Respiratory Video Recap—October 31, 2025

This biweekly video recap highlights the most impactful respiratory updates, spanning scientific progress, industry moves, and regulatory milestones.

Watch Our Video Summary Capturing Respiratory News from the Last Two Weeks

🧬 BRAFTOVI + MEKTOVI show long-term survival in BRAF V600E mNSCLC (PHAROS) [1] [EU • 19 Oct 2025]

https://www.businesswire.com/news/home/20251017611442/en/Pfizers-BRAFTOVI-MEKTOVI-Shows-Sustained-Long-Term-Survival-in-Patients-with-Advanced-Lung-Cancer

Context: Single-arm Phase 2 in treatment-naïve and previously treated metastatic NSCLC with BRAF V600E.
Key point: Median OS 47.6 months in treatment-naïve and 22.7 months post-therapy; safety consistent (per company).
Implication: May influence prescriber choice and payer reviews pending full data.

🍁 Dupixent approved in Canada for eosinophilic COPD add-on therapy [2] [CA • 22 Oct 2025]

https://www.newswire.ca/news-releases/dupixent-r-dupilumab-injection-approved-in-canada-for-adults-with-inadequately-controlled-chronic-obstructive-pulmonary-disease-copd–809243479.html

Context: Adults with inadequately controlled COPD and raised eosinophils on maximal inhaled therapy.
Key point: Based on BOREAS and NOTUS Phase 3, reporting 30% and 34% exacerbation reductions over 52 weeks.
Implication: May influence prescriber choice and payer reviews pending full data.

🌍 Low-carbon Ventolin MDI achieves Phase 3 equivalence vs current propellant [3] [UK • 22 Oct 2025]

https://www.gsk.com/en-gb/media/press-releases/gsk-announces-positive-pivotal-phase-iii-data-for-next-generation-low-carbon-version-of-ventolin-salbutamol-metered-dose-inhaler/

Context: Salbutamol MDI using HFA-152a propellant compared with HFA-134a version.
Key point: Therapeutic equivalence and comparable safety; company cites potential 92% per-inhaler GHG reduction.
Implication: Access programs. May expand screening, initiation, and follow-up at scale.

🧡 Sanofi’s efdoralprin alfa meets endpoints in AATD emphysema (ElevAATe) [4] [23 Oct 2025]

https://www.newsmp.com/news/articleView.html?idxno=249528

Context: Global Phase 2 with Q3W or Q4W dosing vs weekly augmentation therapy.
Key point: Met primary and key secondary endpoints; more time with functional AAT in normal range; safety similar to plasma-derived therapy (endpoint specifics not detailed).
Implication: May influence prescriber choice and payer reviews pending full data.

🧪 Vertex links lower sweat chloride to improved outcomes; ALYFTREK data at NACFC [5] [US • 23 Oct 2025]

https://news.vrtx.com/news-releases/news-release-details/vertex-presents-new-data-across-portfolio-cystic-fibrosis

Context: Multiple abstracts including pooled and post-hoc analyses across CFTR modulators.
Key point: Achieving sweat chloride <60 and <30 mmol/L associated with lower antibiotic use; ALYFTREK showed greater sweat chloride reductions vs TRIKAFTA in Phase 3 (numbers not restated).
Implication: Observational/RWE. Could inform practice and payer discussions; interpretation depends on design and confounding control.

🧷 GSK licenses EMP-012 siRNA for COPD from Empirico [6] [UK • 28 Oct 2025]

https://www.gsk.com/en-gb/media/press-releases/gsk-and-empirico-enter-license-agreement-for-clinical-stage-first-in-class-oligonucleotide-candidate/

Context: Phase 1 siRNA targeting a distinct inflammatory pathway; potential in non-type 2 COPD.
Key point: $85m upfront, up to $660m in milestones; longer dosing interval potential and combo optionality.
Implication: Partnerships/BD. Signals pipeline investment and modality expansion.

