Fri, Mar. 20, 10:37 AM
- Biogen Idec (BIIB +6.3%) jumps of double normal volume in response to its announcement of positive interim results of a Phase 1b study evaluating BIIB037 (aducanumab) for the treatment of patients with early-stage Alzheimer's disease (AD). Treatment with aducanumab produced a dose- and time-dependent reduction of amyloid plaque in the brain, the buildup of which is believed to play a key role in the development of AD symptoms.
- The interim analysis involved 166 patients up to Week 54 in four dosage cohorts: placebo, 1 mg/kg, 3 mg/kg and 10 mg/kg. A fifth arm, 6 mg/kg, involved 30-week data. The placebo arm was virtually unchanged at 26 and 54 weeks but there were statistically significant reductions in amyloid plaques in all dosage arms except 1 mg/kg at 26 weeks. At Week 54, greater reductions were observed in the 3 and 10 mg/kg arms (data from the 6 mg/kg arm was not available yet).
- Biogen group SVP and Chief Medical Officer Alfred Sandrock, M.D., Ph.D., says, "This is the first time an investigational drug for [AD] has demonstrated a statistically significant reduction on amyloid plaque as well as a statistically significant slowing of clinical impairment in patients with prodromal or mild disease. Based on these results, we are advancing the aducanumab clinical program to Phase 3 with plans to initiate enrollment later this year."
- An estimated 25M people live with AD worldwide. Drug candidates that target amyloid plaque have not been successful in clinical studies to date.
Fri, Mar. 20, 9:23 AM
Fri, Jan. 30, 9:12 AM| 4 Comments
Thu, Jan. 29, 4:32 PM
Dec. 2, 2014, 11:32 AM
- Biogen (BIIB +5.3%) jumps on double normal volume in response to its disclosure of interim data at an investors conference from an early-stage study of BIIB037 that demonstrated encouraging results. BIIB037 is designed to clear amyloid plaques from the brain. The study results indicated that it reduced amyloid levels in the brain in both a dose- and time-dependent way. It also demonstrated a positive effect on cognition after 54 weeks.
- The company says it will move aggressively into later-stage trials.
- Alzheimer's disease has been a tough nut to crack for drug makers. Pfizer, J&J and Eli Lilly have all experienced clinical trial failures, for example. Biogen did not issue a press release on its results because it was primarily a safety study.
Dec. 2, 2014, 9:12 AM
Nov. 14, 2014, 12:00 PM| 41 Comments
Oct. 22, 2014, 9:44 AM
- Biogen Idec (BIIB -10.6%) is under selling pressure after this morning's earnings call. Some observers perceive that Tecfidera sales came in a bit light despite its 98% yoy growth. The company also disclosed the death of one patient who had taken the drug for four years. The death was apparently due to pneumonia and not due to the drug.
Oct. 22, 2014, 9:19 AM| 1 Comment
Oct. 22, 2014, 7:06 AM
Jul. 23, 2014, 9:11 AM
Feb. 21, 2014, 10:55 AM| Comment!
Jan. 30, 2014, 2:44 PM
- Amid a strong showing for top-tier biotech stocks, Celgene (CELG -2.2%) is in the red after missing Q4 earnings, offering underwhelming guidance and from critical editorial correspondences published in the New England Journal of Medicine.
- Two correspondences raised concerns about Abraxane benefits, toxic effects, incremental cost and the effect of pancreatic tumor location on the drug’s efficacy; however, Citigroup would buy CELG on today's weakness, seeing the drug as a strong seller and the NEJM story as a non-event.
- Alexion Pharma (ALXN +22%), on the other hand, reported a strong Q4 with solid guidance; Brean Capital praises ALXN as "highly committed to developing a portfolio of drugs for diseases that are both rare and severe."
- Also: VRTX +5.5%, BIIB +4.8%.
Jan. 28, 2014, 9:12 AM
- Deutsche's Robyn Karnauskas makes a big call on big-cap biotechs, boosting price targets for Biogen (BIIB) to $415 from $340, Celgene (CELG) to $190 from $170, and Gilead (GILD) to $132 from $95. The $132 PT for Gilead is a new Street high "by a nautical mile," says Notable Calls, and Karnauskas sees upside all the way to $165.
- "We view large-cap biotech as fundamentally stable yet providing attractive growth," she writes, citing more diversified businesses, pipelines, new product launches, strong balance sheets, and strong free cash flow. "Therefore, we are changing our valuation methodology to 2015 PE multiples from DCF for Gilead, Celgene, and Biogen. Our '15 EPS estimates are higher than consensus and we think near-term franchise success could drive re-rating."
- GILD +2.7%, CELG +1.3% premarket
- Related ETFs: IBB, XBI, BIB, BBH, FBT, PBE, BIS
Jan. 9, 2014, 8:30 AM
- Shares in Sangamo BioSciences (SGMO) jump 15.4% after it announces a partnership with Biogen Idec (BIIB) for the development of new therapies for two inherited blood disorders, sickle cell disease and beta-thalassemia.
- Sangamo will receive $20M up front, as much as $300M in milestone payments and royalties.
- The companies will use Sangamo's zinc finger nuclease genome-editing technology to address "the abnormal structure or underproduction of hemoglobin" by eliminating a key regulator of gene expression or inserting a corrective gene that will replace a defective one causing disease. (PR)
- Sangamo is holding a conference call to discuss the deal.
Jan. 8, 2014, 10:46 AM
- Nomura's Ian Somaiya (formerly at Piper) is out with a number of healthcare initiations.
- Gilead (GILD +1.7%) is the firm's top biotech pick for 2014 as the company is "set to dominate the HCV market." GILD started at Buy. Price target is $118.
- Neurocrine Biosciences (NBIX -3.2%) started at Buy. Somaiya sees peak sales of $700M for NBI-98854. Price target is $23.
- Celgene (CELG +1.2%) started at Buy. "Revlimid for multiple myeloma, is less than a third of the way to realizing its peak sales potential," Somaiya says. Price target is $236.
- Biogen (BIIB +4.1%) initiated at Buy. Tecfidera, is "a blockbuster ... treatment for MS, with estimated peak sales of $9B," Somaiya notes. Price target is $368.
- Alexion (ALXN +1.5%) initiated at Buy. Price target $150.
- Pharmacyclics (PCYC +1.9%) will "transform the treatment paradigm and disease course of CLL and mantle cell lymphoma MCL." Shares started at Buy. Price target is $137.
- Other initiations: Incyte (INCY +5.9%) started at Buy. Synageva BioPharma (GEVA +3.7%) started at Buy. BioMarin (BMRN +1.2%), Amgen (AMGN), and Infinity Pharmaceuticals (INFI +2.8%) started at Neutral.
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