On March 9, 2026 Ipsen (Euronext: IPN; ADR: IPSEY) reported that it is voluntarily withdrawing Tazverik (tazemetostat) in all indications from all Ipsen markets. Ipsen’s decision to withdraw is based on emerging data from the ongoing Phase Ib/III SYMPHONY-1 trial (evaluating tazemetostat in combination with lenalidomide plus rituximab (R2) vs R2 in follicular lymphoma). The Independent Data Monitoring Committee (IDMC) advised that, based on adverse events of secondary hematologic malignancies, the risks may outweigh potential benefits for patients within this treatment regimen. As a result of these data, Ipsen is withdrawing Tazverik effective immediately, including both for follicular lymphoma (FL) and epithelioid sarcoma (ES).

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In addition to withdrawing Tazverik from the market, Ipsen has initiated steps to stop treatment with tazemetostat for all patients currently enrolled in the ongoing SYMPHONY-1 trial. All participants will receive standard of care, lenalidomide plus rituximab only. The study will remain open, with no further enrolment, to continue the long-term safety follow-up of all participants. Ipsen is also discontinuing all active tazemetostat clinical trials and expanded access programs.

"While this is an extremely disappointing outcome, the safety of patients remains our priority", said Christelle Huguet, PhD & EVP Head of R&D at Ipsen. "Emerging data from this confirmatory study have highlighted a safety profile that is unfavorable compared to that previously observed in clinical evaluation. We will now work closely with investigators and clinical teams to support patients through the respective next steps and transition plans."

Ipsen is working with the United States (U.S.) Food and Drug Administration (FDA) on the next steps to execute the withdrawal of Tazverik and provide all necessary information to complete this process. Tazverik is marketed in the U.S. by Ipsen in FL and ES. Tazverik received accelerated approval from the U.S. FDA in 2020 for adults with relapsed or refractory FL whose tumors are positive for an EZH2 mutation and who have received at least two prior therapies as well as relapsed or refractory FL adult patients who have no satisfactory alternative treatment options. Tazverik also received U.S. FDA accelerated approval in 2020 for the treatment of adults and adolescents aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.

The withdrawal is not expected to impact the Company’s financial guidance.

About Tazverik
Tazverik is an EZH2 inhibitor indicated in the U.S. for the treatment of:
Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies.
Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.
These indications are approved under accelerated approval regulatory pathways based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.
View the U.S. Full Prescribing Information here
Tazverik is available in Japan, Macau, Hong Kong & China via Ipsen partners.

About SYMPHONY-1
SYMPHONY‑1 (EZH‑302; NCT04224493) is an Ipsen‑led global Phase Ib/III study evaluating Tazverik in combination with lenalidomide and rituximab (R²) as a second‑line therapy for relapsed/refractory follicular lymphoma. This study also serves as the confirmatory trial required under the accelerated approval pathway for Tazverik in follicular lymphoma.

The trial spans 229 sites across 15 countries, including the U.S., EU, China, and others, and includes independently powered analyses for EZH2‑wild‑type and EZH2‑mutant patient populations.

(Press release, Ipsen, MAR 9, 2026, View Source [SID1234663366])

On March 9, 2026 INOVIO (NASDAQ:INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-associated diseases, cancer and infectious diseases, reported that it will participate in the following scientific conferences:

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Eurogin HPV Conference (Vienna, Austria)
Date: Thursday, March 19
Time: 8:00 AM CET
Presentation: DNA Immunotherapy INO-3107 Demonstrates Long-Term Surgical Intervention Reduction in HPV-6 & 11 RRP

World Vaccine Congress DC (Washington, DC)
Date: Monday, March 30
Time: 11:50 AM ET
Presentation: Novel DNA-Encoded Monoclonal Antibody Technology: Durable and Tolerable In Vivo Expression of mAbs Targeting COVID

Available abstracts will be shared on INOVIO’s website following presentations.

(Press release, Inovio, MAR 9, 2026, View Source [SID1234663365])

On March 9, 2026 ImmunityBio (NASDAQ: IBRX), a commercial-stage immunotherapy company, reported that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of its supplemental Biologics License Application (sBLA) for ANKTIVA (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary tumors.

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The resubmission follows ongoing discussions with the FDA beginning in January 2026, during which the Agency requested additional data to support its review. The request did not include the initiation or design of any new clinical trials. ImmunityBio submitted the requested information in February 2026. After reviewing the additional data, the FDA provided feedback in March requesting updated efficacy data. The company subsequently resubmitted the sBLA for patients with papillary-only NMIBC, including updated long-term follow-up data, and the Agency has acknowledged receipt of the filing. The long-term safety and efficacy results for ANKTIVA plus BCG in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary tumors have been published in The Journal of Urology.

