Sobi Partners with Innate Pharma to License Lacutamab for T-Cell Lymphoma; Yochanra Makes Global Debut in China as First Innovative Drug Designed to Overcome FGFR Inhibitor Resistance; Replimune Secures FDA Accelerated Approval for TUDRIQEV Plus Nivolumab in Advanced Cutaneous Melanoma; FDA Accepts Supplemental Biologics License Application for ENFLONSIA to Broaden RSV Indication in Young Children; Tarsus Pharmaceuticals to Acquire Alkeus Pharmaceuticals

Sobi Licenses Lacutamab from Innate Pharma to Advance Treatment of T-Cell Lymphoma

Swedish Orphan Biovitrum AB (Sobi®) and Innate Pharma SA have announced a strategic partnership aimed at enabling the initiation of the TELLOMAK-3 confirmatory Phase 3 trial of lacutamab in cutaneous T-cell lymphoma (CTCL). The study represents a significant milestone in advancing lacutamab toward a potential accelerated approval in Sézary syndrome, a subtype of CTCL.

As part of the agreement, Innate Pharma will lead the TELLOMAK-3 Phase 3 confirmatory study in CTCL, with the trial designed to support a potential accelerated approval application for lacutamab in Sézary syndrome. Data from the study are also expected to support subsequent regulatory submissions seeking full approval in major markets for Sézary syndrome and mycosis fungoides, the most prevalent form of CTCL.

Under the terms of the partnership, Sobi will obtain exclusive worldwide commercialisation rights for lacutamab following a potential accelerated approval. In addition, Sobi may assume global development rights for the therapy upon the successful completion of the Phase 3 program. The transaction remains subject to customary closing conditions, including receipt of the required antitrust clearance.

Guido Oelkers, President and CEO of Sobi, stated that the partnership marks an important advancement in the company’s portfolio and is consistent with its strategy of collaborating with innovative companies to deliver differentiated treatments for patients with rare diseases. He added that Sobi is looking forward to working with Innate Pharma to progress lacutamab and, pending regulatory approval, expand access to the therapy for patients worldwide.

Jonathan Dickinson, Chief Executive Officer of Innate Pharma, said the company was pleased to partner with Sobi and facilitate the launch of the TELLOMAK-3 study, which represents a pivotal step toward potentially securing accelerated approval for lacutamab in Sézary syndrome. He highlighted Sobi’s rare disease expertise, commercial capabilities, and global presence as complementary to Innate Pharma’s capabilities in CTCL clinical development. The companies share a common objective of advancing lacutamab and making the treatment available to patients globally as rapidly as possible.

Yochanra Enters the Global Market in China, Bringing a New Approach to FGFR Inhibitor Resistance

TransThera Sciences’ Yochanra has become the first drug independently developed in China specifically designed to address the longstanding global challenge of acquired resistance to FGFR inhibitor therapy in patients with cholangiocarcinoma. On August 6, 2026, the National Medical Products Administration (NMPA) officially approved Yochanra® for marketing in China. The therapy has also received multiple regulatory recognitions internationally, including Fast Track Designation and Orphan Drug Designation from the U.S. Food and Drug Administration (FDA), Orphan Drug Designation from the European Medicines Agency (EMA) for biliary tract cancer, as well as inclusion in China’s NMPA List of Products for Priority Review and List of Breakthrough Therapeutic Drugs. As a leading candidate in this therapeutic area, Yochanra® has been presented in oral sessions and featured at several major international scientific conferences, addressing a significant unmet clinical need created by the lack of established treatment options after patients develop resistance to FGFR inhibitors.

The indication approved by the NMPA represents the first of several indications being pursued under Yochanra’s multi-indication development strategy. The drug is approved for adults with advanced, metastatic, or unresectable cholangiocarcinoma harboring an FGFR2 fusion or rearrangement who have previously undergone systemic treatment and FGFR inhibitor therapy. The approval was supported by a multicenter, open-label, single-arm pivotal Phase II clinical trial conducted in China, with findings presented at the 2026 Annual Meeting of the American Society of Clinical Oncology (ASCO).

