BNTX - BioNTech SE
85.50 +0.03 (0.04%)
After hours: 4:28PM EDT
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Performance Outlook
- Short Term2W - 6W
- Mid Term6W - 9M
- Long Term9M+
| Previous Close | 82.11 |
| Open | 82.99 |
| Bid | 85.41 x 900 |
| Ask | 85.57 x 900 |
| Day's Range | 81.84 - 85.44 |
| 52 Week Range | 12.52 - 105.00 |
| Volume | 2,424,948 |
| Avg. Volume | 2,877,031 |
| Market Cap | 20.357B |
| Beta (5Y Monthly) | N/A |
| PE Ratio (TTM) | N/A |
| EPS (TTM) | N/A |
| Earnings Date | May 12, 2020 |
| Forward Dividend & Yield | N/A (N/A) |
| Ex-Dividend Date | N/A |
| 1y Target Est | 61.74 |
Fair Value
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Better Coronavirus Stock: BioNTech or GlaxoSmithKline?
While coronavirus cases in other developed countries are flattening, the U.S. has not been so fortunate. As of July 24, the number of coronavirus cases in the U.S. has reached a new record, with more than 78,000 Americans infected. Currently, two of the largest biotech companies in the world, BioNTech (NASDAQ: BNTX)and GlaxoSmithKline (NYSE: GSK), are part of the race for a COVID-19 cure.
- Benzinga
The Daily Biotech Pulse: Sanofi-GSK Land $2.1B Funding For Coronavirus Vaccine, D-Day For GW Pharma, FDA Nod For Roche
Scaling The Peaks (Biotech Stocks Hitting 52-week Highs July 30) * Achieve Life Sciences Inc (NASDAQ: ACHV) * Annexon Inc (NASDAQ: ANNX) (IPOed July 24) * Atossa Therapeutics Inc (NASDAQ: ATOS) * Bio-Rad Laboratories, Inc. (NYSE: BIO) * Bio-Rad Laboratories, Inc. Class B (NYSE: BIO-B) * Catalent Inc (NYSE: CTLT) * Dr.Reddy's Laboratories Ltd (NYSE: RDY * Edesa Biotech Inc (NASDAQ: EDSA)(announced filing of an IND for a Phase 2/3 study of a COVID treatment candidate) * Hologic, Inc. (NASDAQ: HOLX) * Horizon Therapeutics PLC (NASDAQ: HZNP) * Immunic Inc (NASDAQ: IMUX) * Ligand Pharmaceuticals Inc. (NASDAQ: LGND) * Merit Medical Systems, Inc. (NASDAQ: MMSI) * NeoGenomics, Inc. (NASDAQ: NEO) * OraSure Technologies, Inc. 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(NYSE: PFE) and BioNTech SE - ADR (NASDAQ: BNTX) announced an agreement with the Ministry of Health, Labour and Welfare in Japan to supply 120 million doses of their BNT162 mRNA-based vaccine candidate against SARS-CoV-2, subject to clinical success and regulatory approval, beginning in the first half of 2021.The companies have already signed agreements with the U.K. and U.S. governments for supplying BNT162.Tiziana Applies For Patent For Nasal Administration of its Monoclonal Antibody as a Potential COVID-19 Cure Tiziana said it has submitted a patent application for the potential use of nasally administered Foralumab, a fully human anti-CD3 monoclonal antibody, for the treatment of COVID-19, either alone or in combination with other anti-viral drugs.The stock was soaring 47.53% to $7.30 in pre-market trading Friday.Roche's Combo Therapy Gets FDA Nod For Skin Cancer Roche Holdings AG (OTC: RHHBY) said the FDA approved Tecentriq plus Cotellic and ZelboraF for the treatment of BRAF V600 mutation-positive advanced melanoma patients.Sanofi/GSK Gets $2.1B U.S. Government Funding For COVID-19 Vaccine Supply Sanofi SA (NASDAQ: SNY) and GlaxoSmithKline plc (NYSE: GSK) announced an agreement with the U.S. government under the Operation Warp Speed project, for up to $2.1 billion in funding, more than half of which is to support further development of the vaccine, including clinical trials, with the remainder used for manufacturing scale-up and delivery of an initial 100 million doses of the vaccine. Sanofi will receive the majority of the funding.The U.S. government has a further option for the supply of an additional 500 million doses longer term, the companies said.Axovant Announces Manufacturing Supply Agreement With U.K. Gene Therapy Company Axovant Gene Therapies Ltd (NASDAQ: AXGT) said its subsidiary has signed a three-year Clinical Supply Agreement with U.K.'s Oxford Biomedica plc, under which the latter will manufacture GMP batches for Axovant to support the ongoing and future clinical development of AXO-Lenti-PD, a clinical-stage gene therapy product to treat moderate to severe Parkinson's Disease.J&J's Psoriasis Drug Gets Label Expansion; Coronavirus Vaccine Produces Positive Results in Pre-clinical Studies Johnson & Johnson's (NYSE: JNJ) Janssen unit said the FDA approved an expanded indication for Stelara as a treatment for pediatric patients, who struggle with the skin lesions or plaques associated with moderate to severe plaque psoriasis.Separately, J&J announced publication in the journal Nature results of preclinical studies of its adenovirus serotype 26 vector-based vaccine, which showed the investigational vaccine elicited a robust immune response as demonstrated by "neutralizing antibodies," successfully preventing subsequent infection and providing complete or near-complete protection in the lungs from the virus in non-human primates. The company expects to commence Phase 3 studies in September.Earnings Corvus Pharmaceuticals Inc's (NASDAQ: CRVS) second-quarter loss narrowed from the year-ago period but was wider than the consensus estimate.The stock fell 6.32% to $4 in after-hours trading.Opko Health Inc. (NASDAQ: OPK) said its second-quarter revenues increased from $226.4 million to $301.2 million. The company reversed from a loss of 10 cents per share to a profit of 5 cents per share.View more earnings on IBBThe stock lost 6.09% to $5.55 in after-hours trading.Emergent Biosolutions Inc (NYSE: EBS) reported a 62.3% year-over-year jump in second-quarter revenues and its adjusted EPS exceeded estimates. The company raised its 2020 guidance.The shares were climbing 6.04% to $102.82.Gilead Sciences, Inc. (NASDAQ: GILD) said its second-quarter revenues fell from $5.7 billion in 2019 to $5.1 billion in 2020. The non-GAAP EPS fell from $1.72 to $1.11, missing the consensus estimate of $1.45. The company raised its product sales and EPS guidance for the full year.Gilead shares were retreating 3.43% to $69.85.DBV TECHNOLOGIE/S ADR (NASDAQ: DBVT) reported a higher operating income for the first half but its net loss widened year-over-year.The stock was advancing 8.05% to $4.16.On The Radar PDUFA Dates GW Pharmaceuticals PLC- ADR (NASDAQ: GWPH) awaits FDA verdict on its sNDA for Epidiolex for the treatment of seizures associated with tuberous sclerosis complex.Earnings AbbVie Inc (NYSE: ABBV) (before the market open) ImmunoGen, Inc. 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Pfizer, BioNTech to supply 120 million doses of coronavirus vaccine to Japan
The companies did not disclose the financial details of the agreement, but said terms were based on the volume of doses and the timing of the delivery. The United States has signed a similar deal with Pfizer and BioNtech for 100 million doses for nearly $2 billion, which amounts to a $39 price tag for what is likely to be a two dose treatment course.
