On May 4, 2026 NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer and other major diseases, reported FDA acceptance of a protocol amendment to the ongoing pivotal NANORAY-312 study.

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This protocol amendment, submitted by NANORAY-312 global sponsor Johnson & Johnson, eliminates the previously planned interim analysis and modifies the final analysis to include fewer events than originally planned and to be conducted sooner.

In Nanobiotix’s view, this decision could accelerate and expand the global registration pathway for JNJ-1900 (NBTXR3) in head and neck cancer, providing the opportunity for earlier increased revenue generation for the Company.

Nanobiotix anticipates that the modified final analysis should readout in the same timeframe as the previously planned interim analysis. Exact timing will depend on when clinical events occur.

Per the license agreement, Nanobiotix is eligible to receive hundreds of millions in aggregate payments in the next few years, subject to the achievement of remaining development and regulatory milestone events related to the first two programs evaluating JNJ-1900 (NBTXR3) in head and neck cancer and lung cancer.

About JNJ-1900 (NBTXR3)

JNJ-1900 (NBTXR3) is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. Its proof-of-concept was achieved in soft tissue sarcomas through a successful randomized Phase 2/3 study in 2018. The product candidate’s mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that JNJ-1900 (NBTXR3) could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.

Radiotherapy-activated JNJ-1900 (NBTXR3) is being evaluated across multiple solid tumor indications as a single agent or combination therapy. The program is led by NANORAY-312—a global, randomized Phase 3 study in locally advanced head and neck squamous cell cancers. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of JNJ-1900 (NBTXR3) activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the Phase 3 study.

Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several Phase 1 and Phase 2 studies evaluating JNJ-1900 (NBTXR3) across tumor types and therapeutic combinations. In 2023, Nanobiotix announced a license agreement for the global co-development and commercialization of JNJ-1900 (NBTXR3) with Janssen Pharmaceutica NV, a Johnson & Johnson company.

(Press release, Nanobiotix, MAY 4, 2026, https://www.globenewswire.com/news-release/2026/05/04/3287230/0/en/nanobiotix-announces-protocol-amendment-to-ongoing-global-phase-3-head-and-neck-cancer-study.html [SID1234665076])

On May 4, 2026 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), reported financial results for the first quarter ended March 31, 2026, and provided recent operational updates.

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"During the first quarter, we continued to build momentum across our ZYNLONTA program," said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. "Looking ahead, we have multiple near-term catalysts, including topline results from LOTIS-5 anticipated in the second quarter, full results expected from both LOTIS-5 and LOTIS-7 by year-end, as well as additional updates from the investigator-initiated studies in indolent lymphomas ahead. We believe that we are well-positioned to expand ZYNLONTA’s role across B-cell malignancies, accelerating our expected growth trajectory starting in 2027."

First Quarter 2026 Operational Updates and Upcoming Milestones

LOTIS-5 topline results anticipated in 2Q 2026. The Company continues to expect to announce topline results from the LOTIS-5 Phase 3 confirmatory trial of ZYNLONTA (loncastuximab tesirine-lpyl) in combination with rituximab in the second quarter of 2026, with full results anticipated by year-end. If positive, the Company intends to submit a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) before year-end, with potential compendia inclusion in the first half of 2027 and confirmatory approval in 2L+ diffuse large B-cell lymphoma (DLBCL) thereafter.

LOTIS-7 trial ongoing with data anticipated by year-end. The LOTIS-7 Phase 1b trial evaluating ZYNLONTA in combination with the bispecific antibody glofitamab (COLUMVI) in patients with relapsed or refractory (r/r) DLBCL is ongoing, with expected completion of enrollment at the selected 150 µg/kg dose in the first half of 2026. The Company plans to share full data at a medical meeting and through publication by the end of 2026. The Company also intends to evaluate potential regulatory and compendia pathways.

Investigator-Initiated trials (IITs) evaluating ZYNLONTA in additional B-cell malignancies progressing. The University of Miami Sylvester Comprehensive Cancer Center-led multi-center trials of ZYNLONTA in combination with rituximab to treat r/r follicular lymphoma (FL) and ZYNLONTA as a monotherapy to treat marginal zone lymphoma (MZL) are ongoing. The Company anticipates publication of data from both IITs between the end of 2026 and mid-2027. Assuming positive data, the Company intends to assess potential regulatory and compendia pathways.

First Quarter 2026 Financial Results

Product Revenues: Net product revenues were $20.0 million for the first quarter of 2026, as compared to $17.4 million for the first quarter of 2025. The increase in revenue versus the prior year was primarily driven by volume increase, which reflects the normal variability in customer ordering patterns as well as higher price.

