Clene, Inc.
http://clene.com
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Latest From Clene, Inc.
Accelerated Approval: ALS Drug Could Test New Congressional Directive On Survival
Clene leadership spoke with the Pink Sheet about its push for accelerated approval for its ALS nanoparticle treatment. A new nudge from Congress asking the US FDA to consider survival data in accelerated approval could help.
Seelos Aims For Conservative Approach After ALS Drug Shows Efficacy Signal
CEO Raj Mehta told Scrip Seelos anticipates conducting a Phase III study of SLS-005 after the cohort in HEALEY ALS failed overall, but indicated some efficacy in patients not receiving Relyvrio.
Finance Watch: Public Companies Pursue All Options To Fund R&D, Launches
Public Company Edition: Follow-on offerings may not be the favored path to funding development programs or product launches after major milestones in the current environment. Amicus secured $430m in a deal with Blackstone, while OPKO’s Modex garnered up to $168m from BARDA.
Apellis Follows Wave Life By Shelving ALS Candidate After Trial Miss
Apellis’s pegcetacoplan – approved for two other indications – will not go forward in amyotrophic lateral sclerosis after a Phase II failure, two days after Wave Life made a similar call in the neurodegenerative disease.
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Biotechnology
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- Clene
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