In the last 7 days, the Estimize universe has seen significant EPS revisions for 146 companies heading into upcoming earnings reports, with 75 downward revisions vs 71 upward revisions. The sector posting the greatest percentage of positive revisions is Industrials, while Health Care has seen the greatest percentage of negative revisions.

Estimize EPS Consensus Revisions For Upcoming Announcements

Sector Up Down Grand Total Percent Up Percent Down Consumer Discretionary 20 23 43 47% 53% Consumer Staples 4 4 8 50% 50% Energy 11 10 21 52% 48% Financials 3 3 100% 0% Health Care 5 14 19 26% 74% Industrials 7 4 11 64% 36% Information Technology 19 16 35 54% 46% Materials 2 3 5 40% 60% Telecommunications 0 1 1 100% 100% Utilities 0 0 0 0% 0% Total 71 75 146 49% 51%

BIGGEST INDUSTRIALS UPWARD REVISIONS

Rank Company Revision % 1 BLDP 71.88% 2 HDSN 50.00% 3 ABCO 20.86% 4 AL 2.07% 5 CBI 1.41%

BIGGEST INDUSTRIALS DOWNWARD REVISIONS

Rank Company Revision % 1 UFPI -1553.49% 2 PSIX -9.89% 3 RRTS -4.81% 4 FDX -1.47% 5 ATU -0.10%

BIGGEST HEALTH CARE UPWARD REVISIONS

Rank Company Revision % 1 CLVS 171.08% 2 EVHC 54.64% 3 VVUS 19.54% 4 AGEN 12.04% 5 ZYNE 9.21%

BIGGEST HEALTH CARE DOWNWARD REVISIONS

$SRPT

Sarepta Therapeutics

Written by Ophir Gottlieb, 11-18-2015 Without getting paranoid, there is evidence (albeit circumstantial), that an FDA committee was pushed in a way that is at the very least odd, and at the very most, outright tampering and fraud. FIRST An Update The risk in SRPT stock is exploding as reflected by the option market. Here is the IV30® (via Livevol) which is a fancy way of saying the expected future volatility in the stock price for the next 30 calendar days.

The risk is refelection of the news coming out in a matter of days from BMRN and this news: On November 17th, Sarepta Therapeutics revealed that a peer-reviewed medical journal, the Annals of Neurology, published the results from a midstage trial testing its treatment for a fatal form of muscular dystrophy (Source: WSJ). The stock is finally rising after a catastrophic drop.

The study found that at three years of treatment, patients experienced a slower rate of disease progression when compared to untreated matched historical controls and the investigational drug continued to be well-tolerated. Source: BusinessWire

In English, SRPT is on the clock for an FDA committee meeting on January 22nd to recommend its drug to treat Duchenne muscular dystrophy (DMD), a disease which affects around 1 in 3,600 boys, which results in muscle degeneration and premature death. There are no cures or treatments available but SRPT has one and so does (maybe) BioMarin (BMRN). The incredible story is included below, and it's not only mind blowing, it may point to FDA member tampering, malfeasance and an incredible opportunity. The main stream media doesn't have the vocabulary to understand breaking biotechnology and technology. Get free news alerts (once a day) from us and you will be the expert in the room. Get Our (Free) News Alerts. There's just no ther way to say it, the stock market reaction for SRPT of late has been abrupt and utterly bizarre if not confounding. Here's the stock chart, and note the wild collapse in the stock.

I originally posted an article on SRPT on July 9th, 2015 and October 15th. The mainstream media doesn't have the vocabulary to understand breaking technology and biotech. Join Us: Try free breaking news alerts once a day. WHY SRPT Stock Collapsed Two things have happened. First, in an odd twist, the date expected for the FDA committee to meet was Nov. 23 and 24th and all parties believed that both BMRN and SRPT would both be reviewed on those days so the FDA could get a real handle on the two drugs and certainly approve at least one. But... It turned out BMRN will in fact meet with the FDA committee on Nov 23rd, but SRPT has been bumped to Jan. 22, 2016. That's not because the drug is less promising. Nothing has changed and tentative FDA schedules surprise people all of the time. In fact, by most accounts, SRPT's drug candidate is far superior to BMRN's. However, the fact that SRPT has been bumped back crushed the stock and does smell, even if it sounds paranoid, of some back channel FDA committee agreement. Parent and doctor advocacy groups almost immediately protested the date change, not because of the stock price, but because of the dire need for the medicine for children. If you enjoyed this story, you simply won't believe the fantatsic reports and tools CML Pro members get for just $10 a month. Get CML Pro, become the most powerful investor simply by having knoweldge. The oddity and potential smoking gun of impropriety here is that the FDA committee had a wonderful opportunity to listen to and examine the data behind the only two drug candidates in the world to treat this disease at the same time, and make a recommendation based on all the data. But they didn't... and SRPT stock got hammered. Second, SRPT offered 3.25 million shares in a public offering at $39 per share. Sarepta plans to use the net proceeds from the offering for product and commercial development and general corporate purposes. That's a good thing. The main stream media simply doesn't have the lexicon to understand breaking biotechnology. It just doesn't. Get free news alerts (once a day) from us and you will be the expert in the room. THE Bizarre Over Reaction The market punished SRPT because its drug (if approved) will be two-months behind BMRN for release. Friends, this is a public company with a remarkable drug that will likely get approved and two-months means nothing to the stock price. This is not a one-time drug sale, it's a magnificent pipeline and treatment with decades of sales ahead of it. But again, all evidence points to SRPT having a superior drug, why has this date change happened, anyway? Even more bizarre, the PDUFA date (not the committee hearing date), which is the date that the drug gets an actual approval or disapproval status, was always going to be two-months behind BMRN. This was a known entity for now more than three-months and was never disputed. Yes, this two-month gap has always been known. I quote myself from the prior article in September:

