Market reactionShares fell 10% on Nov 5.
Clene develops CNM-Au8, an oral gold nanocrystal drug for ALS; it submitted an NDA in October 2026 seeking accelerated approval, and the drug is not approved.
Clene submitted an NDA in October 2026 asking FDA to approve CNM-Au8 for ALS under accelerated approval. The case rests on falls in neurofilament light, a nerve-damage marker, and survival data from open-label follow-up rather than a controlled endpoint. FDA approved tofersen for a genetic ALS form on this marker in 2023, so the path exists. FDA must first accept the filing. A $4 million registered direct offering in September funds Clene only to mid-first quarter 2027.
Thesis checklist
1 risk needs attention
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Next decision point
Tests: FDA accepts the NDA
Does FDA accept the CNM-Au8 NDA for review and set a decision date?
Strong, inconclusive and weak outcomes
What to look for in the result and how each would move the checklist
Price and material events
Select an event marker to read the update below. Marker colors show Thesis status.
Clene filed its ALS NDA on biomarker data; FDA's filing decision is next
CNM-Au8 NDA filed for ALS on surrogate biomarker data alone, with cash running out before any FDA decision
Nanocrystalline gold chasing ALS accelerated approval on biomarker surrogates alone, with cash expiring at the filing window
FDA-confirmed accelerated approval path for ALS hinges on NDA acceptance and whether NfL qualifies as a surrogate — runway expires the same quarter the filing lands
About this history: every entry shows when the Thesis moved and what it said. The reasoning behind each move (the evidence, the analysis and the source filing) and the earnings write-ups are part of a subscription.
Dates, trials and completed outcomes are open to everyone. What each upcoming milestone hinges on is part of a subscription.
Disease areas: Neurology and pain, Skin diseases
Catalyst calendar · Upcoming FDA decisions · Thesis changes
Competitive landscape
9 peers tracked
Cash: Market-data provider estimate; measurement period unavailable.
Debt: Market-data provider estimate; a complete comparable filing balance is unavailable.
Quarterly burn: Estimated from trailing free cash flow; measurement period unavailable.
Net cash and estimated runway require verified matching measurement periods. Missing debt components are not assumed to be zero.
Runway: No underlying guidance available.