Mon, Aug. 17, 4:33 PM
- Major stock indexes rebounded from opening declines to finish modestly higher, after a solid housing report showed some strength on a lightly traded Monday.
- Homebuilding stocks paced gainers, including Toll Brothers (TOL +2.3%); Ryland (RYL +2.1%); KB Home (KBH +3.1%), Lennar (LEN +2.7%) and Taylor Morrison Home (TMHC +2.9%).
- The S&P 500 gained 0.5% to 2,102.44; for 2015, it's up 2.12%. The move up came despite a grim reading from New York manufacturing that sent bond yields lower. TLT +0.5%; TBT -0.8%.
- Volumes overall were about 20% below recent average.
- Sector gains were broadly distributed, with a flat energy sector as the laggard. Healthcare stocks performed well, paced by dollar volume leaders Gilead Sciences (GILD +0.7%), Johnson & Johnson (JNJ +1.1%) and Biogen (NASDAQ:BIIB) +1.1%.
Fri, Aug. 14, 8:50 AM
- Akebia Therapeutics (NASDAQ:AKBA) initiated with Equal Weight rating and $10 (33% upside) price target by Morgan Stanley.
- Rockwell Medical (NASDAQ:RMTI) initiated with Underweight rating and $7 (39% downside risk) price target by Morgan Stanley.
- Incyte (NASDAQ:INCY) initiated with Overweight rating and $125 (16% upside) price target by Barclays.
- TG Therapeutics (NASDAQ:TGTX) coverage resumed by HC Wainwright with a Buy rating and $22 (39% upside) price target.
- Biogen (NASDAQ:BIIB) initiated with Buy rating and $380 (21% upside) price target by HC Wainwright.
- ProNAi Therapeutics (NASDAQ:DNAI) initiated with Outperform rating and $36 (44% upside) price target by Wedbush.
- Chiasma (NASDAQ:CHMA) initiated with Overweight rating and $40 (62% upside) price target by Barclays.
- Natera (NASDAQ:NTRA) upgraded to Overweight from Equal Weight by Morgan Stanley. Price target maintained at $20 (29% upside).
- Merck (NYSE:MRK) upgraded to Outperform from Market Perform by BMO Capital Markets. Price target raised to $70 (19% upside) from $65.
- Keryx Biopharmaceuticals (NASDAQ:KERX) downgraded to Neutral from Buy by Roth Capital. Price target lowered to $6 (1% downside risk) from $11.
Mon, Aug. 3, 1:43 PM
- In a recent review of the Kronos Early Estrogen Prevention Study (KEEPS) trial, Dr. JoAnn Manson, investigator and co-author, discusses the therapeutic potential of estrogen for improving cognition and mood.
- The KEEPS study, published in PLOS Medicine last month, randomly assigned 693 women to one of the following three treatment groups: daily oral conjugated estrogen 0.45 mg with daily cyclical oral micronized progesterone 200 mg, estradiol patch (transdermal) 50 µg with cyclical micronized progesterone for 12 days a month, and placebo. Investigators assessed treatment groups for cognition and mood.
- After 4 years of treatment and follow-up, the study showed that the oral and transdermal estrogen did not provide statistically significant cognition benefits. In respect to mood, oral conjugated estrogen showed a favorable, but non-statistically significant effect on anxiety and depressive symptoms, whereas the transdermal estradiol had neutral effects.
- The results suggest that oral conjugated transdermal estrogen could possess a therapeutic benefit for women with mood symptoms. However, more research is required to assess the therapeutic benefit of estrogen for cognition. Dr. Manson stresses that cognitive outcomes are generally more correlative for younger, newly menopausal than for older women.
- This comes as micro cap Synthetic Biologics (SYN +1.9%) is expected to produce a top-line MRI readout for the Phase 2 study of Trimesta (oral estriol) in female multiple sclerosis patients suffering from cognitive dysfunction. A positive top-line readout would pave the way for continued advancement of the company's cognition program. The investigational drug is also being developed in a separate post-Phase 2 program in combination with Teva's (TEVA +1.1%) blockbuster MS drug Copaxone for the treatment of relapses in MS.
