Thirty-six doctors, all experts in Duchenne muscular dystrophy, or DMD, have written a letter to the U.S. Food and Drug Administration urging the agency to approve Sarepta Therapeutics’ (SRPT) experimental therapy eteplirsen.

The lobbying effort seeking to bolster support for eteplirsen and Sarepta — and counter previously released FDA criticism of the drug — is ramping up as an advisory committee meeting on April 25 nears.

Last month, 109 members of Congress sent their own letter to the FDA urging the agency to accelerate the approval of a DMD drug, without mentioning eteplirsen by name.
Sarepta shares rose 16% to $20.92 Monday after the scientific letter was released publicly. The letter was dated Feb. 24 and was addressed to Billy Dunn, the director of the FDA’s neurology division in charge of the eteplirsen clinical review.

“We suggest that the most scientifically robust way forward and the most ethical choice for the Duchenne community is in the context of an accelerated approval followed by a confirmatory trial,” wrote Dr. M. Carrie Miceli and Dr. Stanley Nelson, co-director of the Center for Muscular Dystrophy at UCLA, referring to eteplirsen.

The full letter can be downloaded and read here.

In the letter, Miceli and Nelson rebut some of the criticism leveled against the eteplirsen clinical data by FDA staff when the medical review of the drug was made public in January. The letter also expresses support for updated eteplirsen data submitted by Sarepta to the FDA.

The FDA accepted Sarepta’s supplemental eteplirsen data and extended the drug’s review period by three months from February to May. As previously reported, the FDA’s decision to extend the eteplirsen review period could be a signal that the new data satisfy the agency’s initial concerns.

 

Source: The Street

Cymabay Therapeutics, Inc. (CBAY) ended last trading session with a change of -23.53 percent. It trades at an average volume of 193.94K shares versus 1.34M shares recorded at the end of last trading session. The share price of $1.30 is at a distance of 58.54 percent from its 52-week low and down -86.02 percent versus its peak. The company has a market cap of $30.47M and currently has 23.44M shares outstanding. The share price is currently 4.5 percent versus its SMA20, 9.19 percent versus its SMA50, and -35.38 percent versus its SMA200. The stock has a weekly performance of 4 percent and is -23.08 percent year-to-date as of the recent close.

Cymabay Therapeutics, Inc. (CBAY) on March 17, 2016 announced top line results from its pilot Phase 2 clinical study of MBX-8025 in patients with homozygous familial hypercholesterolemia (HoFH). The study demonstrated that the range of responses to MBX-8025 was broad, but that MBX-8025 provided a clinically meaningful reduction in low-density lipoprotein cholesterol (LDL-C) for a subset of patients. This is the first study to demonstrate the potential utility of a PPARδ agonist in HoFH.

This was an open label, dose escalation study of 12 weeks duration conducted at five centers in Europe and Canada. Thirteen patients were enrolled, all of whom had genetically confirmed HoFH, including two subjects who had functionally negative mutations in their LDL receptor (LDL-R) genes. All of the subjects were taking ezetimibe and were on maximum statin therapy. None of the study participants received lomitapide, mipomersen or a PCSK9 inhibitor. Eight patients were undergoing concomitant apheresis on a weekly or biweekly schedule. Despite being on maximal conventional therapy, the average baseline LDL-C was 368 mg/dL. Subjects received once daily treatment with 50 mg of MBX-8025 for 4 weeks, after which the dose was escalated to 100 and 200 mg in successive 4-week periods. The goals of the study were to evaluate the effect on LDL-C as well as a spectrum of other lipid-related parameters, including PCSK9 levels, and to collect safety information.

Two per-protocol analyses were performed on 12 subjects. The data for one subject was excluded because of multiple missed apheresis visits throughout the study which caused marked fluctuations in LDL-C levels. A responder analysis was carried out which reflects the largest decrease in LDL-C observed during treatment for each subject. Three subjects (25%) exhibited a greater than or equal to 30% decrease. Five subjects (42%) had a greater than or equal to 20% decrease, including one patient that was receptor negative, and 7 (58%) had a greater than or equal to 15% decrease. Five subjects (42%) had a less than 15% decrease. The average maximum decrease in the study was 19%. Because of the high baseline LDL-C levels in these individuals, these percentage decreases correspond to significant absolute decreases in LDL-C (mean decrease of 109 mg/dL for the subjects with a greater than or equal to 15% decrease). Although reductions in LDL-C tended to be greater at the higher doses, no clear dose response was observed.

In a second analysis, the mean change in LDL-C for each subject was calculated by averaging values across all doses and dosing periods while on treatment. The overall mean change for all 12 subjects was a decrease of 10%. Eight of these subjects had a mean decrease in LDL-C of 16%, including 3 with a greater than 20% decrease. This included one patient that was receptor negative. This was offset by 4 patients who showed a mean increase of 4%.

