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AIM ImmunoTech Announces 50% Objective Response Rate (ORR) in UPMC Recurrent Ovarian Cancer Phase 2 Clinical Trial, Suggesting Breakthrough Combination Potential

On May 7, 2026 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported the Final Primary Endpoint Report on Objective Response Rate data from a University of Pittsburgh Medical Center ("UPMC") Phase 2 clinical trial – in which AIM and Merck Sharp & Dohme ("Merck") are collaborators – evaluating Ampligen (rintatolimod) in combination with checkpoint inhibition and chemotherapy in recurrent ovarian cancer-data that may signal a major step forward in overcoming resistance to immunotherapy. The study aimed to improve clinical outcomes by overcoming the immunosuppressive tumor microenvironment characteristic of ovarian cancer through locoregional and systemic immune activation strategies. This clinical trial was financially supported by a Merck grant.

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Read more about the study at ClinicalTrials.gov: NCT03734692.

Topline results included:

50% Objective Response Rate (ORR), including 21% complete responses
79% Clinical Benefit Rate
Median Overall Survival of 32.5 months
Durable responses exceeding 70+ months in select patients
No Grade 4 or 5 toxicities observed
Read the full UPMC Primary Endpoint Report here.

Collection of additional secondary endpoint data including progression-free survival, time to disease progression and overall survival is expected to be completed in January 2027.

Robert P. Edwards, MD, McCall Chair of Obstetrics, Gynecology, and Reproductive Science at the University of Pittsburgh School of Medicine, stated: "This single-arm Phase 2 trial is the third in a series of consecutive studies evaluating IP chemotherapy or chemoimmunotherapy using this analytical approach. The addition of IP Ampligen and systemic PD-1 checkpoint inhibition to IP cisplatin chemotherapy resulted in a significant improvement in both clinical response rates and immune activation across highly comparable patient cohorts in the 3 trials."

AIM Chief Executive Officer Thomas K. Equels stated, "These results represent what we believe is a strong step forward in the potential to enhance treatment of recurrent ovarian cancer, if further studies support findings of relatively low toxicity, clinical benefit and durable response. Once again, data suggests that Ampligen may unlock the full potential of checkpoint immunotherapies. We are particularly encouraged by the durability of the observed responses. This supports our proposition that Ampligen has the potential to play a major role in solid tumor immuno-oncology – expanding the number of patients who benefit from checkpoint inhibitors across multiple cancer types, including ovarian cancer and pancreatic cancer. With strong intellectual property protection extending into 2039 and a growing body of positive clinical evidence, we believe we are well positioned to advance Ampligen into later-stage development and strategic partnerships."

(Press release, AIM ImmunoTech, MAY 7, 2026, View Source [SID1234665297])

argenx Reports First Quarter 2026 Financial Results and Provides Business Update

On May 7, 2026 argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, reported its first quarter 2026 results and provided a business update.

"argenx continues to deliver meaningful impact for patients, reflected by our 17th consecutive quarter of VYVGART growth," said Karen Massey, Chief Executive Officer of argenx. "Looking ahead, VYVGART has the potential to become the first and only approved therapy across MG, pending FDA decisions on label expansions into seronegative and ocular populations. At the same time, we are extending our leadership in FcRn into rheumatology, beginning with the upcoming myositis readout. Our next pipeline candidate, empasiprubart, is progressing toward its first registrational readout in MMN, and we continue to advance a broad and differentiated pipeline. With these opportunities, we remain focused on delivering transformative outcomes for patients while creating sustained value for all stakeholders."

Vision 2030

argenx continues to advance its ‘Vision 2030’ anchored in the ambition to treat 50,000 patients globally with its medicines, secure 10 labeled indications, and progress five pipeline candidates into Phase 3 development by 2030.

Expanding global VYVGART opportunity and shaping the long-term future of FcRn

VYVGART (IV: efgartigimod alfa-fcab and SC: efgartigimod alfa and hyaluronidase-qvfc) is a first-and-only IgG Fc-antibody fragment that targets the neonatal Fc receptor (FcRn). It is approved in three indications, including generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP) globally, and primary immune thrombocytopenia (ITP) in Japan. argenx is driving broad adoption as the leading precision biologic in MG and CIDP while advancing multiple label expansions. argenx is also shaping the future of FcRn medicines by advancing new pipeline candidates and delivery modalities.

