On April 3, 2026 Bristol-Myers Squibb Company (Headquarters: Tokyo, Japan) today received approval for a partial amendment to the manufacturing and marketing authorization for its CD19-targeted CAR T-cell therapy, "Breyangi Injection" (generic name: lysokabutagen maralucell, hereinafter "Breyangi"), for the treatment of relapsed or refractory marginal zone lymphoma (hereinafter, MZL) and relapsed or refractory mantle cell lymphoma (hereinafter, MCL). This approval will allow Breyanzi to be offered as a treatment option for relapsed or refractory MCL regardless of the number of prior treatment lines, and for relapsed or refractory MZL from the third line of treatment onward.
This adds a new option to these disease areas where there remains a high level of unmet medical need.

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MZL and MCL are both B-cell lymphomas that fall under the category of non-Hodgkin lymphoma. MZL is a subtype that accounts for about 7% of all non-Hodgkin lymphomas. While many patients achieve remission with initial treatment, relapses are not uncommon, and there has been a need for new treatment options that provide long-term, sustained therapeutic effects. In addition, some cases of MZL can progress to diffuse large B-cell lymphoma, which is a more aggressive form of lymphoma.

MCL is a highly malignant and rare form of non-Hodgkin lymphoma, accounting for approximately 3% of all non-Hodgkin lymphomas. It originates from cells that make up the "mantle zone" of the lymph nodes. The average age at diagnosis is in the mid-60s, and it is more common in the elderly. There is no established standard treatment for MCL that can be expected to cure the disease, and ultimately, disease progression or recurrence occurs. Treatment options for relapsed or refractory MCL are limited.

This approval is based on efficacy and safety results obtained in the MZL cohort of the international collaborative Phase II clinical trial (TRANSCEND FL trial) for patients with relapsed or refractory low-grade B-cell non-Hodgkin lymphoma, and in the MCL cohort of the overseas Phase I clinical trial (TRANSCEND NHL 001 trial) for patients with relapsed or refractory B-cell non-Hodgkin lymphoma.

Angela Davis, Head of Research and Development at Bristol-Myers Squibb Company, stated:

"This approval further expands the indications for Breyange as a CD19-targeted CAR T-cell therapy for B-cell malignancies.
This new single-dose CAR T-cell therapy is highly significant for patients with relapsed or refractory MCL and MZL who have received multiple treatments.
Bristol-Myers Squibb will continue to drive the development and delivery of innovative cell therapies worldwide, aiming to bring long-term benefits to patients facing serious illnesses."

About the TRANSCEND FL trial (Marginal Zone Lymphoma (MZL))
The TRANSCEND FL trial is a phase II, open-label, multicenter study evaluating the efficacy and safety of Breyanzi. Cohort 4 (patients with MZL prior to two or more systemic therapies) includes 67 adult patients with relapsed or refractory indolent B-cell NHL (65 non-Japanese patients and 2 Japanese patients).

The primary endpoint is the overall response rate (ORR), while secondary endpoints include the complete response rate (CRR), duration of response (DOR), DOR in patients who achieved complete response (CR), progression-free survival (PFS), overall survival (OS), safety, and cytokinetics, among others.

In the efficacy analysis population of 66 patients (including 2 Japanese patients) treated with Breyanzi, the primary endpoint, the overall response rate (95% CI), was 95.5% (87.3-99.1), which was statistically significant against the threshold of 50% (p<0.0001). Both Japanese patients showed a response. The
safety profile was consistent with previously reported findings, and no new safety signals were observed.

About the TRANSCEND NHL 001 trial (Mantle cell lymphoma (MCL))
The TRANSCEND NHL 001 trial is a phase I, open-label, multicenter study evaluating the efficacy and safety of Breyanzi. The MCL cohort (patients with MCL prior to two or more systemic therapies) includes 88 adult patients with relapsed or refractory B-cell non-Hodgkin lymphoma (NHL). Patients with one or more prior systemic therapies were also included, although they were not the primary target for the efficacy analysis.

The primary endpoints are safety and overall response rate (ORR), while secondary endpoints include complete response rate (CRR), duration of response (DOR), progression-free survival (PFS), PFS ratio, overall survival (OS), changes in health-related quality of life, and cellular dynamics.

