CUMBERLAND PHARMACEUTICALS ANNOUNCES PLANS TO FILE NEW DRUG APPLICATION FOR IFETROBAN DMD PROGRAM

(NASDAQ:CPIX) Cumberland Pharmaceuticals Inc. provided an update on its ifetroban product candidate, which is in development as a potential treatment for cardiomyopathy associated with Duchenne muscular dystrophy (DMD). The company announced plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ifetroban for this indication. Cumberland held a pre-NDA meeting with the FDA in fall 2026 to discuss the format and content of the planned submission, including required reports and analyses. The company is proposing the FIGHT DMD™ trial as the pivotal study, supplemented by comparison data from two natural history databases, to support product approval. The FDA granted Cumberland's request for a rolling review of the NDA, allowing completed sections to be submitted prior to the full application. This decision follows an End-of-Phase 2 meeting with the FDA in September 2025 and a Type C meeting in January 2026, during which the FDA suggested a Phase 3 trial and raised issues regarding the Phase 2 study, including the suitability of the LVEF endpoint and the statistical analysis plan. Cumberland responded by providing additional efficacy data, natural history data from a second DMD registry, and documentation of the statistical analysis plan's development. The planned NDA submission for Traditional Approval will include data from the FIGHT DMD™ clinical study, its ongoing open-label extension, two natural history databases, preclinical data, manufacturing information, and a safety database covering more than 1,400 subjects across approximately 30 clinical studies. The FDA requested additional analysis, particularly regarding missing data and other supporting information, which Cumberland will provide. The 12-month FIGHT DMD™ trial (NCT03340675) demonstrated a significant 5.4% absolute improvement in left ventricular ejection fraction (LVEF) (p=0.002) for high-dose ifetroban compared to a control group. The study also showed reductions in cardiac damage markers (NT-proBNP and cardiac troponin I) in the high-dose group. All patients who completed the 12-month study continued in the open-label extension, with long-term cardiac MRI data from Months 24 and 36 being analyzed for NDA inclusion. Through 36 months of treatment in both the Phase 2 trial and open-label extension, ifetroban maintained a favorable safety profile with no treatment-related serious adverse events or new safety concerns. Novel blood biomarker evaluation showed a 30% reduction in MYL3 and a 50% reduction in MYOD1, as well as a 2.4-fold increase in FGF16 and a 2.1-fold increase in TSPAN7 with ifetroban treatment compared to placebo. Ifetroban is proposed as a once-daily oral medication that blocks the thromboxane receptor. The drug has received Orphan Drug Designation, Rare Pediatric Disease Designation, and Fast Track Designation from the FDA for DMD cardiomyopathy. There is currently no approved treatment specifically targeting DMD heart disease. Cumberland has secured a growing portfolio of patents for ifetroban in this indication, and the FDA has conditionally accepted DYSCORBAN® as the proprietary name. Cumberland is also developing ifetroban for other indications, including systemic sclerosis, idiopathic pulmonary fibrosis, and cancer metastasis, with a Phase 2a trial in high-risk solid tumors achieving its primary safety endpoint and showing favorable trends in decreased metastasis recurrence and metastasis-free survival.

Encompass Health expands in Fort Bend County, Texas, with second small-format hospital in Houston area

(NYSE:EHC) Encompass Health Corp. announced plans to expand inpatient rehabilitation capacity in Fort Bend County with a new project in Richmond, Texas. The new hospital will be the company's second small-format inpatient rehabilitation hospital announced and the second serving the greater Houston area, with another small-format project in Conroe. The Richmond facility will have 24 beds and will operate as a satellite location of Encompass Health Rehabilitation Hospital of Sugar Land. The hospital is expected to open in 2028. The facility will provide specialized inpatient rehabilitation care to patients in Richmond and surrounding communities. Patients will receive 24-hour nursing care and physical, occupational, and speech therapy from an interdisciplinary team of specialized nurses, therapists, and physicians. The hospital will serve patients recovering from major illnesses and injuries, including stroke, neurological conditions, brain and spinal cord injuries, amputations, and complex orthopedic conditions. Craig Funk, Encompass Health group president, stated that the greater Houston area continues to experience significant growth and emphasized the company's commitment to ensuring access to high-quality inpatient rehabilitation care. Encompass Health is the largest owner and operator of inpatient rehabilitation hospitals in the United States. The company has a national footprint that includes 179 hospitals in 39 states and Puerto Rico. Encompass Health is recognized by Newsweek as America's Most Awarded Leader in Inpatient Rehabilitation. The company is ranked among Fortune's World's Most Admired Companies™ and Forbes' America's Best Companies. Encompass Health is also recognized by Becker's Healthcare and Modern Healthcare as a top healthcare employer.

Lycia Therapeutics Announces Closing of Upsized Initial Public Offering and Full Exercise of Underwriters’ Option to Purchase Additional Shares

(NASDAQ:LYCA) Lycia Therapeutics, Inc. announced the closing of its upsized initial public offering of 20,286,000 shares of its common stock. This total includes the exercise in full by the underwriters of their option to purchase 2,646,000 additional shares. The initial public offering price was $18.00 per share. The aggregate gross proceeds to Lycia from the initial public offering, before deducting underwriting discounts and commissions and other offering expenses, were approximately $365.1 million. All shares in the offering were offered by Lycia. Lycia’s common stock began trading on the Nasdaq Global Select Market on October 23, 2026, under the symbol “LYCA.” Jefferies, TD Cowen, Evercore ISI, and Guggenheim Securities acted as joint book-running managers for the offering. LifeSci Capital acted as a passive book-running manager. Registration statements relating to the securities issued and sold in the initial public offering were filed with the Securities and Exchange Commission and became effective on October 22, 2026. A prospectus describing the terms of the initial public offering has been filed with the SEC. Lycia Therapeutics is a clinical-stage biotechnology company focused on the discovery and development of novel therapeutics designed to degrade disease-causing extracellular proteins. The company’s proprietary LYTAC (Lysosomal Targeting Chimera) platform is used to generate cataLYTAC degraders. The lead candidates are LCA-0061, a cataLYTAC degrader of IgE for food allergy and other allergic diseases, and LCA-0321, a LYTAC degrader designed to selectively deplete the autoantibodies that cause Graves’ disease. Lycia was founded on the work of Nobel laureate Carolyn Bertozzi, Ph.D., professor of chemistry and HHMI investigator at Stanford University.

