Today, 7:54 AM
- Tony Kingsley, Biogen's (NASDAQ:BIIB) EVP, Global Commercial Operations, decides to leave the company. The reason for his departure is not disclosed. John Cox, EVP, Pharmaceutical Operations & Technology will assume his duties until a replacement is named.
- Mr. Kingsley joined the firm in January 2010 as SVP, U.S. Commercial Operations.
Yesterday, 12:57 PM
- Final results from the Phase 3 DECIDE study just published in the New England Journal of Medicine showed the superiority of ZINBRYTA (daclizumab high-yield process [HYP]) to interferon beta-1a 30 mcg IM injection in patients with relapsing-remitting multiple sclerosis (RRMS). The post-hoc analyses showed that more patients treatment with ZINBRYTA, co-developed by Biogen (BIIB -1.9%) and AbbVie (ABBV -1%), achieved significantly better outcomes across a range of measurements at two years compared to interferon beta-1a (Biogen's Avonex). The results were presented today at the 31st Congress of the European Committee for Treatment and Research in MS in Barcelona.
- 24.6% of patients receiving ZINBRYTA showed no evidence of disease activity at two years compared to 14.2% for interferon beta-1a (p<0.0001).
- The ZINBRYTA cohort showed greater improvement in cognitive processing speed and prevention of clinically meaningful cognitive decline as measured by the Symbol Digit Modalities Test (SDMT): (+4.08[12.4] vs. +2.89[12.7]; p=0.0274). Higher proportions of ZINBRYTA patients achieved at least a three-point gain (60.0% vs. 54.1%; p=0.0153) or a four-point gain (55.4% vs. 50.1%; p=0.0366) in SDMT scores at Week 96.
- Daclizumab is a new form of humanized monoclonal antibody that selectively binds to interleukin-2 (IL-2) receptor subunit CD25, a protein that is over-expressed on T cells that become abnormally activated in MS. It modulates IL-2 signaling without causing general immune cell depletion.
- ZINBRYTA's New Drug Application (NDA) and Marketing Authorization Application (MAA) are currently under review at the FDA and EMA, respectively.
- Avonex is administered once per week via subcutaneous injection while daclizumab is administered once per month via the same route. Another Biogen offering for MS, Plegridy (peginterferon beta-1a), is administered once every two weeks.
Wed, Sep. 30, 12:49 PM
- Bruised and battered biotech investors get some welcome buying today as bargain hunters open their wallets. The iShares Nasdaq Biotech Index Fund (IBB +2%) is up nicely, albeit on average volume.
- Key tickers: (AMGN +1.6%)(BIIB +2.5%)(GILD +1%)(CELG +0.7%)(DEPO +12.4%)(HZNP +8.6%)(NVO +0.7%)(AGN +4.9%)(VRX +6.4%)(REGN +0.9%)(TEVA +2%)(SHPG +2.6%)
Sun, Sep. 27, 8:59 AM
- The $8B iShares Nasdaq Biotechnology ETF (NASDAQ:IBB) fell 4.9% on Friday and 13% for the week - its worst weekly performance since the height of the financial panic seven years ago. Many biotech ETFs eat the same cooking - Gilead (NASDAQ:GILD), Amgen (NASDAQ:AMGN), Biogen (NASDAQ:BIIB), and Regeneron (NASDAQ:REGN) among the popular names - and FBT, XBI, and BBP fell in amounts similar to IBB.
- The news flow was relatively quiet late in the week, but Hilary Clinton's promise Monday to clamp down on drug prices set things in negative motion for the momo sector.
- Barron's Chris Dieterich reminds that a flood of biotech IPOs in recent years has filled the small cap universe with these highly speculative names, and biotech now makes up 7% of the iShares Russell 2000 Index (NYSEARCA:IWM). Indeed. The IWM fell 3.7% for the week, nearly tripling the decline of the S&P 500.
- ETFs: IWM, TZA, TNA, UWM, VB, VBK, URTY, SCHA, TWM, IWO, RWM, SRTY, VTWO, RCG, JKJ, VTWG, TWOK, FYX, JKK, EWRS, ZSML, FYC, SMLL, RYRSX
Fri, Sep. 25, 3:07 PM
- A sharply lower healthcare sector (XLV -3%) has dragged the S&P 500 (SPY -0.2%) into the red and the Nasdaq (NASDAQ:QQQ) down a full 1%. The Dow (DIA +0.4%) remains higher, courtesy of a post-earnings 9% moonshot in Nike.
- Biotechs (IBB -5.7%) and Pharmaceuticals (XPH -5.9%) are hardest hit, continuing to feel the pressure from Hillary Clinton's assault on drug-pricing. Gilead (GILD -2.5%), Biogen (BIIB -3.5%), Celgene (CELG -5.4%), Amgen (AMGN -3.6%), Allergan (AGN -4%), Mylan (MYL -5.6%).
