On December 6, 2025 Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, reported positive initial data from the RALLY-MF Phase 2 trial of DISC-0974 in anemia of MF at the ASH (Free ASH Whitepaper) Annual Meeting in Orlando, FL. The data demonstrated that treatment with DISC-0974 resulted in substantial reductions in hepcidin and increases in iron levels translating to positive impact on clinically meaningful measures of anemia across a broad range of patient types.

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"We are excited that we continue to see robust hematologic responses to DISC-0974 regardless of background JAK inhibitor therapy," said John Quisel, J.D., Ph.D., President and Chief Executive Officer of Disc Medicine. "It is also encouraging to see these hematologic improvements translating into reduced transfusion burden and fatigue. We look forward to advancing this program with the goal of addressing a significant unmet need as anemia is one of the key manifestations of MF and there is currently no therapy approved to treat anemia in this population."

This ongoing Phase 2 open-label study had enrolled 47 adult patients with MF and anemia as of the data cutoff date of October 16, including 34 patients with sufficient follow up to be included in the responder analysis (non-transfusion dependent receiving no transfusions (nTD, n=24), transfusion dependent with low transfusion burden (TD Low, n=7) and transfusion dependent with high transfusion burden (TD High, n=3)). The trial was comprised of both patients receiving concomitant JAK inhibitor therapy (n=18) and not receiving JAK inhibitor therapy (n=16). DISC-0974 was administered subcutaneously at 50 mg every 4 weeks for up to 6 treatments. Initial results demonstrated:

Consistent, substantial decreases in hepcidin reaching >75% reduction from baseline and corresponding increases in serum iron
63% of baseline nTD patients achieved a hemoglobin increase of ≥1 g/dL for ≥12 weeks (overall response) and 50% had an increase of ≥1.5 g/dL for ≥12 weeks (major response)
71% of TD Low patients achieved transfusion independence (TI, major response) over a 16-week period
67% of TD High patients with at least 85 days on study achieved a ≥50% reduction in transfusion requirement (overall response)
Initial data for additional n=3 TD High patients trending towards major response of TI >12 weeks
50% of patients receiving concomitant JAK inhibitor therapy achieved a major hematologic response
Dosing with DISC-0974 was associated with improvements in FACIT-Fatigue scores in nTD and TD Low participants
DISC-0974 was generally well-tolerated. Diarrhea and urinary tract infections, neither considered serious, were the only adverse events (AE) that were considered related to DISC-0974 and reported in two or more subjects. The majority of AEs were not considered related to DISC-0974.
Additional data to be shared in H2 2026
Disc also shared a poster overviewing the trial design for the ongoing Phase 2 study of the anti-TMPRSS6 antibody DISC-3405 in polycythemia vera requiring frequent phlebotomy.

Management will host a call during the ASH (Free ASH Whitepaper) meeting to review highlights of the presented data and plans for next steps in development on Sunday, December 7 at 7:30am EST. Please register for the event on the Events and Presentations page of Disc’s website (View Source).

(Press release, Disc Medicine, DEC 6, 2025, View Sourcenews-releases/news-release-details/disc-medicine-presents-positive-initial-data-rally-mf-phase-2 [SID1234661198])

On December 5, 2025 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported it will present a total of 14 abstracts with its research collaborators from multiple studies demonstrating the value of its tissue-free liquid biopsy tests at the 2025 San Antonio Breast Cancer Symposium (SABCS), taking place Dec. 9–12, 2025.

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Oral presentations will highlight results generated with Guardant Reveal, the company’s tissue-free test for detecting minimal residual disease (MRD) and Guardant360 Liquid, the company’s comprehensive multiomic profiling test, both leveraging Guardant’s proprietary epigenomic technology powered by the Guardant Infinity Smart Platform. Collectively, these studies demonstrate how blood-based testing can uncover risk, guide treatment selection, and influence long-term patient management across the breast cancer continuum, from early-stage disease through metastatic settings.

Guardant’s MRD presentations reinforce the value of tissue-free circulating tumor DNA (ctDNA) testing for both neoadjuvant treatment response assessment and post-treatment surveillance in early-stage breast cancer. In a retrospective analysis of HER2-positive patients, ctDNA measured with Guardant Reveal demonstrated strong prognostic significance in the neoadjuvant setting, showing a correlation with pathological complete response and three-year invasive disease-free survival. In an independent study of triple-negative breast cancer patients, Guardant Reveal accurately predicted relapse risk and detected ctDNA more frequently and earlier than orthogonal methods.

