On December 19, 2025 Tolmar, Inc. (Tolmar) reported that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Rubraca (rucaparib), enabling its use prior to chemotherapy for eligible patients with metastatic castration-resistant prostate cancer (mCRPC). The approval is supported by the pivotal TRITON3 Phase 3 trial, which demonstrated that Rubraca is the first and only PARP inhibitor to exceed the efficacy of docetaxel in a direct, head-to-head comparison, marking a significant evolution in treatment sequencing for patients with DNA damage repair (DDR)-deficient tumors.

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"This approval reflects a breakthrough moment for patients and for precision oncology," said Anil D’Souza, Chief Executive Officer of Tolmar. "For years, oncologists have relied on docetaxel as an important therapy in this setting. Now, TRITON3 has shown that Rubraca can not only move ahead of chemotherapy but outperform it—supported by clear genomic rationale and superior progression-free survival. Bringing Rubraca earlier in the treatment journey offers physicians a more targeted approach for patients with BRCA mutated prostate cancer."

The TRITON3 study is a Phase 3, multicenter, open-label, randomized trial of rucaparib in chemotherapy-naïve mCRPC patients who had been previously treated with an androgen receptor directed therapy. The study enrolled 405 patients with a mutation in BRCA or ATM who were randomized to rucaparib or the control group, which consisted of physician’s choice of docetaxel, abiraterone acetate, or enzalutamide. Approximately 55% of the patients in the control arm received docetaxel. The primary endpoint was radiographic progression-free survival (rPFS) by independent radiology review (IRR), in patients with mutations in BRCA1, BRCA2 or ATM. TRITON3 was designed as a Phase 3 trial to confirm and expand the efficacy data from TRITON2 in an earlier treatment setting in mCRPC against a relevant control arm. Patients were selected for therapy based on an FDA-approved companion diagnostic for rucaparib.

Key findings include:

Superiority in Radiographic Progression-Free Survival (rPFS):
Rubraca achieved a statistically significant improvement in rPFS vs. the control arm, delivering a median rPFS of 11.2 months vs. 6.4 months , HR 0.50
In a sub-analysis of Rubraca vs Docetaxel, the rPFS was 11.2 months vs. 8.3 months with docetaxel in the BRCA subgroup
Compelling Genomically Driven Benefit:
Patients with BRCA mutations demonstrated the strongest response, showing a ~50% reduction in risk of progression or death vs. docetaxel
Rubraca Tolerability Profile:
The safety profile of Rubraca observed in TRITON3 was consistent with previous studies. In TRITON3, the discontinuation rate for TEAEs was 14.8% for Rubraca-treated patients and 21.5% for the control arm
Prostate cancer is the most diagnosed cancer in U.S. men, with an estimated 313,780 new cases diagnosed in 2025.2 Approximately 10 to 20 percent of patients progress to castration-resistant prostate cancer, an incurable disease, within five years of diagnosis.3 The vast majority have metastases at diagnosis or develop metastases within two years.3 Of these, an estimated 13% have BRCA-mutated mCRPC,4 a disease characteristic associated with a poor prognosis.5 Men with mCRPC and the presence of a germline BRCA2 mutation, a prognostic marker, have more aggressive disease and poorer survival.6 While less common in prostate cancer, germline mutations in BRCA1 are also associated with more aggressive disease6. mCRPC generally responds to initial androgen deprivation therapy.7 However, most patients will inevitably develop treatment resistance.7

Rubraca (rucaparib) U.S. Prostate Cancer FDA-Approved Indication

INDICATION

RUBRACA (rucaparib) is indicated for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy. Select patients for therapy based on an FDA-approved companion diagnostic for RUBRACA.

SELECT IMPORTANT SAFETY INFORMATION

Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) occur in patients treated with RUBRACA, and are potentially fatal adverse reactions. In 2141 treated patients with ovarian and prostate cancer, MDS/AML occurred in 34 patients (1.6%), including those in long term follow-up. Of these, 14 occurred during treatment or during the 28-day safety follow-up (0.7%).
The duration of RUBRACA treatment prior to the diagnosis of MDS/AML ranged from < 2 months to approximately 72 months. The cases were typical of secondary MDS/cancer therapy-related AML; in all cases, patients had received previous platinum-containing chemotherapy regimens and/or other DNA damaging agents.

In ARIEL3, of patients with ovarian cancer associated with a germline and/or somatic BRCA mutation who were treated with RUBRACA, MDS/AML occurred in 9 out of 129 (7%) patients treated with RUBRACA and 4 out of 66 (6%) patients treated with placebo. The duration of therapy with RUBRACA in patients who developed secondary MDS/cancer therapy-related AML varied from 1.2 to 4.7 years.

