Yeji
CRLconf 0.85

molgramostim inhalation — CRL

$SVRA · Savara Inc · autoimmune pulmonary alveolar proteinosis
Event date
May 27, 2025
375 days ago
Sponsor runway
18 mo
$202.8M liquid

Evidence

On May 27, 2025, Savara Inc. issued a press release announcing that it has received a refusal to file letter from the U.S. Food and Drug Administration for the Biologics License Application for molgramostim inhalation solution to treat patients with autoimmune pulmonary alveolar proteinosis.
Source: 8-K filed 2025-05-27View on EDGAR ↗0001193125-25-126273

Comparable historical crls· last 5 years · same event type

No comparable historical outcomes in our database yet — backfill of past readouts arrives next ingestion cycle.

Recent insider activity· ±90 days

3 insiders · 3 buys · 0 sells
Buy
2025-06-20
Hawkins Richard J
Director
48,225 @ $2.04$99K
Buy
2025-05-29
McCracken Joseph S
Director
10,000 @ $2.08$21K
Buy
2025-03-31
RAMSAY DAVID A
Director
150,000 @ $2.77$416K