On June 29, 2026 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, reported the acceptance of data on 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for presentation at the European Association of Nuclear Medicine (EANM) Annual Congress 2026, to be held on October 17-21 in Vienna, Austria. These include:

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Top Rated Oral Presentation of data from the Co-PSMA investigator-initiated trial (IIT) with 64Cu-SAR-bisPSMA, led by Prof Louise Emmett at St Vincent’s Hospital, Sydney.
Three-patient case report on detection of prostate cancer recurrence using 64Cu-SAR-bisPSMA following negative standard-of-care (SOC) prostate-specific membrane antigen (PSMA) positron emission tomography (PET) scan on Siemens Biograph Vision Quadra.
Case reports from the theranostic Phase I/IIa SECuRE trial1 on two participants with metastatic castration-resistant prostate cancer (mCRPC) who achieved undetectable disease following 67Cu-SAR-bisPSMA treatment as reported this year.
EANM 2026 Annual Congress is one of the world’s leading nuclear medicine conferences and the acceptance of these abstracts is testament to the strength of the data generated by Clarity’s products and the promising prospects for SAR-bisPSMA to change the paradigm in the diagnosis and treatment of prostate cancer.

64Cu-SAR-bisPSMA

Prof Emmett’s Co-PSMA trial compared 64Cu-SAR-bisPSMA head-to-head with the current SOC 68Ga-PSMA-11 PET/computed tomography (CT) in patients in biochemical recurrence (BCR) of prostate cancer with low PSA, following radical prostatectomy. The study demonstrated improved diagnostic performance of 64Cu-SAR-bisPSMA next-day imaging vs. 68Ga-PSMA-11 across all key parameters assessed, including mean number of lesions per participant (1.26 vs. 0.48, p<0.0001), total number of lesions (63 vs. 24), true positive rate (71% vs. 29%) and proportion of participants with a positive scan (78% vs. 36%, respectively)2.

In addition to the Co-PSMA presentation, 64Cu-SAR-bisPSMA is also being highlighted through real-world case profiles. The case study abstract reports on three patients with BCR of prostate cancer who were negative on SOC PSMA PET/CT (68Ga-PSMA-11 and/or 18F-DCFPyL) using Siemens Biograph Vision Quadra, but positive with subsequent 64Cu-SAR-bisPSMA PET/CT in all three cases. Baseline prostate-specific antigen (PSA) in the 3 patients ranged from 1.4–21.0 ng/mL. Next-day imaging (24 hours post-injection) detected a 2.25-fold increase in lesions (nine versus four) compared with same-day (1 hour post-injection) imaging, with additional lesions identified in the prostate bed and lymph nodes. For the lesions visible at both 64Cu-SAR-bisPSMA imaging timepoints, mean maximum standardised uptake value (SUVmax) increased from 3.5 to 6.1, a 1.8-fold increase in tracer uptake.

Importantly, 64Cu-SAR-bisPSMA imaging changed planned clinical management in all three patients. In one patient this enabled targeted radiotherapy to 64Cu-SAR-bisPSMA-positive lesions and allowed androgen deprivation therapy (ADT) to be deferred over a 3-year period while achieving PSA responses, a patient-centric relevant outcome given the side-effect burden of ADT2.

The patient described above, Steve Hunter, who received 64Cu-SAR-bisPSMA under compassionate use, commented, "I was diagnosed with prostate cancer in 2016 and initially had the usual treatment of a prostatectomy and radiation therapy. Although initially quite successful, in 2023 my blood PSA indicated that my cancer was returning, doubling every six months. With SOC PSMA imaging currently available, no lesions were detectable. I was informed by more than one doctor that what I had was a micro-metastatic version of prostate cancer; that is, I had a large number of cancers too small to be detected, and worse, my only option was ADT and the significant side effects I would suffer.

"My recent career has been dedicated to the area of advanced medical imaging utilising PET, single-photon emission computed tomography (SPECT) and magnetic resonance imaging (MRI). I have also worked in the past in oncology research. My experiences led me to believe that what I really had were a small number of tumours that were undetectable by the current SOC PSMA PET/CT imaging even on a state-of-the-art PET/CT system. I contacted Dr Alan Taylor in 2023 and asked if there was any possibility of being tested using their next-day imaging, knowing that this would significantly enhance the chance of finding these tumours. The results were beyond my expectations. Three tumours were found and I underwent targeted external beam radiation. Since then, I have repeated this process with Clarity and Alan’s support a few times to scan, find and subsequently treat the ensuant small number of tumours that arise, with stereotactic radiation therapy.

