Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new preclinical or clinical trial data and further analyses of existing preclinical or clinical trial data; risks associated with preliminary data; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when data from the BNT162 mRNA vaccine program will be published in scientific journal publications and, if so, when and with what modifications; whether regulatory authorities will be satisfied with the design of and results from these and future preclinical and clinical studies; whether and when any biologics license applications may be filed in any jurisdictions for any potential vaccine candidates under the collaboration; whether and when any such applications may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the products benefits outweigh its known risks and determination of the products efficacy and, if approved, whether any such vaccine candidates will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of any such vaccine candidates, including development of products or therapies by other companies; manufacturing capabilities or capacity, including whether the estimated numbers of doses can be manufactured within the projected time periods indicated; whether and when a future production agreement with the United States will be reached; whether and when other supply agreements will be reached; uncertainties regarding the ability to obtain recommendations from vaccine technical committees and other public health authorities regarding any such vaccine candidates and uncertainties regarding the commercial impact of any such recommendations; and competitive developments. If you enjoy betting on volatile biotech names, then check out Progenity(NASDAQ:PROG). Progenitys vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies. "We very much want to see that time gap [between high and low-income countries] reduced, such that there's no space between the two," said Padmini Srikantiah, lead on the RSV vaccine launch at Gates. In addition to engagements with governments, Pfizer and BioNTech have provided an expression of interest for possible supply to the COVAX Facility, a mechanism established by Gavi, the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations (CEPI) and World Health Organization (WHO) that aims to provide governments with early access to a large portfolio of COVID-19 candidate vaccines using a range of technology platforms, produced by multiple manufacturers across the world. Were eager to work with innovators who share our values and our focus. Pfizer pledge for more equal access to RSV shot faces hurdles Pretty much immediately, the early investors were in the red. Click here to access Benzinga's FDA Calendar. The initial public offering price is $15.00 per share. When typing in this field, a list of search results will appear and be automatically updated as you type. Pfizer has a windfall of cash it's looking to deploy. Thinking about buying stock in AT&T, Tesla, Pfizer, Progenity, or Oncorus, Inc. ONCR disclosed in a filing with the SEC that Stephen Harbin, its chief operating officer and chief of staff, bought 30,000 shares in the company. View the full release here: https://www.businesswire.com/news/home/20200722005438/en/. 2 Resilient Stocks to Buy Now, 2 Fairly Safe Stocks You'll Regret Not Buying on the Dip. Once swallowed, the OBDS capsule is designed to transit the intestinal tract and trigger in the small intestine, where it will use liquid jet release to inject drug directly into the small intestine for optimal bioavailability. The company had learned during the COVID-19 pandemic that "parallel development" to meet the needs of different regions was possible, Anderson said. Early discussions with the WHO are underway, but the process will be complicated because Pfizer's RSV vaccine is not designed for syringes that automatically disable after one injection, which are preferred by the health agency for safety reasons to prevent reuse. Given this, the behemoth may not be looking for another oncology company right away. Both collaborators are committed to developing these novel vaccines with pre-clinical and clinical data at the forefront of all their decision-making. The other main concern is that Progenity announced last week that it was shifting its focus from prenatal testing kits to the companys biotech pipeline. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Here's a roundup of top developments in the biotech space over the last 24 hours: Roche Holding AG RHHBY unit Spark Therapeutics, announced data from its Phase 1/2 clinical trial of investigational SPK-8011 in hemophilia A showing, at a median efficacy follow-up of 33.4 months, 16 of 18 study participants had sustained factor VIII, which permitted prophylaxis cessation and reduction in bleeding episodes. CureVac N.V. CVAC announced the online publication in the journal Nature, extended preclinical study of the second-generation vaccine candidate, CV2CoV, jointly developed with GlaxoSmithKine plc GSK, showing results from a direct comparison of CV2CoV with Comirnaty, the licensed mRNA vaccine developed by Pfizer, Inc. PFE/BioNTech SE BNTX. Each of these forward-looking