"As far back as 2007, IL-15 was identified by leading scientific and medical organizations, including the NCI, NIH, FDA, AACR (Free AACR Whitepaper), and ASH (Free ASH Whitepaper), as the number one ranked immunotherapy molecule with the potential to cure cancer," said Dr. Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio. "The mechanism of action of ANKTIVA’s IL-15 superagonist activity was affirmed by the FDA’s approval of ANKTIVA in 2024 for BCG-unresponsive NMIBC with carcinoma in situ (CIS), with or without papillary tumors. The long-term data in papillary disease alone demonstrate prolonged disease-free survival and durable bladder preservation, consistent with ANKTIVA’s IL-15-based mechanism of action."

Dr. Soon-Shiong added, "We welcome FDA Commissioner Dr. Makary’s recent statements in The New England Journal of Medicine highlighting the importance of a "plausible mechanism of action" as an emerging regulatory pathway. The mechanism of action of ANKTIVA, which was recognized in the NCI’s 2007 report and reaffirmed in the FDA-approved 2024 package insert, embodies the principles underlying this approach."

Based on the IL-15 mechanism of action and results from the QUILT 3.055 study, the Saudi Food and Drug Authority (SFDA) recently approved ANKTIVA in combination with checkpoint inhibitors for patients with second-line and later metastatic non-small cell lung cancer (NSCLC) whose disease has progressed after standard therapies, including checkpoint inhibitor treatment. In this setting, multiple randomized studies of investigational agents compared with docetaxel chemotherapy have failed to demonstrate improved outcomes, underscoring the significant unmet need among patients who experience relapse or progression after checkpoint inhibitor therapy. Notably, the recent randomized PRAGMATICA-LUNG (SWOG S2302) trial in the same disease setting, which compared pembrolizumab plus ramucirumab versus docetaxel, did not demonstrate improved survival compared with docetaxel, reporting a median overall survival of approximately nine months with docetaxel chemotherapy.

ImmunityBio plans to present the clinical data supporting the SFDA approval of the chemotherapy-free regimen of ANKTIVA plus checkpoint inhibitors, which demonstrated nearly double the median overall survival historically observed with docetaxel chemotherapy. The Company also intends to continue discussions with the FDA and other global regulatory authorities regarding potential treatment options for patients with second line and later metastatic NSCLC who have exhausted currently available standards of care, including checkpoint inhibitors.

About the Papillary Indication: The sBLA submission for BCG-unresponsive NMIBC papillary disease is supported by long-term results from the QUILT 3.032 Phase 2/3 trial (Cohort B) in 80 patients with high-grade papillary-only NMIBC. As published in The Journal of Urology (Chang et al., 2025), the study met its primary endpoint with a 12-month disease-free survival (DFS) rate of 58.2% (95% confidence interval: 46.6-68.2%). Patients treated with intravesical ANKTIVA plus BCG demonstrated a 96.0% disease-specific survival (DSS) rate at 36 months, with median DSS not yet reached. Progression-free survival (PFS) was 94.9% at 12 months and 83.1% at 36 months, indicating durable prevention of progression to muscle-invasive disease. Bladder preservation remained high, with cystectomy-free survival of 92.2% at 12 months and 81.8% at 36 months, meaning over 80% of patients avoided radical cystectomy through three years of follow-up. These results highlight the potential of ANKTIVA plus BCG to provide durable bladder-sparing outcomes and a chemotherapy-free immunotherapy alternative for patients with high-risk papillary NMIBC.

About ANKTIVA (nogapendekin alfa inbakicept-pmln)
The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. A key component in the Company’s BioShield platform, ANKTIVA is a first-in-class IL-15 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones.

IMPORTANT SAFETY INFORMATION

INDICATION AND USAGE: ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

WARNINGS AND PRECAUTIONS: Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle-invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after a second induction course of ANKTIVA with BCG, reconsider cystectomy.

DOSAGE AND ADMINISTRATION: For Intravesical Use Only. Do not administer by subcutaneous or intravenous routes.

Please see the complete Indication and Important Safety Information and Prescribing Information for ANKTIVA at Anktiva.com.

(Press release, ImmunityBio, MAR 9, 2026, View Source [SID1234663364])

On March 9, 2026 HUTCHMED (China) Limited ("HUTCHMED" or the "Company") (Nasdaq/AIM:HCM; HKEX:13) reported an update regarding TAZVERIK (tazemetostat), an oncology therapy licensed from Epizyme, Inc. ("Epizyme"), an Ipsen ("Ipsen") company, in China. Epizyme is the Marketing Authorization Holder of TAZVERIK in the Chinese mainland, for which HUTCHMED Limited (a subsidiary of the Company) acts as the domestic agent/licensee. Ipsen has informed HUTCHMED that it is voluntarily withdrawing TAZVERIK in the US. As a result, steps have been taken to initiate the market withdrawal and product recall in China. Consequently, HUTCHMED Limited has initiated a withdrawal and product recall from the Chinese mainland, Hong Kong and Macau, and is discontinuing all active tazemetostat clinical trials. Existing patients should consult their treating physicians immediately to discuss their treatment options.

