On May 11, 2026 GSK plc (LSE/NYSE: GSK) reported that it has entered into an exclusive strategic collaboration with Sino Biopharmaceutical, (SBP Group), through its subsidiary Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (CTTQ), to accelerate bepirovirsen in mainland China at launch. Bepirovirsen is a potential first-in-class treatment for chronic hepatitis B (CHB) under priority regulatory review in China. CTTQ is a market leader in hepatitis B in China with one of the country’s most comprehensive liver disease portfolios and a broad commercial footprint covering more than 5,000 medical centres across care settings. CTTQ has played a significant role in advancing the diagnosis and treatment of hepatitis B in China.

The collaboration combines GSK innovation with CTTQ’s local scale and in-market execution to reach more patients, more quickly. Under the agreement, CTTQ will be responsible for importation, distribution, hospital access, and promotional and non-promotional activities for bepirovirsen in mainland China. GSK will remain the marketing authorisation holder and retain responsibility for regulatory, quality, pharmacovigilance and global medical strategy. The agreement also grants GSK the ability to review certain early-stage pipeline assets of the SBP Group to evaluate the potential for collaboration opportunities outside China.

Mike Crichton, President International, GSK, said: "Chronic hepatitis B affects 75 million people in China1 and is a leading cause of liver cancer in the country.2 By combining GSK’s innovation with CTTQ’s extensive local scale and execution, we want to reach more patients, deliver greater impact, and directly address one of China’s most pressing healthcare priorities."

Chronic hepatitis B is a national health priority in China. The latest National Action Plan for the Prevention and Treatment of Viral Hepatitis (2025-2030) has set out functional cure as a treatment goal for Hepatitis B. Functional cure occurs when the hepatitis B virus DNA and viral protein – hepatitis B surface antigen (HBsAg) – are undetectable in the blood for at least 6 months after stopping all treatment. Functional cure is associated with a meaningful reduction in the risk of long-term complications, including liver cancer.3

Bepirovirsen was granted Breakthrough Therapy designation in China in August 2021 and accepted for Priority Review in April 2026. The regulatory submission is supported by positive results from the B-Well 1 and B-Well 2 phase III trials, which demonstrated statistically significant and clinically meaningful functional cure rates.

Collaboration terms
Under the terms of the agreement, CTTQ will purchase bepirovirsen from GSK under agreed supply terms for an initial term of 5.5 years. The term may be extended thereafter by mutual agreement. GSK will book sales of bepirovirsen supplied to CTTQ through the collaboration.

GSK also has the ability to review certain early-stage pipeline assets of the SBP Group to evaluate potential collaboration opportunities outside China.

About chronic hepatitis B
Hepatitis B is a viral infection that can cause both acute and chronic liver disease. Chronic Hepatitis B (CHB) occurs when the immune system is unable to clear the virus, resulting in long-lasting infection. CHB affects more than 250 million people worldwide. Each year, the disease causes approximately 1.1 million deaths.1 Many patients often require lifelong antiviral therapy for viral suppression; making functional cure a critical goal in disease management.

CHB remains a significant public health challenge in China, affecting an estimated 75 million people and causing approximately 450,000 deaths annually.1 84.4% of patients with liver cancer in China are associated with CHB infection.2 Functional cures are associated with a significant reduction in the risk of long-term liver complications, including liver cancer.3

About bepirovirsen
Bepirovirsen is a triple action investigational antisense oligonucleotide (ASO), designed to inhibit the replication of viral DNA in the body, suppress the level of hepatitis B surface antigen (HBsAg) in the blood, and stimulate the immune system to increase the chances of a durable and sustained response.

GSK licensed bepirovirsen from Ionis and collaborated with them on its development. Bepirovirsen has been recognised by global regulatory authorities for its innovation and potential to address significant unmet need in hepatitis B, with Priority Review, Fast Track and Breakthrough Designations from the US FDA, Priority Review and Breakthrough Therapy designation in China and SENKU designation in Japan.

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(Press release, GlaxoSmithKline, MAY 11, 2026, View Source [SID1234665436])

On May 11, 2026 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported updated positive survival observations from its ongoing Phase 1 clinical trial of liraltagene autoleucel, or lira-cel, the Company’s follicle-stimulating hormone receptor ("FSHR")-targeted CAR-T therapy being developed for the treatment of recurrent ovarian cancer.