"BioMarin Pharmaceutical (BMRN) also has a drug under FDA review called drisapersen (from Prosensa in acquisition). Interestingly, Drisapersen's PDUFA date is Dec. 27, 2015 two months before SRPT gets its big day." Source: A Small Cap Biotech Ready to Explode

Sarepta Therapeutics

There's just no ther way to say it, the stock market reaction for SRPT of late has been abrupt and utterly bizarre if not confounding. I originally posted an article on SRPT on July 9th, 2015. The quick and dirty is that the firm has a drug in the final phase of approval from the FDA and the stock was ripping, up from $11 to nearly $40. It has a competitor in the field, BMRN, also ready to get a drug approved. Here's where everything went sideways for SRPT, with the stock down 30% in a few weeks. Why SRPT Stock is Collapsing Two things have happened, neither of which are bearish. First, in an odd twist, the date expected for the FDA committee to meet was Nov. 23 and 24th and all parties believed that both BMRN and SRPT would both be reviewed on those days. It turns out BMRN will in fact meet with the FDA committee on Nov 23rd, but SRPT has been bumped to Jan. 22, 2016. That's not because the drug is less promising, it's simply because SRPT is just a little behind BMRN in its submission of data. Nothing has changed and tentative FDA schedules surprise people all of the time. In fact, by most accounts, SRPT's drug candidate is far superior to BMRN's. Second, SRPT offered 3.25 million shares in a public offering at $39 per share. Sarepta plans to use the net proceeds from the offering for product and commercial development and general corporate purposes. That's a good thing. But.. Here's the stock price chart since 10-5-2014 through today (10-15-2015).

The Bizarre Over Reaction The market is punishing SRPT because its drug (if approved) will be two-months behind BMRN for release. Friends, this is a public company with a remarkable drug that will likely get approved and two-months means nothing to the stock price. This is not a one-time drug sale, it's a magnificent pipeline and treatment with decades of sales ahead of it. Even more bizarre, the PDUFA date, which is the date that the drug gets an actual approval or disapproval status, was always going to be two-months behind BMRN. This was a known entity for now more than three-months and was never disputed. Yes, this two-month gap has always been known. I quote myself from the prior article in September:

"BioMarin Pharmaceutical (BMRN) also has a drug under FDA review called drisapersen (from Prosensa in acquisition). Interestingly, Drisapersen's PDUFA date is Dec. 27, 2015 two months before SRPT gets its big day." Source: A Small Cap Biotech Ready to Explode

Sarepta Therapeutics, Inc., is a biopharmaceutical company that focuses on the discovery and development of RNA-based therapeutics for the treatment of rare, infectious, and other diseases. The company has no products out to market and no revenue, but has a market cap of $1.4 billion and a stock price up 150% in the last six-months, including a one-day pop on May 20th from $16.38 to $26.34. Let's take a look at a biotech that is either on the cusp of releasing its first ever product to market, or a disastrous fall if the FDA's final review is negative. The option market is pricing in the entity changing event to occur between November 20th and December 18th, 2015, with ~40% odds of it happening in November before the 20th. The price range reflected by the December options for SRPT is ~[$14, $54], and that's just one standard deviation. So, yeah, this is a massive event. An assumption held by most is that the committee will meet on Nov. 23-24 because those dates are listed on a tentative calendar of advisory panels. But that's not a sure thing. What's Going On SRPT has a drug candidate called eteplirsen that addresses Duchenne muscular dystrophy (DMD), a rare disease that affects the protective sheath surrounding muscle fibers. Here's the news as it came out: 1. July 10th, 2014: In a press release from the company, we learned:

Sarepta Therapeutics, Inc. (NASDAQ:SRPT), a developer of innovative RNA-based therapeutics, today announced data through Week 144 from Study 202, a Phase IIb open-label extension study of eteplirsen in patients with Duchenne muscular dystrophy (DMD). After nearly three years of follow up, results on the 6-minute walk test (6MWT) showed a decline in walking ability at a rate slower than would be expected based on available DMD natural history data. In addition, a continued stabilization of respiratory muscle function was observed, as assessed by pulmonary function tests. As previously reported, Study 202 met its primary endpoint of increased novel dystrophin as assessed by muscle biopsy at Week 48 and is now in the long-term extension phase in which patients continue to be followed for safety and clinical outcomes.

