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May 21, 2015, 10:58 AM
- Thinly traded nano cap Intellipharmaceutics (IPCI +17.3%) heads north on a 10x surge in volume in response to its announcement that the FDA may not require a Phase 3 study for its abuse-deterrent opioid candidate, Rexista Oxycodone XR, if bioequivalence to Purdue Pharma's Oxycontin is demonstrated. The company believes that its previously completed Phase 1 trials fulfill this criterion.
- The firm intends to file its New Drug Application (NDA) within the next 6 - 12 months. Approval is not guaranteed, however. After reviewing the data, the FDA may still require further studies.
- Rexista Oxycodone XR's formulation deters abuse by instantaneously coagulating and entrapping the drug in a viscous hydrogel when pulverized and hydrated. It is also designed to prevent dose dumping if taken with alcohol.
- Related tickers: (PTIE -1.9%)(DRRX)(COLL +1.9%)(ZGNX)(MNK -0.3%)(ACT +1.1%)(TEVA +1.6%)(ABBV -0.7%)(LCI -0.7%)(ALKS -1%)(EGLT -0.1%)(PFE -0.2%)(ACUR -2.4%)
May 21, 2015, 9:17 AM
- New additions to Goldman's hedge fund hotels - 50 stocks which most frequently appear among the largest ten holdings of hedge funds: AerCap (NYSE:AER), Assured Guaranty (NYSE:AGO), Baker Hughes (NYSE:BHI), Citizens Financial (NYSE:CFG), Colony Capital (NYSE:CLNY), Dresser-Rand (NYSE:DRC), Family Dollar (NYSE:FDO), Hospira (NYSE:HSP), Netflix (NASDAQ:NFLX), NXP Semi (NASDAQ:NXPI), Pharmacyclics (NASDAQ:PCYC), Visa (NYSE:V), and Walgreens (NASDAQ:WBA).
- Since 2001, the basket has outperformed the S&P 500 in 66% of quarters by an average of 73 basis points. YTD, however, it has underperformed by nine bps. Goldman notes the current basket overweights Consumer Discretionary (22%) and underweights Consumer Staples (2%).
- Looking at the full list, Actavis (NYSE:ACT) leads the way, with 77 funds naming the stock as a top 10 holding. Next up is Apple (NASDAQ:AAPL) with 69, then Facebook (NASDAQ:FB) at 42. For the entire list of 50, the average is 26 funds making a stock a top 10 holding.
- The rest in order: Valeant (NYSE:VRX), Microsoft (NASDAQ:MSFT), DirecTV (NASDAQ:DTV), Citigroup (NYSE:C), Time Warner (NYSE:TWC), Delta (NYSE:DAL), Cheneire (NYSEMKT:LNG), Yahoo (NASDAQ:YHOO), Liberty Global (NASDAQ:LBTYK), AIG, SunEdison (NYSE:SUNE), Air Products (NYSE:APD), Amazon (NASDAQ:AMZN), GM, BofA (NYSE:BAC), JPMorgan (NYSE:JPM), Macquarie Infrastructure (NYSE:MIC), American Airlines (NASDAQ:AAL), Charter Communications (NASDAQ:CHTR), Google (GOOG, GOOGL), Ally Financial (NYSE:ALLY), NorthStar Realty (NYSE:NRF), Priceline (NASDAQ:PCLN), eBay (NASDAQ:EBAY), MasterCard (NYSE:MA), Alibaba (NYSE:BABA), Micron (NASDAQ:MU), Williams (NYSE:WMB), Gilead (NASDAQ:GILD), Berkshire Hathaway (BRK.A, BRK.B), Dolar General (NYSE:DG), NorthStar Asset (NYSE:NSAM), Brookdale Senior (NYSE:BKD), DISH Network (NASDAQ:DISH).
- See also: Goldman updates list of hedge funds most-shorted stocks (May 21)
May 15, 2015, 12:05 PM
- Cytori Therapeutics (CYTX -3.6%) initiated with Buy rating and $1.25 (95% upside) price target by Ascendiant Capital.
- Intuitive Surgical (ISRG -0.2%) initiated with Neutral rating and $505 (1% upside) price target by Piper Jaffray.
- Aduro Biotech (ADRO -2.4%) initiated with Buy rating and $40 (25% upside) price target by BofA Merrill Lynch and an Outperform rating and $48 (50% upside) price target by Leerink Swann.
- Cidara Therapeutics (CDTX -0.3%) initiated with Outperform rating and $24 (50% upside) price target by Leerink Swann.
