This transcript may contain forward-looking statements about, among other things, our anticipated operating and financial performance, 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, post-approval clinical trial results and other developing data that become available, revenue contribution, growth, performance, timing of exclusivity and potential benefits; manufacturing and product supply; our efforts to respond to COVID-19, including our development of a vaccine to help prevent COVID-19 and our investigational protease inhibitor; our expectations regarding the impact of COVID-19 on our business; plans for and prospects of our acquisitions, dispositions and other business-development activities, and our ability to successfully capitalize on these opportunities; and discussions relating to strategic reviews, capital allocation objectives, dividends and share repurchases, among other things, that involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. 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 . Americans will receive the vaccine for free consistent with U.S. governments commitment for free access for COVID-19 vaccines. We are also in advanced discussions with multiple other government bodies and we hope to announce additional supply agreements soon. The U.S. government also can acquire up to an additional 500 million doses. "It's a process. david lee garza wife; Locations. When typing in this field, a list of search results will appear and be automatically updated as you type. Not long ago, InvestorPlace contributor Chris MacDonald reported that the short interest in PROG stock had spiked in recent weeks. Thats true: the short interest in Progenity shares literally doubled from the end of August to mid-September. EDAP TMS S.A. EDAP reported third-quarter revenues of $11.1 million, almost unchanged from a year-ago period, as lingering COVID-19 impact cut capital equipment sales. By accepting all cookies, you agree to our use of cookies to deliver and maintain our services and site, improve the quality of Reddit, personalize Reddit content and advertising, and measure the effectiveness of advertising. Merck announcedthe U.S. Food and Drug Administration has approved Keytruda for the adjuvant treatment of patients with renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. All shares of common stock and pre-funded warrants to be sold in the offering will be offered by CymaBay. About Pfizer: Breakthroughs That Change Patients Lives. Progenity applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Become a Motley Fool member today to get instant access to our top analyst recommendations, in-depth research, investing resources, and more. The offering of the shares of common stock is being made only by means of a prospectus, including a prospectus supplement, forming a part of an effective registration statement. In some cases, you can identify these statements by forward-looking words such as expect, may, will, or the negative or plural of these words or similar expressions (as well as other words or expressions referencing future events, conditions or circumstances). After all, the Reddit crowd might punish anyone who dares to do that. Weve been committed to making the impossible possible by working tirelessly to develop and produce in record time a safe and effective vaccine to help bring an end to this global health crisis, said Dr. Albert Bourla, Pfizer Chairman and CEO. See here for a complete list of exchanges and delays. The results trailed expectations. For more information, please visit www.BioNTech.de. Invest better with The Motley Fool. However, it could also be used to monoclonal antibodies, peptides, and nucleic acids rather than using an injection. "We are committed to working with the appropriate organizations, including regulatory authorities and other global health partners, to help ensure the vaccine candidate, once approved, is available in lower- and middle-income countries as quickly as possible," a Pfizer spokesperson said when asked about the timeline for the RSV shot. For example, PGN-001 (colon-targeted adalimumab) and PGN-600 (colon-targeted tofacitinib) target ulcerative colitis. $38 becomes the price target." 0 Liked By . Most of those children are under five years old, with 98% living in low and middle-income countries that have fewer healthcare resources to treat the infection. 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. That move will apparently reduce Progenitys operating expenditures by around 70%. Pfizer has several key areas of interest where we are looking to partner with others. They include seeking approval for the shot from the WHO, whose authorization is used by governments that don't have a strong domestic drugs regulator, and by nonprofits - such as the global vaccine alliance Gavi - that fund purchases in low-income countries. The panel discussion will be live-streamed and will be available on demand for three months following the conference to registered attendees. Wednesday before the market open, the company reported better-than-expected third-quarter results. 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. InvestorPlace->, InvestorPlace - Stock Market News, Stock Advice & Trading Tips. All statements, other than statements of historical facts, included in this press release are forward-looking statements. The deal cost Pfizer $650 million upfront, as well as a $350 million equity . Progenity's Drug Delivery System delivers 25 times more [togacitinib] in the colon. Reuters, the news and media division of Thomson Reuters, is the worlds largest multimedia news provider, reaching billions of people worldwide every day. Biora Therapeutics, NaviCap, BioJet, and GITrac are trademarks of Biora Therapeutics, Inc. 