On August 18, 2026 858 Therapeutics, a clinical-stage biotechnology company, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ETX-19477, the company’s internally discovered PARG inhibitor. The designation has been granted for the treatment of adult patients with BRCA-mutated, hormone receptor positive ("HR+"), human epidermal growth factor receptor 2 negative ("HER2-"), unresectable or metastatic breast cancer.

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"For patients with advanced HR+/HER2- breast cancer, there is an urgent need for new treatment options that can delay disease progression," said Jeffrey Stafford, Ph.D., CEO of 858 Therapeutics. "We are pleased that the FDA has granted Fast Track designation to ETX-19477 and are committed to working closely with the agency to accelerate its development. The designation was supported by preclinical findings and emerging clinical data from our ongoing Phase 1/2 trial, including evidence of antitumor activity."

FDA Fast Track status is designed to facilitate the development and expedite the review of new therapies that are intended to treat serious conditions with unmet medical need. Under the Fast Track designation, the ETX-19477 development program will have access to more frequent interactions with the FDA and may be eligible for accelerated approval and/or priority review if certain criteria are met.

ETX-19477 is being evaluated in an ongoing Phase 1/2, open-label, multicenter study in patients with advanced solid tumors, designed to assess safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity. The trial is currently enrolling patients in Phase 2 monotherapy cohorts in BRCA-mutated ovarian cancer and BRCA-mutated HR+/HER2- breast cancer.

About ETX-19477

Poly(ADP-ribose) glycohydrolase (PARG) is an enzyme that catalyzes the removal of poly-ADP-ribose (PAR) chains from proteins during the DNA damage response. PARG inhibition leads to selective cell death in tumors with underlying replication fork defects, including BRCAm tumors, through a mechanism distinct from PARP inhibition. ETX-19477 is an oral, potent, and selective PARG inhibitor that shows robust preclinical activity in mouse models of ovarian, breast, and gastric cancers. 858 Therapeutics is evaluating ETX-19477 in a Phase 1/2 study in patients with advanced solid tumors at multiple sites in the U.S. For more information on the Phase 1/2 study, please visit: View Source

(Press release, 858 Therapeutics, AUG 18, 2026, View Source;Unresectable-or-Metastatic-Breast-Cancer [SID1234670216])

On August 18, 2026 Eikon Therapeutics, Inc. (Nasdaq: EIKN) ("Eikon"), a late-stage clinical biopharmaceutical company dedicated to developing innovative medicines to address serious unmet medical needs, reported that its Chairman and Chief Executive Officer, Roger M. Perlmutter, M.D., Ph.D., will participate in a key opinion leader (KOL) event on Thursday, August 20, 2026, at 9:00 AM ET, hosted by Cantor Fitzgerald and featuring Dr. Timothy A. Yap, MBBS, PhD, FRCP, medical oncologist and physician scientist from the University of Texas MD Anderson Cancer Center.

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Dr. Timothy A. Yap currently serves as Vice President and Head of Clinical Development in the Therapeutics Discovery Division at the University of Texas MD Anderson Cancer Center, and is a Professor in the Department for Investigational Cancer Therapeutics (Phase I Program) and in the Department of Thoracic/Head and Neck Medical Oncology. Dr. Yap is and/or has been Principal Investigator for multiple clinical trials and translational studies evaluating novel strategies for targeting the DNA damage response in cancer and is an expert in the use of PARP inhibitors in oncology. Dr. Yap receives compensation as an advisor to Eikon, and this financial relationship has been disclosed to UT MD Anderson’s Conflict of Interest Committee in accordance with its institutional policy. Dr. Yap will discuss the current therapeutic landscape of PARP inhibition in breast, ovarian, prostate and pancreatic cancer, including usage of approved agents, therapeutic outcomes and limitations of currently available agents targeting PARP and parylation in oncology.

The event will be hosted by Imogen Mansfield at Cantor Fitzgerald. To access the archived webcast, please visit View Source A replay will be available on the Eikon website for 30 days following the event.

(Press release, Eikon Therapeutics, AUG 18, 2026, View Source [SID1234670217])

On August 18, 2026 Pliant Therapeutics, Inc. (Nasdaq: PLRX) reported the receipt of Fast Track designation from the U.S. Food and Drug Administration (FDA) for PLN-101095, an oral, small molecule, dual selective inhibitor of αvβ8 and αvβ1 integrins, in combination with pembrolizumab for the potential the treatment of solid tumors that are resistant to immune checkpoint inhibitors (ICIs). PLN-101095 is currently being evaluated in the Phase 1a/1b FORTIFY trial (NCT06270706) with data expected in 2027.