In TRITON3, MDS/AML occurred in 2 out of 201 patients (1%) with a BRCA mutation treated with RUBRACA. The duration of therapy with RUBRACA in patients who developed secondary MDS/cancer therapy-related AML varied from 1.4 to 2.3 years.

Do not start RUBRACA until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1). Monitor complete blood counts for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities (> 4 weeks), interrupt RUBRACA or reduce dose and monitor blood counts weekly until recovery. If the levels have not recovered to Grade 1 or less after 4 weeks or if MDS/AML is suspected, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. If MDS/AML is confirmed, discontinue RUBRACA.

Based on findings from genetic toxicity and animal reproduction studies, RUBRACA can cause fetal harm. Advise male patients with female partners of reproductive potential or who are pregnant to use effective methods of contraception during treatment and for 3 months following last dose of RUBRACA. Advise male patients not to donate sperm during therapy and for 3 months following the last dose of RUBRACA.

Most common adverse reactions of patients with BRCA-mutated mCRPC treated with RUBRACA in TRITON3 (≥10%, Grade 1-4) were fatigue/asthenia (61%), musculoskeletal pain (53%), nausea (51%), decreased appetite (34%), diarrhea (31%), constipation (31%), vomiting (25%), dyspnea (19%), dysgeusia (18%), edema (18%), abdominal pain (17%), dizziness (16%), weight decreased (16%), rash (13%), headache (12%), peripheral neuropathy (12%), photosensitivity reaction (12%), and urinary tract infection (10%).

Most common select laboratory abnormalities of patients with BRCA-mutated mCRPC treated with RUBRACA in TRITON3 (≥ 25%, Grade 1-4) were increased ALT (68%), decreased neutrophils (67%), decreased phosphate (64%), decreased hemoglobin (60%), increased AST (59%), increased creatinine (56%), increased glucose (45%), decreased lymphocytes (43%), decreased sodium (35%), decreased platelets (34%), and increased calcium (29%).

Most common adverse reactions of patients with BRCA-mutated mCRPC treated with RUBRACA in TRITON2 (≥ 20%; Grade 1-4) were fatigue/asthenia (62%), nausea (52%), decreased appetite (28%), rash (27%), constipation (27%), vomiting (22%), and diarrhea (20%).
Most common laboratory abnormalities of patients with BRCA-mutated mCRPC treated with RUBRACA in TRITON2 (≥ 35%; Grade 1-4) were increased ALT (69%), decreased leukocytes (69%), decreased phosphate (68%), decreased absolute neutrophil count (62%), decreased hemoglobin (59%), increased alkaline phosphatase (44%), increased creatinine (43%), decreased lymphocytes (42%), increased triglycerides (42%), decreased platelets (40%), and decreased sodium (38%).

Concomitant administration of RUBRACA with CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates can increase the systemic exposure of these substrates, which may increase the frequency or severity of adverse reactions of these substrates. If concomitant administration is unavoidable between RUBRACA and substrates of these enzymes where minimal concentration changes may lead to serious adverse reactions, decrease the substrate dosage in accordance with the approved prescribing information.

If concomitant administration with warfarin (a CYP2C9 substrate) cannot be avoided, consider increasing the frequency of international normalized ratio (INR) monitoring.

(Press release, Tolmar Pharmaceuticals, DEC 19, 2025, View Source [SID1234661564])

On December 19, 2025 Wasatch BioLabs (WBL), a leader in native, long-read sequencing and epigenomic analysis, reported a co-marketing agreement with Agilent Technologies to support the adoption of its Direct Targeted Methylation Sequencing (dTMS) platform. The collaboration brings together Agilent’s enrichment chemistries—SureSelect for genomic DNA and Avida for cell-free DNA—and WBL’s proprietary Oxford Nanopore-based native-read workflow, expanding access to scalable targeted multi-omic analysis for RUO and clinical research studies.

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The SureSelect and Avida capabilities both fill a critical gap in native-read sequencing by enabling precise, custom targeting up to 1 Mb, while preserving native DNA features such as methylation and structural variants. By eliminating off-target sequencing, DNA damage of traditional bisulfite-based methods, and biases introduced by PCR amplification, researchers can capture true biology across large and short, customized genomic regions. This opens new doors for liquid biopsy and targeted genomic applications with cost-efficient, scalable, and highly precise approaches suitable for a broad-array of research and screening applications.

