1. BOTOX Significantly Improved Symptoms in Upper Limb Essential Tremor
On Oct 6 2025, AbbVie announced positive topline results from its Phase 2 ELATE trial evaluating onabotulinumtoxinA (BOTOX) for upper limb essential tremor compared to placebo. Upper limb essential tremor is a neurological condition characterised by involuntary, rhythmic shaking in the hands and arms during voluntary movements. OnabotulinumtoxinA is a purified neurotoxin derived from Clostridium botulinum that regulates neurotransmitter release. The study met its primary endpoint, showing a statistically significant improvement in the Tremor Disability Scale-Revised (TREDS-R) at week 18, with the treatment group achieving a greater reduction in scores compared to the placebo arm. Six additional secondary endpoints were also met.
2. Oral IL-23 Receptor Blocker Icotrokinra Showd Strong Efficacy in Phase 2b Ulcerative Colitis Trial
On Oct 7 2025, Johnson & Johnson announced additional Week 12 results from the Phase 2b ANTHEM-UC study evaluating icotrokinra, a first-in-class oral peptide that selectively blocks the IL-23 receptor, in adults with moderately to severely active ulcerative colitis. The study met its primary endpoint, with all once-daily icotrokinra dose groups achieving clinical response at Week 12 and key secondary endpoints were also improved. At Week 12, the 400 mg group achieved a 63.5% clinical response rate versus 27% for placebo, while the 200 mg and 100 mg groups achieved 58.1% and 54.7%, respectively. As early as week 4, there were improvements in clinical remission, symptomatic remission, and endoscopic improvement across all dose groups compared to placebo.
3. TREMFYA Demonstrated Sustained 48-Week Efficacy in Phase 3 Ulcerative Colitis Study
On Oct 7 2025, Johnson & Johnson announced new 48-week results from the Phase 3 ASTRO study evaluating TREMFYA (guselkumab) subcutaneous induction and maintenance therapy in adults with moderately to severely active ulcerative colitis. At Week 48, patients receiving TREMFYA 100 mg every eight weeks and 200 mg every four weeks achieved clinical remission rates of 36.7% and 42.9%, respectively, compared to 7.2% with placebo. Endoscopic improvement was observed in 44.6% and 47.1% of patients versus 11.5% for placebo, while symptomatic remission was achieved in 47.5% and 53.6% of patients versus 14.4% for placebo. The results were consistent across both biologic/JAK inhibitor-naïve and refractory subgroups.
4. FDA Approved SIMPONI as First Subcutaneous TNF-α Inhibitor for Pediatric Ulcerative Colitis
On Oct 7 2025, Johnson & Johnson announced that the U.S. FDA had approved SIMPONI (golimumab) for the treatment of children with moderately to severely active ulcerative colitis. SIMPONI is administered subcutaneously via a pre-filled syringe, and golimumab can block TNF-α and reduce inflammation. The approval was based on results from the PURSUIT program, which included two open-label studies. In the Phase 3 PURSUIT 2 study, 32% of pediatric patients achieved clinical remission at Week 6 (primary endpoint), 58% achieved clinical response (secondary endpoint), and 40% showed endoscopic improvement (secondary endpoint). Among those in remission at Week 6, 57% maintained remission at Week 54.
5. Four-Year Data Confirm Durable, Steroid-Free Efficacy of Omvoh in Ulcerative Colitis
On Oct 7 2025, Eli Lilly and Company showed 4-year data on Omvoh (mirikizumab-mrkz), which helps patients with moderately to severely active ulcerative colitis (UC) to achieve sustained, long-term outcomes. Mirikizumab is an IL-23p19 inhibitor which blocks the downstream signals. After four years of total treatment, 78% of patients achieved corticosteroid-free clinical remission, 78% sustained clinical remission, 81% maintained endoscopic remission, 90% achieved remission on the Inflammatory Bowel Disease Questionnaire, and 66% showed histological-endoscopic mucosal improvement. Additionally, 93% reported at least a three-point improvement on the bowel urgency scale, with 74% experiencing no or minimal urgency. These findings demonstrate the long-term efficacy and suitability of Omvoh as a steroid-free therapy for UC.
6. Pluripotent Stem Cells Therapy Bemdaneprocel Showed Sustained 3-Year Motor Improvements in Parkinson’s Disease
On Oct 7 2025, Bayer and BlueRock Therapeutics announced positive 36-month results from exPDite, a Phase I clinical trial evaluating bemdaneprocel, an investigational cell therapy for Parkinson’s disease. Bemdaneprocel consists of pluripotent stem cell-derived dopaminergic neuron precursor cells, which were designed to replace the dopamine-producing neurons that are progressively lost in the substantia nigra of PD patients.
Clinically, patients showed sustained improvements in motor symptoms, particularly in the high-dose cohort. At 36 months, participants receiving the higher dose experienced a mean 17.9-point reduction in MDS-UPDRS Part III “off-medication” motor scores from baseline, compared to a 13.5-point reduction in the low-dose group Clinically, patients showed sustained improvements in motor symptoms, particularly in the high-dose cohort. At 36 months, participants receiving the higher dose experienced a mean 17.9-point reduction in MDS-UPDRS Part III “off-medication” motor scores from baseline, compared to a 13.5-point reduction in the low-dose group. Moreover, the activities of daily living, assessed by MDS-UPDRS Part II, were reduced by 4.3 points in the high-dose group.
7. FDA Approved JASCAYD as First PDE4B Inhibitor for Idiopathic Pulmonary Fibrosis
On Oct 9 2025, Boehringer Ingelheim announced that the U.S. Food and Drug Administration had approved JASCAYD (nerandomilast) tablets as an oral treatment for adults with idiopathic pulmonary fibrosis. Nerandomilast works by inhibiting phosphodiesterase 4B (PDE4B), an enzyme that breaks down cyclic adenosine monophosphate (cAMP). The approval was supported by results from the Phase 3 FIBRONEER-IPF trial and a second clinical study, which showed that nerandomilast significantly reduced the decline in forced vital capacity (FVC) at week 52 compared to placebo. Patients receiving 18 mg and 9 mg of nerandomilast experienced mean FVC declines of –106 mL and –122 mL, respectively, versus –170 mL with placebo, with benefits evident as early as week two.
8. Libtayo was Apporved by the FDA as for High-Risk Cutaneous Squamous Cell Carcinoma
On Oct 8 2025, Regeneron Pharmaceuticals announced that the U.S. FDA had approved Libtayo (cemiplimab-rwlc), a PD-1 inhibitor, as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma at high risk of recurrence following surgery and radiation. The approval was supported by results from the pivotal Phase 3 C-POST trial, which showed that Libtayo reduced the risk of disease recurrence or death by 68% compared to placebo. Serious adverse reactions occurred in 18% of patients, and those symptoms that occurred in ≥1% of patients in the Libtayo arm were pneumonia (1.5%), rash (1.5%), diarrhea (1.5%), adrenal insufficiency (1%), and arrhythmia (1%).
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