Monitor BOS Phase 2 data readout expected 1Q 2027 as the next binary catalyst; the interim blinded safety signal (5/19 patients with >10% FEV1 decline) warrants attention upon unblinding.
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Executive Summary
IRulya Therapeutics filed an 8-K furnishing an October 2026 corporate presentation. The presentation highlights Phase 2a data for inhaled LAM-001 in PH-ILD showing a +67m improvement in 6MWD and favorable safety, with Phase 2b data expected 1Q 2028, BOS Phase 2 data expected 1Q 2027, and SAPH Phase 2 trial initiation expected 4Q 2026. The company notes an oversubscribed $115M upfront financing from May 2026.
Key Facts
- Phase 2a PH-ILD data: +67.4m 6MWD improvement, -35.3% PVR (exercise), -33.9% PVR (supine), -28.8% NT-proBNP, +1.8% FVC in PH-ILD subgroup (n=4 completers)
- Phase 2b PH-ILD trial (75 patients, placebo-controlled) data anticipated 1Q 2028
- Phase 2 BOS trial fully enrolled (19 patients), data anticipated 1Q 2027; interim safety review noted 5 of 19 subjects had >10% FEV1 decline (blinded)
- Phase 2 SAPH trial (60 patients) anticipated start 4Q 2026, data expected 4Q 2028
- Oversubscribed $115M upfront financing led by leading healthcare investors in May 2026
- 9 US and 25 international patents issued; expected exclusivity into 2035-2047
- Orphan Drug Designation granted for multiple indications in US and EU
Financial Impact
Oversubscribed $115M upfront financing completed May 2026; no current revenue or earnings reported
Risk Factors
- Interim blinded BOS data showed 5 of 19 patients had >10% FEV1 decline; final unblinded results may differ materially
- Phase 2a PH-ILD data based on small sample (n=4 completers) and open-label design; may not replicate in larger placebo-controlled Phase 2b
- Clinical-stage biotech with no approved products or revenue; dependent on future financing and trial outcomes
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001193125-26-424731 |
| Document: d123526d8k.htm | 0001193125-26-424731 |
| Document: 0001193125-26-424731-index-headers.html | 0001193125-26-424731 |
| Document: 0001193125-26-424731-index.html | 0001193125-26-424731 |
| Document: 0001193125-26-424731.txt | 0001193125-26-424731 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 21, 2026 5d ago | 144 | $32.83 | awaiting T+20 | — | $31.38 (−4.42%) |
Oct 19, 2026 7d ago | 3 | $40.27 | awaiting T+20 | — | $31.38 (−22.08%) |
Oct 19, 2026 7d ago | 3 | $40.27 | awaiting T+20 | — | $31.38 (−22.08%) |
Oct 19, 2026 7d ago | 3 | $40.27 | awaiting T+20 | — | $31.38 (−22.08%) |
Oct 19, 2026 7d ago | 3 | $40.27 | awaiting T+20 | — | $31.38 (−22.08%) |
Oct 19, 2026 7d ago | 3 | $40.27 | awaiting T+20 | — | $31.38 (−22.08%) |
Oct 19, 2026 7d ago | 8-K | $34.45 | awaiting T+20 | — | $31.38 (−8.91%) |
Oct 14, 2026 12d ago | SC 13G | $33.23 | awaiting T+20 | — | $31.38 (−5.57%) |
Oct 14, 2026 12d ago | SC 13G | $33.23 | awaiting T+20 | — | $31.38 (−5.57%) |
Oct 6, 2026 20d ago | 8-K | $26.72 | awaiting T+20 | — | $31.38 (+17.44%) |
US Market Status
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