- GlobeNewswire
Pfizer and BioNTech to Supply Japan with 120 Million Doses of Their BNT162 mRNA-Based Vaccine Candidate
* Supply of 120 million doses to be provided in the first half of 2021, subject to regulatory approval * Agreement is part of Pfizer’s and BioNTech’s global commitment to help address the pandemic * Pfizer and BioNTech began a Phase 2b/3 safety and efficacy trial and remain on track to seek regulatory review as early as October 2020, and manufacture globally up to 100 million doses by the end of 2020 and approximately 1.3 billion doses by the end of 2021NEW YORK and MAINZ, Germany, July 31, 2020 (GLOBE NEWSWIRE) -- Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced an agreement with the Ministry of Health, Labour and Welfare (MHLW) in Japan to supply 120 million doses of their BNT162 mRNA-based vaccine candidate against SARS-CoV-2, subject to clinical success and regulatory approval, beginning in 2021. Financial details of the agreement were not disclosed, but the terms were based on the timing of delivery and the volume of doses. As requested by the Government of Japan, deliveries of the vaccine candidate are planned for the first half of 2021.“We are deeply honored to work with the Japanese government and to marshal our scientific and manufacturing resources toward our shared goal of bringing millions of doses of a potential COVID-19 vaccine to the Japanese people as quickly as possible,” said Albert Bourla, Chairman and CEO, Pfizer. “In the face of this global health crisis, Pfizer’s purpose – breakthroughs that change patients’ lives – has taken on an even greater urgency. Under these difficult circumstances, we are proud to help support Japan in its steadfast determination to bring the world together at the 2020 Tokyo Olympics, in a celebration of solidarity, friendship and the power of sport as a global force for good. Our hope is that, subject to clinical and regulatory success, our potential vaccine will help make this happen.”“In bringing the world together at one place, for centuries, the Olympic Games have been a symbol of a global community. As a renewed version of that very spirit, the 2020 Tokyo Olympics may become a symbol for all of us for how all nations around the world can overcome a global pandemic threat together. We are proud and honored that our vaccine candidate may contribute to the efforts undertaken by the government of Japan to turn this vision into reality,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. The BNT162 program is based on BioNTech’s proprietary mRNA technology and supported by Pfizer’s global vaccine development and manufacturing capabilities. The vaccine development program is evaluating at least four experimental vaccine candidates, each of which represents a unique combination of messenger RNA (mRNA) format and target antigen. The BNT162 vaccine candidates are undergoing clinical studies and are not currently approved for distribution anywhere in the world. Both collaborators are committed to developing these novel vaccines with pre-clinical and clinical data at the forefront of all their decision-making.Recently, two of the companies’ four investigational vaccine candidates – BNT162b1 and BNT162b2 – received Fast Track designation from the U.S. Food and Drug Administration (FDA). 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.On July 27, Pfizer and BioNTech announced that following extensive review of preclinical and clinical data from Phase 1/2 clinical trials, and in consultation with the FDA’s Center for Biologics Evaluation and Research (CBER) and other global regulators, the companies selected the BNT162b2 vaccine candidate to move forward into a Phase 2/3 study. BNT162b2 encodes an optimized SARS-CoV-2 full length spike glycoprotein (S), which is the target of virus neutralizing antibodies. In the late-stage trial, the companies will study a 30µg dose level in a 2-dose-regimen among up to 30,000 participants aged 18 – 85 years. It is expected to include approximately 120 sites globally including in regions with significant expected SARS-CoV-2 transmission.Assuming clinical success, Pfizer and BioNTech are on track to seek regulatory review for BNT162b2 as early as October 2020 and, if regulatory authorization or approval is obtained, plan to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses by the end of 2021.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, including those in the emerging markets, 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. About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. 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. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.Pfizer Disclosure Notice The information contained in this release is as of July 31, 2020. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.This release contains forward-looking information about Pfizer’s efforts to combat COVID-19, the collaboration between BioNTech and Pfizer to develop a potential COVID-19 vaccine, an agreement with the government of Japan to supply BNT162 and other potential agreements, the BNT162 mRNA vaccine program, and modRNA candidates BNT162b2 and BNT162b1 (including qualitative assessments of available data, potential benefits, expectations for clinical trials and timing of regulatory submissions, anticipated manufacturing, supply and distribution), that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. 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 risks associated with preliminary data, including the possibility of unfavorable new preclinical or clinical trial data and further analyses of existing preclinical or clinical trial data that may be inconsistent with the data used for selection of the BNT162b2 vaccine candidate and dose level for the Phase 2/3 study; 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 and/or emergency use authorization applications may be filed in any jurisdictions for BNT162b2 or any other potential vaccine candidates; 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 vaccine candidate’s benefits outweigh its known risks and determination of the vaccine candidate’s efficacy and, if approved, whether it 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 a vaccine, 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 additional supply agreements will be reached; uncertainties regarding the ability to obtain recommendations from vaccine technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; and competitive developments.A further description of risks and uncertainties can be found in Pfizer’s 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.About BioNTech Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. 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. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Genevant, Fosun Pharma, and Pfizer.For more information, please visit www.BioNTech.de BioNTech Forward-looking Statements This press release contains “forward-looking statements” of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, statements concerning: BioNTech’s 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. Any forward-looking statements in this press release are based on BioNTech current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: competition to create a vaccine for COVID-19; the ability to produce comparable clinical results in larger and more diverse clinical trials; the ability to effectively scale our productions capabilities; and other potential difficulties. For a discussion of these and other risks and uncertainties, see BioNTech’s Annual Report on Form 20-F filed with the SEC on March 31, 2020, which is available on the SEC’s website at www.sec.gov. 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.Pfizer Contacts:Media Relations Amy Rose +1 (212) 733-7410 Amy.Rose@pfizer.comInvestor Relations Chuck Triano +1 (212) 733-3901 Charles.E.Triano@Pfizer.comBioNTech Contacts:Media Relations Jasmina Alatovic +49 (0)6131 9084 1513 or +49 (0)151 1978 1385 Media@biontech.deInvestor Relations Sylke Maas, Ph.D. +49 (0)6131 9084 1074 Investors@biontech.de
- GlobeNewswire
BioNTech Announces Strategic Collaboration with Regeneron to Advance FixVac and Libtayo® (cemiplimab) Combination in Melanoma
* BioNTech and Regeneron plan to jointly conduct a randomized Phase 2 study combining BNT111 FixVac and Libtayo for the treatment of melanoma that has progressed after prior PD-1 blockade * Combines two immunotherapies with complementary mechanisms of action with the aim to accelerate the path to market approval in melanoma if the trial is successful * Development costs for the clinical trial to be shared equally with each company retaining full commercial rights to their respective product candidatesMAINZ, Germany, July 31, 2020 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) today announced a strategic collaboration with Regeneron for a clinical trial combining BioNTech’s BNT111 FixVac product candidate and Libtayo® (cemiplimab), a fully human anti-PD-1 therapy, for the treatment of melanoma. The companies plan to jointly conduct a randomized Phase 2 study in patients with anti-PD1-refractory/relapsed, unresectable Stage III or IV cutaneous melanoma. Melanoma is the deadliest skin cancer and estimated to kill more than 63,000 people around the world this year.1BNT111 is the most advanced of five clinical stage FixVac product candidates within BioNTech’s broader development pipeline. It is an mRNA cancer immunotherapy targeting four antigens frequently expressed in the tumors of patients with melanoma – NY-ESO-1, MAGE-A3, tyrosinase, and TPTE. BNT111 has demonstrated clinical anti-tumor activity as a monotherapy and in combination with checkpoint inhibitors in an ongoing Phase 1 trial in patients with advanced melanoma after prior checkpoint blockade.“We believe our FixVac platform represents a powerful new drug class of mRNA immunotherapies against cancer. We look forward to working together with Regeneron to advance this product candidate into potentially registrational clinical trials,” said Ugur Sahin, CEO and Co-founder of BioNTech.The two companies plan to pursue a clinical trial for the combination in the second-line treatment setting for advanced melanoma. The companies plan to disclose more details related to the planned Phase 2 study in the third quarter of 2020, with the goal of initiating the trial in the fourth quarter of 2020.“Despite recent treatment advances with anti-PD-1 therapies for patients with melanoma, most patients fail to obtain a durable benefit. The combination of Libtayo and BNT111 FixVac has the potential to augment the immune system’s ability to effectively recognize melanoma in multiple ways and hopefully improve immune targeting to control the cancer,” said Israel Lowy, M.D., Ph.D., Senior Vice President, Translational Science and Oncology, at Regeneron.Under the terms of the agreement, development costs for the clinical trial will be shared equally and both companies will contribute their products for the trial. Each party will retain full commercial rights for its respective product and record revenues related to its own product.Libtayo is being jointly developed by Regeneron and Sanofi.________________________1 WHO International Agency for Research on Cancer (2020): https://gco.iarc.fr/tomorrow/graphic-isotype?type=1&type_sex=0&mode=population&sex=0&populations=900&cancers=16&age_group=value&apc_male=0&apc_female=0&single_unit=10000&print=0About BioNTech Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. 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. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Genevant, Fosun Pharma, and Pfizer.For more information, please visit www.bioNTech.deBioNTech Forward-Looking Statements This press release contains “forward-looking statements” of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, statements concerning: BioNTech’s FixVac program candidate BNT111; BioNTech’s collaboration with Regeneron; timing for commencement of a Phase 2 trial in collaboration with Regeneron; timing for release of additional information relating to this trial; and the registrational potential of any Phase 2 trial we may initiate. Any forward-looking statements in this press release are based on BioNTech current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: discussions with regulatory agencies regarding timing and requirements for additional clinical trials; and the ability to produce favorable clinical results in future clinical trials combining BNT111 and Libtayo. For a discussion of these and other risks and uncertainties, see BioNTech’s Annual Report on Form 20-F filed with the SEC on March 31, 2020, which has been filed with the SEC and is available on the SEC’s website at www.sec.gov. 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.For more information, please contact:Media RelationsJasmina Alatovic Senior Manager Global External Communications Tel: +49 (0)6131 9084 1513 or +49 (0)151 1978 1385 E-mail: Media@biontech.de Investor RelationsSylke Maas, Ph.D. VP Investor Relations & Business Strategy Tel: +49 (0)6131 9084 1074 E-mail: Investors@biontech.de
- Yahoo Finance
Coronavirus update: Sun Belt surge fans recovery fears; Trump ally Herman Cain dies
Grim jobless and economic growth data on Thursday underscored how badly the coronavirus pandemic has damaged the world’s largest economy, as still rising COVID-19 diagnoses amplify concerns for the recovery.
