Shots:
- The European Commission approved multiple innovative therapies across vaccines, oncology, cardiology, immunology, and rare diseases, including products from Moderna, Hansoh Pharmaceutical, Cytokinetics, ImmunityBio, and GSK
- The Committee for Medicinal Products for Human Use also issued positive opinions for late-stage assets from Ipsen, X4 Pharmaceuticals, Novartis, and Moderna, alongside additional recommendations for therapies targeting chronic spontaneous urticaria, WHIM syndrome, pediatric low-grade glioma, and respiratory infections
- These decisions were supported by robust Phase II/III clinical data demonstrating improved vaccine efficacy, reduced exacerbation and infection rates, enhanced exercise capacity and tumor responses, durable complete response rates, and favorable safety profiles across diverse patient populations in the EU
Company: Moderna
Product: mNEXSPIKE
Active Ingredient: COVID-19 mRNA vaccine
Disease: COVID-19
Date: Feb 12, 2026
Shots:
- The EC has approved mNEXSPIKE (mRNA-1283), a COVID-19 vaccine, for active immunization against SARS-CoV-2 in individuals (aged≥12 yrs)
- Approval was based on the P-III trial evaluating mNEXSPIKE (mRNA-1283; 10 µg) versus Spikevax (mRNA-1273; 50 µg) in ~11,400 participants (aged ≥12 yrs), with primary efficacy assessed from 14 days post-vaccination
- mNEXSPIKE showed 9.3% superior relative vaccine efficacy (rVE) in subjects (≥12yrs.), whereas in a descriptive sub-group analysis mNEXSPIKE showed 13.5% higher rVE in participants (≥65yrs.). mRNA-1283 demonstrated a comparable safety profile to mRNA-1273
Company: Hansoh Pharmaceutical
Product: Aumseqa
Active Ingredient: Aumolertinib
Disease: Non-small Cell Lung Cancer
Date: Feb 12, 2026
Shots:
- The EC has approved Hansoh Pharmaceutical’s Aumseqa (aumolertinib mesylate tablets), marketed as Ameile in China, for use as monotx. in adult pts with advanced NSCLC with EGFR exon 19 deletions or exon 21 (L858R) mutations in the 1L therapy, and for advanced EGFR T790M mutation-positive NSCLC
- Aumseqa is an oral, third-generation EGFR tyrosine kinase inhibitor (TKI) that selectively targets mutated EGFR to inhibit tumor cell growth and reduce the spread of EGFR-mutated lung cancer, while sparing normal EGFR activity to minimize off-target effects
- In 2025, Aumolertinib Mesylate Tablets received marketing approval from the MHRA in the UK
Company: Cytokinetics
Product: Myqorzo
Active Ingredient: Aficamten
Disease: Obstructive Hypertrophic Cardiomyopathy
Date: Feb 12, 2026
Shots:
- The EC has approved Cytokinetics’ Myqorzo (5, 10, 15 & 20mg) for the treatment of adults with symptomatic (NYHA, class II-III) oHCM, with first EU launch expected in Germany by Q2’26
- Approval was based on P-III (SEQUOIA-HCM) trial of Myqorzo, showing improved exercise capacity vs PBO at 24wks., with increased peak oxygen uptake by 1.76 vs 0 ml/kg/min, consistent across all subgroups & in pts with or without background beta-blocker therapy. Results were published in The NEJM
- Myqorzo is a QD, oral cardiac myosin inhibitor that directly targets hypercontractility and LVOT obstruction associated with oHCM
Company: ImmunityBio
Product: Anktiva + Bacillus Calmette-Guérin
Active Ingredient: Nogapendekin Alfa Inbakicept
Disease: BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
Date: Feb 18, 2026
Shots:
- The EC has granted conditional approval to Anktiva + Bacillus Calmette-Guérin (BCG) to treat BCG-unresponsive NMIBC with CIS, & with/without papillary tumors in all 30 EEA states, based on P-II/III (QUILT-3.032) study (n=100)
- Trial showed a 71% CR rate, with median duration of CR of 26.6mos., plus DoR range was as long as 54mos. & ongoing. Among responders, CR rates were 66% at 12mos. & 42% at 24mos.
