Tag Archives: Impax Labs

3 Biggest Biotech Crashes This Month

By Keith Speights, The Motley Fool

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What a month! The Dow set all-time highs. So did the S&P 500. But March wasn’t so great for everyone. While the big indexes enjoyed the thrill of victory, these three biotechs experienced the agony of defeat. Here’s what happened.

Serious impact
Impax Laboratories 
suffered from a comedy of errors. Unfortunately, the impact on its shares wasn’t so funny. Shares sank more than 22% during the month.

The culprit for the stock decline was none other than Impax itself. Back in March of last year, the Food and Drug Administration conducted an inspection of the company’s manufacturing facility in Hayward, Calif. Impax Labs had plenty of time to correct those problems. However, when the FDA completed its follow-up inspection earlier this month — one year later, three of the same problems were cited again. To make things worse, the FDA found nine new issues.

In response to the problems, CEO Larry Hsu stated that the company “committed significant resources in [its] efforts to meet FDA requirements.” Obviously, those resources and efforts weren’t enough.   

A long fuse
With a long fuse on a stick of dynamite, you know the explosion is still coming, even if it might take a little longer. The same type of situation has applied for Spectrum Pharmaceuticals . Many observers have expected for quite a while that Fusilev sales would eventually bomb. The explosion finally came in March, resulting in about a 35% drop in Spectrum’s shares.

Critics have been saying for months that sales for non-Hodgkin’s lymphoma drug Fusilev would fall as providers turned to generic alternatives. Fusilev enjoyed an extended period of high sales volumes resulting largely from shortages of generic leucovorin, driving Spectrum’s revenue up tremendously. However, that shortage ultimately ended as Teva and Sagent Pharmaceuticals cranked out more supply.

The anticipated firestorm hit in mid-March after Spectrum announced revenue guidance 40% lower than previously expected.This huge guidance cut stemmed from hospitals that switched to generics. No surprise there. Spectrum insisted that demand for Fusilev in clinics was “stable” and that “solid demand” was anticipated for 2013. Unfortunately for Spectrum, “stable” and “solid” aren’t words that can be accurately used to describe its stock these days.

The biggest crash of all
Impax and Spectrum might have had bad months, but at least they still look better than Ziopharm Oncology . Ziopharm’s stock collapsed more than 60% in March following bad news from a late-stage clinical trial this week.

The company had high hopes that palifosfamide would prove to be a potent treatment for metastatic soft tissue sarcoma. However, the drug failed to significantly improve progression-free survival, the primary endpoint of the phase 3 clinical study. Despite the study’s independent data monitoring committee’s recommendation for continued analysis to follow up on overall survival rates, Ziopharm decided to pull the plug on the program entirely.

What’s next for Ziopharm? The company says it will now regroup and focus on its synthetic biology programs.  

Rising from the ashes<br …read more
Source: FULL ARTICLE at DailyFinance

3 Horrendous Health-Care Stocks This Week

By Keith Speights, The Motley Fool

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Mr. Market was a happy camper this week, with the Dow setting all-time highs. However, a few stocks in the health-care sector didn’t join the party. Here are three of the most horrendous performers for the week.

Manufacturing a downturn
If at first you don’t succeed, try, try again. But what if you try and still don’t succeed? That’s the question facing specialty pharmaceutical company Impax Labs . Shares plunged nearly 17% this week on news that a second inspection of a manufacturing facility by the Food and Drug Administration still found problems. It could have been even worse — at one point during the week, shares were down nearly 27%.

An earlier inspection of the Hayward, Calif., facility was conducted in March 2012. Three of the issues cited in the most recent inspection were initially found last year but had not been corrected. The FDA also found nine new issues.

This situation has proved to be quite embarrassing for Impax and costly for its shareholders. The company stated that it is “working diligently” to address the problems and intends to respond to the FDA soon. 

Missing big
Medical-device maker AngioDynamics saw its shares tumble 12% this week. The company badly missed analyst estimates for revenue and earnings in the last quarter.

The numbers were only preliminary, but they didn’t look great. AngioDynamics said that revenue would probably come in at $82 million for the quarter ended Feb. 28. Analysts were expecting close to $88 million. The company expects to post earnings of $0.04 to $0.06 per share. Even the high end of that range is still well below the $0.09 per share analysts expect.

What happened? AngioDynamics CEO Joseph DeVivo said the company expected to build momentum in the quarter but was caught off-guard by softness in elective procedure volumes. However, DeVivo also maintained that the poor results should be temporary. 

Feeling heat
Shareholders in DepoMed felt the heat this week after an FDA advisory panel rejected hot-flash drug Sefelsa. The stock dropped 9.5% on the decision.

The advisory panel voted 12-2 against recommending Sefelsa. The panel thought DepoMed’s three studies didn’t show that the drug actually reduced hot flashes in menopausal women. Without solid efficacy results, the panel thought the benefits weren’t sufficient to overcome safety issues with Sefelsa. Side effects for the drug include dizziness, fatigue, balance problems, and increased suicidal thoughts.

What’s next for DepoMed? The company has pulled the plug on all spending on Sefelsa in treating hot flashes for now. However, it continues to sell the drug under the brand name Gralise for managing postherpetic neuralgia. DepoMed also sells anti-inflammatory drug Zipsor and diabetes drug Glumetza, which partner Santarus markets in the United States.

None of the above
I normally attempt to pick the best of the horrendous health-care stocks of the week, but this week I must admit that I’m stumped. It’s hard to have much confidence in Impax Labs after failing an FDA inspection for the second …read more
Source: FULL ARTICLE at DailyFinance

These Stocks Missed the Dow's Record Run

By Dan Caplinger, The Motley Fool

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It’s not every day that the Dow Jones Industrials set a new all-time high. For the first time in more than five years, the Dow set a new record, rising more than 125 points to close at 14,254, well above its former closing record of 14,164. With that milestone behind them, investors will now turn their attention to the S&P 500, which is now less than 2% below its closing record high of 1,565.

Today’s rally was broad-based, with only two losing stocks in the Dow. One was Coca-Cola , which fell 0.4%. Fool contributor Alex Planes suggested earlier today that news from rival Dr Pepper Snapple might have sent Coke’s shares lower, but the other issue Coca-Cola faces is simply that with slow growth and defensive characteristics, the stock isn’t a favored place for investors during big bull markets like we’ve seen lately. The other Dow loser was Merck, which fell 0.2%.

Elsewhere, Impax Labs fell more than 25% when an FDA inspection of a California manufacturing facility found a dozen problems, three of which had already been cited in a previous 2011 warning letter. Despite the unquestionable promise of Parkinson’s drug Rytary, Impax needs to get its internal operations in better shape to comply with regulatory requirements and bring the drug through the approval process to market.

Finally, SandRidge Energy dropped 4.5%, with an even bigger 11% decline for its SandRidge Mississippian Trust I . Despite impressive dividend yields, SandRidge’s trusts have fallen short of distribution targets even as production has ramped up, and that’s weighing on the parent entity as well. Still, if rock-bottom prices for natural gas ever recover, SandRidge has positioned itself to post impressive gains in the future.

Coke’s drop today isn’t the first setback investors have faced, as the soft-drink giant faces some new threats to its continued market dominance. We’ve recently compiled a premium research report containing everything you need to know about Coca-Cola. If you own or are thinking about buying shares in the company, you’ll want to click here now and get started!

var FoolAnalyticsData = FoolAnalyticsData || []; FoolAnalyticsData.push({ eventType: “TickerReportPitch”, contentByline: “Dan Caplinger”, …read more
Source: FULL ARTICLE at DailyFinance