AMGN Gets FDA Nod, Data Awaits RGLS In Feb, FORWARD Puts ALKS On The Back Foot

(RTTNews) - Alkermes plc.'s (ALKS) first two of three phase III efficacy studies of ALKS 5461 for the adjunctive treatment of major depressive disorder in patients who have an inadequate response to standard therapies for clinical depression have not met the primary efficacy endpoint.

One of the trials, dubbed FORWARD-4, tested two dose levels of ALKS 5461 (2mg/2mg and 0.5mg/0.5mg) compared to placebo while the second trial, named FORWARD-3, tested one dose level of ALKS 5461 (2mg/2mg) compared to placebo.

The third trial, known as FORWARD-5, is ongoing, testing two dose levels of ALKS 5461 (2mg/2mg and 1mg/1mg).

Alkermes says it will provide an update later this quarter on the projected timing of completion of FORWARD-5.

ALKS touched a 52-week low of $33.66 on Thursday before closing the day's trading at $33.69, down 44.24%.

Amgen's (AMGN) supplemental New Drug Application of Kyprolis in combination with steroid medication dexamethasone or with Celgene's approved multiple myeloma drug, Revlimid (lenalidomide) plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy has received FDA approval.

The FDA also approved Kyprolis as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy. This FDA decision converts to full approval the initial accelerated approval Kyprolis received in July 2012 as a single agent, noted the company.

In a clinical trial, dubbed ENDEAVOR, patients with relapsed multiple myeloma treated with Kyprolis and dexamethasone achieved 50 percent greater progression-free survival of 18.7 months compared to 9.4 months in those receiving Velcade and dexamethasone, a current standard of care in relapsed multiple myeloma.

Kyprolis had global sales of $364 million during the first nine months of 2015.

AMGN closed Thursday's trading at $152.78, down 1.44%.

Five Prime Therapeutics Inc.'s (FPRX) drug candidate FPA144 has demonstrated early evidence of anti-tumor activity in two out of the six patients with 3+ FGFR2b-positive gastric cancer and in a patient with 2+ FGFR2b-positive bladder cancer enrolled in part 1a of the ongoing phase I clinical trial.

Based on the encouraging data, the company plans to continue evaluating FPA144 as a monotherapy in refractory gastric cancer, as a combination therapy in the front-line gastric cancer setting and as a potential treatment for other types of cancer.

FPRX closed Thursday's trading at $35.99, up 3.81%.

Halozyme Therapeutics Inc. (HALO) is all set to earn a $5 million milestone payment from AbbVie (ABBV), following the dosing of the first subject in a clinical trial evaluating Humira using the former's ENHANZE drug-delivery technology.

Halozyme's ENHANZE drug-delivery platform is based on its proprietary recombinant human hyaluronidase enzyme (rHuPH20).

Last June, AbbVie signed a collaboration with Halozyme, valued at roughly $1.19 billion.

Under the terms of the agreement, Halozyme has granted to AbbVie a worldwide license to develop and commercialize products for up to nine targets, combining rHuPH20 with AbbVie's proprietary compounds.

Halozyme, which received an initial payment of $23 million, is entitled to receive additional payments upon AbbVie's achievement of specified development, regulatory and sales-based milestones, totaling up to $130 million per target. Halozyme is also entitled to tiered royalty payments based on net sales of products using the ENHANZE technology.

HALO closed Thursday's trading at $9.80, up 0.51%.

NephroGenex Inc.'s (NRX) oral drug candidate Pyridorin for the treatment of diabetic nephropathy, which is under a pivotal phase III study, has been deemed to have a continued acceptable safety and tolerability profile in the second review by the independent Data and Safety Monitoring Board.

The DSMB has unanimously recommended that the study continue without modification.

NRX closed Thursday's trading at $1.10, down 3.51%.

Regulus Therapeutics Inc. (RGLS) has completed enrollment in a phase II study evaluating a combination of RG-101 with multiple approved directly acting antivirals, or DAAs, for HCV infection. The interim results from this study are expected in mid-February 2016.

The company anticipates primary endpoint results for sustained viral response data 12 weeks following conclusion of treatment (SVR12) to be disclosed late in Q2 2016.

RGLS closed Thursday's trading at $6.15, down 5.09%.

vTv Therapeutics Inc. (VTVT) has initiated a phase II trial of TTP273 in Type 2 diabetic patients on stable doses of metformin. The topline results from this study, dubbed LOGRA, are expected at the end of 2016.

A phase II trial of another investigational drug TTP399 in Type 2 diabetic patients on a stable dose of metformin is also underway, and results are expected in mid-2016.

vTv Therapeutics went public on the Nasdaq Global Market on July 30, 2015, priced at $15 per share.

VTVT closed Thursday's trading at $6.91, up 1.92%.