. PEDMARK is also the first and only therapeutic agent with proven efficacy and safety data with an established dosing regimen, across two open-label, randomized Phase 3 clinical studies, the Children’s Oncology Group (COG) Protocol ACCL0431 and SIOPEL 6.

Additionally, PEDMARK is recommended for the adolescent and young adult (AYA) population by the National Comprehensive Cancer Network, or NCCN, with a 2A endorsement.

Approximately 500,000 patients in the U.S. are diagnosed annually with cancers that could be treated with a platinum-based chemotherapy.vii,viii The incidence of ototoxicity depends upon the dose and duration of chemotherapy, and many of those treated will require lifelong hearing aids. Until the FDA approval of PEDMARK, there were no preventative agents for this hearing loss. Patients with hearing loss resulting from cancer treatment have a statistically significant worse quality of life compared with peers who have no hearing loss.ixx

PEDMARK has been studied by co-operative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, COG ACCL0431 and SIOPEL 6. Both studies have been completed. The COG ACCL0431 protocol enrolled childhood cancers typically treated with intensive cisplatin therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, medulloblastoma, and other solid tumors. SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors.

Indications and Usage

PEDMARK (sodium thiosulfate injection) is indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors.

Limitations of Use

The safety and efficacy of PEDMARK have not been established when administered following cisplatin infusions longer than 6 hours. PEDMARK may not reduce the risk of ototoxicity when administered following longer cisplatin infusions, because irreversible ototoxicity may have already occurred.

Important Safety Information

PEDMARK is contraindicated in patients with history of a severe hypersensitivity to sodium thiosulfate or any of its components.

Hypersensitivity reactions occurred in 8% to 13% of patients in clinical trials. Monitor patients for hypersensitivity reactions. Immediately discontinue PEDMARK and institute appropriate care if a hypersensitivity reaction occurs. Administer antihistamines or glucocorticoids (if appropriate) before each subsequent administration of PEDMARK. PEDMARK may contain sodium sulfite; patients with sulfite sensitivity may have hypersensitivity reactions, including anaphylactic symptoms and life-threatening or severe asthma episodes. Sulfite sensitivity is seen more frequently in people with asthma.

PEDMARK is not indicated for use in pediatric patients less than 1 month of age due to the increased risk of hypernatremia or in pediatric patients with metastatic cancers.

Hypernatremia occurred in 12% to 26% of patients in clinical trials, including a single Grade 3 case. Hypokalemia occurred in 15% to 27% of patients in clinical trials, with Grade 3 or 4 occurring in 9% to 27% of patients. Monitor serum sodium and potassium levels at baseline and as clinically indicated. Withhold PEDMARK in patients with baseline serum sodium greater than 145 mmol/L.

Monitor for signs and symptoms of hypernatremia and hypokalemia more closely if the glomerular filtration rate (GFR) falls below 60 mL/min/1.73m2.

Administer antiemetics prior to each PEDMARK administration. Provide additional antiemetics and supportive care as appropriate.

The most common adverse reactions (≥25% with difference between arms of >5% compared to cisplatin alone) in SIOPEL 6 were vomiting, nausea, decreased hemoglobin, and hypernatremia. The most common adverse reaction (≥25% with difference between arms of >5% compared to cisplatin alone) in COG ACCL0431 was hypokalemia.

Please see full Prescribing Information for PEDMARK at: www.PEDMARK.com.

(Press release, Fennec Pharmaceuticals, DEC 9, 2025, View Source [SID1234661313])

On December 9, 2025 Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for cancer and immunological diseases, reported new data from its hematology portfolio at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. Highlights include golidocitinib, a Janus kinase 1 (JAK1) only inhibitor, in T-cell lymphoma, and birelentinib, a non-covalent LYN/BTK dual inhibitor, in B-cell lymphoma.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Golidocitinib

Newly diagnosed PTCL
Two dose regimes of golidocitinib combined with CHOP have been explored for the treatment of newly diagnosed PTCL. Both demonstrated promising antitumor activities and a manageable safety profiles.

Golidocitinib 75mg daily with CHOP, followed by 150mg maintenance after CHOP, showed an ORR of 94.1% and a CR rate of 64.7%. By the data cutoff date, 85% of patients remained on treatment.
Golidocitinib 150mg daily with CHOP, followed by 150mg maintenance after CHOP, showed an ORR of 88.9% and a CR rate of 61.1%

R/R PTCL
An updated 2-year follow-up from the MD Anderson Cancer Center cohort of the multinational pivotal trial JACKPOT8 Part B showed that golidocitinib monotherapy in patients with relapsed or refractory peripheral T-cell lymphoma (r/r PTCL) achieved an objective response rate (ORR) of 53.8% and a complete response (CR) rate of 46.1%. Median progression-free survival (PFS) was 37.9 months and the 2-year PFS rate was 58.3%. The research findings validated golidocitinib’s long-lasting efficacy and tolerability in the U.S. patient population.