As of December 27, 2025, the study had enrolled 50 patients with advanced cholangiocarcinoma, all of whom had previously received at least one line of chemotherapy and treatment with an FGFR inhibitor. After a median follow-up of 12 months, blinded independent central review (BICR) reported the following outcomes:

• The objective response rate (ORR) was 28.0%, with 14 patients achieving a confirmed partial response.
• The median duration of response (DoR) was 8.5 months (95% CI: 5.6–12.5 months), while the disease control rate (DCR) reached 82.0%.
• The median progression-free survival (PFS) was 6.0 months (95% CI: 4.4–8.3 months).
• The median overall survival (OS) was 20.7 months (95% CI: 11.8 months–not estimable).

Overall, Yochanra demonstrated sustained antitumor activity in the trial, along with a manageable safety and tolerability profile.

The global cholangiocarcinoma therapeutics market was valued at approximately US$2.0 billion in 2024 and is expected to reach US$3.2 billion by 2027. Approximately 25.2% of patients with cholangiocarcinoma are estimated to harbor FGFR alterations. Evidence published in Cancer Treatment Reviews in 2023 highlighted the development of acquired resistance following FGFR inhibitor treatment. Patients who develop resistance frequently carry one or more mutations, often involving multiple sites, creating substantial challenges for the development of effective therapies. Although several biotechnology companies outside China have explored treatment approaches in this area, related development programs have ultimately failed. Moreover, neither Chinese nor U.S. clinical treatment guidelines currently provide high-level recommendations for patients with cholangiocarcinoma who progress after developing resistance to FGFR inhibitors, leaving a significant unmet need for an established standard of care.

Yochanra is designed to address this challenge through a distinctive FGFR-binding mechanism that enables it to retain strong binding activity while overcoming resistance mutations across multiple sites. Clinical studies have shown that the therapy can effectively counter acquired resistance, potentially offering a new treatment option for patients with FGFR2 fusion- or rearrangement-positive cholangiocarcinoma whose disease has progressed following prior FGFR inhibitor therapy.

The NMPA’s marketing authorization marks the approval of Yochanra®’s first indication in China. In cholangiocarcinoma, global enrollment has been completed for the Phase III registrational multicenter study, while a Phase III confirmatory trial in China is advancing in parallel. Beyond cholangiocarcinoma, TransThera Sciences plans to continue progressing Yochanra® through clinical development across multiple indications, to provide additional treatment options for patients with cancers including prostate cancer, breast cancer, and liver cancer.

Replimune’s TUDRIQEV Receives FDA Accelerated Approval for Melanoma Patients Progressing After Anti-PD-1 Therapy

Replimune Group, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to TUDRIQEV™ (vusolimogene oderparepvec-wtpg), formerly known as RP1, in combination with nivolumab for the treatment of adults with unresectable advanced cutaneous melanoma whose disease has progressed following an anti-PD-1 antibody-based therapy. The approval is based on objective response rate (ORR) and duration of response (DoR), with continued approval potentially dependent on the confirmation of clinical benefit through one or more confirmatory trials.

The Phase II IGNYTE trial included 140 patients, of whom 91 had at least one non-injected lesion and were included in the efficacy-evaluable population. Among these patients, treatment with TUDRIQEV plus nivolumab produced an ORR of 24.2%, while the median duration of response reached 14.1 months. The combination demonstrated a generally manageable safety profile, with most adverse events being mild to moderate in severity. The study population comprised a high-risk group, including 80% of patients with Stage 4 disease, 13% who had previously received anti-PD-1 adjuvant therapy, 54% with PD-L1-negative tumors, and patients with lung and liver lesions in 45% and 24% of cases, respectively. Findings from the IGNYTE trial were published in the Journal of Clinical Oncology.

Sushil Patel, Ph.D., CEO of Replimune, described the FDA decision as a significant milestone for the company, highlighting the years of research behind TUDRIQEV and its potential to address the unmet needs of patients with advanced melanoma. He also expressed appreciation to the patients, investigators, melanoma community, and FDA for their contributions to bringing the therapy forward. Following the approval, Replimune stated that it would prioritize efforts to make TUDRIQEV available to eligible patients.

