On August 24, 2026 GSK plc (LSE/NYSE: GSK) reported the US Food and Drug Administration (FDA) has accepted for priority review a supplemental Biologics License Application (sBLA) for Jemperli (dostarlimab) for patients with previously untreated stage II and III mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) locally advanced rectal cancer. The FDA has assigned a PDUFA action date of February 2027. The application is also eligible for expedited review through the National Priority Voucher program, which could result in an earlier FDA decision1.

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Rectal cancer, a type of bowel cancer, affects around 770,000 people globally each year2 and approximately 5-10% of cases have the dMMR/MSI-H subtype3. Chemotherapy, radiation and surgery are the standard of care and while often effective, they can have lasting adverse effects on bowel, urinary and sexual function, fertility and overall quality of life4,5,6.

The application is based on positive data from the registrational phase II, single-arm AZUR-1 trial, which met its primary objective by demonstrating a meaningful and sustained clinical complete response rate for 12 months (cCR12) with no detectable signs of cancer for at least one year. In interim data, the safety and tolerability profile of dostarlimab was generally consistent with its well-characterised and manageable safety profile observed across solid tumours. These data will be submitted for presentation at a scientific congress later in 2026.

AZUR-1 results represent a substantial improvement compared to the historical standard of care7. The data support the potential for dostarlimab, if approved, to become the first immunotherapy capable of eliminating or delaying the need for chemotherapy, radiation and surgery for some patients in this population. These findings build on earlier research conducted with Memorial Sloan Kettering Cancer Center (MSK), which first demonstrated the potential for dostarlimab to achieve clinical complete responses without other treatments in patients with dMMR/MSI-H locally advanced rectal cancer.

Dostarlimab was previously granted Fast Track and Breakthrough Therapy Designations in this setting8,9. The application has also been accepted under Project Orbis, an FDA Oncology Center of Excellence initiative that enables coordinated reviews by international health authorities and may support earlier regulatory decisions and patient access. Regulatory decisions remain independent in each country.

About stage II and III dMMR/MSI-H locally advanced rectal cancer
Rectal cancer affects around 770,000 people globally each year2. Around 5–10% of rectal cancers are mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H)3. These tumours have a specific genetic characteristic where they are unable to properly repair DNA damage, leading to an accumulation of mutations. This unique biological feature often makes them highly responsive to immunotherapies like dostarlimab10,11. These biomarkers are most commonly found in endometrial, colorectal and other gastrointestinal cancers, but can also be present in other solid tumours12.

About AZUR-1
AZUR-1 is a global, open-label, single-arm, registrational phase II trial evaluating dostarlimab monotherapy in patients (n=154) with previously untreated stage II and III dMMR/MSI-H locally advanced rectal cancer. The trial was designed to assess sustained clinical complete responses for 12 months (cCR12) and determine whether dostarlimab alone could enable patients to avoid chemotherapy, radiation and surgery. Patients received nine cycles of dostarlimab over six months, administered as a 500mg intravenous infusion every three weeks. In interim data, the safety and tolerability profile of dostarlimab was generally consistent with its well-characterised and manageable safety profile observed across solid tumours.

The AZUR-1 results represent a substantial improvement compared to the historical standard of care. They build on earlier research conducted in collaboration with Memorial Sloan Kettering Cancer Center, which first demonstrated the potential for dostarlimab to achieve clinical complete responses without other treatments in patients with dMMR/MSI-H locally advanced rectal cancer.

About Jemperli  
Jemperli, a programmed death receptor-1 (PD-1)-blocking antibody, is the backbone of GSK’s ongoing immuno-oncology based research and development programme. A robust clinical trial programme includes studies of Jemperli alone and in combination with other therapies in gynaecologic, colorectal and head and neck cancers, as well as where there are opportunities for transformational outcomes.

Jemperli was discovered by AnaptysBio, Inc. and licensed to TESARO, Inc., under a collaboration and exclusive license agreement signed in March 2014. Under this agreement, GSK is responsible for the ongoing research, development, commercialisation and manufacturing of Jemperli.

More information about the product and its indications is available at EU product information13 and US product information14.  Jemperli is not currently approved anywhere in the world for locally advanced rectal cancer.