Rare subtypes of PTCL
Golidocitinib monotherapy demonstrated compelling clinical activity with a favorable safety profile in heavily pretreated relapsed or refractory T-cell and NK-cell large granular lymphocyte leukemia (r/r T-LGLL) patients. Results from a prospective study showed an ORR of 92.3% and a CR rate of 61.15%. Additionally, the study reported a 100% response among STAT3-wildtype patients.

A Phase II clinical study showed that golidocitinib in combination with CHOP demonstrated profound antitumor activity in treatment-naïve monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL). The ORR was 85.7% and the CR rate was 71.4%, demonstrating a significant therapeutic advance over conventional chemotherapy.

PTCL-associated HLH
In r/r PTCL-associated hemophagocytic lymphohistiocytosis (HLH), golidocitinib-based regimens demonstrated dual anti-HLH and antitumor efficacy, with rapid clinical improvement and an ORR of 46.7%. Most patients achieved systemic and hematologic recovery with a manageable safety profile. These findings highlight the potential of JAK1 inhibition in this high-risk disease.

Birelentinib

Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) is a malignancy originating from mature B-cell non-Hodgkin lymphoma (B-NHL). While Bruton’s tyrosine kinase (BTK) inhibitors have transformed the treatment of B-cell lymphomas, resistance remains a significant challenge. Two primary types of resistance mutations have been identified after BTK inhibitor treatment for B-NHL: BTK-dependent and non-BTK pathway-mediated resistance. Although the BTK-dependent resistance is well-characterized, the emergence of kinase-impaired BTK mutations underscores the increasingly recognized role of non-BTK pathways.

Birelentinib is designed to block both BTK-dependent and BTK independent BCR signaling. Building upon promising data presented orally at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting and the 18th International Conference on Malignant Lymphoma (ICML), updated follow-up data of birelentinib reported at this ASH (Free ASH Whitepaper) Annual Meeting demonstrated potent anti-tumor efficacy with a manageable safety profile in heavily pre-treated CLL/SLL patients.

At 50 mg QD (RP3D), birelentinib achieved an ORR of 84.2%. Tumor responses were observed irrespective of prior BTK inhibitor, BCL-2 inhibitor or BTK degrader treatment, and in patients with kinase-proficient or kinase-impaired BTK mutation. Antitumor efficacy proved durable, with no new safety concerns identified during follow-up.

Based on the encouraging results, birelentinib has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA). The global multicenter Phase III study in r/r CLL/SLL is currently ongoing.

About Golidocitinib (DZD4205)

Golidocitinib is currently the first and only Janus kinase 1 (JAK1) inhibitor being evaluated for the treatment of r/r PTCL. In June 2024, golidocitinib was approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (r/r PTCL).

At the data cut-off date of August 31, 2023, golidocitinib has demonstrated robust and durable anti-tumor efficacy, with an ORR of 44.3%. All subtypes benefited well, and the ORR of common subtypes exceeded 40%. More than 50% of the patients with tumor remission achieved a complete response with a CRR of 23.9%. Per IRC assessment, the median duration of response (mDoR) reached 20.7 months. As of February 2024, golidocitinib showed a median overall survival (mOS) of 24.3 months.

Golidocitinib was granted Fast Track Designation by the U.S. FDA for the treatment of r/r PTCL in February 2022. In September 2023, the CDE accepted its NDA and granted Priority Review for the treatment of r/r PTCL. The Phase I clinical data of golidocitinib (JACKPOT8 PART A) were published in Annals of Oncology (Impact Factor: 51.8), and global pivotal trial data of golidocitinib for the treatment of r/r PTCL (JACKPOT PART B) were published in The Lancet Oncology (Impact Factor: 54.4).

About Birelentinib (DZD8586)

Two resistance mechanisms have been found in patients whose diseases have progressed on a BTK inhibitor treatment: the BTK C481X mutation and BTK-independent BCR signaling pathway activation. Birelentinib is a first-in-class, non-covalent, LYN/BTK dual inhibitor with full blood-brain barrier (BBB) penetration, designed to treat both BTK-dependent and BTK-independent B-cell non-Hodgkin lymphoma (B-NHL).

