Whitehawk Therapeutics Reports Third Quarter 2026 Financial Results and Recent Highlights

On November 9, 2026 Whitehawk Therapeutics, Inc. (Nasdaq: WHWK), a clinical-stage oncology therapeutics company applying advanced technologies to established tumor biology to efficiently develop improved antibody drug conjugate (ADC) cancer treatments, reported financial results for the quarter ended September 30, 2026, and provided recent corporate highlights.

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"We continue to dose escalate patients in our Phase 1 programs for HWK-007 and HWK-016 and remain on track to report initial data in the first half of 2027," said Dave Lennon, PhD, President and Chief Executive Officer of Whitehawk Therapeutics. "We also initiated the Phase 1 trial of HWK-206, marking the advancement of all three of our original ADC programs into clinical development within the last 12 months. With its improved biparatopic design, HWK-206 has demonstrated enhanced preclinical antitumor activity compared to other SEZ6-targeted ADCs. Our global clinical development strategy is focused on efficiently evaluating how these preclinical attributes translate in patients with small-cell lung cancer."

Q3 2026 and Recent Operational Highlights:

Continued to advance the ongoing Phase 1 trials of HWK-007 and HWK-016.
HWK-007, a PTK7-targeting ADC, is being evaluated in patients with non-squamous, EGFR wild-type non-small cell lung cancer; platinum-resistant ovarian cancer; and endometrial cancer (NCT07444814).
HWK-016, a MUC16-targeting ADC, is being evaluated in patients with advanced ovarian and endometrial cancers (NCT07470853).
Initiated the Phase 1 clinical trial of HWK-206 in the U.S. and received Fast Track designation from the U.S. Food and Drug Administration (FDA).
HWK-206 is a novel, biparatopic, SEZ6-targeting ADC utilizing the same TOP1i-linker payload as Whitehawk’s first two programs. HWK-206 is being developed initially for small-cell lung cancer (SCLC) and other neuroendocrine tumors.
Whitehawk submitted an Investigational New Drug (IND) application in China and anticipates activating its first clinical sites in China in Q1 2027.
The study is designed to evaluate an accelerated sequence of planned dose levels, starting at 3 mg/kg, informed by Whitehawk’s experience with HWK-007 and HWK-016. The initial dose-escalation portion will focus on patients with SCLC, providing an opportunity to evaluate HWK-206 against established clinical benchmarks.
Initial Phase 1 data from HWK-206 is expected by year-end 2027.
Presented real-world analyses supporting PTK7 as a durable ADC target in EGFR wild-type NSCLC at World Conference on Lung Cancer 2026. PTK7 expression remained stable following standard-of-care therapies, supporting its relevance as a target in second-line or later-line EGFR wild-type NSCLC.
Presented real-world analyses supporting MUC16 as a durable ADC target in ovarian cancer at International Gynecologic Cancer Society 2026. MUC16 expression remained high and stable following standard-of-care therapies, supporting its potential utility in both combination approaches and relapsed settings. High MUC16 expression was associated with poor real-world overall survival in high-grade serous ovarian carcinoma, the most common subtype of ovarian cancer.
Appointed Vijay Iyengar, MD, to Board of Directors. Dr. Iyengar, a former Incyte executive, brings extensive oncology, corporate strategy, business development and medical affairs experience to Whitehawk.
Q3 2026 Financial Results:

Cash, cash equivalents and short-term investments as of September 30, 2026, were $169.7 million as compared to $145.7 million as of December 31, 2025. Cash is anticipated to fund operations into 2H 2028 based on current plans.
Research and development expenses were $18.1 million for the three months ended September 30, 2026, as compared to $14.3 million for the three months ended September 30, 2025.
Net loss for the three months ended September 30, 2026, was $21.2 million as compared to $17.7 million for the three months ended September 30, 2025.
Upcoming Investor Conferences:

Jefferies Global Healthcare Conference in London – management will participate in investor meetings, and Dave Lennon will participate in a fireside chat on November 16, 2026, at 9:30 AM GMT.
Piper Sandler 38th Annual Healthcare Conference – management will participate in investor meetings, and Dave Lennon will present a corporate overview on December 2, 2026, at 1:30 PM ET.
A live webcast of the fireside chat and presentation can be accessed by visiting the Whitehawk Therapeutics IR website and will be available for replay for approximately 30 days following the events.

(Press release, Whitehawk Therapeutics, NOV 9, 2026, View Source [SID1234674508])

Illumina advances MRD research portfolio with ultrasensitive duplex sequencing technology

On November 9, 2026 Illumina, Inc. (NASDAQ: ILMN) reported an expansion of its molecular residual disease (MRD) research portfolio with an early access program for an ultrasensitive sequencing workflow. Designed to detect trace amounts of circulating tumor DNA (ctDNA) in plasma samples, the workflow’s duplex chemistry analyzes both strands of a DNA molecule to increase confidence in detection. It combines the latest sequencing and software advances from the NovaSeq X platform and DRAGEN bioinformatics software to support longitudinal, whole-genome studies of MRD.