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Updated data were presented on May 7, 2026, at the International Society for Cell & Gene Therapy ("ISCT") 2026 Annual Meeting by Cheryl Cox, MHA, Operations Director of the Cell Therapies and Gene Expression Engineering Facility at Moffitt Cancer Center. The presentation, titled "A Phase I clinical trial of an infusion of autologous T cells genetically engineered with a chimeric receptor to target the follicle-stimulating hormone receptor in patients with recurrent ovarian cancer," reviewed the trial design, objectives and current clinical status of Anixa’s ongoing Phase 1 trial of lira-cel.

Several trial participants have lived significantly beyond their median expected survival of three to four months, based on disease stage and prior therapy history. One patient survived 28 months following treatment, three patients have survived greater than one year following treatment, at 18, 17 and 17 months, respectively, and four additional patients have survived 11, 11, 8 and 7 months, respectively. Three of the patients who reached 18, 17 and 11 months, respectively, remain alive, and one additional patient who was treated more recently is also currently alive.

Preliminary safety observations presented at ISCT include:

No dose-limiting toxicities ("DLTs") have been encountered in the first three dose cohorts.
All doses have been administered successfully by the intraperitoneal ("IP") route.
There have been no observations of Immune Effector Cell-Associated Neurotoxicity Syndrome ("ICANS") or significant Cytokine Release Syndrome ("CRS").
All significant adverse events observed to date have been unrelated to lira-cel administration.
Dr. Amit Kumar, Chairman and Chief Executive Officer of Anixa, stated, "The updated survival observations from this ongoing Phase 1 trial continue to be encouraging, particularly given the advanced disease status and limited treatment options for patients with recurrent ovarian cancer. While this remains an early-stage study, lira-cel has continued to demonstrate a favorable preliminary safety profile, with no dose-limiting toxicities, ICANS or CRS observed in the first three dose cohorts. We believe these findings support continued dose escalation and clinical evaluation."

Dr. Kumar continued, "We look forward to treating patients in the next dose cohort, which is expected to evaluate a dose approximately three times higher than the previous cohort and to include lymphodepletion with cyclophosphamide and fludarabine. This approach may create a more favorable environment for CAR-T cell expansion, persistence and activity."

About Lira-cel, Anixa’s CAR-T Therapy for Recurrent Ovarian Cancer
Liraltagene autoleucel, or lira-cel, is Anixa’s investigational autologous CAR-T therapy designed to target the follicle-stimulating hormone receptor ("FSHR"), which Anixa believes represents a unique CAR-T target in ovarian cancer. FSHR is selectively expressed on ovarian cells, tumor vasculature and certain cancer cells, but not in most healthy tissue. The ongoing Phase 1 trial (ClinicalTrials.gov Identifier: NCT05316129) is enrolling adult women with recurrent ovarian cancer who have progressed after at least two prior therapies.

The trial is designed to evaluate the safety and tolerability of lira-cel, determine the maximum tolerated dose, and assess preliminary evidence of clinical activity.

(Press release, Anixa Biosciences, MAY 11, 2026, View Source [SID1234665459])

On May 11, 2026 Sironax, a global clinical-stage biotechnology company developing transformative therapies for neurodegenerative, inflammatory and immunologic, metabolic, and rare diseases, reported that the U.S. Food and Drug Administration (FDA) has designated its SARM1 inhibitor SIR2501 as a Fast Track product for chemotherapy-induced peripheral neuropathy (CIPN). SIR2501 is a first-in-class allosteric inhibitor of SARM1, a key driver of nerve damage in a broad range of neurological diseases.

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The FDA grants Fast Track designation to facilitate the development and expedite the review of drugs to treat serious conditions, fill unmet medical needs, and bring promising therapies to patients more quickly. Drugs granted this designation are eligible for more frequent interactions with the agency regarding development plans, a rolling NDA/BLA review, and potential priority review and accelerated approval.