Generated $1.3 billion in global product net sales in the first quarter of 2026, representing an increase of approximately 63% or $0.5 billion in year-over-year growth
Prescription Drug User Fee Act (PDUFA) target action date for anti-acetylcholine receptor antibody negative (AChR-Ab-) gMG (MuSK+, LRP4+ and triple seronegative) is May 10, 2026
Positive topline results from ADAPT OCULUS were recently presented at AAN; these data support planned sBLA submission to expand VYVGART label into oMG
Topline results from ALKIVIA study (myositis) expected in third quarter of 2026
Topline results from ADVANCE-NEXT study (primary ITP) expected in first half of 2027
Registrational study in Graves’ disease (GD) expected to initiate in 2026, expanding development into thyroid-driven autoimmunity
Topline results from UNITY study (Sjogren’s disease) expected in second half of 2027
VYVGART SC autoinjector expected to launch in 2027 for all approved indications
Progressing two future FcRn molecules: ARGX-213 is Phase 3-ready and ARGX-124 is in Phase 1

Advancing empasiprubart

Empasiprubart is a first-in-class, humanized monoclonal antibody designed to inhibit complement factor C2, selectively blocking activation of the classical and lectin complement pathways. It is being evaluated in registrational studies in multifocal motor neuropathy (MMN) and CIDP, and in a combination study with VYVGART in gMG.

Topline results from EMPASSION study (MMN) expected in fourth quarter of 2026
Topline results from EMVIGORATE and EMNERGIZE studies (CIDP) expected in second half of 2027
Decision for Phase 2 VARVARA study (Delayed Graft Function) expected mid-year 2026 following completion of 52-week efficacy analysis
ADAPT-Forward combination study ongoing to evaluate empasiprubart as an add on therapy to efgartigimod in gMG
Delivering next wave of immunology innovation

By the end of 2026, the argenx pipeline is expected to include a total of ten molecules in clinical development. Beyond efgartigimod and empasiprubart, this includes adimanebart (a MuSK agonist); ARGX-121 (anti-IgA), ARGX-109 (anti-IL-6), and three additional molecules from the Immunology Innovation Program (IIP). Collectively, these programs support argenx’s goal of launching, on average, one new pipeline candidate per year.

Adimanebart CMS registrational study on track to start in third quarter of 2026
Phase 2 study of ARGX-121 in IgA nephropathy (IgAN) expected to start in 2026
Three new first-in-class molecules on track to enter Phase 1 in 2026, including ARGX-118 (Galectin-10 inhibitor), ARGX-125 (bispecific antibody), and TSP-101, the Fn14-targeting program from the Tensegrity research collaboration

Key business highlights

On May 6, 2026, Karen Massey was appointed Chief Executive Officer and executive director of the argenx Board of Directors following the Annual General Meeting of Shareholders. Tim Van Hauwermeiren was appointed non-executive director and Chairperson of the Board of Directors
In March 2026, argenx expanded its global presence in Asia with the establishment of an argenx affiliate in China to broaden its access to novel biology and support early-stage research
FIRST QUARTER 2026 FINANCIAL RESULTS

argenx SE

UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENTS OF PROFIT OR LOSS

Three Months Ended
March 31,
(in millions of $ except for per share data) 2026 2025
Product net sales $ 1,298 $ 790
Other operating income* 15 17
Total operating income 1,313 807

Cost of sales $ (121) $ (81)
Research and development expenses* (443) (311)
Selling, general and administrative expenses (355) (276)
Total operating expenses (919) (668)

Operating profit $ 394 $ 139

Financial income $ 44 $ 37
Financial expense (1) (1)
Exchange (losses)/gains (11) 27

Profit for the period before taxes $ 426 $ 202
Income tax expense $ (60) $ (33)
Profit for the period $ 366 $ 169
Profit for the period attributable to:
Owners of the parent $ 366 $ 169
Weighted average number of shares outstanding 62,056,886 60,983,325
Basic profit per share (in $) $ 5.90 $ 2.78
Weighted average number of shares outstanding for diluted profit per share 66,356,591 65,664,300
Diluted profit per share (in $) $ 5.52 $ 2.58
*Comparative figures have been aligned with the presentation adopted in the current period, reflecting the combination of: collaboration revenue and other operating income, as well as the combination of research and development expenses and loss from investment in a joint venture.