(Press release, GlaxoSmithKline, AUG 24, 2026, View Source [SID1234670293])

On August 24, 2026 Valerio Therapeutics (FR0010095596 – ALVIO), a biotechnology company pioneering next-generation precision-guided RNA therapeutics ("Valerio" or the "Company"), reported the signing of a definitive share purchase agreement (the "SPA") and of the related contribution agreement (the "Contribution Agreement") for the acquisition of 100% of the share capital and voting rights of Etherna Immunotherapies NV ("Etherna") (the "Acquisition"), based on an enterprise value of €30 million, and a €40.25 million private investment in public equity (PIPE) financing supported by existing shareholders and new investors (the "Financing").

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"The acquisition of Etherna marks a decisive step in Valerio’s strategy: to build a leading player in RNA therapeutics. By combining Etherna’s RNA and LNP platforms with our proprietary cell-targeting technologies, we are creating a powerful innovation engine designed to accelerate the development of next-generation RNA medicines. Most importantly, our combined platforms enable us to overcome a bottleneck that has held the field back for decades: reaching tissues beyond the liver and, in doing so, opening the way to the treatment of a broad range of diseases that have so far been beyond the reach of conventional mRNA delivery." said Gilles Besin, Ph.D., CEO of Valerio.

"Signing this agreement is a defining moment for Etherna, and I could not be prouder of what our team has built with the support of our investors. Over the past years, we have turned a decade of mRNA and LNP expertise into platforms capable of reaching far beyond what conventional mRNA and delivery and manufacturing technologies could ever achieve. Joining forces with Valerio gives that platform the scale, the targeting capabilities and the resources to move faster and further than we could alone. I want to thank our shareholders, partners and, above all, our people for their trust and dedication in getting us here. Together with Valerio, Etherna’s science and manufacturing will deliver transformative medicines to patients who need them most.", said Bernard Sagaert, CEO of Etherna.

Terms and Conditions of the Acquisition

The Acquisition marks a major milestone in Valerio’s strategy to build a leading platform in targeted nucleic acid medicines. By uniting three complementary technology platforms – nucleic acid chemistry, LNP delivery and targeted moiety engineering – within a fully integrated biotech supported by in-house manufacturing capabilities, the Acquisition aims to position Valerio to accelerate the development of next-generation RNA medicines targeting tissues beyond the liver.

The Acquisition will be settled through (i) a cash consideration, fully funded by the Financing, and (ii) a share consideration through contributions in kind of Etherna shares (the "Contributions") to the Company.

The Contributions remain subject to Valerio shareholders approval at an extraordinary general meeting to be convened for that purpose expected to be held on or about October 6, 2026. Approval is secured by irrevocable voting undertakings from existing shareholders representing more than 70% of the voting rights of the Company.

Shares issued as consideration for the Contributions will be valued at the same Subscription Price as the New Shares issued in the Financing. A contribution auditor (commissaires aux apports) has been appointed to assess the valuation of the Contributions and issue a fairness report. Certain lenders and managers of Etherna will also subscribe to new Valerio shares through the set-off of their receivables owed by Etherna at the same subscription price.

The consideration for the Acquisition is based on an enterprise value of €30 million (on a debt-free, cash-free basis) subject to customary purchase price adjustments and contingent earn-out payments.

Main Terms of the Financing

The Financing was carried out through the issuance of 68,220,333 new ordinary shares (the "New Shares"), at a subscription price of €0.59 per share (i.e., a par value of €0.01 and an issuance premium of €0.58 per New Share) (the "Subscription Price"), representing a discount of 25% to the 3-day VWAP prior to pricing.

The New Shares are issued through a capital increase without shareholders’ preferential subscription rights by way of an offering referred to in paragraph 1 of article L. 411-2 of the French Monetary and Financial Code (Code monétaire et financier), and pursuant to the decisions of the Company’s Chief Executive Officer on August 21, 2026, acting upon sub-delegation of the Company’s Board of Directors on July 30, 2026, in accordance with the delegations granted pursuant to the 15th resolutions and within the limits set by the 22nd resolution of the Company’s combined shareholders’ meeting held on June 16, 2026 (the "General Meeting").

