AUXL, GILD Get Thumbs Up, COV Snaps Up GIVN, KPTI On The Move, PGNX Awaits Data

(RTTNews) - Auxilium Pharmaceuticals Inc. (AUXL) touched a new high of $22 on Friday before closing at $21.64, following FDA approval for the expanded indication of XIAFLEX in the treatment of Peyronie's disease.

XIAFLEX is already approved in the U.S., EU, Canada and Australia for the treatment of adult Dupuytren's contracture patients with a palpable cord.

Covidien plc (COV) is all set to acquire Israeli maker of the PillCam endoscopic pill camera - Given Imaging Ltd. (GIVN)- for $30.00 per share in cash, which equates to a value of approximately $860 million.

On a reported U.S. GAAP basis, Covidien expects the transaction to be dilutive to both operating margin and earnings per share in fiscal 2014. On an adjusted basis, excluding one-time items and transaction costs, the company expects the transaction to be neutral to both operating margin and EPS in fiscal 2014. The transaction is expected to be accretive to operating margin and EPS both on a U.S. GAAP and on an adjusted basis in fiscal 2015 and beyond.

COV closed Friday's trading at $68.07, up 0.86%.

Gilead Sciences Inc.'s (GILD) Sovaldi (sofosbuvir) 400 mg tablets, a once-daily oral drug, has received FDA approval for the treatment of chronic hepatitis C infection as a component of a combination antiviral treatment regimen. A 28-tablet bottle of Sovaldi in the United States is $28,000.

GILD closed Friday's trading at $73.99. In after-hours, the stock rose 1.01% to $74.74.

Infinity Pharmaceuticals Inc. (INFI) presented updated data from a phase I study of IPI-145 today, which showed that the drug candidate was highly active in patients with relapsed/refractory chronic lymphocytic leukemia, with a nodal response rate of 89 percent and an overall response rate of 48 percent.

According to Infinity, the results support DUO, the company's phase III registration study of IPI-145 in patients with relapsed/refractory CLL, which is now enrolling patients.

Karyopharm Therapeutics Inc.'s (KPTI) experimental oral drug Selinexor (KPT-330) has demonstrated preliminary evidence of anti-cancer activity as a single agent in a majority of heavily pretreated relapsed and/or refractory non-Hodgkin lymphoma and chronic lymphocytic leukemia patients in an ongoing phase I clinical trial.

The company plans to continue to evaluate new indications for potential treatment with Selinexor based on the initial results as well as to assess the maximum tolerated dose and dosing schedule. More data from the phase I trial and investigator-sponsored single agent and combination studies are expected to be reported in the first half of 2014.

KPTI closed Friday's trading 5.49% higher at $16.91.

Progenics Pharmaceuticals Inc., (PGNX) has completed enrollment of chemotherapy experienced patients in a phase II trial to assess the anti-tumor activity and tolerability of its antibody drug conjugate, PSMA ADC in patients with metastatic castrate resistant prostate cancer.

The company has also initiated treatment of a cohort of chemotherapy naive patients who have progressed on hormonal therapies. This cohort is now enrolling.

The topline data on the chemotherapy experienced cohort of the phase II PSMA ADC trial will be presented at the American Society of Clinical Oncology's 2014 Genitourinary Cancers Symposium Meeting in San Francisco in January 2014.

PGNX closed Friday's trading at $4.60, up 2.45%. In after-hours, the stock gained 6.30% to $4.89.

Synthetic Biologics Inc. (SYN) on Friday said that it has entered into worldwide license and option agreements with Cedars-Sinai Medical Center, a non-profit hospital and research institution, to develop novel anti-infective approaches for Irritable Bowel Syndrome, Obesity and Diabetes.

The new approach targets non-bacterial intestinal microorganism life forms known as archaea.

SYN closed Friday's trading 4.15% higher at $1.23.

TG Therapeutics Inc. (TGTX) has initiated a multi-center phase II clinical trial to evaluate the safety and efficacy of its drug candidate TG-1101 in combination with cancer drug *Imbruvica for patients with Chronic Lymphocytic Leukemia and Mantle Cell Lymphoma.

Imbruvica, developed by Johnson & Johnson (JNJ) and Pharmacyclics (PCYC), is approved by FDA to treat patients with mantle cell lymphoma.

TGTX closed Friday's trading at $4.16, down 3.48%.

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