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"Researchers need effective ways to find the faintest traces of tumor DNA—signals that can be especially difficult to detect in early-stage, low-shedding, or low-mutation-burden tumors," said Cande Rogert, vice president, Global Head of Advanced Science, Illumina. "This early access technology is an important step toward helping researchers explore those challenging settings with greater sensitivity and generate evidence that can advance MRD research."

The new duplex sequencing technology expands the Illumina MRD research portfolio by adding an ultra-accurate option for ctDNA monitoring when greater sensitivity is needed. It complements Illumina WGS Oncology Prep, which supports both tumor fingerprinting and longitudinal ctDNA monitoring in a standardized whole-genome workflow. Announced earlier this year, WGS Oncology Prep is also available through early access.

NYU Langone Health is an early access user of the new technology, applying the approach to MRD research. "MRD research is moving fast, and new tools are making it possible to bring ultrasensitive, tumor-informed analysis in-house. We are excited to be part of the early access program and look forward to generating evidence with a non-bespoke approach that can help advance our understanding of disease recurrence," said Matija Snuderl, MD, director of Molecular Pathology at NYU Langone Health.

Kits for the early access program are expected to ship in the first quarter of 2027. The research-use-only workflow supports 5-10 ng of cfDNA input and combines NovaSeq X sequencing with duplex chemistry to deliver quality scores above Q65 for exceptionally high sequencing accuracy. DRAGEN bioinformatics generates duplex consensus reads, optimizes quality scores and interrogates thousands of tumor-specific variants across the genome, combining evidence from the few that may be present in plasma. In representative studies, the workflow demonstrated reproducible detection of ctDNA at 2.5 parts per million (ppm) levels.

Duplex sequencing confirms each base call using both complementary strands of the original DNA molecule. Observing the same change on both strands increases confidence that the finding is biological rather than an error introduced during library preparation or sequencing. Detection at low single-digit ppm levels means identifying only a few ctDNA fragments among 1 million total DNA fragments.

Illumina is advancing MRD research with scalable solutions designed for local implementation in laboratories around the world. Unlike approaches that require a custom-built panel for each sample, Illumina’s WGS-based MRD research workflows use a standardized process from library preparation through DRAGEN analysis, helping simplify laboratory operations while delivering a turnaround time of less than five days. The approach allows researchers to generate and publish their data, helping to accelerate discovery and advance the field of MRD research.

(Press release, Illumina, NOV 9, 2026, View Source [SID1234674507])

Myosin Therapeutics to Attend Society for Neuro-Oncology 2026 Annual Meeting

On November 9, 2026 Myosin Therapeutics reported that Dr. Courtney Miller (CEO) and Dr. Karen Smith (CMO) will attend the 31st Annual Meeting of the Society for Neuro-Oncology (SNO), taking place November 12–15, 2026, in Philadelphia, Pennsylvania. During the conference, they will meet with current clinical investigators and potential development partners to discuss progress in the company’s ongoing Phase 1/2 STAR-GBM clinical trial of MT-125, as well as preparations for transition into the Phase 2 portion in early 2027 and additional clinical indications later that year.

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The NCI-supported STAR-GBM trial (NCT07185880), conducted at Mayo Clinic sites in Florida, Arizona and Minnesota, is evaluating MT-125 in patients with newly diagnosed, MGMT unmethylated glioblastoma (GBM). The study is progressing ahead of schedule through its Phase 1 dose escalation stage. The Phase 2 expansion will further evaluate MT-125 in additional treatment regimens, including oral maintenance therapy and a synergistic combination treatment.

"With STAR-GBM progressing toward its next phase of clinical development, SNO provides an important opportunity to engage directly with the investigators and the neuro-oncology community who are helping advance this novel approach to treating glioblastoma," said Courtney Miller, PhD, Chief Executive Officer of Myosin Therapeutics. "Our focus at SNO is on solidifying the clinical and strategic relationships that will ensure the next stage of development is successful."

Myosin Therapeutics is advancing MT-125, a first-in-class non-muscle myosin inhibitor designed to disrupt fundamental mechanical dependencies of cancer cells, leading to tumor cell death. Unlike conventional approaches that target processes such as molecular signaling pathways, MT-125 targets the physical machinery required for cancer cells to grow, divide, invade, metastasize, repair themselves, and survive. MT-125 has received FDA Orphan Drug Designation for malignant gliomas and FDA Fast Track Designation for GBM, and the company’s science is supported by two peer-reviewed publications in Cell.