The issuance of the 68,220,333 New Shares will result in a capital increase of €40.25 million (i.e., a nominal amount of €682,203.33 and a total issuance premium of €39,567,793.14), representing approximately 13.7% of the Company’s share capital and voting rights outstanding before the Financing.

Existing shareholders Artal International SCA, Financière de la Montagne and Saint James Luxembourg subscribed for €18.0 million, €7.0 million and €1.0 million respectively. Artal International SCA and Financière de la Montagne, who are also members of or represented on Valerio’s Board of Directors, did not take participate in the vote on the Financing at the Board of Directors’ meeting held on July 30, 2026.

Following the settlement-delivery of the New Shares expected on August 26, 2026, the Company’s share capital will be €5,676,686.34 divided into 567,668,634 ordinary shares.

Impact of the Financing on Cash Flow and Use of Proceeds

The Company intends to use the net proceeds from the Financing, together with its existing cash and cash equivalents, to: (i) fund the cash component of the consideration payable in connection with the Acquisition; (ii) advance its proprietary pipeline, including VTX-001, VTX-002 and VTX-003, as well as IND-enabling activities for VTX-001; (iii) integrate Etherna into Valerio, including by investing in and scaling Etherna’s GMP manufacturing capabilities at its Niel facility to support the Company’s clinical supply requirements and build internal capacity for mRNA and LNP production, and by combining the two organizations’ research, technical operations and quality functions on a single platform; and (iv) fund working capital and other general corporate purposes.

The expected use of net proceeds reflects the Company’s current intentions, based on its present plans and business condition. The amounts and timing of the Company’s actual expenditures will depend on numerous factors, including the progress of its development programs, the timing and outcome of the integration of Etherna, and any unforeseen cash needs.

Based on its current operating plan and forecasted expenses, and taking into account its cash and cash equivalents together with the net proceeds from the Financing, the Company believes it has sufficient resources to fund its planned operating expenses and capital expenditure requirements for at least 18 months following the closing of the Financing. This estimate is based on assumptions that may prove to be incorrect, and the Company may use its capital resources sooner than currently expected.

Shareholding Structure after the Financing

On an illustrative basis, a shareholder holding 1% of the Company’s share capital before the Financing and who did not participate in the Financing will hold 0.88% of the Company’s share capital after the issuance of the New Shares.

To the Company’s knowledge, the shareholding structure, on a non-diluted basis, before and after the Financing, breaks down as follows:

Before Financing After Financing
Shareholders Number of Shares % Share Capital % Voting Rights Number of Shares % Share Capital % Voting Rights
Artal International SCA 219 981 537 44.04 % 44.04 % 250 490 011 44.1% 44.1%
Financière de la Montagne 90 486 732 18.12 % 18.12 % 102 351 138 18.0% 18.0%
Fidat Ventures 43 478 260 8.71 % 8.71 % 43 478 260 7.7% 7.7%
SCP Esperanza 2019 41 977 806 8.40 % 8.40 % 41 977 806 7.4% 7.4%
Others 103 523 966 20.73 % 20.73 % 129 371 419 22.8% 22.8%
499 448 301 100.00 % 100.00 % 567 668 634 100.00 % 100.00 %
Lock-up Agreements

In connection with the Financing, the Company has entered into a lock-up agreement restricting the issuance of additional ordinary shares for a period ending ninety (90) calendar days following the date of settlement-delivery, subject to customary exceptions.

In addition, the investors subscribing to the Financing, have agreed to a sixty (60) calendar days lock-up on the New Shares, following the date of settlement-delivery, subject to customary exceptions.

Settlement-delivery of the Financing

The admission of the New Shares to trading on the Euronext Growth market in Paris is scheduled for the time of settlement and delivery, which is expected to take place on August 26, 2026.

The New Shares will be immediately assimilated to the Company’s existing shares already traded on Euronext Growth in Paris, and will be able to be traded, from their issuance, on the same listing line (ISIN code: FR0010095596).

The Financing has not given rise to a prospectus submitted for approval by the AMF, nor to an information document containing the information set out in Annex IX of Regulation (EU) 2017/1129, as amended.

