On June 26, 2026 Servier reported it will present new and updated data at the 22nd International Symposium on Pediatric Neuro-Oncology (ISPNO 2026) June 28 – July 1 in Sydney, Australia. Servier’s presence at ISPNO 2026 emphasizes its advancing leadership in neuro-oncology research with the addition of OJEMDA (tovorafenib) to its growing glioma portfolio following the recent acquisition of Day One Biopharmaceuticals.

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"Our upcoming presentations at ISPNO 2026 help strengthen the robust body of evidence supporting the safety and efficacy of OJEMDA, further establishing it as a standard of care for children with relapsed/refractory pediatric low-grade glioma," said Elly Barry, MD, Chief Medical Officer, Day One Biopharmaceuticals, now part of Servier Group. "These latest analyses from the pivotal FIREFLY-1 study – as well as the results from our caregiver survey – underscore our fierce commitment to supporting children with pediatric low-grade glioma and their caregivers, and the continued development of OJEMDA as part of Servier’s growing glioma portfolio."

Servier will present updated three-year follow up growth recovery data from the pivotal Phase 2 FIREFLY-1 study in an oral presentation on July 1. The results suggest that most children with BRAF-altered pediatric low-grade glioma (pLGG) who experienced reduced growth velocity while being treated with OJEMDA experienced growth recovery after discontinuing treatment.

A separate analysis of the three-year follow up FIREFLY-1 data evaluating the impact of prior therapy on OJEMDA activity in BRAF-altered pLGG will also be presented in an oral presentation on July 1. Clinical benefits were observed with OJEMDA across lines of therapy, with trends toward improved durability in MAPK inhibitor-naïve patients.

Servier will also share results from a survey of pLGG caregivers about communication with their child’s diagnosing provider. Caregivers in the U.S. were invited by advocacy organizations and fellow caregivers to complete an online survey to understand caregivers’ experience of provider communication about pLGG diagnosis, including what language was used, what information was communicated, and how the approach to communication affected understanding. Data were collected using a custom-developed survey comprised of primarily closed-ended questions – scaling, yes/no, and multiple choice. This study was funded by Day One Biopharmaceuticals, a Servier Group Company.

The survey results identified both effective and suboptimal aspects of caregiver-provider communication during pLGG diagnosis and early treatment decision-making, highlighting opportunities to improve communication, strengthen trust, and increase caregiver confidence and preparedness.

(Press release, Servier, JUN 26, 2026, View Source [SID1234668970])

On June 26, 2026 Replimune Group, Inc. (NASDAQ: REPL), a clinical-stage biotechnology company pioneering the development of novel oncolytic immunotherapies, reported that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma. The FDA considers this a complete, class 1 response with a goal date of August 2, 2026, and has notified the company to expect an advisory committee meeting in late July.

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"We are pleased that the FDA has demonstrated urgency in reconsidering the RP1 BLA with an expeditious action date in recognition of the significant unmet need for advanced melanoma patients and support from the broader melanoma community," said Sushil Patel, Ph.D., CEO of Replimune. "We look forward to a productive scientific and clinical discussion on the risk/benefit profile of RP1 in this difficult to treat setting."

The resubmission seeks accelerated approval of RP1 in advanced melanoma based on data from the IGNYTE clinical trial, which evaluated RP1 combined with nivolumab in patients with confirmed progression on an anti-PD-1 containing regimen.

About Advanced Melanoma

Melanoma is the fifth most common cancer in the United States, with approximately 112,000 new cases estimated in 2026 and the most lethal form of skin cancer, accounting for nearly 8,500 deaths annually. Melanoma is considered advanced when the cancer has spread beyond the primary tumor. Standard of care therapy includes immune checkpoint blockade, to which approximately half of patients will not respond or will progress after treatment, leaving a significant population in need of effective therapeutic alternatives.

About RP1

RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate, based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R⁻) and GM-CSF. RP1 is designed to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

(Press release, Replimune, JUN 26, 2026, View Source [SID1234668968])

On June 26, 2026 MaaT Pharma (EURONEXT: MAAT – the "Company"), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, reported that the CHMP of the EMA has adopted a negative opinion on the conditional MAA for MaaT013, under the brand name Xervyteg, for the treatment of acute Graft-versus-Host Disease (aGvHD) in adult patients with gastrointestinal involvement refractory to prior lines of therapy. This confirms the previously announced negative trend opinion disclosed on May 20, 2026. The Company has reviewed grounds cited by the CHMP and confirms its plan to seek re-examination of the opinion as previously announced.

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Under EMA procedures, the re-examination includes the appointment of a new rapporteur and co-rapporteur who will conduct a new and independent evaluation of the dossier. MaaT Pharma will also request a Scientific Advisory Group (SAG) hearing with hematology experts on aGvHD to provide input and insights to the CHMP into, among other things, the clinical reality of managing aGvHD with complex concomitant therapies and patients in high need of solutions due to the severity of the disease and the lack of any other efficient third-line therapy so far.

In its opinion of June 25, 2026, the CHMP maintained the position that, given the use of concomitant therapies to manage aGvHD, the data package, primarily based on the ARES single-arm study, does not allow sufficient attribution of the observed clinical effect and safety to the study treatment alone.

Based on current EMA procedural timelines, a new CHMP opinion is expected within 60 days following validation of the re-examination request, with a second decision anticipated in the CHMP September Session (September 14-17, 2026).