DETAILS OF THE FINANCIAL RESULTS

Total operating income for the three months ended March 31, 2026, was $1.3 billion compared to $0.8 billion for the same period in 2025, and consists of:

Product net sales of VYVGART for the three months ended March 31, 2026, were $1.3 billion compared to $0.8 billion for the same period in 2025.
Other operating income for the three months ended March 31, 2026, was $15 million compared to $17 million for the same period in 2025. The other operating income primarily relates to research and development tax incentives and payroll tax rebates.
Total operating expenses for the three months ended March 31, 2026, were $0.9 billion compared to $0.7 billion for the same period in 2025, and mainly consists of:

Cost of sales for the three months ended March 31, 2026, was $121 million compared to $81 million for the same period in 2025. The cost of sales was recognized with respect to the sale of VYVGART.
Research and development expenses for the three months ended March 31, 2026, were $0.4 billion compared to $0.3 billion for the same period in 2025. The expenses mainly relate to:
Advancing efgartigimod across multiple severe autoimmune diseases;
Progressing empasiprubart into multiple indications;
Executing studies for adimanebart in rare neuromuscular diseases; and
Early-stage discovery and preclinical programs to sustain long-term pipeline growth.
Selling, general and administrative expenses for the three months ended March 31, 2026, were $0.4 billion compared to $0.3 billion for the same period in 2025. The selling, general and administrative expenses mainly relate to professional and marketing fees linked to global commercialization of the VYVGART franchise, and personnel expenses.

Financial income for the three months ended March 31, 2026, was $44 million compared to $37 million for the same period in 2025.

Income tax expense for the three months ended March 31, 2026, was $60 million compared to $33 million for the same period in 2025. Income tax expense for the three months ended March 31, 2026, consists of $102 million of current income tax expense and $42 million of deferred tax benefit, compared to $29 million of current income tax expense and $4 million of deferred tax expense for the comparable prior period.

Profit for the period of three months ended March 31, 2026, was $366 million compared to $169 million in 2025, representing 116% growth year-over-year. The basic profit per share was $5.90 for the three months ended March 31, 2026, compared to $2.78 in 2025.

Cash, cash equivalents and current financial assets1 consisted of $4.3 billion in cash, cash equivalents and $0.6 billion in current financial assets which totaled $4.9 billion as of March 31, 2026, compared to $3.5 billion in cash and cash equivalents and $0.9 billion in current financial assets which totaled $4.4 billion as of December 31, 2025.

EXPECTED 2026 FINANCIAL CALENDAR

July 23, 2026: Half Year and Second Quarter 2026 Financial Results and Business Update
October 22, 2026: Third Quarter 2026 Financial Results and Business Update
CONFERENCE CALL DETAILS

The first quarter 2026 financial results and business update will be discussed during a conference call and webcast presentation today at 2:30 PM CET/8:30 AM ET. A webcast of the live call may be accessed on the Investors section of the argenx website at argenx.com/investors. A replay of the webcast will be available on the argenx website.

(Press release, argenx, MAY 7, 2026, View Source [SID1234665213])

Photocure ASA: Results for the first quarter of 2026

On May 7, 2026 Photocure ASA (OSE:PHO) reported Hexvix/Cysview revenues of NOK 139.0 million in the first quarter of 2026 (Q1 2025: NOK 125.3 million), and an adjusted EBITDA of NOK 15.3 million (Q1 2025: NOK 9.7 million) for the company. In 2026, Photocure expects product revenue growth in the range of 7% to 11% on a constant currency basis and adjusted EBITDA margin expansion.

"Photocure delivered a solid start to 2026, with strong growth across all territories and continued execution across both our commercial and strategic priorities. Revenue growth was robust in North America and Europe, reflecting accelerating adoption of blue-light cystoscopy and increasing procedural penetration in key markets," says Dan Schneider, President & Chief Executive Officer of Photocure.

The company continued to execute on its plan to expand blue-light cystoscopy (BLC) use in Q1 2026 with the installation of 11 new Saphira towers in the U.S. — 4 new accounts and 7 blue light tower upgrades. Photocure had 413 active accounts in the U.S. at the end of the quarter, an increase of 21% versus the first quarter of 2025. Across Europe, a total of 75 Olympus Visera Elite III BLC capable systems were installed since the launch in Q1 2025.

Total revenues ended at NOK 264.6 million in the first quarter of 2026, an increase from NOK 125.3 million in Q1 2025. The total revenue in Q1 2026 includes recognized milestone payments of NOK 125.6 million for the approval of Cevira in China and the acceptance of the marketing authorization approval request in Europe. Reported EBITDA was NOK 128.3 million (NOK 1.8 million). EBIT ended at NOK 120.7 million (NOK -5.6 million). Cash and cash equivalents were NOK 192.7 million at the end of the period.

"As a very important regulatory and strategic update, the U.S. Food and Drug Administration has provided clarity on the reclassification pathway for OAY-related equipment (Diagnostic Endoscopic Light Source Systems) following its response to the Karl Storz Citizen Petition and has confirmed plans to initiate a proposed reclassification process in the second half of 2026. This marks an important step towards a more structured and predictable regulatory framework for BLC equipment in the U.S. market. For Photocure, reclassification has the potential to be a step-change driver for the business, unlocking a significantly larger commercial opportunity, as we move towards double-digit penetration across the expanded market relative to where we are today," Schneider adds.