License Revenues and Royalties: License revenue and royalties were $0.8 million for the first quarter of 2026, as compared to $5.6 million for the first quarter of 2025. The decrease was primarily driven by a prior year milestone received from our partner.

Cost of Product Sales: Cost of product sales was $3.6 million for the first quarter of 2026, as compared to $2.1 million for the first quarter of 2025. The increase in cost of product sales was primarily attributable to a $1.2 million increase in certain personnel costs, which includes a change in focus of these personnel from research and development clinical supply activities to commercial manufacturing activities.

Research and Development (R&D) Expense: R&D expense was $19.9 million for the first quarter of 2026, as compared to $28.9 million for the first quarter of 2025. The decrease was primarily driven by a $6.1 million decrease in external costs as a result of discontinued programs and completion of the IND-enabling activities for our PSMA-targeting ADC. The decrease was also driven by a shift of certain personnel costs totaling $2.1 million to cost of product sales ($1.2 million), inventory capitalization ($0.6 million), and selling and marketing expense ($0.3 million), reflecting a change in focus of these personnel from research and development activities toward commercial manufacturing and fulfillment activities.

Selling and Marketing (S&M) Expense: S&M expense was $12.7 million for the first quarter of 2026, as compared to $10.6 million for the first quarter of 2025. The increase was primarily due to higher wages and benefits, and marketing and advertising expenses.

General & Administrative (G&A) Expense: G&A expense was $9.9 million for the first quarter of 2026, as compared to $10.0 million for the first quarter of 2025.

Total Operating Expenses and Adjusted Total Operating Expenses: Total operating expenses were $46.1 million for the first quarter of 2026, as compared to $51.5 million for the first quarter of 2025. On a non-GAAP basis, total adjusted operating expenses were $42.9 million for the first quarter of 2026, as compared to $49.1 million for the first quarter of 2025. The reduction in total adjusted operating expenses was primarily driven by lower R&D expenses.

Net Loss and Adjusted Net Loss: Net loss for the first quarter of 2026 was $33.0 million, or a net loss of $0.21 per basic and diluted share, as compared to a net loss of $38.6 million, or a net loss of $0.36 per basic and diluted share, for the first quarter of 2025. Adjusted net loss, which is a non-GAAP financial measure, was $19.7 million, or an adjusted net loss of $0.13 per basic and diluted share, for the first quarter of 2026, as compared to adjusted net loss of $24.0 million, or $0.22 per basic and diluted share, for the first quarter of 2025. The lower net loss and adjusted net loss were primarily due to lower operating expenses and on a per basic and diluted share basis, by a higher number of weighted average shares outstanding.

Cash and Cash Equivalents: As of March 31, 2026, cash and cash equivalents were $231.0 million, compared to $261.3 million as of December 31, 2025, a change primarily driven by cash used in operations and for annual bonus payments. The Company has an expected cash runway at least into 2028.

Conference Call Details

ADC Therapeutics management will host a conference call and live audio webcast to discuss first quarter 2026 financial results and provide a company update today at 8:30 a.m. EDT. To access the conference call, please register here. Registrants will receive the dial-in number and unique PIN. It is recommended that you join 10 minutes before the event, though you may pre-register at any time. A live webcast of the call will be available under "Events & Presentations" in the Investors section of the ADC Therapeutics website at ir.adctherapeutics.com. The archived webcast will be available for 30 days following the call.

(Press release, ADC Therapeutics, MAY 4, 2026, View Source [SID1234665042])

On May 4, 2026 Biohaven Ltd. (NYSE: BHVN) (Biohaven or the Company), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat a broad range of rare and common diseases, reported financial results for the first quarter ended March 31, 2026, and provided a review of recent accomplishments and anticipated upcoming developments.

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Vlad Coric, M.D., Chairman and Chief Executive Officer of Biohaven, commented, "We are planning for a transformative year ahead at Biohaven, with multiple potential value-driving milestones on the horizon. In the coming several weeks, we expect the initiation of our pivotal clinical trials to advance our novel MoDE and TRAP extracellular protein degradation platform into two pivotal studies, BHV-1300 for Graves’ disease and BHV-1400 for IgA nephropathy. These pivotal trials represent a key milestone for the degrader platform and further extends the clinical validation of our strategy to selectively degrade disease-causing proteins with our precision immunology technology. In the second half of 2026, we expect to report pivotal data from our epilepsy program and topline results from our obesity program."

