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GALT Faces Big Test Today, ABBV Clears Psoriasis Trial, DEPO Cuts 40% Of Staff

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Today's Daily Dose brings you news about an important announcement to be made by Galectin; Ironwood Pharma's phase II study results of IW-1973 in patients with type 2 diabetes and hypertension; Depomed's NUCYNTA deal and restructuring; Heron's public offering; AbbVie's psoriasis study results and Zogenix's Dravet syndrome trial results.

Read on...

AbbVie's (ABBV) fourth pivotal phase III clinical trial evaluating drug candidate Risankizumab (150 mg) for the treatment of patients with moderate to severe plaque psoriasis has met all co-primary and ranked secondary endpoints.

In the study, dubbed IMMhance, nearly half (47 percent) of Risankizumab patients achieved complete skin clearance compared to 1% in placebo arm at week 161. Among Risankizumab patients who achieved clear or almost clear skin at week 28, 87% percent maintained this response at one year (week 52).

Top-line results of the other three pivotal phase III trials of Risankizumab in psoriasis were previously announced in October 2017.

ABBV closed Monday's trading at $95.22, down 1.12%.

Biostar Pharmaceuticals Inc. (BSPM) has regained compliance with NASDAQ's continued listing requirement.

The Company was put on notice by the NASDAQ in August for not filing its Quarterly Report on Form 10-Q for the fiscal year ended June 30, 2017. Biostar filed the Quarterly Report on November 15, 2017.

BSPM closed Monday's trading at $1.75, down 3.31%.

Depomed Inc (DEPO) has entered into a definitive Commercialization Agreement with Collegium Pharmaceutical Inc. (COLL) for its oral analgesic NUCYNTA, and has decided to relocate its headquarters and implement a restructuring.

In the first nine months of 2017, Nucynta franchise brought in product sales of $183.3 million for Depomed compared to $206.5 million in the year-ago period.

Under the terms of the agreement, Collegium will commercialize both NUCYNTA Extended Release and NUCYNTA Immediate Release, and Depomed will receive a royalty rate on all NUCYNTA revenues based on certain net sales thresholds.

As long as the agreement is in force, for the first four years, Depomed will receive a minimum royalty of $135 million per year, and the royalty rate will be adjusted after the patent on NUCYNTA expires, which may not occur until at least late 2025.

With regard to relocation, Depomed is planning to move from Newark, California sometime in mid-2018 and is currently evaluating potential Midwest and East Coast locations.

In line with this relocation, the Company will trim its workforce by 40% to approximately 70 employees and reduce its headquarters office space requirement by 50%. Depomed expects to save approximately $10 million annually as a result of the headquarters restructuring and relocation.

DEPO closed Monday's trading at $7.15, up 0.56%. In after-hours, the stock was up 4.90% to $7.50.

Galectin Therapeutics Inc. (GALT) will be announcing the results of its phase IIb trial of GR-MD-02 in NASH cirrhosis, dubbed NASH-CX, on Tuesday morning, December 5, 2017.

The company will host a conference call and webcast, including a slide presentation, beginning at 8:30 a.m. ET on December 5, 2017.

Non-alcoholic steatohepatitis (NASH) is a chronic inflammatory disease that progressively leads to fibrosis and eventually cirrhosis (scarring of the liver).

GALT closed Monday's trading at $2.48, up 2.06%. In after-hours, the stock was up 48.79% to $3.69.

Shares of Heron Therapeutics Inc. (HRTX) were down over 8% in extended trading on Monday, following announcement of an underwritten public offering of its common stock.

Last month, the FDA approved the Company's Cinvanti for the prevention of chemotherapy-induced nausea and vomiting. Cinvanti is expected to be launched commercially in the U.S. in January of next year.

HRTX closed Monday's trading at $17.15, down 0.58%. In after-hours, the stock was down 8.19% to $15.74.

Ironwood Pharmaceuticals Inc.'s (IRWD) two phase IIa studies of IW-1973 in patients with type 2 diabetes and hypertension have yielded encouraging top-line results.

In both studies, treatment with IW-1973 led to blood pressure reductions and improvements in metabolic parameters, including reductions in fasting plasma glucose and cholesterol levels, in patients who were taking a stable regimen of therapies to manage their disease, according to the Company.

However, 1 patient with erosive esophagitis receiving IW-1973 is said to have suffered a serious adverse event - an upper gastrointestinal hemorrhage.

The Company recently initiated two new phase II studies of IW-1973 for the treatment of diabetic nephropathy and for the treatment of heart failure with preserved ejection fraction (HFpEF).

IRWD closed Monday's trading at $16.25, down 6.18%.

Zogenix Inc.'s (ZGNX) new data from its first phase III trial of investigational drug ZX008 for the treatment of Dravet syndrome shows that patients treated with ZX008 were more likely to achieve clinically meaningful reduction in seizure frequency compared to those on placebo.

Top-line results from this study, dubbed Study 1, were previously reported in September 2017.

Patients treated with ZX008 were rated as 'very much improved' or 'much improved' in overall condition compared to placebo.

To know more about Zogenix, please visit our Company Spotlight column.

ZGNX closed Monday's trading at $34.53, down 11.25%.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

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