Natera to Participate in the 44th Annual J.P. Morgan Healthcare Conference

On December 22, 2025 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported that it will participate in the 44th Annual J.P. Morgan Healthcare Conference in San Francisco, CA on Tuesday, Jan. 13, 2026 at 4:30 p.m. PT (7:30 p.m. ET). Members of management will deliver a presentation and host a Q&A with the investment community at the conference.

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A live webcast may be accessed through the investor relations section of the Natera website at investor.natera.com. A replay of the event will be available shortly following the conference.

(Press release, Natera, DEC 22, 2025, View Source [SID1234661598])

Vividion Publishes Discovery of First-in-Class KEAP1 Activator, Supporting Ongoing Clinical Program in Oncology

On December 22, 2025 Vividion Therapeutics, Inc. (Vividion), a clinical-stage biopharmaceutical company, and a wholly owned and independently operated subsidiary of Bayer AG, reported the publication of a manuscript describing the discovery and preclinical characterization of small molecules that activate KEAP1 via a novel covalent allosteric molecular glue mechanism to drive degradation of NRF2.

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The article, "A covalent allosteric molecular glue suppresses NRF2-dependent cancer growth" (Roy et al., Cancer Discov.), establishes NRF2 degradation via KEAP1 activation as a promising therapeutic approach for NRF2-activated cancers, including non-small cell lung cancer, esophageal squamous cell carcinoma, and head and neck squamous cell carcinoma.

"NRF2 has long stood as a symbol of undruggable cancer biology. Our team has opened a new chapter in targeting this critical cancer pathway through the discovery of KEAP1 activators," said Aleksandra Rizo, M.D., Ph.D., President and Chief Executive Officer of Vividion. "This research reflects the power of our platform to reveal unexpected allosteric mechanisms that could directly contribute to improved therapeutic efficacy, and ultimately better patient outcomes, for people with hard-to-treat cancers."

NRF2 is a transcription factor that promotes tumor growth, immune suppression, and resistance to cancer therapies. However, despite its clear role in disease progression, NRF2 has resisted direct pharmacologic inhibition due to its lack of canonical small-molecule binding pockets. Using Vividion’s covalent-first chemoproteomics platform, researchers discovered electrophilic small molecules that covalently bind to a specific cysteine residue on KEAP1 (C151) and induce an allosteric conformational change that enhances KEAP1’s interaction with the CUL3 E3 ligase complex. This stabilization of the KEAP1-CUL3 complex restores KEAP1’s ability to drive NRF2 degradation.

In preclinical models, these KEAP1 activators led to robust suppression of NRF2 signaling and showed meaningful antitumor activity across several tumor types with NRF2 pathway activation. Importantly, pharmacologic NRF2 degradation also enhanced the effects of multiple chemotherapies and radiotherapy, supporting the therapeutic potential of KEAP1 activation in overcoming treatment resistance in NRF2-driven cancers. Collectively, these findings provide a strong mechanistic and translational rationale for the clinical evaluation of KEAP1 activators.

"By showing that KEAP1 can be pharmacologically activated, Vividion has pioneered a new therapeutic approach to treating NRF2-driven cancers," said Matt Patricelli, Ph.D., Chief Scientific Officer of Vividion. "Mechanistic insights from these studies informed the design of our clinical KEAP1 activator, VVD-037, and its rational combinations with other cancer therapies. We’re excited to continue to explore its potential across the many cancer types driven by NRF2 dysregulation."

VVD-037, Vividion’s lead KEAP1 activator, is currently being evaluated in a Phase I clinical trial (NCT05954312) in patients with solid tumors characterized by NRF2 pathway activation.

(Press release, Vividion Therapeutics, DEC 22, 2025, View Source [SID1234661583])

Novocure to Present at 44th Annual J.P. Morgan Healthcare Conference

On December 22, 2025 Novocure (NASDAQ: NVCR) reported that management will participate in the 44th Annual J.P. Morgan Healthcare Conference taking place in San Francisco on January 12-15, 2026. Frank Leonard, Chief Executive Officer, will present on behalf of the company and address questions on Wednesday, January 14, at 9:45 a.m. PST. Mr. Leonard will be joined by William Doyle, Executive Chairman, and Christoph Brackmann, Chief Financial Officer, for one-on-one meetings with investors throughout the conference.

