Chiasma Inc (NASDAQ:CHMA)
Chiasma Inc (NASDAQ:CHMA) shares were up over 32% on Friday despite having announced a loss in their Q2 2017 financial release. The market responded forcefully to the news that Chiasma reached an agreement with the U.S. Food and Drug Administration (FDA) on the design of a new Phase 3 clinical trial for its octreotide capsules product candidate – provisionally trade-named Mycapssa. Mycapssa is being developed for the maintenance therapy of adult patients with acromegaly, a hormonal disorder.
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The agreed-upon study is designed to address the concerns previously raised in the FDA’s Complete Response Letter (CRL) and was reached through Special Protocol Assessment (SPA) with the FDA’s Division of Metabolism and Endocrinology Products. A Special Protocol Assessment (SPA) is a process by which an applicant and the FDA reach an agreement on the protocol design, endpoints and analysis of a Phase 3 clinical study prior to initiation, in order to determine if the study adequately addresses scientific and regulatory requirements for FDA approval.
The trial, referred to as “OPTIMAL”, is a randomized, double-blind, placebo-controlled, nine-month trial in 50 adult acromegaly patients (at least 20% of whom must be recruited from the United States). OPTIMAL utilizes levels of insulin-like growth factor, IGF-1, as the sole primary endpoint measure Chiasma Inc (NASDAQ:CHMA) believes the trial is adequately powered to assess maintenance of biochemical control with octreotide capsules compared to placebo in adult acromegaly patients who previously demonstrated biochemical control on somatostatin receptor ligand injections. The Company anticipates release of top-line data from this new Phase 3 clinical trial by the end of 2019.
For Q2 2017, Chiasma Inc (NASDAQ:CHMA) reported a net loss of (-$6.9) million, or (-$0.28) per share. In Q2 2016, Chiasma reported a net loss of (-$26.7) million, or (-$1.10) per share. Q2 R&D expenses were $4.3 million versus $14.8 million for the same period in 2016. The decrease was primarily due to approximately $7.4 million of non-recurring API purchases and pre-commercial manufacturing validation activities in 2016. There were also reduced compensation-related costs. There was also a Q2 drop of $0.8 million in clinical trial costs compared with Q2 2016.
I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.
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About the author: Monica has an undergraduate degree in Accounting and an MBA she earned – with Honors. She has six years of experience in the financial markets and has been an analyst for the past two years.