2. January 12th, 2015: SRPT released further results of that Phase IIb open-label extension study of eteplirsen and this came out: "[after] more than three years of treatment, results of the 6-minute walk test (6MWT) at 168 weeks showed continued ambulation across all patients evaluable on the test, however all patients showed a decline in distance walked on this measure since the week 144 timepoint (Source: Benzinga). At week 120 patients had experienced a decline of just 13.9 meters from baseline. By week 144 this figure grew to 33.2 meters, and at week 168 it blew up to to 76.7 meters (Source: The Motley Fool. The stock dropped 16% in the following two days down to $11.61. Become an Expert on any Company.

3. May 19th, 2015: SRPT was given the "go head" from U.S. regulators to file a new drug application for eteplirsen, getting the company on the FDA agenda, while the 144 week result was still out there without a real causation assigned to it. 4. August 20th and 21st, 2015: SRPT announced that it will move forward with its plans to seek regulatory approval for eteplirsen after conferencing with FDA officials in a pre-New Drug Approval (NDA) meeting on August 19th where the company was given the green light to file the NDA (Source: TheStreet.com). FDA has also granted Rare Pediatric Disease Designation for the drug. This designation supplements the Orphan Drug Designation and Fast Track Status previously granted by the FDA for this drug (Source: MDA.org ). Analysts from Baird wrote: "We believe the decision to reaffirm their previous timelines without FDA minutes is an indication that this meeting went very well. We do not think it is feasible that management could have misread the agency, given the controversy surrounding their dialogue in the past, and believe the agency is indicating a favorable bias that will result in NDA acceptance and priority review." 5. August 25th, 2015: The FDA announced that it had in fact accepted Sarepta's new drug application filing for eteplirsen, granting it priority review status and setting its PDUFA decision date for Feb. 26, 2016. "Priority Reveiew Status" is designated to drugs that offer benefit over existing therapies, or provide a treatment where no adequate therapy exists. Now What? Now we wait. The FDA advisory committee is expected to meet in November and SRPT is likely going to release some post-marketing study requirements. The way this FDA committee works is a little weird, so here's a go at it. The committee will offer its advice on whether the drug should be approved. It's common that the FDA will act as the committee suggests but it is not a guarantee. BioMarin Pharmaceutical (BMRN) also has a drug under FDA review called drisapersen (from Prosensa in acquisition). Interestingly, Drisapersen's PDUFA date is Dec. 27, 2015 two months before SRPT gets its big day. Drisapersen's has had a previous failure in phase III and Sarepta's still has that "unusual" result in the six-minute walk test results to the FDA. Summary SRPT has had its ups and down, seeing its stock price trade as low as $11 and as high as $37 in the last year, alone. It's management appears to have totally botched an advisory committee request and in a rather unusual moment, the FDA itself clarified its points on the development timeline. But after a very (very) long trial for its DMD drug, things look good. When I say "good," I mean, it has reached the final endpoint and the data looks promising. An FDA advisory committee will judge the drug and the FDA will take that into account and make a final decision. The addressable market for this drug has been estimated to be about $700 million in sales which isn't quite blockbuster status, but it's a non-trivial win if it goes through and the $1.4 billion market cap as of today would represent less than a 2:1 price to sales. SRPT would instantaneously become a takeover candidate for any number of mega cap biotechs.

Sarepta Therapeutics ($SRPT) is a biopharmaceutical company based in Cambridge Massachusetts.  They are making drugs to fight some serious diseases.  Some deep stuff.  And after over a year of their stock price doing nothing, it seems to be coming back to life.  

The chart below shows that long tight consolidation.  But then after coming to an agreement with the FDA on submitting rolling NDA it jumped.  I have no idea what rolling NDA is but I do know what the price action is saying:  BUY.

The stock rose $10 on that news.  Over 60%.  And since then it has consolidated.   You might think that 60% move was enough, but the chart suggests you could see another $10 move very soon.  The consolidation since the move up has put the stock back into the Bollinger Bands® and has been tightening against resistance at 26.85.  

The RSI has remained bullish and strong through this and then MACD pulled back only in a minor way.  With the consolidation in a bull flag a break to the upside would look for a move up to 36.  And with 45% short interest this is not a pipe dream.  Are you ready for this?