On May 18, 2026 Perspective Therapeutics, Inc. ("Perspective," the "Company," "we," "us," and "our") (NYSE AMERICAN: CATX), a radiopharmaceutical development company pioneering advanced treatments for cancers throughout the body, reported that the first patients were dosed with [212Pb]VMT-α-NET and [212Pb]PSV359 in two new cohorts of Phase 1/2a studies in neuroendocrine tumors and solid tumors, respectively.

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The first patient was treated with [212Pb]VMT-α-NET in a fourth cohort of the Company’s ongoing Phase 1/2a clinical trial of [212Pb]VMT-α-NET in patients with unresectable or metastatic somatostatin receptor type 2 (SSTR2) expressing neuroendocrine tumors (NETs). This cohort explores optimizing a 20 mCi cumulative dose by front-loading, with 6.0 mCi in the first dose, 5.0 mCi in the second dose, 5.0 mCi in the third dose, and 4.0 mCi in the fourth dose. The design of this dosing regimen will help determine whether front-loading could change response kinetics and further improve response rate and tolerability at the same cumulative administered dose.

Additionally, the first patient was treated with [212Pb]PSV359 in a third cohort of the Company’s Phase 1/2a dose-finding trial to determine safety and preliminary anti-tumor activity of the radiopharmaceutical [212Pb]PSV359 in patients with solid tumors that express fibroblast activation protein alpha (FAP-α). Cohort 3 was cleared to open following a safety monitoring committee review of safety data from Cohort 2. Patients in Cohort 3 are receiving up to four fixed administered doses of PSV359 at 6.0 mCi every eight weeks.

About [212Pb]VMT-α-NET

Perspective designed [212Pb]VMT-α-NET to target and deliver 212Pb to tumor sites expressing somatostatin receptor type 2 (SSTR2). The Company is conducting a multi-center, open-label, dose-escalation, dose-expansion study (clinicaltrials.gov identifier NCT05636618) of [212Pb]VMT-α-NET in patients with unresectable or metastatic SSTR2-positive neuroendocrine tumors who have not received prior radiopharmaceutical therapies (RPT).

Interim analysis with a data cut-off date of March 4, 2026 was previously presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026 (AACR 2026) in April 2026, including efficacy data on half of the patients in Cohort 2 and both patients in Cohort 1. Initial efficacy data for the remaining patients in Cohort 2 and eight patients in Cohort 3 are pending, and submissions for presentations at additional medical conferences during 2026 are planned.

About PSV359

PSV359 was designed to target and deliver 212Pb to tumor sites expressing FAP-α, associated with multiple highly prevalent solid tumors, with patients in need of additional treatment options. The targeting moiety may also be radiolabeled with 203Pb or 68Ga (known as PSV377) to detect FAP-α expression in individual patients. Preclinical imaging and therapy as well as human imaging results suggest Perspective’s proprietary targeting ligand has improved levels of target engagement and uptake in tumors, as well as reduced retention in healthy tissues, which may result in a desirable therapeutic index.

Perspective is conducting a multi-center, open-label, dose-finding and dose-expansion study (clinicaltrials.gov identifier NCT06710756) of [212Pb]PSV359 in patients with advanced solid tumors that express FAP-α as determined by imaging with [203Pb]PSV359. The primary objective of the dose finding phase of the study is to assess the safety and tolerability of various doses of [212Pb]PSV359 in order to determine the recommended Phase 2 dose to be used in the expansion phase of the study, where anti-tumor activities may be an additional primary outcome measure.

(Press release, Perspective Therapeutics, MAY 18, 2026, View Source [SID1234665853])

On May 18, 2026 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it has obtained approval from the Ministry of Health, Labour and Welfare (MHLW) on March 9, 2026 for FoundationOneCDx Cancer Genomic Profile to be used as a companion diagnostic for Alecensa (generic name: alectinib), an anti-cancer agent/ALK inhibitor for ALK fusion gene-positive solid tumors.

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This approval enables the detection of ALK fusion gene using the FoundationOne CDx Cancer Genomic Profile to guide the decision to use Alecensa for ALK fusion gene-positive solid tumors. The efficacy and safety of Alecensa for advanced or recurrent ALK fusion gene-positive solid tumors were evaluated in an investigator initiated Japanese Phase II clinical study (TACKLE study), and an approval for a partial change to the marketing authorization was obtained on May 18, 2026.

FoundationOne CDx Cancer Genomic Profile has continuously expanded its tumor-agnostic companion diagnostic capabilities, enabling a single comprehensive genomic profiling test to support treatment plans for multiple medicines. With the addition of Alecensa as a companion diagnostic for ALK fusion gene-positive solid tumors, beyond its already approved use in non-small cell lung cancer, the potential treatment options for patients with solid tumors are expected to expand. As a leading company in oncology, Chugai is committed to realizing more advanced personalized healthcare in the oncology field and contributing to patients through the wider adoption of comprehensive genomic profiling.