"I am so grateful to Clarity in making these scans available. This approach has proven to be highly successful by allowing me to obtain clear information about my disease and defer requiring ADT therapy and all the associated side effects with this treatment. I am currently symptom-free and hope to remain like this for a long time. It certainly demonstrates the importance of this agent for patients like me."

67Cu-SAR-bisPSMA

The therapeutic potential of 67Cu-SAR-bisPSMA is also being showcased at the EANM 2026 Annual Congress through a case study of the two participants from Clarity’s Phase I/IIa SECuRE trial1, a theranostic study in mCRPC that Clarity reported earlier this year. Both participants had Stage IV mCRPC at study entry. Participant A (64 years old, baseline PSA: 6.06 ng/mL with metastatic bone disease) received prior definitive radiotherapy and ADT, docetaxel for metastatic hormone-sensitive disease and enzalutamide for mCRPC with additional palliative stereotactic body radiotherapy. He went on to receive four cycles of 67Cu-SAR-bisPSMA across 5 months. His PSA declined by 95.7% to 0.26 ng/mL within 4 weeks of first cycle and became undetectable (limit of detection 0.02 ng/mL) after the third cycle, remaining undetectable at 33 weeks (last follow-up). No metastatic disease was detected on follow-up bone scan and 64Cu-SAR-bisPSMA PET/CT following treatment with 67Cu-SAR-bisPSMA.

Patient A: Lesion uptake of 64Cu-SAR-bisPSMA PET at baseline (left), following two cycles of 67Cu-SAR-bisPSMA (8 GBq each; centre) and following four cycles of 67Cu-SAR-bisPSMA (right). Coloured arrows indicate metastatic bone lesions within each region: red – skull; blue – ribs and sternum; orange – spine; green – pelvis.​ No detectable disease was observed on the post-treatment PET. Images are shown as maximum intensity projections. SUV: standardised uptake value.

Participant B (76 years old, baseline PSA: 3.25 ng/mL with nodal metastases) had undergone salvage prostate fossa radiotherapy with ADT and later progressed to mCRPC treated with abiraterone and ongoing ADT. He received two cycles of 67Cu-SAR-bisPSMA across 2 months, with concomitant enzalutamide. His PSA declined by 94.2% to 0.19 ng/mL within 4 weeks of first cycle and was undetectable at 8 weeks, remaining undetectable at 16 weeks (last follow-up), with a complete response per Response Evaluation Criteria in Solid Tumors v1.1 (RECIST) and undetectable disease on 64Cu-SAR-bisPSMA PET/CT after two cycles of treatment.

Patient B: Lesion uptake of 64Cu-SAR-bisPSMA PET at baseline (left images) and following two cycles of 67Cu-SAR-bisPSMA (8 GBq each; right images). PET images on the right were acquired 1 month after the second cycle and show no lesion uptake of 64Cu-SAR-bisPSMA compared to baseline. Red arrows indicate metastatic nodal lesions. Top images: maximum intensity projections. Bottom images: coronal sections of the corresponding insets. SUV: standardised uptake value.

Both participants experienced mostly mild and transient 67Cu-SAR-bisPSMA-related adverse events, with Participant A reporting Grade 1 nausea, vomiting, flu-like symptoms (all resolved) and Participant B having Grade 1 altered taste, dry eyes, eye pain, fatigue, salivary gland soreness (all resolved) as well as Grade 2 anaemia (ongoing at the last assessment).

Dr Alan Taylor, Executive Chairperson of Clarity Pharmaceuticals, commented, "The EANM Annual Congress is a conference focused specifically in our area of nuclear medicine, and we are very pleased to see Professor Louise Emmett and her team receive yet another Top Rated Oral Presentation for her excellent work on the Co-PSMA trial, which corroborated previously reported improvement in diagnostic performance of 64Cu-SAR bisPSMA over SOC PSMA imaging in BCR patients3. The Co-PSMA data has already been published in a high impact factor journal, European Urology2, and presented at the European Association of Urology 2026 conference. This additional recognition from EANM is testament to the high quality and clinical relevance of this head-to-head trial.