Dr. Coric continued, "Additionally, our first-in-class FGFR3-directed ADC, BHV-1530, continues dose escalation with no dose-limiting toxicities observed to date, and we have begun an expansion cohort in advanced endometrial cancer with our next-generation TROP-2 directed ADC BHV-1510 in combination with Libtayo. We are also excited about progress with our TYK2/JAK1 inhibitor for early Parkinson’s disease and continue to advance enrollment in this trial. Finally, our thought leadership in neurology was on display last month at AAN, where we notably delivered a total of 5 oral presentations and posters highlighting our differentiated neuroscience and immunoscience portfolio. Though our approach has been marked by a disciplined and careful management of resources, we are pleased with progress achieved in recent months and look forward to sharing more detailed and robust updates across our portfolio at our annual R&D Day at the Yale Innovation Summit on May 27, 2026 in New Haven, Connecticut."

First Quarter and Recent Business Updates

First Quarter 2026 and Recent Business Highlights

Completed Enrollment in Phase 2 Obesity Study with Taldefgrobep Alfa – Taldefgrobep alfa, a myostatin-activin pathway inhibitor, offers the potential to achieve high-quality weight loss in people living with obesity. Biohaven initiated a taldefgrobep Phase 2 proof-of-concept study in obesity in 4Q 2025. This randomized, placebo-controlled dose-ranging study is evaluating the efficacy and tolerability of once-weekly and once-monthly taldefgrobep as monotherapy, via self-administered autoinjector, in adults living with overweight and obesity. Topline data from the study are expected in 2H 2026.
Oral and poster presentations at AAN underpinned breadth of development work across core programs – In April 2026, the Company delivered 1 oral presentation and 4 posters at the AAN Annual Meeting, showcasing development programs including Kv7 ion channel activation, extracellular protein degraders, and TYK2/JAK1 inhibition.
Expected Upcoming Milestones:

We believe Biohaven is well positioned to achieve significant, value-creating milestones in 2026 across numerous programs:

Selective Kv7 Ion Channel Activator (Opakalim):

Continue two Phase 2/3 studies in focal epilepsy; initial topline results for the first study expected in 2H 2026.
Myostatin-Activin Pathway Inhibitor (Taldefgrobep alfa):

Completed enrollment in Phase 2 study in obesity in 1Q 2026; topline results expected in 2H 2026.
Lead TRAP and MoDE Extracellular Protein Degraders (BHV-1400 and BHV-1300)

BHV-1400: Pivotal study initiation in IgAN study expected mid-year 2026
BHV-1300: Pivotal study initiation in Graves’ disease expected mid-year 2026.
Capital Position:

Cash, cash equivalents, marketable securities and restricted cash as of March 31, 2026, totaled approximately $351.8 million.

First Quarter 2025 Financial Highlights:

Research and Development (R&D) Expenses: R&D expenses, including non-cash share-based compensation costs, were $103.8 million for the three months ended March 31, 2026, compared to $187.6 million for the three months ended March 31, 2025. The decrease of $83.8 million was primarily due to decreases in direct program and preclinical spend, and non-cash share-based compensation expense in 2026 as compared to the same period in the prior year. The decrease in direct program spend was largely due to our strategic reprioritization of programs which was implemented in the fourth quarter of 2025. The decrease in R&D expense included a $17.0 million decrease in preclinical research programs, which was primarily due to an upfront share payment valued at $4.9 million and an accrual for an upfront cash payment of $5.0 million related to agreements entered into during the three months ended March 31, 2025.

General and Administrative (G&A) Expenses: G&A expenses, including non-cash share-based compensation costs, were $26.6 million for the three months ended March 31, 2026, compared to $34.0 million for the three months ended March 31, 2025. The decrease of $7.4 million was primarily due to decreased non-cash share-based compensation expense. Non-cash share-based compensation expense was $9.8 million for the three months ended March 31, 2026, a decrease of $8.0 million as compared to the same period in 2025. Non-cash share-based compensation expense was lower in 2026 primarily due to our annual equity incentive awards granted in the first quarter of 2026, which had a lower grant date fair value per share than the annual awards granted in the first quarter of 2025.

Other (Expense) Income, Net: Other (expense) income, net was other expense, net of $0.2 million for the three months ended March 31, 2026, compared to other income, net of $0.5 million for the three months ended March 31, 2025. The decrease of $0.3 million was primarily due to non-cash losses related to changes in fair value of our notes payable liability under the Note Purchase Agreement with Beetlejuice SA LLC, an affiliate of Oberland Capital Management LLC, entered into during the second quarter of 2025 (the NPA), and decreased investment income during the three months ended March 31, 2026, which was partially offset by losses recorded for the non-cash changes in the fair value of our forward contracts and derivative liabilities in connection with the amendment to our Membership Interest Purchase Agreement with Knopp Biosciences LLC in May 2024 (the Knopp Amendment) during the three months ended March 31, 2025.

Net Loss: Biohaven reported a net loss for the three months ended March 31, 2026 of $130.5 million, or $0.88 per share, compared to $221.7 million, or $2.17 per share, for the same period in 2025. Non-GAAP adjusted net loss for the three months ended March 31, 2026 was $102.2 million, or $0.69 per share, compared to $166.8 million, or $1.64 per share, for the same period in 2025. These non-GAAP adjusted net loss and non-GAAP adjusted net loss per share measures, more fully described below under "Non-GAAP Financial Measures," exclude non-cash share-based compensation charges and losses from the change in fair value of derivatives. A reconciliation of the GAAP financial results to non-GAAP financial results is included in the tables below.

(Press release, Biohaven Pharmaceutical, MAY 4, 2026, View Source [SID1234665061])

On May 4, 2026 Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) ("Alpha Tau"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported the presentation of updated pooled results from two first-in-human clinical trials of Alpha DaRT in pancreatic ductal adenocarcinoma (PDAC) at Digestive Disease Week (DDW) 2026, the world’s premier international gastroenterology conference.

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The abstract, entitled "Updated Results of Feasibility, Safety, and Tumor Control in Two First-In-Human Trials of a Novel Alpha-Emitting Radionuclide for Pancreatic Adenocarcinoma," was selected for podium presentation in the Pancreatic Cancer I: Diagnosis and Treatment session. The abstract is based on combined data from two clinical protocols conducted at Hadassah Medical Center in Jerusalem, Israel, and was presented by Philip Blumenfeld, MD, Director of Advanced Radiotherapy Unit, Sharett Institute of Oncology, Hadassah Medical Center. This marks the first time that Alpha DaRT clinical results have been selected for oral presentation at a major gastroenterology conference.

Clinical Results

The results were pooled from two clinical studies of Alpha DaRT treating localized unresectable and metastatic pancreatic cancers in a heterogeneous patient population, including those who were ineligible to receive chemotherapy as well as those who had undergone up to four prior lines of chemotherapy. Despite this breadth and complexity of clinical backgrounds, 100% local disease control was achieved across all 19 evaluable patients based on modified RECIST v1.1 criteria, as measured by best overall response, reflecting 15 (79%) with stable disease and 4 (21%) with partial response, a landmark result underscoring the potential of Alpha DaRT as a compelling intratumoral treatment regardless of prior treatment history.

The safety profile was also highly encouraging. Among 26 subjects treated, only 8 device-associated adverse events were observed in 7 subjects (27%), all of which resolved within two weeks, with the exception of one instance of lingering fatigue.

Uzi Sofer, CEO of Alpha Tau, stated: "These results represent a highly significant milestone for Alpha DaRT and for Alpha Tau’s strategic mission to establish intratumoral alpha-emitting radiotherapeutics as a meaningful option in oncology’s most challenging indications. What makes these data particularly compelling is not only the efficacy and safety signal – which are both exceptional – but also the fact that this treatment was designed to integrate naturally into the existing patient pathway and GI workflow. The ability to deliver Alpha DaRT via EUS, a procedure which gastroenterologists already perform routinely, makes this treatment highly attractive from a clinical adoption perspective. Furthermore, the combination of a localized treatment with systemic approaches represents a major advantage over combinations of other systemic therapies with chemotherapy regimens, which often carry significant toxicity burdens. We believe Alpha DaRT has the potential to fundamentally change how pancreatic cancer is treated, and these results bring us closer to realizing that potential."

"These are some of the most challenging, heavily pre-treated patients in oncology – patients for whom available options are extremely limited," commented Robert Den, MD, Chief Medical Officer of Alpha Tau. "Nevertheless, consistency of response across such a diverse cohort is a powerful signal of Alpha DaRT’s potential. Coupled with a very promising safety profile characterized by low rates of device-associated adverse events and rapid resolution, these results provide a strong foundation for the advancement of Alpha DaRT in pancreatic cancer and further reinforce the scientific basis for our ongoing U.S. multicenter pancreatic cancer IMPACT trial."

