Chiasma Inc (NASDAQ:CHMA)
Chiasma Inc (NASDAQ:CHMA) a biopharmaceutical firm focused on enhancing the lives of patients with serious and rare chronic diseases, released a corporate assessment of 2016. Mark J. Fitzpatrick, the President and CEO of Chiasma, reported that 2016 was a tough year for them following the receipt of a Complete Response Letter for Mycapssa at the time of heir PDUFA date in last April.
Despite this setback, they remain committed to advancing new treatment options for people with acromegaly. The registration in the Phase 3 MPOWERED™ trial of Mycapssa to support the submission of a Marketing Authorization Application with the EMA met their 2016 enrollment objectives.
Further, the company is well-funded and has a motivated and experienced team focused on the sustained pursuit of regulatory nod of octreotide capsules for the cure of people with acromegaly in the U.S.
Chiasma Inc (NASDAQ:CHMA) continues to assess prospective pathways forward with the U.S. FDA to potentially secure regulatory nod in the U.S. for Mycapssa for the cure of adult subjects with acromegaly. On April 15, 2016 the U.S. FDA, in its CRL to company’s New Drug Application for Mycapssa, strongly suggested that the company perform a randomized, controlled and double-blind trial that enrolls subjects from the United States and is of adequately long duration to confirm that control of disease activity is steady at the time point chosen for the primary efficacy assessment.
Following a close of review meeting, the U.S. FDA suggested that some of its issues could potentially be resolved through a placebo-controlled trial design. Chiasma admits this feedback and remains to assess pathways forward to possibly secure nod in the U.S. for Mycapssa
Chiasma Inc (NASDAQ:CHMA) continues to register its MPOWERED™ Phase 3 study of Mycapssa while managing specific elements of the trial to preserve resources for a prospective pathway forward in the United States. The MPOWERED study enrolled subjects consistent with 2016 enrollment goals.
In light of its current assessment of prospective U.S. development courses for Mycapssa in acromegaly, Chiasma is changing certain aspects of the MPOWERED™ trial in an attempt to preserve resources required to potentially manufacture data packages that could be appropriate for submission in both the U.S. and the European Union.
Some adjustments to the MPOWERED trial may delay the anticipated timing of a MAA submission with the European Medicines Agency, previously estimated to happen in 2019.
In the last trading session, the stock price of Chiasma Inc (NASDAQ:CHMA) closed flat at $1.70. The market cap of the firm stands at $43.32 million.
|Last Price a/o 3:21 PM EST||$1.75|
|Market Cap (mlns)||40.76M|
|Shares Outstanding (mlns)||23.39M|
|Share Float (mlns)||22.53M|
|Short Interest Ratio||6.53|
I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy.
About the author: Monica Gray has an undergraduate degree in Accounting and an MBA – earned with Honors. She has six years of experience in the financial markets and has been a securities analyst for the past two years.