- Benzinga
The Daily Biotech Pulse: Bristol-Myers, Bluebird Bio Resubmit Multiple Myeloma Drug BLA, FSD To Close Medicinal Cannabis Business, Hologic's Blowout Quarter
Scaling The Peaks (Biotech Stocks Hitting 52-week Highs July 29) * Abbott Laboratories (NYSE: ABT) * ABIOMED, Inc. (NASDAQ: ABMD) * Adamis Pharmaceuticals Corp (NASDAQ: ADMP) * Annexon Inc (NASDAQ: ANNX) (went public Friday) * Bio-Rad Laboratories, Inc. Class B (NYSE: BIO-B) * Hologic, Inc. (NASDAQ: HOLX) * Intuitive Surgical, Inc. (NASDAQ: ISRG) * ITAMAR MED LTD/S ADR (NASDAQ: ITMR) * Merit Medical Systems, Inc. (NASDAQ: MMSI) * NeoGenomics, Inc. (NASDAQ: NEO) * Novavax, Inc. (NASDAQ: NVAX) * OncoSec Medical Inc (NASDAQ: ONCS) * Paratek Pharmaceuticals Inc (NASDAQ: PRTK) (moved on rumors of a BARDA loan) * Penumbra Inc (NYSE: PEN) * Qiagen NV (NYSE: QGEN) * Zoetis Inc (NYSE: ZTS)Down In The Dumps (Biotech Stocks Hitting 52-week Lows July 29) * Forma Therapeutics Holdings Inc (NASDAQ: FMTX * Genfit SA (NASDAQ: GNFT) * Gritstone Oncology Inc (NASDAQ: GRTS) * Nkarta Inc (NASDAQ: NKTX) * ORIC Pharmaceuticals Inc (NASDAQ: ORIC) * RA Medical Systems Inc (NYSE: RMED) * Sonnet BioTherapeutics Holdings, Inc. (NASDAQ: SONN) * Tricida Inc (NASDAQ: TCDA) * Verrica Pharmaceuticals Inc (NASDAQ: VRCA)Stocks In Focus Spring Bank To Merge With Privately Held F-Star Therapeutics Spring Bank Pharmaceuticals Inc (NASDAQ: SBPH) said it will merge with privately held F-star Therapeutics, Limited, an oncology-focused biopharma. The merger is to effected as a share exchange transaction.The combined company, operating under the name F-star Therapeutics, will advance F-Star's immuno-oncology pipeline of multiple tetravalent bispecific antibody programs, as well as Spring Bank's STING agonist, SB 11285, which is in a Phase 1/2 clinical trial.Spring Bank shares were up 31.73% at $2.74 premarket Thursday.Bristol-Myers, Bluebird Resubmit Multiple Myeloma Immunotherapy Regulatory ApplicationBristol-Myers Squibb Co (NYSE: BMY) and bluebird bio Inc (NASDAQ: BLUE) said they have resubmitted the NDA for idecabtagene vicleucel, their investigational B-cell maturation antigen-directed chimeric antigen receptor T cell immunotherapy, for the treatment of adult patients with relapsed and refractory multiple myeloma.The submission provides additional details on the Chemistry, Manufacturing and Controls module to address the outstanding regulatory requests from the FDA in May 2020 following the original BLA submission from March 2020.In premarket trading, Bristol-Myers Squibb shares were down 0.76% at $58.70 and Bluebird bio shares were trading 0.58% higher at $62.70.BioNTech Announces Publication Of Positive Phase 1 Data For Cancer Vaccine BioNTech SE - ADR (NASDAQ: BNTX) announced the publication of interim Phase 1 data for its FixVac cancer vaccine program BNT111 in the journal Nature. The company noted that the study evaluated safety and tolerability of vaccinated patients with stage IIIB-C and stage IV melanoma."The interim data shows that BNT111 alone and in combination with PD-1 checkpoint blockade, while being well tolerated, mediates durable objective responses in melanoma patients that had progressed after prior checkpoint blockade," the company said.Vaccine-induced antigen-specific memory T cells persisted for more than one year under continuous monthly vaccination, according to BioNTech.See also: The Week Ahead In Biotech: Spotlight On GW Pharma, Ultragenyx FDA Decisions, Pfizer Earnings Quest Diagnostics Announces EUA For Technique To Increase COVID-19 Molecular Diagnostics Capacity Quest Diagnostics Inc (NYSE: DGX) said the FDA granted emergency use authorization for a new laboratory technique that speeds the process of extracting viral RNA from specimens and will enable the company to expand its daily capacity of COVID-19 molecular diagnostic tests on behalf of patients in the United States.The stock gained 1.81% to $128.41 in after-hours trading.FSD To Close Medicinal Cannabis Operations In Bid To Focus On Pharma Operations FSD Pharma Inc (NASDAQ: HUGE) said it has notified Health Canada of its decision to forfeit the licenses of its wholly owned subsidiary, FV Pharma, and suspend all activities by FV Pharma within 30 days of the notification date.View more earnings on IBBFSD Pharma said it has started the process of liquidating all FV Pharma assets, including the sale of the company's cannabis production facility in Cobourg, Ontario.Instead, the company said it will advance pharmaceutical R&D efforts on its lead compound FSD201, while also continuing to explore the acquisition of other compelling compounds to expand its drug development pipeline.FSD said it is working on submitting an IND to the FDA for the use of FSD201 to treat hospitalized COVID-19 patients. The company also anticipates starting a Phase 2 trial before the end of 2020.The stock was soaring 140.91% to $9.01 premarket Thursday.Imara Lead Asset Gets Fast Track Designation, Rare Pediatric Drug Designation For Beta-Thalassemia Imara Inc (NASDAQ: IMRA) said the FDA granted Fast Track designation and Rare Pediatric Disease designation for its lead clinical asset, IMR-687, for the treatment of beta-thalassemia.Earnings Hologic reported third-quarter revenue of $822.9 million, down 3.5% due to the Cynosure divestiture. Organic revenues were up 7.7%. The company reported non-GAAP EPS of 75 cents, well ahead of the 38-cent-per-share consensus estimate.Citing strong demand for its COVID-19 tests and the ongoing recovery of the other divisions, the company issued above-consensus guidance for the fourth quarter.The stock was up 9.34% premarket at $69.98.Alimera Sciences Inc 's (NASDAQ: ALIM) second-quarter revenue fell 8% year-over-year to $10 million and the loss per share narrowed from $1.06 to 51 cents. Analysts, on average, estimated a loss of $1.61 per share.The stock jumped 32.12% to $8 in after-hours trading.Genocea Announces Positive Initial Phase 1/2 Data For Neoantigen Vaccine Candidate In Advanced Solid Tumors Genocea Biosciences Inc (NASDAQ: GNCA) said initial clinical data on the first five patients from Part B of a Phase 1/2 study that's exploring the combination of GEN-009 and immune checkpoint inhibitor-based regimens in advanced solid tumors showed that three achieved independent RECIST responses starting from the first GEN-009 dose.Overall, two of the first five patients achieved complete responses and three experienced partial responses, the company said.The stock was gaining 6.84% to $4.63 premarket Thursday.Offerings Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI), which saw its shares skyrocket Tuesday following a positive readout, came under pressure after it said it intends to offer shares of its common stock in an underwritten registered public offering. The company priced its 21.67-million-share common stock offering at $3 per share for raising gross proceeds of about $65 million.All of the shares in