Zymeworks Announces Acquisition of Theravance Biopharma; Ipsen to Acquire Kartos Therapeutics; Viridian Therapeutics Wins U.S. FDA Approval for Lumvoa; Replimune Reaches FDA Milestone with RP1 BLA Resubmission Acceptance; Epicrispr Announces Encouraging Clinical Data for EPI-321 in FSHD

Zymeworks Signs Definitive Agreement to Acquire Theravance Biopharma

Zymeworks Inc. has signed a definitive agreement to acquire Theravance Biopharma, Inc., marking a strategic step in expanding its commercial portfolio. The acquisition will bring YUPELRI®, the first and only once-daily nebulized long-acting muscarinic antagonist (LAMA) approved for the maintenance treatment of chronic obstructive pulmonary disease (COPD), into Zymeworks’ partnered asset portfolio, reinforcing the company’s commitment to addressing serious diseases and improving patient outcomes.

Following the completion of the transaction, YUPELRI® is expected to generate near-term commercial revenue alongside existing cash flows from Ziihera® (zanidatamab-hrii). These revenues will support Zymeworks’ disciplined capital allocation strategy, enabling continued investment in its internal research and development pipeline, the acquisition of additional partnered assets, and the return of value to shareholders. Rather than relying solely on a traditional passive royalty model, Zymeworks’ business strategy emphasizes acquiring and actively optimizing commercial assets to achieve royalty-like returns while maintaining greater operational control, strategic flexibility, and long-term value creation.

After the acquisition closes, Zymeworks plans to implement Theravance Biopharma’s previously announced restructuring initiatives, aligning the organization’s resources around the commercialization of YUPELRI®. The company expects these efforts to significantly reduce research and development as well as general and administrative expenses while identifying additional operational efficiencies across the combined business. Zymeworks also intends to retain much of Theravance Biopharma’s existing hospital-focused commercial infrastructure to support YUPELRI®’s continued market presence.

Ipsen Bolsters Oncology Pipeline with Kartos Therapeutics Acquisition

Ipsen has signed a definitive agreement to acquire Kartos Therapeutics, strengthening its oncology portfolio with the addition of navtemadlin, an investigational MDM2 inhibitor that aims to reactivate the tumor-suppressor protein p53. The therapy is being developed for patients with intermediate- and high-risk TP53 wild-type (TP53wt) myelofibrosis who demonstrate an inadequate response to the current standard treatment, ruxolitinib. Clinical findings to date indicate that navtemadlin has the potential to provide meaningful therapeutic benefits when used in combination with ruxolitinib.

Commenting on the acquisition, Ipsen CEO David Loew stated that the transaction reinforces the company’s commitment to expanding its late-stage oncology pipeline with innovative cancer therapies. He highlighted navtemadlin’s potential to establish a new treatment approach for myelofibrosis patients who do not achieve sufficient benefit from existing therapies, with a possible market launch as early as 2028.

Although ruxolitinib remains the standard treatment for myelofibrosis by improving spleen enlargement and disease-related symptoms, many patients eventually experience inadequate clinical responses, often leading to treatment discontinuation. Following ruxolitinib failure, prognosis remains poor, with median overall survival ranging between one and two years.

Navtemadlin is currently being investigated in the global Phase III POIESIS study, which plans to enroll more than 600 patients across over 250 clinical sites. The trial is evaluating navtemadlin in combination with ruxolitinib in patients with intermediate- and high-risk TP53wt myelofibrosis who have shown a suboptimal response to standard therapy. The study builds upon encouraging results from the earlier Phase Ib/II KRT-232-109 trial, where the combination demonstrated clinically meaningful efficacy and evidence of disease-modifying activity.

Data presented at the 2023 European Hematology Association Congress showed promising outcomes among patients with inadequate responses to ruxolitinib (n=19). After 24 weeks of treatment, 42% achieved at least a 25% reduction in spleen volume, while 32% experienced a reduction of at least 35%. Additionally, 32% reported a 50% or greater improvement in total symptom scores. The study also suggested potential disease-modifying effects, with 71% of evaluable patients showing at least a 20% reduction in driver variant allele frequency and 57% demonstrating an improvement of one or more grades in bone marrow fibrosis based on central review by Week 24.

U.S. FDA Approves Viridian Therapeutics’ Lumvoa for Thyroid Eye Disease

Viridian Therapeutics announced that the FDA has approved Lumvoa™ (veligrotug-vvze) for the treatment of thyroid eye disease (TED), a rare autoimmune disorder that causes inflammation and tissue remodeling in and around the eye. The condition can result in symptoms such as eye bulging (proptosis), double vision (diplopia), pain, and impaired vision.

