UPDATE: Acorda Therapeutics shares crater 26% premarket after FDA rejects application for Parkinson’s treatment

Acorda Therapeutics Inc. shares slid 26% premarket Tuesday, after the company said it has received a Refusal to File letter from the U.S. Food and Drug Administration regarding its new drug application for inbrija, an investigational treatment for symptoms of Parkinson’s disease. The FDA said the NDA was not complete enough to permit a substantive review. Specifically, it questioned the date by which the manufacturing site would be ready for inspection, as well as the submission of the drug master production record. The company said it will seek a meeting with the FDA and that it believes the issues can be addressed. “We will work with the FDA as quickly as possible to address the open issues and to clarify the path to successfully re-file our application,” Chief Executive Ron Cohen said in a statement. “We remain confident in INBRIJA’s data package and its promise as an important new therapy for people with Parkinson’s disease.” Shares have gained 37% in 2017, while the S&P 500 has gained 9%.

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YogaWorks acquires Tranquil Space’s 2 studios in Washington, D.C.

YogaWorks Inc. said Tuesday it has acquired Tranquil Space’s two studios in the Washington, D.C. metro area, without providing financial details. The company, which completed its IPO on Aug. 11, said it now has 52 studios on the east coast. Tranquil Space was founded by Kimberly Wilson in 1999, and has two studios in Arlington, Va. and in the Dupont Circle neighborhood of Washington. Shares were not yet active premarket, but are down 5.6% in the week to date, while the S&P 500 is flat.

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From:: Stock Market News

Best Buy shares gain 5% after company’s fiscal Q2 earnings hit above Wall Street expectations

Shares of electronics retailer Best Buy Co. rose nearly 5% during premarket trade on Tuesday after the company reported fiscal 2018 second quarter earnings that came in above Wall Street expectations. Best Buy reported net earnings of $209 million, or 67 cents per share for the quarter, up from $198 million, or 61 cents per share during the same quarter a year ago. Adjusted earnings per share were 69 cents in the quarter, above FactSet’s consensus of 63 cents. Revenue was $8.9 billion, up from $8.5 billion a year ago, and above FactSet’s $8.7 billion consensus. Also, same-store sales were up 5.4% in the quarter, better than FactSet’s expected 2.1% “Our higher-than-expected comparable sales of 5.4% were driven by stronger consumer demand for technology products and by the strong execution of our strategy,” said Best Buy Chief Executive Hubert Joly in a statement. “Against a backdrop of continued healthy consumer confidence, we believe broad-based product innovation is resonating with consumers and driving higher spend.” Best Buy raised its guidance for the full year, now expecting revenue to grow about 4.0%, compared with the previous 2.5% expectation. Non-GAAP operating income is expected to grow about 4.0% to 9.0%, an increase compared with the previous 3.5% to 8.5% projected growth. Shares of Best Buy have gained more than 46% in the year to date, while the S&P 500 index is up more than 9%.

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From:: Stock Market News

Acorda Therapeutics shares crater 24% premarket after FDA rejects application for Parkinson’s treatment

Acorda Therapeutics Inc. shares slid 24% premarket Tuesday, after the company said it has received a Refusal to File letter from the U.S. Food and Drug Administration regarding its new drug application for inbrija, an investigational treatment for symptoms of Parkinson’s disease. The FDA said the NDA was not complete enough to permit a substantive review. Specifically, it questioned the date by which the manufacturing site would be ready for inspection, as well as the submission of the drug master production record. The company said it will seek a meeting with the FDA and that it believes the issues can be addressed. “We will work with the FDA as quickly as possible to address the open issues and to clarify the path to successfully re-file our application,” Chief Executive Ron Cohen said in a statement. “We remain confident in INBRIJA’s data package and its promise as an important new therapy for people with Parkinson’s disease.” Shares have gained 37% in 2017, while the S&P 500 has gained 9%.

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Stock market ‘fear gauge’ VIX remains up over 20% in wake of latest North Korean action

The CBOE VIX Volatility index jumped some 25%, hitting 14.16, in the wake of the latest North Korean missile launch, which crossed into Japan’s airspace. Haven investments including gold, bonds and select currencies also got a boost overnight and early Tuesday in the wake of these developments. VIX, considered the stock market’s “fear gauge,” remains sharply higher ahead of the U.S. stock open. It was last changing hands at 13.75, up 21%. Tuesday’s intraday high remains below the year high of 17.28 struck on August 11 after President Donald Trump responded to North Korea’s Kim Jong-Un with a pledge of “fire and fury.”

