AMBI Snapped Up, ALIM's Iluvien Gets FDA Nod, GLYC Faces Glitch In Study

(RTTNews) - AbbVie Inc.'s (ABBV) ongoing phase II study of its investigational compound Veliparib in combination with chemotherapy has demonstrated a 35 percent improvement in progression-free survival and a 30 percent improvement in overall survival in patients with previously untreated metastatic or advanced non-small cell lung cancer.

The company initiated a phase III clinical trial evaluating Veliparib in patients with squamous non-small cell lung cancer earlier in 2014 to confirm the results of the just reported phase 2 study.

ABBV closed Friday's trading at $59.19, up 2.05%.

Alimera Sciences Inc. (ALIM) has been granted FDA approval for its sustained release intravitreal implant ILUVIEN for the treatment of diabetic macular edema in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure.

The company currently intends to begin selling ILUVIEN in the U.S. in the first quarter of 2015.

ILUVIEN, licensed from pSivida Corp. (PSDV), has already received marketing authorization approvals in Austria, Denmark, France, Germany, Italy, Norway, Portugal, Spain, Sweden and the United Kingdom for the treatment of vision impairment associated with chronic diabetic macular edema, considered insufficiently responsive to available therapies.

ALIM closed Friday's trading at $4.93, down 4%. In after-hours, the stock rose 23% to $6.06.

Ambit Biosciences (AMBI) is all set to be acquired by Daiichi Sankyo Co. Ltd. for $15 per share in cash. In addition to the upfront cash payment, each Ambit Biosciences stockholder will receive one Contingent Value Right, entitling the holder to receive an additional cash payment of up to $4.50 for each share they own if certain commercialization related milestones are achieved.

The total transaction is valued at up to $410 million.

AMBI closed Friday's trading at $8.20, down 1.68%.

GlycoMimetics Inc. (GLYC) on Friday announced that the initiation of a phase III trial of Rivipansel for the treatment of vaso-occlusive crisis of sickle cell disease will be significantly delayed due to a manufacturing development issue impacting formulated drug supply.

Rivipansel is being developed in partnership with Pfizer Inc. (PFE) - with the pharma giant being responsible for ongoing clinical development of the compound.

GlycoMimetics has previously reported that it expected commencement of Rivipansel phase III trial before the end of 2014.

GLYC closed Friday's trading down 12.64% at $7.19.

Ignyta Inc. (RXDX) on Sunday announced that promising signs of antitumor activity and no dose-limiting toxicities were observed in the first-in-human ALKA-372-001 phase I clinical trial of RXDX-101.

The company also revealed that to date, there have been one complete response in a patient with a ROS1 alteration, partial responses in five patients with each of TrkA, ROS1 and ALK alterations, and prolonged stable disease in two patients.

RXDX closed Friday's trading at $7.54, up 2.72%.

Nektar Therapeutics (NKTR) announced that the Committee for Medicinal Products for Human Use, which advises the European Medicines Agency on marketing approvals for new drugs, has adopted a positive opinion for MOVENTIG, an investigational drug for the treatment of opioid-induced constipation in adult patients who have had an inadequate response to laxatives.

MOVENTIG was approved in the U.S. under the trade name MOVANTIK on September 16, 2014. Nektar has an exclusive worldwide license agreement with AstraZeneca for MOVANTIK.

NKTR closed Friday's trading at $12.71, up 0.87%.