"Fast Track designation for SIR2501 in CIPN is a meaningful recognition of the urgent unmet medical need and the potential of our entire SARM1 program," said Dr. Shefali Agarwal, Sironax President and CEO. "The FDA’s designation not only validates our approach in CIPN, but also the broader potential of SARM1 inhibition to address additional neurological diseases. We are inspired to advance this potential therapy for millions of patients around the world."

CIPN is a common nerve-damaging side effect of chemotherapy that affects the hands and feet. Symptoms include burning or shooting pain, loss of temperature and tactile sensation, muscle weakness, and impaired fine motor skills. A significant number of cancer patients receive high-risk chemotherapy (e.g., taxanes, platinum, vinca alkaloids), develop CIPN, and subsequently discontinue or reduce chemo regimen due to the disease.

"For too long, millions of cancer patients have found themselves in the difficult position of experiencing painful symptoms while receiving their cancer treatment," said Dr. Robert Coleman, Gynecologic Oncologist, Texas Oncology, and Chief Medical Officer of Vaniam Group; and one of the country’s preeminent gynecologic oncologists. "Unfortunately, the severity of these symptoms has led many patients to either curtail or completely stop their treatment regimens. I’m pleased that a potential treatment for CIPN is advancing that could at last address this condition."

About SIR2501
SIR2501 is a first-in-class allosteric inhibitor of SARM1, a key driver of nerve damage in diseases such as CIPN and amyotrophic lateral sclerosis (ALS). By binding SARM1 away from its active site and maintaining the enzyme in an inactive state, SIR2501 is designed to protect nerves and prevent degeneration, while avoiding potential adverse effects observed with orthosteric inhibitors. SIR2501 has demonstrated strong neuroprotective effects in multiple preclinical models, and global Phase 1b/2 clinical trials evaluating SIR2501 in patients with CIPN and ALS are ongoing.

(Press release, Sironax, MAY 11, 2026, View Source [SID1234665475])

On May 11, 2026 Halozyme Therapeutics, Inc. (Nasdaq: HALO) ("Halozyme" or the "Company") reported its financial and operating results for the first quarter ended March 31, 2026, and provided an update on its recent corporate activities.

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"I am pleased to announce our new $1 billion share repurchase program and that we project to repurchase at least $400 million in 2026, which is a reflection of our strong cash generation and confidence in the long-term value and durability of our business. We started 2026 with exceptional momentum, highlighted by three new recent collaboration and licensing agreements with Vertex, Oruka and GSK, demonstrating the strong interest in Hypercon and ENHANZE and showcasing the real potential to exceed our goal of three new SC delivery platform deals this year. The two Hypercon multi-target agreements confirm the strong interest of biopharma companies to reduce injection volume through hyperconcentration and allow more flexible administration in the home. Our new multi-target agreement with GSK represents a significant opportunity for ENHANZE with multiple promising oncology targets, including its first potential application with antibody drug conjugates. This momentum creates durable new royalty opportunity beginning in the 2030s and extending to at least the mid-2040s," said Dr. Helen Torley, President and Chief Executive Officer of Halozyme.

"The growing number of indications for our approved products and new Phase 3 data milestones represent increased opportunity for ENHANZE. Most recently, VYVGART Hytrulo was FDA-approved for all serotypes of generalized myasthenia gravis (gMG), representing a significant expansion of addressable patients. The VYVGART Hytrulo opportunity is further extended with positive Phase 3 data in ocular myasthenia gravis, increasing the MG addressable market by an additional 7,000 patients in the U.S. alone. Additionally, DARZALEX Faspro gained its 12th and 13th approved indications and expanded further in newly diagnosed and early second line multiple myeloma patients, the two largest, longer-duration of treatment patient populations. Takeda also announced positive Phase 2/3 data for its 20% immunoglobulin TAK-881 in patients with primary immune deficiency, creating the potential for the 11th ENHANZE product launch."

"Our opportunity with ENHANZE was further enhanced in the quarter by two new Phase 1 study starts, increasing the number of ENHANZE products in development to nine, well on our way to the expected 13 ENHANZE products in development by year-end 2026. We project these ENHANZE products have the potential for approvals beginning in 2029+, creating a new wave of royalty revenue. The five signed Hypercon agreements, which include the opportunity for 17 targets to be developed, with first approvals projected in the 2030/2031 time period represents a third exciting wave of new royalty revenue opportunity. This continued performance and progress resulted in strong first quarter financial results and we are pleased to reaffirm our 2026 outlook, including expectations for ENHANZE royalty revenue to exceed $1 billion for the full year," Dr. Torley concluded.

