On September 22, 2026 Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for cancer patients, reported the U.S. Food and Drug Administration (FDA) has granted conditional acceptance of LYRFIGTU as the brand name for lirafugratinib, which is currently under FDA Priority Review as a treatment option for patients with advanced/metastatic cholangiocarcinoma (CCA) harboring FGFR2 fusion or other rearrangement.

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 proposed name Lyrfigtu (pronounced leer fig tu) was developed in accordance with the FDA’s guidance on proprietary names. Final acceptance of the Lyrfigtu brand name will be established upon FDA approval of lirafugratinib. In January, the FDA accepted Elevar’s new drug application for lirafugratinib and subsequently granted Priority Review to the application and assigned a Prescription Drug User Fee Act target action date of September 25, 2026.

"The FDA’s conditional acceptance of the Lyrfigtu brand name represents another important milestone in Elevar’s effort to potentially commercialize lirafugratinib and, if approved, introduce a new therapeutic option for patients confronted with cholangiocarcinoma," said Dong-Gun Kim, chief executive officer of Elevar. "With the PDUFA date set for later this month, we are hopeful of a positive result and highly focused on preparing for a potential launch to make the drug available to doctors and patients as quickly as possible, subject to FDA approval."

CCA, also known as bile duct cancer, is rare, with about 8,000 people in the U.S. newly diagnosed each year, according to the American Cancer Society.

In the Phase 1/2 ReFocus trial (NCT04526106), lirafugratinib demonstrated a confirmed objective response rate (ORR) of 46% and a median duration of response of 11.8 months in patients with the proposed indication. Its safety profile in the clinical data is being evaluated by the FDA as part of the ongoing review process. Adverse events observed in the trial were managed through dose adjustments.

About Lirafugratinib

Lirafugratinib (aka RLY-4008) is a potent, selective and oral small molecule inhibitor of FGFR2, a receptor tyrosine kinase that is frequently altered in certain cancers. FGFR2 is one of four members of the FGFR family, a set of closely related proteins with highly similar protein sequences and properties. Lirafugratinib is currently being evaluated in a clinical trial to enroll additional patients with previously treated, advanced or metastatic solid tumors other than CCA harboring FGFR2 fusion or rearrangement, who have not been treated with prior FGFR inhibitors. Lirafugratinib is an investigational product candidate and has not been approved by the U.S. Food and Drug Administration for any indication. Elevar has an exclusive license to lirafugratinib from Relay Therapeutics, Inc. for commercialization worldwide.

(Press release, Elevar Therapeutics, SEP 22, 2026, View Source [SID1234671015])

On September 22, 2026 MAIA Biotechnology, Inc. (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, reported that enrollment has reached 65 patients in its ongoing pivotal Phase 3 trial, THIO-104, evaluating its novel telomere-targeting therapy as a third-line (3L) treatment for advanced non-small cell lung cancer (NSCLC). The THIO-104 trial currently has 38 trial sites activated in 6 foreign countries (Taiwan, Romania, Turkey, Georgia, Poland and Hungary).

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!

"Reaching 65 randomized patients marks an important milestone in our Phase 3 trial. With additional clinical sites expected to begin enrolling patients, we remain on track to achieve our goal of more than 100 randomized patients by year-end," said Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA. "As we’ve stated previously, statistical assessments of the Phase 3 trial point to a very high probability of technical success for regulatory approval of ateganosine.1 We believe third-line NSCLC is an excellent market entry segment due to the substantial unmet medical need in this large immunotherapy-resistant and chemotherapy-resistant population. No current standard of care exists in this NSCLC treatment setting and competition for clinical trial patients is limited."

In its most recent assessment, ateganosine sequenced with a checkpoint inhibitor showed 90.5% interim disease control rate (DCR) in heavily pretreated 3L NSCLC in MAIA’s ongoing phase 2 THIO-101 clinical trial. This measure contrasts with reported 25%–35% DCRs for standard third-line chemotherapy regimens.