"Data from trials with 64Cu-SAR-bisPSMA to date2,3,4 provide an early view of what is expected to be the largest single body of work ever undertaken on PSMA imaging agents comparing same-day and next-day imaging in the pre-prostatectomy and BCR spaces, supporting our two ongoing registrational Phase III clinical trials5,6. Furthermore, we have now generated head-to-head data in a range of clinical trials where 64Cu-SAR-bisPSMA has always outperformed SOC imaging under multiple conditions. As part of this commitment to the highest standard of clinical validation and rigor, we have also continued to generate data under the Special Access Scheme (SAS) in Australia and Expanded Access Program (EAP) in the US, building a growing body of real-world evidence that complements and confirms the findings of clinical trial data generated to date, which we will continue to release to the market in preparation for commercialisation. This body of knowledge is now in the range of 700-800 patients dosed with 64Cu-SAR-bisPSMA and imaged on a wide range of different cameras, spanning multiple geographies and numerous clinical settings. Beyond the data, what drives our team in the development of this product is the effect it can have on patients’ lives and the positive feedback we continue to receive from clinicians and patients. The ability to detect lesions where other products cannot and have a real, positive impact on a cancer journey of men and their families battling this disease is what unites and motivates our team and collaborators to persevere and work harder towards our mutual goal.

"We recognise that there is significant interest in this product, which is expected, given its potential to change the diagnostic field and reshape treatment pathways in prostate cancer management. This is why we continue to design and support robust clinical trials with rigorous methodologies and work directly with clinicians through SAS and EAP programs, including head-to-head studies against SOC imaging and investigating same-day versus next-day imaging. We will continue to release these data, all in preparation to enter the large and growing market of PSMA PET imaging with our continued audacious goal of taking a product from the Australian benchtop to blockbuster status. In the entire history of Australian life sciences, this has only been achieved by a number of pharmaceutical products you can count on one hand, the most widely recocognised of which is Gardasil. At Clarity, with clinical trials on track and our regulatory, manufacturing, medical, clinical and commercial teams in place, we are entirely committed to this goal, especially for our fellow teammates, our shareholders and the patients we serve. This is a truly Australian story, with the potential to deliver meaningful impact for patients around the world.

"At Clarity, this does not stop at diagnostic products, and our core mission continues to be to improve treatment outcomes for patients with cancer. 67Cu-SAR-bisPSMA represents a key asset within our therapeutic portfolio for achieving this goal. The continued encouraging results from the SECuRE trial, together with the two most recently announced cases where participants achieved undetectable disease, further build on a growing body of evidence supporting the clinical potential of 67Cu-SAR-bisPSMA to make a difference in the lives of prostate cancer patients. In the two mCRPC patients, 67Cu-SAR-bisPSMA demonstrated marked anti-tumour activity with only three or fewer cycles, leading to undetectable disease by PSA and imaging, with most adverse events being mild and transient. These findings reinforce the potential role of 67Cu-SAR-bisPSMA in addressing a significant unmet need in mCRPC treatment."

Product Abstract Title
64Cu-SAR-bisPSMA Top Rated Oral Presentation: #1803
Prospective Comparison of 64Copper[64Cu]SAR-bisPSMA vs 68Gallium[68Ga] PSMA-11 PET/CT for Biochemical Recurrence of Prostate Cancer Following Radical Prostatectomy (Co-PSMA Trial)Session Date: Monday, October 19 2026
Session Time: 8:00AM – 9:30AM
64Cu-SAR-bisPSMA E-Poster: #296
Real-world Detection of Prostate Cancer Recurrence With 64Cu-SAR-bisPSMA Imaging Following Negative Standard-Of-Care PSMA PET: A Three-Patient Case Report
67Cu-SAR-bisPSMA E-Poster: #1786
67Cu-SAR-bisPSMA leads to Undetectable Disease in Metastatic Castration-Resistant Prostate Cancer Patients: Two Case Reports From The Phase I/IIa SECuRE Trial

Presentations will be available on Clarity’s official website after the EANM 2026 Congress: claritypharmaceuticals.com/pipeline/scientific_presentations

(Press release, Clarity Pharmaceuticals, JUN 29, 2026, View Source [SID1234668987])

On June 29, 2026 Nuvectis Pharma, Inc. (Nasdaq: NVCT), a clinical stage biopharmaceutical company focused on the development of innovative therapies for the treatment of immune complement-related conditions and oncology, reported the pricing of its previously announced underwritten public offering of 5,000,000 shares of its common stock at a price of $20.00 per share, with expected gross proceeds to Nuvectis of $100 million. Nuvectis has also granted the underwriters a 30-day option to purchase up to 750,000 additional shares of its common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on or about July 1, 2026, subject to satisfaction of customary closing conditions.

