Company Overview and News
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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Puma Biotechnology Inc. (PBYI - Free Report) announced that the European Commission has given a marketing approval to its kinase inhibitor Nerlynx (neratinib). The drug has been approved as an extended adjuvant treatment of early stage hormone receptor positive (HER2-positive) breast cancer in patients, previously treated with Roche’s (RHHBY - Free Report) Herceptin-based adjuvant therapy.
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The major pipeline and regulatory updates in the biotech sector over the past week included Amgen (AMGN - Free Report) ’s Blincyto getting EC approval for a label expansion and Puma Biotechnology (PBYI - Free Report) winning EC approval for Nerlynx. Meanwhile, MannKind (MNKD - Free Report) shares surged on a deal with United Therapeutics Corporation.
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2018-08-12 seekingalpha - 1
Good day everyone and welcome to today's Celcuity Release of Second Quarter of 2018 Financial Results. At this time, all participants are in a listen-only mode. And later, you will have the opportunity to ask questions during the question-and-answer session. [Operator Instructions] Please note that this call may be recorded and I will be standing by if you should need any assistance.
2018-08-11 seekingalpha - 1
Puma Biotechnology is an interesting name, trading near its lows while the pick up of its approved product goes quite well.
2018-08-11 zacks - 3
Puma Biotechnology, Inc. (PBYI - Free Report) incurred a loss of $1.17 per share for the second quarter of 2018, narrower than the Zacks Consensus Estimate of a loss of $1.26 per share and the year-ago loss of $2.10.
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2018-08-10 seekingalpha - 1
Ladies and gentlemen, good afternoon. My name is Adam, and I will be your conference call operator for today. At this time, all participants are in a listen-only mode. After the speakers' formal remarks, there will be a question-and-answer session. [Operator Instructions] As a reminder, this program is being recorded.
pbyi-10q_20180630.htm UNITED STATES
8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549
The second-quarter reporting cycle is coming to an end. Though the quarterly results were marked by all around positive surprises and plenty of momentum on the revenue side, the downtrend in earnings estimate revisions for the current period (third quarter 2018) is a concern.
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2018-07-02 seekingalpha - 2
Discussion: Second Phase 3 trial of Spectrum Pharmaceutical’s (SPPI) Rolontis met primary efficacy endpoint. The endpoint was non-inferiority in duration of severe neutropenia (‘DSN) between Rolontis and Neulasta (pegfilgrastin). Neutropenia is a condition of abnormally low level of white blood cell. The condition is often a side effect of some types of chemotherapy. Earlier, first Phase 3 study met endpoint in DSN across all four cycles for non-inferiority of rolontis to non-inferiority of pegfilgrastim.
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2018-06-29 sec.gov - 6
Form 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549
2018-03-12 - Asif
Company Overview Puma Biotechnology is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. The company in-license the global development and commercialization rights to three drug candidates – PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357. Neratinib is a potent irreversible tyrosine kinase inhibitor, or TKI, that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2 and HER4. Currently, Puma Biotechnology is primarily focused on the U.S. commercialization of NERLYNX (neratinib), its first U.S. Food and Drug Administration, or FDA, approved product, and on the further development of the oral version of neratinib for additional indications in the treatment of HER2-positive breast cancer. The company believe neratinib has clinical application in the treatment of several other cancers as well, including non-small cell lung cancer and other tumor types tha...
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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