On September 9, 2026 Full-Life Technologies ("Full-Life", the "Company"), a privately held, fully integrated, clinical-stage actinium-based global radiopharmaceutical company, reported that the U.S. Food and Drug Administration ("FDA") has cleared the Company’s Investigational New Drug ("IND") application for [225Ac]Ac-FL-261 and that the program has received Australian Human Research Ethics Committee ("HREC") approval and completed the Clinical Trial Notification ("CTN") process with Therapeutic Goods Administration ("TGA"). These clearances enable Full-Life to advance a Phase 1 clinical trial of [225Ac]Ac-FL-261 in the United States and Australia in patients with c-MET-expressing non-squamous non-small cell lung cancer ("nsNSCLC").

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!

"These regulatory clearances represent an important milestone for FL-261 and our strategy to expand targeted alpha therapy into various solid tumors," said Debora Barton, MD, Chief Medical Officer of Full-Life Technologies. "[225Ac]Ac-FL-261 is designed to selectively target c-MET-expressing tumors by delivering potent alpha radiation directly into the tumor sites. We look forward to advancing FL-261 into its Phase 1 trial and generating key clinical evidence that will help translate our preclinical findings and inform the continued development of this promising program."

The planned first-in-human Phase 1 study will evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of [225Ac]Ac-FL-261 in patients with nsNSCLC. Full-Life plans to conduct clinical development in the United States, Australia and other key regions.

About [225Ac]Ac-FL-261

[225Ac]Ac-FL-261 is Full-Life’s potential first-in-class c-MET-targeted alpha radioconjugate for multiple solid tumor indications. It is designed to selectively bind c-MET-expressing tumors and deliver alpha-particle radiation directly to tumor cells. FL-261 is one of the various radiopharmaceutical assets developed utilizing Full-Life’s proprietary UniRDC discovery platform.

About UniRDC

UniRDC is Full-Life’s proprietary discovery platform which allows for rapid generation of radiopharmaceutical development candidates with optimized therapeutic properties. By integrating proprietary synthetic chemistry and protein-engineering capabilities, UniRDC enables high and sustained tumor uptake in humans while avoiding key safety organs, addressing two long-standing challenges in radiopharmaceutical chemistry. The platform supports an accelerated path from target selection to a development candidate with human biodistribution data in less than 24 months. UniRDC has been dosed in over 100 patients, generated three clinical-stage assets to date and been validated by multiple partnerships with strategic pharmaceutical partners.

(Press release, Full-Life Technologies, SEP 9, 2026, View Source [SID1234670692])

On September 9, 2026 Amgen (NASDAQ:AMGN) will present at the Morgan Stanley 24th Annual Global Healthcare Conference at 11:30 a.m. ET on Tuesday, September 15, 2026. Jay Bradner, executive vice president, Research and Development, Artificial Intelligence and Data at Amgen, and Thomas Dittrich, executive vice president and chief financial officer at Amgen, reported it will present at the conference. The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

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 webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

(Press release, Amgen, SEP 9, 2026, View Source [SID1234670691])

On September 9, 2026 HanchorBio, Inc. (TWSE: 7827), a global clinical-stage biotechnology company developing next-generation immunotherapies for oncology and immune-mediated diseases, reported that the U.S. Food and Drug Administration (FDA) has cleared its HCB101 Single-Patient Expanded Access Protocol (HCB101- EA-001) as "safe to proceed".

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 FDA determination enables a patient who experienced clinical benefit while receiving HCB101 in the Company’s Phase 1 study to continue treatment with HCB101 beyond the parent clinical trial. Expanded Access, or compassionate use, allows patients with serious or life-threatening diseases to receive investigational therapies outside standard clinical trials when specific regulatory criteria are met. In an individual-patient Expanded Access request, FDA considers the patient’s clinical circumstances, including whether the potential benefit justifies the potential risks and whether those risks are reasonable in the context of the disease.

"For us, this starts with the patient," said Scott Liu, Ph.D., Founder and Chairman of HanchorBio. "When a patient is benefiting from an investigational therapy and has limited treatment options, we believe every appropriate avenue to continue access should be considered. HCB101 was created to make a meaningful difference, and this milestone reflects the patient-first principle guiding our FBDB platform."