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Cantor is acting as sole book runner for the offering. H.C. Wainwright & Co., Laidlaw & Company (UK) Ltd., Lucid Capital Markets, Maxim Group LLC, Roth Capital Partners and Titan Partners, a division of American Capital Partners are acting as co-managers for the offering.

Nuvectis intends to use the net proceeds from the offering to continue to advance the development programs of NXP100, NXP200, and NXP900 or any future product candidate, hiring of additional personnel, capital expenditures, costs of operating as a public company and other general corporate purposes.

The shares of common stock described above are being offered by Nuvectis pursuant to its shelf registration statement on Form S-3 (File No. 333-293459) filed with the U.S. Securities and Exchange Commission ("SEC") on February 13, 2026 and declared effective by the SEC on February 20, 2026. The preliminary prospectus supplement relating to and describing the terms of the offering has been filed with the SEC and is available on the SEC’s web site at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying prospectus relating to these shares of common stock may also be obtained, when available, by contacting Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, New York 10022, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, Nuvectis Pharma, JUN 29, 2026, View Source [SID1234669003])

On June 29, 2026 AB Science SA (Euronext – FR0010557264 – AB) reported an update on the Phase 1 study of the molecule AB8939 and the completion of Step 3, evaluating the combination of AB8939 + venetoclax in patients with acute myeloid leukemia (AML) associated with a very unfavorable genetic profile.

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Step 3 evaluated the combination of AB8939 plus venetoclax administered over a 14-day cycle. A total of six patients were treated across two dose levels of AB8939 (16 mg/m² and 21.3 mg/m²), each in combination with venetoclax. The combination was well-tolerated, with no dose-limiting toxicity (DLT) and no hematological toxicity observed at either dose level, allowing selection of the recommended Phase 2 dose (RP2D).

Encouraging preliminary signs of efficacy were observed. Of the six patients treated, four achieved an objective response (one complete remission with incomplete hematologic recovery and three partial responses), corresponding to a 67% overall response rate (ORR). The two remaining patients achieved stable disease, resulting in a 100% disease control rate (CDR). These responses were achieved after a single cycle of treatment (14 days) in heavily pre-treated patients receiving second- to fourth-line therapy. Notably, two of the responding patients had previously progressed on venetoclax in combination with other chemotherapies.

The patients treated all have very difficult to treat cytogenetic profiles, including complex karyotype, TP53 mutation, NRAS mutation, monosomy 5 and 7 and MECOM-rearrangement, that typically have a poor prognosis due to their aggressive disease course and treatment resistance

This is a high response rate in a population where standard-of-care therapies achieve ORR of 10–30% in adverse-risk, multiply pre-treated AML (Gill H, et al. Cancer Med. 2020;9(10):3371-3382).

Response after the first 14 days cycle in the six patients treated in Step 3 (AB8939 + venetoclax)

Patient AB8939 dose Line of therapy Key adverse genetics Best response
Patient 1 16 mg/m² 2nd RUNX1 and NRAS mutations CRi
Patient 2 16 mg/m² 2nd MECOM-rearrangement, complex karyotype, monosomy 5 and 7 PR
Patient 3 16 mg/m² 4th TP53 mutation, complex karyotype, monosomy 5 and 7 PR
Patient 4 21.3 mg/m² 3rd TP53 mutation, complex karyotype, monosomy 5 and 7 PR
Patient 5 21.3 mg/m² 2nd TP53 mutation SD
Patient 6 21.3 mg/m² 2nd TP53 mutation (very high-risk MDS) SD
Complete remission (CRc) is defined as CRc = CR + CRh + CRi + CRp

CR=Bone marrow blasts <5%; of circulating blasts; low level (<5%); extramedullary disease; ANC ≥1.0 x 109/L (1000/μL); platelet count ≥100 x 109/L (100 000/μL).
CRh =ANC ≥ 0.5 × 109/L (500/μL) and platelet count ≥ 50 × 109/L (50 000/μL), otherwise all other CR criteria met
CRi =All CR criteria except for residual neutropenia (<1.0 x 109/L [1000/μL]) or thrombocytopenia (<100 x 109/L [100 000/μL]).
CRp =All CR criteria except platelet count < 100 × 109/L (100 000/μL)
Partial remission (PR) requires bone marrow response of at least 50% with a residual % between 5% and 25%.
Progressive disease (PD): > 50% increase in marrow blasts over baseline (a minimum 15% increase is required in cases <30% blasts at baseline).

