On August 19, 2026 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Moderna, Inc. (NASDAQ: MRNA) reported positive topline results from the Phase 3 INTerpath-001 trial evaluating adjuvant treatment with intismeran autogene (intismeran; V940 or mRNA-4157), a novel investigational mRNA-based individualized neoantigen therapy (INT) being jointly developed by Merck and Moderna, in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with completely resected stage IIB-IV melanoma. The trial met its primary endpoint of recurrence-free survival (RFS) and a key secondary endpoint of distant metastasis-free survival (DMFS). This represents the first positive Phase 3 readout for an individualized neoantigen therapy (INT) and for an mRNA-based cancer therapy, as well as the first Phase 3 study to demonstrate a clinically meaningful improvement over KEYTRUDA alone, a standard-of-care immunotherapy, in the adjuvant setting for patients with resected melanoma.

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At a pre-specified interim analysis, intismeran in combination with KEYTRUDA as adjuvant therapy demonstrated statistically significant and clinically meaningful improvements in RFS and DMFS compared to KEYTRUDA alone for patients with completely resected stage IIB, IIC, III or IV cutaneous melanoma who had not undergone prior treatment with systemic therapy. In accordance with the trial protocol, the study will continue in order to evaluate other key secondary endpoints, including overall survival (OS).

The safety profiles of intismeran and KEYTRUDA in this trial were consistent with those observed in previously reported studies for the combination, with no new safety signals observed.

These data will be presented at an upcoming international medical meeting and shared with regulatory authorities.

"Today’s results represent a landmark moment for adjuvant melanoma treatment. This is the first Phase 3 study to show that intismeran, a treatment designed based on the unique mutational ‘fingerprint’ of a patient’s own tumor, given in combination with pembrolizumab can reduce the risk of recurrence or death in patients with completely resected stage IIB-IV melanoma compared to KEYTRUDA alone," said Professor Georgina Long, the study’s principal investigator and medical director of Melanoma Institute Australia, Chair of Melanoma Medical Oncology and Translational Research at the University of Sydney. "Intismeran in combination with pembrolizumab has the potential to establish a new treatment paradigm in the adjuvant melanoma setting, helping patients remain cancer-free for longer."

"By intervening earlier in the course of disease, when many cancers are considered most treatable, the goal of adjuvant therapy given after surgery is to increase the possibility of cure for more patients," said Dr. Dean Y. Li, president, Merck Research Laboratories. "These first Phase 3 findings for intismeran in combination with KEYTRUDA as adjuvant therapy reinforce the promise of a more personalized approach to cancer treatment. We believe individualized neoantigen therapies have the potential to redefine how patients with completely resected stage IIB-IV melanoma are treated. Together with Moderna, we look forward to presenting data from INTerpath-001 at an international medical meeting and sharing with regulatory authorities."

"These Phase 3 findings represent a pivotal moment for the field of cancer research. For many years, the idea of creating an mRNA treatment designed specifically for an individual patient’s cancer was aspirational. We are now helping turn that vision into a reality," said Stéphane Bancel, CEO of Moderna. "Together with Merck, we have started to demonstrate the transformative potential of this technology to address critical unmet needs in the adjuvant melanoma setting. We are deeply grateful to the patients, investigators and study teams whose contributions make this progress possible."

Merck and Moderna are advancing the robust INTerpath clinical development program evaluating the safety and efficacy of intismeran in combination with KEYTRUDA and other anti-cancer therapies, and as a monotherapy. The INTerpath program currently consists of nine total Phase 2 and Phase 3 clinical trials across multiple tumor types and stages of disease, including melanoma, non-small cell lung cancer (NSCLC), bladder cancer and renal cell carcinoma. Additional clinical studies include the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial in adjuvant melanoma and a Phase 1 study exploring adjuvant pancreatic ductal adenocarcinoma, perioperative gastric carcinoma and perioperative NSCLC.

Today’s Phase 3 readout builds on previously reported Phase 2b results for intismeran in combination with KEYTRUDA from the KEYNOTE-942/mRNA-4157-P201 trial, including the five-year follow-up data presented at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting, in which the combination demonstrated a 49% reduction in the risk of recurrence or death (HR=0.51; [95% CI, 0.294-0.887]) and a 59% reduction in the risk of distant metastasis or death (HR=0.411; [95% CI, 0.200-0.843]) compared to KEYTRUDA alone.

About INTerpath-001
INTerpath-001 is a randomized, double-blind, placebo- and active-comparator-controlled global Phase 3 trial (ClinicalTrials.gov, NCT05933577) evaluating the safety and efficacy of intismeran in combination with KEYTRUDA compared to KEYTRUDA alone in patients with high-risk (stage IIB-IV) resected cutaneous melanoma. The trial enrolled 1,137 patients who, following complete surgical resection, were randomized 2:1 to receive intismeran (1 mg every three weeks for up to nine doses) and KEYTRUDA (400 mg every six weeks up to nine cycles [for approximately one year]) versus KEYTRUDA alone for approximately one year until disease recurrence or unacceptable toxicity, or for a total treatment duration of up to approximately 56 weeks, whichever was sooner.