the offering are to be sold by the company.The stock was down 17.53% premarket to $3.20. On The Radar Earnings * Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX) (before the market open) * Repligen Corporation (NASDAQ: RGEN) (before the market open) * Novocure Ltd (NASDAQ: NVCR) (before the market open) * Blueprint Medicines Corp (NASDAQ: BPMC) (before the market open) * Iradimed Corp (NASDAQ: IRMD) (before the market open) * Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) (before the market open) * Agios Pharmaceuticals Inc (NASDAQ: AGIO) (before the market open) * Eli Lilly And Co (NYSE: LLY) (before the market open) * Elanco Animal Health Inc (NYSE: ELAN) (before the market open) * Evelo Biosciences Inc (NASDAQ: EVLO) (before the market open) * BioTelemetry Inc (NASDAQ: BEAT) (after the close) * MacroGenics Inc (NASDAQ: MGNX) (after the close) * Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) (after the close) * Emergent Biosolutions Inc (NYSE: EBS) (after the close) * Bio-Rad Laboratories, Inc. Class A Common Stock (NYSE: BIO) (after the close) * Anika Therapeutics Inc (NASDAQ: ANIK) (after the close) * Gilead Sciences, Inc. (NASDAQ: GILD) (after the close) * Natus Medical Inc (NASDAQ: NTUS) (after the close) * Retrophin Inc (NASDAQ: RTRX) (after the close) * Veracyte Inc (NASDAQ: VCYT) (after the close) * Ultragenyx Pharmaceutical Inc (NASDAQ: RARE) (after the close) * Globus Medical Inc (NYSE: GMED) (after the close) * Quidel Corporation (NASDAQ: QDEL) (after the close) * EXACT Sciences Corporation (NASDAQ: EXAS) (after the close) * Aimmune Therapeutics Inc (NASDAQ: AIMT) (after the close) * Corvus Pharmaceuticals Inc (NASDAQ: CRVS) (after the close) * MacroGenics Inc (NASDAQ: MGNX) (after the close)Related Link: Pfizer Analyst Says COVID-19-Driven Rally Not Backed By Vaccine Economics See more from Benzinga * The Daily Biotech Pulse: Merck's Breakthrough Therapy Designation, Sonoma Surges On Sanitizer News, Sanofi-Glaxo And More * The Daily Biotech Pulse: Spectrum's Positive Dementia Readout, Pfizer, BioNTech Start Late-Stage Coronavirus Trial, resTORbio Receives COVID-19 Funding(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
- GlobeNewswire
BioNTech Publishes Data from mRNA-based BNT111 FixVac Melanoma Trial in Nature
* Preliminary Phase 1 results from Lipo-MERIT trial with data from 89 patients highlight favorable tolerability profile of BNT111 in advanced melanoma patients * Efficacy analysis in a subset of 42 checkpoint-inhibitor (CPI)-experienced metastatic melanoma patients shows that BNT111 mediates durable responses both as a single agent and in combination with anti-PD-1 antibodies * Durable objective responses by BNT111 are associated with activation and strong expansion of tumor-antigen-specific CD4+ and CD8+ T cells * Phase 2 trial with registrational potential planned to commence in 2020MAINZ, Germany, July 30, 2020 (GLOBE NEWSWIRE) -- BioNTech SE (NASDAQ: BNTX, “BioNTech” or “the Company”), announced today the publication of interim Phase 1 data for the Company’s FixVac cancer vaccine program BNT111 in the journal Nature. The Lipo-MERIT trial is a multicenter, open-label, dose-escalation Phase 1 trial (NCT02410733) to evaluate safety and tolerability of vaccinated patients with stage IIIB-C and stage IV melanoma. The publication titled “An RNA vaccine drives immunity in checkpoint-inhibitor-treated melanoma” summarizes the findings of an exploratory interim analysis (data extraction date July 29, 2019). Safety assessment was performed in 89 advanced melanoma patients treated with intravenously delivered repeated doses of mRNA-based cancer vaccine BNT111 ranging from 7.2µg to 400µg. Overall, BNT111 treatment was well tolerated with no dose limiting toxicity. Most common adverse events were mild to moderate, transient flu-like symptoms, such as pyrexia and chills. Assessment of blood cytokines showed transient upregulation of cytokines such as Interferon-alpha (IFNa), Interferon-gamma (IFNγ) and Interleukin-12 (IL12) in line with a toll-like-receptor (TLR)-mediated antiviral immune modulation critical for expansion of Th1 type antigen-specific T cells.Efficacy was evaluated in a subset of 42 checkpoint-inhibitor (CPI)-experienced patients with radiologically evaluable melanoma assessed by imaging of metastatic lesions before and after vaccination. At the data extraction date, three patients out of 25 patients in the BNT111 monotherapy group experienced a partial response, seven patients showed stable disease and one patient showed a complete metabolic remission of metastatic lesions. Of the 17 patients treated with the combination of BNT111 with anti-PD-1, six patients developed a partial response. Treatment with BNT111 resulted in the expansion and activation of circulating tumor-antigen-specific T cells with memory-function that exhibited strong cytotoxic activity against tumor cells. Vaccine-induced T cells displayed a Th1 phenotype which is of importance for cell-mediated immune responses such as activation of antigen-specific cytotoxic T cells.This interim data shows that BNT111 alone and in combination with PD-1 checkpoint blockade, while being well tolerated, mediates durable objective responses in melanoma patients that had progressed after prior checkpoint blockade. Vaccine-induced antigen-specific memory T cells persisted for more than one year under continuous monthly vaccination.BNT111 is composed of four melanoma antigens (NY-ESO-1, MAGE-A3, tyrosinase, and TPTE) and is the most advanced of five clinical-stage FixVac product candidates within BioNTech’s broader development pipeline. The FixVac platform is an off-the-shelf mRNA immunotherapy approach that targets a fixed combination of shared non-mutated tumor-associated antigens specific to each cancer type.Further FixVac cancer vaccine candidates are currently investigated in Phase 1 clinical trials for prostate cancer (BNT112) (Clinicaltrials.gov Identifier NCT04382898), HPV16-positive cancers (BNT113) (Clinicaltrials.gov Identifier NCT03418480), triple negative breast cancer (BNT114) (Clinicaltrials.gov Identifier NCT02316457) and ovarian cancer (BNT115) (Clinicaltrials.gov Identifier NCT04163094).About FixVac BioNTech’s FixVac platform candidates consist of a fixed combination of mRNA-encoded non-mutated antigens shared within specific cancer types. They feature the Company’s proprietary RNA-lipoplex delivery formulation which is designed to enhance stability and translation of the mRNA cargo as well as specifically target dendritic cells to trigger a strong and precise innate and adaptive immune response against cancer cells overexpressing the respective antigen.About BioNTech Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. 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. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Genevant, Fosun Pharma, and Pfizer.For more information, please visit www.BioNTech.de.BioNTech Forward-looking Statements This press release contains “forward-looking statements” of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, statements concerning: BioNTech’s FixVac program candidate BNT111; timing for commencement of a Phase 2 trial; and the registrational potential of any Phase 2 trial we may initiate for BNT111. Any forward-looking statements in this press release are based on BioNTech current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: discussions with regulatory agencies regarding timing and requirements for additional clinical trials; and the ability to produce comparable clinical results in future clinical trials. For a discussion of these and other risks and uncertainties, see BioNTech’s Annual Report on Form 20-F filed with the SEC on March 31, 2020, which has been filed with the SEC and is available on the SEC’s website at www.sec.gov. 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.For more information, please contact:Media Relations Jasmina Alatovic Senior Manager Global External Communications Tel: +49 (0)6131 9084 1513 or +49 (0)151 1978 1385 E-mail: Media@biontech.deInvestor Relations Sylke Maas, Ph.D. VP Investor Relations & Business Strategy Tel: +49 (0)6131 9084 1074 E-mail: Investors@biontech.de
- Barrons.com
Glaxo and Sanofi to Provide Covid-19 Vaccine to the U.K. ‘We Don’t Expect to Profit.’
A rift is opening between drug companies that say they plan to profit off their vaccines and those that won’t.
- Barrons.com
Pfizer CEO Says Companies Should Make Profit On Covid-19 Vaccines
Albert Bourla, (PFE)’s CEO, has no patience for the argument that pharmaceutical companies should not be making a profit on the drugs and vaccines they introduce to fight Covid-19. “I think it’s very wrong,” Bourla told Barron’s on Tuesday. The private sector found the solution for diagnostics, and the private sector found the solution for therapeutics and is along [the] way to find more solutions for therapeutics and vaccines.
- Investor's Business Daily
Pfizer Earnings Top, Coronavirus Vaccine Enters Phase 3 Trial; Dow Stock Nears Buy Point
Pfizer earnings beat second-quarter views from Wall Street after the Dow Jones giant said its coronavirus vaccine has started a Phase 3 trial. Pfizer stock rose, nearing a buy point.
- Yahoo Finance Video
Coronavirus latest: Tuesday, July 28
On late Monday evening, Pfizer and BioNTech announced that they were starting their late-stage human trial of their coronavirus vaccine. This comes as Kodak received the first Defense Production Act loan for $765 million to increase domestic production for ingredients used in generic drugs. Yahoo Finance’s Anjalee Khemlani breaks down the latest news about the coronavirus on The Final Round.
- Yahoo Finance Video
Analyst: Pfizer’s COVID-19 vaccine candidate is ‘biggest near-term catalyst’ for co.
CFRA Research Equity Analyst Sel Hardy joins Yahoo Finance’s Akiko Fujita to break down Pfizer’s second quarter earnings beat, and discuss the company’s global coronavirus vaccine trial.
- Yahoo Finance
Coronavirus update: Pfizer starts Phase 3 trial as Fauci voices optimism on vaccine timeline
The global search for a coronavirus vaccine appears to be taking flight, with a number of drug companies making headway on a possible treatment.
- Bloomberg
Pfizer’s October Goal in Vaccine Race Scrutinized by Street
(Bloomberg) -- Wall Street analysts and specialists are weighing the possibility that Pfizer Inc. and BioNTech SE may file their Covid-19 vaccine candidate with regulators by October after the pair said a late-stage Covid-19 vaccine study kicked off on Monday evening.Pfizer rose Tuesday on the announcement with its German partner, just hours after similar news from Moderna Inc. With AstraZeneca Plc already in Phase 3, it’s a “three-horse race,” Jared Holz said from the Jefferies health-care trading desk. “The government involvement makes us think we could hear anecdotal reports of trial progress even before the interim data is available later in the year,” he wrote to clients.Holz expects at least one vaccine will get an emergency use authorization before November, which many have thought may give President Donald Trump a new foothold in the election as his polling numbers slip in favor of Democratic contender Joe Biden. But not everyone is as optimistic over an October timeline.UBS analyst Navin Jacob said Pfizer’s program may have a “slight edge” over Moderna, but a Centers for Disease Control adviser that Jacob spoke with cast doubts about the October target. Some on Wall Street also reflected surprise that the vaccine candidate Pfizer and BioNTech selected was not the same shot that investors had seen detailed data from.Pfizer rose as much as 2.7% on Tuesday after posting second-quarter earnings that topped estimates and increasing its sales forecast. UBS, Navin JacobJacob spoke to an expert from the CDC’s Advisory Committee on Immunization Practices, who said an autumn 2020 readout from a Phase 3 trial would be “a stretch” as the rate of new infections for patients in the trial would likely be too slow. He predicted an initial look at results was more likely to come in the first half of next year.Jacob said Pfizer’s international study may have an advantage over Moderna’s U.S. based study if the trial is in areas where Covid-19 is quickly spreading. He was also positive on the results seen so far which seem to indicate the BNT162 program “may have slightly better efficacy.”SVB Leerink, Geoffrey PorgesThe selection of BNT162b2, “though a clear possibility,” according to Porges, “was somewhat of a surprise given the companies shared detailed data for BNT162b1, which vaccinates against the receptor binding domain (RBD) of the spike protein.” He expects the decision was driven by potentially better immune responses in older adults.“All leading companies are now targeting the spike protein, highlighting correlated clinical risk and long-term market erosion risk,” Porges said. That concentration calls into question the long-term viability of a market for these vaccines, he said.Pfizer’s vaccine appears to be enrolling in hotspots amid state reopenings, “inclusion of all these sites could increase the speed for enrollment, as well as shorten the time for accumulating enough events.”Barclays, Carter Gould“We previously viewed recent BNT162b1 data as the most promising vaccine candidate to date, and b2 at least directionally appears to have a better profile,” though the analyst notes more details are needed.He expects further characterization of BNT162b2, as well as details on the recent $1.95 billion contract with the U.S., and EU efforts to secure access, to be discussed on Tuesday’s call.Pfizer’s call is set to start at 10 a.m. in New York.(Updates shares in fifth paragraph.)For more articles like this, please visit us at bloomberg.comSubscribe now to stay ahead with the most trusted business news source.©2020 Bloomberg L.P.