This diversity of responsive patients appears to corroborate the mechanism of action of AB8939, which is capable of destabilizing microtubules while evading multi-drug resistance and also targeting cancer stem cells without eliminating non tumoral stem cells

These results corroborate the positioning of AB8939 in patients with adverse genetics, complex karyotypes, TP53 mutations, NRAS and KRAS mutations, monosomy 5 and 7, and MECOM-rearrangement, which represents the highest unmet medical need.

Nicholas J. Short, MD, Associate Professor and Co-Lead of the Section of Developmental Therapeutics, Department of Leukemia, MD Anderson Cancer Center, said, "This new data is very encouraging, particularly considering the very adverse risk profile of this patient’s leukemia. These early efficacy and safety data suggest that AB8939 can be combined with venetoclax and could have significant activity in the highest-risk subtypes of AML. There is a strong interest in continuing the development of this combination in patients whose AML has high-risk features that are expected to lead to resistance to venetoclax + azacitidine."

Professor Olivier Hermine, MD, President of the Scientific Committee of AB Science and member of the Académie des Sciences in France, said, "There is a strong rationale to combine AB8939 and venetoclax as both molecules have low hematologic toxicity and complementary mode of actions. These first results are supportive of this rationale."

With Step 3 completed, the next step is Step 4, evaluating the triple combination of AB8939 + venetoclax + azacitidine.

About AB8939

AB8939 is a drug candidate that targets (i) cancer cells by destabilizing microtubules (essential for cell division) and (ii) cancer stem cells by inhibiting ALDH1A1 and ALDH2 (enzymes essential for maintaining their physiological state and survival).

AB8939 has shown in vitro activity in Ara-C (cytarabine, which is one of the standards of care) resistant patient cell lines, including adverse genetic MECOM and TP53 mutations.
Analysis of cell lines responsive to AB8939 showed that AB8939 is effective in cell lines with TP53 mutations, MECOM, and complex karyotypes, whereas ARAC and azacitidine are not effective.
AB8939 increased survival and had an additive effect in combination with venetoclax (another standard of care) in vivo in a MECOM-grafted PDX mouse model.
AB8939 increased survival and had an additive effect in combination with Vidaza (azacitidine, another standard of care) in vivo in the MECOM PDX#C1005 mouse model of leukemia.
AB8939 eradicated Leukemia Cancer Stem Cells in vivo in a human PDX AML mouse model, which is compatible with targeting stem cells via ALDH.

AB8939 is currently being evaluated in a Phase 1 clinical trial (study AB18001, NCT05211570) in patients with refractory and relapsed AML.

The Phase 1 clinical trial of AB8939 has completed its first three steps. The first two steps determined the maximum tolerated dose (MTD) after 3 and 14 consecutive days of monotherapy. In both cases, the MTD was 21.3 mg/m².

The third step, now completed, evaluated the combination of AB8939 and venetoclax. Six patients were treated across two dose levels (AB8939 14 days at a dose of 16 mg/m² + venetoclax 14 days, then AB8939 14 days at a dose of 21.3 mg/m² + venetoclax 14 days), with no dose-limiting toxicity observed, supporting selection of the recommended Phase 2 dose. The next step (Step 4) will evaluate the triple combination of AB8939 + venetoclax + azacitidine.

Medical need in AML and AB8939 mechanism of action

Although several drugs have been registered for AML, 70% of patients still relapse and die, creating a persistent unmet medical need for effective treatments. Acute myeloid leukemia remains the most lethal form of leukemia in humans.

AML is a heterogeneous disease, and its outcome is highly dependent on genetic factors. TP53 mutation has a very poor prognosis, with a median overall survival (OS) of 5.5 months. NRAS and KRAS mutants have a poor prognosis, with a median OS of 12.1 months. MECOM also has a very poor prognosis in AML, with a median OS of 5.5 months in relapsed or refractory settings.