- There has never been an FDA-approved oral estriol drug for any indication. However, oral estriol has been used to treat post-menopausal symptoms for over 40 years throughout Europe and Asia. The market opportunity for Trimesta is likely significant, with more than 400,000 patients in the U.S. and 2.3 million worldwide. The majority of such patients are young adults aged 20-50. 70% of MS patients are women, and 50% of MS patients are affected by cognitive dysfunction. Annual worldwide sales of existing MS therapies exceed $14 billion, and none of them effectively address cognitive dysfunction.
- MS-related tickers: (BIIB +0.6%)
Tue, Jul. 28, 1:41 PM
- Teladoc (TDOC -2.2%) initiated with Overweight rating and $38 price target by JP Morgan; a Buy rating and $38 (23% upside) price target by Deutsche Bank; a Buy rating and $37 price target by SunTrust Bank and an Outperform rating by William Blair.
- Natera (NTRA +0.1%) initiated with Equal Weight rating and $20 (11% upside) price target by Morgan Stanley.
- Aegerion Pharmaceuticals (AEGR +9.4%) upgraded to Buy from Hold by Jefferies. Price target maintained at $26 (30% upside).
- Centene (CNC) upgraded to Buy from Neutral by UBS. Price target maintained at $80 (16% upside).
- Biogen (BIIB +2.4%) upgraded to Outperform from Market Perform by Bernstein. Price target lowered to $385 (21% upside) from $436.
- Anthem (ANTM +1.3%) upgraded to Buy from Neutral with $185 (21% upside) price target by Sterne Agee CRT. Cigna (CI -0.2%) also upgraded to Buy with a $190 (30% upside) price target.
- Alexion Pharmaceuticals (ALXN +2.6%) upgraded to Overweight from Not Rated by JP Morgan. Price target is $249 (23% upside).
- IGI Labs (IG +0.5%) upgraded to Buy from Neutral by Roth Capital. Price target raised to $11 from $7 (18% downside risk).
- Omnicare (OCR +0.3%) downgraded to Neutral from Overweight by JP Morgan. Price target lowered to $90 (6% downside risk) from $98.
- Ultragenyx (RARE +3.4%) downgraded to Equal Weight from Overweight by Morgan Stanley. Price target raised to $126 (5% upside) from $77.
- Biogen (BIIB +2.1%) downgraded to Neutral by Baird. Price target lowered to $316 (0% upside) from $480.
- Sunesis Pharmaceuticals (SNSS +21%) downgraded to Sell from Buy by Roth Capital Partners. Price target lowered to $1 (22% downside risk) from $5.50.
Tue, Jul. 28, 2:38 AM
- So what's Allergan (NYSE:AGN) doing with all that cash from the Teva deal? CEO Brent Saunders plans to use the money to increase the size of the firm's existing drug business, expand into new therapy areas and pursue larger deals.
- When asked if Allergan planned to spend the cash within 18 months, Saunders replied that he would, as long as the company could maintain its investment-grade credit rating.
- Possible targets: Biogen (NASDAQ:BIIB), AbbVie (NYSE:ABBV) and Amgen (NASDAQ:AMGN).
- Previously: Teva to buy Allergan Generics for $40.5B (Jul. 27 2015)
Fri, Jul. 24, 12:45 PM
Fri, Jul. 24, 9:17 AM
Fri, Jul. 24, 7:20 AM
- Biogen (NASDAQ:BIIB) Q2 results ($M): Total Revenues: 2,591.7 (+7.0%); Net Product Sales: 2,198.6 (+6.9%); Joint Business: 337.5 (+11.3%).
- Net Income: 927.3 (+28.2%); EPS: 3.93 (+30.6%).
- Key Product Sales: Tecfidera: 883.3 (+12.2%); Avonex: 615.2 (-20.5%); Tysabri: 463.1 (-13.2%); Plegridy: 74.5; Eloctate: 74.3; Alprolix: 54.5.
- Revenue growth has decelerated the past five quarters: 50.5%; 40.5%; 37.4%; 34.3%; 20.0%; 7.0%.
- 2015 Guidance: Revenues Growth: 6 - 8% from 14 - 16% due to lower expected Tecfidera growth; EPS: $14.25 - 14.70 from $15.45 - 15.85; Non-GAAP EPS: $15.50 - 15.95 from $16.60 - 17.00.
- Shares are down 6% premarket on average volume.
Fri, Jul. 24, 6:51 AM
Thu, Jul. 23, 5:30 PM
Thu, Jul. 23, 1:24 PM
Wed, Jul. 22, 4:37 PM
- Lipocine (NASDAQ:LPCN) initiated with Buy rating and $36 (163% upside) price target by Roth Capital Partners.