In July 2025, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for ateganosine for the treatment of NSCLC. This designation allows for more frequent FDA communication, potential rolling review, and eligibility for Accelerated Approval and Priority Review. If approved, ateganosine will hold FDA New Chemical Entity (NCE) five-year marketing exclusivity. An NCE is a small molecule drug with a novel active ingredient that hasn’t been previously approved or marketed.

About Ateganosine

Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment of ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

(Press release, MAIA Biotechnology, SEP 22, 2026, View Source [SID1234671014])

On September 22, 2026 X-Chem, a global leader in innovative drug discovery services, reported the achievement of a milestone following Relay Therapeutics’ initiation of a Phase 3 clinical trial of a drug candidate developed from a compound identified through an X-Chem DNA-encoded chemical library (DEL) screen.

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!

Relay Therapeutics, a leader in cutting-edge approaches to drug discovery, licensed an inhibitor of the oncology target phosphoinositide 3- kinase alpha (Pl3Ka) that was discovered through an X-Chem DEL screen. The inhibitor demonstrated differentiated pharmacology, mutant selectivity, a novel allosteric binding site and served as a starting point for Relay’s innovative development of zovegalisib (RLY-2608), currently in a clinical trial. The initiation of this Phase 3 trial represents a milestone under the companies’ Research Collaboration and License Agreement.

"The unique selectivity and binding site of RLY-2608 are a testament to the power of the X-Chem DEL platform to discover unique chemical matter with differentiated pharmacology," said X-Chem CEO Karen Lackey. "We are thrilled that our discovery platforms helped provide a starting point for a potential new treatment for patients with breast cancer. Hats off to the Relay team for having the drive and vision to push this project forward."

"X-Chem’s excellence in DEL technology was apparent from the very beginning of this exciting project, and we are pleased to continue to advance the clinical development of zovegalisib in patients with PI3Ka-driven diseases," said Relay CEO Sanjiv Patel.

(Press release, X-Chem, SEP 22, 2026, View Source [SID1234671013])

On September 22, 2026 Cartography Biosciences, Inc., a clinical-stage biotechnology company advancing a differentiated pipeline of antibody-based cancer therapies, reported that CEO and co-founder Kevin Parker, Ph.D., will participate in the following upcoming investor conferences:

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!

BofA Healthcare Trailblazers Private Company Conference: September 23-24 in Boston
Needham Private Biotech and MedTech Company Virtual 1×1 Forum: October 13-14
Goldman Sachs Healthcare Private Company Conference: October 19 in New York City
Leerink Partners Biopharma Private Company Connect: October 20-21
UBS Global Biopharma Conference: November 16-17 in London

(Press release, Cartography Biosciences, SEP 22, 2026, View Source [SID1234671011])

On September 22, 2026 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for the treatment of cancer and inflammatory diseases, reported that it will host an in-person investor event with a live webcast on Tuesday, October 20, 2026, beginning at 8:30 AM ET, in New York City.

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 event will highlight new data from the ARC-20 platform study, which is evaluating casdatifan, a next-generation HIF-2α inhibitor, alone or in combination, as a first-, second- and late-line treatment for clear cell renal cell carcinoma (ccRCC). Featured presenters will include members of the Arcus management team and Dr. Rana McKay, Professor of Medicine and Urology at the University of California San Diego, who is a leading academic expert in the treatment of kidney cancer with deep experience using HIF-2α inhibitors.