The challenge in AML is the recurrence of tumors due to a combination of two factors: the resistance of cancer cells to chemotherapy and relapse due to the persistence of cancer stem cells. This challenge may be overcome by AB8939’s dual mechanism of action.

First, AB8939 blocks the proliferation of leukemia cells through microtubule disruption. It is not subject to multi-drug resistance as it does not bind to PgP, which is responsible for efflux outside the cells, and is not degraded by myeloperoxidase.
Second, AB8939 targets leukemia cancer stem cells by inhibiting ALDH and promotes bone marrow repopulation of normal progenitors.
AB8939 + venetoclax combination

There is a strong rationale to combine AB8939 with venetoclax

Both molecules exhibit low hematologic toxicity. This combination is expected to be less toxic than azacitidine + venetoclax as first-line treatment for AML
These molecules have different and complementary targets in cancer cells. There is an additive, even synergistic, efficacy potential for the combination, with three mechanisms of action in a single treatment.
Venetoclax’s mechanism of action inhibits the BCL2 pathway, a protein that prevents apoptosis (programmed cell death) in cancer cells. BCL2 is a key factor in AML resistance, as it allows cancer cells to survive despite treatment
AB8939 is pro-apoptotic, destabilizing microtubules, and would benefit from BCL2 inhibition to optimize apoptosis
In addition, AB8939 specifically targets cancer stem cells by inhibiting ALDH, reducing resistance to treatment and limiting the risk of relapse

Next steps

Following completion of Step 3, the next step is to initiate Step 4, evaluating the triple combination of AB8939 + venetoclax + azacitidine, and to launch an expansion study in approximately 15 AML patients eligible for AB8939 + venetoclax at the appropriate dose. The expansion phase is expected to generate robust preliminary evidence of efficacy in the AML label, sufficient to support the clinical development plan and a beneficial partnership agreement.

AB Science has started to discuss three possibilities for registration studies, which are not mutually exclusive, with the European Medicines Agency (EMA) and US Food and Drug Administration (FDA):

AB8939 + venetoclax as first-line treatment, with aged patients and/or patients with adverse genetics (complex karyotypes, TP53 mutations, NRAS and KRAS mutations, monosomy 5 and 7, and MECOM-rearrangement)
AB8939 + venetoclax as a second- or third-line treatment, in all patients or patients with adverse genetics
AB8939 as a single agent in MECOM as a second or third-line treatment.

Addressable market with AB8939 in relapsed/refractory AML

Treatments for relapsed or refractory AML represent an estimated market size potential of greater than EUR 2 billion per annum.

Region Incidence Case
(1) % Relapse or Refractory (2,3) % Insured Patients (4) Drug Price (€) Market Size
(per in Mio EUR)
USA / CANADA 23,700 50%

90% 100,000(5) 1 000 000
EUROPE 27,600 90% 60,000 770 000
APAC 27,800 30% 60,000 250 000
INDIA 11,000 30% 60,000 100,000
LATAM 7,200 30% 60,000 65 000
MENA 3,900 30% 60,000 35 000
TOTAL 90,200 2 200 000
EUROPE = EU27 + Norway + United Kingdom + Switzerland ; APAC = Australia, People’s Republic of China , Japan, New Zealand, Singapore, Taiwan ; LATAM = Argentina, Brazil, Chile, Colombia, Costa Rica, Mexico ; MENA = Algeria, Bahrain, Egypt, Israel, Kuwait, Morocco, Oman, Qatar, Saudi Arabia, Tunisia, United Arab Emirates
(1) Zhou, Y et al. Global, regional, and national burden of acute myeloid leukemia, 1990–2021: a systematic analysis for the global burden of disease study 2021. Biomark Res 12, 101 (2024).
(2) Ravandi F. Relapsed acute myeloid leukemia: Why is there no standard of care Best Pract Res Clin Haematol. 2013;26(3):253-9
(3) Walter RB et al. Resistance prediction in AML: analysis of 4601 patients from MRC/NCRI, HOVON/SAKK, SWOG and MD Anderson Cancer Center. Leukemia (2015) 29:312–20. .
(4) Estimated
(5) Choi M. et al. Costs per patient achieving remission with venetoclax-based combinations in newly diagnosed patients with acute myeloid leukemia ineligible for intensive induction chemotherapy. Journal of Managed Care & Specialty Pharmacy Volume 28, Number 9. View Source

Intellectual property

AB8939 intellectual property rights in AML are secured until 2036 through a ‘composition of matter’ patent and potentially until 2041 with a 5 years extension. Two additional ‘second medical use’ patent applications have been filed to protect the use of AB8939 in the treatment of AML with specific chromosomal abnormalities. If these applications are accepted, the protection for AB8939 will be extended until 2044 and 2046 for these AML subpopulations.

