Respiratory Video Recap—December 12, 2025

This biweekly respiratory update covers regulatory milestones, late- and early-stage clinical data, strategic pipeline shifts, and emerging technologies shaping pulmonary and airway disease care.

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

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Week 28 November–4 December 2025
Week 5 –11 December 2025

📚 See the full Respiratory archive on our research hub page.

Transcript

Welcome to the latest edition of Respiratory Research Updates, covering breakthroughs in the past two weeks. Brought to you by LucidQuest.

First, Beyfortus, nirsevimab, is now available in Malaysia to protect all infants against RSV during their first season. This single dose option has shown high, sustained effectiveness with a favorable safety profile in trials and real world programs. Access pathways may scale screening, initiation, and follow up.

Next, in idiopathic pulmonary fibrosis, investigators reported an inhalable dual drug lipid nanoparticle that carries verteporfin and berbamine. In a mouse model, the approach reduced fibrosis and stiffness and improved lung function compared with oral pirfenidone, with better tolerability. These are preclinical data, and translation will require rigorous study design and control of confounding.

In alpha-1 antitrypsin deficiency, Regeneron and Tessera Therapeutics announced a 50–50 global partnership to develop TSRA-196, an in vivo Gene Writing program intended to correct SERPINA1 with a one time treatment. Tessera receives 150 million dollars upfront plus milestones. The partners expect an IND and multiple CTAs this year.

Turning to biologics, the FDA cleared a 300 mg per 2 mL prefilled syringe of OMLYCLO, omalizumab-igec, the interchangeable Xolair biosimilar. This joins 75 mg and 150 mg presentations that were approved in March 2025, expanding dosing flexibility across asthma, chronic rhinosinusitis with nasal polyps, food allergy, and chronic spontaneous urticaria.

On drug discovery strategies in IPF, Accendatech highlighted a Phase 2 safety setback with a STAT3 inhibitor and discussed risks of transcription factor targeting. The company contrasted this with approaches such as TNIK inhibition and the natural product ACT001, and referenced AI and precision-medicine strategies. The announcement did not specify the affected clinical endpoint.

Kamada discontinued its Phase 3 InnovAATe study of inhaled alpha-1 antitrypsin in AATD after a prespecified futility analysis indicated a low likelihood of benefit on FEV1. The decision was not driven by safety, and the company reiterated its 2025 revenue and EBITDA guidance.

In pulmonary arterial hypertension, the FDA cleared Cereno Scientific to begin a global Phase IIb study of CS1, a histone deacetylase modulator, as add on therapy. Approximately 126 patients on background treatment will be enrolled. The primary endpoint is pulmonary vascular resistance at Week 36, with 6 minute walk distance as a key outcome. The design includes re randomization to test durability, and first patient in is planned for the second quarter of 2026.

Finally, GRI Bio announced positive topline results from a 12 week randomized, placebo controlled Phase 2a study of GRI-0621 in IPF with 35 participants. The primary endpoint of safety was met. Collagen turnover biomarkers improved, and exploratory analyses suggested forced vital capacity gains, all of which warrant confirmation in larger and longer studies.

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Why It Matters

Infant RSV prevention access scales in Southeast Asia with a single-dose option backed by real-world data [1].
Gene editing, epigenetic modulation, and inhaled nanoparticles diversify respiratory pipelines across AATD, PAH, and IPF [2][3][7].
Interchangeable omalizumab biosimilar options may ease injection burden and intensify price competition in allergy and asthma [4].
Futility governance continues to shape late-stage respiratory programs, as seen in inhaled AATD therapy [6].
Early IPF signals, including biomarker shifts and functional trends, need confirmation in larger, longer studies [8].

🗓️ Explore weekly details and sources

Week 28 November–4 December 2025
Week 5 –11 December 2025

📚 See the full Respiratory archive on our research hub page.

FAQ

What does Beyfortus’ Malaysia availability cover?

Protection for newborns and infants during their first RSV season with a single dose, supported by high real-world effectiveness and favorable safety [1].

What is TSRA-196 aiming to do?

Provide a one-time, in vivo Gene Writing correction of SERPINA1 for AATD, with IND and multiple CTAs planned under a 50–50 Regeneron–Tessera collaboration [3].

How does the new OMLYCLO presentation help?

The FDA-cleared 300 mg/2 mL syringe can reduce injections and expand flexibility across approved omalizumab indications, with interchangeability to Xolair [4].

Why did Kamada discontinue its inhaled AAT trial?

A prespecified futility analysis indicated low likelihood of FEV1 benefit. The decision was not due to safety issues; financial guidance was reiterated [6].

What will CS1 Phase IIb measure?

Pulmonary vascular resistance at Week 36 and 6-minute walk distance in an add-on, dose-finding, re-randomization design to inform Phase 3 dose and durability [7].

What did GRI-0621 show in IPF?

Met primary safety, improved collagen-turnover biomarkers, and showed exploratory FVC gains over 12 weeks in a small RCT [8].

Entities / Keywords

Sanofi; AstraZeneca; Beyfortus; nirsevimab; RSV; NPRA; Malaysia • VB-RT nanoparticles; verteporfin; berbamine; IPF; Advanced Science • Regeneron; Tessera Therapeutics; TSRA-196; Gene Writing; SERPINA1; AATD • Celltrion; OMLYCLO; omalizumab-igec; Xolair; interchangeable biosimilar • Accendatech; STAT3; NF-κB; TNIK; ACT001; IPF • Kamada; InnovAATe; inhaled AAT; AATD; FEV1 • Cereno Scientific; CS1; HDAC inhibitor; PAH; PVR; 6MWD • GRI Bio; GRI-0621; IPF; collagen turnover; FVC.