OCLS Gets A Facelift, NBIX Halts Trials, CBYL For The Long Haul, CMRX On Track

(RTTNews) - Carbylan Therapeutics (CBYL) has completed enrollment of its 510-patient phase III pivotal trial of Hydros-TA for the treatment of pain associated with osteoarthritis. The top-line data from this trial are expected in early 2016.

The company went public as recently as April 9, 2015, priced at $5.00 per share. The stock touched a new high of $9.22 on Monday before closing the day's trading at $9.04.

Celator Pharmaceuticals Inc. (CPXX) announced that the number of patients in its 32units/m2 dose cohort, investigator-initiated clinical study, evaluating CPX-351 Liposome Injection in patients with untreated high-risk myelodysplastic syndrome or acute myeloid leukemia, at high risk of treatment-related mortality, has been increased from 20 to 30, following encouraging efficacy and safety results.

CPXX closed Monday's trading at 2.70, up 2.27%.

Chimerix Inc. (CMRX) has successfully completed enrollment of the targeted 450 patients in a phase III trial, dubbed SUPPRESS, evaluating Brincidofovir for the prevention of clinically significant cytomegalovirus infection in hematopoietic cell transplant, also known as bone marrow or stem cell transplant recipients.

The primary endpoint of SUPPRESS trial is prevention of clinically significant CMV infection through the first 24 weeks post-transplant. The company anticipates reporting topline data from this study in early 2016.

CMRX closed Monday's trading at $42.53, up 1.14%.

InSite Vision Inc. (INSV.OB) has agreed to merge with QLT Inc. (QLTI) (QLT.TO), and the new company will retain the name of QLT, and will continue to trade on NASDAQ under the ticker "QLTI" and on the Toronto Stock Exchange under the ticker "QLT".

InSite Vision plans to file a New Drug Application later this week with the FDA for marketing approval of its drug candidate BromSite to reduce post-operative inflammation and prevent pain following cataract surgery, and continued progression of a phase 3 clinical trial of QLT091001, QLT's Orphan Drug and FDA Fast Track designated retinoid product candidate for the treatment of inherited retinal diseases in the first half of 2016. The merged companies expect to file a second NDA for InSite Vision's DexaSite for the treatment of blepharitis in 2016.

The transaction is expected to close in the third quarter of 2015.

QLTI closed Monday's trading 7.55% higher at $3.99.

Lipocine Inc. (LPCN) plans to complete formulation optimization on LPCN 1107 and then commence a multiple-dose pharmacokinetic dose selection study in pregnant women in the fourth quarter of 2015 or first quarter of 2016.

LPCN 1107 is an oral product candidate of 17-alpha hydroxyprogesterone caproate under development for the indication of prevention of recurrent preterm birth.

At the completion of the pharmacokinetic selection study, the company plans to schedule an End-of-phase 2 meeting with the FDA to obtain agreement on a phase III development plan.

LPCN closed Monday's trading at $7.30, down 0.14%.

Mesoblast Ltd.'s (MBLTY.PK) investigational mesoblast cell therapy MPC-300-IV in patients with diabetic nephropathy has proven to be safe in a phase II trial, and it demonstrated reduced damaging inflammation, and preserved or improved renal function over at least 24 weeks.

The company noted that the trial's primary efficacy endpoint of decline or change in glomerular filtration rate, or GFR, was in line with the 2012 joint workshop held by the FDA and the National Kidney Foundation which recommended that time to 30-40% decline in GFR is an acceptable primary endpoint for evaluating potential benefits of new therapies for patients with diabetes and advanced chronic kidney disease.

MBLTY.PK closed Monday's trading at $18.68, up 2.92%.

Navidea Biopharmaceuticals' (NAVB) investigator-initiated, comparative study of Lymphoseek injection versus filtered Tc-99m Sulfur Colloid (fTcSC) in patients with breast cancer undergoing lymphoscintigraphy has demonstrated that the fTcSC caused statistically significant greater levels of pain after injection compared to Lymphoseek.

Lymphoseek, designed for the precise identification of lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer, is approved by the FDA for use in solid tumor cancers where lymphatic mapping is a component of surgical management and for guiding sentinel lymph node biopsy in patients with clinically node negative breast cancer, melanoma or squamous cell carcinoma of the oral cavity. Lymphoseek has also received European approval in imaging and intraoperative detection of sentinel lymph nodes in patients with melanoma, breast cancer or localized squamous cell carcinoma of the oral cavity.

NAVB closed Monday's trading at $1.42, unchanged from the previous day's close. In after-hours, the stock was up 15.49% to $1.42.

Shares of Neurocrine Biosciences Inc. (NBIX) were down more than 5% in extended trading on Monday after the company announced that it has suspended two planned clinical studies of NBI-77860 for the treatment of classical congenital adrenal hyperplasia out of an abundance of caution.

The two clinical studies that were halted include a single dose study in adolescent females with classic congenital adrenal hyperplasia and a multiple dose study in adults with classic congenital adrenal hyperplasia. The company had not enrolled any subjects in either study and accordingly, there have been no adverse events reported.

NBIX touched a new high of $45.98 on Monday before closing the day's trading at $45.28. In after-hours, the stock was down 5.01% to $43.01.

Shares of Oculus Innovative Sciences Inc. (OCLS) were up more than 13% in extended trading on Monday, following FDA clearance for the company's new Alevicyn SG Antipruritic Spray Gel with both prescription and over-the-counter indications.

Produced using the patented Microcyn Technology, the Alevicyn SG prescription product, under the supervision of a healthcare professional, is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including radiation dermatitis and atopic dermatitis. It may also be used to relieve the pain of first- and second-degree burns and helps to relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.

The company expects to launch Alevicyn SG in the U.S. in July 2015, via its direct dermatology sales force.

OCLS closed Monday's trading 30.37% higher at $1.76. In after hours, the stock gained another 13.64% to $2.00.

Ultragenyx Pharmaceutical Inc. (RARE) has completed patient enrollment in the pivotal phase III study of recombinant human beta-glucuronidase (rhGUS, UX003).

The study, designed to assess the efficacy and safety of rhGUS in 12 patients between 5 and 35 years of age, was initiated last December, and results from this study are expected in 2016.

RARE closed Monday's trading at $88.77, down 0.53%.