New data to be presented will include:

First-line TKI-free combinations:
Casdatifan plus zimberelimab (anti-PD-1 antibody): Data will include safety and early efficacy, including rate of primary progression, overall response rate (ORR), and progression-free survival (PFS) for 30 patients with a median follow-up of approximately 11 months.
Casdatifan plus ipilimumab plus zimberelimab: Data will include safety and rate of primary progression for approximately 20 patients. Safety data from this cohort will support initiation of the first-line registrational trial PEAK-20, evaluating casdatifan plus ipilimumab plus nivolumab, expected to occur in the fourth quarter of 2026.
Second-line TKI-containing combination:
Casdatifan plus cabozantinib: Efficacy data will include ORR, PFS, and early overall survival (OS) for 43 patients with a minimum of 18 months and a median of approximately 21 months of follow-up and a subgroup analysis of efficacy (including PFS and OS) based on prior therapy. Safety and tolerability data will also be provided for this cohort. This is the same combination and patient population being evaluated in the registrational trial PEAK-1, expected to be fully enrolled at the end of 2026.
Late-line monotherapy:
Casdatifan monotherapy: Data will include OS, as well as updated ORR and PFS, for 121 patients in the pooled monotherapy cohorts, with median follow-up of approximately 28 months.
Arcus will also be highlighting new subgroup analyses, including evaluation of casdatifan monotherapy efficacy for both PFS and OS by prior therapy. In addition, Arcus will share the first translational data correlating pharmacodynamic markers of HIF-2α inhibition with overall survival.
The presentation will also include market opportunity and review of Arcus’s development strategy, which is designed to generate evidence to secure casdatifan as a backbone therapy in ccRCC so that every patient has the opportunity to benefit from casdatifan across each line of therapy over the course of their care.

Please contact Arcus Investor Relations regarding in-person attendance. The event will be broadcast live via webcast here: https://event.summitcast.com/view/oP6P82VnbjK87kUbV5QALF/guest_book?session_id=WJm4z43QhGbWA8FEbbv5AM. A replay will be available following the live event in the "Investors & Media" section of the Arcus Biosciences website at www.arcusbio.com.

About Casdatifan (AB521)

Casdatifan is a small-molecule inhibitor of hypoxia-inducible factor 2-alpha (HIF-2a), a master switch that turns on hundreds of genes in response to low oxygen levels. In a majority of people with the most common form of kidney cancer (clear cell renal cell carcinoma), genetic anomalies result in the dysregulation of this master switch and transformation of normal kidney cells into cancerous ones.

Casdatifan was designed to provide deep and durable inhibition of the HIF-2a pathway. Early clinical studies have shown high response rates and a low primary progression rate relative to clinical benchmarks, warranting further investigation in late-stage studies. Casdatifan, which is administered in pill form once daily, has a safety profile that allows it to be investigated in combination with other treatments.

The casdatifan development strategy is designed to generate evidence needed to establish casdatifan as a backbone therapy so that every ccRCC patient has the opportunity to benefit from casdatifan across each line of therapy. In addition to partner-operationalized studies, including combinations with casdatifan and anti-PD-X/VEGF bispecifics, Arcus is investigating casdatifan across multiple cohorts in the ARC-20 platform study, alone and in combination with other potential new treatment options, including in:

The first-line setting with cohorts evaluating casdatifan plus zimberelimab, an anti-PD-1 (ongoing); casdatifan plus zimberelimab and ipilimumab, an anti-CTLA-4 (ongoing); and casdatifan plus ivonescimab, an anti-PD-1/VEGF bispecific (planned)
The second-line setting with a cohort evaluating casdatifan plus cabozantinib, a TKI, in immunotherapy-experienced patients (ongoing)
The late-line setting with a cohort evaluating casdatifan plus tivozanib, a TKI, in HIF-2a inhibitor-experienced patients (planned)
Arcus is also enrolling PEAK-1, the global Phase 3 study evaluating casdatifan plus cabozantinib versus cabozantinib in immunotherapy-experienced patients with metastatic ccRCC. Arcus expects to complete enrollment in PEAK-1 and to initiate the Phase 3 PEAK-20 study in first-line metastatic ccRCC by year-end 2026.

Casdatifan is an investigational molecule. Approval from any regulatory authority for its use has not been received, and its safety and efficacy have not been established. Taiho has development and commercial rights in Japan and other countries in Asia, excluding China. Arcus Biosciences holds full rights to casdatifan everywhere else globally.

(Press release, Arcus Biosciences, SEP 22, 2026, View Source [SID1234671010])