- Paratek Pharmaceuticals (PRTK +0.6%) initiated with Buy rating and $37 (32% upside) price target by Guggenheim Securities.
- KemPharm (KMPH +0.4%) initiated with Outperform rating and $18 (44% upside) price target by RBC Capital.
- XTL Biopharmaceuticals (XTLB -1.4%) initiated with Buy rating and $6 (200% upside) price target by H.C. Wainwright.
- Actavis (ACT +0.3%) initiated with Buy rating and $358 (20% upside) price target by Mizuho Securities.
May 11, 2015, 7:28 AM
- Actavis (NYSE:ACT) Q1 results ($M): Total Revenues: 4,234.2 (+59.5%); North American Brands: 1,736.0 (+192.3%); NA Generics: 1,778.2 (+6.4%); Anda Distribution: 461.6 (+18.3%); Allergan: 258.4; Net Income: -535.2 (-654.6); EPS: -1.85 (-436.4); Quick Assets: 2,130.9 (+526.4%); CF Ops: 525.0 (+19.4%).
- Key Product Sales: Namenda: 396.0; Dermatology/Est. Brands: 228.3; Bystolic: 164.1; Delzicol/Asacol HD: 136.2; Linzess/Costella: 96.2.
- 2015 Guidance: Revenues: $20.5B - 21.0B; Non-GAAP EPS: $17.00 - 18.50.
May 11, 2015, 6:34 AM
- Actavis (NYSE:ACT): Q1 EPS of $4.30 beats by $0.36.
- Revenue of $4.2B (+65.4% Y/Y) beats by $170M.
May 10, 2015, 5:30 PM
May 4, 2015, 1:09 PM
- New York, NY-based Anterios (Pending:ANTE) is set for its IPO of 3.9M shares of common stock at $12 - 14.
- The clinical stage biopharmaceutical firm develops botulinum products for therapeutic and aesthetic applications. Botulinum toxin type A (botulinum) is currently almost a $3B global market, led by Allergan's (AGN) Botox.
- The firm's lead product candidate is the Phase 2-stage ANT-1207, a topical formulation of botulinum for the treatment of primary axillary hyperhidrosis (excessive underarm sweating), facial acne and lateral canthal lines (crow's feet wrinkles). Its second candidate is AI-09, an injectable botulinum that will be packaged as a ready-to-use liquid. Currently available injectable botulinum products are lyophilized which require reconstitution prior to use.
- 2014 Financials ($M): Operating Expenses: 5.7 (+50.3%); Net Loss: (5.7) (-34.1%); Cash Burn: (4.8) (-48.8%).
Apr. 27, 2015, 7:44 AM
- In his "We Are Full of Bull" note this morning, Morgan Stanley's Adam Parker says the economy will accelerate in Q2 and Q3, bringing stocks along for the ride. If investors are gun-shy thanks to record levels for the averages, Parker suggests looking for names with decent long-term earnings forecasts trading at a discount to the market.
- The ten largest U.S. stocks trading at a discount, but with above-average expected growth rates: Apple (NASDAQ:AAPL), Citigroup (NYSE:C), Gilead (NASDAQ:GILD), Union Pacific (NYSE:UNP), Actavis (NYSE:ACT), Twenty-First Century Fox (NASDAQ:FOXA), Time Warner (NYSE:TWX), Ford (NYSE:F), BlackRock (NYSE:BLK).
- Conversely, one might want to avoid those stocks selling for substantial premiums. The ten largest stocks trading at a premium to the market while growing at a below-average rate: Exxon (NYSE:XOM), Procter & Gamble (NYSE:PG), Chevron (NYSE:CVX), Coca-Cola (NYSE:KO), Pepsico (NYSE:PEP), Schlumberger (NYSE:SLB), MMM, McDonald's (NYSE:MCD), UPS, Nike (NYSE:NKE).
- Source: Bloomberg
Apr. 24, 2015, 3:52 PM
- Burlington, MA-based CoLucid Pharmaceuticals (Pending:CLCD) is set for its IPO of 5.36M shares of common stock at $13 - 15.
- The clinical stage biopharmaceutical firm is developing a small molecule for the acute treatment of migraine headaches. Lasmiditan, currently in Phase 3 development in an oral tablet form, is a 5-HT1F receptor agonist that blocks the pain transmission without the side effects of the class of migraine therapies called triptans. The 5-HT1F receptor is a serotonin subtype that lacks the vasoconstrictive properties of other serotonin receptors, which can cause adverse cardiac events in patients with cardiovascular or cerebrovascular disease. Top-line data from a Phase 3 study, called SAMURAI, is expected in Q3 2016. A second Phase 3 evaluating an IV formulation of lasmiditan should commence in H1 2016.