Citius Oncology Reports Continued Institutional Demand and 120% Growth in Shipments of LYMPHIR® Units to U.S. Wholesalers During the Fiscal Fourth Quarter of 2026

(NASDAQ:CTOR) Citius Oncology, Inc., an oncology-focused biopharmaceutical company and majority-owned subsidiary of Citius Pharmaceuticals, Inc. (NASDAQ:CTXR), announced preliminary, unaudited LYMPHIR (denileukin diftitox-cxdl) unit sales to U.S. wholesalers and institutional vial orders for the fiscal fourth quarter ended September 30, 2026. For the three months ended September 30, 2026, U.S. wholesalers purchased 792 units of LYMPHIR, compared to 360 units for the three months ended June 30, 2026, representing an increase of 120%. Prescribing centers ordered 950 LYMPHIR vials from wholesalers during the fiscal fourth quarter, compared to 926 in the fiscal third quarter. As of the date of the release, 54 institutions have ordered LYMPHIR, up from 44 as of August 14, 2026. The company’s expanded commercial team achieved nationwide coverage in August 2026. Citius Oncology is more than halfway to its goal of having LYMPHIR on formulary at 100 priority institutions by calendar year-end. The company recognizes revenue when wholesaler orders are fulfilled, with revenue based on LYMPHIR units sold to wholesalers, net of estimated gross-to-net adjustments. The unit information is preliminary and unaudited, based on management's current estimates, and subject to completion of year-end closing procedures and audit of fiscal 2026 financial statements. The company expects to report complete fiscal fourth quarter and fiscal year 2026 results in December 2026 with the filing of its Annual Report on Form 10-K. LYMPHIR is a targeted immunotherapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL) indicated for use in Stage I–III disease after at least one prior systemic therapy, and was approved by the FDA and launched in the U.S. in December 2025. Management estimates the initial CTCL market for LYMPHIR currently exceeds $400 million, is growing, and is underserved by existing therapies. Citius Oncology holds robust intellectual property protections for LYMPHIR, including orphan drug designation, complex technology, trade secrets, and pending patents for immuno-oncology use as a combination therapy with checkpoint inhibitors. Citius Pharmaceuticals, Inc. is the majority owner of Citius Oncology and has a late-stage pipeline including Mino-Lok (a catheter lock solution) and CITI-002 (Halo-Lido, a topical formulation for hemorrhoids). A pivotal Phase 3 trial for Mino-Lok and a Phase 2b trial for Halo-Lido were completed in 2023, with Mino-Lok meeting primary and secondary endpoints. Citius Pharma is actively engaged with the FDA to outline next steps for both programs.

Ris-Rez positive Ph 3 osteosarcoma data in China

(LSE:GSK) GSK plc and Hansoh Pharmaceutical Group Co., Ltd. announced positive results from the ARTEMIS-011 pivotal phase III trial in China evaluating risvutatug rezetecan (Ris-Rez) in patients with relapsed or progressed osteosarcoma after at least two prior lines of systemic therapy. The trial met its primary endpoint, showing Ris-Rez reduced the risk of disease progression or death by 67% compared to chemotherapy, with a hazard ratio of 0.33 (95% CI, 0.20-0.55; p<0.0001) after a median follow-up of 7.1 months. Median progression-free survival (PFS) was 5.5 months for Ris-Rez versus 1.4 months for chemotherapy. Grade 3 or higher treatment-related adverse events (TRAEs) occurred in 93% of patients receiving Ris-Rez and 83% of those receiving chemotherapy, with haematologic events being the most common. TRAEs led to discontinuation in 4% of Ris-Rez patients and 2% of chemotherapy patients. The results were presented at the European Society for Medical Oncology (ESMO) Congress 2026 and will support a regulatory submission by Hansoh in China. Hesham Abdullah, Senior Vice President, Global Head of Oncology, R&D, GSK, stated that this is Hansoh’s second positive phase III study for Ris-Rez in China and that the findings are important for patients with relapsed osteosarcoma, where treatment options are extremely limited. Lu Xie, Medical and Pediatric Oncologist for Sarcoma and Principal Investigator of ARTEMIS-011, highlighted the lack of approved therapies and standard of care for relapsed osteosarcoma and the significance of the PFS improvement. GSK holds exclusive rights to develop and commercialise Ris-Rez outside mainland China, Hong Kong, Macau, and Taiwan, and is advancing a global clinical development programme, including the ongoing phase II EMBOLD Sarcoma-202 trial in advanced osteosarcoma and soft tissue sarcoma. Ris-Rez is a novel investigational antibody-drug conjugate targeting the B7-H3 protein, highly expressed in more than 10 solid tumour types, and is being developed for over 40 indications by 2040. More than 1,000 patients have received Ris-Rez as part of GSK’s global EMBOLD clinical trial programme. Ris-Rez has received orphan drug designations in the US, Japan, and the EU for SCLC, Breakthrough Therapy Designation in the US, and Priority Medicines (PRIME) Designation from the EMA for relapsed or refractory ES-SCLC, as well as Breakthrough Therapy Designation in the US for relapsed or refractory osteosarcoma. ARTEMIS-011 was a multicentre, randomised, open-label phase III trial in China, randomising patients 1:1 to receive Ris-Rez 12.0 mg/kg every 3 weeks or gemcitabine 1,000 mg/m² on days 1 and 8 plus docetaxel 75 mg/m² on day 8 every 3 weeks. The primary endpoint was IRC-assessed PFS, with secondary endpoints including investigator-assessed overall survival, investigator-assessed PFS, safety, IRC-assessed objective response rate, disease control rate, and duration of response. The EMBOLD Sarcoma-202 phase Ib/II study is evaluating Ris-Rez in previously treated unresectable advanced or metastatic sarcomas globally, with primary endpoints of PFS and confirmed ORR, and secondary endpoints including safety, DOR, and patient-reported outcomes. Osteosarcoma is a rare cancer with a global incidence of approximately 3.4 cases per million people per year, mainly affecting children and young adults, and accounts for 20-40% of all bone cancers. Following first-line chemotherapy, treatment options for relapsed osteosarcoma are severely limited, with no clear standard of care or approved therapies after two prior lines of treatment.

