secwatch.observer — SEC 8-K summary
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Issuer:     Savara Inc (SVRA)
CIK:        0001160308
Form:       8-K
Filed at:   2024-06-26T23:59:59+00:00
Accession:  0001193125-24-168501
Event type: other_material
Sentiment:  positive
Materiality: 0.90
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Savara reports positive Phase 3 IMPALA-2 results for molgramostim in aPAP; primary endpoint met
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- Primary endpoint met: DLCO improved by 6.00% predicted at Week 24 vs placebo (p=0.0007).
- Statistically significant improvement sustained at Week 48: DLCO 6.90% (p=0.0008).
- SGRQ Total Score statistically significant at Week 24 (-6.59 points, p=0.0072); SGRQ Activity and exercise capacity nominally significant.
- Well-tolerated; no drug-related discontinuations; 97% completed double-blind; all patients elected 96-week open-label.
- Company plans to complete BLA submission to FDA in first half of 2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1160308/000119312524168501/0001193125-24-168501-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1160308/000119312524168501/d860197d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-24-168501

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