INNL Bleeds Over Dashed Hopes, CRBP To Report Data In Q1, FDA Snubs CEMP

(RTTNews) - Corbus Pharmaceuticals Holdings Inc. (CRBP) has completed its phase II study of investigational Resunab for the treatment of cystic fibrosis. The topline data from this study are expected in the first quarter of 2017.

A phase II, 12-month open label extension study of Resunab in systemic sclerosis and a phase II study in skin-predominant dermatomyositis, with a 12-month open label extension study in dermatomyositis are ongoing. A phase II study of Resunab in systemic lupus erythematosus is planned to commence in the first quarter of 2017.

CRBP closed Thursday's trading at $8.60, down 2.82%.

Shares of Cempra Inc. (CEMP) plunged over 57% on Thursday as the FDA refused to approve both oral and intravenous formulations of Solithromycin for the treatment of community-acquired bacterial pneumonia in adults.

Although no further information on Solithromycin efficacy has been requested by the FDA, the company has been asked to provide additional clinical safety information and resolve manufacturing facility inspection deficiencies before the NDAs can be approved.

CEMP is down nearly 92% year-to-date. The stock touched a new low of $2.55 on Thursday before closing the day's trading at $2.60, down 57.38%.

The FDA has refused to even review Innocoll's (INNL) new drug application for XARACOLL, the company's product candidate for the treatment of postsurgical pain, and has issued a Refusal to File letter.

The regulatory agency has noted that the New drug Application, which was submitted by the company in October 2016, was not sufficiently complete to permit a substantive review, and that in order for XARACOLL to be characterized as a drug/device combination, the company should submit additional information.

INNL closed Thursday's trading at $1.77, down 1.67%. In after-hours, the stock was down nearly 50% to $0.89.

Prima BioMed Ltd.'s (PBMD) phase I study of investigational IMP321 in combination with Merck & Co. Inc.'s (MRK) key drug Keytruda has demonstrated safety and tolerability at the first dose level. The Database Safety Monitoring Board has recommended continuance of the dose escalation as planned.

Prima's Chief Medical Officer, Dr Frédéric Triebel, said: "The majority of metastatic melanoma patients do not respond well to KEYTRUDA, a key reason being that their tumors are poorly infiltrated by activated T cells expressing PD-1. By introducing IMP321, a first-in-class Antigen Presenting Cell (APC) activator, these patients may now be able to repopulate their tumor with more activated T cells which are responsive to KEYTRUDA. So, by combining the effect of 'pushing the gas' with IMP321 and 'releasing the brake' with KEYTRUDA we propose a rational therapeutic approach to increase the response rate by further boosting anti-tumor CD8 T cells."

PBMD closed Thursday's trading at $2.50, up 7.42%.