Northwest Biotherapeutics Announces Expansion of Its Technical Team

(OTCQB:NWBO) Northwest Biotherapeutics announced an expansion of its technical team in the US, with a focus on scaling up production capacity and preparing for clinical trials in cancers beyond brain cancer. The company has recently hired a Quality Assurance (QA) and Regulatory Affairs Manager, who was previously Director of DC Operations, Center for Immunotherapy at Roswell Park Cancer Center. This Manager will lead QA functions, oversee regulatory compliance in US cGMP operations, and assist in regulatory training of production personnel. Northwest Biotherapeutics has also hired a Director of Information Technologies, who was formerly Director of Technology at Team Logic IT, the company's external IT service provider. The new Director of Information Technologies will assist the Chief Information Officer in scaling up operations, including handling, distribution, and tracking of personalized cancer vaccine products. Additionally, the company has added a Manager of Investor Relations, a former institutional fund manager with over 30 years of experience at top tier asset managers and at long-only funds and hedge funds, to assist the Head of Investor Relations with investor and shareholder communications. To balance increased expenditures from these hires, the company is eliminating selected positions not essential for ramp-up of priority operational areas. So far, only one US position has been terminated, but further reductions may occur as the company continues to review its personnel mix. A similar review process is underway in the UK, with expansion of personnel in priority areas and reduction of others. The company’s lead program is DCVax-L for glioblastoma (GBM), for which a 331-patient Phase III trial has been completed, results presented at scientific meetings, published in JAMA Oncology, and a Marketing Authorization Application (MAA) submitted in the UK, which is currently under review. Northwest Biotherapeutics has also developed DCVax-Direct for inoperable solid tumor cancers, completed a 40-patient Phase I trial, and plans to pursue Phase II trials this year. The company previously conducted a Phase I/II trial with DCVax-L for advanced ovarian cancer in collaboration with the University of Pennsylvania.

(OTCQB:NWBO) Northwest Biotherapeutics announced an expansion of its technical team in the US. The company is increasing expenditures in key operational areas but is offsetting these by eliminating selected non-essential positions. The net result is a net increase in US personnel headcount, while operating costs remain in the same range as before these changes. Northwest Biotherapeutics is prioritizing two operational areas: scaling up production capacity, including restarting manufacturing in the US to supplement or back up UK capacity, and preparing for clinical trials in cancers beyond brain cancer. The company recently hired a Quality Assurance (QA) and Regulatory Affairs Manager, who was previously Director of DC Operations, Center for Immunotherapy at Roswell Park Cancer Center. This Manager will lead QA functions, oversee regulatory compliance in US cGMP operations, and assist in regulatory training of production staff. A Director of Information Technologies has also been hired, who was formerly Director of Technology at Team Logic IT, the company's external IT service provider. This individual will assist the Chief Information Officer in scaling up operations, including handling, distribution, and tracking of personalized cancer vaccine products. The company has added a Manager of Investor Relations, a former institutional fund manager with over 30 years of experience at top-tier asset managers, long-only funds, and hedge funds, who will assist the Head of Investor Relations with investor and shareholder communications. To balance increased expenditures, the company has so far terminated one US position and will continue to review personnel, potentially eliminating additional roles not aligned with evolving priorities. A similar review process is underway in the UK, focusing on expanding personnel with expertise needed for priority operations and reducing others. Northwest Biotherapeutics has a broad platform technology for DCVax® dendritic cell-based vaccines. Its lead program is DCVax®-L for glioblastoma (GBM), for which a 331-patient Phase III trial has been completed, results presented at scientific meetings, published in JAMA Oncology, and a Marketing Authorization Application (MAA) submitted in the UK, which is currently under review. The company has also developed DCVax®-Direct for inoperable solid tumor cancers, completed a 40-patient Phase I trial, and plans to pursue Phase II trials this year. A Phase I/II trial with DCVax-L for advanced ovarian cancer was previously conducted with the University of Pennsylvania.

U.S. Renal Care Presents Analysis of VOICE Trial Demonstrating Favorable Safety Outcomes for Patients Treated with Vadadustat Versus an ESA During a Late-Breaking Session at American Society of Nephrology Kidney Week

(NASDAQ:AKBA) Akebia Therapeutics, Inc. announced that U.S. Renal Care (USRC) presented data from the Vafseo Outcomes In Center Experience (VOICE) trial at ASN Kidney Week 2026, highlighting significantly improved safety outcomes in patients treated with vadadustat compared to an erythropoiesis-stimulating agent (ESA). The VOICE trial enrolled 2,116 patients and was a randomized, open-label, active-controlled, noninferiority trial sponsored by USRC to measure the safety of vadadustat administered three times weekly versus standard-of-care ESA, using a hierarchical composite endpoint of mortality and hospitalization rates. The trial demonstrated a win odds of 1.16 (95% CI 1.06, 1.28, p=0.0016), establishing non-inferiority and superiority of the primary composite endpoint. The hospitalization rate was 10% lower in patients treated with vadadustat versus ESA, with 111.1 versus 123.1 hospitalizations per 100 patient-years and an incidence rate ratio of 0.90 (95% CI, 0.82, 0.99). There was no statistically significant difference between mortality rates with vadadustat versus ESA (8.8% versus 8.8% per 100 patient-years, incidence rate ratio of 1.00 (95% CI 0.72, 1.39)). Exposure-adjusted serious adverse events were lower with vadadustat (121.5 events per 100 patient-years) compared to ESA (134.2 events per 100 patient-years). Vadadustat improved hemoglobin control versus ESA, with a 64% reduction in the odds of a hemoglobin above 12 g/dL (29.6% vs. 51.2%, p<0.0001), a 57% reduction in the odds of a hemoglobin above 13 g/dL (6.4% vs. 12.7%, p<0.0001), and a 61% reduction in the odds of a hemoglobin above 14 g/dL (1.6% vs. 3.2%, p=0.0044). There was no overall difference in low hemoglobin excursions (below 9, 8, or 7 g/dL). The odds of ESA rescue were 28% less likely with vadadustat versus ESA (44.6% vs. 52.8%, p=0.0006). Vafseo (vadadustat) was approved by the U.S. FDA in March 2024 for the treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least three months and has been available in the U.S. since January 2025. Vafseo is approved for once-daily administration and is the only oral HIF-PHI for anemia in the U.S. market or in development. U.S. Renal Care partners with nephrologists to care for more than 37,000 people living with kidney disease across 32 states. Vafseo is approved for use in 37 countries. The most common adverse reactions (occurring at ≥ 10%) were hypertension and diarrhea. Hepatocellular injury attributed to Vafseo was reported in less than 1% of patients, with elevated serum ALT, AST, and bilirubin levels observed in 1.8%, 1.8%, and 0.3% of CKD patients treated with Vafseo, respectively. Worsening of hypertension was reported in 14% of Vafseo and 17% of darbepoetin alfa patients, with serious worsening in 2.7% of Vafseo and 3% of darbepoetin alfa patients. Seizures occurred in 1.6% of Vafseo and 1.6% of darbepoetin alfa patients. Gastric or esophageal erosions occurred in 6.4% of Vafseo and 5.3% of darbepoetin alfa patients, with serious GI erosions in 3.4% of Vafseo and 3.3% of darbepoetin alfa patients. Malignancies were observed in 2.2% of Vafseo and 3.0% of darbepoetin alfa patients. Vafseo is not recommended in patients with cirrhosis or active, acute liver disease.