Risk Factors

The Company draws the public’s attention to the risk factors related to the Company and its activities presented in the 2025 annual financial report published on April 28, 2026, which is available free of charge on the website of the Company (View Source).

In addition, investors are invited to consider the following risks: (i) shareholders’ stake in the Company will be diluted further to the issuance of the New Shares for the shareholders who did not participate in the Financing, (ii) the market price for the Company’s shares may fluctuate and fall below the subscription price of the shares issued pursuant to the Financing, (iii) the volatility and liquidity of the Company’s shares may fluctuate significantly, (iv) sales of the Company’s shares may occur on the market and have a negative impact on the market price of the shares, and (v) the Company’s shareholders could undergo a potentially material dilution resulting from any future capital increases that are needed to finance the Company.

Advisors

Van Lanschot Kempen NV is acting as exclusive financial advisor for the Acquisition and as Sole Placement Agent in connection with the Financing. Goodwin Procter LLP is acting as legal counsel to Valerio Therapeutics.

Moelis & Company is acting as financial advisor to Etherna. Deloitte (Belgium) and August Debouzy (France) are acting as legal counsels to Etherna.

(Press release, eTheRNA, AUG 24, 2026, View Source [SID1234670292])

On August 24, 2026 Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to ERAS-0015 for the treatment of patients with metastatic pancreatic adenocarcinoma. ERAS-0015 is an oral, highly potent pan-RAS molecular glue designed to inhibit RAS signaling with a potential best-in-class profile.

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"Receiving FTD is an important milestone for ERAS-0015 and reflects the urgent need for new therapies for patients with metastatic pancreatic cancer," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "Together with the encouraging clinical activity and favorable tolerability observed to date, this FTD helps to position us to rapidly advance the clinical development of ERAS-0015, including working closely with FDA on a planned Phase 3 trial in pancreatic cancer, alongside two additional potentially pivotal trials in lung cancer. We look forward to reporting additional monotherapy and combination data in the first half of 2027."

FTD is intended to facilitate development and expedite the review of therapies for serious conditions with unmet medical needs. Designated programs may benefit from more frequent interactions with the FDA and, if relevant criteria are met, may be eligible for benefits such as accelerated approval, priority review, and rolling review.

In July 2026, Erasca reported updated preliminary data from the AURORAS-1 Phase 1 trial in the U.S. demonstrating encouraging clinical activity, including a 57% uORR8wk in patients with second-line or later (2L+) KRAS G12X pancreatic ductal adenocarcinoma (PDAC) receiving ERAS-0015 monotherapy at the recommended dose for expansion (RDE) of 32 mg once daily.1 All responding patients across doses remained on treatment as of the data cutoff, and ERAS-0015 continued to demonstrate favorable tolerability.2 Additional data from the monotherapy expansion and combination dose escalation cohorts, including the panitumumab combination, are expected in the first half of 2027.

The uORR8wk is the overall response rate (ORR) (confirmed and unconfirmed responses) for patients who received first dose of ERAS-0015 at least 8 weeks prior to the May 25, 2026 data cut off.
2 May 25, 2026 data cut off

About ERAS-0015
ERAS-0015 is an investigational, oral, highly potent pan-RAS molecular glue designed to inhibit RAS signaling with a potential best-in-class profile. Erasca is evaluating ERAS-0015 in the AURORAS-1 Phase 1 trial in patients with RAS-mutant solid tumors. Early dose escalation data in AURORAS-1 demonstrated favorable safety and tolerability results, well-behaved, linear PK, and confirmed and unconfirmed partial responses in multiple patients across multiple tumor types with different RAS mutations, including confirmed partial responses at doses as low as 8 mg once daily (QD). ERAS-0015 is also designed to prevent resistance against mutant-selective inhibitors through inhibition of RAS wildtype variants. In addition, ERAS-0015 has demonstrated favorable absorption, distribution, metabolism, and excretion (ADME) and pharmacokinetic (PK) properties in multiple animal species.

(Press release, Erasca, AUG 24, 2026, View Source [SID1234670291])

On August 24, 2026 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXL) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, reported that Bria-MEL+, its personalized whole cell melanoma immunotherapy vaccine candidate, has achieved a key genetic engineering milestone, advancing the program toward clinical development.