Recent Corporate Highlights:
•In May 2026, the Company announced a new share repurchase program to repurchase up to $1 billion of its outstanding common stock by December 31, 2028, with an expectation of buying back at least $400 million of shares in 2026.

Recent Partner Highlights:
•In May 2026, argenx announced U.S. Food and Drug Administration ("FDA") approval of a supplemental Biologics License Application ("sBLA") for VYVGART Hytrulo with ENHANZE for the treatment of adult patients with generalized myasthenia gravis ("gMG") including all serotypes – anti-AChR-Ab positive, anti-MuSK-Ab positive, anti-LRP4-Ab positive, and triple seronegative.
•In May 2026, Halozyme and GSK plc ("GSK") entered into a global collaboration and license agreement for ENHANZE with multiple oncology targets, including the first potential application in antibody-drug conjugates ("ADCs"). Under the terms of the agreement, GSK will make an upfront payment and potential future milestone payments and royalties on net sales of products developed with ENHANZE.
•In May 2026, Halozyme and Oruka Therapeutics, Inc. ("Oruka") entered into a global exclusive collaboration and license agreement for Halozyme’s Hypercon technology for use with ORKA-001, in development for psoriasis and related inflammatory diseases and one additional target. Under the terms of the agreement, Oruka will make an upfront payment and potential future milestone payments and mid-single digit royalties on net sales of products developed using the Hypercon technology.
•In May 2026, Takeda announced positive topline results from its pivotal Phase 2/3 trial of TAK-881 with ENHANZE in Primary Immunodeficiency Disease.
•In April 2026, Halozyme and Vertex Pharmaceuticals Incorporated ("Vertex") entered into a global exclusive collaboration and license agreement that provides Vertex access to Hypercon technology for use in up to three targets. Under the terms of the agreement, Vertex will make a $15 million upfront payment and potential future milestone payments and royalties on net sales of products developed using the Hypercon technology.

First Quarter Partner Highlights:
•In March 2026, Pfizer nominated a new undisclosed non-exclusive target to be studied with ENHANZE.
•In March 2026, Janssen announced the Committee for Medicinal Products for Human Use of the European Medicines Agency granted approval for self or caregiver administration of DARZALEX (daratumumab) SC formulation for patients living with multiple myeloma from the fifth dose, if determined to be appropriate by their healthcare professional and following proper training, making it the first oncology injectable approved for self-administration in Europe.
•In March 2026, Janssen announced the FDA approved TECVAYLI (teclistamab-cqyv) in combination with DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) for the treatment of adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy.
•In February 2026, argenx announced positive topline results from the Phase 3 ADAPT oculus trial of VYVGART with ENHANZE in ocular myasthenia gravis.
•In January 2026, argenx initiated a Phase 1 study to evaluate ARGX-124 with ENHANZE.
•In January 2026, Janssen announced the FDA approved DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.