Approval information The underlined and bolded part has been newly added.

Intended uses or indications

The product is used for comprehensive genomic profiling of tumor tissues in patients with solid cancers.
The product is used for detecting gene mutations and other alterations to support the assessment of drug indications listed in the table below.
Alterations Cancer type Relevant drugs
Activated EGFR alterations Non-small cell lung cancer (NSCLC) afatinib, erlotinib, gefitinib, osimertinib, dacomitinib
EGFR exon 20 T790M alterations osimertinib
ALK fusion genes alectinib, crizotinib, ceritinib, brigatinib
ROS1 fusion genes entrectinib
MET exon 14 skipping alterations capmatinib
BRAF V600E and V600K alterations Malignant melanoma dabrafenib, trametinib, vemurafenib, encorafenib, binimetinib
ERBB2 copy number alterations (HER2 gene amplification positive) Breast cancer trastuzumab
AKT1 alterations capivasertib
PIK3CA alterations
PTEN alterations
KRAS/NRAS wild-type Colorectal cancer cetuximab, panitumumab
Microsatellite instability high nivolumab
Microsatellite instability high Solid tumors pembrolizumab
Tumor mutational burden high pembrolizumab
NTRK1/2/3 fusion genes entrectinib, larotrectinib, repotrectinib
RET fusion genes selpercatinib
ALK fusion genes alectinib
BRCA1/2 alterations Ovarian cancer olaparib
BRCA1/2 alterations Prostate cancer olaparib, talazoparib
FGFR2 fusion genes Biliary tract cancer pemigatinib

(Press release, Chugai, MAY 18, 2026, View Source [SID1234665819])

On May 18, 2026 Biotheryx, Inc., a biopharmaceutical company focused on the discovery and development of first-in-class protein degraders for cancer and inflammatory diseases, reported the data from its first-in-human Phase 1 Dose Escalation study evaluating BTX-9341, a novel CDK4/6 bifunctional degrader, as monotherapy and in combination with fulvestrant in participants with advanced/metastatic HR+/HER2- breast cancer who received prior CDK4/6 inhibitor therapy. The Phase 1 Dose Expansion portion of the study is currently ongoing.

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"BTX-9341 has a highly favorable safety profile, with no clear evidence of key class related toxicities of other CDK4/6 inhibitors including gastrointestinal toxicities (diarrhea, nausea, vomiting), hepatotoxicity and prolongation of the QTc interval," said Dr. Rachel M Layman, MD (Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center). "The drug shows encouraging clinical activity in a heavily pretreated patient population in the post-CDK4/6 inhibitor setting and shows compelling evidence of the importance of targeting CDK2/4/6 to address multiple resistance pathways."

Data from the Phase 1 Dose Escalation study demonstrate evidence of clinical activity, including prolonged partial response and stable disease in a heavily pretreated patient population. Pharmacokinetic analyses showed BTX-9341 exposures consistent with target engagement concentrations. Importantly, BTX-9341 was well tolerated, with participants on treatment for over 12 cycles (48 weeks), including on monotherapy and in combination with fulvestrant. Adverse events were mild to moderate and easily manageable.

Key Highlights from Dose Escalation Portion of the Phase 1 Study

Favorable safety and tolerability profile with no serious adverse events or treatment discontinuations due to adverse events in all participants (N=28). Hematologic adverse events were transient and reversible. There were no ≥ Grade 3 non-hematologic events.
Approximate dose-proportional pharmacokinetics supporting once-daily dosing.
Clinical activity was observed in a heavily pretreated patient population post-CDK4/6 inhibitors with up to 6 prior lines of therapy in the metastatic setting; approximately 40% and 36% of participants had received chemotherapy and PI3K/AKT/mTOR or other targeted therapies, respectively. Clinical Benefit Rates1 (CBRs) of 41.7% and 80% were observed in treatment-evaluable participants2 (n=24), and participants representative of the dose expansion criteria (n=10), respectively.
Target engagement consistent with CDK4/6 degradation mechanism based on a significant reduction in serum Thymidine Kinase activity, and reductions in the levels of CDK4, CDK6, and CDK2 in peripheral blood mononuclear cells (PBMCs). This is consistent with BTX-9341’s unique ability to address multiple convergent resistance mechanisms to CDK4/6 inhibitor therapies by degrading CDK4/6 and inhibiting downstream transcription of CDK2.
The study is still ongoing with multiple participants remaining on treatment for 12 to >18 cycles. The data are as of May 6, 2026.
"These encouraging clinical results mark an important milestone for our Phase 1 study evaluating BTX-9341, a first-in-class CDK4/6 bifunctional degrader," said Dr. Leah Fung, CEO of Biotheryx. "BTX-9341 has demonstrated a promising safety and tolerability profile, along with early signs of clinical activity in participants whose disease progressed following prior CDK4/6 inhibitor therapy. Given that CDK6 upregulation and Cyclin E amplification are established mechanisms of resistance to CDK4/6 inhibitors, these findings highlight the importance of degrading CDK4/6 and inhibiting downstream transcription of CDK2 to address convergent resistance mechanisms and may redefine the post-CDK4/6 inhibitor setting in advanced/metastatic HR+/HER2- breast cancer."