Together, these findings demonstrate the validity of Guardant Reveal as a reliable approach for ctDNA detection and monitoring in both neoadjuvant and surveillance settings.

"Breast cancer care increasingly depends on understanding tumor biology at every stage of disease, and Guardant’s data continues to reaffirm the growing value of multiomic liquid biopsy as a powerful, non-invasive tool to equip providers with the data necessary to tailor therapy and treatment," said Dr. Craig Eagle, Chief Medical Officer at Guardant Health. "We look forward to sharing our findings demonstrating the power of blood in helping provide clinicians with deeper clarity and more confident decision-making for their patients."

Other data highlights to be presented include:

Data showcasing the clinical utility of Guardant Reveal in predicting outcomes in patients with early-stage HER2-positive breast cancer. In this analysis, early ctDNA clearance throughout treatment was linked to better outcomes, underscoring ctDNA as a sensitive marker of treatment response and highlighting the value of tissue-free testing for real-time response monitoring.
Data supporting the clinical value potential of non-invasive, methylation-based, continuous breast cancer subtype monitoring by Guardant360 Liquid to uncover tumor evolution and heterogeneity that may guide more precise treatment decisions. In this analysis, Guardant360 Liquid showed agreement to tissue-based monitoring and replicated previously reported accuracy.
Data showcasing Guardant360 Liquid methylation-based breast cancer subtyping feature as a noninvasive liquid tool to dynamically reassess ER, HER2 and triple negative status in patients who are resistant to ER therapy but don’t carry an ESR1 mutation. In this study, Guardant360 Liquid predicted real-world outcomes in previously AI-treated patients receiving subsequent lines of therapy.
Guardant-Led Research at SABCS 2025

Presentation

Title

Time / Location

Wednesday, December 10

PD2-09

Molecular Evolution in Early and Late-Stage Tumors

7:00 – 8:30am CST / 301 ABC

GS1-07

Circulating tumor DNA (ctDNA) in human epidermal growth factor receptor

9:30am – 12:00pm / Hall 1

PS1-12-05

Liquid biopsy–based molecular profiling using GUARDANT360 CDx at progression on CDK4/6i+ET: findings from the AGO-B CAPTOR study

12:30pm – 2:00pm / Exhibit Hall

PS1-11-09

Real-world prevalence of estrogen receptor (ER) 1 mutations (ESR1m) among patients with ER+/ human epidermal growth factor receptor 2 (HER2)− metastatic breast cancer (MBC) after first-line (1L) treatment with endocrine therapy (ET) and/or cyclin dependent kinase 4/6 inhibitors (CDK4/6i)

12:30pm – 2:00pm / Exhibit Hall

RF3-05

Tissue-free circulating tumor DNA detection in patients with early triple negative breast cancer from the c-TRAK-TN trial

12:30pm – 2:00pm / Exhibit Hall

PS2-07-02

Tissue-free epigenomic circulating tumor DNA (ctDNA) analysis pre- and post-surgery in early breast cancer: clinical features and prognostic utility

4:30pm – 5:30pm / Stars at Night

PS2-07-18

Prognostic effects of methylation-based HR and HER2 assessments by liquid biopsy in ESR1 mutation negative advanced breast cancer

4:30pm – 5:30pm / Stars at Night

PS2-07-16

Clinicogenomic characterization and ctDNA detection of ESR1 fusion positive metastatic breast cancer

5:00pm – 6:30pm / Exhibit Hall

PS2-09-21

Real-world clinical outcomes and genomic insights for patients with PIK3CA-mutant metastatic breast cancer following progression on CDK4/6 inhibitor therapy

5:00pm – 6:30pm / Exhibit Hall

PS2-08-17

Prevalence and clinical significance of exon 6 ESR1 gene fusions in advanced breast cancer after disease progression on aromatase inhibitors

5:00pm – 6:30pm / Exhibit Hall

PS2-10-19

Circulating tumor DNA (ctDNA) as a strong prognostic biomarker of minimal residual disease (MRD) using a tissue-free, epigenomic assay in early-stage breast cancer.