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Bria-MEL+ is a cell-based therapeutic cancer vaccine designed to harness a patient’s own immune system to combat melanoma. The program is personalized yet ‘off-the-shelf ’: a simple patient saliva test will determine which of the several premanufactured treatment cell lines will be selected for personalized treatment, avoiding the need to manufacture a unique product for each individual patient.

"Bria-MEL+ is designed to combine the advantages of personalized immunotherapy with the accessibility of an off-the-shelf vaccine," said William V. Williams, MD, President and Chief Executive Officer of BriaCell. "By eliminating individualized manufacturing, we believe this approach has the potential to broaden access, shorten treatment timelines, and reduce treatment costs while preserving patient-specific matching."

"Building on the encouraging efficacy and tolerability results from BriaCell’s metastatic breast cancer immunotherapy program, we continue to expand our pipeline with additional personalized, cell-based immunotherapy vaccine candidates, including Bria-MEL+ for melanoma," stated Miguel A. Lopez-Lago, PhD, BriaCell’s Chief Scientific Officer.

About Bria-MEL+

Bria-MEL+ is a personalized, off-the-shelf, genetically modified whole-cell cancer vaccine designed to activate multiple components of the immune system, including innate and adaptive immune responses, to target and destroy melanoma cells. The program is derived from BriaCell’s Bria-OTS+ (off-the-shelf) cellular immunotherapy platform and is being developed using premanufactured cell lines selected through patient HLA matching.

BriaCell’s Bria-MEL+ expands the Company’s personalized immunotherapy platform which is led by Bria-IMT, currently in a pivotal Phase 3 trial for metastatic breast cancer. BriaCell is also advancing Bria-OTS in breast cancer, in which the first patient dosed experienced sustained complete resolution of a lung metastasis, and Bria-PROS+ in prostate cancer which has recently received FDA clearance to initiate clinical evaluation. The Bria-MEL+, Bria-PROS+ and Bria-OTS programs are based on matching patient HLA type with the corresponding immunotherapy cell line.

Earlier In 2026, BriaCell reported preclinical data from the Bria-OTS+ platform at the AACR (Free AACR Whitepaper) Annual Meeting, Bria-OTS+ demonstrated activation of both adaptive and innate immunity, including naïve/resting T cells, dendritic cells, and natural killer (NK) cells, inducing immune memory and eliciting "serial killer" activity against cancer cells. BriaCell believes this multipronged immune activation supports the potential of the Bria-OTS+ platform to generate anti-tumor immune responses and informs the development of Bria-MEL+ for melanoma.

BriaCell has commenced development activities to support production of Bria-MEL+ for potential clinical use. Bria-MEL+ recently passed a key milestone in the genetic engineering process, streamlining the path to the clinic.

Melanoma Facts

The American Cancer Society estimates that approximately 112,000 new cases of melanomas will be diagnosed in the United States in 2026, including about 65,400 in men and 46,600 in women. Based on 2021–2023 Surveillance, Epidemiology, and End Results (SEER) data, approximately 2.2% of men and women will be diagnosed with skin melanoma during their lifetime.

Despite major advances in treatment, melanoma remains a significant unmet medical need. Approximately 8510 people are expected to die from melanoma in the United States in 2026, including about 5500 men and 3010 women. Melanoma accounts for only about 1% of skin cancers but causes a large majority of skin cancer deaths.

(Press release, BriaCell Therapeutics, AUG 24, 2026, View Source [SID1234670290])

On August 23, 2026 Anbogen Therapeutics Inc. (TPEx: 7784) ("Anbogen" or the "Company"), a clinical-stage precision oncology company, reported that it has entered into a Collaborative Research Agreement (CRA) with the Laboratory of Veterinary Surgery, Graduate School of Agricultural and Life Sciences, The University of Tokyo, to evaluate ABT-301 (Imofinostat), the Company’s selective Class I histone deacetylase inhibitor (HDACi), across multiple solid tumor types (including osteosarcoma, melanoma, soft tissue sarcoma, bladder cancers and other refractory solid tumors) using established veterinary oncology models.