"Multi-omic biology is essential for understanding disease, but for broad adoption it has to be delivered in a way that scales," said Dean Lilley, Senior Director of Product Development at Wasatch BioLabs. "Our alignment with Agilent ensures that native-read targeted sequencing delivers integrated genetic and epigenetic insight, while establishing the consistency, reproducibility, and operational reliability required for high-throughput research and potential future clinical translation.

Early adopters in oncology, neurology, rare disease, and prenatal research are already applying dTMS to resolve structural variation, allelic context, repeat expansions, and methylation patterns in a unified assay. These programs demonstrate how native-read targeted sequencing can support more comprehensive, mechanism-informed profiling across research areas such as liquid biopsy and large cohort studies.

"Partnering with Wasatch BioLabs allows Agilent to deliver a next-generation experience for customers who need both innovation and operational flexibility," said Nina Green, vice president and general manager of Agilent’s Clinical Diagnostics Division. "By integrating SureSelect and Avida enrichment with Wasatch’s novel sequencing technology and robust send-out service model, we are enabling customers to access high-quality NGS data without workflow barriers. This collaboration accelerates adoption, improves turnaround times, and provides a powerful, innovation-led path to achieving high-confidence genomic insights at any scale."

Under the agreement, WBL and Agilent will jointly deliver scientific content, educational programming, and technology demonstrations through 2027. The organizations anticipate the collaboration will scale adoption of native-read targeted sequencing and accelerate the development of cost-efficient, relevant native-read assays.

WBL welcomes additional partners interested in integrating the targeted sequencing assay into their research or development programs. The service will remain in early access through Q1 2026. Early adopters will have the opportunity to shape future enhancements and gain first access to new capabilities.

(Press release, Agilent, DEC 19, 2025, View Source [SID1234661565])

On December 19, 2025 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of autoimmune disease, reported the pricing of an underwritten public offering of 35,714,286 shares of its common stock (or pre-funded warrants to purchase shares of common stock in lieu thereof) and accompanying common stock warrants to purchase an aggregate of 17,857,143 shares of common stock. Each share of common stock (or pre-funded warrant to purchase shares of common stock in lieu thereof) and accompanying common stock warrant are being sold together at a combined public offering price of $0.28 (or $0.279, in the case of pre-funded warrants to purchase shares of common stock). The aggregate gross proceeds of the offering are expected to be approximately $10 million, before deducting underwriting discounts and commissions and other offering expenses. Each common stock warrant will have an exercise price of $0.30 per share, will be exercisable immediately and will expire five years from the date of issuance. The offering is expected to close on or about December 22, 2025, subject to satisfaction of customary closing conditions. In addition, Cue Biopharma has granted the underwriters an option for a period of 30 days to purchase up to an additional 5,357,140 shares of its common stock and/or warrants to purchase up to 2,678,570 shares of common stock at the public offering price, less underwriting discounts and commissions. All of the securities are being offered by Cue Biopharma.

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H.C. Wainwright & Co. is acting as sole book-running manager for the offering. Newbridge Securities Corporation is acting as co-manager for the offering.

The securities are being offered pursuant to an effective shelf registration statement on Form S-3 (File No. 333-271786) that was filed with the Securities and Exchange Commission (the "SEC") on May 9, 2023, and declared effective on May 26, 2023. The offering was made only by means of a prospectus supplement and accompanying prospectus that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering have been filed with the SEC and may be obtained for free by visiting the SEC’s website at www.sec.gov. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC. When available, copies of the final prospectus supplement and accompanying prospectus relating to the offering may also be obtained by contacting: H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (212) 856-5711 or e-mail at [email protected].

This press release does not constitute an offer to sell, or a solicitation of an offer to buy these securities, 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, Cue Biopharma, DEC 19, 2025, View Source [SID1234661557])

On December 19, 2025 IN8bio, Inc. ("IN8Bio" or the "Company") (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative γδ T cell therapies for cancer and autoimmune diseases, reported that it has entered into a definitive securities purchase agreement ("SPA") with certain institutional and accredited investors for up to approximately $40.2 million in gross proceeds through a private placement, priced at-the-market under Nasdaq rules. The net proceeds from the initial tranche of the financing are expected to fund the Company’s current operating plans into the first half of 2027.

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The private placement includes new and existing investors including Coastlands Capital, Stonepine Capital Management and 683 Capital Partners, LP along with directors and officers of the Company.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the private placement.