- The company licensed lasmiditan from Eli Lilly.
- 2014 financials ($M): Operating expenses: 2.3 (+43.8%); Net Loss: (3.0) (-34.6%); CF Ops: (0.8) (+49.3%).
- Migraine-related tickers: (OFIX +0.4%)(TEVA +1.8%)(AVNR)(RDHL +0.5%)(PTX -3%)(ALDR -0.8%)(ENDP -0.8%)(JNJ +0.6%)(AMGN -0.7%)(DEPO +1.2%)(AGN)
Apr. 13, 2015, 8:46 AM
- Depomed (NASDAQ:DEPO) and Actavis (NYSE:ACT) settle their patent infringement suit regarding the latter's Abbreviated New Drug Application (ANDA) for a generic version of Gralise (gabapentin). The settlement allows Actavis to begin selling a generic version on January 1, 2024 or earlier under certain circumstances.
- A year ago, Depomed announced settlements with two other Gralise ANDA filers that permitted them to market generic versions beginning in 2024.. The suit again Actavis was unresolved because it appealed a district decision in favor of Depomed. The appeal was dismissed after the settlement.
- Previously: Depomed prevails over Actavis in Gralise patent infringement case (Aug. 19, 2014)
Apr. 7, 2015, 3:58 PM
- Shire plc (SHPG +4.4%) is confident that it will prevail in a patent challenge from hedge fund Hayman Capital Management regarding its ulcerative colitis drug Lialda (mesalamine). The company won a previous challenge to its patent, which expires in 2020, in 2013 by Actavis (ACT -0.8%) unit Watson. No competitor has been able to get a generic mesalamine on the U.S. market, a fact that strengthens Shire's position.
- Generic firms aren't giving up, though. A trial versus Mylan is set to begin September 1.
- Lialda/Mezavant (brand name in Europe) generated almost $634M in sales for Shire in 2014.
Apr. 1, 2015, 3:30 PM
- Actavis (ACT -1%) should outperform following its purchase of Allergan, and FDA action dates for eluxadoline and cariprazine could also be catalysts.
- Though Occidental Petroleum is the team's top pick in energy, Anadarko (APC +1.1%) is the best short-term play on a recovery in oil prices.
- Strong fundamentals and easy year-over-year comps make AvalonBay (AVB -0.9%) a pick in apartment rentals.
- A favorable Supreme Court ruling in King vs. Burwell by the end of June provides plenty of upside possibility with little downside for HCA Holdings (HCA -0.8%).
- Also on the buy list are Ingersoll-Rand (IR -1.5%), Nvidia (NVDA +0.2%), UTX (UTX -1.1%), and Disney (DIS +0.4%).
- Making the underperform list is the Gap (GPS -2.2%) thanks to less room for cost cutting and a forecast for continued weakness in sales. Also a Q2 sell: Tesla (TSLA -1%) " lacks any real technological advantage over its competitors" says the team, seeing a significant Q1 loss, an increase in the already-high cash burn, and a questionable delivery outlook.
- Source: Benzinga
Mar. 31, 2015, 1:23 PM
- Allergan's former Chairman & CEO David Pyott converted equity awards totaling $534M after the company was acquired by Actavis (ACT -0.9%). He traded 3M stock options for $497M in cash and swapped more than 285K shares and restricted shares for $36.9M.
- No word, though, on Mr. Pyott's post-Allergan plans other than he won't be joining Actavis' board.
Mar. 31, 2015, 9:08 AM
Mar. 17, 2015, 10:10 AM
Mar. 11, 2015, 10:01 AM
- Based on feedback from the FDA, Egalet (EGLT) now plans to submit a New Drug Application (NDA) for its abuse-deterrent, extended-release oral morphine product, Egalet-001, by the end of the year.
- The company will initiate a pivotal bioequivalence study comparing the 60 mg dose to Purdue's MS Contin later this month. Bioequivalence to MS Contin has already been demonstrated at the 15 mg and 30 mg doses.
- Egalet-001 incorporates the company's Guardian Technology to deter abuse. It utilizes injection molding to create a hard matrix and shell that is designed to be difficult to crush, grind, chew or dissolve. It also turns to gel when exposed to water.
- Related tickers: (ZGNX -23.4%)(ACUR)(ALKS +0.5%)(PFE +0.6%)(ABBV +0.7%)(LCI +1.6%)(ACT +1.7%)(MNK +1.6%)(TEVA +2.6%)
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