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. Worried About a Recession? After submitting your request, you will receive an activation email to the requested email address. As you can see, Progenity is a small biotechnology company thats in a state of transition. With COVID-19 cases rising worldwide, there's a pressing need for an efficacious oral therapy that can be administered not only to hospitalized patients but also to those well enough to be given a prescription as outpatients. Forward-looking statements include statements regarding Progenitys expectations regarding the completion and intended use of the proceeds of the registered direct offering. Type a symbol or company name. To make the world smarter, happier, and richer. But the vaccine will need a different delivery system to be used in developing countries in Africa and Asia, including alternative packaging and syringes. The Motley Fool has a disclosure policy. +49 (0)6131 9084 1513 or +49 (0)151 1978 1385[emailprotected] . When the symbol you want to add appears, add it to My Quotes by selecting it and pressing Enter/Return. Be the change you want to see in the world! The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. In addition to participating on the panel, the company will also be meeting with potential and existing pharmaceutical partners. The session will explore oral delivery of biologics and the many technological approaches currently under investigation and showing promising results, including Progenitys Oral Biotherapeutic Delivery System (OBDS), which is designed to enable needle-free systemic delivery of large-molecule biologics in a liquid formulation. Currently limited by Federal law to investigational use only. The Bottom Line The case highlights how equitable global access will require better advance planning by drugmakers, governments and health organizations, health officials say. In premarket trading, the stock was slipping 2.48% to $3.94. 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. Novonordisk, guys be ready for another big pharma too, GLP-1 is NVOs money maker, Progenity can make it work much better. 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. 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 . PROG stock dropped to $9 in July 2020, and closed out the year trading at $5 and change. Get stock recommendations, portfolio guidance, and more from The Motley Fool's premium services. Click here to access Benzinga's FDA Calendar. Part of the Health & Pharma team, recent notable pieces include an investigation into healthcare for young transgender people in the UK as well as stories on the rise in measles after COVID hit routine vaccination, as well as efforts to prevent the next pandemic. 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. Investor Contact:Robert UhlManaging Director, Westwicke ICRir@progenity.com (619) 228-5886, Media Contact:Kate Blom-LoweryCG Lifemedia@progenity.com (619) 742-6294. Learn about SARS-CoV-2, the coronavirus that causes COVID-19, what you can do to stay safe and prevent the spread, and our scientific efforts to help bring an end to the current global health crisis. All rights reserved. Right now PROG stock is the entrenched domicile of Reddit's apes staging a late in-the-game coup against the outfit's bear population. That stock offering provided Progenity with a significant amount of capital, but dilution typically isnt viewed as a good thing for long-term investors. LONDON, April 28 (Reuters) - Pfizer Inc (PFE.N) has pledged to deliver critical new medicines more quickly in low-income nations, but its first such vaccine effort faces hurdles likely to delay . The net loss per share also remained flat at 3 cents per share. The CDx test is based on Burning Rock's self-developed next generation sequencing-based liquid biopsy solution, the OncoCompass Target panel. This informationincluding product informationis intended only for residents of the United States. Burning Rock Biotech Limited BNR announced a strategic partnership with Germany's MERCK . The Pfizer/BioNTech vaccine development program is evaluating at least four experimental vaccines, each of which represents a unique combination of messenger RNA (mRNA) format and target antigen. She previously worked at the Telegraph newspaper and Channel 4 News in the UK, as well as freelance in Myanmar and the Czech Republic. Preparations for those modifications are just beginning, according to the World Health Organization and the company - which is likely to push back delivery by several years. Precaution: investigational drug/device combination products. 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. These forward-looking statements are based on Progenitys expectations and assumptions as of the date of this press release. Whether thats a good thing or not, Ill let you decide. There are no guarantees of that happening, of course. The company would begin delivering the drug later this year and concluding in 2022. It is used to assess patients for preeclampsia (a potentially fatal pregnancy complication). With a market cap of less than $2 billion and a potential blockbuster that has possible optionality into other autoimmune diseases, Aurinia looks undervalued and could find itself being acquired sooner rather than later. Sorry, you need to enable JavaScript to visit this website. Media Relations "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. Unleashing the next wave of scientific innovations, Research and Business Development Partnerships. Looking ahead, Progenity Chief Scientific Officer Matthew Cooper anticipates that the company will pursue "partnership opportunities for commercialization" of the