On Aug. 25, shares of Alzheimer’s biotech Cassava Sciences (NASDAQ:SAVA) fell by more than 30% before recouping some of their losses. Investors had come across a citizen petition to the U.S. Food and Drug Administration (FDA) by New York-based securities litigation firm Labaton Sucharow calling for a clinical trial halt of the company’s phase 3 study for its lead Alzheimer’s drug, simufilam. Labaton Sucharow filed the petition on Aug. 18, and the FDA acknowledged the reports in the petition on Aug. 23.
There’s clearly a lot on the line for patients and investors alike. So what went wrong with Cassava to attract such rigorous skepticism on simufilam?
Image source: Getty Images.
Top 5 Biotech Stocks To Watch Right Now: Biogen Idec Inc(BIIB)
Biogen Idec Inc. discovers, develops, manufactures, and markets therapies for the treatment of neurodegenerative diseases, hemophilia, and autoimmune disorders in the United States and internationally. Its marketed products include the AVONEX for the treatment of relapsing multiple sclerosis (MS); RITUXAN for treating relapsed or refractory, CD20-positive, and B-cell Non-Hodgkin?s lymphoma (NHL); TYSABRI to treat relapsing MS; FUMADERM for the treatment of severe plaque psoriasis in adult patients; and FAMPYRA, an oral compound for the improvement of walking in adult patients with MS with walking disability. Biogen Idec Inc.?s products under Phase III consist of PEGylated interferon beta-1a designed to prolong the effects and reduce the dosing frequency of interferon beta-1a; BG-12 for the treatment of MS; Daclizumab, a monoclonal antibody in relapsing MS; Long-lasting factor IX and VIII fusion protein for the treatment of hemophilia B; GA101, a monoclonal antibody for t he treatment of chronic lymphocytic leukemia and NHL; and Dexpramipexole, an orally administered small molecule for the treatment of amyotrophic lateral sclerosis. The company?s Phase I clinical trial products include Anti-LINGO for use in multiple sclerosis, Neublastin for use in neuropathic pain, CD40L for use in systemic lupus erythematosus, ANTI-TWAEK humanized monoclonal antibody for TWEAK, and BIIB037 for use in Alzheimer’s disease; and Phase II clinical trial product comprises OCRELIZUMAB, a humanized monoclonal antibody for treating CD20. It has collaboration agreements with Genentech, Inc.; Elan Pharma International, Ltd; Acorda Therapeutics, Inc.; Portola Pharmaceuticals, Inc.; Swedish Orphan Biovitrum AB; Abbott Biotherapeutics Corp; and Vernalis plc. The company was formerly known as IDEC Pharmaceuticals Corporation and changed its name to Biogen Idec Inc. in November 2003. Biogen Idec Inc. was founded in 1985 and is headquartered in Weston, Massachusetts.
- [By ]
Just last Thursday, March 21, Biogen (Nasdaq: BIIB) and its partner, Japanese biopharmaceutical company Eisai (OTC: ESALY), said that their experimental Alzheimer’s therapy, which at that time was at the second stage of clinical trials, was a bust. BIIB dropped 29.2% on the day, and ESALY by 35% on the same day.
- [By Chris Hill]
In this episode of Motley Fool Money, host Chris Hill and analysts Emily Flippen, Jim Mueller, and Jason Moser hit on some of the biggest recent news in the market. Disney (NYSE:DIS) finishes up its merger with Fox, and it’s ready to take on a crowded streaming space. CVS Health (NYSE:CVS) diversifies into CBD lotion. Levi Strauss (NYSE:LEVI) enters the public markets with a bafflingly high market cap, while Nike (NYSE:NKE) sells off on higher-than-expected revenue and profits. Biogen’s (NASDAQ:BIIB) biggest trial bombs, and the stock tanks along with it. Papa John’s (NASDAQ:PZZA) welcomes Shaq into its board of directors. And, as always, the analysts share some stocks on their radar. Plus, stay tuned for an interview with Lake House Capital’s Joe Magyer about investing in Australia — the biggest trends, biggest worries, and some Aussie picks to add to your watch list.
Top 5 Biotech Stocks To Watch Right Now: Amgen Inc.(AMGN)
Amgen Inc., a biotechnology medicines company, discovers, develops, manufactures, and markets human therapeutics based on advances in cellular and molecular biology for grievous illnesses primarily in the United States, Europe, and Canada. The company markets recombinant protein therapeutics in supportive cancer care, nephrology, and inflammation. Its principal products include Aranesp and EPOGEN erythropoietic-stimulating agents that stimulate the production of red blood cells; Neulasta and NEUPOGEN to stimulate the production of neutrophils, which is a type of white blood cell that helps the body to fight infections; and Enbrel, an inhibitor of tumor necrosis factor that plays a role in the body?s response to inflammatory diseases. The company also markets other products comprising Sensipar/Mimpara, a small molecule calcimimetic that lowers serum calcium levels; Vectibix, a monoclonal antibody that binds specifically to the epidermal growth factor receptor; and Nplate, a thrombopoietin (TPO) receptor agonist that mimics endogenous TPO, the primary driver of platelet production. In addition, it provides Denosumab, a human monoclonal antibody that targets RANKL, an essential regulator of osteoclasts. Further, the company offers product candidates in mid-to-late stage development in a variety of therapeutic areas, including oncology, hematology, inflammation, bone, nephrology, cardiovascular, and general medicine consisting of neurology. It markets its products to healthcare providers, including physicians or their clinics, dialysis centers, hospitals, and pharmacies; consumers; and wholesale distributors of pharmaceutical products. The company has various collaborative arrangements with Pfizer Inc.; GlaxoSmithKline plc; Takeda Pharmaceutical Company Limited; Daiichi Sankyo Company, Limited; Array BioPharma Inc.; Kyowa Hakko Kirin Co. Ltd.; and Cytokinetics, Inc. Amgen Inc. was founded in 1980 and is headquartered in Thousand Oaks, California.
