Alpha Fusion Initiates Company-Sponsored Clinical Trial of Alpha-Emitting Radiopharmaceutical af-001 in Patients with Differentiated Thyroid Cancer

On October 31, 2025 Alpha Fusion Inc. (Headquarters: Chiyoda-ku, Tokyo; CEO: Sunao Fujioka; hereinafter "Alpha Fusion") reported the initiation of a company-sponsored Phase I clinical trial (jRCT2031250472) of the alpha-emitting radiopharmaceutical af-001, which contains [211At]NaAt as its active pharmaceutical ingredient, in patients with differentiated thyroid cancer (papillary and follicular carcinoma).

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This clinical trial is designed based on the results of an investigator-initiated Phase I study conducted at The University of Osaka, and consists of Part Ia and Part Ib.

In Part Ia, the maximum tolerated dose (MTD) of a single intravenous administration of af-001 will be determined in patients with differentiated thyroid cancer who are refractory to or intolerant of standard therapies. Part Ib will evaluate the efficacy and safety of multiple intravenous administrations of af-001 to determine the recommended dose for Phase II trials in patients with differentiated thyroid cancer who have not received prior radioactive iodine (RAI) therapy (RAI-naïve).

Part Ia of the study will be conducted at the National Cancer Center Hospital East (Principal Investigator: Dr. Makoto Tahara, Chief, Department of Head and Neck Medical Oncology), and Part Ib will be conducted at multiple sites in Japan.

The clinical development of af-001 will proceed with the goal of obtaining regulatory approval for use in patients with RAI-naïve differentiated thyroid cancer (papillary and follicular carcinoma). If clinical efficacy and safety are indicated in this patient population, af-001 is expected to contribute as a next-generation radiopharmaceutical and as a novel therapeutic option for differentiated thyroid cancer.

af-001 is manufactured under GMP for investigational products in collaboration with the Kobe City Medical Center General Hospital (Director: Dr. Yasuki Kihara; Chuo-ku, Kobe City, Hyogo), and promptly delivered to the National Cancer Center Hospital East after production.

Regarding the initiation of this study, Sunao Fujioka, CEO of Alpha Fusion Inc., commented as follows:

"Based on the achievements of the investigator-initiated Phase I study in patients refractory or intolerant to standard therapies, we expect to maximize the potential of af-001 by confirming its safety and efficacy in RAI-naïve patients. Alpha Fusion is fully committed to advancing the clinical development of af-001, with the ultimate goal of providing outpatient alpha-emitting radiopharmaceutical therapy to more patients with thyroid cancer. In addition, we are pursuing multiple research and development pipelines utilizing At-211, aiming to create innovative radiopharmaceuticals for various types of cancer."

Background

RAI therapy is the standard treatment for differentiated thyroid cancer. However, in cases involving multiple metastases or insufficient therapeutic response despite clear iodine uptake, repeated RAI treatments may be required.

Moreover, due to radiation protection requirements in Japan, RAI therapy must be administered in shielded rooms, leading to hospitalization that imposes psychological stress on patients and financial burdens on hospitals. A survey in Japan reported an average waiting time of approximately 3.7 months, and 23% of facilities having a wait time exceeding six months (Survey Report on the Utilization of RI Therapy Rooms for Thyroid Cancer, 2022).

Given these challenges, there is a growing demand for patient-centric radiopharmaceuticals that can achieve potent tumor-reducing effects in an outpatient setting.

About At-211 (af-001)

af-001 is a radiopharmaceutical containing astatine-211 (At-211) as its active pharmaceutical ingredient. It is selectively taken up by differentiated thyroid cancer cells through the sodium/iodide symporter (NIS) and exerts a cytotoxic effect by emitting alpha particles.

At-211 emits alpha particles with higher energy than beta particles, inducing double-strand DNA breaks in cancer cell nuclei and leading to tumor regression.
Because alpha particles have a very limited range (approximately several tens of micrometers), af-001 can deliver strong therapeutic effects while minimizing damage to surrounding normal tissues. Consequently, substituting RAI with the limited-range alpha emitter af-001 may enable outpatient-based treatment.

With these unique characteristics, af-001 is being developed as a next-generation radiopharmaceutical and a novel treatment for differentiated thyroid cancer, offering both efficacy and safety.