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The collaboration will be led by Lecturer Daiki Kato, Professor Takayuki Nakagawa, and Professor Manabu Mochizuki, Director of the Affiliated Veterinary Medical Center, The University of Tokyo. The research team brings extensive expertise in translational oncology, cancer immunotherapy, and genomic medicine in companion animals, and operates one of Asia’s most comprehensive comparative oncology platforms.

Accelerating Human Clinical Development Through Comparative Oncology

The primary strategic objective of this collaboration is to generate the scientific evidence required to support the expansion of ABT-301’s human clinical indications and to optimize the compound’s combination strategies ahead of future clinical trials. Naturally occurring cancers in dogs are widely recognized as clinically and molecularly analogous to their human counterparts. Among these, canine osteosarcoma represents one of the most extensively studied comparative oncology models due to its remarkable biological and clinical similarities to human osteosarcoma. Insights generated from this naturally occurring disease provide a unique opportunity to evaluate therapeutic strategies at disease stages that are often difficult to study in early human clinical development, making canine data directly informative for human clinical trial design, patient selection strategies, and regulatory submissions. Using The University of Tokyo’s proprietary preclinical models, the collaboration will evaluate ABT-301 as a monotherapy and in combination with other agents, with comprehensive mechanistic analyses to elucidate its mechanism of action and identify the molecular backgrounds most predictive of response. Findings will directly inform indication selection and combination regimen design for future human trials.

Dr. John Hsu, Chairman and CEO of Anbogen Therapeutics, said: "Comparative oncology is far more than animal research. It is a powerful platform for generating cross-species translational evidence that can bridge preclinical findings and human clinical development. Through this collaboration, we aim to evaluate ABT-301 in models that more closely reflect real-world disease biology, generating scientifically robust translational data to support future indication expansion and clinical development decisions. This strategic partnership will enable us to systematically assess ABT-301 across a broad range of difficult-to-treat solid tumors and extend its clinical potential beyond our current colorectal cancer program. The resulting evidence will be critical for designing and supporting the expansion of our ongoing human clinical development into new indications."

ABT-301 is currently being evaluated in a Phase I/II clinical trial in combination with anti-PD-1 and anti-VEGF in patients with pMMR/non-MSI-High metastatic colorectal cancer. As an isoform-selective Class I HDACi, ABT-301 is designed to modulate the tumor immune microenvironment and sensitize tumors to immune checkpoint inhibition where lies the potential applicability across immunologically cold solid tumors. Importantly, independent Phase III clinical studies evaluating other HDAC inhibitors in combination with immune checkpoint inhibitors have demonstrated significant synergistic efficacy in advanced cancers, including a marked improvement in progression-free survival (PFS). These external clinical findings provide strong proof-of-concept for the HDAC inhibitor–immune checkpoint inhibitor combination strategy and further support the clinical development of ABT-301 across multiple cancer indications.

Dr. Daiki Kato, The University of Tokyo, said: "Naturally occurring cancers in dogs and cats develop spontaneously under environmental and lifestyle conditions shared with humans and evolve through immune editing to acquire complex tumor immune microenvironments. These unique characteristics enable naturally occurring canine and feline cancer models to faithfully recapitulate key biological, immunological, and clinical features that are difficult to reproduce in conventional preclinical models. We believe this collaborative research will generate robust translational evidence to support the clinical development of ABT-301. Our research team is fully committed to maximizing the scientific impact of this collaboration and to providing the scientific evidence needed to support indication expansion and future clinical development of ABT-301."

About ABT-301 (Imofinostat)

ABT-301 is an orally available, selective Class I HDAC inhibitor designed to reverse immune evasion in solid tumors by enhancing antigen presentation and promoting anti-tumor immune activity. ABT-301 is currently being evaluated in a Phase I/II clinical trial in combination with anti-PD-1 and anti-VEGF therapy for the treatment of metastatic colorectal cancer. The Company believes that ABT-301’s mechanism of action has broad applicability across multiple immunotherapy-resistant solid tumor types.

(Press release, Anbogen Therapeutics, AUG 23, 2026, View Source [SID1234670286])