Tag Archives: request

2 Hotly Debated Drugs Due For FDA Decisions Next Week

In the week before Memorial Day, the FDA is due to decide whether to approve two of the most divisive drugs in the biotech industry, both of them crucial for the companies that make them, Sarepta Therapeutics and Intercept Pharmaceuticals. Thursday is the deadline for eteplirsen, Sarepta Therapeutics ‘ ( SRPT ) treatment for Duchenne muscular dystrophy (DMD). Just getting to the filing took years of negotiation between Sarepta and the FDA, and May 26 is three months later than the decision was originally supposed to be made. And after all that, Wall Street is placing low odds on the drug’s approval. That’s based mainly on last month’s advisory committee meeting on eteplirsen, which voted 7 to 3 (with 3 abstentions) that the drug’s effectiveness wasn’t adequately proven by Sarepta’s tiny clinical trial. Sarepta stock hit a four-year low of 8, on April 26, as multiple analysts downgraded it on the assumption the drug will be rejected. Nonetheless, DMD is a devastating disease without a current treatment, and the families of the children affected have turned into a formidable lobby to get something on the market — especially after BioMarin Pharmaceutical ‘s ( BMRN ) rival drug Kyndrisa was rejected in January. Some observers say the families’ desperation might be enough to move the agency. Oppenheimer analyst Christopher Marai on May 2 upgraded Sarepta on the grounds that, in the past, the FDA has been more flexible in such cases of unmet need. He also pointed out that the stock was now cheap. Sarepta stock has remained volatile but has steadied somewhat the past couple of weeks. On Friday, shares jumped 8.8%, to 19.15. Intercept’s Liver-Disease Treatment Expected To Get OK A day after the Sarepta decision, Intercept Pharmaceuticals ‘ ( ICPT ) liver-disease treatment Ocaliva is due for a verdict. Ocaliva’s advisory committee vote last month went the opposite way of eteplirsen’s, with the panel unanimously supporting approval for the drug, which treats the rare disease primary biliary cholangitis (PBC). As a result, Wall Street generally expects approval. Bears, however, are still growling about Ocaliva’s safety, which they say could limit the drug’s label. The day after the panel vote, Morgan Stanley analyst Andrew Berens drove down Intercept’s stock with the theory that the FDA would discourage use in patients with advanced cirrhosis. This might affect not only the relatively small PBC market, but also the much, much bigger possibilities for Ocaliva in non-alcoholic steatohepatitis (NASH). Intercept is testing the drug in NASH, and approval wouldn’t be for a couple of years, but it’s a major part of the stock’s bull thesis, as analysts see annual sales in the multi-billions. Intercept stock has been on a downtrend this month, but it rose 2.4% this past week. On Friday, shares closed up 2.2%, at 134.28.

Facebook’s Alleged Liberal News Bias Gets Comedy Treatment

Facebook ( FB ) CEO Mark Zuckerberg met with conservative news figures this week to address concerns that editors of the social network’s Trending Topics feature have been suppressing conservative viewpoints. That gave comedians and satirists a great opening to take some shots at Facebook for its alleged liberal bias. “Late Show” host Stephen Colbert slammed Facebook for having misplaced priorities. “Apparently, Facebook censored popular stories about conservative topics from appearing on the trending news section. Folks, I think this is wrong,” Colbert said. “If Facebook is going to censor things, why not get rid of the stuff people really don’t want to see, like your ex’s tropical honeymoon? Or invitations to co-workers’ improv shows?” Satirical news website The Onion presented a fake response from Zuckerberg, who questioned why people are getting their news from Facebook to begin with. “Facebook is a great place to connect with friends and family, but frankly, if you’re on our site for 20 minutes or longer during the day and you’re reading the articles on here as your main connection to what’s actually happening in the world, then I’d say you’re a little mistaken about what this site is actually all about,” fake Zuckerberg said. “I’m happy to show anyone how to get to a regular news site if you need a little help.” Online comic The Joy of Tech also took a jab at the Facebook bias controversy. Plus, the story was material for political cartoonists including Jeff Darcy of Cleveland.com and Rick McKee of the Augusta Chronicle . Amazon, Tesla Also Come In For Some Zingers Facebook’s trending-news hullabaloo isn’t the only tech subject tickling funny bones lately. What follows are recent jokes from late-night comedians Jimmy Fallon, Conan O’Brien and James Corden. Their zingers were directed at Amazon.com ( AMZN ), CBS ( CBS ), Alphabet ( GOOGL )-owned Google, Priceline ( PCLN ), Tesla Motors ( TSLA ), Twitter ( TWTR ) and Uber Technologies. Fallon: Tesla unveiled its new model 3 electric car. And I saw that fans were camping outside Tesla stores to reserve one. Camping out is actually great practice for when their cars run out of power 30 miles from the nearest outlets. Fallon: Amazon Prime just unveiled new buttons you can press to order Doritos, Red Bull, and Trojan condoms. Yeah, Doritos, Red Bull and condoms. Or as that’s called in New Jersey, “A gift basket.” Fallon: The CEO of Priceline just resigned after it was revealed that he had an affair with an employee. As you can imagine, his wife is pretty mad, but on the bright side, at least he knows where to find a good deal on hotels. Fallon: CBS announced that season 33 of “Survivor” will be called “Survivor: Millennials vs. Gen-X.” It’ll start in September, and end 20 minutes later when both teams realize there’s no Wi-Fi. Conan: This week is the 43rd anniversary of the first cellphone call. Historians still don’t know which movie theater it took place in. Conan: Over the weekend, a man broke the world record for “Donkey Kong,” making it through the entire game using up just one life. That’s right — his own. Conan: Google has created several new emojis aimed at empowering women. So congratulations women, you asked for equal pay and you got five new emojis. Corden: The social media platform Twitter just signed a historic deal with the NFL to live stream Thursday Night Football games this coming season. Before this, the only thing Twitter ever live streamed was Kanye West’s meltdowns. Corden: The driverless car thing seems like it’s really catching on lately. In fact, the ride-sharing company Uber has begun testing driverless cars on the streets of Pittsburgh. Finally, Uber found a way to make out-of-work actors even more out of work. Corden: But don’t worry, for all of you who love Uber, the experience isn’t really going to change. To keep in line with Uber’s brand, their driverless cars will be programmed to smell like cologne and also make female passengers really uncomfortable.

