Respiratory Today—May 15, 2026

This week’s Respiratory update highlights regulatory progress, clinical development advances, AI-enabled diagnostics, RNA-editing innovation, and strategic partnerships across pulmonary disease care.

In Today’s Newsletter

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🤝 Cereno and PHA Europe & Global partner on patient-centered PH development [1] [Europe • 11 May 2026]

https://www.cerenoscientific.com/en/newsroom/press-releases?slug=cereno-scientific-enters-collaboration-with-pha-europe-and-global-to-advance-patient-centered-drug-development-in-pulmonary-hypertension
Context: Cereno Scientific is developing CS1 for PAH and other rare cardiovascular and pulmonary programs.
Key point: Cereno Scientific and PHA Europe & Global will integrate patient input into clinical design, materials, and communication.
Implication: Signals pipeline investment and modality expansion.

🇨🇳 Chance Pharma CXG87 NDA accepted by China NMPA [2] [China • 07 May 2026]

https://www.prnewswire.com/news-releases/chance-pharma-announces-nmpa-acceptance-of-new-drug-application-for-investigational-respiratory-drug-cxg87-302766379.html
Context: CXG87 is an improved budesonide/formoterol dry powder inhalation therapy for respiratory diseases such as asthma.
Key point: China’s NMPA accepted Chance Pharma’s NDA after a Phase III asthma study met non-inferiority versus Symbicort Turbuhaler.
Implication: May influence prescriber choice and payer reviews pending full data.

👃 ENA Respiratory advances INNA-051 Phase IIa POSITS study [3] [US • 11 May 2026]

https://enarespiratory.com/ena-respiratory-successfully-completes-first-part-of-phase-ii-study-of-inna-051-nasal-spray-designed-to-protect-against-symptomatic-viral-respiratory-infections/
Context: INNA-051 is a once-weekly dry powder nasal spray designed to prime antiviral host defenses.
Key point: ENA completed Part A of POSITS in 200 US participants with no safety concerns identified, enabling Part B.
Implication: May influence prescriber choice and payer reviews pending full data.

🫁 aTyr aligns efzofitimod Phase 3 plan with FDA feedback [4] [US • 11 May 2026]

https://investors.atyrpharma.com/news-releases/news-release-details/atyr-pharma-provides-regulatory-and-clinical-update-efzofitimod
Context: Efzofitimod is a biologic immunomodulator in development for pulmonary sarcoidosis and other ILD settings.
Key point: aTyr plans a June 2026 IND for a new Phase 3 study using FVC as the primary endpoint and KSQ-Lung as key secondary.
Implication: May influence prescriber choice and payer reviews pending full data.

🧬 AIRNA presents AIR-001 and RNA-editing preclinical data [5] [US • 12 May 2026]

https://forbion.com/news-insights/news/airna-presents-new-preclinical-data-on-aatd-therapeutic-candidate-air-001-and-cardiometabolic-rna-editing-programs-at-asgct/
Context: AIR-001 is a subcutaneous GalNAc oligonucleotide for AATD, now in Phase 1 RepAIR1.
Key point: AIRNA reported preclinical RNA-editing data for AIR-001 and cardiometabolic targets at ASGCT 2026.
Implication: Signals pipeline investment and modality expansion.

🚀 Varda and United Therapeutics test microgravity-enabled pulmonary formulations [6] [US • 13 May 2026]

https://www.prnewswire.com/news-releases/varda-space-industries-and-united-therapeutics-collaborate-to-advance-microgravity-enabled-treatments-for-rare-pulmonary-disease-302770786.html
Context: Varda’s platform processes pharmaceutical payloads in low Earth orbit and returns them via reentry capsules.
Key point: Varda and United Therapeutics will study microgravity processing of small-molecule pulmonary disease medicines.
Implication: Signals pipeline investment and modality expansion.