🌬️ Amneal gets FDA tentative approval for generic QVAR MDI [7] [US • 29 Oct 2025]

https://investors.amneal.com/news/press-releases/press-release-details/2025/Amneal-Receives-U-S–FDA-Tentative-Approval-for-Beclomethasone-Dipropionate-HFA-Inhalation-Aerosol/default.aspx

Context: Beclomethasone dipropionate HFA 40/80 mcg for asthma maintenance; company’s first MDI.
Key point: Generic equivalent to QVAR, establishing presence in complex respiratory inhalation.
Implication: Regulatory/generics. Introduces competition that may affect pricing and formulary access.

🫀 TX45 improves hemodynamics in PH-HFrEF, Phase 1b Part B [8] [US • 29 Oct 2025]

https://investors.tectonictx.com/news-releases/news-release-details/tectonic-therapeutic-announces-positive-topline-data-phase-1b

Context: Open-label, single IV dose in 14 patients; follow-on to PH-HFpEF Part A; APEX Phase 2 ongoing.
Key point: Directional improvements in PCWP, PVR, CO, TPR and mPAP, supportive day-29 echo, well tolerated.
Implication: May influence prescriber choice and payer reviews pending full data.

Why It Matters

Canada’s first biologic for eosinophilic COPD may reset care for frequent exacerbators on maximal inhaled therapy [2].
Decarbonizing reliever MDIs while retaining equivalence supports climate goals without limiting patient choice [3].
Biomarker-guided targets in CF, using sweat chloride, are linking to real-world utilization and outcomes [5].
Novel modalities, from siRNA to Fc-relaxin, broaden respiratory options beyond inhaled small molecules [6][8].
AATD innovation and generic ICS inhalers show parallel progress on innovation and affordability [4][7].

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FAQ

What survival did PHAROS report for BRAF V600E mNSCLC?

Median OS was 47.6 months in treatment-naïve and 22.7 months in previously treated patients, with safety consistent with prior findings. PHAROS is single-arm, so comparisons are contextual [1].

Who qualifies for Dupixent under Canada’s COPD approval?

Adults with inadequately controlled COPD and raised eosinophils on maximal inhaled therapy. Approval is based on BOREAS and NOTUS, which reduced exacerbations over one year [2].

How does the low-carbon Ventolin differ from current MDIs?

Phase 3 showed therapeutic equivalence and comparable safety vs HFA-134a Ventolin. Company estimates a 92% per-inhaler GHG reduction using HFA-152a, pending approvals [3].

What did Sanofi’s ElevAATe show in AATD?

Efdoralprin alfa met primary and key secondary endpoints with Q3W or Q4W dosing, maintaining functional AAT in the normal range more often vs augmentation therapy; safety was similar. Detailed endpoints were not specified in the source [4].

Why did GSK license EMP-012?

EMP-012 is a first-in-class siRNA in Phase 1 for COPD targeting a distinct inflammatory pathway, with potential in non-type 2 disease and longer dosing intervals. Deal: $85m upfront plus milestones and royalties [6].

What did TX45 demonstrate in PH-HFrEF?

Single-dose TX45 produced meaningful improvements across left-sided and pulmonary hemodynamics, supportive day-29 echo changes, and good tolerability. Phase 2 APEX continues in PH-HFpEF [8].

Entities / Keywords

Pfizer; BRAFTOVI; encorafenib; MEKTOVI; binimetinib; PHAROS; mNSCLC; BRAF V600E • Sanofi; Regeneron; Dupixent; dupilumab; Health Canada; COPD; eosinophilic COPD; BOREAS; NOTUS • GSK; Ventolin; salbutamol; HFA-152a; low-carbon MDI • Sanofi; efdoralprin alfa; SAR447537; INBRX-101; ElevAATe; AATD • Vertex; ALYFTREK; vanzacaftor/tezacaftor/deutivacaftor; TRIKAFTA; sweat chloride; NACFC • GSK; Empirico; EMP-012; siRNA; COPD • Amneal; beclomethasone dipropionate HFA; QVAR; MDI; ANDA • Tectonic Therapeutic; TX45; Fc-relaxin; PH-HFrEF; PH-HFpEF; APEX.