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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])

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.

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])

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.

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])

enGene Reports Full Year 2025 Financial Results and Provides Business Update

On December 22, 2025 enGene Holdings Inc. (Nasdaq: ENGN, "enGene" or the "Company"), a clinical-stage, non-viral genetic medicines company, reported its financial results for the full year ended October 31, 2025, and provided a business update.

"We are closing 2025 in a position of strength: enrollment in LEGEND’s pivotal cohort is complete and the recent data update from the LEGEND pivotal cohort supports an emerging, competitive profile for the use of detalimogene as the first choice therapy in BCG-unresponsive NMIBC if approved," said Ron Cooper, President and Chief Executive Officer. "With recent acceptance into FDA’s CDRP program and a cash position of $342.4 million, extending our runway into the second half of 2028, we are entering the new year laser-focused on scaling our organization in preparation for our planned BLA filing in the second half of 2026 and a potential approval in 2027."

Recent Corporate Updates

LEGEND pivotal cohort update: In November, the Company reported updated preliminary data from LEGEND’s pivotal cohort for patients who were enrolled following a protocol amendment that was implemented in the fourth quarter of 2024 ("post-amendment patients"). The preliminary analysis of the post-amendment patients with at least one post-baseline disease assessment included 62 patients at 3 months and 37 patients at 6 months. Data from these patients demonstrated:

63% complete response (CR) rate at any time (n=62);
56% CR rate at 3 months (n=62);
62% CR rate at 6 months (n=37), including 4 patients who successfully converted to CR post reinduction; and
All 5 patients who completed the 9-month assessment had a CR.
The Company completed enrollment of 125 patients in the pivotal cohort, exceeding its target by 25%. Data from these patients demonstrated a generally favorable tolerability profile:

42% of patients experienced a treatment-related adverse event (TRAE);
1.6% of patients experienced dose interruptions due to TRAEs; and
0.8% of patients experienced dose discontinuations due to TRAEs.
The Company continues to believe that detalimogene’s emerging profile supports its potential first line use in patients with high-risk, BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ (CIS).

Additional LEGEND cohort updates: In conjunction with its November data update for LEGEND’s pivotal cohort, the Company provided an enrollment update for LEGEND’s three additional cohorts:

Cohort 2a, evaluating detalimogene in patients with high-risk NMIBC with CIS who are naïve to treatment with BCG, has enrolled 30 patients.
Cohort 2b, evaluating detalimogene in patients with high-risk, NMIBC with CIS who have been exposed to BCG but have not received adequate BCG treatment, has enrolled 45 patients.
Cohort 3, evaluating detalimogene in BCG-unresponsive patients with high-risk, papillary-only NMIBC, has enrolled 36 patients.
Successful completion of public offering: In November, the Company successfully closed an underwritten public offering of its common shares and pre-funded warrants at an offering price of $8.50 per share and $8.4999 per pre-funded warrant. The offering totaled $140.1 million in net proceeds, following the full exercise of the underwriters’ option to purchase additional shares.

Development and Readiness Pilot (CDRP) Program: In November, the Company was selected as one of nine companies to participate in FDA’s Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) program. The FDA created the CDRP Program to facilitate CMC development for therapies with compressed clinical development timeframes based on the anticipated clinical benefits of earlier patient access to the therapy. The initiative is designed to promote earlier and more structured engagement between sponsors and the FDA on CMC development strategies, and since its inception, has led to increased collaboration with the FDA so sponsors can confidently scale up manufacturing capacity while clinical development is ongoing. Acceptance into the program further supports enGene’s confidence in detalimogene’s potential and aligns with enGene’s commitment to strong manufacturing practices as clinical development advances.

Key executive hire: In September, enGene announced the appointment of Hussein Sweiti, M.D., MSc, as Chief Medical Officer. Dr. Sweiti is a surgical oncologist and physician-scientist with more than 15 years of experience spanning clinical practice, oncology clinical research, global drug development, regulatory submissions, and medical affairs. He most recently served as Global Medical Head, Oncology Clinical Development at Johnson & Johnson (J&J), where he led end-to-end clinical strategy and execution for the company’s bladder cancer portfolio. He was intimately involved in U.S. Food and Drug Administration (FDA) interactions that culminated in J&J’s FDA approval in high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) earlier this month.

Anticipated Milestones

Following discussion with the FDA on its statistical analysis plan and the accumulation of sufficient 12-month CR data points, enGene expects to provide a data update on the LEGEND trial’s pivotal cohort in the second half of 2026.
Planned BLA filing for LEGEND’s pivotal cohort in the second half of 2026.
Fourth Quarter 2025 Financial Results
As of October 31, 2025, cash, cash equivalents and marketable securities were $202.3 million. An additional $140.1 million in net proceeds was raised during a public offering in November. The Company expects that its cash and cash equivalents together with the net proceeds from the November financing will fund operating expenses, debt obligations and capital expenditures into the second half of 2028.

