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NEWS

Cytokinetics Reports the EC Approval of Myqorzo (Aficamten) for Obstructive Hypertrophic Cardiomyopathy (oHCM)

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…
February 18, 2026

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NEWS

GSK Reports the EC Approval of Exdensur (Depemokimab) for Asthma with Type 2 Inflammation and CRSwNP

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%…
February 17, 2026

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Eli lilly
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Eli Lilly Reports P-III (LIBRETTO-432) Trial Findings on Retevmo (Selpercatinib) in RET Fusion-Positive NSCLC

Shots: Eli Lilly has reported P-III (LIBRETTO-432) trial data assessing Retevmo vs PBO in 151 pts with RET fusion-positive NSCLC following completion of definitive radiotherapy or surgery with curative intent, & other adjuvant therapy, if indicated Trial met its 1EP, showing improvement in investigator-assessed EFS in early-stage (II-IIIA) pts, plus OS data was immature but demonstrated a…
February 17, 2026

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Innocare Pharma
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InnoCare Pharma Reports First Patient Dosing in P-II/III Trial of Soficitinib for Chronic Spontaneous Urticaria

Shots: InnoCare has dosed the first patient with soficitinib (ICP-332) in the P-II/III trial for the treatment of chronic spontaneous urticaria Additionally, the company has completed enrolment in soficitinib’s P-III trial for mod. to sev. atopic dermatitis & P-II trial for vitiligo Soficitinib (ICP-332) is a selective TYK2 inhibitor in development for T-cell–mediated autoimmune diseases,…
February 16, 2026

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Astrazeneca
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AstraZeneca Reports P-III (LOGOS & KALOS) Trial Findings on Breztri Aerosphere for Uncontrolled Asthma

Shots: The P-III (LOGOS & KALOS) trials evaluated Breztri Aerosphere (BGF; 320/28.8/9.6μg or 320/14.4/9.6μg) vs PT009 (ICS/LABA via Aerosphere) & Symbicort pressurized metered-dose inhaler (pMDI) in pts with uncontrolled asthma; Regulatory filings in asthma are under review in all major regions In pooled analysis, Breztri improved lung function by 76 mL in morning pre-dose trough…
February 13, 2026

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Moderna
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Moderna Reports the EC Approval of mNEXSPIKE to Protect Against COVID-19 

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%…
February 12, 2026

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NEWS

Acrotech Biopharma and Otsuka Pharmaceutical Receive the US FDA Approval for Adquey to Treat Mild-to-Mod. Atopic Dermatitis 

Shots:  The US FDA has approved Adquey (difamilast 1%) ointment for treating mild-to-mod. atopic dermatitis in adults and children aged≥ 2 yrs.  Approval was based on multiple pivotal P-III trials, which showed a significantly higher proportion of patients treated with ADQUEY achieving IGA success after 4 wks vs vehicle, with a consistent safety profile  Adquey is a non-steroidal topical PDE-4 inhibitor for BID treatment…
February 12, 2026

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