Advancing to Dose Expansion

Based on these findings, the company is continuing with its Phase 1 Dose Expansion portion of the trial. The expansion cohorts have begun enrolling participants and will further evaluate the efficacy and safety of BTX-9341 in combination with fulvestrant and will build on the safety, tolerability, pharmacokinetics and pharmacodynamic activity of BTX-9341 established in the Dose Escalation phase. The trial is being conducted at multiple sites in the United States and is expected to enroll up to 78 participants across two treatment arms based on the recommended dose identified in the earlier Dose Escalation phase. The primary endpoint of this study is the Overall Response Rate (ORR), with key secondary endpoints including the measurement of investigator-assessed Clinical Benefit Rate (CBR) and Progression Free Survival (PFS).

About BTX-9341

BTX-9341 is a first-in-class, oral degrader of CDK4/6, important targets for a range of cancers and clinically validated in HR+/HER2- breast cancer. In preclinical breast cancer models, BTX-9341 demonstrated enhanced activity compared with CDK4-only and CDK4/6 inhibitors through potent and highly selective catalytic degradation of CDK4 and CDK6, robust inhibition of CDK2 transcription, cell cycle arrest, and ultimately superior in vivo efficacy in breast cancer xenografts. Beyond this increased efficacy potential, BTX-9341 is differentiated from CDK4-only and CDK4/6 inhibitor approaches through the ability to overcome key resistance mechanisms that can limit the impact of inhibitors in second line HR+/HER2- metastatic breast cancer.

(Press release, BioTheryX, MAY 18, 2026, View Source;breast-cancer-302774140.html [SID1234665838])

On May 18, 2026 Fortress Biotech, Inc. (Nasdaq: FBIO) ("Fortress"), an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty income, reported that Lindsay A. Rosenwald, M.D., Chairman, President and Chief Executive Officer, will participate in a fireside chat at A.G.P.’s Annual Virtual Healthcare Conference, taking place on Wednesday, May 20, 2026. The fireside chat is scheduled to begin at 12:20pm ET.

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To register for the conference, visit the A.G.P. Registration Link.

(Press release, Fortress Biotech, MAY 18, 2026, View Source [SID1234665854])

On May 18, 2026 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it received regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) for the additional indication of its anti-cancer agent/ALK inhibitor Alecensa (generic name: alectinib) for advanced or recurrent ALK fusion gene-positive solid tumors, including pediatric patients. This is the world’s first tumor-agnostic approval for an ALK inhibitor.

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"We are delighted that Alecensa, discovered by Chugai, has been approved as the world’s first tumor-agnostic therapy for patients with ALK fusion-positive solid tumors.
This approval expands access to Alecensa beyond its established use in non-small cell lung cancer and anaplastic large cell lymphoma, bringing a new treatment option to patients across a wide range of cancer types. We will continue striving to further contribute to personalized healthcare, delivering the most appropriate treatment to each patient, regardless of cancer type or age," said Chugai’s President and CEO, Dr. Osamu Okuda.

This approval is based on the results of the TACKLE study, an investigator initiated Japanese Phase II clinical study evaluating the efficacy and safety of Alecensa in pediatric and adult patients with rare cancers harboring ALK gene abnormalities (fusion / rearrangement genes, activating mutations, and gene copy number amplification) in advanced or recurrent settings. In this study, the response rate as assessed by the central review committee, which was the primary endpoint, was 43.8% (7/16 patients, 95% CI: 19.8%-70.1%) in the full analysis set (FAS) of the main cohort. In the ALK fusion gene-positive subpopulation within this cohort, the response rate was 70.0% (7/10 patients, 95% CI: 34.8%–93.3%). In addition, in the ALK fusion gene-positive subpopulation of the overall FAS pooled across all cohorts, the response rate was 76.5% (13/17 patients, 95% CI: 50.1%-93.2%), and the efficacy data in patients with ALK fusion gene-positive tumors from this study were considered the key basis for regulatory approval. The incidence of adverse events was 73.1% (19/26 patients), with the main adverse reactions being lymphocyte count decreased, and neutrophil count decreased at 23.1% each (6/26 patients), anemia at 19.2% (5/26 patients), and blood creatinine increased at 15.4% (4/26 patients). The safety profile observed in this study was similar to the previously established safety profile of Alecensa, with no new safety signals identified.