- Benzinga
The Daily Biotech Pulse: Spectrum's Positive Dementia Readout, Pfizer, BioNTech Start Late-Stage Coronavirus Trial, resTORbio Receives COVID-19 Funding
Scaling The Peaks (Biotech Stocks Hitting 52-week Highs July 27) * Arcturus Therapeutics Holdings Inc (NASDAQ: ARCT) * Bio-Rad Laboratories, Inc. Class B Common Stock (NYSE: BIO) * Fulgent Genetics Inc (NASDAQ: FLGT) * Genocea Biosciences Inc (NASDAQ: GNCA) * Inozyme Pharma Inc (NASDAQ: INZY) (went public Friday) * ITAMAR MED LTD/S ADR (NASDAQ: ITMR) * MediciNova, Inc. (NASDAQ: MNOV) (announced an agreement with BioComoor to jointly develop a SARS-CoV-2 vaccine) * Mediwound Ltd (NASDAQ: MDWD) * Nurix Therapeutics Inc (NASDAQ: NRIX) (went public Friday) * Penumbra Inc (NYSE: PEN) * Qiagen NV (NYSE: QGEN) * RENALYTIX AI ADR (NASDAQ: RNLX) * Trevena Inc (NASDAQ: TRVN)Down In The Dumps (Biotech Stocks Hitting 52-week Lows July 27) * Annexon Inc (NASDAQ: ANNX) (went public Friday) * Fusion Pharmaceuticals Inc (NASDAQ: FUSN) * Happiness Biotech Group Ltd (NASDAQ: HAPP) * Immatics NV (NASDAQ: IMTX) * Nkarta Inc (NASDAQ: NKTX) * ORIC Pharmaceuticals Inc (NASDAQ: ORIC) * Psychemedics Corp. (NASDAQ: PMD) * Repare Therapeutics Inc (NASDAQ: RPTX) * Tricida Inc (NASDAQ: TCDA) * Verrica Pharmaceuticals Inc (NASDAQ: VRCA)Stocks In Focus Spectrum's Cancer Drug Meets Primary Endpoint In Late-Stage Registrational Trial Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI) announced that its ZENITH20 Phase 2 clinical trial evaluating poziotinib in previously treated non-small cell lung cancer patients with HER2 exon 20 insertion mutations, enrolled in Cohort 2, met the pre-specified primary endpoint.The intent-to-treat analysis demonstrated a confirmed objective response rate of 27.8%, the company said. The median duration of response was 5.1 months, with a median follow up of 8.3 months. The disease control rate was 70% and the median progression-free survival was 5.5 months.On safety, the company said the safety profile was in line with the type of adverse events seen with other second-generation EGFR tyrosine kinase inhibitors and similar to Cohort 1."There are currently no approved therapies for HER2 patients with exon 20 insertion mutations in NSCLC and we are looking forward to reviewing this data with the FDA to determine the path forward," said Francois Lebel, Spectrum's chief medical officer. The company said it is in the process of requesting a meeting with the FDA to discuss the data and its plans for a NDA submission.The stock was jumping 50.93% to $4.89 premarket Tuesday.Lumos To Sell Priority Review Voucher To Merck For $60M Lumos Pharma Inc (NASDAQ: LUMO) said it has entered into a definitive agreement to sell its Priority Review Voucher to Merck & Co., Inc. (NYSE: MRK).The PRV was granted in conjunction with the FDA approval of Ervebo, a vaccine developed by its licensee, Merck, for the prevention of the Ebola virus disease.Under the terms of the original license agreement, Lumos Pharma is entitled to retain 60% of the value of the PRV. Based upon an agreed valuation of $100 million, Merck will now pay Lumos $60 million.The stock was up 9.79% at $16.26 premarket.Pfizer, BioNTech Finalize Coronavirus Vaccine Candidate, Start Phase 2/3 Study Close on the heels of Moderna Inc (NASDAQ: MRNA) initiating a late-stage study of its coronavirus vaccine candidate, Pfizer Inc. (NYSE: PFE) and BioNTech SE - ADR (NASDAQ: BNTX) announced the start of a global Phase 2/3 safety and efficacy study to evaluate a single nucleoside-modified.The companies said they have decided to advance their BNT162b2 vaccine candidate into the Phase 2/3 study at 30mcg dose levels in a two-dose regimen.Separately, Pfizer reported forecast-beating results for its second quarter and raised its 2020 guidance.Pfizer shares were up 3.6% at $38.89 premarket, while BioNTech shares were higher by 3.6% at $38.89.See also: The Week Ahead In Biotech: Spotlight On GW Pharma, Ultragenyx FDA Decisions, Pfizer Earnings Reata Announces Investigator-Sponsored Study Of COVID-19 Drug Reata Pharmaceuticals Inc (NASDAQ: RETA) said researchers at NYU Grossman School of Medicine are initiating an investigator-sponsored trial dubbed BARCONA to study the effect of bardoxolone methyl in patients suffering from COVID-19.The company said it is providing drug supply for the trial and NYU will initiate the Phase 2 study with a primary endpoint of safety.Prevail Awarded Composition Of Matter Patent For Dementia Gene Therapy Candidate Prevail Therapeutics Inc (NASDAQ: PRVL) said the U.S. Patent and Trademark Office on June 23 issued a composition of matter patent, with claims directed to the AAV vector used in PR006, its experimental gene therapy program for the treatment of frontotemporal dementia patients with GRN mutations.The base patent term extends until October 2038, excluding patent term extensions or coverage in additional related patent filings, the company said.In after-hours trading, the stock added 3.34% to $16.69.resTORbio Announces National Institute On Aging Funding For COVID-19 Study resTORbio, Inc. (NASDAQ: TORC) said the National Institute on Aging has agreed to fund a randomized, double-blind, placebo-controlled pilot study of RTB101, an investigational, orally administered potent small molecule inhibitor of target of rapamycin complex 1, as compared to placebo for COVID-19 post-exposure prophylaxis in older adults.The study is supported by additional data observed in resTORbio's Phase 2b and Phase 3 clinical trials, which suggest the potential of RTB101 to reduce the severity of laboratory-confirmed