AB8939 has also received orphan drug designation for AML by both the EMA and FDA. This orphan drug designation confers 10 and 7 years of marketing exclusivity in Europe and the US, respectively, from the date of product registration.

AB Science is the sole proprietary holder of AB8939 and its family of compounds.

(Press release, AB Science, JUN 29, 2026, View Source [SID1234668988])

On June 29, 2026 Kyowa Kirin, Inc., a wholly owned subsidiary of Kyowa Kirin Co. Ltd (TSE: 4151), reported positive results from PROSPER, a real-world observational study of mogamulizumab in adults with mycosis fungoides (MF) or Sézary syndrome (SS). In the study, patients reported clinically meaningful improvements in skin symptoms (itch, flaking, and redness) and body temperature regulation as early as week 4, with improvements in sleep and health-related quality of life (HRQoL) starting at week 12. Improvements were sustained throughout the study period, with additional gains in HRQoL reported through week 48.

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"Cutaneous T-cell lymphoma can affect far more than just the skin, impacting how patients feel and function every day," said Professor Julia Scarisbrick, Principal Investigator, Honorary Professor of Dermatology, University Hospitals Birmingham NHS Foundation Trust. "These findings from the PROSPER study are encouraging because they show that in patients with MF or SS, mogamulizumab can help ease symptoms that affect everyday life, and those improvements can be long-lasting."

Mycosis fungoides and Sézary syndrome are two sub-types of cutaneous T-cell lymphoma (CTCL), a rare form of non-Hodgkin lymphoma that primarily affects the skin, presenting as patches, plaques, tumors, or reddening of the entire skin, and may be associated with severe itching. The disease may spread to lymph nodes, blood, and/or other organs in some patients.

"Clinical studies are stronger when they are shaped by the voices and lived experiences of people living with the disease," said Susan Thornton, study author and co-CEO, Cutaneous Lymphoma Foundation. "Collaboration between industry and the patient community is essential to designing studies that generate more relevant insights into symptom burden, quality of life, and the day-to-day treatment experience."

Key PROSPER Findings

The study included 73 patients with relapsed or refractory MF or SS (n=41 MF; n=32 SS). Patient-reported outcomes were collected at baseline and throughout the study using:

A CTCL-specific symptom diary assessing the severity of skin itch, pain, redness, and flaking, frequency of sleep problems, and difficulty regulating body temperature
The MF/SS-CTCL-QoL questionnaire, which measured the impact of CTCL on daily life
The Brief Fatigue Inventory (BFI), which assessed fatigue severity and its impact on daily functioning

Mean symptom scores (mean +/- standard deviation) improved from baseline to week 48 across key skin symptoms, including itch (−2.5 ±3.4), flaking (−3.1 ±3.5), redness (−3.1 ±3.5), and pain (−1.7 ±4.4). Clinically meaningful improvements in skin itch, flaking, and redness were observed as early as week 4, and improvements in pain by week 12 (i.e., exceeding the minimum important difference (MID)). These effects were sustained through week 48.

By week 48, 30% of patients reported at least a 2-point improvement in sleep, and 37% reported better body temperature regulation. Patients also showed significant, clinically meaningful improvements in disease-specific health-related quality-of-life scores (MF/SS-CTCL-QoL) beginning at week 12, with further gains through week 48. While fatigue scores changed little among patients with MF, patients with SS showed a significant improvement in total BFI scores, reaching the MID threshold at week 48.

"Studies like PROSPER show why real-world data generation matters, particularly in rare cancers like mycosis fungoides and Sézary syndrome," said Angela Williams, PhD, Global Head of Health Economics and Outcomes Research at Kyowa Kirin. "These data help broaden understanding of the lived experience of patients and care partners with mogamulizumab treatment in everyday practice, including the impact on symptoms and quality-of-life that may not be fully reflected by outcomes collected in clinical trial."