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ProSiebenSat.1 shares drop after revenue warning

ProSiebenSat.1 lost 11% early Tuesday after the German media company reduced its revenue guidance for the third quarter in the German-speaking broadcasting segment, though it did confirm its full-year group targets. ProSiebenSat.1 said in a statement late Monday that it now expects the German segment’s third-quarter revenue to drop by mid-single digit percentage compared with the prior year. That means previous expectations of higher TV advertising revenue performance in the segment are “unlikely to be met,” the company said.

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Dow futures fall following North Korean missile test

U.S. stock-index futures were sliding lower late Monday in New York, with futures for the Dow down nearly 110 points at its nadir, after reports that North Korea fired a ballistic missile that flew over Japanese airspace, reigniting geopolitical tensions that had cooled between North Korea and U.S. allies in the Pacific Rim. Dow Jones Industrial Average futures were down about 85 points, or 0.4%, at 21,706 in late-Monday trade. Those for the S&P 500 index were down 0.5% at 2,430, and Nasdaq-100 futures retreated by 0.6% at 5,809. According to South Korean military officials and Japan’s government, a ballistic missile passed through Japanese airspace over the island of Hokkaido around 6 a.m. local time before splashing into the Pacific Ocean. South Korean military officials said the missile was launched outside the North Korean capital of Pyongyang and flew more than 1,600 miles. The three main equity benchmarks ended little changed at regular close of trade on Monday, with the Dow and S&P 500 ended near break-even levels, while the Nasdaq Composite Index posted a modest gain of 0.3%. The launch marks the first time since 2009 that North Korea has fired a missile over the mainland Japan, according to Kyodo News and comes as South Korea and the U.S. are engaged in military training drills, which began Aug. 21. After reports of the missile, haven gold rose to its highest level since around September at $1,323.30 an ounce in electronic trade, according to FactSet data.

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From:: Stock Market News

Dow futures down nearly 100 points following report of North Korean missile test

U.S. stock-index futures were sliding firmly lower late Monday in New York, with futures for the Dow down nearly 110 points at its lows, after reports indicated that North Korea fired a ballistic missile that flew over Japanese airspace, reigniting geopolitical tensions that had cooled between North Korea and U.S. allies in the Pacific Rim. Dow Jones Industrial Average futures were down about 90 points, or 0.4%, at 21,700 in late-Monday trade, those for the S&P 500 index were down 0.6% at 2,428, and Nasdaq-100 futures retreated by 0.7% at 5,804. According to South Korean military officials and Japan’s government, a ballistic missile passed through Japanese airspace over the island of Hokkaido around 6 a.m. local time before splashing into the Pacific Ocean. South Korean military officials said the missile was launched outside the North Korean capital of Pyongyang and flew more than 1,600 miles. The three main equity benchmarks ended little changed at regular close of trade on Monday, with the Dow and S&P 500 ended near break-even levels, while the Nasdaq Composite Index posted a modest gain of 0.3%.

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From:: Stock Market News

North Korea test-fires missile over northern Japan, rattling markets

Markets were rattled late Monday after North Korea test-fired a ballistic missile that flew over northern Japan. The South Korean military confirmed the missile launch, and Japan’s government said it passed through Japanese airspace over the island of Hokkaido around 6 a.m. local time before splashing into the Pacific Ocean. Nikkei 225 futures fell as much as 2.1% while the Dow Jones futures index opened more than 100 points lower after the launch, while the U.S. dollar fell 0.8% against the Japanese yen. South Korean military officials said the missile was launched outside the North Korean capital of Pyongyang and flew more than 1,600 miles. Japanese officials had issued a warning to local residents to seek shelter as a precaution. U.S. military officials told NBC News that it was the first time a North Korean missile test on a high-altitude trajectory passed over Japan. It was the 12th ballistic missile test by North Korea so far this year.

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From:: Stock Market News

Senior, Mid-Level Execs Shuffled at Mortgage Firms

As one mortgage firm replaces its chief executive officer, another organization recruited a new chief information officer, and two more hired new chief marketing officers.

On Aug. 16, Pacific Union Financial LLC disclosed that its president and CEO, Rick Skogg, will retire at the end of this year to spend more time with his family.

Replacing Skogg, who took the helm in 2012, will be Evan Michael Stone, who is the owner and chairman of the Irving, Texas-based company. Stone founded Pacific Union in 2004.


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From:: Financing