Results of the Investigator-Initiated Clinical Trial and Positioning of the Company-Sponsored Trial

Prior to this company-sponsored trial, an investigator-initiated Phase I clinical trial (Alpha-T1 Trial) of [211At]NaAt, identical in composition to af-001, was conducted at The University of Osaka under the supervision of Dr. Tadashi Watabe, Principal Investigator (NCT05275946).

The study indicated the safety and tolerability of [211At]NaAt in patients with differentiated thyroid cancer refractory or intolerant to standard therapies. Additionally, the study reported a ≥50% reduction in thyroglobulin concentration (a tumor marker) and cases of disappearance of 131I uptake on imaging.

The present company-sponsored trial aims to evaluate the efficacy and safety of af-001 (identical in pharmaceutical ingredient to TAH-1005, [211At]NaAt) in RAI-naïve patients, with the objective of determining the recommended dose for subsequent Phase II studies.

(Press release, Alpha Fusion, OCT 31, 2025, View Source [SID1234659210])

NANOBIOTIX Announces Strategic Royalty Monetization Agreement With Healthcare Royalty for up to $71 Million and Extends Cash Runway Toward Long-Term Growth

On October 31, 2025 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 that it has entered into a royalty-based financing agreement with HealthCare Royalty ("HCRx"), providing up to $71 million in non-dilutive capital and establishing the financial foundation for self-sustainability and the advancement of next wave nanotherapeutic platforms for long-term growth.

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"This non-dilutive financing reflects our commitment to preserving long-term shareholder value, while strategically aligning capital to unlock the full potential of our nanotherapeutics platforms. Importantly, this funding provides the resources to advance the company through critical potential milestones that will lead to self-sustainability and durable value creation," said Bart van Rhijn, Chief Financial and Business Officer at Nanobiotix.

Key Terms of the Royalty Financing Agreement

At the closing of the agreement, Nanobiotix will receive an upfront payment of $50 million and expects to receive an additional $21 million one year post closing subject to reaching certain conditions
Assuming $71 million is funded, success-based1 remuneration to HCRx includes:
Repayment from a defined portion of royalties on the first $1 billion of net sales and a portion of certain regulatory and commercial milestone payments, subject to a cap of approximately $124 million (1.75x Multiple on Invested Capital ("MOIC")) if repayment is completed by end of 2030, increasing to approximately $178 million (2.50x MOIC) if repayment occurs thereafter (the Return Cap figures assume $71 million is funded)
Following achievement of the Return Cap, a royalty-only tail period will commence, which entitles HCRx to a predefined, reduced share of royalties not to exceed $14.9 million per year; the tail period will expire 10 years following the first commercial sale of JNJ-1900 (NBTXR3) in the US
Payment and repayment obligations under both this royalty financing agreement with HCRx and the existing royalty agreement with the European Investment Bank (EIB) will be furnished through the transfer of receivables from the JNJ-1900 (NBTXR3) license agreement to a French law trust
"We are excited to partner with Nanobiotix at this pivotal stage of its growth" said Clarke Futch, Chairman and Chief Executive Officer at HCRx. "The differentiated nature of their physics-based approach and the compelling clinical profile of JNJ-1900 (NBTXR3) align with our mission of supporting innovative therapies that address areas of significant unmet need. This investment underscores our confidence in this first-of-its-kind approach to cancer treatment, which has the potential to redefine standards of care and establish an entirely new class of therapy."

TD Cowen acted as sole financial advisor to Nanobiotix.

Assuming the drawdown of the second tranche one year post closing, this financing extends Nanobiotix cash runway into early 2028 subject to closing of the agreement. This extension of cash runway does not include potential milestone payments from the JNJ-1900 (NBTXR3) licensing agreement. The Company continues to expect to receive the first potential milestone payments related to clinical development in head and neck cancer (NANORAY-312) and lung cancer (CONVERGE) within this timeframe, and has thereby established the financial foundation for self-sustaining long-term growth.

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, OCT 31, 2025, View Source [SID1234659207])

Disc Medicine to Participate in Upcoming Investor Conferences

On October 31, 2025 Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, reported that company management will participate in fireside chats at three upcoming investor conferences:

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Guggenheim Second Annual Healthcare Innovation Conference on Monday, November 10th at 4:30 p.m. ET.
Stifel 2025 Healthcare Conference on Thursday, November 13th at 8:40 a.m. ET.
Jefferies London Healthcare Conference on Wednesday, November 19th at 2:00 p.m. GMT.

Live webcasts of the fireside chats will be available through the investor relations section of the Company’s website at ir.discmedicine.com and an archived replay will be available after each event.

(Press release, Disc Medicine, OCT 31, 2025, View Source [SID1234659206])

Corvus Pharmaceuticals to Present at the Guggenheim 2nd Annual Healthcare Innovation Conference

On October 31, 2025 Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, reported that members of its leadership team will conduct one-on-one meetings with investors and participate in a fireside chat presentation at the Guggenheim 2nd Annual Healthcare Innovation Conference, which is being held in Boston, MA. The fireside chat will be on Monday, November 10, 2025 at 8:30 am ET.

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A webcast of the fireside chat will be available live and for 90 days following the event. The webcast may be accessed via the investor relations section of the Corvus website.

(Press release, Corvus Pharmaceuticals, OCT 31, 2025, View Source [SID1234659205])

AbbVie Reports Third-Quarter 2025 Financial Results

On October 31, 2025 AbbVie (NYSE:ABBV) reported financial results for the third quarter ended September 30, 2025.

"AbbVie continues to deliver outstanding results, with significant momentum across key areas of our portfolio. We are also making great progress advancing our pipeline and investing in innovation to support AbbVie’s long-term growth," said Robert A. Michael, chairman and chief executive officer, AbbVie. "Based upon the strength of our business and its promising outlook, we are once again raising our quarterly cash dividend."

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Third-Quarter Results

•Worldwide net revenues were $15.776 billion, an increase of 9.1 percent on a reported basis, or 8.4 percent on an operational basis.

•Global net revenues from the immunology portfolio were $7.885 billion, an increase of 11.9 percent on a reported basis, or 11.2 percent on an operational basis.
◦Global Skyrizi net revenues were $4.708 billion, an increase of 46.8 percent on a reported basis, or 46.0 percent on an operational basis.
◦Global Rinvoq net revenues were $2.184 billion, an increase of 35.3 percent on a reported basis, or 34.1 percent on an operational basis.
◦Global Humira net revenues were $993 million, a decrease of 55.4 percent on a reported basis, or 55.7 percent on an operational basis.

•Global net revenues from the neuroscience portfolio were $2.841 billion, an increase of 20.2 percent on a reported basis, or 19.6 percent on an operational basis.
◦Global Vraylar net revenues were $934 million, an increase of 6.7 percent.
◦Global Botox Therapeutic net revenues were $985 million, an increase of 16.1 percent on a reported basis, or 15.8 percent on an operational basis.
◦Global Ubrelvy net revenues were $354 million, an increase of 31.5 percent.
◦Global Qulipta net revenues were $288 million, an increase of 64.1 percent on a reported basis, or 63.1 percent on an operational basis.

•Global net revenues from the oncology portfolio were $1.682 billion, a decrease of 0.3 percent on a reported basis, or 1.3 percent on an operational basis.
◦Global Imbruvica net revenues were $706 million, a decrease of 14.8 percent.
◦Global Venclexta net revenues were $726 million, an increase of 7.1 percent on a reported basis, or 4.9 percent on an operational basis.
◦Global Elahere net revenues were $170 million, an increase of 23.3 percent on a reported basis, or 22.4 percent on an operational basis.

•Global net revenues from the aesthetics portfolio were $1.193 billion, a decrease of 3.7 percent on a reported basis, or 4.2 percent on an operational basis.
◦Global Botox Cosmetic net revenues were $637 million, a decrease of 4.9 percent on a reported basis, or 5.4 percent on an operational basis.
◦Global Juvederm net revenues were $253 million, a decrease of 2.2 percent on a reported basis, or 3.2 percent on an operational basis.

•On a GAAP basis, gross margin in the third quarter was 66.4 percent. The adjusted gross margin was 83.9 percent.

•On a GAAP basis, selling, general and administrative (SG&A) expense was 22.6 percent of net revenues. The adjusted SG&A expense was 21.6 percent of net revenues.

•On a GAAP basis, research and development (R&D) expense was 14.7 percent of net revenues. The adjusted R&D expense was 14.3 percent of net revenues.

•Acquired IPR&D and milestones expense was 17.0 percent of net revenues.

•On a GAAP basis, operating margin in the third quarter was 12.1 percent. The adjusted operating margin was 30.9 percent.