statements involves risks and uncertainties. Reply Private New. So lets start with a short and an, admittedly, cringe-inducing price history of this fast-moving biotechnology stock. The companies currently expect to manufacture globally up to 100 million doses by the end of 2020 and potentially more than 1.3 billion doses by the end of 2021, subject to final dose selection from their clinical trial. Let's learn about each other and discover synergies, goals, needs and capabilities. The industry leader for online information for tax, accounting and finance professionals. "It's a process. All statements, other than statements of historical facts, included in this press release are forward-looking statements. While there is some tough competition out there, Blueprint has shown it can quickly bring drugs to market. Pfizer engages in flexible partnership models that includes research collaborations, venture capital investments, academic alliances for drug development, early stage seed funding, establishing incubators, licensing, and spinning out of companies. Progenity recently signed its third partnership with a major pharmaceutical company to evaluate delivery of large molecules using the OBDS platform. Biosimilars Deals 2021 Archives | Pearce IP Progenity, Inc. PROG said in a series of filings with the SEC that insiders, including Hutan Hashemi, chief compliance officer, and Matthew Cooper, chief compliance officer, disposed shares in the company. Progenity has been working on an oral delivery method, i.e. Pfizer Inc. - Pfizer 2023 Annual Meeting of Shareholders Written by PROG stock dropped to $9 in July 2020, and closed out the year trading at $5 and change. Indian broadcaster New Delhi Television Ltd (NDTV) , part of the embattled Adani Group, posted a 97.6% plunge in quarterly profit on Monday due to weak advertising demand. Investor Contact:Robert UhlManaging Director, Westwicke ICRir@progenity.com (619) 228-5886, Media Contact:Kate Blom-LoweryCG Lifemedia@progenity.com (619) 742-6294. SAN DIEGO, Sept. 21, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (Nasdaq: PROG), an innovative biotechnology company, announced today that the company will participate in the 11 th annual Partnership Opportunities in Drug Delivery (PODD) Conference, October 28-29, 2021 in Boston. About ProgenityProgenity, Inc. is a biotechnology company innovating in the fields of womens health, gastrointestinal health and oral biotherapeutics. Progenity fits just about any definition of a penny stock: it has a low share price, a low market cap, and its as volatile as it gets. "I think we're doing better than in years before," she said. Lupus nephritis is an autoimmune disorder that's especially harsh on the kidneys, with approximately 10% to 30% of patients experiencing kidney failure within 15 years, despite current therapies. Forward-Looking Statements of Pfizer Inc. So what happened? AstraZeneca's Tagrisso, which has a similar target, hauled in a whopping $4.3 billion-plus in FY 2020. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law. She still expects it to be several years before the RSV vaccine is launched in lower-income countries. Going back to the beginning, Progenity conducted its initial public offering (IPO) on June 22, 2020. All rights reserved. In some cases, you can identify forward-looking statements by terms such as may, might, will, objective, intend, should, could, can, would, expect, believe, design, estimate, predict, potential, develop, plan or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward looking statements. According to Progenity, the Preecludia test is expected to target an addressable market of up to $3 billion per year in the U.S. We engage in partnerships with innovators to push forward great science and continually seek new partners that are actively researching bold scientific ideas, capabilities and technologies that have the potential to bring innovative treatments to patients in need. The drugmaker received a $28 million grant from the Bill and Melinda Gates Foundation in September to support the launch of the respiratory syncytial virus vaccine in poorer countries, where RSV - a common cold-like virus - is much more likely to be lethal for very young children. Our tests have achieved market-leading reliability and performance benchmarks within their . . Thus, the patent for Preecludia represents a major step forward for Progenity. Its first oncology drug, Gavreto, is a once-a-day oral medication for non-small cell lung cancer, as well as certain types of thyroid cancer with a mutation in a specific gene called RET. The U.S. government also can acquire up to an additional 500 million doses. A description of these risks and uncertainties can be found in Pfizers most recent Annual Report on Form 10-K and in its subsequent reports on Form 10-Q, including in the sections thereof captioned Risk Factors and Forward-Looking Information and Factors That May Affect Future Results, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.govandwww.pfizer.com. The precision-medicine company also has two candidates entering phase 1 studies for non-small cell lung cancer with mutations within a