10.05.2017 07:58:47

ARRY Hits Trial Goals, DEPO Falls On Q1 Results, SAGE Awaits Data In Q3

(RTTNews) - Today's Daily Dose brings you news about AXDX public offering; ARRY's COLUMBUS trial results; DEPO's earnings miss; GWPH's upcoming milestone and the many clinical catalysts of SAGE to keep an eye on.

Read on...

Accelerate Diagnostics Inc. (AXDX) is now offering to sell 2.75 million shares of its common stock to the public at a price of $28.85 each.

The gross proceeds to the Company from the offering are expected to be approximately $79.3 million. The offering is expected to close on or about May 15, 2017.

The underwriters have been granted a 30-day option to purchase up to an additional 412,500 shares of its common stock at the public offering price, less the underwriting discounts and commissions.

AXDX closed Tuesday's trading at $28.85, down 1.03%.

Shares of Array BioPharma Inc. (ARRY) were up more than 11% in extended trading on Tuesday, following positive top-line results from part 2 of its phase III study of Binimetinib plus Encorafenib for BRAF-mutant melanoma.

In the phase III study, dubbed COLUMBUS, the median progression free survival for patients on combination of Binimetinib plus Encorafenib was 12.9 months versus 9.2 months for patients on Encorafenib alone.

Binimetinib and Encorafenib are investigational medicines of Array BioPharma.

The Company is planning to file an NDA for Binimetinib plus Encorafenib in June or July 2017.

ARRY closed Tuesday's trading at $7.02, up 0.86%. In after-hours, the stock was up 11.40% to $7.82.

Shares of Depomed Inc. (DEPO) plunged more than 13% in after-hours on Tuesday as the Company's first quarter earnings and revenue fell short of analysts' expectations.

On a non-GAAP basis, net income in the first quarter of 2017 rose to $5.7 million or $0.13 per share on revenues of $95 million. Analysts polled by Thomson Reuters expected the Company to earn of $0.14 per share on revenue of $103.06 million.

The Company had reported non-GAAP net income of $2.4 million or $0.07 per share and revenue of $104.8 million for the first quarter of 2016.

Looking ahead, the Company expects non-GAAP revenue of $410 to $430 million. Analysts are looking for revenue of $473 million.

GW Pharmaceuticals plc (GWPH) is all set to submit its NDA for Epidiolex in the indications of Dravet syndrome and Lennox-Gastaut Syndrome by mid-2017.

GWPH closed Tuesday's trading at $109.13, down 0.48%.

Shares of Supernus Pharmaceuticals Inc. (SUPN) were down more than 8% in extended trading on Tuesday, following the earnings and revenue misses for the first quarter of 2017.

The net income for the first quarter of 2017 is $10.29 million or $0.19 per share on total revenue of $57.6 million. Analysts polled by Thomson Reuters expected the company to earn $0.23 per share on revenue of $59.39 million.

The Company had reported net income of $4.82 million or $0.08 per share and total revenue of $44.2 million in the year-ago quarter.

SUPN closed Tuesday's trading at $32.90, up 3.13%. In after-hours, the stock fell 8.51% to $30.10.

Sage Therapeutics Inc. (SAGE) has announced that Part A of its phase II trial of SAGE-217 in Parkinson's disease has demonstrated signal of activity in reducing Parkinsonian tremor.

Based on the encouraging data, the Company plans to proceed to an open-label Part B of the phase II study of SAGE-217 as an adjunctive treatment to anti-Parkinsonian agents in tremor-predominant patients.

The Company's phase III trial of Brexanolone as an acute interventional treatment for super-refractory status epilepticus, dubbed STATUS, is nearing completion. Top-line data readout from this trial is now expected in the third quarter of 2017.

The Company also has a couple of catalysts coming its way in the second half of this year and beyond.

-- Top-line data readout from Phase 3 Hummingbird Study (202B) of Brexanolone in postpartum depression in the second half of this year. -- Top-line data readout from Phase 3 Hummingbird Study (202C) of Brexanolone in postpartum depression in the second half of this year. -- Top-line data readout from Phase 2 trial of SAGE-217 in essential tremor in the second half of this year. -- Top-line data readout from Phase 2 trial of SAGE-217 in PPD in the second half of this year. -- Top-line data readout from Part B of Phase 2 trial of SAGE-217 in Parkinson's disease in the second half of this year. -- Top-line data readout from Phase 1 single-ascending dose trial of SAGE-718 in the second half of this year. -- Top-line data readout from Part B of Phase 2 trial of SAGE-217 in MDD in the first half of 2018.

SAGE closed Tuesday's trading at $66.03, down 3.21%.

Theravance Biopharma Inc. (TBPH) has a couple of catalysts to watch out for in the coming months.

-- Data from Phase 1b study of TD-1473 in patients with ulcerative colitis in mid-2017. -- Data from Phase 2b study of Velusetrag in patients with gastroparesis in mid-2017. -- Data from Phase 2a study of TD-9855 in patients with neurogenic orthostatic hypotension in 2017. -- Completion of the 12-month Phase 3 safety study of Revefenacin in patients with COPD in mid-2017; Potential NDA filing in late 2017.

TBPH closed Tuesday's trading at $40.65, up 1.47%.

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Aktien in diesem Artikel

Sage Therapeutics Inc 5,06 -6,09% Sage Therapeutics Inc
Supernus Pharmaceuticals Inc 34,20 -1,16% Supernus Pharmaceuticals Inc
Theravance Biopharma Inc When Issued 9,25 -0,54% Theravance Biopharma Inc When Issued