MYGN, SGEN Boost Outlook, AMRI On A High, ENDP Opens Wallet, IMGN Slammed

(RTTNews) - Advaxis Inc. (ADXS) said that the FDA has granted Orphan Drug Designation for ADXS-HPV, its lead drug candidate, for the treatment of human papillomavirus-associated head and neck cancer. ADXS-HPV is under phase I testing.

ADXS closed Tuesday's trading at $3.78, down 1.05%.

Aeterna Zentaris Inc. (AEZS) (AEZS.TO) has submitted a New Drug Application for AEZS-130 to the FDA for evaluation of adult growth hormone deficiency. Whether or not the AEZS-130 NDA is accepted for review by the regulatory agency will be known in 60 days. The compound is also in a phase II trial as a treatment for cancer-induced cachexia.

AEZS closed Tuesday's trading 2.21% higher at $1.39.

Albany Molecular Research Inc. (AMRI) touched a new high of $14.08 on Tuesday before closing at $13.93 following the resolution of all issues related to its Burlington, Massachusetts aseptic fill-and-finish facility raised by the FDA in a 2010 warning letter.

The Burlington facility provides cGMP manufacturing and sterile filling of parenteral drugs using specialized technologies, including lyophilization and BUBBLE-FREE FILLING, a unique patented technology.

Cellular Biomedicine Group Inc. (CBMG) has received approval to conduct a phase IIb clinical trial for ReJoin, a human adipose-derived mesenchymal precursor cells therapy, bio-engineered for knee osteoarthritis. Enrollment in the trial is expected to begin during Q4, 2013.

CBMG.OB closed Tuesday's trading 7.69% higher at $6.30.

Endo Health Solutions (ENDP) has reached a definitive agreement to acquire Paladin Labs Inc. (PLB.TO) in a stock and cash transaction valued at approximately $1.6 billion of which approximately 98% will be paid in shares. The transaction is expected to be immediately accretive to Endo's 2014 adjusted earnings per share.

ENDP surged 28.83% on Tuesday to close at $56.22.

ImmunoGen Inc. (IMGN) dropped more than 18 percent to $13.41 following the company's decision to stop its phase II study of IMGN901 in small-cell lung cancer as the trial's independent Data Monitoring Committee found the compound unlikely to demonstrate a sufficient improvement in progression-free survival.

Keryx Biopharmaceuticals Inc. (KERX) touched a new high of $14.07 on Tuesday before closing at $13.18 following the successful top-line results from its phase II study of Zerenex in non-dialysis dependent chronic kidney disease (NDD-CKD) patients with elevated serum phosphorus and iron deficiency anemia. According to the trial results, Zerenex demonstrated highly statistically significant changes in serum phosphorus and transferrin saturation (TSAT) compared to placebo over the 12-week treatment period.

Myriad Genetics Inc. (MYGN) rose more than 9 percent to $27.55 in extended trading on Tuesday following stellar fiscal first quarter 2014 results and increased fiscal year 2014 outlook.

Seattle Genetics Inc. (SGEN) said that it now expects 2013 net product sales of its lead cancer drug, ADCETRIS, to be in the range of $140 million to $145 million, up from its prior forecast of $130 million to $140 million. The company has also boosted its collaboration and license agreement revenues for the year to a range of $95 million to $100 million from its earlier forecast range of $85 million to $95 million.

SGEN closed Tuesday's trading at $38.44, down 1.51%. In after-hours, the stock gained 1.43% to $38.99.

Sorrento Therapeutics Inc. (SRNE) has entered into an antibody and vaccine development collaboration with The Scripps Research Institute, or TSRI, of La Jolla, CA. The agreement entitles Sorrento an exclusive, worldwide license to TSRI's novel technologies based on ghrelin signaling inhibition for the prevention and treatment of obesity and other metabolic disorders.

SRNE closed Tuesday's trading at $9.40, down 1.57%.

Biotech stocks can be risky as their fortunes depend on two key events namely clinical trial results and FDA decisions. Nevertheless, the returns can be impressive when the stocks are bought and sold at the right time.

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