Arcturus Therapeutics' Early Cystic Fibrosis Trial Results Encouraging - Analyst Cautiously Optimistic

Zinger Key Points
  • The absolute change in percent predicted FEV1 in the first four CF participants was observed to be an average of 4.0% at day 8.
  • William Blair notes that the results are encouraging, although several key questions remain ahead of the presentation.
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On Tuesday, Arcturus Therapeutics Holdings Inc. ARCT announced that it will present Phase 1 results in healthy volunteers and new Phase 1b interim data in cystic fibrosis (CF) for ARCT-032 at the European Cystic Fibrosis Conference.

“We were pleased to observe ARCT-032 treatments for the first four patients were generally safe and well tolerated with no serious adverse events,” said Joseph Payne, President & CEO of Arcturus Therapeutics. “Furthermore, we observed an encouraging trend towards lung function improvements in the first four CF participants after only two inhaled administrations.”

“The absolute change in percent predicted FEV1 (Forced Expiratory Volume in 1 second) in the first four CF participants was observed to be an average of 4.0% at day 8,” said Dr. Juergen Froehlich, Chief Medical Officer of Arcturus Therapeutics.

William Blair notes that the results are encouraging, although several key questions remain ahead of the presentation.

William Blair’s analyst notes it is crucial to determine if the patients were using Vertex Pharmaceuticals Incorporated’s VRTX Trikafta or if they had a genetic deletion, making them ineligible for CFTR modulator therapy. 

A 4% improvement over Trikafta would be significant, especially since Vertex’s second-generation Vanza triple did not outperform the current Trikafta treatment. Thus, an additional 4% improvement could be impactful.

As William Blair looks forward to additional detail at the conference presentation on June 7 and the planned company update on July 1, the preliminary results are encouraging if able to show an improvement on top of the standard of care or in those patients who are ineligible for current CFTR modulators. 

Arcturus’ current share value is primarily driven by Kostaive commercial expectations, CSL profit sharing from respiratory vaccine programs, and the company’s cash position, with minimal value attributed to the therapeutic pipeline.

The analyst reaffirms the Outperform rating.

Price Action: ARCT shares are up 21.90% at $37.07 at the last check on Tuesday.

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