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"While immune checkpoint inhibitors have fundamentally changed the oncology treatment landscape, primary or acquired resistance remains a significant barrier for the majority of patients," said Bernard Coulie, M.D., Ph.D., President and Chief Executive Officer of Pliant. "This Fast Track designation underscores the urgent need for innovative therapies for immune checkpoint inhibitor-refractory solid tumors and recognizes the potential of PLN-101095. We look forward to working closely with the FDA as we advance this program."

FDA’s Fast Track designation is intended to facilitate and expedite the development and review of new drugs to treat serious or life-threatening conditions. To qualify, available clinical and non-clinical data need to demonstrate the potential to address unmet medical need. The benefits of Fast Track designation include opportunities for frequent meetings with the FDA to discuss trial design, development plans and data needed to support drug approval, as well as the ability to submit a New Drug Application (NDA) on a rolling basis, and eligibility for priority review, if relevant criteria are met.

(Press release, Pliant Therapeutics, AUG 18, 2026, View Source [SID1234670218])

On August 18, 2026 BlossomHill Therapeutics, Inc. (Nasdaq: BLSM), a clinical-stage biopharmaceutical company applying an intentional, chemistry-based approach to design and develop innovative small molecule medicines for the treatment of cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to BH-30643 for the treatment of adult patients with advanced or metastatic epidermal growth factor receptor (EGFR) C797S-positive non-small cell lung cancer (NSCLC) after prior treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI). BH-30643 is being evaluated in SOLARA, a global Phase 1/2, first-in-human clinical trial enrolling patients at more than 40 sites in 10 countries.

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"Fast Track designation is an important regulatory milestone and reflects FDA’s recognition, based on its review of our preliminary data, of the potential for BH-30643 to address a significant unmet medical need in this molecularly defined population, for which no oral targeted therapies are approved," said Geoff Oxnard, M.D., Chief Medical Officer of BlossomHill Therapeutics. "Receiving this designation reaffirms our confidence in the development strategy for BH-30643 as a novel EGFR inhibitor designed to overcome C797S-mediated resistance. It also provides opportunities for more frequent engagement with FDA and potential access to other expedited programs, including potential eligibility for rolling review and accelerated approval, if applicable criteria are met."

The FDA’s Fast Track process was designed to bring new medicines to patients more quickly, facilitating the development and expediting the review of therapies intended to treat serious conditions and address unmet medical needs. Companies whose programs are granted Fast Track designation are eligible for more frequent interactions with FDA regarding all aspects of a designated drug’s clinical development program, as well as for rolling review of a New Drug Application (NDA), meaning that completed sections may be submitted and reviewed on an ongoing basis rather than upon completion of the entire application. Fast Track–designated programs may also be eligible for Accelerated Approval and Priority Review if the applicable criteria for those programs are met. For more information on the Fast Track process, please visit the FDA’s official website.

About BH-30643
BH-30643 is an investigational, novel, orally bioavailable, non-covalent, macrocyclic, brain-active, mutant-selective, OMNI-EGFR inhibitor for the treatment of EGFR-mutant NSCLC. BH-30643 was designed to overcome the limitations of currently approved EGFR inhibitors, which were discovered over a decade ago without the current, modern understanding of the structure and protein dynamics of mutant EGFRs. In preclinical studies, BH-30643 demonstrated potent inhibitory activity across diverse EGFR mutation categories – classical activating mutations, on-target resistance mutations such as C797S with or without T790M, atypical mutations and exon 20 insertions – while maintaining marked selectivity over wild-type EGFR. BH-30643 is being evaluated in SOLARA, a global Phase 1/2, first-in-human clinical trial spanning more than 40 sites in 10 countries. Ongoing dose expansion cohorts are enrolling in both TKI-pretreated and TKI-naïve settings, including a C797S resistance cohort. For additional information on SOLARA, including a list of study sites and how to enroll, please visit clinicaltrials.gov (NCT06706076).

(Press release, BlossomHill Therapeutics, AUG 18, 2026, View Source [SID1234670219])

On August 18, 2026 CHARM Therapeutics ("CHARM", "The Company"), a biotechnology company addressing resistance in acute myeloid leukemia (AML) with a best-in-class menin inhibitor, reported the formation of its Clinical Advisory Board to support the advancement of CHM-029 into clinical studies for AML, an aggressive cancer of the blood and bone marrow.

