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HUTCHMED Announces Update on Licensed Oncology Product TAZVERIK® in China

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])

Defence Therapeutics Announces Closing Of Private Placement Of Units For Gross Proceeds Of $9,595,000

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.

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])

Coherus Oncology Reports Full Year and Fourth Quarter 2025 Financial Results and Provides Business Update

On March 9, 2026 Coherus Oncology, Inc. (Nasdaq: CHRS), reported financial results for the full year and fourth quarter 2025, and provided an overview of recent business highlights.

"We are pleased with our progress in 2025, having doubled LOQTORZI sales while completing the transformation from a biosimilars company to an innovative oncology company focused on overcoming immune resistance in cancer. At the same time, we continued to reduce our overall debt since its peak in 2024 by over 90% to $38.8 million," said Denny Lanfear, Coherus Chairman and Chief Executive Officer. "We are now strategically positioned with growing revenues from our foundational PD-1 inhibitor, potential deal opportunities across the portfolio and geographies, and two promising pipeline candidates with multiple 2026 clinical readouts."

"We are aggressively advancing casdozokitug, our first-in-class IL-27 targeting antibody in 1L hepatocellular carcinoma, which demonstrated a 17% complete response rate in a previous Phase 2 study," said Rosh Dias, MD, Chief Medical Officer. "At the same time, we also have a broad clinical program with tagmokitug, our highly selective CCR8 targeting cytolytic antibody, in multiple tumor cohorts including gastrointestinal cancers and head and neck cancer with strong scientific and clinical rationale in each. We now look forward to initiating the combination study with J&J’s T-cell engager pasritamig, in metastatic castration resistant prostate cancer (mCRPC), in the second half of this year."

"Tumor targeted T regulatory cell depleting agents have broad potential applicability in combination with immune agents like TCE and toripalimab, ADCs, T-cell engagers and radiotherapy," said Theresa LaVallee, PhD, Coherus Chief Scientific and Development Officer. "With a potentially best-in-class molecule we look forward to advancing tagmokitug combinations both with partners and with LOQTORZI."

RECENT BUSINESS HIGHLIGHTS

LOQTORZI (toripalimab-tpzi) Commercial Updates

LOQTORZI net revenue for Q4 2025 was $12.4 million, an 11% increase over $11.2 million in Q3 2025 and a 64% increase over $7.5 million in Q4 2024. Growth in Q4 2025 was driven largely by higher patient demand from both new account starts as well as repeat use in existing accounts. Average duration of treatment among existing patients also continued to grow.
LOQTORZI remains the only FDA-approved and available treatment in the U.S. for recurrent, locally advanced or metastatic nasopharyngeal carcinoma (NPC,) representing an overall $250 million addressable market.
In December 2025, compelling six-year overall survival (OS) follow-up results from the Phase 3 JUPITER-02 trial evaluating LOQTORZI plus chemotherapy in recurrent or metastatic nasopharyngeal carcinoma (RM-NPC) were presented at ESMO (Free ESMO Whitepaper) Asia. In this exploratory post-hoc analysis, patients receiving LOQTORZI plus gemcitabine and cisplatin achieved a median OS of 64.8 months, nearly double that of chemotherapy alone (33.7 months), and an observed 38% reduction in risk of death (HR 0.62; 95% CI, 0.45–0.85).
ADVANCEMENT OF INNOVATIVE, NEXT-GENERATION ONCOLOGY PIPELINE

Tagmokitug is a highly selective cytolytic CCR8 antibody that specifically binds and preferentially depletes CCR8+ tumor regulatory T cells (Tregs) with no off-target binding.

