secwatch.observer — SEC 8-K summary
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Issuer:     Amylyx Pharmaceuticals, Inc. (AMLX)
CIK:        0001658551
Form:       8-K
Filed at:   2022-08-11T23:59:59+00:00
Accession:  0001193125-22-218745
Event type: earnings
Sentiment:  neutral
Materiality: 0.65
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Amylyx Q2 net loss $54.1M ($0.93/shr); ALBRIOZA launched in Canada; FDA PDUFA Sept 29
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- Net loss $54.1M vs $21.9M in Q2 2021; R&D $24.3M, G&A $30.0M; no product revenue.
- Cash & equivalents $206.7M at June 30, down from $255.2M at March 31, 2022.
- ALBRIOZA (AMX0035) commercially launched in Canada on July 29, 2022.
- FDA AdCom meeting Sept 7, 2022; PDUFA decision date Sept 29, 2022 for ALS NDA.
- EU MAA under review; decision expected first half 2023; commercial prep underway.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1658551/000119312522218745/0001193125-22-218745-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1658551/000119312522218745/d392710d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-22-218745

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer