Morning Buzz: Flexion Therapeutics (FLXN), Apple (AAPL), Priceline (PCLN), Catalyst Pharmaceuticals (CPRX), Regulus (RGLS)

Wall Street

Shares of Flexion Therapeutics, Inc. (FLXN) are higher by 31% to $14.28 in pre-market trading on Wednesday after the pharmaceutical company said its lead drug candidate Zilretta met the main goal of reducing pain in patients with moderate to severe osteoarthritis knee pain in a Phase 3 study.

Apple Inc. (AAPL) – CEO Tim Cook said late Tuesday his company would oppose and challenge a demand from a U.S. judge to help the FBI access an iPhone recovered from one of the San Bernardino shooters.

“We have great respect for the professionals at the FBI, and we believe their intentions are good. Up to this point, we have done everything that is both within our power and within the law to help them,” Cook wrote in a letter published on Apple’s website.

“But now the U.S. government has asked us for something we simply do not have, and something we consider too dangerous to create. They have asked us to build a backdoor to the iPhone,” he said.

Cook called the court order an “unprecedented step” by the federal government, noting that Apple “oppose[s] this order, which has implications far beyond the legal case at hand.”

In other Apple news this morning, Carl Icahn reduced his AAPL stake by 7 million shares, according to a Tuesday SEC filing. David Einhorn also trimmed his Apple stake in 4Q15.

The Priceline Group Inc. (PCLN) shares are up 129 points to $1,239.90 in pre-market trading Wednesday following a top and bottom-line beat in their Q4 earnings report.

The online booking service posted earnings of $12.63 per share on revenues of $2.00 billion, up 8.7% from a year ago. Analysts were expecting EPS of $11.81 on revenues of $1.96 billion.

For the current quarter ending in April, Priceline provided EPS guidance of $9.00-$9.60 versus consensus of $9.60 per share. The company also issued revenue projection of $2.01-$2.14 billion, compared to the consensus revenue estimate of $2.07 billion.

Catalyst Pharmaceuticals (CPRX) shares are plunging by more than 50 percent in pre-market trading after the firm announced that it has received a “refuse to file” letter from the FDA on its new drug application for a rare, muscle-wasting disorder.

Regulus Therapeutics Inc. (RGLS) stock is surging nearly 48% in active pre-market trade Wednesday after the company reported positive results from a phase 2 study of RG-101 for the treatment of Hepatitis C Virus.

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