Preclinical and clinical biomarker research for tagmokitug was published in the December 2025 issue of Molecular Cancer Therapeutics, describing the high selectivity, picomolar binding affinity and significant effector mediated killing of CCR8+ cells. The findings showed that tagmokitug demonstrated no off-target binding and selectively eliminated CCR8+ T regulatory cells and not other T cells, supporting its potential as an anti-cancer treatment.
The Phase 1b tagmokitug/toripalimab combination dose optimization studies in 2L HNSCC and 2L upper GI adenocarcinoma cancers are underway, with initial data readouts expected in mid-2026.
A Phase 1b study evaluating the tagmokitug/toripalimab combination, with and without chemotherapy, in 1L and 2L esophageal squamous cell carcinoma (ESCC), respectively, is underway with a first data readout expected in 2H 2026.
A Phase 1b/2a study evaluating tagmokitug/toripalimab combination in 4L+ colorectal cancer is enrolling patients and initial data is expected in 2H 2026.
A Phase 1b clinical study in patients with metastatic castration-resistant prostate cancer (mCRPC) in combination with pasritamig, a T-cell engaging bispecific antibody, is anticipated to begin in 2H 2026.
Casdozokitug is a first-in-class IL-27 antagonistic antibody currently being evaluated in a Phase 2 study in patients with first line uHCC (unresectable hepatocellular carcinoma) to assess treatment benefit, safety and response biomarkers.

Enrollment is ongoing in the randomized Phase 2 trial of casdozokitug/toripalimab/bevacizumab in 1L uHCC, with the first data readout expected in mid-2026.
Data presented during ASCO (Free ASCO Whitepaper) GI 2025 demonstrated a 38% overall response rate and a 17% complete response rate with the addition of casdozokitug to the current standard of care.
EQUITY FINANCINGS

In October 2025, the Company sold 4,634,995 shares of common stock and warrants with an exercise price of $0.01 per share to purchase 463,498 shares of common stock for net proceeds of approximately $7.9 million. In February 2026, Coherus sold 28,600,000 shares of its common stock in public offering for proceeds of approximately $47.0 million, net of Underwriters’ discounts and commissions.
FOURTH QUARTER 2025 FINANCIAL RESULTS

Net revenue from continuing operations was $12.7 million and $7.7 million during the three months ended December 31, 2025 and 2024, respectively, and $42.2 million and $26.4 million during the years ended December 31, 2025 and 2024, respectively. LOQTORZI net product revenue increased $4.8 million and $21.7 million compared to the three months and full year ended December 31, 2024, respectively, driven primarily by volume growth of LOQTORZI, which launched in January 2024. The increase in the full year period was partially offset by a decrease in other revenue primarily driven by a $6.3 million upfront fee recognized in 2024 for the out-license of rights to commercialize toripalimab within Canada.

Cost of goods sold (COGS) from continuing operations was $4.0 million and $2.8 million during the three months ended December 31, 2025 and 2024, respectively, and $13.8 million and $8.7 million during the years ended December 31, 2025 and 2024, respectively. The increases were primarily due to volume growth of LOQTORZI.

Research and development (R&D) expenses from continuing operations were $31.0 million and $20.8 million for the three months ended December 31, 2025, and 2024, respectively, and $108.9 million and $91.8 million for the years ended December 31, 2025, and 2024, respectively. The increases were primarily due to development costs for casdozokitug and tagmokitug, partially offset by savings from discontinued programs, reduced headcount, and lower infrastructure costs.

Selling, general and administrative (SG&A) expenses from continuing operations were $23.6 million and $29.6 million during the three months ended December 31, 2025, and 2024, respectively, and $100.6 million and $125.5 million during the years ended December 31, 2025, and 2024, respectively. The decreases were driven primarily by lower headcount and decreased operating costs following Coherus’ recent divestitures. The year-over-year decrease was further attributable to net charges for write-offs of intangible assets and associated contingent consideration liabilities totaling $4.2 million in 2025 down from $6.8 million in 2024.

Interest expense from continuing operations was $2.3 million and $1.9 million for the three months ended December 2025 and 2024, respectively, and $9.0 million and $10.7 million for the year ended December 31, 2025, and 2024, respectively. Cash paid for interest, which relates to borrowings reflected in both continuing operations and discontinued operations, was $9.9 million and $25.4 million for the years ended December 31, 2025 and 2024, respectively. The year-over-year decrease was primarily due to lower average outstanding debt.

Net (loss) from continuing operations for the fourth quarter of 2025 was $46.9 million, or $(0.39) per share on a diluted basis, compared to a net loss of $46.1 million, or $(0.40) per share on a diluted basis, for the same period in 2024. Net loss for the year ended December 31, 2025, was $183.1 million, or $(1.56) per share on a diluted basis, compared to a net loss of $215.4 million, or $(1.88) per share on a diluted basis, for the same period in 2024.

