February 17, 2026

Janux Therapeutics Doses first participant in P1

Janux Therapeutics has dosed the first participant in P1 clinical study of its JANX011, marking the first clinical evaluation of its proprietary Adaptive Immune Response Modulator (ARM) platform. Preclinical data showed that a single SC dose led to profound and sustained B-cell depletion with low cytokine release, suggesting a favorable safety profile. This open-label study will assess safety, tolerability, PK, and PD to inform dose selection and future autoimmune indications.

Source: Janux Therapeutics PR Feb 17, 2026

February 18, 2026

Novartis Releases Positive Topline Data from P3 of Remibrutinib

Novartis released positive topline data from P3 RemIND study of Remibrutinib, which met its primary endpoint and showed significantly improved complete response rates vs placebo in 3 common types of chronic inducible urticaria (CIndU) (Symptomatic Dermographism, Cold Urticaria, and Cholinergic Urticaria) at week 12. Remibrutinib could become the first targeted treatment for CIndU, addressing a major unmet need, based on the results. Following these findings, Novartis has submitted an sNDA to the U.S. FDA for symptomatic dermographism and plans to submit the full data to global regulators and present detailed results at upcoming medical congresses.

Source: Novartis PR Feb 18, 2026

February 21, 2026

J&J Publishes LTE Results of TREMFYA for UC

J&J released new results from P2/3 QUASAR long-term extension (LTE) study showing that TREMFYA (guselkumab) maintained durable benefits in adults with moderately to severely active ulcerative colitis (UC) who had an inadequate response or intolerance to prior therapies. At Wk 140 (~3 years):

• 80.8% of patients achieved clinical remission
• 78.6% experienced histo-endoscopic mucosal improvement
• Over 50% were in endoscopic remission
• ~89% of eligible participants completed treatment
• Among those in remission at Wk 44, 87.5% maintained remission through Wk 140
• Effectiveness was consistent regardless of prior use of biologics or JAK inhibitors

Importantly, no new safety concerns were observed. These findings, presented at the ECCO’26, highlight TREMFYA’s potential for long-term disease control in ulcerative colitis.

Additional Information:

J&J had two additional studies selected among the top 10 oral abstracts at the ECCO’26, reinforcing its focus on advancing treatments for inflammatory bowel disease.

• P2b ANTHEM-UC study of Icotrokinra for Ulcerative Colitis
• P3 UNITI Jr study of STELARA (ustekinumab) for Crohn’s disease

Source: PR Newswire Feb 21, 2026

February 24, 2026

Novo Nordisk Releases Top-line Data from Chinese P2 Study of UBT251

Novo Nordisk and The United Laboratories International Holdings (TUL) reported positive topline data from Chinese P2 study of UBT251, QW injectable triple agonist targeting GLP-1, GIP, and glucagon receptors. UBT251 is being co-developed by Novo Nordisk and TUL’s subsidiary United Biotechnology, which leads development in Greater China while Novo Nordisk oversees global development. The study evaluated 2 mg, 4 mg, and 6 mg doses vs placebo in people with overweight or obesity and showed a mean weight loss of up to 19.7% (17.5 kg) from a baseline of 92.2 kg after 24 wks, vs. with 2.0% (1.6 kg) with placebo. All dose groups achieved statistically significant improvements in key secondary endpoints, including waist circumference, blood glucose, blood pressure, and lipid levels. Novo Nordisk has initiated a global P1b/2a study in 330 patients, with topline results expected in 2027, and plans to start a P2 trial in T2D in H2’26. United Biotechnology will present detailed Chinese P2 data later in 2026 and is preparing to launch a P3 trial in Chinese patients with overweight or obesity.

Source: Global Newswire PR Feb 24, 2026

February 26, 2026

Positive Topline Data from P3 ADAPT OCULUS of VYVGART

Argenx has released positive top-line data from P3 ADAPT OCULUS study of VYVGART (efgartigimod alfa and hyaluronidase-qvfc) for ocular myasthenia gravis (oMG) that met its primary endpoint, showing that patients treated with VYVGART had a statistically significant improvement in their Myasthenia Impairment Index (MGII) patient-reported ocular scores by wk. 4 vs. placebo. In practical terms, patients experienced meaningful relief from key eye-related symptoms, including double vision (diplopia) and drooping eyelids (ptosis), highlighting the therapy’s potential to improve daily functioning and QoL for individuals with oMG. The data support a planned sBLA submission to the FDA for label expansion into oMG which is already approved in anti-AChR Abs positive gMG.

Source: Argenx PR Feb 26, 2026

February 27, 2026

Galderma Releases Long-term Data from Nemluvio

Galderma has released new long-term data showing that Nemluvio (nemolizumab) continues to deliver strong, lasting disease control for people with moderate-to-severe prurigo nodularis for up to three years. The findings come from an interim analysis of the ongoing OLYMPIA LTE study, the longest study ever reported in this condition.

