BCRX To Watch Out For, GTIV Adopts Poison Pill, TEVA, QGEN, DRTX Get FDA Nod

(RTTNews) - BioCryst Pharmaceuticals Inc. (BCRX) will be reporting results from OPuS-1, a phase IIa trial of orally-administered BCX4161 in patients with hereditary angioedema, on Tuesday, May 27, 2014 at 8:30 a.m. Eastern Time.

The OPuS-1 clinical trial is testing 400 mg of BCX4161 administered three times daily for 28 days in up to 25 hereditary angioedema patients who have a high frequency of attacks (= 1 per week), in a randomized, placebo-controlled, two-period cross-over design.

BCRX has traded in a range of $1.42 to $13.33 in the last 1 year. The stock closed Friday's trading at $9.01, down 0.83%.

Durata Therapeutics Inc.'s (DRTX) DALVANCE has received FDA approval for use in the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).

DALVANCE becomes the first and only IV antibiotic approved for the treatment of ABSSSI with a two-dose regimen of 1000 mg followed one week later by 500 mg, each administered over 30 minutes.

DRTX closed Friday's trading at $16.89, up 5.50%.

Gentiva Health Services Inc. (GTIV) has adopted a poison-pill defense in the wake of an unsolicited, non-binding proposal from Kindred Healthcare Inc., which has made a $14.00 per share bid for the company.

GTIV closed Friday's trading at $13.68, down 0.15%.

Provectus Biopharmaceuticals Inc.'s (PVCT) drug candidate PV-10 for the treatment of patients with locally advanced cutaneous melanoma has been denied the designation of Breakthrough Therapy by FDA at this time for lack of sufficient data. Further data may cause the Agency to revisit this decision at a later date.

The company recently completed phase II trials of PV-10 as a therapy for metastatic melanoma.

PTC Therapeutics Inc. (PTCT) closed Friday's trading at $20.03, up 30.74%, following positive CHMP opinion for its investigational treatment for nonsense mutation Duchenne muscular dystrophy (nmDMD), Translarna.

The CHMP advises the European Medicines Agency on marketing approvals for new drugs. The final decision of the European Commission will be delivered within three months.

QIAGEN N.V. (QGEN) has added one more to its growing menu of clinically validated companion diagnostics, with the FDA approving the company's therascreen KRAS RGQ PCR Kit to guide the treatment of metastatic colorectal cancer patients with Amgen's Vectibix.

This marks the third FDA approval of a companion diagnostic from QIAGEN that has been paired with a novel medicine.

QGEN closed Friday's trading at $22.57, up 0.09%. In extended trading, the stock gained another 1.91% to $23.

Teva Pharmaceutical Industries Ltd., (TEVA) has received FDA approval for QVAR with a dose counter for the ongoing treatment of asthma as a preventative therapy in patients five years of age and older. The dose counter is designed to help asthma patients, as well as their caregivers, keep track of the number of doses remaining in the canister. The new product will be commercially available later this year.

TEVA closed Friday's trading at $51.77, up 2.19%.