coronavirus infections as previously announced, the company said.View more earnings on IBBThe stock was advancing 10.32% to $2.78 premarket Tuesday.AstraZeneca's Diabetes Drug Aces Late-Stage Study In Kidney Disease AstraZeneca plc (NYSE: AZN) said FARXIGA significantly reduced the worsening of renal function or risk of death in patients with chronic kidney disease with and without Type 2 diabetes in a Phase 3 trial.Earnings Medpace Holdings Inc (NASDAQ: MEDP) reported second-quarter revenue that fell 4.3% to $205 million, and GAAP net income fell from 73 cents per share to 64 cents per share.The company guided to full-year revenue of $880 million to $920 million and EPS of $3.62-$3.83. Analysts, on average, estimate revenue of $839.49 million and EPS of $2.56.The stock was up 11.29% at $125 premarket Tuesday.Crispr Therapeutics AG's (NASDAQ: CRSP) second-quarter collaboration revenues fell from $300,000 in 2019 to $100,000 in 2020. The net loss per share widened from $1.01 to $1.30. Analysts had estimated a loss for 95 cents for the quarter.The stock lost 5.18% to $87.35 premarket Tuesday.Offerings Allena Pharmaceuticals Inc (NASDAQ: ALNA) said it has entered into an underwriting agreement with H.C. Wainwright & Co., under which the underwriter has agreed to purchase on a firm commitment basis 5.125 million shares of its common stock at a price to the public of $1.30 per share, for gross proceeds of $6.7 million.The stock was slipping 16.23% to $1.29 premarket. Nemaura Medical Inc (NASDAQ: NMRD) said it intends to offer for sale shares of its common stock and warrants to purchase shares of its common stock in an underwritten public offering.The stock was down 21.81% at $7.24 premarket.BioXcel Therapeutics Inc (NASDAQ: BTAI) said it has commenced an underwritten public offering of $200 million in shares of its common stock.The company said it intends to use the net proceeds of this offering to fund ongoing clinical trials, commercialization preparation and for general corporate purposes.The stock was down 2.91% at $56.69 premarket Tuesday.Zentalis Pharmaceuticals Inc Inc (NASDAQ: ZNTL) announced the commencement of a proposed underwritten public offering of 3.75 million shares of its common stock. All the shares are being offered by the company.CorMedix Inc. (NYSE: CRMD) said it plans to offer shares of its common stock in an underwritten public offering. The company plans to use the net proceeds for general corporate purposes, including obtaining regulatory approval and commercialization of Defencath in the U.S., R&D, and working capital and capital expenditures.The stock was down 13.17% at $5.21 premarket.Tcr2 Therapeutics Inc (NASDAQ: TCRR) said it has commenced an underwritten public offering of 6 million shares of its common stock. The company intends to use the net proceeds of the offering to advance its clinical and earlier stage programs and for R&D, working capital and general corporate purposes.The stock was up 4.33% at $17.10 premarket.On The Radar Clinical Readouts Alector Inc (NASDAQ: ALEC) will present at the Alzheimer's Association International Conference, or AAIC, preliminary data from a Phase 2 open-label study evaluating AL001 in individuals with frontotemporal dementia.vTv Therapeutics Inc (NASDAQ: VTVT) is due to present at the AAIC analysis of already-released Phase 3 data for Azeliragon in mild Alzheimer's disease.Earnings * Exagen Inc (NASDAQ: XGN) (before the market open) * Pfizer (reported Q2 revenue of $11.8 billion and adjusted EPS of 78 cents vs. consensus estimate of $11.55 billion and 66 cents, and raised FY20 guidance) * Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) (before the market open) * Masimo Corporation (NASDAQ: MASI) (after the close) * AtriCure Inc. (NASDAQ: ATRC) (after the close) * Amgen, Inc. (NASDAQ: AMGN) (after the close) * NeoGenomics, Inc. (NASDAQ: NEO) (after the close) * DexCom, Inc. (NASDAQ: DXCM) (after the close) * Infinity Pharmaceuticals Inc. (NASDAQ: INFI) (after the close)Related Link: Pfizer Analyst Says COVID-19-Driven Rally Not Backed By Vaccine Economics See more from Benzinga * The Daily Biotech Pulse: Mixed Tidings From Novavax, Radius Health Out-licenses Breast Cancer Drug, 3 IPOs * The Daily Biotech Pulse: Midatech Shelves Sale Plan, G1 Therapeutics Out-Licenses, Entera Bio Jumps On Survey Results(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
- MarketWatch
Pfizer's stock surges after profit and revenue beats, raised guidance
Shares of Pfizer Inc. surged 3.4% in premarket trading Tuesday, after the drug maker reported profit and revenue that beat expectations and raised its full-year outlook, despite the challenges resulting from the COVID-19 pandemic. The results come after Pfizer and BioNTech SE said late Monday that a late-stage trial of its COVID-19 vaccine candidate has started. Pfizer reported net income that fell to $3.43 billion, or 61 cents a share, from $5.05 billion, or 89 cents a share, in the year-ago period. Excluding non-recurring items, adjusted earnings per share fell to 78 cents form 80 cents but beat the FactSet consensus of 67 cents. Revenue declined 11% to $11.80 billion but was above the FactSet consensus of $11.58 billion. Biopharma revenue rose 4% to $9.80 billion while Upjohn revenue dropped 32% to $2.01 billion. For 2020, the company raised its guidance ranges for adjusted EPS to $2.85 to $2.95 from $2.82 to $2.92 and for revenue to $48.6 billion to $50.6 billion from $48.5 billion to $50.5 billion. The stock has slipped 4.2% year to date through Monday, while the Dow Jones Industrial Average has declined 6.9%.