Photocure’s partners Richard Wolf and Asieris achieved a significant milestone with the April approval of the System blue BLC platform in China, which will be commercialized alongside Hexvix following its prior approval by the National Medical Products Administration (NMPA) in November 2024, enabling a fully integrated drug–device offering. At the same time, the recent CE mark and early commercial traction of blue light–compatible systems in Europe from the leading global medtech company Stryker, reinforce the growing recognition of BLC as an important standard in bladder cancer management and supporting broader adoption over time.

"Cevira, originally developed by Photocure and out-licensed to Asieris, was approved in China by the NMPA in March as a first-in-class non-invasive therapy for cervical precancerous lesions. Shortly thereafter, Cevira was endorsed with Level 1A evidence in expert consensus guidelines in China, reinforcing its clinical adoption potential. In Europe, the European Medicines Agency accepted the Marketing Authorization Application for Cevira during the quarter as well. The approval of Cevira in China and the EMA acceptance serve as milestones with contractual payments owed to Photocure in the amounts of 11.0 million and 2.0 million dollars respectively. The NMPA approval milestone is in dispute, with Asieris having paid 6.6 million of the 11.0 million dollars owed. Photocure believes its legal position to collect the full amount is strong and intends to engage in discussions with Asieris to explore potential pathways forward," Schneider says, and continues:

"Furthermore, in addition to our Hexvix/Cysview base business and partnered developments mentioned above, Photocure also remains committed to advancing a strategy of building an integrated diagnostics platform and leveraging our existing strong commercial footprints in North America and Europe. The uro-oncology landscape is rapidly evolving toward more personalized and data-driven care pathways, increasing the importance of multi-modal precision diagnostics tools. During the quarter, we made a targeted 3.0 million dollar minority investment in Vesica Health, a company within precision diagnostics, developing and launching a multi-omic urine biomarker test for early detection of bladder cancer with best-in-class performance. Our initiatives in flexible cystoscopy with Richard Wolf, AI-enabled software with Claritas/ISC, biomarkers with Vesica Health, and other innovations are progressing as planned, with the goal of improving early detection, diagnostic confidence, surveillance and treatment decision-making."

Photocure sees multiple drivers supporting continued growth in its base business, including sustained procedural adoption, expansion of installed equipment, increased utilization across existing accounts, and continued upgrade cycles to next-generation imaging systems. In addition, several strategic catalysts will further enhance its trajectory, including FDA reclassification of BLC to bring additional rigid equipment manufacturers to the U.S. and the reintroduction of flexible BLC solutions.

"We remain confident in Photocure’s momentum and continued positive trajectory. We expect strong underlying revenue growth across all regions, with product revenue growth of 7% to 11% on a constant currency basis, supported by sustained commercial execution. As operating leverage improves, we anticipate further expansion in adjusted EBITDA margin, reflecting the scalability of our platform and disciplined execution across the base business alongside a strategic platform extension. Our focus remains on delivering consistent execution and building long-term shareholder value," Schneider concludes.

Please find the full financial report and presentation enclosed.

(Adjusted) EBITDA and other alternative performance measures (APMs) are defined and reconciled to the IFRS financial statements as a part of the APM section of the first quarter 2026 financial report on page 22.

The quarterly report and presentation will be published at 07:00 CET and will be publicly available at www.photocure.com. Dan Schneider, CEO, Erik Dahl, CFO, and Priyam Shah, VP of IR will host a live webcast at 14:00 CET.

The presentation will be held in English and questions can be submitted throughout the event. The streaming event is available through: View Source

The presentation is scheduled to conclude at 14:45 CET.

(Press release, PhotoCure, MAY 7, 2026, View Source [SID1234665212])

(E,E)-bisantrene Discovered to Function via Silencing of c-MYC Expression

On May 6, 2026 Racura Oncology, an Australian Phase 3 stage clinical biopharmaceutical company, reported the discovery of the primary mechanism of action (MOA) of its lead oncology asset, (E,E)-bisantrene. Bisantrene has a long clinical history of activity across a range of cancer indications, but its mechanism of action has been unknown.

Preclinical studies undertaken by Racura and collaborators identified that (E,E)-bisantrene exerts its anticancer activity by binding to and stabilizing G-quadruplex (G4) DNA and RNA structures, key regulatory elements involved in controlling oncogene expression.