5:00pm – 6:30pm / Exhibit Hall

Thursday, December 11

PD9-03

Comprehensive genomic profiling and clinically targetable mutations of metastatic invasive lobular and no special type breast cancer

7:00am – 8:30am / Hemisfair Ballroom

PS4-01-11

Exploration of racial differences in variants of uncertain significance (VUS), ESR1 and PIK3CA mutation frequency, matched therapy use, and outcomes in metastatic breast cancer (mBC)

7:00am – 8:30am / Hemisfair Ballroom

PS4-02-10

Agreement of cell-free DNA methylation-based molecular breast subtyping and tissue subtyping in hormone receptor positive metastatic breast cancer: a clinical cohort analysis

5:00pm – 6:30pm / Exhibit Hall

The full abstracts for Guardant Health and a list of all abstracts being presented at SABCS 2025 can be found on the SABCS website.

For information and updates from the conference, visit booth #942 and follow Guardant Health on LinkedIn, X (Twitter) and Facebook.

(Press release, Guardant Health, DEC 5, 2025, View Source [SID1234661180])

On December 5, 2025 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, and Foresight Diagnostics, a leader in ultrasensitive molecular residual disease (MRD) detection, reported that Natera has completed a transaction to acquire Foresight.

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Foresight is a cancer diagnostics company and CLIA-registered laboratory. The company’s circulating tumor DNA (ctDNA)-based MRD tests leverage its patented PhasED-Seq technology, targeting phased variants. With this technology, Foresight has reported performance with LOD95 of 0.3 parts per million and detection below 0.1 ppm1.

Foresight was founded by Stanford University physicians and scientists, Maximilian Diehn, M.D., Ph.D., Ash Alizadeh, M.D., Ph.D., and David Kurtz, M.D., Ph.D., together with Jake Chabon, Ph.D., Foresight’s chief scientific officer and chief executive officer. The company has authored more than 40 scientific publications and presentations and partnered with more than 30 biopharma and academic researchers.

Strategic Rationale

The transaction combines Natera’s leading commercial and operational infrastructure for the delivery of personalized MRD testing with Foresight’s unique phased variant technology and leadership in lymphoma. It builds on Natera’s broad intellectual property portfolio for tumor-informed and personalized MRD products including in phased variants, and promises to accelerate MRD adoption in lymphoma and other solid tumor types.

Signatera platform with phased variants: The integration of phased variants into the Signatera platform will further differentiate and strengthen test performance across solid tumors. This enhanced version is available immediately for research use for biopharma and academic partners and is expected to be launched for clinical use in 2026.
Leadership in lymphoma: The transaction builds on Foresight’s clinical research momentum in B-cell lymphomas, a large patient population with more than 75,000 new cases annually in the U.S.2 Earlier this year, Foresight data provided the foundation for the inclusion of ctDNA MRD into the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for diffuse large B-cell lymphoma. Additionally, Foresight’s CLARITY MRD assay for lymphoma is being used in three prospective MRD-driven clinical trials informing treatment decisions for patients. Foresight CLARITY joins Natera’s extensive MRD product portfolio and will continue to support clinical trials, translational research and future applications.
At the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting beginning on December 6, Natera and Foresight will have a total of 15 abstracts featuring Signatera and PhasED-Seq, including seven oral presentations.

Transaction Terms

Natera has closed the acquisition of Foresight in an all-stock transaction consisting of a $275 million upfront with an additional $175 million in earnouts tied to the achievement of revenue- and reimbursement-based milestones.

"This acquisition reinforces Natera’s position at the forefront of precision oncology," said Steve Chapman, chief executive officer of Natera. "Foresight’s phased variant technology and leadership in lymphoma complement Natera’s strong capabilities in personalized MRD testing, improving the value we can deliver to patients, clinicians, biopharma partners and the broader healthcare system."

"Foresight’s mission has always been to improve the lives of cancer patients worldwide through innovative diagnostics," said Chabon. "As we join Natera, I’m deeply grateful to our employees, partners and investors who have helped bring us to this moment. Together, we can realize this mission on a far greater scale, accelerating the pace of discovery across both hematologic and solid tumors."

Gibson, Dunn & Crutcher LLP is serving as legal counsel to Natera. Wilson Sonsini Goodrich & Rosati is serving as legal counsel to Foresight, while Centerview Partners LLC is acting as its financial advisor.