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The Clinical Advisory Board brings together world-leading experts in AML with extensive expertise across clinical oncology, hematology, translational research, and early-phase trial design. They will provide strategic guidance as CHARM advances CHM-029 into first-in-human studies this year.

Gary D. Glick, Ph.D., Interim Chief Executive Officer at CHARM Therapeutics, said: "The formation of our Clinical Advisory Board marks an important step as we advance CHM-029, our next-generation best-in-class menin inhibitor, toward the clinic. The strength of this group reflects the quality of our science and ambition to change the treatment landscape for patients with AML. CHM-029 has been designed to address resistance observed with first-generation menin inhibitors, and we look forward to working with our advisors to translate this into a compelling clinical development strategy."

Dr. Erkut Bahceci, Chief Medical Officer at CHARM Therapeutics, added: "Acute myeloid leukemia remains a devastating disease, with a five-year survival rate of less than 30%. First-generation menin inhibitors marked a shift in the treatment landscape but for many patients they have been limited with the emergence of resistance, compromising durability of response and patient outcomes. That’s the challenge we are focused on solving and I look forward to collaborating with this distinguished group of experts who have been at the forefront in advancing targeted therapies for AML and who understand both the scientific complexities and clinical realities of treating this devastating disease."

Clinical Advisory Board Members:

Dr. Naval Daver is a Professor and Director of the Leukemia Research Alliance Program in the Department of Leukemia at the University of Texas MD Anderson Cancer Center (MDACC) and is an internationally renowned AML clinical investigator focused on molecularly targeted and immune-based therapies in AML. He currently serves as the principal investigator on over 25 ongoing national and international clinical trials. He co-leads the AML program at MDACC that has led many of the recent FDA drug approvals in AML. He has published more than 600 manuscripts and is an editor on numerous high impact journals.

Dr. Hartmut Döhner is a Professor of Medicine and Chairman of the Department of Internal Medicine III at Ulm University, Germany, with over 40 years’ experience in oncology and hematology. He is a globally recognized leader in leukemia research and has been instrumental in defining the genetic landscape of acute leukemias and was a leading contributor to the European LeukemiaNet risk stratification guidelines, a critical framework for genetic risk classification in AML. His work has been central to the identification, characterization and clinical implementation of genetic alterations in both acute and chronic leukemias. He has also served as Chairman of the German-Austrian AML Study Group.

Dr. Bob Löwenberg is an em-Professor of Hematology at Erasmus University Rotterdam, bringing over 40 years’ experience in clinical hematology supported by more than 10 major accolades in the field. His distinguished career includes serving as an Eleanor Roosevelt Fellow and as a Visiting Assistant Professor at the UCLA School of Medicine in Hematology and Oncology. He has co-founded two biotechnology companies, both of which were subsequently acquired, and has held leadership roles in major international organizations including the European Hematology Association (EHA) (Free EHA Whitepaper). He founded the HOVON Cooperative Group, a leading cooperative clinical trial consortium in hemato-oncology in Europe. He has also served on multiple scientific advisory boards and held senior roles at the European School of Hematology. He is an elected member of the Royal Academy of Sciences and Arts of The Netherlands, the European Academy of Cancer Sciences and the Academia Europaea.

Dr. Eytan Stein is the Chief of the Leukemia Service, hematologic oncologist and clinical researcher at Memorial Sloan Kettering Cancer Center, with over 15 years’ experience in early-stage drug development and precision medicine approaches for blood cancers. He led the pivotal clinical trial demonstrating that revumenib, a menin inhibitor, was effective in patients whose cancers harbored molecular mutations commonly found in AML, work that helped establish menin inhibition as one of the most promising new therapeutic directions in the field.

Prof. Paresh Vyas is a Professor of Hematology at the University of Oxford with over 25 years of experience specializing in myeloid disorders, including AML. He serves as Deputy Director of the MRC Molecular Haematology Unit and is a member of the UK AML and MDS clinical trials group, with expertise spanning early-phase trial design and translational research. He co-founded the international EVOLVE consortium, which delivers innovative AML clinical trials, and established Oxford’s Therapy Acceleration Laboratory (TAL), a state-of-the-art facility supporting centralized laboratory analyses for clinical trials from Phase I through Phase III.

(Press release, CHARM Therapeutics, AUG 18, 2026, View Source [SID1234670220])