At the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, Racura presented new preclinical data demonstrating that (E,E)-bisantrene directly binds and stabilizes G4 DNA structures within the c-MYC gene promoter region, resulting in potent suppression of c-MYC expression and broad cytotoxic activity in a wide range of cancer models.[1][2]

The MYC protein functions as a master regulator of gene expression, governing thousands of genes involved in cell growth, differentiation, survival, metabolic reprogramming, chemotherapy resistance, and immune surveillance.[3] Crucially, MYC is the most commonly deregulated oncogene across human cancers, and has often been referred to as the ‘holy grail’ of targets due to its prevalence across many cancer indications. The promoter region of the c-MYC gene contains G4 DNA structures, which can suppress MYC expression when stabilized by drug binding.[4]

Race Oncology CEO and Managing Director, Dr Daniel Tillett said, "The discovery that (E,E)-bisantrene acts primarily by binding to G4-DNA structures leading to the inhibition of c-MYC expression fundamentally changes our thinking on how to best use this drug in the clinic.

This body of work significantly advances our understanding of (E,E)-bisantrene and highlights its potential as a best-in-class therapy targeting a central driver of cancer, MYC dysregulation."

(Press release, Racura Oncology, MAY 6, 2026, View Source [SID1234665239])

Pathos AI Acquires Majority Stake in DeuterOncology to Advance Next-Generation MET Inhibitor Identified by Pathos Foundry Platform

On May 6, 2026 Pathos AI, a clinical-stage AI and technology company advancing its own pipeline of cancer therapies, reported the acquisition of a majority stake in DeuterOncology, a Belgium-based company developing DO-2, a third-generation MET kinase inhibitor for patients with MET-altered cancers. The asset was systematically identified, evaluated, and advanced to acquisition through the Pathos Foundry platform.

Identified by Foundry

As part of its core operations, Pathos utilizes Foundry to continuously analyze large-scale clinical and scientific datasets, including conference proceedings, regulatory filings, published trial data, and proprietary real-world evidence. This enables Pathos to identify high-potential, undervalued oncology assets in a systematic and unbiased way.

In late 2025, Foundry flagged DO-2 as a top-ranked candidate based on its mechanism of action, pharmacokinetic profile, early clinical signal, and probability of success relative to the competitive landscape. Foundry then evaluated its clinical merit, translational feasibility, competitive positioning, and acquisition viability to generate a composite recommendation. The entire process, from initial identification to management’s final investment decision, was completed in a fraction of the time required by traditional due diligence.

"The traditional approach to finding clinical assets is built on relationships, conference presence, and reputation. Foundry is built on data," said Iker Huerga, CEO of Pathos AI. "It evaluates every asset purely on its merits — mechanism, pharmacokinetics, clinical signal, and probability of success. DO-2 scored at the top of our models. Ultimately, the best molecule wins."

A Highly Differentiated MET Inhibitor

MET inhibitors are an established therapeutic class for MET-altered Non-Small Cell Lung Cancer (NSCLC), but every approved agent is limited by peripheral edema rates of 62-82%, frequently requiring dose reductions and treatment discontinuation.

DO-2’s deuterated structure and "fast on / fast off" binding kinetics deliver potent MET inhibition for 8-12 hours per day. This provides sufficient target coverage for robust antitumor activity without causing the sustained endothelial damage that drives chronic edema.

In a Phase 1 study of 28 patients, DO-2 demonstrated 100% tumor shrinkage in all evaluable MET exon 14 skipping NSCLC patients (10/10). It also demonstrated a superior safety profile with zero Grade 4 adverse events, and a peripheral edema rate of just 5% (versus 62-82% for competitors), and a highly convenient 60 mg once-daily oral dose. Patent exclusivity extends to December 2040.

"Pathos’s ability to recognize the potential of this program through rigorous, data-driven analysis is exactly the kind of conviction that will bring DO-2 to the patients who need it," said Dr. Timothy Perera, Founder and CEO of DeuterOncology.

Foundry doesn’t just find drugs. It develops them. The platform is composed of thousands of AI agents working in parallel, powered by the Pathos Oncology Foundation Model. These agents identify undervalued assets and propose portfolio decisions for management. Throughout the entire development lifecycle, Foundry continuously analyzes the totality of emerging data to ensure Pathos programs maintain the highest possible probability of success while directly supporting clinical trial execution.

The same system that identified DO-2 will now guide its clinical development. DO-2 is one of four major portfolio decisions made through Foundry in Q1 2026 alone.

"We are not interested in process automation. We are redesigning drug development from first principles," said Huerga. "DO-2 is proof that the system works."

(Press release, Pathos AI, MAY 6, 2026, View Source [SID1234665238])