- Pieris Pharmaceuticals (NASDAQ:PIRS) initiated with Buy rating and $7 (149% upside) price target by Roth Capital Partners.
- Lannett (NYSE:LCI) initiated with Buy rating and $75 (27% upside) price target by Susquehanna Financial Group.
- Akorn (NASDAQ:AKRX) initiated with Neutral rating and $48 (5% upside) price target by Susquehanna Financial Group.
- Intuitive Surgical (NASDAQ:ISRG) upgraded to Buy from Hold by Canaccord Genuity. Price target raised to $615 (12% upside) from $517.
- Anacor Pharmaceuticals (NASDAQ:ANAC) upgraded to Buy from Neutral by Goldman Sachs. Price target raised to $195 (30% upside) from $60.
- Biogen (NASDAQ:BIIB) downgraded to Neutral from Buy by Piper Jaffray. Price target lowered to $410 (5% upside) from $485.
Wed, Jul. 22, 10:14 AM
- A prespecified interim analysis of results from a Phase 1b clinical trial, PRIME, assessing Biogen's (BIIB -2.8%) aducanumab (BIIB037) in patients with prodromal or mild Alzheimer's disease (AD) showed a statistically significant reduction in beta amyloid in the brain. The data are being presented today at the Alzheimer's Association International Conference 2015 in Washington, DC.
- PRIME is a randomized, double-blind, placebo-controlled study assessing four dosage levels of aducanumab: 1, 3, 6 and 10 mg/kg.
- PET imaging using the radiotracer florbetapir was used to measure plaque levels in the brain. At week 54, the standardized uptake value ratio in the placebo arm was unchanged but was reduced in the 3 mg/kg, 6 mg/kg and 10 mg/kg cohorts by -0.135 (p<0.001), -0.210 (p<0.001) and -0.268 (p<0.001), respectively. The reduction in the 1 mg/kg arm (-0.055) fell short of statistical significance.
- Patients receiving 6 mg/kg of aducanumab for up to 54 weeks showed an improvement in the slowing of clinical decline, as measured by MMSE and CDR-SB scales, although not statistically significant. The positive effects on slowing clinical decline were dose-dependent.
- Measured by MMSE, patients receiving placebo declined by an average of 2.81 points at week 52. Average clinical declines in the 1, 3, 6 and 10 mg/kg arms were 2.18, 0.70, 1.96 and 0.56, respectively. The declines in the 3 and 10 mg/kg cohorts were statistically significant, but were not in the 1 and 6 mg/kg groups. The linear trend for dose response was statistically significant (p<0.05) although, ideally, the 6 mg/kg arm would have performed in line with the 3 and 10 mg/kg arms.
- Measured by CDR-SB, the placebo arm worsened by an average of 1.87 points at week 54. The average declines for the 1, 3, 6 and 10 mg/kg arms were 1.72, 1.37, 1.11 and 0.63, respectively, demonstrating a clear dose-dependent effect (p<0.05). The 10 mg/kg cohort was the only arm to achieve statistical significance, however.
- Aducanumab is a human recombinant monoclonal antibody derived from a library of B cells collected from elderly subjects with no signs of cognitive impairment and cognitively impaired elderly subjects with unusually slow cognitive decline. The work was done with Neurimmune's technology platform called Reverse Translational Medicine. Biogen licensed aducanumab in 2007.
Wed, Jul. 15, 7:36 AM
Tue, Jul. 14, 1:34 PM
- Believing upcoming data (due on July 22) on the 54-week efficacy of Biogen's (NASDAQ:BIIB) aducanumab Alzheimer's drug "will show a strong trend or reach statistical significance," BofA/Merrill's Ying Huang has upgraded to Buy. His target remains $466.
- Ahead of Biogen's July 24 Q2 report, Huang also predicts (citing IMS script data) U.S. sales of Biogen's Tecfidera multiple sclerosis drug will beat a $727M consensus. He sees ""results from a Phase 2 study for Tysabri in acute ischemic stroke (mid 2015), Phase 2 for neublastin in neuropathic pain (mid 2015), and Phase 3 for Tysabri in SPMS (2H2015)" as additional potential catalysts.
Fri, Jul. 10, 11:50 AM
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