Non-GAAP net loss from continuing operations for the fourth quarter of 2025 was $40.4 million, or $(0.34) per share on a diluted basis, compared to $39.4 million, or $(0.34) per share for the same period in 2024. Non-GAAP net loss for the year ended December 31, 2025 was $159.2 million, or $(1.36) per share on a diluted basis, compared to a net loss of $166.5 million, or $(1.45) per share for the same period in 2024. See "Non-GAAP Financial Measures" below for a discussion on how Coherus calculates non-GAAP net loss from continuing operations and a reconciliation to the most directly comparable GAAP measures.

Cash, cash equivalents and marketable securities totaled $172.1 million as of December 31, 2025, compared to $126.0 million as of December 31, 2024. The balance at December 31, 2025 was inclusive of Transition Service Agreement (TSA)-related collections that will be applied to associated TSA payables and accrued liabilities which totaled $65.1 million as of December 31, 2025.

Conference Call Information
When: Monday, March 9, 2026, starting at 4:30 p.m. Eastern Standard Time

To access the conference call, please pre-register through the following link to receive dial-in information and a personal PIN to access the live call: View Source

Webcast: View Source

A live and archived webcast will be available on the "Investors" section of the Coherus website at View Source

Please dial in 15 minutes early to ensure a timely connection to the call.

(Press release, Coherus Oncology, MAR 9, 2026, View Source [SID1234663361])

Bristol Myers Squibb Announces Positive Phase 3 Results from the SUCCESSOR-2 Study of Oral Mezigdomide in Relapsed or Refractory Multiple Myeloma

On March 9, 2026 Bristol Myers Squibb (NYSE: BMY) reported positive interim Phase 3 results from the SUCCESSOR-2 study (NCT05552976). In the trial, oral mezigdomide in combination with carfilzomib and dexamethasone (MeziKd) demonstrated statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus carfilzomib and dexamethasone alone (Kd) in patients with relapsed or refractory multiple myeloma (RRMM). Safety findings were consistent with the known profile of mezigdomide and the combination regimen. Patients will continue to be followed for survival and safety.

"We are excited by these results, which underscore Bristol Myers Squibb’s leadership in treating multiple myeloma and our unwavering commitment to patients living with this persistent and challenging disease," said Cristian Massacesi, executive vice president, chief medical officer and head of development at Bristol Myers Squibb. "Importantly, these findings reinforce the value of our CELMoD program and our targeted protein degradation platform, and strengthen our confidence in bringing forward effective, accessible oral treatment options for patients with difficult-to-treat blood cancers and potentially beyond."

"While treatment advances have been meaningful, far too many patients with multiple myeloma still relapse or stop responding—making the need for new options urgent," said Paul Richardson, MD, Director of Clinical Research and Clinical Program Leader at the Jerome Lipper Multiple Myeloma Center, the Dana-Farber Cancer Institute and RJ Corman Professor of Medicine, Harvard Medical School. "These data underscore the potential of MeziKd as an oral regimen that could address a key unmet need for patients previously exposed to anti-CD38 and lenalidomide."

"It is important for patients to have treatment options that offer enduring disease control," said Meletios-A. (Thanos) Dimopoulos, MD, Professor and Chairman, Department of Clinical Therapeutics at Alexandra Hospital, School of Medicine, National and Kapodistrian University of Athens. "These positive interim data show that adding mezigdomide, a CELMoD specifically optimized for enhanced myeloma cell killing and immune activation compared with IMiD agents, to carfilzomib and dexamethasone may provide clinical benefit in earlier relapse."

Data from SUCCESSOR-2 will be presented at a future medical meeting and results will be shared with health authorities.

About SUCCESSOR-2

SUCCESSOR-2 (NCT05552976) is an inferential, seamless Phase 2/3, multicenter, randomized, open-label study evaluating the efficacy and safety of mezigdomide in combination with carfilzomib and dexamethasone (MeziKd) versus carfilzomib and dexamethasone (Kd) in patients with relapsed or refractory multiple myeloma (RRMM).

The primary endpoint of the Phase 3 portion is progression-free survival (PFS). Key secondary endpoints include overall survival (OS), overall response rate (ORR), duration of response (DoR), time to progression (TTP), time to next treatment (TTNT), minimal residual disease (MRD) negativity, and health-related quality of life (HR-QoL).