Oncothyreon Inc (ONTY) recently recorded 27.72 percent change and currently at $1.29 is 43.33 percent away from its 52-week low and down -72.49 percent versus its peak. It has a past 5-day performance of 16.22 percent and trades at an average volume of 823.94K shares. The stock has a 1-month performance of 24.04 percent and is -41.89 percent year-to-date as of the recent close. There were about 94.95M shares outstanding which made its market cap $122.49M. The share price is currently 20.34 percent versus its SMA20, 1.9 percent versus its SMA50, and -52.93 percent versus its SMA200.

Oncothyreon Inc (ONTY) on March 14, 2016 reported financial results for the year and quarter ended December 31, 2015.

Full Year and Fourth Quarter 2015 Financial Highlights

Cash, cash equivalents and investments totaled $56.4 million as of December 31, 2015, compared to $63.7 million at December 31, 2014, a decrease of $7.3 million, or 11.5%. The decrease was primarily attributable to $28.9 million of cash used in operations during the year ended December 31, 2015, partially offset by the net proceeds of $22.4 million from the closing of concurrent but separate underwritten offerings of common stock and Series B convertible preferred stock in February 2015.
Research and development expenses for the fourth quarter of 2015 decreased by $19.1 million to $6.9 million from $26.0 million in the fourth quarter of 2014. Full year research and development expenses decreased by $18.4 million to $23.5 million in 2015 from $41.9 million in 2014. The fourth quarter and full year decrease in expense was primarily the result of the one-time upfront payment made to Array Biopharma in December 2014.
General and administrative expenses for the fourth quarter of 2015 increased by $0.4 million to $2.3 million, from $1.9 million in the fourth quarter of 2014. Full year 2015 general and administrative expenses were $9.3 million, an increase of $0.3 million from $9.0 million in 2014. This increase was primarily due to patent expenses related to our product candidates.
Net loss for the year ended December 31, 2015 was $32.6 million, or $0.34 per basic and diluted share, compared with a net loss of $50.0 million, or $0.64 per basic and diluted share, for the comparable period in 2014. Net loss for the three months ended December 31, 2015 was $9.1 million, or $0.10 per basic and diluted share, compared with a net loss of $27.6 million, or $0.30 per basic and diluted share, for the comparable period in 2014. The decrease in net loss for the year and quarter was primarily attributable to a $20.0 million upfront payment Oncothyreon made to Array BioPharma upon entering into an exclusive license agreement in December 2014. The decrease in net loss was partly offset by slightly higher general and administrative expenses and lower non-cash income from the change in the fair value of our warrant liability.

Source: Zerg Watch

As the saying goes, there are many possible reasons for an insider to sell a stock, but only one reason to buy — they expect to make money. So let’s look at one noteworthy recent insider buy.

At Cara Therapeutics (CARA), there was insider buying on Thursday, by Director Martin Vogelbaum who purchased 400,000 shares at a cost of $4.87 each, for a total investment of $1.95M. Cara Therapeutics is trading up about 9.3% on the day Monday. Vogelbaum was up about 19.4% on the buy at the high point of today’s trading session, with CARA trading as high as $5.82 at last check today.

 

Source: Forbes

Ocera Therapeutics, Inc. (NASDAQ:OCRX) was upgraded by analysts at Zacks Investment Research from a “hold” rating to a “buy” rating. They now have a $3.75 price target on the stock.

On Friday Ocera Therapeutics, Inc. (NASDAQ:OCRX) share price closed at $2.91. Company return on equity (ROE) is -74.30%. Ocera Therapeutics, Inc. (NASDAQ:OCRX) is -0.35% away from its 52 week high and its 52 week range is $2.00 – 5.06.

On 11 March, Oasis Petroleum Inc. (NYSE:OAS) believes it will be able to generate enough cash to fund operations for the year despite low crude prices, President Taylor Reid said on Friday, a confident outlook as the industry retracts.

Oasis Petroleum Inc. (NYSE:OAS) traded 21.13 Million shares and its share price decreased -3.15% to close at $8.00. Company has 2.20% insider ownership. Oasis Petroleum Inc. (NYSE:OAS) quarterly performance is -5.88% while its year to date (YTD) performance is 8.55%.

On 16 March, Ideal Power, Inc. (NASDAQ:IPWR) successfully tested and demonstrated a new Variable Frequency Drive (VFD) based on its award-winning, patented Power Packet Switching Architecture™ (PPSA). Variable frequency drives are part of the broader power conversion marketplace where Ideal Power’s PPSA technology is rapidly gaining market acceptance.