specific gene called EGFR. While were looking at data, it should be noted that Progenitys earnings per share over the 12 months that ended in June was -$4.28. A further description of risks and uncertainties can be found in Pfizers Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned Risk Factors and Forward-Looking Information and Factors That May Affect Future Results, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com. After all, the Reddit crowd might punish anyone who dares to do that. Progenity, Inc. is offering 6,666,667 shares. On July 20th, the companies announced early positive update from German Phase 1/2 COVID-19 vaccine study, including first T Cell response data. Partnerships can save lives. As part of its GI-targeted therapeutics program, Progenity is preparing to initiate early clinical studies of its PGN-600 program for targeted delivery of a proprietary formulation of tofacitinib . SAN DIEGO, Sept. 21, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (Nasdaq: PROG), an innovative biotechnology company, announced today that the company will participate in the 11thannual Partnership Opportunities in Drug Delivery(PODD) Conference, October 28-29, 2021 in Boston. To see how InvestorsObserver's proprietary scoring system rates these stocks, view the InvestorsObserver's PriceWatch Alert by selecting the corresponding link. Precaution: investigational drug/device combination products. "They could have tried sooner," said Erin Sparrow, WHO's technical officer for the RSV vaccine, referring to Pfizer. The Gates grant will be used to fund trials of a multi-dose vial, which are likely to begin next year and may take another year to complete, a source with knowledge of the plans said. SEC Filing | Biora Therapeutics, Inc. +1 (212) 733-7410[emailprotected] The products discussed herein may have different labeling in different countries. Progenitys vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies. We are pleased to have signed this important agreement with the U.S. government to supply the initial 100 million doses upon approval as part of our commitment to address the global health threat. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Worried About a Recession? PROG stock closed yesterday at $2.04. Looking ahead, Progenity Chief Scientific Officer Matthew Cooper anticipates that the company will pursue partnership opportunities for commercialization of the Preecludia test. and our This $5 billion biotech is the first and only company to have two internally discovered and developed medicines that received U.S. Food and Drug Administration (FDA) approval within a decade of its founding. This webcast may contain forward-looking statements about, among other things, our anticipated operating and financial performance, reorganizations, business plans and prospects; expectations for our product pipeline, in-line products and product candidates, including anticipated regulatory submissions, data read-outs, study starts, approvals, clinical trial results and other developing data that become available, revenue contribution, growth, performance, timing of exclusivity and potential benefits; strategic reviews; capital allocation objectives; dividends and share repurchases; plans for and prospects of our acquisitions, dispositions and other business development activities, and our ability to successfully capitalize on these opportunities; manufacturing and product supply; our efforts to respond to COVID-19, including the Pfizer-BioNTech COVID-19 vaccine and our investigational protease inhibitor; and our expectations regarding the impact of COVID-19 on our business that involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Pharma Atea Pharmaceuticals (AVIR -0.61%)reported interim phase 2 results at the end of June showing that its lead COVID-19 oral treatment, AT-527, could rapidly reduce the viral load in COVID-19 patients. Unleashing the next wave of scientific innovations, Research and Business Development Partnerships. NEW YORK, Oct. 25, 2021 /PRNewswire/ -- InvestorsObserver issues critical PriceWatch Alerts for T, TSLA, PFE, PROG . This agreement is one of many steps towards providing global access to a safe and efficacious vaccines for COVID-19. If You Do This, You Won't Have to Worry About Them, Join Over Half a Million Premium Members And Get More In-Depth Stock Guidance and Research, Motley Fool Issues Rare All In Buy Alert, Pfizer announced a global collaboration with Arvinas, Copyright, Trademark and Patent Information. It has an approved drug with a blockbuster addressable market, and that drug may have optionality for other autoimmune conditions as well (though it's not actively being studied in other diseases at the moment). Three candidates come to mind, but one seems like an ideal tuck-in acquisition. GUESS who produces togacitinib PFIZER! The post Progenity Stock Is a Zero-or-Hero Holding for Biotech Bidders appeared first on InvestorPlace. This designation was granted based on preliminary data from Phase 1/2 studies that are currently ongoing in the United States and Germany as well as animal immunogenicity studies.
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