Under the terms of the SPA, the private placement includes an initial closing of approximately $20.1 million in gross proceeds. At the initial closing, the Company will sell 5,127,029 shares of common stock at a purchase price of $1.38 per share and, in lieu of common stock, pre-funded warrants to purchase up to 9,452,677 shares of common stock, at a purchase price $1.3799 for each pre-funded warrant. The pre-funded warrants will have an exercise price of $0.0001 per share and will be immediately exercisable. The Company will be eligible to receive up to an additional approximately $20.1 million in gross proceeds in exchange for up to 14,579,706 shares of common stock (or, for certain investors, pre-funded warrants in lieu of common stock), subject to achieving certain milestone-driven conditions related to preclinical data for the Company’s CD-19 targeting INB-619 product candidate and share price.

IN8bio intends to use the net proceeds from the private placement to fund the IND enabling studies of INB-619, for use in oncology and autoimmune diseases. The Company expects to generate early animal model data for initial discussions with the U.S. Food and Drug Administration ("FDA") in 2026 with pivotal animal model data and potential IND submission in 2027. The Company also intends to use a portion of the net proceeds to fund the submission of data from the INB-200 and INB-400 Phase 1 and Phase 2 clinical programs in newly diagnosed glioblastoma to the FDA. Funds will be used to seek FDA feedback and guidance on any potential registrational pathway, as well as for working capital and general corporate purposes.

The initial closing of the private placement is expected to occur on or about December 22, 2025, subject to satisfaction of customary closing conditions.

The offer and sale of the foregoing securities is being made in a private placement pursuant to an exemption under the Securities Act of 1933, as amended (the "Securities Act"), and the securities have not been registered under the Securities Act or applicable state securities laws. The securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and applicable state securities laws. Concurrently with the execution of the securities purchase agreement, the Company and the investors entered into a registration rights agreement pursuant to which the Company has agreed to file a registration statement with the Securities and Exchange Commission (the "SEC") registering the resale of the shares of common stock and shares of common stock issuable upon the exercise of the warrants following the closing of each tranche.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy the securities, nor shall there be any sale of the securities 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, In8bio, DEC 19, 2025, View Source [SID1234661558])

On December 19, 2025 Nimbus Therapeutics, LLC ("Nimbus Therapeutics" or "Nimbus"), a biotechnology company that designs and develops breakthrough medicines through its powerful computational drug discovery engine, reported the completion of dose escalation (Part A) in its Phase 1/2 clinical trial of NDI-219216, the company’s investigational non-covalent Werner syndrome helicase (WRN) inhibitor for the treatment of microsatellite instability-high (MSI-H) tumors.

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Data thus far from the dose escalation portion of the trial demonstrated that NDI-219216 has a favorable safety profile, with no dose-limiting toxicities or severe treatment-related adverse events observed through the maximum administered dose (MAD). No maximum tolerated dose (MTD) was reached. Pharmacokinetic and pharmacodynamic data indicated that NDI-219216 achieved robust WRN target engagement for more than 24 hours at multiple dose levels. The company completed dose escalation approximately nine months ahead of schedule, with enrollment continuing to accelerate across global clinical sites.

"Completing dose escalation represents an important milestone in the clinical development of NDI-219216," said Anita Scheuber, M.D., Ph.D., Senior Vice President, Therapeutic Area Head, Oncology at Nimbus. "We are encouraged by the favorable safety profile and robust target coverage that is translating into early clinical activity in patients. The accelerated timeline, driven by strong patient recruitment, underscores the significant unmet need in this patient population. These results reinforce our confidence in NDI-219216’s differentiated profile and its potential to address patients with MSI-H tumors who have limited treatment options. We look forward to sharing clinical data at an upcoming scientific conference."

The Phase 1/2 clinical trial (NCT06898450) is an open-label study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of NDI-219216 in patients with advanced solid tumors. The study is being conducted in three parts: Part A (dose escalation), Part B (dose optimization), and Part C (dose expansion). With Part A now complete, the trial is advancing to Part B, which will determine the recommended dose(s) for further evaluation.

About NDI-219216

NDI-219216 is a highly potent and selective non-covalent investigational inhibitor of Werner syndrome helicase (WRN) activity being developed for the treatment of MSI-H tumors. WRN is a DNA helicase required for DNA replication and DNA repair and is a validated synthetic lethal target for tumors with microsatellite instability (MSI). MSI is a phenotypic consequence of deficient mismatch repair (dMMR) and occurs in various tumor types, including colorectal, gastric, and endometrial cancers. In preclinical studies, treatment with NDI-219216 exhibited robust antitumor activity across multiple cell line-derived xenograft (CDX) and patient-derived xenograft (PDX) MSI-H tumor models, including models for colorectal, gastric, and endometrial cancers.

(Press release, Nimbus Therapeutics, DEC 19, 2025, View Source [SID1234661559])