- Also, the cystectomy-free survival was 96%, 90%, & 84% at 12, 24, & 36mos., respectively, while disease-specific survival for all pts was 99% at both 24 & 36mos. Under the conditional approval, ImmunityBio will continue patient follow-up & submit long-term data to the EMA
- GSK Reports the EC Approval of Exdensur (Depemokimab) for Asthma with Type 2 Inflammation and CRSwNP
Company: GSK
Product: Exdensur
Active Ingredient: Depemokimab
Disease: Asthma with Type 2 Inflammation and CRSwNP
Date: Feb 17, 2026
Shots:
- EC approved Exdensur as an add-on maintenance therapy for asthma pts (≥12yrs.) with type 2 inflammation (eosinophilic) & as add-on therapy for inadequately controlled CRSwNP, based on P-III (SWIFT & ANCHOR) trials, respectively
- In SWIFT-1 (n=382) & SWIFT-2 (n=380), Exdensur reduced asthma exacerbations by 58% & 48% over 52wks. (1EP), with pooled data showing a 72% reduction in hospitalizations vs PBO + SoC, & fewer exacerbations resulting in hospital/ER events (1% & 4% vs 8% & 10%)
- ANCHOR-1 (n=271) & ANCHOR-2 (n=257) trials assessed Exdensur vs PBO in CRSwNP pts on intranasal corticosteroids, which showed reduced nasal polyp size at 52wks. & improved nasal obstruction verbal response over Wks. 49-52
Company: Ipsen
Product: Ojemda
Active Ingredient: Tovorafenib
Disease: R/R BRAF-Altered Pediatric Low-Grade Glioma
Date: Feb 26, 2026
Shots:
- The CHMP has recommended conditional approval of Ojemda monotx. for the treatment of pts (≥6mos.) with pLGG harbouring a BRAF fusion or rearrangement or BRAF V600 mutation, who have progressed after ≥1 prior systemic therapies
- Opinion was based on the ongoing P-II (FIREFLY-1) trial assessing Ojemda (QW, PO) in 137 relapsed or refractory BRAF-altered pLGG pts (6mos. to 25yrs.) across 2 arms: Arm 1 (n=77) for efficacy analyses & Arm 2 for safety data for an additional 60 pts
- Trial showed an improved ORR of 71% per RANO-HGG & 53% per RAPNO-LGG criterias, with clinical benefit rate of 77% & 58%, respectively. Based on RAPNO-LGG, among responders, median time to response was 5.4mos. & mDoR was 18mos.
Company: X4 Pharmaceuticals
Product: Xolremdi
Active Ingredient: Mavorixafor
Disease: WHIM Syndrome
Date: Feb 26, 2026
Shots:
- The CHMP has recommended approval of Xolremdi, under exceptional circumstances, for the treatment of WHIM syndrome, with EC’s decision expected in Q2’26
- Opinion was backed by the global P-III (4WHIM) trial assessing Xolremdi vs PBO in 31 pts (≥12yrs.) with WHIM syndrome, which showed improved absolute lymphocyte counts, absolute neutrophil counts, & fewer infections, plus Xolremdi significantly increased time above threshold for TAT-ANC & TAT-ALC
- Trial also showed benefit across composite endpoint, with ~40% reduction in total infection score as per infection severity, & 60% lower annualized infection rate, while total wart change scores showed no difference between arms over 52wks.
Company: Novartis
Product: Rhapsido
Active Ingredient: Remibrutinib
Disease: Chronic Spontaneous Urticaria
Date: Feb 26, 2026
Shots:
- The CHMP has recommended approval of remibrutinib for CSU in adults with inadequate response to H1-antihistamines, with a final decision from the EC expected within ~2 mos.
- Opinion was supported by the global P-III REMIX-1 & 2 trials in 925 pts uncontrolled on second-generation H1-antihistamines, where remibrutinib showed superiority vs PBO in ISS7, HSS7 & UAS7 at Wk 12, with itch and hive improvement from Wk 1 sustained to Wk 52, along with QoL and sleep benefits and a favorable safety profile without liver concerns
- Remibrutinib is a highly selective oral BTK inhibitor that blocks the BTK pathway responsible for histamine release, helping reduce itching, hives, and swelling associated with CSU
Company: Moderna
Product: mCOMBRIAX
Active Ingredient: Influenza and COVID 19, mRNA Vaccine
Disease: Influenza and COVID-19
Date: Feb 26, 2026
Shots:
- The CHMP has recommended approval of mCOMBRIAX (mRNA-1083), a combination vaccine for prevention of influenza and COVID-19 in patients ≥50 yrs. If granted, the approval would be valid in all 30 EEA states
- Opinion was based on a P-III trial evaluating mRNA-1083 in ~8,000 adults across two cohorts: ≥65yrs (n~4,000) vs co-administered Fluzone High‑Dose / Efluelda + Spikevax and 50–64yrs (n~4,000) vs Fluarix + Spikevax, where all 1EPs were met, demonstrating non-inferiority of immune response with acceptable safety and tolerability
- mCOMBRIAX builds on advances from mNEXSPIKE, Moderna’s COVID-19 vaccine, and mRNA-1010, its investigational seasonal influenza vaccine currently under regulatory review in the US, EU, Canada, and Australia
Note: The following drugs have been granted CHMP; however, no PR was available:
- Onerji (levodopa / carbidopa)
- Palsonify (paltusotine)
Related Post: Insights+: EMA Marketing Authorization of New Drugs in January 2026