About PROSPER

The objective of the PROSPER (ClinicalTrials.gov ID NCT05455931) study is to gain insight into the experiences of patients with MF or SS receiving mogamulizumab in real-world clinical practice through the collection of patient-reported outcomes (PRO) data, enriched with qualitative data on disease and treatment experience. The study was designed with input from patients and caregivers to ensure patient-relevant outcomes were selected, and it was conducted in six countries across North America, Europe, and the Middle East, at 19 sites working with patients with MF or SS. Patients were followed for up to 50 weeks from study enrollment.

U.S. POTELIGEO (mogamulizumab-kpkc) Indication

POTELIGEO injection for intravenous infusion is indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy.

Important Safety Information

WARNINGS AND PRECAUTIONS

Dermatologic toxicity: Monitor patients for rash throughout the course of treatment. For patients who experienced dermatologic toxicity in Trial 1, the median time to onset was 15 weeks, with 25% of cases occurring after 31 weeks. Interrupt POTELIGEO for moderate or severe rash (Grades 2 or 3). Permanently discontinue POTELIGEO for life-threatening (Grade 4) rash or for any Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN).

Infusion reactions: Most infusion reactions occur during or shortly after the first infusion. Infusion reactions can also occur with subsequent infusions. Monitor patients closely for signs and symptoms of infusion reactions and interrupt the infusion for any grade reaction and treat promptly. Permanently discontinue POTELIGEO for any life-threatening (Grade 4) infusion reaction.

Infections: Monitor patients for signs and symptoms of infection and treat promptly.

Autoimmune complications: Interrupt or permanently discontinue POTELIGEO as appropriate for suspected immune-mediated adverse reactions. Consider the benefit/risk of POTELIGEO in patients with a history of autoimmune disease.

Complications of allogeneic HSCT after POTELIGEO: Increased risks of transplant complications have been reported in patients who received allogeneic HSCT after POTELIGEO. Follow patients closely for early evidence of transplant-related complications.

ADVERSE REACTIONS

The most common adverse reactions (reported in ≥10% of patients) with POTELIGEO in the clinical trial were rash, including drug eruption (35%), infusion reaction (33%), fatigue (31%), diarrhea (28%), drug eruption (24%), upper respiratory tract infection (22%), musculoskeletal pain (22%), skin infection (19%), pyrexia (17%), edema (16%), nausea (16%), headache (14%), thrombocytopenia (14%), constipation (13%), anemia (12%), mucositis (12%), cough (11%), and hypertension (10%).

You are encouraged to report suspected adverse reactions to Kyowa Kirin, Inc. at 1-844-768-3544 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see additional Important Safety Information in full Prescribing Information as well as Patient Information.

(Press release, Kyowa Hakko Kirin, JUN 29, 2026, View Source [SID1234669004])

On June 29, 2026 Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing antibody drug conjugates (ADCs) with novel RNA splicing modulator payloads, reported the completion of its previously announced PIPE through the consolidation of the remaining scheduled investment closings into a single funding event. Combined with warrant exercises completed in May, the Company received approximately $8.3 million in total capital during Q2 2026.

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"We appreciate the decision of our investor group to complete the remaining funding earlier than originally scheduled, and for some of these investors to further increase their commitment through warrant exercises." said Abizer Gaslightwala, President and Chief Executive Officer of Akari Therapeutics. "This additional capital is expected to provide added financial flexibility as we advance AKTX-101 towards a Phase 1 first-in-human clinical trial while advancing our proprietary PH1 RNA splicing modulator ADC payload through potential strategic partnerships."

As previously announced, Akari entered into a securities purchase agreement with certain existing investors pursuant to which the Company agreed to sell and issue in a private placement an aggregate of 1,470,588 ADSs or prefunded warrants to purchase ADSs together with Series H warrants, Series I warrants and Series J warrants to each purchase 1,470,588 ADSs.

Under the purchase agreement, the $5.5 million gross proceeds of the offering were to be funded in three separate tranches, the first of which occurred at the end of May 2026, and the second and third closings of which were supposed to occur during June and July 2026, respectively. Subsequently, the parties agreed to consolidate the second and third closings into one final closing, which occurred on June 26, 2026. The issuance of the associated Series H, Series I and Series J warrants remains subject to shareholder approval at the Company’s Annual General Meeting scheduled for June 30, 2026.

Separately, during May 2026 the Company received approximately $2.8 million in additional proceeds from the exercise of warrants by some of the investors who participated in the PIPE.

(Press release, Akari Therapeutics, JUN 29, 2026, View Source [SID1234668989])