First Quarter 2026 Financial Highlights:
•Total revenue was $376.7 million, compared to $264.9 million in the first quarter of 2025. The 42% year-over-year increase was primarily driven by royalty revenue growth and an increase in product sales. Revenue included $240.7 million in royalties, an increase of 43% compared to $168.2 million in the first quarter of 2025, primarily driven by continued sales uptake of ENHANZE partner products that have launched since 2020, predominantly DARZALEX SC by Janssen, VYVGART Hytrulo by argenx and Phesgo by Roche in all geographies and contributions from other recently launched products.
•Cost of sales was $79.2 million, compared to $48.4 million in the first quarter of 2025. The increase in cost of sales was primarily due to an increase in bulk rHuPH20 sales.
•Amortization of intangibles expense was $29.5 million, compared to $17.8 million in the first quarter of 2025. The increase in amortization of intangibles expense was due to the acquisition of Elektrofi, Inc. ("Elektrofi") in November 2025.
•Research and development expense was $25.6 million, compared to $14.8 million in the first quarter of 2025. The increase was primarily due to the acquisition of Elektrofi and Surf Bio, Inc. ("Surf Bio") in the fourth quarter of 2025.
•Selling, general and administrative expense was $57.9 million, compared to $42.4 million in the first quarter of 2025. The increase was primarily due to an increase in consulting and professional service fees, including litigation costs incurred in connection with patent infringement litigation, the acquisition of Elektrofi and Surf Bio, and an increase in compensation expense.
•Operating income was $184.5 million, compared to $141.5 million in the first quarter of 2025.
•Net income was $150.0 million, compared to $118.1 million in the first quarter of 2025.
•EBITDA was $218.3 million, compared to $162.0 million in the first quarter of 2025. Adjusted EBITDA was $229.5 million, compared to $162.0 million in the first quarter of 2025.1
•GAAP diluted earnings per share was $1.22, compared to $0.93 in the first quarter of 2025. Non-GAAP diluted earnings per share was $1.60, compared to $1.11 in the first quarter of 2025.1
•Cash, cash equivalents, restricted cash and marketable securities were $320.9 million on March 31, 2026, compared to $145.4 million on December 31, 2025. The increase was primarily driven by cash generated from operations.

Financial Outlook for 2026
The Company is reiterating its 2026 financial guidance ranges, which were last provided on February 17, 2026.
For the full year 2026, the Company expects:
•Total revenue of $1.710 billion to $1.810 billion, representing growth of 22% to 30% over 2025 total revenue, primarily driven by increases in royalty revenue and product sales from API.

•Revenue from royalties of $1.130 billion to $1.170 billion, representing growth of 30% to 35% over 2025.
•Adjusted EBITDA of $1.125 billion to $1.205 billion, representing growth of 71% to 83% over 2025, including new Hypercon and Surf Bio investment of approximately $60 million.
•Non-GAAP diluted earnings per share of $7.75 to $8.25, representing growth of 87% to 99% over 2025. The Company’s earnings per share guidance includes new Hypercon and Surf Bio investment of approximately $60 million and does not consider the impact of potential future share repurchases.

Table 1. 2026 Financial Guidance
Guidance Range
Total Revenue $1.710 to $1.810 billion
Royalty Revenue $1.130 to $1.170 billion
Adjusted EBITDA1
$1.125 to $1.205 billion
Non-GAAP Diluted EPS1
$7.75 to $8.25

1 EBITDA, Adjusted EBITDA and Non-GAAP Diluted EPS are Non-GAAP financial measures. See "Note Regarding Use of Non-GAAP Financial Measures" below for an explanation of these measures. Reconciliations between GAAP reported and Non-GAAP financial information for actual results are provided at the end of this earnings release.

Webcast and Conference Call
Halozyme will host its Quarterly Update Conference Call for the first quarter ended March 31, 2026 today, Monday, May 11, 2026, at 1:30 p.m. PT/4:30 p.m. ET. The conference call may be accessed live with pre-registration via link: View Source The call will also be webcast live through the "Investors" section of Halozyme’s corporate website and a recording will be made available following the close of the call. To access the webcast and additional documents related to the call, please visit Halozyme.com.

(Press release, Halozyme, MAY 11, 2026, View Source [SID1234665437])

On May 11, 2026 Inhibrx Biosciences, Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company"), a clinical-stage biopharmaceutical company focused on developing novel biologic therapeutic candidates, reported positive interim results from the randomized, first-line Phase 2 portion of the HexAgon study. The trial evaluated the safety and efficacy of INBRX-106, a hexavalent OX40 agonist, in combination with pembrolizumab (the combination arm) versus pembrolizumab monotherapy (the control arm) in first-line patients with treatment-naïve, PD-L1 positive (CPS ≥ 20) metastatic or unresectable recurrent Head and Neck Squamous Cell Carcinoma (HNSCC).

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HNSCC was selected as a proof-of-concept indication, as PD-1 monotherapy is active in this tumor type but leaves significant room for improvement. The trial design was modeled after KEYNOTE-048, focusing on patients with high PD-L1 expression (CPS ≥ 20) in order to further sharpen the ability to detect a treatment effect above checkpoint inhibition alone. A clear signal of added benefit in this study design would support INBRX-106’s potential to enhance checkpoint inhibitor efficacy across checkpoint inhibitor-sensitive indications.

