Sign up
Pharma Capital

Chiasma shares surge after FDA agrees to redefine late-stage study endpoints

The biopharma is developing a drug to treat acromegaly, a pituitary gland disorder
Pills
Shares were up in Tuesday afternoon trading

Biopharma company Chiasma Inc (NASDAQ:CHMA) saw its shares jump double digits after reaching an agreement with the U.S. Food and Drug Administration to modify endpoints in its Phase III clinical trial.

The company is conducting a late-stage study of its drug Mycapssa, an oral medication developed to treat adult patients with acromegaly. The disorder occurs when an adenoma, a benign tumor of the pituitary gland, overproduces growth hormone and causes enlargement of the face, hands and feet.

“We believe the SPA Modification agreement we are announcing today with the FDA favorably alters the mix of secondary endpoints to be reviewed by the FDA in evaluating the totality of evidence of octreotide capsules’ treatment effect,” said CEO Mark Fitzpatrick in a company statement.

The fourth and fifth secondary endpoints in the trial have been altered to include descriptive statistics within the treatment groups, which the company believes will be sufficient to prove that the drug works.

Prior to making the changes, Chiasma wasn’t confident that the endpoints showcased Mycapssa’s efficacy.

The FDA has sent a Special Protocol Assessment Agreement Modification letter to the company to make the changes official.

Shares of the Massachusetts-based biopharma were up nearly 7% to US$1.55.



Register here to be notified of future CHMA Company articles
View full CHMA profile View Profile
View All

© biotech Capital 2018

Biotech Capital, a subsidiary of Proactive Investors, acts as the vanguard for listed biotech companies to interact with institutional and highly capitalised investors.
Headquartered in London, Biotech Capital is led by a team of Europe's leading analysts and journalists, publishing daily content, covering all key movements in the Biotechnology market.