FDA’s determination that HCB101-EA-001 is "safe to proceed" applies specifically to this individual-patient Expanded Access protocol and does not constitute approval of HCB101 or an FDA determination of efficacy.

"Working within the FDA framework, we translated an individual patient’s need into a practical solution allowing treatment to continue," said Alvin Luk, Ph.D., M.B.A., President and Chief Medical Officer (Group) and Chief Executive Officer (USA) of HanchorBio. "That is where clinical medicine, regulatory science, and drug development properly align."

A Potential First for the SIRPα-Fc Fusion Protein Class

While Expanded Access pathways have previously been utilized for the anti-CD47 monoclonal antibody, HCB101-EA-001 is clinically and structurally distinct:

Targeted Continuation: Unlike broad population access programs, HCB101-EA-001 was specifically established to extend treatment for an individual patient who determined clinical benefit during a Phase 1 clinical trial.

Novel Mechanism: HCB101 is an engineered SIRPα-Fc fusion protein designed to block the CD47-SIRPα "don’t eat me" signal and trigger macrophage-mediated tumor-cell phagocytosis.

Based on publicly available information, HanchorBio believes this is the first reported U.S. Expanded Access case for a SIRPα-Fc fusion protein, setting a significant precedent as HanchorBio continues to advance the program globally across multiple tumor types and combination strategies.

About HCB101

HCB101 is an investigational engineered SIRPα–IgG4 Fc fusion protein developed using HanchorBio’s FBDB platform. HCB101 blocks CD47–SIRPα signaling to restore macrophage-mediated antitumor immunity and downstream de novo T-cell activation. It is being evaluated as monotherapy (NCT05892718) and in combination (NCT06771622) across solid and hematologic malignancies and holds U.S. FDA Orphan Drug Designation for gastric cancer.

(Press release, Hanchor Bio, SEP 9, 2026, View Source [SID1234670690])

On September 9, 2026 IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a leading precision medicine oncology company, and Servier, an independent international pharmaceutical group governed by a foundation, reported that the first patient has been dosed in OptimUM-11, a global Phase 3 registrational trial evaluating darovasertib, a first-in-class oral protein kinase C (PKC) inhibitor, in combination with crizotinib, an oral cMET inhibitor, as adjuvant therapy for patients with primary uveal melanoma who have completed local therapy and have an increased risk of developing metastatic disease. Currently, there are no approved adjuvant treatment options for patients with primary uveal melanoma.

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!

"Dosing the first patient in OptimUM-11 represents an important milestone in our strategy to advance darovasertib across the uveal melanoma patient journey," said Darrin M. Beaupre, M.D., Ph.D., Chief Medical Officer of IDEAYA Biosciences. "Patients with primary uveal melanoma are commonly at risk for metastatic recurrence following treatment of their primary tumor, highlighting the need for an effective systemic therapy in the adjuvant setting to delay or prevent disease progression. We believe the darovasertib combination has the potential to address the principal pathways associated with the initiation and metastatic progression of uveal melanoma, and we look forward to working with our partner Servier and the global investigator community to advance this registrational trial."

"Preventing or delaying metastatic recurrence could fundamentally change the treatment journey for patients with high-risk primary uveal melanoma," said Arnaud Lallouette, Executive Vice President Global Medical & Patient Affairs at Servier. "Through OptimUM-11, Servier and IDEAYA are jointly advancing a global registrational study of the darovasertib combination with the goal of establishing a new adjuvant treatment option for patients worldwide."

OptimUM-11 is being conducted by IDEAYA in collaboration with its partner, Servier, to evaluate darovasertib in combination with crizotinib as an adjuvant therapy for patients with primary uveal melanoma. The trial is expected to enroll approximately 450 patients who have completed primary local therapy and have an increased risk of metastasis. Patients will be eligible irrespective of HLA status and will be randomized 1:1 to receive darovasertib in combination with crizotinib for 12 months or observation. The primary endpoint of the trial is relapse-free survival. IDEAYA retains regulatory and commercial rights to darovasertib in the United States, while Servier holds all such rights outside the United States. The companies will share the associated development costs of the trial.