Commenting on the approval, Steve Mahoney, President and Chief Executive Officer of Viridian, stated that the authorization of Lumvoa represents a major milestone in expanding treatment options for patients with TED. He noted that the therapy was developed with a strong focus on patient needs and marks Viridian’s first FDA-approved medicine as well as its inaugural commercial product. Mahoney also highlighted the company’s extensive launch preparations, particularly following the receipt of the FDA’s Breakthrough Therapy Designation, emphasizing that both medical affairs and commercial teams are fully prepared to support healthcare providers and patients from the outset.

The FDA granted approval under its Priority Review pathway based on positive findings from the pivotal Phase III THRIVE (active TED) and THRIVE-2 (chronic TED) clinical trials. Lumvoa, a full insulin-like growth factor-1 receptor (IGF-1R) antagonist, is the first approved therapy for TED with prescribing information supported by clinical data in both active and chronic forms of the disease. In both studies, the treatment successfully achieved the primary endpoint along with all secondary endpoints, demonstrating statistically significant and clinically meaningful improvements across major TED signs and symptoms by Week 15.

Patients in both Phase III trials received a 12-week treatment regimen designed to minimize treatment burden. Clinical benefits emerged rapidly, with reductions in proptosis observed as early as three weeks after treatment initiation. Additionally, Lumvoa became the first approved TED therapy to demonstrate statistically significant improvements in both diplopia response and complete resolution across patients with active and chronic disease. Prior to approval, the therapy received both Breakthrough Therapy Designation and Priority Review from the FDA, underscoring its potential to address a significant unmet medical need.

Replimune Secures FDA Acceptance of RP1 BLA Resubmission for Advanced Melanoma

Replimune Group announced that the FDA has accepted the resubmitted Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of patients with advanced melanoma. The agency classified the submission as a complete Class 1 resubmission, assigning a target action date of August 2, 2026. The FDA has also informed the company that it expects to convene an advisory committee meeting in late July to discuss the application.

Commenting on the development, Sushil Patel, Ph.D., Chief Executive Officer of Replimune, said the company is encouraged by the FDA’s expedited review timeline, which reflects the significant unmet medical need among patients with advanced melanoma as well as support from the broader melanoma community. He added that Replimune looks forward to engaging in scientific and clinical discussions regarding the benefit-risk profile of RP1 in this challenging treatment setting.

The resubmitted application seeks accelerated approval for RP1 in combination with nivolumab based on findings from the IGNYTE clinical trial. The study assessed the combination therapy in patients with advanced melanoma whose disease had progressed despite treatment with an anti-PD-1–containing regimen.

Epicrispr Demonstrates First Clinical Evidence of Lean Muscle Volume Gains with EPI-321 in FSHD

Epicrispr Biotechnologies reported new interim findings from its ongoing open-label Phase 1/2 first-in-human trial evaluating EPI-321 for the treatment of facioscapulohumeral muscular dystrophy (FSHD). The data provide the first clinical evidence that a therapeutic intervention can increase muscle volume in patients with FSHD, highlighting the potential of EPI-321 to deliver a disease-modifying effect.

Based on the data cutoff of May 12, 2026, a total of nine patients had received treatment across two dosing cohorts. EPI-321 demonstrated a favorable safety profile, with no serious adverse events reported. Six patients received a single intravenous infusion at the target dose of 2×10¹³ vg/kg (Cohort 1), while three patients were administered a higher single IV dose of 4×10¹³ vg/kg (Cohort 2).

Among the first three evaluable patients in Cohort 1, all experienced increases in lean muscle volume six months after treatment compared with baseline measurements. On average, patients gained approximately 370 mL of lean muscle, equivalent to about 0.8 pounds of muscle mass, with individual increases ranging from approximately 0.5 to 1.3 pounds. Some individual muscles demonstrated lean muscle volume gains of up to 15%.

These results mark a significant advancement for FSHD, a progressive neuromuscular disorder associated with continuous muscle wasting and weakness. Unlike the muscle loss typically observed in previous FSHD clinical trials, including recent Phase 3 studies, all evaluable patients treated with EPI-321 showed consistent improvements in muscle volume at the six-month assessment. Earlier findings from the same trial had also demonstrated favorable improvements in muscle strength and functional outcomes at three months. Currently, no approved therapies are available for FSHD.

EPI-321 is an investigational gene regulation therapy designed to suppress DUX4, the primary genetic driver of FSHD. Built on Epicrispr’s proprietary Gene Expression Modulation System (GEMS) platform, the therapy aims to achieve durable regulation of disease-causing gene expression without modifying the underlying DNA sequence. Administered as a single-dose intravenous treatment, EPI-321 is intended to provide long-term suppression of DUX4 activity and sustained protection against DUX4-mediated muscle damage.