Stryker completes acquisition of ZuriMED to enhance its shoulder offering

(NYSE:SYK) Stryker has completed its acquisition of ZuriMED, a privately held company and developer of the FiberLocker System. The FiberLocker System is a commercialized rotator cuff augmentation technology designed to increase the biomechanical strength of rotator cuff repair. This acquisition adds the FiberLocker System to Stryker’s Sports Medicine portfolio and expands its shoulder care offerings. The addition is intended to support shoulder specialists and surgeons with innovative solutions across the continuum of shoulder care. Andy Pierce, Group President, MedSurg and Neurotechnology at Stryker, stated that ZuriMED brings specialized expertise and a differentiated technology that complements Stryker’s growing shoulder care capabilities. He also noted the opportunity to advance the FiberLocker technology, expand access to innovative treatment options, and deliver greater value for customers and patients. Stryker is described as a global leader in medical technologies, offering products and services in MedSurg, Neurotechnology, and Orthopaedics. Stryker impacts more than 150 million patients annually.

GT Biopharma Selected for Oral Presentation at the SITC 2026 Annual Meeting

(NASDAQ:GTBP) GT Biopharma, Inc. announced that it has been selected for an oral presentation at the Society for Immunotherapy of Cancer (SITC) 2026 Annual Meeting. The presentation is titled 'Inhibition of the KRAS oncoprotein sensitizes pancreatic cancer to NK cell immunotherapy.' The abstract number for the presentation is 655. The presenter is Paarth Dodhiawala from the University of Minnesota Medical School. The presentation is scheduled for Friday, November 6, 2026, from 3:05-3:20 PM MT. The location for the presentation is North Building – 300 Level – Halls BC. The presentation is part of Session 106a: Combination Therapies Involving Cell Therapy, which runs from 1:45-3:25 PM MST. The session will discuss strategies to extend the clinical impact of cell therapies through rational combination approaches. GT Biopharma, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of immuno-oncology therapeutic products based on its proprietary TriKE® NK cell engager platform. The TriKE® platform is designed to harness and enhance the cancer killing abilities of a patient’s immune system’s natural killer cells. GT Biopharma has an exclusive worldwide license agreement with the University of Minnesota to further develop and commercialize therapies using TriKE® technology.

Theralase Provides Bladder Cancer Clinical Study Update

(TSXV:TLT, OTCQB:TLTFF) Theralase® Technologies Inc. provided an update on its Phase II BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) Carcinoma In-Situ (CIS) clinical study (Study II) and its expanding oncology pipeline. Study II enrolled 96 patients, exceeding the statistical analysis plan's calculated population size of 90 patients. Of these, 87 patients have completed the study and 9 remain on study pending secondary endpoint assessment. The patient demographics were: 81% aged ≥ 65 years, 82% male, 83% white, 82% diagnosed with pure CIS, 12% with CIS + T1, 6% with CIS + Ta, 98% BCG-Unresponsive, and 2% BCG-Intolerant. The median number of BCG installations was 15.4. For the primary endpoint (CR at any point in time), 60 out of 93 patients (64.5%) achieved a Complete Response (CR) with a 95% confidence interval of [49.2, 79.9], and 68 out of 93 (73.1%) achieved a Total Response (CR and IR) with a 95% confidence interval of [56.8, 89.5]. For the secondary endpoint (duration of CR at 450 days), 22 out of 54 patients (40.7%) maintained CR (95% CI: [24.6, 56.9]), and 24 out of 54 (44.4%) maintained Total Response (95% CI: [28.6, 60.3]). The median duration of response was 14.9 months (95% CI: 12.1, 17.7). For the tertiary endpoint (safety at 450 days), 87 out of 87 patients (100.0%) were assessed. Treatment Emergent Adverse Events (TEAEs) included hematuria (47.9%), urinary frequency (39.5%), and urinary urgency (32.3%), with median resolution times of 15, 36, and 43 days, respectively. There were 25 (26.9%) Serious Adverse Events documented: 1 Grade I, 3 Grade II, 14 Grade III, 4 Grade IV (all resolved between 1 to 82 days), and 3 Grade V; 92% were not TEAEs. Patients were followed for up to 3 years post-procedure. At 2 years, 11 out of 49 patients (22.4%) maintained CR (95% CI: [10.5, 34.4]); at 3 years, 9 out of 49 (18.4%) maintained CR (95% CI: [7.5, 29.2]). One patient demonstrated a CR for 7 years after a single Theralase® procedure. Study II utilized Ruvidar® (TLD-1433) activated by the TLC-3200 Medical Laser System and was conducted at 11 clinical sites in Canada and the United States. Enrollment into Study II is complete, with full clinical data collected on 87 patients. Theralase® is analyzing and compiling data for submission of a New Drug Submission (NDS) to Health Canada and a New Drug Application (NDA) to the United States FDA, with marketing decisions anticipated in 2027. In 2027, Theralase® will pursue licensing agreements for global marketing and distribution of light-activated Ruvidar®. The company is working with a Good Laboratory Practices (GLP) laboratory to complete GLP toxicology studies for Rutherrin® to determine Maximum Tolerated Dose (MTD) and Human Equivalent Dose (HED) for additional oncological conditions, expected to be completed in 1Q2027. Subject to regulatory approval, Theralase® intends to commence clinical development through Phase 0/I/II adaptive clinical studies for Glioblastoma Multiforme (GBM), Non-Small Cell Lung Cancer (NSCLC), and Muscle Invasive Bladder Cancer (MIBC) in 2027. In 2027, Theralase® also plans to commence GLP toxicology studies for topical Ruvidar® for Herpes Simplex Virus-1 (HSV-1) derived cold sores and, subject to regulatory approval, Phase I/II/III adaptive clinical studies for HSV-1 derived cold sores.