In the primary efficacy analysis population of 74 patients (including only those who received 100 × 10⁶ CAR-expressing live T cells and had received two or more prior systemic therapies, including alkylating agents, Bruton’s tyrosine kinase inhibitors, and rituximab (or other CD20-targeted drugs)), the overall response rate (95% CI), which was the primary endpoint, was 86.5% (76.5–93.3), and the lower limit of the 95% CI was statistically significant against the pre-defined threshold of 40% (p<0.0001). In addition, in the efficacy analysis population of 77 patients (including those who received 100 × 10⁶ CAR-expressing live T cells and had received one or more prior systemic therapies), the ORR (95% CI) was 87.0% (77.4–93.6).
The safety profile was consistent with previously reported findings, and no new safety signals were observed.

(Press release, Bristol-Myers Squibb, APR 3, 2026, View Source [SID1234665483])

On April 2, 2026 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that KEYTRUDA (pembrolizumab), in combination with paclitaxel, with or without bevacizumab, is approved in the European Union (EU) for the treatment of platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma in adults whose tumors express PD-L1 with a Combined Positive Score (CPS) ≥1 and who have received one or two prior systemic treatment regimens. This approval, which also covers KEYTRUDA SC [known as KEYTRUDA QLEXTM (pembrolizumab and berahyaluronidase alfa-pmph) in the U.S.], makes this regimen the first and only PD-1 inhibitor-based treatment option for eligible patients with platinum-resistant ovarian cancer in the EU.

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"Despite recent advances, patients with ovarian cancer face a significant unmet need when their disease progresses and becomes resistant to standard platinum-based therapy," said Dr. Nicoletta Colombo, director of the Gynecologic Oncology Program at the European Institute of Oncology in Milan, Italy. "The approval of this pembrolizumab-based regimen is an important advance that provides a crucial new treatment option and represents a welcome addition to the treatment landscape for appropriate patients with PD-L1-positive platinum-resistant ovarian cancer across Europe."

This approval is based on results from the Phase 3 KEYNOTE-B96 trial (also known as ENGOT-ov65), in which KEYTRUDA plus paclitaxel, with or without bevacizumab, demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS), the trial’s primary endpoint, and overall survival (OS), a key secondary endpoint, for patients with platinum-resistant recurrent ovarian cancer whose tumors expressed PD-L1 (CPS ≥1) compared to placebo plus paclitaxel, with or without bevacizumab. The approval follows a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), received in February 2026.

"We’re proud to bring this KEYTRUDA-based regimen to appropriate patients in Europe with PD-L1-positive platinum-resistant ovarian cancer – giving this community access to the region’s first PD-1 inhibitor treatment approach for this disease," said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories. "This milestone marks real progress for patients and advances our broader mission of expanding access to effective options for women’s cancers globally."

In the KEYNOTE-B96 trial, KEYTRUDA plus paclitaxel, with or without bevacizumab, demonstrated a statistically significant and clinically meaningful improvement in PFS, reducing the risk of disease progression or death by 28% (HR=0.72 [95% CI, 0.58-0.89]; p=0.0014) in patients with platinum-resistant recurrent ovarian cancer whose tumors expressed PD-L1 (CPS ≥1) when compared to placebo plus paclitaxel, with or without bevacizumab. For patients with platinum-resistant recurrent ovarian cancer whose tumors expressed PD-L1 (CPS ≥1) who received the KEYTRUDA-based regimen, median PFS was 8.3 months (95% CI, 7.0-9.4) versus 7.2 months (95% CI, 6.2-8.1) for patients receiving the placebo regimen.

The KEYTRUDA-based regimen also demonstrated a statistically significant and clinically meaningful improvement in OS for patients with platinum-resistant recurrent ovarian cancer whose tumors expressed PD-L1 (CPS ≥1), reducing the risk of death by 24% (HR=0.76 [95% CI, 0.61-0.94]; p=0.0053) compared to placebo plus paclitaxel with or without bevacizumab. For patients with platinum-resistant recurrent ovarian cancer whose tumors expressed PD-L1 (CPS ≥1) who received the KEYTRUDA-based regimen, median OS was 18.2 months (95% CI, 15.3-21.0) versus 14.0 months (95% CI, 12.5-16.1) for patients receiving the placebo regimen.