Beyond GBM, Myosin is advancing a broader oncology pipeline focused on aggressive, treatment-resistant cancers. Preclinical studies have demonstrated the potential of MT-125 in solid and hematologic cancers, supporting the company’s strategy to develop MT-125 as a pan-oncology therapeutic. Myosin is planning to initiate clinical development in two additional cancers in 2027 while continuing preclinical and translational activities with other company assets.

(Press release, Myosin Therapeutics, NOV 9, 2026, View Source [SID1234674506])

PharmaLogic to Acquire Lantheus’ CDMO Business and Springfield, New Jersey Manufacturing Facility

On November 9, 2026 PharmaLogic Holdings Corp. ("PharmaLogic" or the "Company"), the only independent contract development and manufacturing organization (CDMO) of scale dedicated exclusively to radiopharmaceuticals, reported a definitive agreement to acquire the CDMO business and Springfield, New Jersey manufacturing facility from Lantheus Holdings, Inc. ("Lantheus") (NASDAQ: LNTH). The financial terms of the transaction were not disclosed.

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The Springfield facility is a state-of-the-art radiopharmaceutical manufacturing site with a proven track record in theranostic manufacturing, research and clinical development. Its highly skilled team will join Agilera, PharmaLogic’s therapeutic CDMO franchise, upon completion of the transaction. The transaction also includes a long-term supply agreement under which Agilera will manufacture lutetium Lu 177 dotatate for Lantheus.

The acquisition expands PharmaLogic’s capacity to manufacture radiopharmaceutical therapeutics in the U.S. Agilera brings more than 15 years of experience supporting the development and commercial launch of radioligand therapies (RLTs) and currently supplies an alpha therapy to more than 30 countries. With the Springfield facility, PharmaLogic becomes the first therapeutic CDMO to offer a transatlantic platform, giving partners an end-to-end solution for RLTs, from early clinical development through commercial launch and global supply.

"This acquisition strengthens Agilera’s unique capabilities in radioligand therapies and expands our capacity in the U.S.," said Etienne Montagut, President and Chief Executive Officer of PharmaLogic. "We are proud to welcome the talented Springfield team, who will help us scale our operations to meet growing demand from our partners and the patients they serve."

"We have a long-standing relationship with PharmaLogic, which has been an important manufacturing partner for our PET products," said Mary Anne Heino, Executive Chairperson and Chief Executive Officer of Lantheus. "With its proven radiopharmaceutical expertise and manufacturing capabilities, PharmaLogic is the right long-term owner for the CDMO business and Springfield facility, with the capabilities to build on this foundation while supporting reliable supply of our newly approved radiotherapeutic for patients and healthcare providers."

The transaction is subject to applicable regulatory review and the satisfaction of other customary closing conditions. The parties will continue to operate independently until the closing.

Advisors

Leerink Partners served as financial advisor to the Company, and Goodwin Procter LLP served as legal advisor.

Solomon Partners Securities LLC served as financial advisor to Lantheus, and Covington & Burling LLP served as legal advisor.

(Press release, Lantheus, NOV 9, 2026, View Source [SID1234674505])

Black Diamond Therapeutics to Host Webcast Highlighting Updated Silevertinib Phase 2 Data and FDA Feedback Supporting a Clear Phase 3 Path to Potential Accelerated Approval in 1L EGFR-NCM NSCLC

On November 9, 2026 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, including silevertinib, a potential best-in-class brain-penetrant epidermal growth factor receptor (EGFR) inhibitor, reported it will host a webcast for investors to present updated results from its ongoing Phase 2 trial of silevertinib in frontline patients with EGFR mutated non-small cell lung cancer and FDA feedback supporting a clear Phase 3 path to potential accelerated approval in that patient population on Tuesday, November 10, 2026, at 7:30 a.m. ET.

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Webcast information

The webcast can be accessed under "Events and Presentations" on the Investors section of the Black Diamond website at www.blackdiamondtherapeutics.com. A replay of the webcast will be available following the completion of the event for a limited time.

About Silevertinib

Silevertinib is an investigational oral, covalent, brain-penetrant fourth-generation tyrosine kinase inhibitor (TKI) that selectively targets classical and more than 50 non-classical EGFR mutations in NSCLC. It is also designed to potently inhibit key EGFR alterations seen in GBM, including EGFRvIII, while avoiding the paradoxical EGFR activation reported with reversible TKIs. To date, over 200 patients with EGFRm NSCLC or EGFR-altered GBM have been treated with silevertinib.

In addition to the ongoing Phase 2 trial of silevertinib in patients with non-classical EGFRm NSCLC, the Company is also conducting a randomized Phase 2 trial of silevertinib in patients with newly diagnosed EGFRvIII-positive GBM (NCT07326566).

(Press release, Black Diamond Therapeutics, NOV 9, 2026, View Source [SID1234674504])