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
Thu, Jul. 2, 7:32 AM
- Biogen (NASDAQ:BIIB) and (NASDAQ:AGTC) enter into a collaboration and license agreement to develop gene-based therapies for multiple ophthalmic diseases. The partnership will focus on the development of a portfolio of AGTC's therapeutic programs, including a clinical stage candidate and pre-clinical stage candidate, for orphan diseases of the retina that can lead to blindness in children and adults. The deal also includes options for early stage discovery programs in two ophthalmic diseases and one non-ophthalmic disorder. Biogen will make an equity investment in AGTC and will have a license for manufacturing rights.
- Under the terms of the agreement, Biogen will make an upfront payment of $124M to AGTC, including a $30M equity investment at $20.63 per share and certain prepaid R&D expenses. Biogen will have a license to AGTC's XLRS and XLRP programs and the option to license discovery programs for three additional indications at the time of clinical candidate selection.
- AGTC is eligible to receive more than $1B in upfront and milestone payments, including up to ~$473M for the two lead programs, and high single-digit to mid-teen royalties on net sales. Biogen will makes payments up to ~$593M across the discovery programs including royalties on net sales in the same range.
- AGTC CEO Sue Washer says, "We expect this collaboration to further validate our novel adeno-associated virus (AAV) gene therapy platform and support the development of new therapies that may allow for transformative treatments of these rare inherited eye diseases and other clinical indications."
- AGTC will host a conference call this morning at 8:00 am ET to discuss the deal.
- AGTC is up 21% premarket on increased volume.
Fri, Jun. 26, 7:41 AM
- The European Medicines Agency (EMA) accepts for review the Marketing Authorization Application (MAA) from Biogen (NASDAQ:BIIB) and Swedish Orphan Biovitrum AB (OTC:BIOVF) for Alprolix (rFIXFc), a recombinant factor IX Fc fusion protein for the potential treatment of hemophilia B. The validation initiates the EMA's formal review process. A CHMP opinion could happen in Q1 2016 followed by a final decision from the European Commission ~60 days later.
- Alprolix is currently cleared for the treatment of hemophilia B in the U.S., Canada, Japan and Australia.
- Biogen and Swedish Orphan (Sobi) are collaborating on the development and commercialization of the product. Biogen has manufacturing and commercialization rights in North America and other regions of the world not covered by Sobi while Sobi retains the rights in Europe, North Africa, Russia and certain markets in the Middle East.
Wed, Jun. 10, 9:30 AM
- Biogen (NASDAQ:BIIB) and Samsung Bioepis announce results from separate Phase 3 trials comparing their biosimilar candidates to their respective reference products. The data were presented at the European League Against Rheumatism Annual Congress in Rome, Italy.
- 24-week data from one Phase 3 study comparing SB4 to the etanercept reference product Enbrel (NASDAQ:AMGN) in patients with moderate-to-severe rheumatoid arthritis (RA) showed equivalent efficacy. 596 patients were randomized to receive either SB4 (n=299) or Enbrel (n=297). The ACR20 (American College of Rheumatology: 20% improvement in RA symptoms) response rate at week 24 in the full analysis set was 73.8% in the SB4 arm versus 71.7% in the Enbrel arm. Full 52-week data will be available at a later date.
- 30-week data from a second Phase 3 comparing SB2 to the infliximab reference product, Remicade (NYSE:JNJ), in patients with moderate-to-severe RA also showed equivalent efficacy. 584 patients were randomized to receive either SB2 (n=291) or Remicade (n=293). The ACR20 response rate at Week 30 in the full analysis set for the SB2 arm was 55.5% compared to 59.0% in the Remicade arm.
- Data from a Phase 1 study assessing the pharmacokinetic equivalency of another biosimilar candidate, SB5, to its reference product, adalimumab [AbbVie's (NYSE:ABBV) Humira], will be presented as well.
- Samsung Bioepis is a joint venture between Biogen and Samsung Biologics.
Thu, May 7, 5:39 PM
Wed, Apr. 29, 9:22 AM
- The FDA accepts for review the Biologics License Application (BLA) for Zinbryta (daclizumab high-yield process) for the treatment of patients with relapsing forms of multiple sclerosis (MS). The drug was co-developed by Biogen (NASDAQ:BIIB) and AbbVie (NYSE:ABBV).
- 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 is the next-generation MS offering that builds on the success of Biogen's $2.9B blockbuster Avonex (interferon beta-1a).
- The European Medicines Agency validated (accepted for review) Zinbryta's Marketing Authorization Application (MAA) last month.
- Previously: Zinbryta trumps Avonex in MS trial (Sept. 12, 2014)
Fri, Apr. 24, 12:57 PM
- Privately-held French biotech medDay Pharmaceuticals reports results from a Phase 3 clinical trial (MS-SPI) evaluating MD1003, a pharmaceutical-grade biotin, for the treatment of primary and secondary progressive multiple sclerosis. The study met its primary endpoint in the intent-to-treat population with 12.6% of patients treated with MD1003 showing an improvement in EDSS (Expanded Disability Status Scale) or TW25 (a timed 25-foot walk) at Month 9 compared to 0% for placebo (p=0.0051).
- Secondary analyses showed evidence of a decrease in the risk of disease progression. Mean EDSS scores in the treatment group between the start of treatment and Month 12 decreased (-0.03) compared to progression (+0.13) in the placebo cohort (p=0.015). Four percent of patients in the MD1003 group showed EDSS progression at Month 9 confirmed at Month 12 compared to 13% for placebo (p=0.07).
- Biotin is a B-vitamin known as vitamin H or coenzyme R. It plays a key role in cell growth, the production of fatty acids and the metabolism of fats and amino acids.
- The data were presented at the American Academy of Neurology Annual Meeting in Washington, DC. Full results will be submitted for publication in a peer-reviewed journal.
- MS-related tickers: (BIIB -5.9%)(SNY +0.3%)(NVS -0.9%)(TEVA +1.4%)(FWP -0.3%)(OPXA)(RCPT +0.1%)(CHRS -3.3%)(ABBV +1.7%)
Fri, Apr. 24, 7:47 AM
- Biogen (NASDAQ:BIIB) Q1 results ($M): Total Revenues: 2,554.9 (+20.0%); Net Product Sales: 2,172.3 (+24.6%); Joint Business: 330.6 (+11.4%).
- Key Product Sales: Tecfidera: 824.9 (+17.8%); Avonex: 692.7 (-9.0%); Tysabri: 462.6 (+4.9%); Plegridy: 61.8; Eloctate: 53.6; Alprolix: 43.1.
- Net Income: 820.2 (+70.9%); EPS: 3.49 (+72.8%); Operating Earnings: 1,221.6 (+50.8%); Net Earnings Yield: 32.1% (+42.4%).
- Updated guidance not provided in press release.
- Shares down 2% premarket on modest volume.
Fri, Apr. 24, 7:04 AM
Thu, Apr. 23, 5:30 PM
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