CERU Gains Big On Nanoparticle Deal, LLY Gets FDA Nod, BABY Makes Big Strides

(RTTNews) - AbbVie (ABBV) and Neurocrine Biosciences Inc. (NBIX) on Wednesday presented detailed results from two replicate pivotal Phase III clinical trials of Elagolix in premenopausal women who suffer from endometriosis.

The companies reported positive top-line data from the first phase III trial of Elagolix in January of 2015 while positive top-line results from the second study were announced in February of this year.

According to the detailed results, at month three and month six, patients treated with Elagolix reported statistically significant reductions in scores for menstrual pain and non-menstrual pelvic pain associated with endometriosis compared to placebo as measured by the Daily Assessment of Endometriosis Pain scale.

AbbVie plans to submit the Elagolix New Drug Application to the FDA for endometriosis in 2017.

ABBV closed Wednesday's trading at $61.43, down 0.19%.

Alexion Pharmaceuticals Inc.'s (ALXN) investigational drug ALXN1007 has been granted orphan drug designation for the treatment of acute graft-versus-host disease by the FDA.

ALXN1007 is currently under a phase IIa study in subjects with newly diagnosed acute graft-versus-host disease involving the lower gastrointestinal tract. Data from this trial are expected *next June. (Sourced from ClinicalTrials.gov).

ALXN closed Wednesday's trading at $120.31, down 0.85%.

Shares of Cerulean Pharma Inc. (CERU) were up nearly 40% on Wednesday after the company announced a strategic collaboration with Novartis (NVS) to create nanoparticle-drug conjugates directed at up to five targets.

The deal entitles Cerulean to receive an upfront payment of $5 million plus funding for five full-time equivalents in addition to preclinical, clinical, regulatory, sales milestones and single-digit to low double-digit tiered royalties for each target.

CERU closed Wednesday's trading at $0.95, up 39.54%.

The FDA has granted accelerated approval to Eli Lilly and Co.'s (LLY) Lartruvo in combination with Doxorubicin for the treatment of patients with advanced soft tissue sarcoma. This becomes the first FDA-approved front-line therapy for soft tissue sarcoma in four decades.

In clinical trials, the median overall survival was 26.5 months for the LARTRUVO-Doxorubicin arm compared to 14.7 months in patients who received Doxorubicin alone.

A confirmatory phase III trial of Lartruvo, dubbed ANNOUNCE, is underway, and continued approval of the drug depends upon the confirmatory trial results.

LLY closed Wednesday's trading at $78.56, down 0.27%.

Shares of Natus Medical Inc. (BABY) rose over 5% on Wednesday, following better-than-expected third quarter results and rosy outlook for the fourth quarter of 2016.

For the fourth quarter 2016, the company expects revenue of $107.0 million to $109.0 million, and non-GAAP earnings per share guidance of $0.52 to $0.55. Analysts polled by Thomson Reuters expect the company to earn non-GAAP earnings of $0.48 per share and revenue of $104.62 million.

However, for full year 2016, the company lowered its revenue guidance range to $381.2 million to $383.2 million from its previous estimated range of $388 million to $390 million.

Natus now expects non-GAAP earnings per share guidance for the year to range between $1.63 and $1.66 compared to its prior outlook range of $1.67 to $1.70 per share, and analysts' estimate of $1.55 per share.

BABY closed Wednesday's trading at $42.00, up 5.79%.