On February 24, 2026 Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW ("Alpha Tau"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported that Japan’s Ministry of Health, Labour and Welfare ("MHLW") has granted regulatory (Shonin) marketing approval for Alpha DaRT for the treatment of unresectable locally advanced or locally recurrent head and neck cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In Japan, the Shonin approval process is the most rigorous pathway for medical devices, conducted after a review and recommendation by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). This marks the first regulatory approval of the Alpha DaRT platform outside Israel. As part of the approval, Alpha Tau will need to conduct a post-market surveillance (PMS) study enrolling 66 patients in total at five selected leading clinical centers in Japan. The PMS study is intended to further evaluate the safety and clinical performance of Alpha DaRT in real-world clinical settings and to generate additional real-world clinical evidence in collaboration with Japanese physicians and treatment centers.

"Receiving Shonin approval in Japan is a significant milestone for Alpha Tau and for the Alpha DaRT platform," said Uzi Sofer, Chief Executive Officer of Alpha Tau. "Japan has granted our first marketing approval outside of Israel, and is a country with deep clinical expertise in head and neck oncology. We are grateful to HekaBio for their leadership during this process, and to the six medical societies in Japan who have continually provided their support for the approval and future launch of Alpha DaRT in Japan. Our immediate focus is on working closely with Japanese clinicians to complete the PMS study and to generate high-quality clinical data in patients with unresectable locally advanced or locally recurrent disease. In parallel we anticipate initiating discussions shortly with the MHLW regarding potential reimbursement approaches for Alpha DaRT in Japan. We believe this approval represents an important first step toward broader clinical evaluation of Alpha DaRT, and look forward to discussing with the PMDA further potential clinical studies in Japan evaluating the use of Alpha DaRT in additional tumor types."

Robert E. Claar, CEO of HekaBio K.K., said, "The Alpha DaRT program has been the primary focus for our team for 7 years, and we’re delighted to reach this Shonin milestone with Alpha Tau Medical for the benefit of patients in Japan. Along the way, we got strong and continuous support from medical professionals, regulators and the government of Japan to enable approval for this breakthrough therapy. An approval in Japan in advance of the US and Europe for a foreign-originated new category medical device is an extremely rare event, and we’re grateful to all of our partners who made this possible. Our team is enthusiastically preparing to launch Alpha DaRT to deliver hope and clinical benefit to patients in Japan."

Dr. Jun Itami, Director, High-Precision Radiation Therapy Center, Shin-Matsudo Central General Hospital, said, "Through this domestic clinical trial, Alpha DaRT has demonstrated promise, representing a major advance in the fight against cancer. Demonstrating the efficacy of intratumoral alpha-particle radiation therapy, a modality long considered difficult to implement, for patients who have not responded to conventional therapies is a highly meaningful achievement, offering a new treatment option.

By confirming both safety and efficacy in this study, we have opened the door to delivering this therapy in real-world clinical practice, thereby expanding the range of treatment options available to patients. This outcome also provides important insights for future clinical research aimed at broadening indications.

Bringing hope to patients and their families by offering ‘a new treatment option’ is not only clinically valuable but also provides psychological support in the care setting. Alpha DaRT holds the potential to turn that hope into reality.

Further validation and long-term safety evaluation will be necessary, but we are confident that these results represent a major step forward in advancing discussions toward broader clinical application."

(Press release, Alpha Tau Medical, FEB 24, 2026, View Source [SID1234662897])

On February 24, 2026 Alkermes plc (Nasdaq: ALKS) reported that management will participate in a fireside chat at the TD Cowen 46th Annual Health Care Conference on Monday, March 2, 2026 at 9:10 a.m. ET (2:10 p.m. GMT). The live webcast may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

(Press release, Alkermes, FEB 24, 2026, View Source [SID1234662896])

On February 24, 2026 Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company focused on developing therapies to counteract the devastating progression of neurodegeneration, reported that management will participate in a corporate presentation at the TD Cowen 46th Annual Health Care Conference on Tuesday, March 3, 2026, at 3:10 pm ET.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live webcast of the corporate presentation will be available on the "Events & Presentations" page within the Investors section of the Alector website at View Source A replay will be available on the Alector website for 90 days following the event.