Biomeds And Banks In Basing Mode After A Strong Week

Generic drug and biotech firms scored two of the top three gains among industries this past week. Super regional banks, led by BB&T ( BBT ), SunTrust Banks ( STI ), Northern Trust ( NTRS ) and Fifth Third Bancorp ( FITB ), was the other fast-rising group. The biotech group rose 6% for the week. The gain was disproportionately influenced by some thinly-traded names, particularly Amphastar ( AMPH ),  a maker of injectable and inhalable drugs. It surged 16% on the week. Emergent BioSolutions ( EBS ) popped 6% for the week, putting it at a new high and in buy range above a 41.06 buy point in a double-bottom-with-handle base.  Emergent’s bread-and-butter product BioThrax is an anthrax vaccine. Emergent is also planning to spin off its Aptevo Therapeutics subsidiary, which has a prostate cancer treatment in clinical trials, later this year. Analysts project a 3% earnings decline this year, followed by a 73% rebound in 2017. Another potential group leader is IBD 50 stock Medivation ( MDVN ).  Owner of the prostate cancer treatment Xtandi, Medivation shares are up 24% since clearing a 48.87 buy point in April. Investors who opted out of that back-and-forth breakout could look at the chart as a 14-month cup pattern, which puts shares just below a 63.04 handle buy point. Medivation is under uncertain pressure from France’s pharma giant Sanofi ( SNY ), which is reportedly gearing up for a board battle after Medivation declined the company’s $9.3 billion takeover offer last month. Analysts consensus plots a 31% EPS gain this year, rising 63% in 2017.  Sales are expected to slip 1% in 2016, rebounding to a 26% gain next year. One other biotech worth mentioning is Incyte ( INCY ). The Delaware-based specialist in blood cancer treatments is up since April 1, but needs more work on building the right side of a potential new base.  Its Relative Strength Rating is sickly and the stock remains deep below its 40-week moving average. But analysts project a 222% revenue gain this year, partly due to its acquisition of the European operations of Ariad Pharmaceuticals, set to close in June, followed by sharp rebound to profitability next year. Among generic drug makers, Allergan ( AGN ) and Akorn ( AKRX ) show some of the more telling chart action in the group. Allergan rose almost 3%, to just below its 10-week moving average, a line that has acted as a ceiling for the stock since early January. Akorn retook its 10-week line the previous week, then quickly advanced to push through resistance at its 40-week line. Allergan has no possible buy point in sight, and Akorn needs time if its current consolidation is to become a base. The RS ratings for both stocks are dismal, but their fundamentals remain sound, and an upturn in institutional investor for the stocks would count as a positive for the market. Beyond the drug trade, banks also posted a strong week, buoyed by rising indications that the Federal Reserve is leaning toward a rate hike in June.  Investment banks also took strength from JPMorgan Chase ’s ( JPM ) announcement on Tuesday that it would lift its dividend by 9%. SunTrust, Northern Trust and Fifth Third have all technically formed cup-with-handle patterns. SunTrust and Northern Trust show the strongest Relative Strength Ratings, and the handles of their base patterns have formed above 10-week support. One other factor to note: All four banks show Accumulation/Distribution Ratings of B- or better, suggesting they are seeing strong buying interest from institutional investors.