The primary endpoint is RFS, defined as the time from randomization to any disease recurrence (local, locoregional, regional or distant) as assessed by the investigator, or death due to any cause. Key secondary endpoints include DMFS, OS, safety, tolerability and quality of life.

About intismeran autogene
Intismeran autogene (intismeran; V940 or mRNA-4157) is a novel, potential first-in-class investigational messenger RNA (mRNA)-based individualized neoantigen therapy (INT) jointly developed by Merck and Moderna. Intismeran is designed and produced using a patient’s tumor sample to identify the unique mutational signature, or "fingerprint," of their cancer and generate an anti-tumor immune response. Each therapy consists of a synthetic mRNA coding for up to 34 neoantigens and is tailored to the unique biology of an individual patient’s tumor. Upon administration, the RNA-encoded neoantigen sequences are translated in the body and presented to the immune system, a key step in generating specific T-cell responses against cancer cells. Individualized neoantigen therapies are designed to train and activate an anti-tumor immune response based on the unique mutational signature of a patient’s tumor.

About melanoma
Melanoma, one of the deadliest forms of skin cancer, is characterized by the uncontrolled growth of pigment-producing cells. The rates of melanoma have been rising over the past few decades, with more than 330,000 new cases diagnosed worldwide in 2022. In the U.S., skin cancer is one of the most common types of cancer diagnosed, and melanoma accounts for a large majority of skin cancer deaths. It is estimated there will be about 112,000 new cases of melanoma diagnosed and over 8,500 deaths resulting from the disease in the U.S. in 2026 alone. Despite advances in treatment, patients with resected melanoma remain at risk of disease recurrence, which most often occurs within the first two years. The majority of recurrences are metastatic rather than localized, highlighting the ongoing need for treatment approaches that may help reduce the risk of recurrence and improve long-term outcomes.

(Press release, Merck & Co, AUG 19, 2026, View Source [SID1234670226])

On August 19, 2026 Chemomab Therapeutics Ltd. (Nasdaq: CMMB) ("Chemomab"), a clinical stage biotechnology company developing innovative therapeutics for immune-fibrotic diseases with high unmet need, reported financial and operating results for the second quarter ended June 30, 2026, and provided a corporate update.

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Adi Mor, PhD, co-founder and Chief Executive Officer of Chemomab, said, "The planned merger with Scipher Medicine continues to advance. As we have reported, Scipher’s validated AI network medicine platform, SPECTRA, identified nebokitug as the leading candidate to address a major unmet need in rheumatoid arthritis (RA), a $24 billion market. We believe this merger provides our shareholders a compelling opportunity to potentially realize value through the clinical advancement of nebokitug in a large indication, as well as through Scipher’s revenue-generating precision medicine business and its biopharma partnerships. The opportunity also remains to secure a potential partner for a nebokitug Phase 3 trial in primary sclerosing cholangitis (PSC), an indication with no FDA-approved therapies. We look forward to working with our colleagues at Scipher to complete the proposed transaction and expedite the initiation of the Phase 2 trial in RA, marking an important new phase in the development of nebokitug and our anti-CCL24 platform."

Reg Seeto, MBBS, Chief Executive Officer of Scipher Medicine, said, "We believe the announced strategic merger with Chemomab is a unique opportunity to transform the treatment of immunology-based diseases with precision medicine. We plan to start with nebokitug in patients with rheumatoid arthritis, which like other immunology-based diseases is complex in origin. This complexity results in a heterogeneous patient population with unmet medical needs, since one-size-fits-all therapies do not work well for many patients. In RA, this approach has resulted in the majority of moderate-to-severe patients not achieving an enduring response, despite multiple available treatment options."

Dr. Seeto continued, "We reached out to Chemomab because SPECTRATM, our validated AI-enabled network medicine platform, had identified nebokitug’s novel mechanism as the highest ranked clinical program for potentially achieving efficacy in RA compared to both current and pipeline drugs in development. We intend to develop a nebokitug-specific molecular treatment-response signature (MTRS) using the technology that built the only MTRS approved by CMS in immunology. We believe this technology could increase the probability of clinical success, as we preferentially target the population that may benefit from nebokitug. Oncology has already demonstrated patient benefit with precision medicine by improving outcomes in a targeted population and has expanded the overall market with this approach of the right drug for the right patient. We see the field of immunology as the next frontier for precision medicine and we are already leading the way.