This approval authorizes marketing of this KEYTRUDA treatment regimen for this indication in all 27 EU member states, as well as Iceland, Liechtenstein and Norway. Timing for commercial availability of KEYTRUDA for this indication in individual EU countries will depend on multiple factors, including the completion of national reimbursement procedures.

In February 2026, KEYTRUDA plus paclitaxel, with or without bevacizumab, was approved by the U.S. Food and Drug Administration (FDA) to treat adult patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma whose tumors express PD-L1 (CPS ≥1), as determined by an FDA-authorized test, and who have received one or two prior systemic treatment regimens.

About KEYNOTE-B96/ENGOT-ov65

KEYNOTE-B96, also known as ENGOT-ov65, is a multicenter, randomized, double-blind placebo-controlled Phase 3 trial (ClinicalTrials.gov, NCT05116189) sponsored by Merck and conducted in collaboration with the European Network for Gynecologic Oncology Trial (ENGOT) groups investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy (paclitaxel), with or without bevacizumab, compared to placebo plus chemotherapy with or without bevacizumab for the treatment of platinum-resistant recurrent ovarian cancer. The primary endpoint is PFS, as assessed by investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), and OS is a key secondary endpoint. The trial enrolled 643 patients with epithelial ovarian, fallopian tube or primary peritoneal carcinoma, regardless of PD-L1 tumor expression status, who received one or two prior lines of systemic therapy for ovarian carcinoma, including at least one line of platinum-based chemotherapy. Of the 643 enrolled patients, 72% of patients had tumors expressing PD-L1 (CPS ≥1). Patients were enrolled in KEYNOTE-B96 regardless of PD-L1 tumor expression status. Patients were randomized (1:1) to receive either KEYTRUDA plus paclitaxel, with or without bevacizumab, or placebo plus paclitaxel, with or without bevacizumab. KEYTRUDA (400 mg) or placebo were administered on Day 1 of each six-week treatment cycle and paclitaxel (80 mg/m2) was administered on Days 1, 8 and 15 of each three-week treatment cycle. The option to use bevacizumab was by investigator choice prior to randomization. Bevacizumab (10 mg/kg) was administered on Day 1 of a two-week treatment cycle.

Results from the final analysis of the KEYNOTE-B96 trial evaluating KEYTRUDA plus paclitaxel, with or without bevacizumab, including PFS and OS results for patients with platinum-resistant recurrent ovarian cancer regardless of PD-L1 status, were recently presented at the European Society of Gynaecological Oncology (ESGO) 2026 Congress.

About platinum-resistant ovarian cancer

Ovarian cancer often begins in the fallopian tubes or the ovaries. As of 2022, it is the eighth most commonly diagnosed cancer and the eighth leading cause of cancer death among women worldwide. Globally, there were more than 324,000 patients diagnosed with ovarian cancer and almost 207,000 deaths from the disease in 2022. In many regions, its incidence has been increasing, with estimates projecting a 42% increase in new cases worldwide by 2040. Over 80% of patients diagnosed with ovarian cancer will experience disease progression following standard treatment with platinum-based chemotherapy regimens. Of these patients, approximately 25% will experience disease progression within six months of completing first-line platinum-based chemotherapy – defined as primary platinum-resistant ovarian cancer. Prognosis is particularly poor for these patients and approved treatment options are limited.

(Press release, Merck & Co, APR 2, 2026, View Source [SID1234664152])

On April 2, 2026 MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering allogeneic invariant natural killer T (allo-iNKT) cell therapies to restore immune balance and treat immune-mediated diseases and cancer, reported that an abstract featuring its investigational iNKT cell therapy, agenT-797, has been accepted for presentation at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting, taking place May 11-15, 2026, in Boston, MA.

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Presentation Details:

Abstract Title: AgenT-797 Allogeneic iNKT Cell Therapy Demonstrates Adaptive Immune Modulation in Cancer and ARDS
Presenter: Terese C. Hammond, MD; Program Director of Pulmonary and Critical Care, Kaweah Health Medical Center; Head of Inflammatory and Pulmonary Diseases, MiNK Therapeutics
Additional information on the poster presentation including session location and timing details will be made available by ASGCT (Free ASGCT Whitepaper) via the ASGCT (Free ASGCT Whitepaper) Annual Meeting conference program website in mid-April.

