Movement Alert|Ionis Pharmaceuticals Rises 5.9% Overnight, ALS Drug Ulefnersen Meets Primary Endpoint in Phase 3 Trial

Market Focus
Sep 23

On September 23, Ionis Pharmaceuticals rose 5.9% overnight, trading at $48.45/share, with turnover of $259,700.

On the news front, Ionis Pharmaceuticals and Otsuka Pharmaceutical announced that the Phase 3 Fusion study of ulefnersen successfully met its primary endpoint, demonstrating statistically significant improvement in survival and function in patients with FUS gene mutation-associated amyotrophic lateral sclerosis (ALS). The trial also met key secondary endpoints, significantly reducing a critical nerve damage biomarker and delaying death or the need for permanent ventilation.

Ulefnersen is an antisense oligonucleotide therapy designed to intervene in the disease process at its genetic root. If ultimately approved, it would become the first potential disease-modifying therapy for FUS-ALS, filling an unmet medical need in this rare disease indication. The companies stated they plan to engage with the FDA and other regulatory authorities regarding potential expedited approval pathways. Separately, the FDA PDUFA target action date for the company's another drug, Zilganersen for Alexander disease, was also set for September 22.

(The above content is based on publicly available market information, generated by a program or algorithm, and is intended solely as a stock movement alert. It does not constitute investment advice or a basis for trading decisions.)

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Most Discussed

  1. 1
     
     
     
     
  2. 2
     
     
     
     
  3. 3
     
     
     
     
  4. 4
     
     
     
     
  5. 5
     
     
     
     
  6. 6
     
     
     
     
  7. 7
     
     
     
     
  8. 8
     
     
     
     
  9. 9
     
     
     
     
  10. 10