Second Quarter 2026 and Recent Highlights:

Entered into Definitive Merger Agreement with Scipher Medicine. On July 8, 2026, Chemomab announced that it had entered into a definitive merger agreement (the "Merger Agreement") with Scipher Medicine Corporation pursuant to which the companies will combine in an all-stock transaction (the "Merger"). Under the terms of the Merger Agreement, Chemomab equity holders are expected to own approximately 32% of the combined company, with Scipher equity holders owning approximately 68%, subject to customary adjustments. The combined company is valued at $150 million prior to a concurrent $30 million private placement financing and is expected to have sufficient cash to fund operations through the readout of the nebokitug Phase 2 RA trial. The private placement is being led by a syndicate of current Scipher investors, including Northpond Ventures, with participation from Khosla Ventures, Blue Owl Healthcare Opportunities, funds managed by Neuberger, and other leading investors, and includes 100% warrant coverage, with the warrants having an exercise price based on a $75 million valuation. In addition, immediately following the closing, Chemomab shareholders will receive contingent value rights (CVRs), providing the opportunity to receive future cash payments of $10 million upon U.S. Food and Drug Administration approval of nebokitug for any indication and $40 million if Chemomab’s PSC program advances to a Phase 3 clinical trial or is partnered, in each case subject to the terms and conditions of the CVR agreement. Upon completion of the Merger, the combined company is expected to operate as Scipher Medicine Corporation and trade on the Nasdaq Capital Market under the ticker symbol "SCIP." The combined company plans to initially focus on advancing nebokitug, a first-in-class clinical stage anti-CCL24 antibody, into a Phase 2 clinical trial for the treatment of rheumatoid arthritis, with topline results expected in the first half of 2028. Following the closing, Dr. Reginald Seeto will serve as Chief Executive Officer of the combined company, and Chemomab co-founder and Chief Executive Officer Dr. Adi Mor will join the combined company’s Board of Directors.
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Presented three abstracts on May 30, 2026 at EASL 2026, the Annual Congress of the European Association for the Study of the Liver in Barcelona, Spain.

In one EASL 2026 study1, Olink-generated analyses of circulating proteins in patient samples from the nebokitug PSC Phase 2 SPRING trial were used to generate an AI/machine learning model to identify patients who showed a combined improvement in three key fibrosis-related measures. The model showed strong performance and reliability, accurately distinguishing patients who met the combined improvement definition from those who did not.

A second EASL 2026 study2 examined the impact of nebokitug treatment on four PSC-specific gene expression programs (GEPs). Treatment with nebokitug was associated with statistically significant and dose-dependent reductions in the signatures linked to the PSC-related fibrotic and immune proteins. These findings provide further support for nebokitug’s CCL24 blocking activity as a mechanism-based approach targeting core molecular drivers of PSC pathogenesis.

A third EASL 2026 study3 examined nebokitug and its CCL24 target in patients with both PSC and inflammatory bowel disease (IBD). This study evaluated whether CCL24 inhibition modulates inflammatory and tissue-remodeling signatures relevant to PSC-IBD pathogenesis. The authors conclude that treatment with nebokitug resulted in improvements across inflammatory and tissue-remodeling proteins relevant to PSC with coexisting intestinal inflammation from ulcerative colitis and Crohn’s disease. These findings suggest that CCL24 inhibition may beneficially impact shared gut–liver inflammatory circuits in patients with co-existing PSC and IBD.

Presented new data from the company’s Phase 2 SPRING trial of nebokitug in PSC in an oral presentation at Digestive Disease Week (DDW 2026)4. On May 4, 2026, a new proteomic study showed that treatment with nebokitug resulted in dose-dependent reductions in multiple inflammatory and tissue-remodeling signatures relevant to both PSC and IBD. The authors conclude that inhibition of nebokitug’s CCL24 target may provide meaningful benefit in PSC patients with concomitant IBD.
1 – AI-driven proteomic profiling differentiates composite improvement following treatment with nebokitug in PSC; T. Snir, R. Aricha, J. Lawler, C Cirillo, D. Weiner, and A. Mor; EASL 2026 Abstract No. 1839; Immune-mediated and cholestatic disease: Clinical aspects; May 30, 2026, 8:30 – 16:00 CEDT

2 – Nebokitug down-regulates core fibrotic and immune pathways defined by single-cell liver profiling; R Aricha, T Snir, J Lawler, C Cirillo, D Weiner, A Mor; EASL 2026 Abstract No. 1852; Immune-mediated and cholestatic disease: Clinical aspects; May 30, 2026, 8:30 – 16:00 CEDT

3 – Nebokitug modulates gut-liver inflammatory and tissue remodeling signatures in PSC patients with coexisting IBD; R Aricha, T Snir, J Lawler, C Cirillo, D Weiner, and A Mor; EASL 2026 Abstract No. 1859; Immune-mediated and cholestatic disease: Clinical aspects; May 30, 2026, 8:30 – 16:00 CEDT

4 – Nebokitug modulates inflammatory and tissue-remodeling signatures in patients with PSC and coexisting IBD: Biomarker findings from SPRING Phase 2 trial; P. Mantry, T Snir, R Aricha, J Lawler, C Cirillo, D Weiner, A Mor; DDW 2026 Abstract No. 4484827, Advances in the Management of Primary Sclerosing Cholangitis; May 4, 2026, 2:00 – 3:30 PM CDT

Second Quarter 2026 Financial Highlights:

Cash Position: Cash, cash equivalents and short-term bank deposits were $6.7 million as of June 30, 2026, compared to $8.0 million as of March 31, 2026.