(Press release, Alector, FEB 24, 2026, View Source [SID1234662895])

On February 24, 2026 Novartis reported multiple US real-world studies delivering new insights across metastatic prostate cancer care. The analyses utilize data from Novartis’ PRECISION platform to evaluate Pluvicto (lutetium (177Lu) vipivotide tetraxetan) effectiveness and sequencing as well as real‑world treatment patterns in earlier metastatic disease. These studies will be presented at the ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium on February 26, 2026.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Pluvicto shows real-world effectiveness in taxane-naïve mCRPC patients
Real-world use of Pluvicto resulted in a median progression-free survival (PFS) of 13.5 months (95% CI: 11.7 – 14.7 months) in men with metastatic castration-resistant prostate cancer (mCRPC) who had been treated with ≥1 androgen receptor pathway inhibitor (ARPI) and were taxane-naïve. Results showed chemo-naïve patients treated with Pluvicto after only 1 ARPI had longer median PFS (15.8 months; 95% CI: 11.7 – 18.6 months) than those who received Pluvicto after multiple ARPIs (12.7 months; 95% CI: 10.7 – 14.0 months)1.

"This analysis validates what many of us have seen in the clinic – that lutetium Lu 177 vipivotide tetraxetan can achieve clinically relevant responses across a diverse set of patients and in various practice settings," said Daniel George, Professor of Medicine and Surgery at Duke University School of Medicine. "These results show reassuring consistency with the PSMAfore pivotal trial and should strengthen clinicians’ confidence in using radioligand therapy for patients after one ARPI."

Outcome All patients (n=500) 1 ARPI (n=256) >1 ARPI (n=244)
Median PFS 13.5 months
(95% CI: 11.7 – 14.7 months) 15.8 months
(95% CI: 11.7 – 18.6 months) 12.7 months
(95% CI: 10.7 – 14.0 months)
PSA50 62.6% 61.4% 63.8%
PSA50 indicates ≥50% decline in prostate-specific antigen levels from baseline

The real-world findings are consistent with PSMAfore, which supported the approval of Pluvicto for patients with PSMA-positive mCRPC who have been treated with an ARPI and are considered appropriate to delay taxane-based chemotherapy. In PSMAfore, Pluvicto more than doubled median rPFS compared to a change in ARPI (11.6 months vs. 5.6 months) at an updated exploratory analysis2. These findings should be considered within the context of varying study designs, patient populations, and endpoints across the analyzed cohorts*.

"Pluvicto is redefining the standard of care for metastatic prostate cancer. Novartis is committed to advancing the science of radioligand therapy through ongoing rigorous clinical development and real-world evidence generation," said Liviu Niculescu, Chief Medical Officer, US at Novartis. "These real-world findings build on the evidence from our robust clinical trial program and contribute to a broader understanding of treatment outcomes observed in routine practice."

Study assesses response with systemic therapies when used after Pluvicto
A second study showed that patients with mCRPC achieved meaningful clinical responses with systemic therapies after discontinuing Pluvicto (including taxane, ARPI, PARP inhibitor or other), most of whom had prior exposure to ARPI and chemotherapy2.

Subsequent therapy Median PFS
All (n=442) 8.6 months (95% CI: 7.2 – 10.1 months)
ARPI (n=176) 10.7 months (95% CI: 8.1 – 19.3 months)
Taxane (n=188) 7.2 months (95% CI: 5.9 – 9.4 months)
"With the emergence of new advanced therapies for metastatic prostate cancer, including radioligand therapies, optimizing the sequencing of systemic therapies has become increasingly important for clinicians," said Dr. Xiao Wei at the Dana-Farber Cancer Institute. "These findings are reassuring, as they suggest that treatment with lutetium Lu 177 vipivotide tetraxetan does not preclude the effectiveness of subsequent therapies for appropriate patients."

Analysis shows gaps in guideline-adherent care for mHSPC
Despite clear clinical guidelines recommending treatment intensification with androgen deprivation therapy (ADT) and ARPI for metastatic hormone-sensitive prostate cancer (mHSPC), a substantial proportion of men continue to receive ADT alone. In a large US real-world study, nearly four in ten (39.2%) men received ADT monotherapy while just over half (55.5%) received combination ADT+ARPI (n=43,415 patients treated between 2020 and 2025)5. While adoption of guideline‑recommended therapy is improving, these data underscore a significant remaining opportunity for patients to receive optimal care.

About the PRECISION data platform
PRECISION – the PRostatE Cancer dISease observatION platform – is a US real-world evidence platform developed by Novartis and urology and oncology experts. The platform harmonizes data from more than 56,500 patients with metastatic prostate cancer to generate RWE studies that inform clinical decisions and everyday care.

*Analysis of PFS in the PRECISION data platform included biochemical, radiographic and clinical assessments. In PSMAfore, the primary endpoint was rPFS defined as the time from randomization to radiographic disease progression (assessed by blinded independent central review) or death.