•Net interest expense was $667 million.

•On a GAAP basis, the tax rate in the quarter was 73.7 percent. The adjusted tax rate was 24.5 percent.

•Diluted earnings per share (EPS) in the third quarter was $0.10 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $1.86. These results include an unfavorable impact of $1.50 per share related to acquired IPR&D and milestones expense.

Recent Events

•AbbVie announced the U.S. Food and Drug Administration (FDA) approval of a supplemental New Drug Application (sNDA) that updates the indication statement for Rinvoq (upadacitinib) for the treatment of adults with moderately to severely active ulcerative colitis (UC) and moderately to severely active Crohn’s disease (CD). The updated indication statement allows the use of Rinvoq prior to the use of tumor necrosis factor (TNF) blocking agents in patients for whom use of these treatments is clinically inadvisable and who have received at least one approved systemic therapy.

•AbbVie announced positive topline results from the second of two pivotal studies of the Phase 3 UP-AA clinical program evaluating the safety and efficacy of Rinvoq in adult and adolescent patients with severe alopecia areata (AA). In the study, Rinvoq achieved the primary endpoint, demonstrating that 45.2% and 55.0% of patients with severe AA treated with Rinvoq 15 mg and 30 mg, respectively, reached 80% or more scalp hair coverage at week 24 as defined by the severity of alopecia tool (SALT) score ≤ 20. Key secondary endpoints, including improvements in eyebrows and eyelashes, as well as the percentage of subjects with 90% or more scalp coverage (SALT ≤ 10) and complete scalp hair coverage (SALT=0) at week 24, were also met. Rinvoq’s safety profile in AA was generally consistent with that in approved indications, and no new safety signals were identified in this study.

•AbbVie announced topline results from two replicate Phase 3 studies evaluating the efficacy and safety of Rinvoq 15 mg in adult and adolescent patients living with non-segmental vitiligo (NSV). In the studies, Rinvoq achieved the co-primary endpoints of 50% reduction in total Vitiligo Area Scoring Index (T-VASI 50) from baseline and 75% reduction in Facial Vitiligo Area Scoring Index (F-VASI 75) from baseline at week 48. Additionally, across both studies, statistically significant differences were observed with Rinvoq versus placebo in key ranked secondary endpoints, including F-VASI 50 at week 48. The safety profile of Rinvoq in both studies was generally consistent with that observed in approved indications.

•AbbVie announced positive topline results from the Phase 3b/4 head-to-head SELECT-SWITCH study evaluating the efficacy and safety of Rinvoq compared to Humira (adalimumab) in adult patients with moderate to severe rheumatoid arthritis (RA), who had an inadequate response or intolerance to a single TNF inhibitor other than Humira. In the study, Rinvoq demonstrated superiority versus Humira in the primary endpoint of achieving low disease activity and demonstrated superiority for additional ranked secondary endpoints at week 12. Rinvoq’s safety profile was consistent with previously reported studies, with no new safety risks identified.

•AbbVie announced that it completed its acquisition of Capstan Therapeutics. The acquisition adds a potential first-in-class in vivo targeted lipid nanoparticle (tLNP) anti-CD19 CAR-T therapy candidate for B cell-mediated autoimmune diseases as well as a proprietary tLNP platform designed to deliver RNA payloads, such as mRNA, capable of engineering specific cell types in vivo.

•AbbVie announced that it submitted a New Drug Application (NDA) to the FDA for tavapadon, a novel selective dopamine D1/D5 receptor partial agonist for the treatment of Parkinson’s disease (PD). The submission is supported by data from the Phase 3 TEMPO program, which demonstrated symptomatic improvement across the PD spectrum. If approved, tavapadon will enhance AbbVie’s position in PD by providing patients with a once daily oral treatment option.

•AbbVie announced positive topline results from the Phase 2 ELATE trial evaluating the safety and efficacy of Botox (onabotulinumtoxinA) for the treatment of upper limb essential tremor. Botox met the primary endpoint in the Phase 2 trial, demonstrating a statistically significant improvement from baseline in the Tremor Disability Scale-Revised (TREDS-R) total unilateral score compared to placebo. The trial also met all six secondary endpoints. Results from safety analyses were generally consistent with the well-established safety profile of Botox.