Full Year Financial Results ended October 31, 2025
Total operating expenses were $123.2 million for the full year ended October 31, 2025, compared to $62.3 million for 2024. Research and development expenses increased by $56.2 million, primarily driven by increased manufacturing, personnel and clinical costs related to our LEGEND trial and in preparation for our planned Biologics License Application submission in the second half of 2026. General and administrative expenses increased by $4.7 million, primarily driven by personnel and facilities costs as the Company scales its general and administrative function to support the operation of a public company.

For the full year ended October 31, 2025, net loss attributable to common shareholders was approximately $117.3 million, or $2.29 per share, compared to approximately $55.1 million, or $1.46 per share, for the full year 2024. The increase in net loss is mainly attributed to the increase in operating expenses, partially offset by net interest income earned during the period.

About Non-Muscle Invasive Bladder Cancer (NMIBC)
Non-muscle invasive bladder cancer (NMIBC) is a disease that poses a significant burden on both patients and clinics and has a massive economic impact on our healthcare system. NMIBC occurs when cancer cells grow in the tissues that line the interior of the bladder, but the cancer has not yet penetrated the muscle of the bladder wall. NMIBC can present as papillary outgrowths from the bladder wall, which are typically resected, or as carcinoma in situ (CIS), which consists of flat, multifocal lesions that cannot be resected. The two forms can also co-occur. About 75-80% of new bladder cancer diagnoses are NMIBC. Patients suffering from high-risk NMIBC who are unresponsive to the standard of care, Bacillus Calmette-Guérin (BCG), face high rates of disease recurrence (50-70%) and are potentially subject to full removal of the bladder (cystectomy) as a curative but life-altering next step.

About Detalimogene Voraplasmid
Detalimogene is a novel, investigational, non-viral gene therapy for patients with high-risk, non-muscle invasive bladder cancer (NMIBC), including Bacillus Calmette-Guérin (BCG)-unresponsive disease. It is designed to be instilled in the bladder and elicit a powerful yet localized anti-tumor immune response.

Detalimogene was developed using the Company’s Dually Derivatized Oligochitosan (DDX) platform, a technology designed to transform how gene therapies are accessed by patients and utilized by clinicians. Medicines developed with the DDX platform can potentially overcome the limitations of viral-based gene therapies, reduce complexities related to safe handling and cold storage, and streamline both manufacturing processes and administration paradigms.

Detalimogene has received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the U.S. Food and Drug Administration (FDA) based on its potential to address the high unmet medical need for patients with BCG-unresponsive carcinoma in situ (CIS) NMIBC with or without resected papillary tumors who are unable to undergo cystectomy. The RMAT program is intended to expedite the development and review of regenerative medicine therapies for serious or life-threatening conditions, where preliminary clinical evidence suggests potential to address unmet medical needs. Similarly, Fast Track designation is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Detalimogene has also been selected to participate in the FDA’s Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) program. The FDA created the CDRP Program to facilitate CMC development for therapies with compressed clinical development timeframes based on the anticipated clinical benefits of earlier patient access to the therapy.

About the LEGEND Trial
Detalimogene is being evaluated in the ongoing, open-label, multi-cohort, Phase 2 LEGEND trial to establish its safety and efficacy in high-risk NMIBC. LEGEND’s pivotal cohort (Cohort 1) consists of 125 patients with high-risk, BCG-unresponsive NMIBC with CIS (with or without papillary disease) and is designed to serve as the basis of the Company’s planned Biologics License Application (BLA) filing. In addition to this pivotal cohort, LEGEND includes three additional cohorts, including NMIBC patients with CIS who are naïve to treatment with BCG (Cohort 2a); NMIBC patients with CIS who have been exposed to BCG but have not received adequate BCG treatment (Cohort 2b); and BCG-unresponsive high-risk NMIBC patients with papillary-only disease (Cohort 3). The LEGEND trial is actively enrolling patients with sites participating in the USA, Canada, Europe, and the Asia-Pacific region.

(Press release, enGene, DEC 22, 2025, View Source [SID1234661597])

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

On December 22, 2025 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported that James Porter, Ph.D., Chief Executive Officer, will present at the 44th Annual J.P. Morgan Healthcare Conference on Tuesday, January 13, 2026, at 9:00 a.m. PT in San Francisco.

A live webcast will be available in the Investors section of the company’s website at www.nuvalent.com, and archived for 30 days following the presentation.

(Press release, Nuvalent, DEC 22, 2025, View Source [SID1234661596])