Treatment options remain limited for patients with advanced melanoma, with more than half experiencing disease progression within six months of receiving immune checkpoint inhibitors such as anti-PD-1 therapies. Following progression, patients generally have a poor prognosis, with median overall survival of less than one year.

TUDRIQEV is administered through direct intratumoral injection into superficial, deep, and/or visceral lesions. When treating deep or visceral tumors, imaging technology is used to guide administration. The recommended TUDRIQEV dose is determined according to tumor size.

FDA Accepts sBLA for ENFLONSIA to Address RSV Risk in Children Under Two During Their Second Season

Merck announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) seeking to expand the indication for ENFLONSIA™ (clesrovimab-cfor) to include the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in children younger than two years who are at increased risk of developing severe RSV disease through their second RSV season. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of March 22, 2027.

Earlier, in July 2026, the European Medicines Agency (EMA) also accepted an application to extend ENFLONSIA’s marketing authorization in the European Union (EU) for the same high-risk pediatric population. ENFLONSIA received U.S. FDA approval in June 2025 and European Commission approval in April 2026 for the prevention of RSV LRTD in infants born during or entering their first RSV season. The therapy is the first and only RSV preventive option for infants that does not require weight-based dosing.

According to Dr. Macaya Douoguih, vice president and Therapeutic Area Head, Global Clinical Development, Merck Research Laboratories, some children continue to face a substantial risk of severe RSV disease beyond their initial RSV season. She noted that the recent regulatory submissions in the U.S. and EU could help extend ENFLONSIA protection to vulnerable children under two years of age during their second RSV season, potentially easing the considerable burden RSV places on families and healthcare systems.

Despite receiving RSV protection during their first season, certain children remain at elevated risk of severe disease during their second RSV season. This includes children with chronic lung disease, congenital heart disease, or those born very prematurely or moderately preterm who have specific risk factors.

The U.S. and EU regulatory submissions are supported by findings from the Phase III SMART trial (MK-1654-007). Data from the study were presented at RSVVW’26, the 9th conference of the Respiratory Syncytial Virus Foundation (ReSViNET), in February 2026. Interim results from the first RSV season were published in the New England Journal of Medicine in September 2025, while the complete study results were published in JAMA Pediatrics in July 2026.

ENFLONSIA is currently approved in more than 40 countries, including the U.S., Canada, the EU, China, and Japan, for the prevention of RSV LRTD in infants during their first RSV season. Merck is pursuing additional regulatory submissions worldwide, both to secure approvals in new markets and to expand the indication in countries where ENFLONSIA is already available.

Tarsus Pharmaceuticals to Expand Ophthalmology Footprint With Alkeus Pharmaceuticals Acquisition

Tarsus Pharmaceuticals, Inc. announced that it has signed a definitive agreement to acquire Alkeus Pharmaceuticals, Inc., a privately owned biotechnology company focused on retinal diseases and developing gildeuretinol (ALK-001), an investigational once-daily oral treatment for Stargardt disease.

The proposed acquisition marks another significant milestone in Tarsus’ strategy to establish a leading eye care company by delivering differentiated treatments for diseases with substantial unmet medical needs. The transaction is expected to strengthen Tarsus’ expanding retina portfolio, complement the capabilities gained through its acquisition of iRenix Medical, and add a differentiated Phase III development program targeting Stargardt disease.

ALK-001 is an investigational new molecular entity designed to limit the formation and accumulation of toxic vitamin A dimers while maintaining the normal visual cycle. By reducing these damaging byproducts, the therapy is intended to potentially slow retinal degeneration and help preserve vision for a longer period in patients affected by Stargardt disease.

Stargardt disease is an inherited retinal disorder that frequently emerges during childhood or adolescence and causes progressive, irreversible loss of central vision, affecting essential activities such as reading, recognizing faces, driving, and maintaining independence. The disease is associated with the buildup of toxic vitamin A dimers that damage retinal cells, underscoring the need for therapies capable of targeting its underlying biological mechanisms. More than 36,000 individuals in the United States have been clinically diagnosed with Stargardt disease, for which no FDA-approved treatments are currently available.