On Friday shares of Ideal Power, Inc. (NASDAQ:IPWR) ended up at $4.00. This year Company’s Earnings per Share (EPS) growth is -25.50% and next year’s EPS growth is 56.00%. Beta of Ideal Power, Inc. (NASDAQ:IPWR) is 0.96 while company weekly performance is -6.76%.

China Distance Education Holdings Limited (NYSE:DL) announced its participation in the following investor conferences in March and April 2016: Morgan Stanley Hong Kong Investor Summit, March 17, at Morgan Stanley’s offices in the International Commerce Center inHong Kong. Nomura Internet and Education Corporate Day, March 22, at Nomura’s offices in the Two International Finance Center in Hong Kong. Credit Suisse 19th Annual Asian Investment Conference, April 5-6

China Distance Education Holdings Limited (NYSE:DL) increased 1.69% to close at $14.44 on 18 March. Its return on assets (ROA) is 14.10% while return on investment (ROI) is 19.40%. China Distance Education Holdings Limited (NYSE:DL) price to sales (P/S) ratio is 4.72.

On 15 March, Yelp Inc. (NYSE:YELP) announced it has surpassed 100 million cumulative reviews contributed since inception. This milestone will be celebrated by the passionate Yelp community spanning more than 30 countries across five continents and, thanks to Yelp’s mobile translation feature, in 18 different languages.

On 18 March Yelp Inc. (NYSE:YELP) ended the day at $20.76. Company net profit margin stands at -6.00% whereas its return on equity (ROE) is -4.80%. Yelp Inc. (NYSE:YELP) is -60.46% away from its 52 week high.

Source: KC Register

Elizabeth Arden (NASDAQ:RDEN) has climbed 12.94% in the past week and advanced 34.97% in the last 4 weeks. In the past week, the company has outperformed the S&P 500 by 11.43% and the outperformance has advanced to 26.29% for the last 4 weeks period. The stock has recorded a 20-day Moving Average of 23.21% and the 50-Day Moving Average is 12.64%.

Elizabeth Arden (NASDAQ:RDEN) rose 8.32% or 0.59 points on Friday and made its way into the gainers of the day. After trading began at $7.15 the stock was seen hitting $7.9 as a peak level and $7.15 as the lowest level. The stock ended up at $7.68. The daily volume was measured at 542,258 shares. The 52-week high of the share price is $17.44 and the 52-week low is $5.02. The company has a market cap of $230 million. The company shares have dropped 55.35% in the past 52 Weeks. On March 23, 2015 The shares registered one year high of $17.44 and one year low was seen on February 5, 2016 at $5.02. The 50-day moving average is $6.4 and the 200 day moving average is recorded at $9.57. S&P 500 has rallied 2.61% during the last 52-weeks.

Investors should note that the Company has disclosed insider buying and selling activities to the Securities Exchange, Lauzat Eric, officer (President, International) of Elizabeth Arden Inc, executed a transaction worth $30,000 on March 3, 2016. A total of 5,000 shares were purchased at an average price of $6. The Insider information was divulged by the Securities and Exchange Commission in a Form 4 filing. The information is based on open market trades at the market prices.Option exercises are not covered. Currently the company Insiders own 15.2% of Elizabeth Arden shares according to the proxy statements. In the past twelve weeks, the net percent change held by company insiders has changed by 6.78% . Institutional Investors own 80.62% of Elizabeth Arden shares. During last six month period, the net percent change held by insiders has seen a change of -1.54%.

Elizabeth Arden, Inc. is a global beauty products company with a portfolio of fragrance, skin care and cosmetics brands. The Companys product portfolio includes Elizabeth Arden Brand, such as the Elizabeth Arden skin care brands (Visible Difference, Ceramide, Prevage, Eight Hour Cream, Superstart and Elizabeth Arden Pro), Elizabeth Arden branded lipstick, foundation and other color cosmetics products and Elizabeth Arden fragrances (Red Door, 5th Avenue, Elizabeth Arden Green Tea and UNTOLD); designer fragrances, which include Juicy Couture, John Varvatos, and Wildfox Couture; Heritage Fragrances, such as Curve, Elizabeth Taylor, Britney Spears, Halston, Ed Hardy, Geoffrey Beene, Alfred Sung, Giorgio Beverly Hills, Lucky, PS Fine Cologne, White Shoulders, BCBGMAXAZRIA, Rocawear and Jennifer Aniston, and celebrity fragrances, which include the fragrance brands of Justin Bieber, Mariah Carey, Nicki Minaj and Taylor Swift. Its operating segments include North America and International.

Source: Everything Hudson