Company Overview and News
6h sec.gov - 5
2018-09-07 seekingalpha - 3
Discussion: On September 4, Recro Pharma (REPH) reported positive outcome of its meeting with the FDA regarding its NDA for IV meloxicam that was rejected in last May. Based on the discussion with the FDA, the company now plans to submit a revised NDA by the end of this month. Suggestions offered by the FDA now guides the company to include revised labelling language and further information on extractable and leachable items.
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BERKELEY, Calif., Sept. 04, 2018 (GLOBE NEWSWIRE) -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced publication of a preclinical study demonstrating that inhalation of a TLR9 agonist can stimulate effective immunity against lung tumors and complement the actions of PD-1 blockade to generate durable, systemic anti-tumor immunity. The paper titled Inhaled TLR9 Agonist Renders Lung Tumors Permissive to PD-1 Blockade by Promoting Optimal CD4+ and CD8+ T cell Interplay, by Dynavax scientists M.
2018-08-28 genengnews - 1
Researchers are constantly on the hunt to improve the immune systems’ response to tumor cells and are beginning to combine immunotherapy drugs for an even greater response to cancer cells. Now, investigators from the Geffen School of Medicine at UCLA and Dynavax Technologies have just published data from a phase 1b study looking at the combination of the PD-1 blocking biologic pembrolizumab and an experimental agonist of Toll-like receptor 9 (TLR9) called SD-101 for treating aggressive melanoma.
BERKELEY, Calif., Aug. 28, 2018 (GLOBE NEWSWIRE) -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that two peer-reviewed papers reporting clinical studies of SD-101 have been published by Cancer Discovery, a journal publication from American Association of Cancer Research (AACR). The investigators report clinical activity and broad immune activation in the tumor microenvironment when SD-101 is administered in combination with either low dose radiation in patients with indolent lymphoma or in combination with PD-1 blockade in patients with unresectable or metastatic melanoma.
dvax-10q_20180630.htm UNITED STATES
Good day, everyone. Welcome to the Dynavax Technologies Second Quarter two018 Conference. Today's call is being recorded.
2018-08-06 zacks - 1
Dynavax Technologies (DVAX - Free Report) just came out with a quarterly loss of $0.63 per share versus the Zacks Consensus Estimate of a loss of $0.59. This compares to loss of $0.41 per share a year ago. These figures are adjusted for non-recurring items.
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BERKELEY, Calif., July 30, 2018 (GLOBE NEWSWIRE) -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that it will report financial results for the second quarter ended June 30, 2018 after market close on Monday, August 6, 2018, and host a conference call that day to review the results and provide an update on the launch of HEPLISAV-B® [Hepatitis B Vaccine, (Recombinant) Adjuvanted] and its oncology program at 4:30pm ET/1:30pm PT.
Barrick Gold Corporation: “Look, I always think people should have some gold. I like the Gold, GLD, or I like gold, the bullion. It is really hard to own the stocks. Barrick? Sell, sell, sell.”
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BERKELEY, Calif., June 28, 2018 (GLOBE NEWSWIRE) -- Dynavax Technologies Corporation (NASDAQ:DVAX) today announced the formation of a six-member Scientific Advisory Board with significant experience in research, development, and commercialization in the fields of oncology and immunology.
2018-06-25 globenewswire - 1
In a Post-Hoc Analysis of Elderly Diabetic Patients, HEPLISAV-B was Well-Tolerated and Induced Higher Rates of Seroprotection than Engerix-B
2017-10-16 - Asif
Dynavax Technologies is a clinical-stage immunotherapy company focused on leveraging the power of the body’s innate and adaptive immune responses through toll-like receptor (“TLR”) stimulation. Dynavax current product candidates are being investigated for use in multiple cancer indications, as a vaccine for the prevention of hepatitis B and as a disease modifying therapy for asthma. Its lead cancer immunotherapy candidate is SD-101, a C Class CpG TLR9 agonist that was selected for characteristics optimal for treatment of cancer, including high interferon induction. Directly injecting SD-101 into a tumor site optimizes its effect by ensuring proximity to tumor-specific antigens. In animal models, SD-101 demonstrated significant anti-tumor effects at both the injected site and at distant sites. Dynavax is conducting a clinical program intended to assess potential efficacy of SD-101 in a range of tumors and in combination with a range of treatments, including checkpoint inhibitors and...
2018-09-18 - Asif
Overview Rigel Pharmaceuticals is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematologic disorders, cancer and rare diseases. The company's pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company's first FDA-approved product is TAVALISSE™ (fostamatinib disodium hexahydrate), an oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. The company's current clinical programs include Phase 2 studies of fostamatinib in autoimmune hemolytic anemia and IgA nephropathy, and a Phase 1 study for its IRAK program. In addition, Rigel Pharmaceuticals has product candidates in development with partners BerGenBio AS, Daiichi Sankyo, and Aclaris Therapeutics. Since inception, Rigel Pharmaceuticals h...
2018-09-18 - Asif
Overview The company design, develop and sell exoskeleton technology to augment human strength, endurance and mobility. The company's exoskeleton technology serves multiple markets and can be used both by able-bodied users as well as by persons with physical disabilities. Ekso Bionics has sold, rented or leased devices that (a) enable individuals with neurological conditions affecting gait (stroke and spinal cord injury) to rehabilitate and to walk again and (b) allow industrial workers to perform heavy duty work for extended periods. Today, its medical exoskeleton, Ekso GT, is used as a rehabilitation tool to allow physicians and therapists to rehabilitate patients who have suffered a stroke or spinal cord injury. With its unique features designed specifically for hospitals and its proprietary SmartAssist software, Ekso GT allows for the early mobilization of patients, with high step count and high dosage treatments. The intent is to allow the patient’s central nervous syst...
2018-09-18 - Asif
Overview Agile Therapeutics is a forward-thinking women’s healthcare company dedicated to fulfilling the unmet health needs of today’s women. Twirla® and its other current potential product candidates are designed to provide women with contraceptive options that offer greater convenience and facilitate compliance. The company's lead product candidate, Twirla, also known as AG200-15, is a once-weekly prescription contraceptive patch that is at the end of Phase 3 clinical development. Since its inception in 1997, Agile Therapeutics has devoted substantial resources to developing Twirla, building its intellectual property portfolio, business planning, raising capital and providing general and administrative support for these operations. The company incurred research and development expenses of $14.4 million, $20.9 million and $25.6 million during the years ended December 31, 2017, 2016 and 2015, respectively. The company incurred research and development expenses of $2.4 milli...
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