- [By ]
That said, IBB is popular in part because its top holdings at present include Moderna (MRNA), Amgen (AMGN) and Gilead Sciences (GILD) – three very mature and very profitable biotech companies that collectively add up to more than $370 billion in market value. This provides a good foundation for the smaller and more aggressive picks that supplement the portfolio of this healthcare ETF.
- [By Motley Fool Staff]
Every so often on Rule Breaker Investing, Motley Fool co-founder David Gardner shares a five-stock sampler — five active recommendations in either Rule Breakers or Stock Advisor that are poised for great things. This week: five healthcare companies that are innovating treatments and drugs that are making the world healthier. Learn more about Amgen (NASDAQ:AMGN), bluebird bio (NASDAQ:BLUE), Editas Medicine (NASDAQ:EDIT), Illumina (NASDAQ:ILMN), and Vertex Pharmaceuticals (NASDAQ:VRTX) and why you should add these exciting and inspiring stocks to your watch list.
- [By ]
Even though ABBV has more than 100 patents covering Humira, and despite its 2017 patent win over Amgen (Nasdaq: AMGN) requiring AMGN to wait until 2023 before issuing its own copy of Humira, the battle for generic Humira isn’t over.
Top 5 Biotech Stocks To Watch Right Now: ArQule Inc.(ARQL)
ArQule, Inc., a clinical-stage biotechnology company, engages in the research and development of cancer therapeutics directed toward molecular targets and biological processes. Its lead product ARQ 197 is non-adenosine triphosphate competitive inhibitor of the c-Met receptor tyrosine kinase, which is being evaluated as monotherapy and in combination therapy in a Phase II clinical development program that includes trials in non-small cell lung cancer, c-Met-associated soft tissue sarcomas, pancreatic adenocarcinoma, hepatocellular carcinoma, germ cell tumors, and colorectal cancer. The company is also developing ARQ 621, a Phase I program focused on inhibition of the Eg5 kinesin spindle protein. Its clinical stage products include ARQ 501, ARQ 761, and ARQ 171, which are designed to kill cancer cells selectively while sparing normal cells through the direct activation of DNA damage response/checkpoint pathways. In addition, the company involves in pre-clinical development o f B-RAF and AKIP Kinase inhibitors. The company has collaborations with Kyowa Hakko Kirin Co., Ltd. and Daiichi Sankyo Co., Ltd. ArQule, Inc. was founded in 1993 and is headquartered in Woburn, Massachusetts.
- [By Cory Renauer]
It isn’t unusual for oncology stocks to double in a single day after a company announces clinical trial results. Arqule (NASDAQ:ARQL) stands out among its peers because it notched a 67% gain after reporting a partial remission for just one leukemia patient.
- [By Motley Fool Transcribers]
Arqule Inc (NASDAQ:ARQL)Q4 2018 Earnings Conference CallMarch 07, 2019, 9:00 a.m. ET
Prepared Remarks Questions and Answers Call Participants
Top 5 Biotech Stocks To Watch Right Now: Alnylam Pharmaceuticals Inc.(ALNY)
Alnylam Pharmaceuticals, Inc., a biopharmaceutical company, engages in discovering, developing, and commercializing novel therapeutics based on RNA interference (RNAi). Its core product programs under clinical or pre-clinical development include ALN-TTR, a Phase I clinical trial program for the treatment of transthyretin-mediated amyloidosis; ALN-APC, a Phase I clinical trial program for the treatment of hemophilia; ALN-PCS for the treatment of severe hypercholesterolemia; ALN-HPN, a pre-clinical development for the treatment of refractory anemia; and ALN-TMP, a pre-clinical development for the treatment of hemoglobinopathies, including beta-thalassemia and sickle cell anemia. The company?s partner-based programs comprise ALN-RSV01, a Phase II clinical trial program for the treatment of respiratory syncytial virus infection; ALN-VSP, a Phase I clinical trial completed program for the treatment of liver cancers; and ALN-HTT, a pre-clinical development for the treatment of Huntington?s disease. It has strategic alliances with Novartis Pharma AG; F. Hoffmann-La Roche Ltd; Takeda Pharmaceutical Company Limited; Isis Pharmaceuticals, Inc.; Medtronic Inc.; Kyowa Hakko Kirin Co., Ltd.; and Cubist Pharmaceuticals, Inc. The company was founded in 2002 and is headquartered in Cambridge, Massachusetts.
- [By ]
Advisors Asset Management Inc. cut its position in shares of Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY) by 25.1% during the 2nd quarter, according to its most recent 13F filing with the Securities and Exchange Commission. The fund owned 3,685 shares of the biopharmaceutical company’s stock after selling 1,232 shares during the quarter. Advisors Asset Management Inc.’s holdings in Alnylam Pharmaceuticals were worth $625,000 as of its most recent SEC filing.
- [By Max Byerly]
Get a free copy of the Zacks research report on Alnylam Pharmaceuticals (ALNY)
For more information about research offerings from Zacks Investment Research, visit Zacks.com