The Phase 2 portion of the HexAgon study enrolled 68 patients: 33 randomized to the combination arm and 35 to the control arm. Baseline prognostic factors are largely balanced between both arms and the study is being conducted at over 80 sites in the United States, Europe and Asia. Today, the Company presented preliminary data from 53 patients (25 in the INBRX-106 combination arm and 28 in the control arm) with a data cutoff of May 7, 2026, representing the evaluable population for confirmed response, defined as patients who had either experienced confirmed disease progression or death, or completed at least two on-study tumor assessments. The remaining 15 patients in the overall population across both arms had not yet reached the maturity threshold for response confirmation or were not evaluable at the time of this data cut and were therefore not included in this analysis. Active unconfirmed responses and ongoing tumor increases/reductions are present in both arms, and these patients are expected to contribute to the final efficacy dataset in a subsequent update.

In the evaluable population, 11 out of 25 patients (44.0%) in the INBRX-106 combination arm achieved a confirmed objective response, compared with 6 out of 28 patients (21.4%) in the control arm. This represents a 22.6% absolute increase in confirmed responses. Three complete responses were observed in the INBRX-106 combination arm, reflecting tumor clearance, while no complete responses were observed with pembrolizumab alone. Complete responses in first-line HNSCC remain uncommon and are generally associated with more durable outcomes.

These clinical findings were supported by pharmacodynamic data, which showed up to a 15-fold increase in peripheral CD8+ and CD4+ T-cell proliferation and up to a four-fold increase in activation in INBRX-106 combination-treated patients compared with up to 2.5-fold and 1.5-fold increases, respectively, in those receiving pembrolizumab alone. The observation of robust systemic T-cell expansion and activation in combination-treated patients, alongside the clinical activity observed in this arm, is consistent with the expected mechanism of action of INBRX-106 as a potent T-cell costimulator.

The combination of INBRX-106 and pembrolizumab was generally manageable, with a safety profile consistent with the addition of an active immunostimulatory agent to checkpoint blockade. The most common treatment-related adverse events were rash, diarrhea, fatigue, and infusion-related reactions, which were predominantly low-grade. No treatment-related deaths were reported in either arm.

"We are greatly encouraged by these early clinical results," said Mark Lappe, Chief Executive Officer of Inhibrx. "These data, coupled with the clear evidence of T-cell expansion and superior depth of response, give us confidence that INBRX-106 could be the first costimulatory agent to fundamentally shift the efficacy ceiling of immunotherapy, and open the door to combinations with new modalities that could be enhanced by OX40 agonism."

Next Steps

The progression-free survival data from the Phase 2 portion of the HexAgon study are expected to become available in the fourth quarter of 2026. The Company plans to begin the Phase 3 portion of the HexAgon study during the third quarter of 2026.

Based on these promising early results, the Company also aims to evaluate INBRX-106 across broader indications to potentially improve the efficacy of checkpoint inhibitors. This strategy includes initiating a study in the perioperative setting in non-small cell lung cancer (NSCLC) later this quarter. The Company believes OX40 agonism has the greatest potential to drive cure in earlier-stage disease settings, where patients typically retain a more active and responsive immune system. In addition, the Company is beginning to plan for expansion into the front-line metastatic NSCLC setting, with studies expected to begin in 2027. Outside of combination with checkpoint inhibitors, the Company plans to explore combinations with agents that could benefit from T-cell costimulation, such as vaccines, T-cell engagers, and CAR-Ts.

About INBRX-106

INBRX-106 is a hexavalent agonist targeting OX40 (CD134), a costimulatory receptor on T-cells. Utilizing Inhibrx’s proprietary single-domain antibody (sdAb) platform, INBRX-106 is designed to achieve the high-order receptor clustering necessary for robust T-cell activation and survival, a feat that has eluded traditional bivalent antibody approaches. To date, over 175 patients have been treated with INBRX-106.

(Press release, Inhibrx, MAY 11, 2026, View Source [SID1234665460])