Preecludia test. There are patients who are waiting, and together, we might deliver on the promise of better health and longer lives. Pfizer made a commitment on more equitable access last year, following criticism that it prioritized wealthy nations for doses of its COVID-19 shot early in the pandemic. But if it happens, PROG stock could rally powerfully. To opt-in for investor email alerts, please enter your email address in the field below and select at least one alert option. Reuters provides business, financial, national and international news to professionals via desktop terminals, the world's media organizations, industry events and directly to consumers. The autoimmune-focused biotech expects an average annualized net revenue per patient of approximately $65,000. What are you looking for in a partnership? However, undisclosed partnerships being in place currently are almost guaranteed . Reddit and its partners use cookies and similar technologies to provide you with a better experience. Progenity is going to require many years and tons of capital to get any of its proposed drugs to market. The forward-looking statements in the transcript speak only as of the original date of the webcast. 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. Progenity, Inc. PROG said in . About the Oral Biotherapeutic Delivery System (OBDS) Progenitys Oral Biotherapeutic Delivery System (OBDS) is an ingestible capsule designed for needle-free, oral delivery of large molecules, including monoclonal antibodies, peptides, and nucleic acids. Given this, the behemoth may not be looking for another oncology company right away. 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 have a wide range of tools to help investors make smarter decisions when investing in stocks or options. 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. On the date of publication, David Moadeldid not have (either directly or indirectly) any positions in the securities mentioned in this article. Inoculating pregnant women against RSV can protect babies from the virus that kills nearly 100,000 children worldwide each year. Pfizer announced an agreement with the U.S. government to supply 10 million treatment courses of its investigational COVID-19 oral antiviral candidate, Paxlovid, for $5.29 billion, pending and contingent upon regulatory authorization. We are honored to be a part of this effort to provide Americans access to protection from this deadly virus., Expanding Operation Warp Speeds diverse portfolio by adding a vaccine from Pfizer and BioNTech increases the odds that we will have a safe, effective vaccine as soon as the end of this year, said HHS Secretary Alex Azar. Multi-dose vials require the addition of a preservative, which means the manufacturer needs to run new trials to ensure there is no impact on the vaccines safety or efficacy. Burning Rock Biotech Limited BNR announced a strategic partnership with Germany's MERCK Kommanditgesellschaft auf Aktien MKKGY for developing companion diagnostics for the MET inhibitor tepotinib in the mainland China market. Thinking about buying stock in ON Semiconductor, Alignment Healthcare, Advanced Micro Devices, Las Vegas Sands, or DraftKings? "Neutralizing antibody levels measured following full vaccination of animals with either 12g of CV2CoV or a 30g standard dose of Comirnaty were shown to be highly comparable," CureVac said. Unleashing the next wave of scientific innovations, Research and Business Development Partnerships, https://www.businesswire.com/news/home/20200722005438/en/, Understanding Six Types of Vaccine Technologies. On July 22, Pfizer announced a global collaboration with Arvinas, which has a breast cancer treatment in phase 2 trials. A Gates Foundation official said that the investment in the RSV program represented a learning process for the organization and the company on the steps needed for more equitable access. (Note: You may have to copy this link into your browser then press the [ENTER] key.). Select an area below to see where we are focusing our partnering efforts. This informationincluding product informationis intended only for residents of the United States. Actual results may differ materially from these forward-looking statements. 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. Investor Relations Were eager to work with innovators who share our values and our focus. "They could have tried sooner," said Erin Sparrow, WHO's technical officer for the RSV vaccine, referring to Pfizer. Progenity Inc (PROG) Post# of 1456 Go Next 10 . And as well see, the stock has been in a long, persistent downtrend. This disease affects about 80,000 to 100,000 people in the U.S., but fortunately, when combined with current standards of care, Aurinia's drug is more likelyto improve kidney function. According to Progenity, the Preecludia test is expected to target an addressable market of up to $3 billion per year in the U.S. Just know that PROG stock is likely to move far and fast, in one direction or the other. In an interview last month, Pfizer's head of vaccines research and development Annaliesa Anderson said the company still aimed to make its vaccine the first of its kind available for pregnant women in low-income countries more or less in the "same time frame" as in wealthy countries. 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. For a discussion of these and other risks and uncertainties, see BioNTechs Annual Report on Form 20-F filed with the SEC on March 31, 2020, which is available on the SECs website at www.sec.gov. At Pfizer, we promise to treat your data with respect and will not share your information with any third party. Pfizer To Supply 10M Courses Of Oral COVID Pill To US For About $5.29B . The company had learned during the COVID-19 pandemic that "parallel development" to meet the needs of different regions was possible, Anderson said. 