CHMA Trims Workforce, INFI's DYNAMO Disappoints, Marathon Joins DMD Race

(RTTNews) - Chiasma Inc. (CHMA) is all set to implement a corporate restructuring plan in order to focus its resources on the continued development of Mycapssa for the maintenance treatment of adult acromegaly patients.

Accordingly, there will be an immediate reduction of approximately 33% of the company's workforce, including substantially all of its commercial personnel.

Mycapssa was issued a Complete Response Letter by the FDA in April of this year as the regulatory agency felt that substantial evidence of efficacy was not provided to warrant approval.

As a result of the reduction in force, the company estimates that it will incur aggregate charges of approximately $1.4 million to $1.6 million for one-time severance and related costs in the second quarter of 2016, which charges are expected to result in cash expenditures that will be substantially complete by the end of the second quarter of 2017. An estimated additional $0.3 million to $0.4 million of one-time non-cash restructuring charges related to previously capitalized commercial software are also expected this quarter.

CHMA closed Tuesday's trading at $2.57, down 8.21%.

Infinity Pharmaceuticals Inc.'s (INFI) phase II monotherapy study of Duvelisib in patients with refractory indolent non-Hodgkin lymphoma, dubbed DYNAMO, met its primary endpoint of overall response rate. However, the results were not up to the company's expectations.

According to the study results, Duvelisib demonstrated an overall response rate of 46 percent, all of which were partial responses, failing to elicit enthusiasm.

In light of the low overall response rate, AbbVie and Infinity have agreed to pause the AbbVie-sponsored phase 1b/2 study of Duvelisib in combination with Venetoclax.

In an effort to preserve financial resources, Infinity is all set to undertake a strategic restructuring that will close down its discovery research organization, impacting 46 members of the Infinity team, or 21 percent of the workforce.

INFI closed Tuesday's trading at $1.36, down 69.16%.

The Medicines Co. (MDCO) has dosed the first patient in a phase II study of its investigational anesthetic ABP-700 in procedural sedation.

The phase II-III development program for ABP-700 has been named VERONA by the company.

The phase II study is expected to enroll 75 patients undergoing elective colonoscopies at three sites in The Netherlands. Results from this study are anticipated later in 2016.

MDCO closed Tuesday's trading at $36.47, down 0.27%.

Privately held Marathon Pharmaceuticals LLC has submitted a New Drug Application to the FDA for Deflazacort, an investigational Duchenne Muscular Dystrophy drug.

The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing.

Deflazacort is bestowed with Fast Track status, Orphan Drug designation and Rare Pediatric Disease designation for the treatment of Duchenne by the FDA.

Shire plc (SHPG) has agreed to license global rights to all indications for PF-00547659, an investigational bowel disease drug, from Pfizer Inc. (PFE).

PF-00547659 has completed phase II testing, and phase III trials are expected to begin after consultation with global health authorities. Closing of the transaction is subject to HSR approval.

Terms of the deal are kept under wraps.

SHPG closed Tuesday's trading at $171.16, down 1.40%.