CLRB Spikes Over 13%, OVAS In Good Health, INCY, MYL Get FDA Nod

(RTTNews) - Cellectar Biosciences Inc.'s (CLRB) investigational radiopharmaceutical I-131-CLR1404 has been granted orphan drug designation by FDA for the treatment of multiple myeloma, an incurable cancer of plasma cells.

The company's investigational new drug application to begin clinical study of I-131-CLR1404 in patients with relapsed or refractory multiple myeloma, an incurable cancer of plasma cells was accepted by the regulatory agency in September of this year. Cellectar is in the final stages of preparing its clinical sites to initiate a proof-of-concept trial of I-131-CLR1404 in multiple myeloma.

CLRB closed Thursday's trading at $2.71, up 13.87%.

Celldex Therapeutics Inc. (CLDX) has initiated an open-label phase 2 study of its experimental drug CDX-011 in patients with unresectable Stage III or IV melanoma. The study is expected to include up to 10 sites in the United States and will enroll approximately 60 patients, according to the company.

CDX-011 is also being evaluated in patients with metastatic triple negative breast cancers that overexpress glycoprotein NMB (GPNMB). GPNMB is a protein overexpressed by multiple tumor types, including breast cancer and melanoma.

CLDX closed Thursday's trading at $18.26, down 6.36%. In after-hours, the stock gained 1.86% to $18.60.

Five Prime Therapeutics Inc. (FPRX) has initiated patient dosing in a phase 1 clinical trial of its investigational drug FPA144 in gastric cancer.

The company said that FPA144 is being developed initially as a monotherapy for refractory gastric cancer, a significant unmet medical need that may warrant an accelerated development and registration path.

FPRX closed Thursday's trading at $20.65, down 1.20%.

Incyte Corp.'s (INCY) chemotherapy drug Jakafi has been approved by the FDA for another indication - this time for the treatment of patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea.

Polycythemia vera, or PV in short, is a rare blood cancer associated with overproduction of blood cells that can cause serious cardiovascular complications, such as stroke and heart attack. The current standard treatment for PV is phlebotomy (the removal of blood from the body) plus aspirin. When phlebotomy can no longer control PV, chemotherapy such as hydroxyurea, or interferon, is utilized.

Jakafi is already approved for treatment of people with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF, and post-essential thrombocythemia MF.

Incyte's net product revenues of Jakafi in 2013 were $235.4 million, up from $136.0 million in 2012. In the nine months ended September 30, 2014, net product revenues of Jakafi were $251.5 million compared to $162.6 million in the year-ago period.

INCY closed Thursday's trading at $74.12, down 0.72%.

Mylan Inc.'s (MYL) subsidiary Mylan Laboratories Limited has received tentative approval from the FDA for two dosages of abacavir/lamivudine tablets for the treatment of HIV-1 infection in paediatric patients.

The products are expected to be eligible for purchase in early 2015.

Abacavir/lamivudine was approved in the US for adults in August 2004 under the brand name Epzicom and in Europe in December 2004 under the brand name Kivexa.

MYL closed Thursday's trading at $58.23.

OvaScience Inc. (OVAS), which has been routinely hitting new highs, has gained more than 210 percent year-to-date.

The company is developing a proprietary product, AUGMENT, to improve egg health by adding a woman's own mitochondria to her egg during IVF (in vitro fertilization).

The AUGMENT treatment is available in certain IVF clinics in three international regions, and OvaScience remains on track to launch the treatment in a fourth international region this year. It is not available in the United States.

The company is scheduled to make a presentation at the Oppenheimer Healthcare Conference on December 11, 2014.

OVAS closed Thursday's trading 8.99% higher at $28.36.