FoundationOne CDx Cancer Genomic Profile is used as a companion diagnostic to identify people that could potentially benefit from Alecensa for ALK fusion-positive solid tumors. The MHLW granted the approval for the expanded use of FoundationOne CDx Cancer Genomic Profile as a companion diagnostic of Alecensa on March 9, 2026.

Chugai Pharmaceutical, a leading company in the oncology field, remains committed to addressing unmet medical needs in cancer treatment with innovative medicines for patients and healthcare professionals.

Approval Information *Relevant sections only, with modifications underlined

Indications:
◯ ALK fusion-positive advanced or recurrent solid tumors
◯ Adjuvant treatment in ALK fusion-positive non-small cell lung cancer
◯ ALK fusion-positive recurrent or refractory anaplastic large cell lymphoma

Dosage and Administration:

The usual adult dosage is 300 mg alectinib administered orally twice a day.
The usual pediatric dosage of alectinib is based on body weight as shown below and administered orally once or twice daily.

Body Weight Daily dose Dose per administration
(morning/evening)
≥6 kg and <15 kg 150mg 150mg/0mg
≥15 kg and <25 kg 300mg 150mg/150mg
≥25 kg and <35 kg 450mg 300mg/150mg
≥35 kg 600mg 300mg/300mg
[Reference Information]

Chugai Files for Additional Tumor-Agnostic Indication of Alecensa for ALK Fusion / Rearrangement Gene-Positive Solid Tumors Including Pediatric Patients (News release issued on June 26, 2025)
View Source

Chugai Obtains Approval for FoundationOne CDx Cancer Genomic Profile as a Companion Diagnostic of Alecensa for ALK Fusion Gene-Positive Solid Tumors (News release issued on May 18, 2026)
View Source

About the TACKLE study

The TACKLE study (NCCH1712/MK003, jRCT2091220364) is an investigator initiated, multicenter, open-label, single-arm, Japanese Phase II clinical study evaluating the efficacy and safety of Alecensa in pediatric and adult patients with unresectable rare cancers harboring ALK gene abnormalities (fusion / rearrangement genes, activating mutations, gene copy number amplification). In this study, safety and efficacy were evaluated in 26 patients, utilizing genomic information, including data registered with the Center for Cancer Genomics and Advanced Therapeutics (C-CAT). The primary endpoint was response rate, and secondary endpoints included progression-free survival, overall survival, and safety. The TACKLE study is being conducted as a substudy of the MASTER KEY project,1 which promotes the development of treatments for rare cancers through industry-academia collaboration led by the National Cancer Center Hospital, and is being carried out at four sites in Japan: National Cancer Center Hospital, Kyoto University Hospital, Kyushu University Hospital, and Hokkaido University Hospital.

About ALK fusion / rearrangement gene-positive solid tumors

ALK fusion / rearrangement genes are abnormal genes created when the ALK (anaplastic lymphoma kinase) gene fuses with other genes (such as EML4, NPM) as a result of chromosomal translocation.2,3 ALK fusion / rearrangement proteins produced from these fusion / rearrangement genes are thought to promote cancer cell proliferation. ALK fusion / rearrangement genes have been identified in patients with inflammatory myofibroblastic tumors, lung cancer, breast cancer, colorectal cancer, and other cancers.2,4,5

About Alecensa

Alecensa is an oral medicine discovered by Chugai, which is highly selective for ALK and active in the central nervous system. ALK fusion / rearrangement gene-positive lung cancer is found in approximately 3-5% of NSCLC cases.4 Alecensa is already approved in over 100 countries as an initial (first-line) and second-line treatment for ALK fusion / rearrangement gene-positive metastatic NSCLC, including in the United States, Europe, Japan, China, and Taiwan. For adjuvant therapy of ALK fusion / rearrangement gene-positive NSCLC, Alecensa received approval in the United States in April 2024, followed by Europe in June 2024, and Japan in August 2024. In Japan, Alecensa has also been approved for the treatment of recurrent or refractory ALK fusion / rearrangement gene-positive anaplastic large cell lymphoma.

Trademarks used or mentioned in this release are protected by law.

(Press release, Chugai, MAY 18, 2026, View Source [SID1234665820])