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A live audio webcast of this presentation can be accessed from the Investor Relations page of Novocure’s website, View Source, and will be available for replay for at least 14 days following the event.

(Press release, NovoCure, DEC 22, 2025, View Source [SID1234661599])

Incyte Japan Announces Approval of Minjuvi® (tafasitamab) in Combination with Rituximab and Lenalidomide for the Treatment of Relapsed or Refractory Follicular Lymphoma

On December 22, 2025 Incyte Biosciences Japan G.K. reported approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for Minjuvi (tafasitamab) in combination with rituximab and lenalidomide for adult patients with relapsed or refractory follicular lymphoma (2L+ FL).

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"Today’s approval of Minjuvi in combination with rituximab and lenalidomide marks a significant milestone as the first dual-targeted CD19 and CD20 immunotherapy combination for relapsed or refractory FL in Japan," said Yasuyuki Ishida, General Manager, Incyte Biosciences Japan. "By improving progression-free survival, Minjuvi offers a chemotherapy-free option for eligible patients with relapsed or refractory disease. This approval underscores our commitment to bridging critical treatment gaps to patients and families affected by this challenging disease in Japan."

The approval is based on the pivotal Phase 3 inMIND trial, which enrolled 654 adult patients, including patients based in Japan. The study demonstrated that Minjuvi combined with rituximab and lenalidomide significantly improved progression-free survival (PFS) compared to the control arm.1 Patients receiving Minjuvi achieved a median PFS of 22.4 months, significantly longer than the 13.9 months observed in the control arm.1 The hazard ratio was 0.43, with a p-value of less than 0.0001, indicating a substantial reduction in the risk of progression.1

Assessments by an Independent Review Committee confirmed these results, with median PFS not reached in the Minjuvi group, compared to 16.0 months in the placebo group.1 Minjuvi was generally well-tolerated, with respiratory infections, diarrhea and fatigue among the most common adverse reactions.1

FL is the second most common, slow-growing form of B-cell non-Hodgkin lymphoma (NHL) in Japan, accounting for 13.5% of all NHL types.2 It is considered incurable, and approximately 20% of patients experience progression or relapse within the first two years of starting treatment. This early progression (POD24) is associated with a significantly poorer prognosis, with only 34–50% of these patients being alive at five years.3,4,5 Despite advances in treatment, there remains a significant unmet need for additional options for relapsed or refractory FL.

This is the first regulatory approval for Minjuvi in Japan.

About inMIND
The inMIND study (NCT04680052) is a global, double-blind, randomized, placebo-controlled Phase 3 study evaluating the efficacy and safety of tafasitamab in combination with rituximab and lenalidomide compared with placebo in combination with rituximab and lenalidomide in patients with relapsed or refractory follicular lymphoma (FL) Grade 1 to 3a or relapsed or refractory nodal, splenic or extranodal marginal zone lymphoma (MZL). The study enrolled a total of 654 adults (age ≥18 years).6

The primary endpoint of the study is progression-free survival (PFS) by investigator assessment in the FL population, and the key secondary endpoints are PFS in the overall population as well as positron emission tomography complete response (PET-CR) and overall survival (OS) in the FL population.6

For more information about the study, please visit View Source

About Minjuvi (tafasitamab)
Minjuvi (tafasitamab) is a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). Incyte licenses exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc.

In the U.S., Monjuvi (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). Additionally, Monjuvi received accelerated approval in the U.S. in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).

In Europe, Minjuvi received conditional Marketing Authorization from the European Medicines Agency in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT. In addition, in December 2025, the EMA approved Minjuvi, in combination with lenalidomide and rituximab, for the treatment of adult patients with relapsed or refractory FL (Grade 1-3a) after at least one line of systemic therapy.

XmAb is a registered trademark of Xencor, Inc.

Monjuvi, Minjuvi, the Minjuvi and Monjuvi logos and the "triangle" design are registered trademarks of Incyte.

Important Safety Information
Please refer to the Minjuvi Product Information (PI) for precautions concerning indications, dosage and administration and safety information in Japan, Japan Pharmaceuticals and Medical Devices Agency.

(Press release, Incyte, DEC 22, 2025, View Source [SID1234661600])

Update on LATIFY Phase III trial of ceralasertib plus Imfinzi in previously treated advanced non-small cell lung cancer

On December 22, 2025 Astrazeneca reported The LATIFY Phase III trial of ceralasertib in combination with Imfinzi (durvalumab) did not meet the primary endpoint of overall survival (OS) versus standard-of-care docetaxel in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). The trial evaluated patients without actionable genomic alterations (AGAs) whose disease progressed on or after prior immunotherapy and platinum-based chemotherapy.

