NCE-1 Intelligence & Market Opportunity

Qalsody

Tofersen

Neuroprotective

Solution Intraethical

Qalsody is the first FDA‑approved antisense oligonucleotide treatment for amyotrophic lateral sclerosis (ALS) associated with SOD1 gene mutations. It reduces SOD1 protein synthesis by targeting SOD1 mRNA, addressing disease progression at a genetic level.

Approval Date

25-Apr-23

NCE-1 Date

25-Apr-27

NCE Date

25-Apr-28

Commercial snapshot

Market performance & projections

Revenue ($M)

CAGR (%)

0.1119

Projected sales, 2026–2032 ($M)

Analyst projection, $M per year

2026

101

2027

119

2028

133

2029

133

2030

139

2031

148

2032

154

Molecule profile

Details & specifications

Molecule

Tofersen

Innovator

BIOGEN MA INC

Dosage Form

Solution Intraethical

Strength

100 mg/15 mL (6.7 mg/mL)

Therapeutic Category

Neuroprotective

Usage

To treat amyotrophic lateral sclerosis in adults who have a SOD1 gene mutation

Good to know

Frequently asked questions

Why Spring Bio Solution

Intelligence you can file on

Verified regulatory data

Milestones tracked against primary FDA sources and refreshed continuously.

Analyst-built projections

Seven-year sales outlooks modeled by our pharma intelligence team.

First-to-file focus

Exclusivity windows framed around the decisions generics teams actually make.

Partnership on demand

From API sourcing to dossier support — one request starts the conversation.

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Talk to Spring Bio Solution about sourcing, licensing, and filing support for this molecule.