Regeneron Extends Agreement with BARDA to Provide Additional Supply of Ebola Treatment Inmazeb® for U.S. Preparedness

(NASDAQ:REGN) Regeneron Pharmaceuticals, Inc. announced the extension of its agreement with the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services, to supply additional doses of Inmazeb® for U.S. preparedness against Ebola disease. Inmazeb is a three-antibody cocktail (atoltivimab, maftivimab, and odesivimab-ebgn) and was the first Ebola treatment approved by the U.S. FDA, indicated for infection caused by Orthoebolavirus zairense in adults and pediatric patients, including neonates born to infected mothers. Under the new agreement, Regeneron expects to deliver additional treatment doses of Inmazeb to the U.S. government through 2031 and receive payment of approximately $270 million. Inmazeb has been administered to hundreds of patients since 2019 and, in a clinical trial, reduced mortality by approximately 55 percent compared to an active control treatment in patients with low viral load. The original procurement partnership with BARDA began in 2020. Leonard S. Schleifer, M.D., Ph.D., Board Co-Chair, President and CEO of Regeneron, stated that maintaining a ready supply of Inmazeb is critical for preparedness. Separately, Regeneron’s investigational maftivimab monotherapy is being added to the PARTNERS clinical trial to assess its use as a potential treatment for the current Bundibugyo virus disease outbreak in the Democratic Republic of the Congo (DRC). Maftivimab has demonstrated strong efficacy against Bundibugyo virus in in vitro and non-human primate studies, with data now available in preprint on BioRxiv.org and pending peer review. George D. Yancopoulos, M.D., Ph.D., Board Co-Chair, President and Chief Scientific Officer of Regeneron, highlighted the advancement of maftivimab as a potential Ebola treatment. The PARTNERS trial is coordinated by the Pandemic Sciences Institute, University of Oxford, led nationally in the DRC by the Institut National de Recherche Biomédicale (INRB), supported by the Institute of Tropical Medicine (ITM), Antwerp, and sponsored by the World Health Organization (WHO) with support from Africa CDC. Regeneron also supports Afya Foundation’s emergency response efforts during the current outbreak. Inmazeb’s safety and efficacy were established in the 681-patient PALM Trial, conducted during the 2018 DRC Ebola outbreak. The PALM Trial was stopped early in 2019 after interim analysis showed Inmazeb’s superiority in preventing death versus two other investigational treatments. Inmazeb was approved by the FDA in 2020, and in 2022, WHO published guidelines strongly recommending its use for Ebola virus infection. In November 2023, Inmazeb became the first and only Ebola disease treatment to be prequalified by WHO. Since 2018, Inmazeb has been offered at no cost under a compassionate use protocol in countries experiencing Ebola outbreaks caused by Orthoebolavirus zairense, including the DRC and Guinea. In September 2025, Regeneron committed to donate up to 500 doses of Inmazeb to WHO for exclusive use by governments of low- and lower-middle income countries at risk for Ebola outbreaks. The most common adverse events reported in at least 20% of subjects who received Inmazeb were pyrexia, chills, tachycardia, tachypnea, and vomiting. Infusion could not be completed in 1% of subjects due to infusion-associated adverse events. The evaluation of adverse events may have been confounded by the signs and symptoms of the underlying infection. Inmazeb may reduce the efficacy of live vaccines, and concurrent administration should be avoided. The efficacy of Inmazeb has not been established for other species of Orthoebolavirus and Orthomarburgvirus genera.

Iovance Announces Data Showing Durable Responses with Lifileucel TIL Cell Therapy in Advanced Soft Tissue Sarcomas at ESMO 2026

(NASDAQ: IOVA) Iovance Biotherapeutics, Inc. announced that one-time lifileucel monotherapy demonstrated unprecedented efficacy with deep, durable responses in two difficult-to-treat soft tissue sarcomas, metastatic undifferentiated pleomorphic sarcoma (UPS) and dedifferentiated liposarcoma (DDLPS), in a pilot trial presented at the ESMO Congress 2026 in Madrid, Spain. Among the first eight evaluable patients, the physician-assessed confirmed objective response rate (ORR) by RECIST v1.1 was 50%. Four partial responses (2 in UPS and 2 in DDLPS) were all ongoing at 6+, 26+, 40+, and 46+ weeks as of the data cut-off on September 9, 2026. The eight evaluable patients had deep responses despite significant disease burden, with baseline target sum of diameters ranging from 39.0 to 177.6 mm, were refractory to prior lines of systemic therapy (range: 1-7), and received lifileucel that met pre-determined manufacturing specifications. The safety profile was consistent with the lifileucel treatment regimen across other indications. Soft tissue sarcomas comprise approximately 80 tumor subtypes, with an estimated incidence of 4–5 cases per 100,000 people annually in Europe and approximately 3.5 new diagnoses per 100,000 people in the United States each year. Patients with metastatic UPS and DDLPS have a median overall survival (mOS) of less than two years and median progression-free survival (mPFS) of only 5 to 6 months after first-line chemotherapy. In recent clinical studies, current second-line treatment options delivered an ORR of less than 5%, mPFS of approximately 2-3 months, and mOS of approximately 9-10 months. The U.S. Food and Drug Administration (FDA) granted fast track designation for lifileucel in advanced UPS and DDLPS in the second quarter of 2026 based on initial results from the pilot trial. Iovance is rapidly enrolling the SARATOGA (NCT07741877) registrational Phase 2 clinical trial to support two new approvals for lifileucel, with the trial now enrolling at Memorial Sloan Kettering Cancer Center (MSKCC) and other major U.S. cancer centers. The primary endpoint of SARATOGA is ORR per RECIST v1.1 by independent review committee, with secondary endpoints including complete response rate, duration of response, disease control rate, progression-free survival, overall survival, and safety and tolerability. Iovance is also exploring lifileucel in additional metastatic soft tissue sarcomas with high unmet need as part of its clinical development program. Amtagvi (lifileucel) is the first FDA-approved, one-time treatment for previously treated advanced melanoma, now approved in three global markets and available at nearly 100 authorized treatment centers. The Iovance TIL platform includes registrational trials and next-generation programs in additional solid tumors, including gene-edited and IL-12 tethered TIL therapies, next-generation IL-2, and precision immuno-oncology approaches. The ESMO Congress 2026 takes place October 23–27, 2026, at IFEMA Madrid, Spain, and features presentations of practice-changing clinical data, translational science, and educational programming across all major tumor types. The ESMO Congress brings together more than 37,000 clinicians, researchers, patient advocates, and industry representatives from around the world.