In August 2025, birelentinib was granted Fast Track Designation by the U.S. FDA for the treatment of adult patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.

(Press release, Dizal Pharma, DEC 9, 2025, View Source [SID1234661329])

On December 9, 2025 Immix Biopharma, Inc. ("ImmixBio", "Company", "We" or "Us" or "IMMX"), a global leader in relapsed/refractory AL Amyloidosis, reported the closing of its previously announced underwritten registered offering of 19,117,646 shares of its common stock at a price to the public of $5.10 per share, and to certain investors in lieu of common stock, pre-funded warrants to purchase 490,196 shares of common stock at a price to the public of $5.09 per pre-funded warrant, which represents the per share public offering price for the common stock, less the $0.01 per share exercise price for each such pre-funded warrant. The net proceeds to Immix from the offering, after deducting the underwriting discounts, commissions and other offering expenses, were approximately $93.7 million.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The financing includes leading U.S. biotechnology institutional investors and mutual funds.

Morgan Stanley acted as the sole book-running manager for the offering. Citizens Capital Markets and Mizuho acted as co-managers for the offering.

The securities in the registered offering were offered and sold pursuant to a "shelf" registration statement on Form S-3 (File No. 333-269100), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the "SEC") on January 3, 2023, and declared effective on January 11, 2023. A prospectus supplement and accompanying prospectus describing the terms of the registered offering was filed with the SEC and is available on its website at www.sec.gov. Copies of the prospectus supplement and the accompanying prospectus relating to the offering may also be obtained from: Morgan Stanley & Co. LLC, attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, by phone: 1-866-718-1649 or by email: [email protected].

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

(Press release, Immix Biopharma, DEC 9, 2025, View Source [SID1234661314])

On December 9, 2025 GC Genome, a leading clinical genomics and liquid biopsy company, reported that its study analyzing cell-free DNA (cfDNA) fragmentation patterns in 1,154 healthy individuals has been published in Clinical Chemistry (Impact Factor 6.3, 2025). The findings reveal key physiological factors that can interfere with cancer-associated cfDNA signals, offering a foundation for improving the accuracy of liquid biopsy tests.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The study, conducted in collaboration with Professor Min-Jung Kwon and her team at Kangbuk Samsung Medical Center, examined correlations between cfDNA fragmentomic profiles and 65 clinical variables, including age and liver function markers. The goal was to identify potential confounders that could influence cfDNA-based cancer detection in individuals without cancer.

Study Overview

Healthy cohort: 1,154 noncancerous individuals who underwent routine health checkups
Clinical variables included: 65 demographic, hematologic, and biochemical parameters
Three fragmentomic features were derived: cfDNA concentration, short-fragment ratio (SFR), and frequency of cancer-enriched motifs(CEMs)
Key Findings

Liver enzymes(including AST, ALP, γ-GTP) and age were identified as major factors altering cfDNA fragmentation patterns.
Elevated AST or age closely resembled cancer-like fragmentomic signatures, blurring the distinction between noncancer and cancer profiles.
AST showed high similarity to fragmentation size patterns seen in lung cancer patients (cosine similarity = 0.98).
Age showed the highest similarity to cancer-like profiles among clinical variables (cosine similarity = 0.52).
Receiver Operating Characteristic (ROC) analysis confirmed that these physiological variables can act as confounders by reducing the specificity of cfDNA-based detection, potentially leading to false-positive results.
These findings demonstrate that non-cancer physiological factors can influence cfDNA signals, underscoring the need for confounder-aware modeling approaches in liquid biopsy development.

A GC Genome spokesperson stated:

"This study is significant because it uses large-scale data from healthy individuals to identify key confounders that influence cfDNA fragmentation patterns. These insights will play an important role in refining our Multi-Cancer Early Detection (MCED) test, ai-CANCERCH, particularly in reducing false-positive rates and improving test specificity."

About ai-CANCERCH

Launched in September 2023, ai-CANCERCH is an AI-based multi-cancer early detection(MCED) test powered by Lc-WGS. Using just 10 mL of blood, the test detects signals associated with multiple cancers. A major upgrade—expanding from 6 detectable cancers to 10 cancers (colorectal, lung, esophageal, liver, ovarian, pancreatic, biliary, breast, gastric, and head-and-neck)—is planned for January 2026.

(Press release, GC Genome, DEC 9, 2025, View Source [SID1234661330])