(Press release, MiNK Therapeutics, APR 2, 2026, View Source [SID1234664168])

On April 2, 2026 Revolution Medicines, a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, reported that it has begun treating patients in RASolute 303, a global Phase 3 clinical trial evaluating daraxonrasib as monotherapy and in combination with chemotherapy in patients with previously untreated metastatic pancreatic ductal adenocarcinoma (PDAC), a disease predominantly driven by oncogenic RAS variants. RASolute 303 is designed to enroll patients irrespective of tumor RAS genotype.

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"Starting treatment of study participants in the RASolute 303 trial represents an important milestone for our daraxonrasib program and for patients with metastatic pancreatic cancer, a disease with substantial unmet medical need," said Alan Sandler, M.D., chief development officer of Revolution Medicines. "In this trial, we are testing two biologically rational approaches—daraxonrasib as monotherapy and daraxonrasib in combination with chemotherapy—as two distinct, promising strategies to potentially improve patient outcomes. This trial underscores our commitment to advancing RAS(ON) inhibition into earlier lines of therapy, where we believe it can deliver significant benefit."

RASolute 303 (NCT07491445) is a global, randomized, open-label Phase 3 trial evaluating daraxonrasib as monotherapy or in combination with gemcitabine and nab-paclitaxel versus standard-of-care gemcitabine and nab-paclitaxel in patients with previously untreated metastatic PDAC. In this trial, the company is enrolling patients who have not received prior systemic therapy for metastatic disease. The primary endpoints are progression-free survival and overall survival. Key secondary endpoints include additional measures of antitumor activity, safety and tolerability, and patient reported outcomes.

Daraxonrasib is currently being evaluated in four global Phase 3 registrational trials, including three trials in patients with PDAC and one in patients with non-small cell lung cancer (NSCLC).

About Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma
Pancreatic cancer is one of the most lethal malignancies, characterized by its typically late-stage diagnosis, resistance to standard chemotherapy, and high mortality rate. In the U.S., recent estimates indicate that approximately 60,000 people are diagnosed annually with pancreatic cancer, and about 50,000 people will die from this aggressive disease.1

Due to the lack of early symptoms and detection methods, approximately 80% of patients are diagnosed with PDAC at an advanced or metastatic stage. It is the most commonly RAS-driven malignancy of all major cancers, and more than 90% of patients have tumors that harbor RAS mutations.2 Metastatic PDAC remains one of the most common causes of cancer-related deaths in the U.S., with a five-year survival rate of approximately 3%. 3,4

About Daraxonrasib
Daraxonrasib (RMC-6236) is an oral, direct RAS(ON) multi-selective inhibitor with the potential to help address a broad range of cancers driven by oncogenic RAS, including PDAC, NSCLC and colorectal cancer. Daraxonrasib suppresses RAS signaling by blocking the interaction of wild-type and mutant RAS(ON) with its downstream effectors.

(Press release, Revolution Medicines, APR 2, 2026, View Source [SID1234664153])

On April 2, 2026 Adagene Inc. ("Adagene" or the "Company") (Nasdaq: ADAG), a company committed to transforming the discovery and development of novel antibody-based therapies, reported the pricing of its underwritten public offering of 18,666,000 American depositary shares, or ADSs, each representing 1.25 ordinary shares of the Company, par value US$0.0001 per share, at the offering price of US$3.75 per ADS, representing the 30-day volume-weighted average price ("VWAP").

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The gross proceeds to Adagene from the offering are expected to be approximately US$70.0 million, before deducting underwriting discount and offering expenses. The offering is expected to close on April 6, 2026, subject to the satisfaction of customary closing conditions.

Leerink Partners and LifeSci Capital are acting as joint book-running managers for the offering. Lucid Capital Markets is acting as co-manager for the offering.

The offering featured participation from new and existing investors including Janus Henderson Investors, Deerfield Management, Invus, Sirenia and Columbia Threadneedle Investments, among others.

The offering is being made pursuant to a shelf registration statement on Form F-3, including a base prospectus, that was initially filed with the Securities and Exchange Commission (SEC) on May 9, 2025 and became effective on May 30, 2025. A prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available for free on the SEC’s website located at www.sec.gov. Copies of the prospectus relating to the offering may be obtained, when available, from: Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, Massachusetts 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]; or LifeSci Capital LLC, 1700 Broadway, 40th Floor, New York, New York 10019, or by email at [email protected].

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, 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, Adagene, APR 2, 2026, View Source [SID1234664169])