EQS-News: Bronwyn Brophy O’Connor to become CEO of Carl Zeiss Meditec Group in December 2026

(LSE:0DHC) Carl Zeiss Meditec AG has announced that Bronwyn Brophy O’Connor, currently CEO of the Vitrolife Group in Sweden, will become CEO of Carl Zeiss Meditec AG on December 1, 2026. On the same date, she will join the Executive Board of Carl Zeiss AG with responsibility for the Medical Technology segment. Her appointment as successor to current CEO Andreas Pecher was first announced in May 2026, and the start date is now confirmed. Andreas Pecher has served as interim CEO of Carl Zeiss Meditec AG since January 1, 2026, and will continue as President and CEO of Carl Zeiss AG. Effective December 1, 2026, the Management Board of Carl Zeiss Meditec AG will comprise Bronwyn Brophy O’Connor as CEO and Justus Wehmer as CFO. The Executive Board of Carl Zeiss AG will include Andreas Pecher (President and CEO), Stefan Müller (CFO), Bronwyn Brophy O’Connor (Head of the ZEISS Medical Technology segment), Sven Hermann (Head of the ZEISS Consumer Markets segment), Dr. Frank Rohmund (Head of the ZEISS Semiconductor Manufacturing Technology segment), and Dr. Marc Wawerla (Head of the ZEISS Industrial Quality & Research segment). Bronwyn Brophy O’Connor holds a bachelor’s degree in International Marketing and Languages from Dublin City University in Ireland and completed her MBA in 2002. She began her career at Johnson & Johnson in 1997, ending as General Manager of the Cardiovascular Care Group for the U.K. & Ireland in 2012. She then joined Covidien, later acquired by Medtronic, and served as Vice President Early Technologies EMEA and President Women’s Health at Medtronic in Boston, USA, from 2013 to 2018. In 2019, she joined Thermo Fisher Scientific as President for the EMEA region and was promoted to Global President of the Immunodiagnostics Division in Uppsala, Sweden. Since 2023, she has been CEO of the Vitrolife Group, listed on NASDAQ Stockholm and headquartered in Gothenburg, Sweden. Andreas Pecher studied physics at the University of Würzburg, Germany, and the University of Texas at Austin, USA, and holds an MBA from the Kellogg School of Management and a Master of Engineering Management from the McCormick School of Engineering. He began his career at Motorola (now NXP) in Texas, USA, in 1998, and later worked at McKinsey & Company in Germany. He held leadership roles at Renewable Energy Corporation in Oslo, Norway, and Munich, Germany, before joining ZEISS in 2013. He became President and CEO of Carl Zeiss AG on April 1, 2025, and interim CEO of Carl Zeiss Meditec AG on January 1, 2026. Carl Zeiss Meditec AG, listed on the TecDAX and SDAX of the German stock exchange (ISIN: DE0005313704), is a leading medical technology company with 5,784 employees worldwide. The Group generated revenue of €2,228m in fiscal year 2024/25 (to 30 September). The Group’s head office is in Jena, Germany, with subsidiaries in Germany and abroad. More than 50 percent of its employees are based in the USA, Japan, Spain, and France. The Center for Application and Research (CARIn) in Bangalore, India, and the Carl Zeiss Innovations Center for Research and Development in Shanghai, China, strengthen the company’s presence in these economies. Approximately 39 percent of Carl Zeiss Meditec AG’s shares are in free float, and about 59 percent are held by Carl Zeiss AG.

Innovent Announces NMPA Acceptance of a New Indication Application of Sintilimab for the Treatment of Advanced Melanoma

(HKEX:01801) Innovent Biologics, Inc. announced that the China National Medical Products Administration (NMPA) has accepted for review a New Indication Application for sintilimab in combination with Nolgileucel injection (GC101) for the treatment of patients with unresectable or metastatic melanoma whose disease has progressed following at least two lines of prior systemic therapy, including PD-1 antibody therapy. This would be the 11th indication for sintilimab. The application is primarily based on results from the pivotal Phase II clinical study MIZAR-003 (NCT04943913), a multicenter, randomized, open-label, parallel-controlled study evaluating the efficacy and safety of GC101 TIL cell injection with sintilimab support in melanoma patients who have failed or are intolerant to anti-PD-1 antibody therapy. The study results were first presented as an oral Late-Breaking Abstract (LBA 9509) at the 2026 ASCO Annual Meeting in June 2026. As of the data cutoff date of May 12, 2026, the primary endpoint was met. In the experimental arm, the median progression-free survival (mPFS) reached 4.3 months, compared to 1.6 months in the chemotherapy control arm, with a 57% reduction in the risk of disease progression or death (HR=0.43, 95% CI: 0.26–0.68; P=0.0002). Adverse reactions in the experimental arm were manageable, with Grade ≥3 adverse reactions mainly being preconditioning-induced hematologic toxicity, and the median adverse event duration was 8 days in the experimental arm versus 13 days in the control arm; most patients recovered without additional intervention. Professor Guo Jun, Vice President of Peking University Cancer Hospital, commented on the urgent clinical need for more effective treatment options for this patient population and noted the positive antitumor activity and favorable safety profile demonstrated in the MIZAR-003 study. Dr. Hui Zhou, Chief R&D Officer of Oncology at Innovent, stated that the acceptance of the 11th indication application for sintilimab further consolidates its position as a cornerstone therapy in immuno-oncology and marks another milestone for the company. Sintilimab, marketed as TYVYT® in China, is an innovative PD-1 inhibitor co-developed and commercialized by Innovent Biologics and Eli Lilly and Company. Nolgileucel Injection (GC101) was developed using the DeepTIL™ cell enrichment and expansion platform by Juncell Therapeutics and is the world's first TIL therapy that does not require high-intensity lymphodepletion chemotherapy or IL-2 administration. The pivotal Phase II study of GC101 in malignant melanoma has met its primary endpoint and GC101 has been included in the CSCO Guidelines for the Diagnosis and Treatment of Melanoma (2026 Edition). Innovent Biologics has launched 20 products in the market, has 1 asset under NDA review, 5 assets in phase 3 or pivotal clinical trials, and 20 more molecules in early clinical stage. Innovent has entered into more than 30 strategic partnerships with global players such as Eli Lilly, Roche, Takeda, Pfizer, Sanofi, Incyte, and MD Anderson Cancer Center, representing an aggregate value of over RMB 350 billion.

