It's 9 For Humira, SMMT Awaits Data In Q4, Something's Cooking In ZSPH

(RTTNews) - AbbVie Inc.'s (ABBV) anti-inflammatory blockbuster Humira has received FDA approval for yet another indication - this time for the treatment of moderate to severe hidradenitis suppurativa, which represents the ninth approved use in the U.S.

Hidradenitis suppurativa, or HS in short, is a chronic inflammatory skin disease characterized by inflamed, painful lesions typically located around the armpits and groin, on the buttocks and under the breasts.

Earlier this year, the FDA granted HUMIRA orphan drug designation for the treatment of moderate to severe HS (Hurley Stage II and Hurley Stage III disease), a population of fewer than 200,000 patients. The orphan drug designation provides HUMIRA the potential to be granted seven years of market exclusivity for the treatment of moderate to severe HS.

Humira generated sales of $12.5 billion in 2014.

ABBV closed Thursday's trading at $59.58, up 0.54%.

Medicure Inc. (MPH.V) (MCUJF.OB) has submitted a supplemental New Drug Application to the FDA to expand the label for AGGRASTAT to include the treatment of patients presenting with ST segment elevation myocardial infarction (STEMI). The company anticipates that regulatory agency will announce its decision in July 2016.

AGGRASTAT is currently approved by the FDA for treatment of patients presenting with non-ST segment elevation acute coronary syndrome (NSTE ACS).

The net revenue from the sale of AGGRASTAT finished product for the six months ended June 30, 2015 was $7.1 million compared to $3.6 million for the six months ended June 30, 2014.

MCUJF.OB closed Thursday's trading at $2.41, up 5.70%.

Presbia PLC (LENS), an ophthalmic device company, has completed the second stage enrollment in the US FDA pivotal study of Presbia Flexivue Microlens.

The Presbia Flexivue Microlens, a revolutionary optical lens implant for treating presbyopia, the age-related loss of near vision, has been commercially available in the European Union and other countries around the world where it has obtained regulatory approvals.

In February of this year, the company was given the go-ahead to commence the second stage pivotal study of its Microlens, which required enrollment of 337 qualified subjects.

The company went public on January 29, 2015 at a price of $10.00 each. The stock closed Thursday's trading at $6.73, down 6.66%.

Summit Therapeutics plc (SMMT) has completed patient enrollment in its phase II trial evaluating the efficacy of SMT19969 against the current standard of care, Vancomycin for the treatment of C. difficile bacteria infection.

The trial, dubbed CoDIFy, is on-track to report top-line results in the fourth quarter of this year.

The company listed its American Depositary Shares on the NASDAQ in March of this year, priced at $9.90 per ADS.

SMMT closed Thursday's trading at $11.71, down 1.68%.

Theravance Biopharma Inc.'s (TBPH) supplemental New Drug Application for VIBATIV for use against concurrent Bacteremia in cases of Complicated Skin and Skin Structure Infections (cSSSI) or Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia has been accepted for review by the FDA. The FDA's decision is slated for Q2 2016.

VIBATIV for injection is approved in the U.S. for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Staphylococcus aureus when alternative treatments are not suitable. In addition, VIBATIV is approved in the U.S. for the treatment of adult patients with complicated skin & skin structure infections (cSSSI) caused by susceptible isolates of Gram-positive bacteria, including Staphylococcus aureus, both methicillin-susceptible (MSSA) and methicillin-resistant (MRSA) strains.

TBPH closed Thursday's trading at $13.63, up 1.64%.

ZS Pharma Inc. (ZSPH) soared as much as 45% on Thursday to touch an all-time high after the company confirmed that it has participated in preliminary discussions with Actelion Ltd. (ALIOF.OB) regarding a potential strategic transaction.

ZS Pharma's lead therapeutic candidate is ZS-9, an investigational treatment for hyperkalemia. It is under FDA review - with a decision expected on May 26, 2016. It remains to be seen whether or not the discussions will lead to a transaction.

ZSPH, which touched a high of $84.85 on Thursday, closed the day's trading at $74.73, up 28.42%.