The LTE trial included 508 patients who had previously taken part in the P2 and P3 OLYMPIA 1 and OLYMPIA 2 studies, which had already shown Nemluvio’s ability to significantly reduce itch and skin nodules while improving quality of life. Importantly, the long-term results revealed no new safety concerns.

At Wk 148 (nearly three years), the results remained impressive:

• More than 70% of evaluable patients achieved clear or almost clear skin
• Over 85% experienced clinically meaningful relief from itch
• About 75% were itch-free or nearly itch-free
• ~ 90% reported major quality-of-life improvements, with over half reaching scores showing little to no daily life impact from the disease

These long-term outcomes will be presented at the 2026 Winter Clinical Miami meeting.

Source: Business Wire PR Feb 27, 2026

February 16, 2026

ODD for E2086 from MHLW

Eisai received ODD from MHLW (Japan) for E2086 (novel selective Orexin 2 RA), being developed to treat narcolepsy type 1 (affecting an estimated 46,000 patients) in Japan. The decision was based on P1b study data showing that E2086 has the potential to improve daytime wakefulness, which were presented at the World Sleep 2025 congress.

Source: Eisai PR Feb 16, 2026

February 19, 2026

MHLW Grants Approval to Rituxan for Autoimmune Hemolytic Anemia (AIHA)

Chugai Pharmaceutical announces that Zenyaku Kogyo has received regulatory approval from MHLW (Japan) to expand the use of Rituxan (rituximab) for treating Autoimmune Hemolytic Anemia (AIHA). This approval covers both 100 mg and 500 mg IV formulations, following requests from the Japanese Society of Hematology and the Japanese Society of Pediatric Hematology/Oncology. The regulatory authorities accepted a “public knowledge-based” application related to off-label use, submitted on August 29, 2025, that used existing scientific data to support the expanded use of the drug. Rituxan to be co-marketed for AIHA.

Sources: Chugai Pharmaceutical PR Feb 19, 2026

February 20, 2026

ELEVIDYS Launches as First Regenerative Therapy for DMD in Japan

Chugai Pharmaceutical has launched ELEVIDYS (delandistrogene moxeparvovec, IV) in Japan as the country’s first regenerative medicine for DMD. The single-dose gene therapy is approved for ambulatory children (Age: 3-8yrs) who tested negative for anti-AAVrh74 Abs and do not have specific DMD gene deletions. ELEVIDYS received conditional, time-limited approval on May 13, 2025 and was added to Japan’s national reimbursement list on Feb 20, 2026, with a set price of JPY 304,972,042 per patient ($1.96M). The decision was supported by P3 EMBARK global study, in which 125 participants received either delandistrogene moxeparvovec at 1.33×10¹⁴ vg/kg or placebo, with the primary endpoint being change in NSAA score at 52 wks and meaningful improvements were seen in key secondary outcomes. To ensure appropriate use, the company is rolling out safety programs, physician education, and a specialist consultation system, along with post-marketing studies and full patient surveillance to monitor long-term safety and effectiveness.

Source: Chugai Pharmaceutical PR Feb 20, 2026

February 22, 2026

Sugemalimab Receives Approval as a Monotherapy in UK

CStone Pharmaceuticals has received approval from UK’s MHRA for sugemalimab as a monotherapy treatment for adults with unresectable stage III NSCLC (at least 1% PD-L1 expression, with no EGFR, ALK, or ROS1 genetic changes), and no progression following pt-CRT. The approval is based on results from the P3 GEMSTONE-301 study, which showed that sugemalimab improved PFS and extended OS. The company plans to seek approvals for more cancer types, including gastric cancer (GC) and esophageal squamous cell carcinoma (ESCC), and is already marketing the drug in over 60 countries through global partnerships.

Source: PR Newswire Feb 22, 2026

February 23, 2026

Angelini Pharma and Quiver Bioscience to Collaborate for Novel Treatment for Genetic Epilepsies

Angelini Pharma signed a collaboration and licensing agreement with Quiver Bioscience to develop novel treatments for genetic epilepsies. This partnership will combine Quiver’s proprietary drug discovery platform, powered by advanced data assets and AI models with Angelini’s strong expertise in brain health and epilepsy drug development. Angelini has made an undisclosed upfront payment to support Quiver’s research activities and also provide additional milestones up to $120M, along with additional royalties. The agreement also grants Angelini exclusive access to data generated during the collaboration.

Source: Angelini PR Feb 23, 2026

February 25, 2026

GSK Acquires 35Pharma for HS235

GSK has acquired 35Pharma to advance the development of innovative protein-based medicines, including HS235, which has completed P1 in HVs and is set to begin studies in pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with heart failure with preserved ejection fraction (PH-HFpEF). The transaction, which gives GSK full ownership of 35Pharma for $950M in cash at closing. This is subject to customary regulatory approvals. HS235’s underlying mechanism has potential for fat-selective weight loss.

Source: GSK PR Feb 25, 2026

Thank you for your attention! For any queries, contact us at bd@octavusconsulting.com