Cytokinetics, Inc. (CYTK)

[H2R]

From an SA article today:

Cytokinetics' VITALITY-ALS results

After mixed results from Phase II study data, Cytokinetics launched a Phase III study, VITALITY-ALS, with increased dosage to examine Tirasemtiv’s potential as a treatment for Amyotrophic Lateral Sclerosis (ALS). Data from this study is expected in early December.

ALS, also known as Lou Gehrig Disease, is a progressive neurodegenerative disease affecting approximately 20,000 Americans. The disease slowly degrades the brain's ability to control muscle movement eventually leading to respiratory failure and death. It gained national prominence when it was featured in 2014’s Ice Bucket Challenge and the release of the Stephen Hawking biopic The Theory of Everything. Tirasemtiv treats ALS by promoting muscular strength and endurance.

Tirasemtiv has received Orphan Drug designation for its use in treating ALS. However, its Phase III trials had mixed results. Subjects failed to achieve its primary endpoint of increased muscle function versus the baseline, but promising data from secondary endpoints including respiratory function showed enough promise to warrant a Phase III study with an increased dosage.

The Phase III data is pivotal for Cytokinetics. Founded in 1997 the company has, due to various setbacks over the years, failed to ever generate a profit. If the increased dosage of the Phase III study fails to provide significant improvement in motor function of patients or leads to serious side effects, it will provide a serious blow to a company that has seen its stock price surged over the past three years primarily due to the potential of Tirasemtiv.

https://seekingalpha.com/article/4112877-q4-biotech-catalyst-watchlist


Biotech PDUFA / trial results are never easy to predict. I'm Long, but I did not bet the farm on it. I invested about 5% of my portfolio.

Cheers!