On the last check on Friday, Chiasma Inc. (CHMA) was trading at $4.79, up 6.92%. Chiasma stock finished the last trading session at $4.48, up 2.99%. CHMA stock price ranged from $4.30 to $4.49 during the session. CHMA traded 0.63 million shares on the day as compared to its 100-day average daily volume of 2.57 million.
Within the last five days, CHMA stock has dropped by -5.29%, while in the past month it has risen 7.69%. With the CHMA stock rising in the absence of recent news, we can then look to recent developments to provide a more comprehensive understanding of CHMA.
Recently, how have things been at CHMA?
Chiasma is a biopharmaceutical company that develops and commercializes oral treatments for rare and serious chronic diseases, including most cancers, to enhance the lives of patients with a number of challenges associated with existing treatments. CHMA aims to develop oral medications by utilizing its Transient Permeability Enhancer (TPE) technology platform.
The FDA approved the CHMA drug, MYCAPSSA, in June 2020 for the treatment of acromegaly patients who have responded to or tolerated treatment with octreotide or lanreotide. It is somatostatin analog that is available for sale in the U.S., which is the first and only oral somatostatin analog approved by the FDA. CHMA has its headquarters in Needham, Massachusetts, as well as an Israeli subsidiary. Chiasma trademarks include MYCAPSSA, TPE, and CHIASMA.
A Marketing Authorization Application (MAA) has been submitted to the European Medicines Agency (EMA) seeking approval of MYCAPSSA (oral octreotide capsules) as a maintenance therapy for adults with acromegaly.
- During CHMA’s MPOWERED trial, which lasted 15 months, participants were randomized, open-label, active-controlled and placed in a global setting.
- MYCAPSSA was compared to long-acting somatostatin analogs (SSAs) in this non-inferiority trial by CHMA.
- CHMA enrolled 146 adult acromegaly patients, of which 92 patients were successful after six months on MYCAPSSA.
- These patients were then randomized into 9 months of controlled treatment (RCT) on either MYCAPSSA or their previous injectable therapy.
- Its primary outcome was the nine-month average time-weighted measurement of a serum IGF-1 level that was 1.3 times the upper limit of normal.
- As previously reported by CHMA, MPOWERED demonstrated non-inferiority to long-acting SSA injectables.
- MyCAPSSA is the first and only oral treatment for acromegaly approved by the Food and Drug Administration (FDA) and is approved for use in patients who have experienced response and tolerated treatment with injectable octreotide or lanreotide.
What prompted CHMA to submit an MAA?
Chiasma (CHMA) was able to file its MAA because of positive Phase 3 results in MPOWERED. CHMA submitted its MAA as intended to the EMA, a milestone in CHMA’s efforts to bring MYCAPSSA to patients with acromegaly outside of the US.