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. Progenity claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. Each of these forward-looking statements involves risks and uncertainties. InvestorPlace is one of Americas largest, longest-standing independent financial research firms. In addition, the RSV shot is currently only available in a single-dose vial. SAN DIEGO, Oct. 26, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. ("Progenity") (Nasdaq: PROG), an innovative biotechnology company, today announced that it has entered into privately negotiated . Type a symbol or company name. If you experience any issues with this process, please contact us for further assistance. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. Forward-Looking Statements of Pfizer Inc. Now, a new treatment technology being developed oncolytic virus therapy may lend hope for patients battling locally advanced or metastatic solid tumors. When the symbol you want to add appears, add it to Watchlist by selecting it and pressing Enter/Return. 2 Resilient Stocks to Buy Now, 2 Fairly Safe Stocks You'll Regret Not Buying on the Dip. As MacDonald clarified, These tests allow users to see whether any deformities or abnormalities exist with their unborn children. MacDonald also observed that PROG stock had tumbled more than 50% in a single trading session in August. Cision Distribution 888-776-0942 CymaBay Therapeutics, Inc. CBAY announced that it has commenced an underwritten public offering of its common stock and pre-funded warrants. 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. 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). And, needless to say, the odds of any early stage drug actually making it through Phase 3 . These forward-looking statements may include, but may not be limited to, statements concerning: BioNTechs efforts to combat COVID-19; the timing to initiate clinical trials of BNT162 and anticipated publication of data from these clinical trials; the timing for any potential emergency use authorizations or approvals; the potential to enter into additional supply agreements with other jurisdictions or the COVAX Facility; the potential safety and efficacy of BNT162; the collaboration between BioNTech and Pfizer to develop a potential COVID-19 vaccine; and the ability of BioNTech to supply the quantities of BNT162 to support clinical development and, if approved, market demand, including our production estimates for 2020 and 2021. While there is some tough competition out there, Blueprint has shown it can quickly bring drugs to market. Browse an unrivalled portfolio of real-time and historical market data and insights from worldwide sources and experts. In fact, 40.8% of patients see improvements in renal function after 52 treatments with Lupkynis, versus 22.5% receiving standard-of-care treatment alone. Start a conversation with us. The gross proceeds to Progenity from this offering are expected to be approximately $20 million, before deducting the placement agent's fees and other offering expenses. This release contains forward-looking information about Pfizers efforts to combat COVID-19, the BNT162 mRNA vaccine program, a collaboration between BioNTech and Pfizer to develop a potential COVID-19 vaccine, an agreement with the United States to manufacture and deliver BNT162 and other potential agreements, including their potential benefits, manufacturing and distribution and the expected timing of clinical trials and regulatory submissions, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Our Standards: The Thomson Reuters Trust Principles. Started over 40 years ago by a business visionary named Tom Phillips, we publish detailed research and recommendations for self-directed investors, financial advisors and money managers. This press release features multimedia. All quotes delayed a minimum of 15 minutes. On July 20th, the companies announced early positive update from German Phase 1/2 COVID-19 vaccine study, including first T Cell response data. Pfizer says it is committed to a faster timeline for rolling out medicines to poor nations but acknowledges that there are challenges in meeting such goals. Supplemental video of manufacturing vaccines. CymaBay anticipates using the net proceeds from the offering to fund ongoing development of seladelpar and for working capital and general corporate purposes. At the same time, aReddit-fueled run-up might be in store for Progenity. Thinking about buying stock in AT&T, Tesla, Pfizer, Progenity, or Energous Corp? Related Link: The Week Ahead In Biotech (Nov. 14-Nov. 20): BioMarin FDA Decision, Tapering Earnings News Flow, Conference Presentations And More. Three candidates come to mind, but one seems like an ideal tuck-in acquisition. You can sign up for additional alert options at any time. And we haven't even mentioned Blueprint's other approved drug, which is for a rare disease called mastocytosisand has an addressable market in the U.S. of at least $800 million. . Itamar Medical Ltd. ITMR (before the market open), Related Link: Attention Biotech Investors: Mark Your Calendar For November PDUFA Dates. U.S. government placed an initial order of 100 million doses for $1.95 billion and can acquire up to 500 million additional doses Americans to receive the vaccine for free consistent with U.S. government's commitment for free access for COVID-19 vaccines Pfizer and BioNTech remain on track to begin an anticipated Phase 2b/3 safety and efficacy trial later this month, seek regulatory review .

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