Research and Development (R&D) Expenses: R&D expenses were $1.1 million for the second quarter of 2026, compared to $1.3 million for the second quarter of 2025.

General and Administrative (G&A) Expenses: G&A expenses were $1.1 million for the second quarter of 2026, compared to $1.0 million for the second quarter of 2025.

Net Loss: Net loss was $2.2 million, or a net loss of less than $0.01 per basic and diluted ordinary share, for the second quarter of 2026, compared to $2.1 million, or a net loss of less than $0.01 per basic and diluted ordinary share, for the second quarter of 2025. The weighted average number of ordinary shares outstanding, basic and diluted, was 640,243,933 (equal to approximately 8,003,049 ADSs) for the second quarter of 2026.

Liquidity and Capital Resources: Chemomab believes its existing liquidity resources as of June 30, 2026 will enable it to fund its operations through the first quarter of 2027.

Number of Issued and Outstanding Shares: As of June 30, 2026, the company had 579,648,600 issued and outstanding shares compared to 575,381,320 as of December 31, 2025.
Merger Update
Chemomab has confidentially submitted a draft registration statement on Form S-4 to the U.S. Securities and Exchange Commission (SEC) in connection with its proposed Merger with Scipher Medicine. The confidential submission enables the SEC review process to begin while certain required financial information is being finalized, helping to support the transaction timeline. The registration statement is expected to be publicly filed following the SEC’s initial review process, in accordance with applicable SEC rules. The companies expect the Merger to close before the end of 2026, subject to SEC review, shareholder approvals and other customary closing conditions. For additional information, please refer to the company’s Form 6-K filed with the SEC today.

(Press release, Chemomab, AUG 19, 2026, View Source [SID1234670225])

On August 19, 2026 Xspray Pharma reported that the FDA’s Complete Response Letter relates to the previously communicated observations at NerPharMa, concerning outstanding GMP (Good Manufacturing Practice) observations, as well as a request for additional commercial scale consecutive batch data following already implemented corrective actions. Importantly, the FDA has not raised questions regarding Dasynoc’s clinical data, bioequivalence or stability. Furthermore, the risk of medication error raised in previous CRLs has been resolved.

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NerPharMa, the Company’s third-party manufacturer, has completed and announced to the FDA that its remediation work at the facility is complete. The FDA has yet to determine if a reinspection is required for the agency to finalize their assessment of the facility’s status.

Since Xspray’s launch planning necessitated additional commercial scale batches to be produced, the manufacture of these batches will now be prioritized to satisfy the FDA’s request for additional data.

Xspray intends to resubmit the application as soon as possible within 2026 to secure a new PDUFA date and subsequently accelerate the launch.

Blake Leitch, CEO of Xspray Pharma, comments:
"The CRL confirms that the remaining uncertainty is now linked to NerPharMa sufficiently addressing the FDAs observations at their manufacturing site and batch data from consecutive manufacturing runs being provided. As expected, this will require a NDA resubmission.

We had already targeted to proceed with commercial manufacturing as part of our operational plan. We will accelerate this step to ensure a resubmission will occur this as soon as possible in 2026 while simultaneously remain focused on working with our partner to ensure that the remaining FDA requirements of NerPharMa can be met as efficiently as possible.

The CRL does not change the company’s financial position as communicated in the recent Q2-report and we will continue to ensure the right balance between financial discipline and execution readiness as a key priority."

Xspray will continue preparing for commercial launch in the United States, so that the Dasynoc can rapidly reach oncologists and patients with CML and ALL once all regulatory conditions have been fulfilled.

About Dasynoc
Dasynoc is Xspray’s product candidate based on dasatinib, an established treatment for, among other indications, chronic myeloid leukemia and acute lymphoblastic leukemia. Dasynoc is developed using Xspray’s patented HyNap technology and is an amorphous formulation of dasatinib.

The product candidate has demonstrated bioequivalence at a 30 percent lower dose and is designed to enable concomitant use with acid-reducing medicines, a common co-medication that may affect the absorption of conventional dasatinib.

(Press release, Xspray, AUG 19, 2026, View Source [SID1234670210])

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])

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])