About Darovasertib

Darovasertib is a potential first-in-class oral, small-molecule inhibitor of PKC. Darovasertib was designed to inhibit PKC isoforms downstream of the GNAQ and GNA11 oncogenic driver mutations that are present in nearly all uveal melanoma patients. Darovasertib is being evaluated in multiple clinical trials in uveal melanoma, including in patients with metastatic disease (OptimUM-01 and OptimUM-02), as well as in primary uveal melanoma as a neoadjuvant (OptimUM-09 and OptimUM-10) and adjuvant (OptimUM-11) therapy.

IDEAYA has initiated submission of a new drug application (NDA) for darovasertib in combination with crizotinib for patients with first line metastatic uveal melanoma (mUM) under the oncology center of excellence (OCE) real-time oncology review (RTOR) program and expects to complete the NDA submission in the second half of 2026. The U.S. Food and Drug Administration (FDA) has also granted darovasertib Fast Track designation for the treatment of mUM, Orphan Drug designation in primary uveal melanoma and Breakthrough Therapy Designation as a neoadjuvant therapy for patients with primary uveal melanoma for whom enucleation has been recommended. Darovasertib is an investigational product and has not been approved by the FDA or any other regulatory authority.

(Press release, Ideaya Biosciences, SEP 9, 2026, View Source [SID1234670689])

On September 9, 2026 Harbour BioMed (the "Company"; HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology, oncology and other areas, reported that Solstice Oncology, its partner company, has launched with a $225 million Series A financing led by RA Capital Management, with participation from Canaan Partners, Forbion and other investors. Solstice is a clinical-stage immuno-oncology company focused on treating cancer earlier, in the neoadjuvant setting.

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!

Solstice is advancing its lead candidate porustobart, a differentiated, second-generation, Fc-enhanced cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody, across two clinical indications, one in microsatellite-stable (MSS) colon cancer and a second, undisclosed indication. Its Phase 2 trial is evaluating porustobart in combination with pembrolizumab in the neoadjuvant setting for the treatment of MSS clinical stage II-III colon cancer, the indication with the largest segment of colon cancer patients, which has yet to benefit from immunotherapy.

Porustobart was discovered and developed by Harbour BioMed. In February 2026, Harbour BioMed entered into a license agreement and equity partnership with Solstice Oncology for the exclusive development and commercialization of porustobart (also known as HBM4003 in Harbour BioMed’s pipeline) outside Greater China, enabling the advancement of the program globally.

In a Phase 2 clinical study conducted by Harbour BioMed, porustobart in combination with tislelizumab, a PD-1 inhibitor, demonstrated a 30% objective response rate (7 of 23 patients) in late-line patients with MSS metastatic colorectal cancer without liver metastases, with responses showing encouraging durability. The median duration of response was 8.4 months, and porustobart demonstrated a favorable safety profile supporting its continued clinical development. These findings provide clinical support for further evaluating porustobart in combination with PD-(L)1 blockade and in earlier lines of treatment, including the neoadjuvant setting.

"We are pleased to see Solstice Oncology launch with strong support from leading investors and advance porustobart into the neoadjuvant setting," said Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed. "As the originator of porustobart and a partner of Solstice, we look forward to supporting the continued development of this differentiated CTLA-4 antibody and exploring its potential to benefit patients worldwide."

"We believe the greatest opportunity in oncology lies in treating disease earlier, in the neoadjuvant setting, when the tumor is still present, the immune system is still intact, and disease hasn’t yet hardened its resistance to treatment," said Caroline Loew, PhD, CEO of Solstice Oncology. "Treating patients early with an immuno-oncology combination therapy like the one we are evaluating in our Phase 2 trial could allow the immune response to act systemically, reaching micrometastatic disease well beyond the primary tumor, which is where we see the greatest opportunity to improve cure rates and long-term survival. Since founding the company in February, our team has moved with the speed and discipline this opportunity demands, filing and clearing an IND and now advancing directly into a Phase 2 trial, for which we anticipate data in the second half of 2027."

(Press release, Harbour BioMed, SEP 9, 2026, View Source [SID1234670688])