CStone Announces Major Clinical Validation Milestone for CS2009 at ESMO 2026: Data from More Than 300 Patients Support Mechanism, Safety and Broad Antitumor Activity

(HKEX:2616) CStone Pharmaceuticals announced a major clinical validation milestone for CS2009, its investigational PD-1/VEGF/CTLA-4 trispecific antibody, following two Rapid Oral presentations at the European Society for Medical Oncology (ESMO) Congress 2026. CS2009 has generated clinical data from over 300 patients across multiple solid tumor types, achieving proof of mechanism, proof of safety, and proof of concept. Pharmacodynamic observations confirm engagement of PD-1, CTLA-4, and VEGF pathways, supporting the scientific rationale for CS2009's differentiated molecular design. The safety profile is characterized by consistent tolerability and low rates of severe CTLA-4-associated and VEGF-related toxicities, supporting the potential for sustained treatment and combination with other therapies. In first-line PD-L1-high NSCLC, CS2009 monotherapy achieved an ORR of 87.5%, reaching 100% at 30 mg/kg. In heavily pretreated NSCLC, including patients previously exposed to immunotherapy, CS2009 monotherapy demonstrated an ORR of 28.0% at 30 mg/kg, with a median duration of response of 10.5 months. In combination with chemotherapy, CS2009 achieved an ORR of 85.7% at 30 mg/kg in first-line squamous NSCLC and 55.6% at 30 mg/kg in second- or third-line immunotherapy-pretreated NSCLC. In first-line metastatic colorectal cancer (mCRC), CS2009 combined with XELOX achieved an ORR of 63.6% and a DCR of 100%, including an ORR of 68.8% among patients with liver metastases. CS2009 monotherapy demonstrated an ORR of 20.0% and a DCR of 93.3% in heavily pretreated mCRC. CS2009 has also shown encouraging antitumor activity in additional solid tumors, including soft tissue sarcoma, non-clear-cell renal cell carcinoma, small-cell lung cancer, ovarian cancer, hepatocellular carcinoma, gastric cancer, esophageal cancer, metastatic castration-resistant prostate cancer, and triple-negative breast cancer. CStone is preparing global registrational Phase III studies and is actively pursuing strategic partnership discussions with multinational pharmaceutical companies. Dr. Jason Yang, Chief Executive Officer, President of R&D and Executive Director of CStone, stated that the ESMO 2026 data represent a defining milestone in the development of CS2009. He emphasized the robust clinical data validating the scientific rationale, differentiated design, and broad therapeutic potential of CS2009. The company has successfully launched four innovative drugs and secured approvals for 21 new drug applications covering nine indications. CStone's pipeline comprises 13 innovative drug candidates, including potential first-in-class or best-in-class antibody-drug conjugates and mono-/multi-specific antibodies across oncology, immunology, and inflammation.

(HKEX:2616) CStone Pharmaceuticals announced a major clinical validation milestone for CS2009, its investigational PD-1/VEGF/CTLA-4 trispecific antibody, following two Rapid Oral presentations at the European Society for Medical Oncology (ESMO) Congress 2026. Clinical data from over 300 patients across multiple solid tumor types support proof of mechanism, proof of safety, and proof of concept for CS2009. Pharmacodynamic observations confirm engagement of PD-1, CTLA-4, and VEGF pathways, reinforcing the scientific rationale for CS2009's differentiated molecular design. The clinical dataset demonstrates consistent tolerability, with low rates of severe CTLA-4-associated and VEGF-related toxicities. In first-line PD-L1-high NSCLC, CS2009 monotherapy achieved an ORR of 87.5%, reaching 100% at 30 mg/kg. In heavily pretreated NSCLC, including patients previously exposed to immunotherapy, CS2009 monotherapy showed an ORR of 28.0% at 30 mg/kg, with a median duration of response of 10.5 months. In combination with chemotherapy, CS2009 achieved an ORR of 85.7% at 30 mg/kg in first-line squamous NSCLC and 55.6% at 30 mg/kg in second- or third-line immunotherapy-pretreated NSCLC. In first-line metastatic colorectal cancer (mCRC), CS2009 combined with XELOX achieved an ORR of 63.6% and a DCR of 100%, including an ORR of 68.8% among patients with liver metastases. CS2009 monotherapy demonstrated an ORR of 20.0% and a DCR of 93.3% in heavily pretreated mCRC. CS2009 has also shown encouraging antitumor activity in additional solid tumors, including soft tissue sarcoma, non-clear-cell renal cell carcinoma, small-cell lung cancer, ovarian cancer, hepatocellular carcinoma, gastric cancer, esophageal cancer, metastatic castration-resistant prostate cancer, and triple-negative breast cancer. CStone is preparing global registrational Phase III studies and is actively pursuing strategic partnership discussions with multinational pharmaceutical companies. Dr. Jason Yang, Chief Executive Officer, President of R&D and Executive Director of CStone, stated that the ESMO 2026 data represent a defining milestone in the development of CS2009. He emphasized the robust clinical data validating the scientific rationale, differentiated design, and broad therapeutic potential of CS2009. The company has generated data from more than 300 patients in less than two years since entering clinical development. CStone has successfully launched four innovative drugs and secured approvals for 21 new drug applications covering nine indications. The company's pipeline includes 13 innovative drug candidates, including potential first-in-class or best-in-class antibody-drug conjugates and mono-/multi-specific antibodies.