•AbbVie announced that it completed its acquisition of Gilgamesh Pharmaceuticals’ lead investigational candidate, bretisilocin. Bretisilocin is a novel, short-acting serotonin (5-HT)2A receptor agonist and 5-HT releaser psychedelic compound with best-in-class potential, which is currently in Phase 2 clinical development for the treatment of patients with moderate-to-severe major depressive disorder (MDD). Positive topline results from a Phase 2a study of bretisilocin in MDD were previously announced, demonstrating a clinically impactful and statistically significant reduction in severity of depressive symptoms versus low dose active comparator, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) total score.

•AbbVie announced submission of a new Biologics License Application (BLA) to the FDA for approval of pivekimab sunirine (PVEK), an investigational antibody-drug conjugate (ADC), for treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN). The submission is based on data from the Phase 1/2 CADENZA trial, a global study evaluating the safety and efficacy of PVEK in BPDCN. BPDCN is a rare and aggressive blood cancer with significant need for innovative treatment options for both newly diagnosed patients and for those whose prior treatments have resulted in relapsed or refractory (R/R) disease.

•At the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, AbbVie presented new data from its ADC portfolio in patients with difficult-to-treat tumor types. Highlights included three oral presentations for Temab-A (telisotuzumab adizutecan) as a monotherapy or in combination across advanced, solid tumors, as well as new analysis of ABBV-706 for the treatment of R/R small cell lung cancer (SCLC).

•At the Society of Hematologic Oncology (SOHO) Annual Meeting, AbbVie announced updated results from the Phase 2 EPCORE NHL-6 trial evaluating the feasibility of dosing and monitoring patients in the outpatient setting for the first full dose of Epkinly (epcoritamab) monotherapy in adult patients with R/R diffuse large B-cell lymphoma (DLBCL) who have received at least one prior line of systemic therapy. Results from the study demonstrated that the incidence and severity of cytokine release syndrome (CRS) and immune cell-associated neurotoxicity syndrome (ICANS) following treatment with epcoritamab were consistent with previous epcoritamab studies in R/R DLBCL.

•AbbVie announced plans to launch Elahere (mirvetuximab soravtansine-gynx) in the U.K. at a list price equal to the U.S., reflecting the advanced innovation and value of the treatment for adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens. AbbVie is committed to ensuring that developed nations fully recognize the value of our medicines in improving patient outcomes, consistent with the level of recognition in the U.S.

•Allergan Aesthetics announced several marketing initiatives, which include a new national, multichannel, campaign highlighting Botox Cosmetic’s (onabotulinumtoxinA) market leadership, legacy and real-world patient experiences; the launch of a consumer education campaign that is aimed at providing clear, factual information about hyaluronic acid (HA) injectable fillers and the natural-looking results they can achieve; and the launch of SkinVive by Juvederm into 35 new markets.

•AbbVie announced it broke ground on a $195 million state-of-the-art active pharmaceutical ingredient (API) facility that will manufacture immunology, oncology and neuroscience medicines. This North Chicago, Ill. facility is expected to be fully operational and serving patients by 2027. The company also announced the start of construction on a $70 million expansion at its AbbVie Bioresearch Center (ABC) in Worcester, Mass., which will increase biologics manufacturing for immunology and oncology medicines. These projects are part of AbbVie’s previously announced commitment to invest more than $10 billion of capital in the U.S. to broadly support innovation and expand critical manufacturing capabilities and capacity.

Full-Year 2025 Outlook

AbbVie is raising its adjusted diluted EPS guidance for the full year 2025 from $10.38 – $10.58 to $10.61 – $10.65, which includes an unfavorable impact of $2.05 per share related to acquired IPR&D and milestones expense incurred year-to-date through the third quarter 2025. The company’s 2025 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred beyond the third quarter of 2025, as both cannot be reliably forecasted.

Company Declares Dividend Increase of 5.5 Percent

AbbVie is announcing today that its board of directors declared an increase in the company’s quarterly cash dividend from $1.64 per share to $1.73 per share beginning with the dividend payable on February 17, 2026 to shareholders of record as of January 16, 2026. This reflects an increase of approximately 5.5 percent, continuing AbbVie’s strong commitment to returning cash to shareholders through a growing dividend. Since the company’s inception in 2013, AbbVie has increased its quarterly dividend by more than 330 percent. AbbVie is a member of the S&P Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years.

(Press release, AbbVie, OCT 31, 2025, View Source [SID1234659204])