MaaT Pharma remains confident in the clinical profile of MaaT013 (Xervyteg), to treat a population with very limited treatment options and poor prognosis. This is supported by data from the ARES study, as well as data from the CHRONOS study (Clausen et al., 2026) and real-world evidence from its Early Access Program, active in 13 countries, with more than 300 patients treated since 2019. The Company also confirms that the re-examination process has no impact on the ongoing Early Access Program, as of today, and that MaaT013 (Xervyteg) remains available to eligible patients.

MaaT Pharma’s strategy also extends beyond MaaT013 (Xervyteg), supported by the development of MaaT033, an oral microbiome therapy, currently evaluated in a randomized controlled Phase 2 trial for broader prophylactic and outpatient use in hemato-oncology, and by the expansion of its platform into immuno-oncology with the next generation product MaaT034.

(Press release, MaaT Pharma, JUN 26, 2026, View Source [SID1234668966])

On June 26, 2026 Lantheus Holdings, Inc. ("Lantheus" or "Company") (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, reported that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding its New Drug Application (NDA) for LNTH-2501 (Gallium 68 edotreotide), a PET diagnostic imaging kit targeting somatostatin receptor-positive (SSTR+) neuroendocrine tumors (NETs).

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The FDA stated that the agency cannot approve the NDA by the Prescription Drug User Fee Act (PDUFA) action date of June 29, 2026, due to unresolved third-party facility manufacturing-related conditions. The third-party facility is responsible for drug product manufacturing. Satisfactory resolution of the unresolved facility inspection-related conditions is required before the LNTH-2501 NDA may be approved.

The CRL did not identify any concerns regarding the data submitted by Lantheus in support of the application, nor did it identify any issues related to the safety or efficacy of LNTH-2501.

"We remain confident in LNTH-2501 and are committed to bringing this imaging agent to NETs patients and healthcare providers as soon as possible," said Mary Anne Heino, Executive Chairperson and Chief Executive Officer, Lantheus. "The feedback received from the FDA relates solely to our third-party manufacturer, and not to the clinical performance of the product. We are working closely with our partner and the Agency to address these facility manufacturing-related conditions and advance the program."

About LNTH-2501 (Ga 68 edotreotide)
LNTH-2501 (Kit for Preparation of Ga 68 edotreotide Injection), is an investigational radioactive diagnostic kit indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. LNTH-2501 is supplied as a 2-vial kit to radiopharmacies which allows for direct preparation of Ga 68 edotreotide injection with the eluate of Gallium from an on-site generator at the radiopharmacy. LNTH-2501 is not currently approved by the FDA and is not yet available for sale in the United States.

(Press release, Lantheus, JUN 26, 2026, View Source [SID1234668965])

On June 26, 2026 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 and FLT3 inhibitor, reported that eleven clinical sites have been initiated and are now open for patient enrollment in its Phase 2 TakeAim CLL study evaluating emavusertib in combination with zanubrutinib in patients with Chronic Lymphocytic Leukemia. The Company also reaffirmed its guidance for the dosing of the initial five patients in the TakeAim CLL study by the end of July 2026, with data expected in December 2026. In addition, the Company reported that its stockholders approved a reverse stock split proposal at the special meeting of stockholders held on June 25, 2026.

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TakeAim CLL Update

Eleven clinical sites are now open for enrollment in the TakeAim CLL study, reflecting strong investigator interest in the combination of emavusertib and zanubrutinib as a strategy to enable dual blockade of NF-kB, a key driver of CLL disease. The Company reaffirmed its expectations to announce the dosing of the initial five patients in the TakeAim CLL combination study with zanubrutinib by the end of July 2026, with data expected in December 2026.

"We are pleased with both our operational progress in the CLL study and the strong support from our shareholders as we work to regain compliance with the NASDAQ bid price listing requirement," said James Dentzer, President and CEO of Curis, "and we look forward to building on those successes in the weeks and months to come."

Special Meeting Vote Results

At the Company’s special meeting of stockholders held on June 25, 2026, stockholders approved a proposal to amend the Company’s Restated Certificate of Incorporation to effect a reverse stock split of its issued and outstanding shares of common stock at a ratio ranging from 1-for-5 to 1-for-25, in furtherance of the Company’s regaining compliance with Nasdaq’s $1.00 bid price rule, with the final ratio to be determined at the discretion of the Company’s Board of Directors. The Company intends to announce the specific ratio and effective date in advance of the reverse stock split becoming effective. Curis’s shares of common stock will continue to trade on the Nasdaq Capital Market under the ticker symbol "CRIS."

Additional information regarding the reverse stock split proposal can be found in the Company’s definitive proxy statement filed with the Securities and Exchange Commission on June 5, 2026, available at www.sec.gov and www.curis.com.

About the TakeAim CLL Study

The TakeAim CLL is an open label phase 2 study of emavusertib in combination with zanabrutinib in patients with CLL (CA-4948-203, NCT07271667). Participants in the study must be in a partial response (PR) or partial response with lymphocytosis (PR-L), measurable residual disease positive (MRD+) as determined by the ClonoSEQ assay and actively taking zanubrutinib for at least 12 months.

(Press release, Curis, JUN 26, 2026, View Source,-Reaffirms-Patient-Dosing-Guidance,-and-Reports-Stockholder-Approval-of-Reverse-Stock-Split [SID1234668964])