Phathom Pharmaceuticals Provides Update on FDA Litigation

(NASDAQ:PHAT) Phathom Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has established a public docket (Docket No. FDA-2026-N-13038) to solicit comments on legal and regulatory questions related to issues raised by BDR Pharmaceuticals, International Pvt. Ltd. (BDR), an abbreviated new drug application (ANDA) filer referencing VOQUEZNA® (vonoprazan) tablets, in litigation against the FDA. The litigation challenges the FDA’s June 6, 2025 decision granting Phathom’s Citizen Petition, which confirmed that VOQUEZNA benefits from 10 years of New Chemical Entity (NCE) exclusivity through May 3, 2032. The deadline for submitting comments to the public docket is November 23, 2026. Steve Basta, President and Chief Executive Officer of Phathom, stated that the FDA carefully reviewed the NCE exclusivity period for VOQUEZNA and that Phathom will present its case in comments to the FDA and in any appropriate court proceedings. Phathom has moved to intervene in the litigation filed by BDR to continue enforcing its statutory exclusivities. A second ANDA filer, Saba Ilac Sanayii Ve Ticaret AS, has filed a notice in the BDR litigation, claiming to have a pending related case and intends to move to consolidate its case with BDR’s. Phathom has in-licensed exclusive rights to vonoprazan for the U.S., Europe, and Canada. Phathom currently markets vonoprazan in the United States as VOQUEZNA® (vonoprazan) tablets for the relief of heartburn associated with Non-Erosive GERD in adults, for the healing and maintenance of healing of Erosive GERD in adults and relief of associated heartburn, and as part of VOQUEZNA® DUAL PAK® (vonoprazan tablets, amoxicillin capsules) and VOQUEZNA® TRIPLE PAK® (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) for the treatment of H. pylori infection in adults.

Jemperli data show 76% complete response rate

(LSE:GSK) GSK plc announced positive interim results from the phase II AZUR-1 trial evaluating Jemperli (dostarlimab) monotherapy in adults with stage II and III microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR) locally advanced rectal cancer. In an exploratory analysis, 76% of evaluable patients (110/144; 95% CI: 69%, 83%) achieved a complete response to dostarlimab alone. Of these, 68% (98/144; 95% CI: 60%, 76%) achieved a sustained clinical complete response for at least 12 months (cCR12) without surgery, and 12 additional patients had a pathological complete response confirmed through tissue analysis after surgery. No disease recurrences have been reported among responders after a median follow-up of more than two years. The AZUR-1 trial met its primary objective, demonstrating that a clinically significant proportion of patients achieved cCR12. At the time of analysis, 47% of evaluable patients (54/116; 95% CI: 37%, 56%) had achieved cCR12 as assessed by independent central review, with an additional 38 participants having achieved a clinical complete response but not yet reaching the 12-month assessment timepoint. Serious adverse reactions occurred in 20% of patients receiving Jemperli, and the most common adverse reactions were fatigue (32%), rash (22%), diarrhoea (18%), and pruritus (17%). Jemperli was permanently discontinued due to adverse reactions in 3% of patients. The trial enrolled 154 patients who received nine cycles of dostarlimab over six months, administered as a 500mg intravenous infusion every three weeks. Regulatory reviews are ongoing in participating countries through Project Orbis, an FDA Oncology Center of Excellence initiative. Jemperli was discovered by AnaptysBio, Inc. and licensed to TESARO, Inc., with GSK responsible for ongoing research, development, commercialisation, and manufacturing. Around 5–10% of rectal cancers are MSI-H or dMMR. The findings supported the recent US approval of Jemperli in this indication. The results will be presented in a late-breaking oral session at the European Society for Medical Oncology (ESMO) Congress. Dr Andrea Cercek, MD, Section Head of Colorectal Cancer and Co-Director of the Center for Young Onset Colorectal and Gastrointestinal Cancer at Memorial Sloan Kettering Cancer Center, is the Principal Investigator of AZUR-1. GSK develops differentiated medicines for cancers across haematological, lung, gastrointestinal, genitourinary, and gynaecological cancers.

PRTC's Gallop Presents Ph1b LYT-200 Data at ESMO

(LSE:PRTC) PureTech Health plc announced that results from the Phase 1b clinical trial of LYT-200 were presented in an oral session at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, Spain. LYT-200 is a first-in-class monoclonal antibody targeting galectin-9 and is being advanced by PureTech's Founded Entity, Gallop Oncology. The completed Phase 1b trial (NCT05829226) was conducted across nine U.S. sites and evaluated LYT-200 as both monotherapy and in combination regimens in 101 heavily pretreated patients with relapsed/refractory (R/R) high-risk myelodysplastic syndromes (HR-MDS) or acute myeloid leukemia (AML). In R/R HR-MDS, LYT-200 at 12 mg/kg in combination with a hypomethylating agent (HMA) demonstrated a 36.4% complete response plus partial response rate and a 45.5% overall response rate in 11 efficacy-evaluable patients, all of whom had previously received HMA therapy. Two patients in this cohort achieved MRD-negative complete responses and subsequently proceeded to stem cell transplantation. Efficacy-evaluable R/R HR-MDS patients had a median of 3 prior lines of therapy (range: 1-5), and all (100%) had previously been treated with an HMA. Clinical responses were observed across patients with a range of mutations, and all patients had high-risk cytogenetics. LYT-200 demonstrated a favorable and consistent safety profile across all cohorts and dose levels studied (N=101), with no dose-limiting toxicities, infusion-related reactions, LYT-200 dose reductions, or LYT-200-related serious adverse events, discontinuations, or deaths. No overlapping or additive toxicities were observed when LYT-200 was combined with an HMA or venetoclax/HMA. Guenther Koehne, MD, PhD, Deputy Director and Chief of Blood & Marrow Transplant and Hematologic Oncology at Baptist Health Herbert Wertheim Cancer Institute, presented the Phase 1b results at ESMO and commented on the combination of clinical activity, depth of response, and tolerability observed in patients who have already received multiple lines of treatment. Following a successful End-of-Phase 1 meeting with the U.S. Food and Drug Administration (FDA) and receipt of Fast Track designation for R/R HR-MDS, Gallop Oncology plans to advance LYT-200 into Phase 2 development. The STRIDE-MDS trial will be a randomized, double-blind, placebo-controlled Phase 2 trial enrolling approximately 125 patients with R/R HR-MDS. Patients will be randomized 2:2:1 to receive LYT-200 at 12 mg/kg plus an HMA, LYT-200 at 7.5 mg/kg plus an HMA, or placebo plus an HMA. The trial will assess the efficacy of LYT-200 as measured by the rate of complete and partial responses to support dose selection. Gallop plans to initiate the trial after securing external capital. Myelodysplastic syndromes (MDS) affect approximately 60,000-170,000 people in the United States, with an estimated 30-40% of patients diagnosed with the more aggressive form known as high-risk (HR) MDS. Only one therapy has been approved by the U.S. FDA specifically for R/R HR-MDS in the past two decades, and it targets a genetic mutation found in only approximately 3% of patients. LYT-200 has been granted Fast Track designation from the U.S. FDA for the treatment of R/R HR-MDS in combination with a hypomethylating agent and for the treatment of AML. Gallop Oncology is wholly owned by PureTech Health plc.

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