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Ipsen is the sponsor of the ongoing Phase Ib/III SYMPHONY-1 trial (evaluating tazemetostat in combination with lenalidomide plus rituximab ("R²") vs R² in follicular lymphoma). As informed by Ipsen, following a review of emerging data from SYMPHONY-1, the study Independent Data Monitoring Committee advised that, based on adverse events of secondary hematologic malignancies, the risks may outweigh potential benefits for patients within this treatment regimen. As a result of these data, Ipsen is withdrawing TAZVERIK effective immediately, including both for follicular lymphoma ("FL") and epithelioid sarcoma (ES).

Ipsen has announced that, in addition to withdrawing TAZVERIK from the market, Ipsen has initiated steps to stop treatment with tazemetostat for all patients currently enrolled in the ongoing SYMPHONY-1 trial. All participants will receive standard of care, lenalidomide plus rituximab only. The study will remain open, with no further enrollment, to continue the long-term safety follow-up of all participants. Ipsen is also discontinuing all active tazemetostat clinical trials and expanded access programs. Ipsen is working with the US Food and Drug Administration ("US FDA") on the next steps to execute the withdrawal of TAZVERIK and provide all necessary information to complete this process.

The safety and wellbeing of patients is HUTCHMED’s top priority. In alignment with this commitment, HUTCHMED Limited has promptly informed healthcare professionals, the China National Medical Products Administration ("NMPA"), the Hong Kong Department of Health and the Macau Health Bureau of this development. Upon becoming aware of this information, HUTCHMED Limited immediately placed the product on hold, suspending all sales and shipments, and notified healthcare institutions to cease prescribing it and pharmacies to stop dispensing it. HUTCHMED Limited has also immediately notified clinical trial sites in China to discontinue the use of tazemetostat. Furthermore, HUTCHMED Limited is also actively cooperating with regulatory authorities to determine the appropriate next steps for the withdrawal and recall of TAZVERIK in the Chinese mainland, Hong Kong and Macau.

TAZVERIK is a first-in-class methyltransferase inhibitor of EZH2 developed by Epizyme. TAZVERIK monotherapy was approved by the US FDA in 2020 under the US FDA accelerated approval program. TAZVERIK received conditional approval from the NMPA for the treatment of FL as an imported drug. This approval pathway incorporates the evaluation of overseas trial data, references overseas regulatory approvals, and bridging study data to adapt foreign trial results to the Chinese population. Continued registration of TAZVERIK is subject to continuing obligations, including reporting of changes in foreign regulatory status, new safety signals and new evidence affecting the benefit-to-risk profile to patients.

The withdrawal is not expected to impact the Company’s financial guidance. In 2025, HUTCHMED sales of TAZVERIK were US$2.5 million.

(Press release, Hutchison China MediTech, MAR 9, 2026, View Source [SID1234663363])

On March 9, 2026 Defence Therapeutics Inc. ("Defence" or the "Company"), (CSE: DTC, OTCQB: DTCFF, FSE: DTC), a publicly traded biotechnology and precision intracellular drug-delivery company, reported the closing of a private placement (the "Private Placement") of 17,445,455 units (the "Units") at a price of $0.55 per Unit, for aggregate gross proceeds to Defence of $9,595,000.25. Each Unit is comprised of one common share (each, a "Share") and one common share purchase warrant ("Warrants"). Each Warrant entitles its holder to acquire an additional common share of the Company at a price of $0.65 per share for 24 months following the date of issuance.

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As previously announced, the Company executed a binding term sheet (the "Term Sheet") with two arm’s length institutional investors (collectively, the "Investors") in connection with the Private Placement for aggregate gross proceeds of $6,000,000, pursuant to the terms and conditions of a sharing agreement (the "Sharing Agreement") dated and executed as of March 6, 2026 (the "Closing Date"). For more information, please see the Company’s press release dated February 27, 2026.

All 10,909,091 Warrants issued pursuant to the Term Sheet are exercisable at an exercise price of $0.65 per Share for a period of 24 months following the Closing Date. The Warrants include an equity blocker provision that prohibits the holder from exercising any portion of the Warrants if such exercise would result in the holder owning more than 9.99% of the Company’s outstanding Shares. The Investors received a corporate finance fee of 654,546 Units and a non-refundable deposit of 118,182 Units at the Private Placement price in connection with the Sharing Agreement.

Defence intends to use the proceeds from the Private Placement to advance its Antibody Drug Conjugate ("ADC") and Radiopharmaceutical programs, to develop partnerships and for working capital purposes. No finder’s fees were paid in connection with the Private Placement.

Pursuant to applicable Canadian securities laws and in accordance with the Exchange policies, all securities issued under this Private Placement are subject to applicable resale restrictions under applicable securities laws. The Private Placement closed on March 6, 2026.

The Units described herein have not been, and will not be, registered under the U.S. Securities Act or any state securities laws, and accordingly, may not be offered or sold within the United States except in compliance with the registration requirements of the U.S. Securities Act and applicable state securities requirements or pursuant to exemptions there from. This press release does not constitute an offer to sell or a solicitation to buy any securities in any jurisdiction.

(Press release, Defence Therapeutics, MAR 9, 2026, View Source;utm_medium=rss&utm_campaign=defence-therapeutics-announces-closing-of-private-placement-of-units-for-gross-proceeds-of-9595000 [SID1234663362])