(Press release, Novartis, FEB 24, 2026, View Source [SID1234662890])

On February 23, 2026 Aptose Biosciences Inc. ("Aptose" or the "Company") (TSX: APS; OTC: APTOF) reported that it has entered into an amended and restated arrangement agreement (the "Amended and Restated Arrangement Agreement") amending and restating the arrangement agreement dated November 18, 2025 (the "Original Arrangement Agreement"), pursuant to which Aptose will continue from the Canada Business Corporations Act to the Business Corporations Act (Alberta) ("ABCA") (the "Continuance") and subsequently be acquired by HS North America Ltd. (the "Purchaser"), a wholly owned subsidiary of Hanmi Pharmaceutical Co. Ltd. ("Hanmi" and together with the Purchaser, the "Hanmi Purchasers"), by way of a statutory plan of arrangement under the ABCA (the "Arrangement" and, together with the Continuance, the "Transaction").

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Amended and Restated Arrangement Agreement amends and restates the Original Arrangement Agreement to, among other things, schedule a new date for the special meeting of shareholders to seek approval of the Transaction (the "Meeting"), originally scheduled to be held on January 16, 2026 (the "Original Meeting") which has been reconvened to March 31, 2026 at 11:00 a.m. (EST) (the "Reconvened Meeting"). The Original Meeting was postponed to address comments raised by the United States Securities and Exchange Commission ("SEC") on the Company’s transaction statement on Schedule 13E-3, as amended.

Aptose has prepared and filed with the SEC a definitive proxy statement for the Reconvened Meeting (the "Proxy Statement"). A copy of the Proxy Statement will be mailed to all shareholders of the Company as soon as practicable. The Proxy Statement, form of proxy, letter of transmittal, as well as Schedule 13E-3, as amended, will also be available for download under Aptose’s profile on SEDAR+ at www.sedarplus.ca and EDGAR at www.sec.gov.

On December 12, 2025, Aptose obtained an interim order from the Court of King’s Bench of Alberta (the "Court") authorizing the holding of the Meeting and matters relating to the conduct of the Meeting.

Aptose also announced a revised record date for the Meeting, now set for the close of business on February 24, 2026.

The Reconvened Meeting will be held virtually via live audio webcast at https://meetings.lumiconnect.com/400-581-122-608. All shareholders who wish to attend the Reconvened Meeting must follow the procedures set out in the Proxy Statement. Shareholders who are unable to attend the Reconvened Meeting are strongly encouraged to complete, date, sign and return the form of proxy (in the case of registered shareholders) or voting instruction form (in the case of non-registered shareholders) provided with the meeting materials so that as many shareholders as possible are represented and vote at the Reconvened Meeting.

Aptose’s board of directors unanimously recommends that the shareholders vote FOR the special resolutions approving the Continuance and the Arrangement at the Reconvened Meeting.

Aptose also announced today that it has entered into a US$11.1 million second amended and restated 2025 facility agreement with Hanmi (the "Second A&R 2025 Facility Agreement").

The Second A&R 2025 Facility Agreement is uncommitted and administered through multiple advances until May 31, 2026, and will be used to fund Aptose’s business and clinical operations expenses reasonably related to the advancement of Tuspetinib ("TUS"). Aptose has not yet received funds from the Second A&R 2025 Facility Agreement but expects the first advance soon. This Second A&R 2025 Facility Agreement has been amended and restated from the prior December 2025 amended and restated facility agreement between Hanmi and Aptose, which was amended and restated from the prior September 2025 facility agreement between Hanmi and Aptose. No single advance shall be for an amount in excess of US$2,000,000, and any unpaid principal amount with respect to each advance shall accrue interest at six percent (6%) per annum. The Second A&R 2025 Facility Agreement contains customary affirmative and negative covenants and securities that are subject to a number of limitations and exceptions.

Each of the September 2025 facility agreement and December 2025 amended and restated facility agreement constitutes a "related-party transaction" within the meaning of Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions ("MI 61-101") as Hanmi is a related party of the Company under Canadian securities laws. However, the Company is relying on the exemption from the formal valuation and minority shareholder approval requirements contained in MI 61-101 on the basis of the "financial hardship" exemption therein. In its consideration and approval of the September 2025 facility agreement and December 2025 amended and restated facility agreement, the board of directors of the Company, acting in good faith and having taken into account the liquidity, financial position and cash needs of the Company, the alternatives available to the Company, relevant benefits, risks and other factors, including the relative impacts on applicable stakeholders, and such matters they considered relevant or appropriate, unanimously determined that entering into the September 2025 facility agreement and December 2025 amended and restated facility agreement will result in an improvement of the Company’s financial position, and that the terms of the September 2025 facility agreement and December 2025 amended and restated facility agreement are reasonable in the circumstances of Aptose.

(Press release, Hanmi, FEB 23, 2026, View Source [SID1234662914])