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Company Overview and News
It’s a busy week on the U.S. Food and Drug Administration (FDA)’s calendar, although the agency got ahead of itself and approved three of the applications early. Here’s a look.
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Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced that the FDA has approved a supplemental Biologics License Application (sBLA) for its flagship ophthalmology drug, Eylea injection in patients with wet age-related macular degeneration (wet AMD).
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Discussion: Development partners Regeneron Pharmaceuticals (REGN) and Teva Pharmaceutical Industries (TEVA) reported topline results of a Phase 3 clinical trial. The trial was evaluating fasinumab in patients with chronic pain from osteoarthritis of the knee or hip. This is a smaller sub-set involving 3565 patients out of the larger planned trial that involves upto 7000 patients. The main study has a time frame of baseline to 72nd week an during this period the incidence of severe destructive arthropathy (‘DA) will be the primary safety endpoint.
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2018-08-19 seekingalpha - 1
Discussion: Bristol-Myers Squibb's (BMY) OPDIVO (nivolumab) is now FDA approved for patients with metastatic small cell lung cancer (‘SCLC) that has progressed after platinum-based chemo and at least one prior line of therapy. This is the first and till date only FDA-approved Immuno-Oncology treatment option for this patient category. Also because this is the first successful checkpoint inhibitor to be approved for these indications, the researchers consider approval of nivolumab to be “particularly exciting.
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Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) and Regeneron Pharmaceuticals Inc. (NASDAQ: REGN) both saw handy gains on Thursday after the companies posted positive topline results from their late-stage trial of fasinumab in patients with chronic pain from osteoarthritis (OA) of the knee or hip.
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Regeneron Pharmaceuticals, Inc. (REGN - Free Report) suffered a setback when the FDA issued a complete response letter (CRL) to its supplemental Biologics License Application (sBLA) for Eylea injection due to ongoing labeling discussions.
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Growth stocks can be some of the most exciting picks in the market, as these high-flyers can captivate investors’ attention, and produce big gains as well. However, they can also lead on the downside when the growth story is over, so it is important to find companies which are still seeing strong growth prospects in their businesses. One such company that might be well-positioned for future earnings growth is Regeneron Pharmaceuticals, Inc.
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Sarepta Therapeutics, Inc. (SRPT - Free Report) incurred a loss of 43 cents per share in the second quarter of 2018, narrower than the year-ago loss of 48 cents and the Zacks Consensus Estimate of a loss of 47 cents.
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The key headlines in the biotech sector this week include Regeneron Pharmaceuticals’ (REGN - Free Report) strong Q2 results and its $100 million investment in bluebird bio (BLUE - Free Report) . Meanwhile, among regular pipeline and regulatory updates, Gilead (GILD - Free Report) is making further inroads into China with its HIV franchise.
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The last two weeks have marked the second-quarterly financial report by numerous biopharma companies. Here’s a quick look at some of the major ones.
2018-08-20 - Asif
Overview Recro Pharma is a specialty pharmaceutical company that operates through two business divisions: an Acute Care division and a revenue-generating CDMO division. Each of these divisions are deemed to be reportable segments for financial reporting purposes. The company's Acute Care segment is primarily focused on developing and commercializing innovative products for hospital and related acute care settings. The company's lead product candidate is a proprietary injectable form of meloxicam, a long-acting preferential COX-2 inhibitor. IV meloxicam has successfully completed three Phase III clinical trials for the management of moderate to severe pain, consisting of two pivotal efficacy trials and a large double-blind Phase III safety trial, as well as other safety studies. Overall, the total new drug application, or NDA, program included over 1,400 patients. In late July 2017, the company submitted a NDA to the U.S. Food and Drug Administration, or FDA, for IV meloxicam...
2018-08-20 - Asif
Overview Achillion Pharmaceuticals is a clinical-stage biopharmaceutical company focused on advancing its oral factor D inhibitors into late-stage development and commercialization. Each of the drug candidates in its oral factor D portfolio was discovered in its laboratories and is wholly owned by it. Achillion Pharmaceuticals is focusing its drug development activities on alternative pathway-mediated, rare diseases where there are no approved therapies or where existing therapies are inadequate for patients. To advance its investigational drugs into phase III and commercialization, the company plan to work closely with key stakeholders including patients, payors, regulators and healthcare professionals. The company's first-generation factor D inhibitor, ACH-4471, has demonstrated preliminary clinical proof-of-concept in patients with C3 glomerulopathy, or C3G, a disease affecting the kidney, and paroxysmal nocturnal hemoglobinuria, or PNH, a blood disorder, and has advanced...
2018-08-20 - Asif
General Baytex Energy Corp. was incorporated on October 22, 2010 pursuant to the provisions of the ABCA. Baytex is the successor to the business of Baytex Energy Trust, which was transitioned to Baytex on December 31, 2010. Inter-Corporate Relationships The following table provides the name, the percentage of voting securities owned by it and the jurisdiction of incorporation, continuance, formation or organization of its material subsidiaries either, direct and indirect, as at the date hereof. ||Percentage of voting securities (directly or indirectly)|Jurisdiction of Incorporation/Formation| | ------------ | ------------: | :------------: | |Baytex Energy Ltd.|100%|Alberta| |Baytex Energy USA, Inc.|100%|Delaware| |Baytex Energy Partnership|100%|Alberta| Organizational Structure The following simplified diagram shows the inter-corporate relationships among it and its material subsidiaries as of the date hereof. <img src="https://www.sec.gov/A...
as of ET