🧠 Brainomix and Boehringer expand e-Lung partnership in PPF [7] [US • 12 May 2026]

https://www.prnewswire.com/news-releases/brainomix-and-boehringer-ingelheim-advance-strategic-partnership-in-pulmonary-fibrosis-302768599.html
Context: Brainomix e-Lung is FDA-cleared AI imaging software that detects and quantifies abnormalities on thoracic CT. \Key point: Brainomix and Boehringer will run PROGRESS-PPF, a prospective multicenter US study evaluating e-Lung at scale.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

💨 Transpire Bio high-strength generic Trelegy ANDA accepted by FDA [8] [US • 11 May 2026]

https://www.transpirebio.com/transpire-bios-anda-for-generic-high-strength-trelegy-ellipta-accepted-for-filing-by-the-u-s-fda/
Context: The ANDA covers fluticasone furoate, umeclidinium, and vilanterol inhalation powder, a generic high-strength Trelegy Ellipta.
Key point: FDA accepted Transpire Bio’s ANDA, and the company believes it may be first-to-file with Paragraph IV certification.
Implication: Introduces competition that may affect pricing and formulary access.

Why it matters

Pulmonary development is broadening across drug delivery, biologics, RNA editing, AI imaging, and space-enabled formulation.
Regulatory milestones remain a key value driver, with NMPA NDA acceptance, FDA ANDA acceptance, and FDA-guided Phase 3 redesigns.
Patient selection and endpoint strategy are prominent in pulmonary sarcoidosis, PPF, asthma, viral respiratory infection, and AATD.
Partnerships are accelerating capability build-out, from patient engagement to real-world imaging studies and microgravity manufacturing.
Generic respiratory-device competition may reshape access and pricing for high-value inhaled therapies.

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FAQ

What is Cereno Scientific doing with PHA Europe & Global?

Cereno Scientific is collaborating with PHA Europe & Global to bring patient perspectives into PAH and pulmonary hypertension clinical development. The work includes trial design, materials, communication, and awareness. [1]

What is CXG87 from Chance Pharma?

CXG87 is an investigational budesonide/formoterol dry powder inhalation therapy for respiratory diseases such as asthma. China’s NMPA accepted its NDA after a Phase III study reported non-inferiority versus Symbicort Turbuhaler. [2]

What changed for ENA Respiratory’s INNA-051 study?

ENA completed Part A of the Phase IIa POSITS community study in 200 participants with no safety concerns identified. Part B is planned for 900 participants during the next North American respiratory virus season. [3]

What is aTyr Pharma’s next step for efzofitimod?

aTyr plans to submit an IND in June 2026 for a new Phase 3 study in chronic, symptomatic pulmonary sarcoidosis with restrictive lung disease. The planned primary endpoint is change from baseline in FVC at week 48. [4]

What did AIRNA report for AIR-001?

AIRNA presented preclinical data showing AIR-001 edited the PiZ mutation in AATD models and restored functional M-AAT in serum. AIR-001 is currently in a Phase 1 trial. [5]

Why are Brainomix and Boehringer expanding the e-Lung partnership?

The companies plan PROGRESS-PPF, a prospective US multicenter study of e-Lung in progressive pulmonary fibrosis. The goal is to evaluate whether routine use can support earlier clinical diagnosis. [7]

Entities / Keywords

Cereno Scientific, PHA Europe & Global, CS1, PAH, pulmonary hypertension
Chance Pharma, CXG87, budesonide/formoterol, Symbicort Turbuhaler, asthma, NMPA
ENA Respiratory, INNA-051, POSITS, TLR2/6, viral respiratory infections
aTyr Pharma, efzofitimod, EFZO-FIT, pulmonary sarcoidosis, FVC, KSQ-Lung, FDA
AIRNA, AIR-001, AATD, SERPINA1, PiZ, RNA editing, ASGCT
Varda Space Industries, United Therapeutics, microgravity, rare pulmonary disease
Brainomix, Boehringer Ingelheim, e-Lung, PPF, ILD, PROGRESS-PPF, REVISE-PPF
Transpire Bio, Trelegy Ellipta, ANDA, Paragraph IV, asthma, COPD