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Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "Our goal in the LATIFY trial was to reinvigorate the immune response of patients with lung cancer whose tumours stopped responding to available therapies by combining ATR inhibition with immunotherapy. While we are disappointed by this result, we remain committed to pioneering new medicines to address the urgent need to improve outcomes for patients with lung cancer through our industry-leading portfolio."

The combination of ceralasertib and Imfinzi was generally well tolerated, and the safety profile was consistent with the known profiles of each individual medicine, with no new safety concerns identified. These data will be presented at a forthcoming medical meeting.

Notes

NSCLC
Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-fifth of all cancer deaths.1 Lung cancer is broadly split into small cell lung cancer (SCLC) or NSCLC, the latter accounting for about 80-85% of cases.2-3 Patients are most commonly diagnosed with metastatic disease, when the tumour has spread outside the lung.4 Approximately 12% of people with metastatic NSCLC will still be alive five years after diagnosis.5

LATIFY
LATIFY is a randomised, open-label, multi-centre, global Phase III trial of ceralasertib plus Imfinzi in patients with locally advanced or metastatic NSCLC without AGAs, and whose disease has progressed on or after prior anti-PD-(L)1 therapy and platinum-based chemotherapy. Patients were randomised 1:1 to receive ceralasertib 240mg twice daily oral tablets for seven days in combination with a 1,500mg fixed dose of Imfinzi on day eight every four weeks or docetaxel every three weeks until disease progression, unacceptable toxicity, withdrawal of consent or a discontinuation criterion was met.

The trial enrolled 594 patients across more than 20 countries. The primary endpoint is OS and secondary endpoints include progression-free survival, objective response rate, duration of response, time to response, disease control rate and patient reported outcomes.

Ceralasertib
Ceralasertib is an oral, potent and selective inhibitor of the ATR kinase, which is crucial for DNA damage responses and cell survival. Ceralasertib acts on the tumour microenvironment, moving it from a suppressed immune state into an activated state when combined with immunotherapy.

Imfinzi
Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

In lung cancer, Imfinzi is the global standard of care based on OS in the curative-intent setting of unresectable, Stage III NSCLC in patients whose disease has not progressed after chemoradiotherapy (CRT). Additionally, Imfinzi is approved as a perioperative treatment in combination with neoadjuvant chemotherapy in resectable NSCLC, and in combination with a short course of Imjudo (tremelimumab) and chemotherapy for the treatment of metastatic NSCLC. Imfinzi is also approved for limited-stage SCLC in patients whose disease has not progressed following concurrent platinum-based CRT; and in combination with chemotherapy for the treatment of extensive-stage SCLC.

In addition to its indications in lung cancers, Imfinzi is also approved in combination with chemotherapy in locally advanced or metastatic biliary tract cancer and in combination with Imjudo in unresectable hepatocellular carcinoma (HCC). Imfinzi is also approved as a monotherapy in unresectable HCC in Japan and the European Union (EU), and in resectable, early-stage and locally advanced gastric and gastroesophageal junction cancers in the US.

Perioperative Imfinzi in combination with neoadjuvant chemotherapy is approved for muscle-invasive bladder cancer. In May 2025, Imfinzi added to Bacillus Calmette-Guérin induction and maintenance therapy met the primary endpoint of disease-free survival for patients with high-risk non-muscle-invasive bladder cancer in the POTOMAC Phase III trial.

Imfinzi in combination with chemotherapy followed by Imfinzi monotherapy is approved as a 1st-line treatment for primary advanced or recurrent endometrial cancer (mismatch repair deficient disease only in the US and EU). Imfinzi in combination with chemotherapy followed by Lynparza (olaparib) and Imfinzi is approved for patients with mismatch repair proficient advanced or recurrent endometrial cancer in the EU and Japan.

Since the first approval in May 2017, more than 414,000 patients have been treated with Imfinzi. As part of a broad development programme, Imfinzi is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with NSCLC, bladder cancer, breast cancer, ovarian cancer and several gastrointestinal cancers.

(Press release, AstraZeneca, DEC 22, 2025, View Source [SID1234661585])