- ETFs: IBB, IYH, XLV, XBI, VHT, PJP, BBH, FBT, HQH, CURE, XPH, HQL, PBE, FXH, RXL, IHE, FHLC, SBIO, PPH, RYH, BBC, THQ, BBP, RXD, LABU, LABD, UBIO, ZBIO
Fri, Sep. 25, 9:59 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of ELOCTA, a recombinant factor VIII Fc fusion protein product, for the treatment of hemophilia A. If approved, it will be the first hemophilia A therapy with prolonged circulation available in the EU. A final decision by the European Commission usually takes ~60 days.
- ELOCTA, the brand name in Europe, is marketed as ELOCTATE [Antihemophilic Factor (Recombinant), Fc Fusion Protein] in the U.S., Canada, Australia, New Zealand and Japan. The FDA approved it in June 2014.
- Biogen (BIIB +0.8%) and Swedish Orphan Biovitrum (Sobi) (OTC:BIOVF) are collaboration partners on the development and commercialization of ELOCTA/ELOCTATE. Sobi has opt-in rights for Europe, North Africa, Russia and certain countries in the Middle East. Biogen has the rights in North America and all other non-Sobi territories.
Tue, Sep. 15, 11:35 AM
- The FDA approves privately-held Octapharma's NUWIQ, Antihemophilic Factor (Recombinant), an intravenous therapy for adults and children with hemophilia A. The approval includes on-demand treatment and control of bleeding episodes, routine prophylaxis to reduce the frequency of bleeding episodes and perioperative management of bleeding.
- NUWIQ is the first B-domain-deleted recombinant Factor VIII derived from a human cell line, not chemically modified or fused with another protein, for the treatment of hemophilia A, which affects ~16K Americans.
- NUWIQ was cleared in Europe in August 2014.
- Related tickers: (BAX +0.3%)(BXLT -0.5%)(OTCQX:RHHBY +0.6%)(SGMO +2.4%) (OTCPK:CHGCY) (OPK +2.3%)(ALNY)(BIIB +0.5%)(OTCPK:BAYRY +0.4%)
Fri, Sep. 11, 7:28 AM
- Biogen (NASDAQ:BIIB) prices its $6B aggregate principal amount of senior unsecured notes in four tranches.
- $1.50B yielding 2.900% due September 15, 2020; $1.00B yielding 3.625% due September 15, 2022; $1.75B yielding 4.050% due September 15, 2025 and $1.75B yielding 5.200% due September 15, 2045.
- Closing date is September 15. Net proceeds will fund share repurchases, working capital and general corporate purposes.
Wed, Sep. 9, 8:14 AM
- Biogen (NASDAQ:BIIB) exclusively licenses Mitsubishi Tanabe Pharma's (OTC:MTZXY) late-stage MT-1303, an investigational compound for the potential treatment of autoimmune diseases. MT-1303 targets the sphingosine 1-phosphate (S1P) receptor which plays an essential role in immune modulation and suppression of innate immune responses from T cells.
- Biogen will investigate MT-1303 in multiple sclerosis (MS), ulcerative colitis, Crohn's disease and other autoimmune disorders. The product candidate has successfully completed a Phase 2 study in MS.
- Under the terms of the license agreement, Biogen will pay Mitsubishi an upfront fee of $60M and up to $484M in various milestones. It will be responsible for global commercialization and development costs outside of Asian territories. Mitsubishi has the right to participate in Biogen's global clinical trials and has the option to co-promote MT-1303 in the U.S. for non-MS indications.
- The transaction should close in Q4.
Tue, Sep. 8, 9:53 AM
- Biogen (BIIB +1.1%) announces the enrollment of the first patient in its Phase 3 program investigating aducanumab (BIIB037) in patients with early Alzheimer's disease. The late-stage program includes two randomized, double-blind, parallel-group, placebo-controlled trials, ENGAGE and EMERGE, which will assess the safety and efficacy of aducanumab in slowing cognitive impairment and progression of disability.
- The primary endpoint for both ENGAGE and EMERGE is the change from baseline in CDR-SB score at week 78. The estimated primary completion date (final data collection date for the primary endpoint) for both is February 2020. The estimated study completion date for both is February 2022.
- Aducanumab is a human recombinant monoclonal antibody derived from a library of B cells collected from healthy elderly subjects with no signs of cognitive impairment. In a Phase 1b study, patients receiving aducanumab showed a statistically significant reduction in beta amyloid in the brain.
- The enrollment of the first patient triggers a $60M milestone payment to licensor Neurimmune.
- Previously: Biogen's aducanumab shows encouraging results in early stage Alzheimer's study (July 22)
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
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