IPXL Mulls Merger, QURE Attracts Attention, No Let Up In ICPT Ocaliva Concerns

The following are some of the biotech stocks that made their way onto the Day’s Gainers & Losers’ list of September 21, 2017.

GAINERS

1. uniQure N.V. (QURE)

Gained 12.01% to close Thursday’s (Sep.21) trading at $9.51.

News: No news

Near-term catalysts:

— An investigational new drug application for AMT-130 in Huntington’s disease is expected to be filed in 2018.
— The Company is planning to meet with U.S. and European regulators in the early fall to further discuss its plans to begin a pivotal program of AMT-060 in hemophilia B in 2018.

2. Impax Laboratories Inc. (IPXL)

Gained 10.44% to close Thursday’s trading at $23.80.

News: The Company is mulling merger with Amneal Pharmaceuticals LLC, a privately held generic pharmaceutical manufacturer, reports the Wall Street Journal.

3. Intellia Therapeutics Inc. (NTLA)

Intellia is a genome editing company, focused on the development of proprietary, potentially curative therapeutics using the CRISPR/Cas9 system.

Gained 8.33% to close Thursday’s trading at $25.75.

News: No news

4. Supernus Pharmaceuticals Inc. (SUPN)

Gained 7.21% to close Thursday’s trading at $39.40.

News: No news

Recent event:

— On September 18, 2017, the Company announced that it has decided to eliminate the lower dose of 18 mg of SPN-810 in its first phase III clinical trial of SPN-810 for impulsive aggression in patients aged 6 to 12 years who have attention deficit hyperactivity disorder.

Moving forward, all patients will be randomized to either the 36 mg dose arm or placebo, and enrollment is expected to continue through mid-2018.

5. Collegium Pharmaceutical Inc. (COLL)

Gained 6.57% to close Thursday’s trading at $10.06.

News: No news

Recent event:

— On August 9, 2017, the Company reported financial results for the second quarter of 2017.

Net loss for the quarter ended June 30, 2017 shrunk to $21.1 million or $0.72 per share on net product revenue of $3.6 million. This compared with a net loss of $24.5 million or $1.05 per share on nil product revenue for the quarter ended June 30, 2016.

LOSERS

1. Intercept Pharmaceuticals Inc. (ICPT)

Lost 24.89% to close Thursday’s trading at $73.70.

News: The FDA has warned about serious liver injury with Ocaliva, the Company’s drug for rare chronic liver disease due to incorrect dosing.

Ocaliva was granted accelerated approval by the FDA last May for the treatment of primary biliary cholangitis, and was commercially launched in the United States in June 2016.

According to the FDA, there have been 19 cases of death associated…

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