About Targeted Protein Degradation and Novel CELMoD Agents

Targeted protein degradation (TPD) is a differentiated research platform at Bristol Myers Squibb built on more than two decades of scientific expertise, providing new avenues to degrade therapeutically relevant proteins that were previously considered "undruggable." BMS is the only company that has successfully developed and commercialized protein degrader agents for the treatment of multiple myeloma. These agents, known as immunomodulatory drugs (IMiDs), helped establish the current standard of care in the treatment of this disease, which remains without a cure. BMS is building on this foundation with several investigational protein degraders in clinical trials, leveraging three different modalities including CELMoD agents, ligand-directed degraders (LDDs), and degrader antibody conjugates (DACs). This three-pronged approach enables matching the right therapeutic modality to a molecular mechanism of action to modulate targets most effectively and ultimately provide more opportunities for potential breakthroughs that may offer meaningful new options for patients across a broad range of diseases, in and beyond hematology and oncology. Learn more about the science behind TPD at Bristol Myers Squibb.

(Press release, Bristol-Myers Squibb, MAR 9, 2026, View Source [SID1234663359])

Boundless Bio Reports Fourth Quarter and Full Year 2025 Financial Results and Business Highlights

On March 9, 2026 Boundless Bio (Nasdaq: BOLD), a clinical-stage oncology company interrogating extrachromosomal DNA (ecDNA) biology to deliver transformative therapies to patients with previously intractable oncogene amplified cancers, reported financial results and business highlights for the fiscal quarter and full year ended December 31, 2025.

"With the KOMODO-1 trial of BBI-940 actively enrolling, we are excited to evaluate this potentially first-in-class oral Kinesin degrader in patients with breast cancer who are seeking new treatment options. BBI-940 is designed to disrupt ecDNA segregation and inheritance, a differentiated mechanism for targeting chromosomally unstable cancers. The Boundless team is focused on clinical execution and reaching an initial proof-of-concept readout within our existing cash runway," said Zachary Hornby, President and Chief Executive Officer of Boundless Bio.

Business Highlights and Upcoming Milestones

BBI-940 novel Kinesin degrader program

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In January 2026, the U.S. Food and Drug Administration accepted the Company’s Investigational New Drug application for BBI-940, a novel, selective, oral Kinesin degrader.
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KOMODO-1 (Kinesin Oral Molecular Degrader for Oncology-1), a first-in-human clinical trial of BBI-940 in patients with estrogen receptor positive and human epidermal growth factor receptor 2 negative (ER+/HER2-) breast cancer who have progressed following treatment with a cyclin-dependent kinase 4 and/or 6 (CDK4/6) inhibitor plus endocrine therapy, as well as patients with triple-negative breast cancer luminal androgen receptor subtype (TNBC-LAR), is open for enrollment.
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Boundless expects to deliver initial safety and efficacy clinical proof-of-concept data within its existing cash runway timeline.

POTENTIATE clinical trial of BBI-355 and BBI-825

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In January 2026, Boundless announced its intention to cease enrollment in the Phase 1/2 POTENTIATE trial evaluating the combination of BBI-355 and BBI-825 based on market considerations, available clinical data, and prioritization of its BBI-940 program.

Fourth Quarter and Full Year 2025 Financial Results

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Cash Position: Cash, cash equivalents, and short-term investments totaled $107.6 million as of December 31, 2025. The Company expects its cash to fund operations into the second half of 2028, through the anticipated initial clinical proof-of-concept readout from KOMODO-1.
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Research and Development (R&D) Expenses: R&D expenses were $9.8 million for the fourth quarter of 2025 and $44.8 million for the full year 2025, compared to $13.3 million and $55.3 million for the same periods of 2024.
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General and Administrative (G&A) Expenses: G&A expenses were $4.2 million for the fourth quarter of 2025 and $18.7 million for the full year 2025, compared to $5.0 million and $18.0 million for the same periods of 2024.
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Net Loss: Net loss totaled $12.9 million for the fourth quarter of 2025 and $58.2 million for the full year 2025, compared to $16.4 million and $65.4 million for the same periods of 2024.

(Press release, Boundless Bio, MAR 9, 2026, View Source [SID1234663358])