Philip Blumenfeld, MD, Director of Advanced Radiotherapy Unit, Sharett Institute of Oncology, Hadassah Medical Center, and presenter of the abstract, commented: "As a radiation oncologist and member of a multidisciplinary pancreatic cancer team, I see these results as potentially addressing a significant unmet need from several clinical perspectives. Pancreatic cancer has historically been relatively resistant to radiation therapy, and while modern techniques such as SBRT have improved our ability to deliver ablative doses, their use remains constrained by the close proximity of critical gastrointestinal structures. As a result, achieving meaningful local control without toxicity continues to be a major challenge. The ability to deliver intratumoral alpha-particle therapy via EUS, with consistent disease control across treated patients, hopefully represents an important advance in the radiotherapeutic management of this disease. Equally notable is the favorable toxicity profile. In a patient population already heavily burdened by aggressive systemic chemotherapy, a treatment that offers strong local efficacy with minimal added toxicity is highly compelling. This combination makes Alpha DaRT a treatment I am genuinely excited about for my patients."

About Alpha DaRT

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.

(Press release, Alpha Tau Medical, MAY 4, 2026, View Source [SID1234665043])

On May 4, 2026 XtalPi (2228.HK), a leading AI- and robotics-powered innovation platform, reported dual breakthroughs in its strategic partnership with PharmaEngine (4162.TWO) PEP08, a next-generation PRMT5 inhibitor discovered via XtalPi’s platform, has successfully begun enrollments in a Phase I solid tumor trial, achieving a new clinical milestone. Built upon the success of PEP08 at the drug discovery stage, the two companies initiated a second project, targeting a different undisclosed synthetic lethality mechanism.

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PEP08 received clinical clearance in June 2025 and is currently in Phase I evaluation for solid tumors in Australia and the Taiwan region. The enrollment milestone underscores XtalPi’s ability to deliver differentiated molecules with strong drug-like properties, while demonstrating the program’s steady clinical advancement.

Leveraging XtalPi’s integrated quantum physics-, AI-, and robotics-powered platform, PEP08 was designed to overcome the dose-limiting hematological toxicities seen with first-generation PRMT5 inhibitors. The molecule exploits an innovative MTA-cooperative binding mode to specifically target MTAP-deleted tumors—a genomic alteration found in 10-15% of all human cancers, with higher frequencies observed in NSCLC, pancreatic cancer, glioblastoma, and more. Preclinical data presented at 2025 AACR (Free AACR Whitepaper) show PEP08 achieving superior efficacy compared to other clinical-stage MTA-cooperative PRMT5 inhibitors across multiple MTAP-deleted tumor models, supporting a potential best-in-class profile.

Driven by the success of PEP08 at the drug discovery stage, the partnership expanded into a second project. By combining PharmaEngine’s deep oncology expertise with XtalPi’s AI and robotics molecular design engine, the duo aims to capture additional market share in the synthetic lethality space.

Synthetic lethality is widely recognized as challenging yet highly promising frontier in oncology. According to Globocan and industry data, the global market is expected to grow from $4.2 billion to $17.6 billion by 2033, at a 17.3% CAGR. In recent years, several early-stage licensing deals in this space have exceeded $1 billion USD, further underscoring the immense clinical value and commercial appetite for this category.

The clinical advancement of PEP08 and the ongoing collaboration of the second project serve as a dual validation of XtalPi’s AI+robotics discovery engine. By repeatedly meeting rigorous benchmarks in complex target spaces, XtalPi has built a reproducible innovation model that turns deep know-how into high-value clinical assets. Underpinned by a milestone-sharing structure, this model tightly aligns the platform’s evolution with clinical success, quickly translating biological insights into tangible impact for partners and patients around the world.

Dr. Shuhao Wen, Chairman of XtalPi commented, "The clinical progress of PEP08 and the ongoing collaboration of the second project are testaments to the synergy between our teams, and highlights the reliability of XtalPi’s R&D platform in tackling complex targets. We look forward to further applying this model to deliver high-quality pipeline assets for our partners and generate sustained value for our shareholders."

"PharmaEngine has been advancing its R&D capabilities, and our collaboration with XtalPi exemplifies our ability to harness innovative technologies to propel next-generation discoveries in precision oncology," said Dr. Hong-Ren Wang, CEO and President of PharmaEngine. "XtalPi’s R&D platform played a key role in the early-stage discovery of PEP08, providing a robust foundation for its clinical entry. Our collaboration of PEP08 and the second project demonstrates our ongoing efforts to advance cancer treatment development worldwide.

(Press release, XtalPi, MAY 4, 2026, View Source;enabled-pharmaengine-pep08-achieves-enrollment-milestone-with-second-synthetic-lethality-program-underway-302760846.html [SID1234665062])