(Press release, Natera, DEC 5, 2025, View Source [SID1234661181])

On December 5, 2025 Immatics N.V. (NASDAQ: IMTX, "Immatics" or the "Company"), a clinical-stage biopharmaceutical company and the global leader in precision targeting of PRAME, reported that it has agreed to sell 12,500,000 ordinary shares at $10.00 per share in an underwritten offering. The gross proceeds from the offering, before deducting the underwriting discount and offering expenses, are expected to be $125 million. The offering is expected to close on December 8, 2025, subject to customary closing conditions.

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Jefferies, Leerink Partners and Cantor are acting as joint book-running managers for the offering.

A registration statement relating to the securities has been filed with the U.S. Securities and Exchange Commission (the "SEC") and was declared effective on April 3, 2025. The offering is being made only by means of a prospectus supplement and accompanying prospectus. When available, copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained free of charge from

Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, telephone: (877) 821-7388, email: [email protected];
Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, telephone: (800) 808-7525, ext. 6105, email: [email protected];
Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, NY 10022, e-mail: [email protected].
This press release shall 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. Any offers, solicitations or offers to buy, or any sales of securities will be made in accordance with the registration requirements of the Securities Act of 1933, as amended.

(Press release, Immatics, DEC 5, 2025, View Source [SID1234661168])

On December 5, 2025 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported data from a Phase 1b trial of enozertinib (ORIC-114) at the ESMO (Free ESMO Whitepaper) Asia Congress 2025. Data in previously treated NSCLC patients with HER2 exon 20 mutations were presented at a poster session, and the poster can be found in the publication section of ORIC’s website here.

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Enozertinib Phase 1b Trial Design
Enozertinib is being evaluated in a Phase 1b trial in patients with locally advanced or metastatic NSCLC with HER2 exon 20 mutations. Notably, enrollment allows patients with active untreated brain metastases. Prior therapies include chemotherapy and HER2 targeted therapies. The primary endpoint of the trial is to determine the recommended Phase 2 dose (RP2D), and secondary endpoints include investigator-assessed objective response rate (ORR), disease control rate (DCR), and safety.

Previously Treated NSCLC Patients with HER2 Exon 20 Mutations
As of the August 29, 2025 cutoff date, 49 patients were dosed — 26 patients received 80 mg QD oral enozertinib and 23 patients received 120 mg QD. Patients were treated with up to 4 prior therapies, with 80% of patients having received prior chemotherapy and 35% having received a prior HER2 targeted therapy. Brain metastases were present in 47% of patients at baseline, including those with active brain metastases.

Preliminary Safety Analysis
Enozertinib was well tolerated with mostly Grade 1 or 2 treatment-related adverse events (TRAEs), and no significant off-target toxicities. Most frequent TRAEs included paronychia, diarrhea, and dermatitis acneiform. Only 2 patients discontinued treatment due to TRAEs. Higher rates of dose reductions occurred in the 120 mg cohort compared to the 80 mg cohort.

Preliminary Activity Analysis
Tumor responses were observed in both the 80 mg and 120 mg cohorts, including in patients with baseline brain metastases. Patients in the 80 mg cohort experienced deeper tumor regressions potentially due to the lower rate of dose reductions.

35% ORR (26% confirmed ORR) and 100% DCR in the 80 mg cohort
As of the data cutoff (at a median follow-up of 50 weeks), 32% of patients remained on treatment in both the 80 mg and 120 mg cohorts
Next Steps
Based on data generated in patients with EGFR exon 20 and EGFR atypical mutations, 80 mg QD oral enozertinib has been selected as the dose for potential Phase 3 development. Enrollment and follow-up continues in 1L NSCLC patients with EGFR exon 20 and EGFR P-loop and alpha C-helix compressing (PACC) mutations, with the next update expected in mid-2026, ahead of initiation of potential Phase 3 trial(s). Enrollment in HER2 exon 20 has been completed with no further development planned in this patient population.

Conference Call and Webcast Details
In conjunction with the ESMO (Free ESMO Whitepaper) Asia Congress, ORIC will host a conference call and webcast on Saturday, December 6, 2025, at 8:00 pm ET. To join the conference call via phone and participate in the live Q&A session, please pre-register online here to receive a telephone number and unique passcode required to enter the call. A live webcast and audio archive of the conference call will be available through the investor section of ORIC’s website at www.oricpharma.com. The webcast will be available for replay for 90 days following the presentation.

(Press release, ORIC Pharmaceuticals, DEC 5, 2025, View Source [SID1234661169])