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Astria Therapeutics

Certara (NASDAQ: CERT) Stock Quote

Last Trade: US$10.71 0.16 1.52
Volume: 2,102,663
5-Day Change: -8.54%
YTD Change: -39.11%
Market Cap: US$1.720B

Latest News From Certara

RADNOR, Pa., Dec. 02, 2024 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today showcases its impact on research by celebrating more than 100 publications secured in 2024 as well as the 12 Certara scientists included on the 2024 Stanford/Elsevier list, which highlights the top 2% of the most cited scientists across the globe. Stanford/Elsevier's Top 2% Scientist Ranking... Read More
RADNOR, Pa., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today reported its financial results for the third quarter of fiscal year 2024. Third Quarter Highlights: Revenue was $94.8 million, compared to $85.6 million in the third quarter of 2023, representing growth of 11%. Software revenue was $35.9 million, compared to $31.3 million in the third quarter... Read More
RADNOR, Pa., Oct. 28, 2024 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today announced that Company management will participate in the Stephens Annual Investment Conference. Company management will present at 10:00AM CT on Thursday, November 21 st , 2024. A live webcast of the event will be available on Certara’s investor relations website at https://ir.certara.com... Read More
RADNOR, Pa., Oct. 16, 2024 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today announced the appointment of John Reynders, PhD, to its Board of Directors, effective October 15, 2024. “We are excited to welcome an accomplished pharmaceutical industry leader with a track record of success to Certara’s Board,” said William F. Feehery , PhD, CEO of Certara. “John’s... Read More
RADNOR, Pa., Oct. 09, 2024 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today announced that it will release financial results for the third quarter of 2024 after the market close on Wednesday, November 6 th , 2024. Company management will host a conference call to discuss financial results at 5:00PM ET. Investors interested in listening to the conference call are... Read More
RADNOR, Pa., Oct. 02, 2024 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today announced it has completed the acquisition of Chemaxon. Chemaxon develops leading scientific informatics software products used by the life sciences industry for in-silico research. Certara develops advanced modeling and biosimulation solutions used to predict the pharmacokinetic and... Read More
RADNOR, Pa., Sept. 24, 2024 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today announces the celebration of the 25 th anniversary of the Simcyp® Consortium. The Simcyp Consortium has become a global authority on mechanistic physiologically-based pharmacokinetic (PBPK) modeling and simulation. With members from 35 leading biopharmaceutical companies, the Simcyp®... Read More
RADNOR, Pa., Sept. 18, 2024 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today shared the results from its collaboration with Ichnos Glenmark Innovation (IGI) on the first-in-human dose prediction and selection for ISB 2001. IGI’s drug candidate is a trispecific T-cell engager (TCE) being studied as a potential cancer treatment. Preclinical research and biosimulation... Read More
RADNOR, Pa., Aug. 21, 2024 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today announced that Company management will participate in the following investor conferences: Morgan Stanley 22 nd Annual Global Healthcare Conference Date and Time: Wednesday, September 4 at 4:05 p.m. ET Baird Global Healthcare Conference Date and Time: Wednesday, September 11 at 10:15 a.m. ET... Read More
RADNOR, Pa., Aug. 15, 2024 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today announced the launch of Phoenix™ version 8.5. Phoenix is the pharmaceutical industry's gold standard in pharmacokinetic/pharmacodynamic (PK/PD) and toxicokinetic modeling and simulation software. The Phoenix Platform is used by more than 75 of the top 100 pharmaceutical companies worldwide.... Read More
RADNOR, Pa., Aug. 06, 2024 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today reported its financial results for the second quarter of fiscal year 2024. Second Quarter Highlights: Revenue was $93.3 million, compared to $90.5 million in the second quarter of 2023, representing growth of 3%. Software revenue was $38.2 million, compared to $33.7 million in the second... Read More
Combined organization brings broader predictive capabilities to drug discovery at scale Reiterates full year 2024 guidance RADNOR, Pa., July 09, 2024 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today announced it has signed a definitive agreement to acquire Chemaxon, a leading provider of cheminformatics software. The transaction is expected to close in the second... Read More
RADNOR, Pa., July 02, 2024 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today announced that it will release financial results for the second quarter of 2024 after the market close on Tuesday, August 6 th , 2024. Company management will host a conference call to discuss financial results at 5:00PM ET. Investors interested in listening to the conference call are... Read More
RADNOR, Pa., June 17, 2024 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today unveiled its next-generation CoAuthor regulatory writing software. CoAuthor is an advanced writing platform designed for medical writers. It combines generative AI, document templates, Microsoft Word integration, and structured content authoring tools. CoAuthor accelerates the creation of... Read More
RADNOR, Pa., May 29, 2024 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that Company management will participate in the Jefferies Global Healthcare Conference. Company management will present at 11:30AM ET on Wednesday, June 5 th , 2024. A live webcast of the event will be available on Certara’s investor relations website at https://ir.certara.com and will be available... Read More
RADNOR, Pa., May 21, 2024 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, has appointed Rona Anhalt as Chief Human Resources Officer and Daniel Corcoran as General Counsel. "Rona and Daniel are leaders in their fields. They have proven track records of growing teams and building high-performing businesses," said William F. Feehery Ph.D., CEO , Certara. "I’m confident they... Read More
PRINCETON, N.J., May 07, 2024 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today reported its financial results for the first quarter of fiscal year 2024. First Quarter Highlights: Revenue was $96.7 million, compared to $90.3 million in the first quarter of 2023, representing growth of 7%. Software revenue was $39.3 million, compared to $33.0 million in the first quarter of 2023,... Read More
PRINCETON, N.J., April 16, 2024 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today announced the launch of Certara Cloud, the unifying platform that integrates its many scientific software solutions. Customers log into Certara Cloud using a single ID to access and manage their licensed software, linking predictive solutions to modeling and analysis of clinical trial... Read More
PRINCETON, N.J., April 09, 2024 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that it will release financial results for the first quarter of 2024 after the market close on Tuesday, May 7 th , 2024. Company management will host a conference call to discuss financial results at 5:00PM ET. Investors interested in listening to the conference call are required to register... Read More
PRINCETON, N.J., Feb. 29, 2024 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today reported its financial results for the fourth quarter of fiscal year 2023. Fourth Quarter Highlights: Revenue was $88.0 million, compared to $86.6 million in the fourth quarter of 2022, representing growth of 2% over the fourth quarter of 2022. Strong sequential growth with record software bookings and... Read More
PRINCETON, N.J., Feb. 01, 2024 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that it will release financial results for the fourth quarter and full year of 2023 after the market close on Thursday, February 29 th , 2024. Company management will host a conference call to discuss financial results at 5:00PM ET. Investors interested in listening to the conference call are... Read More
PRINCETON, N.J., Dec. 13, 2023 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT) today announced it has acquired Applied BioMath, an industry-leader in providing model-informed drug discovery and development support to help accelerate and de-risk therapeutic research and development (R&D). Together, Certara and Applied BioMath are the life sciences industry’s largest team of experts in quantitative systems pharmacology (QSP),... Read More
PRINCETON, N.J., Nov. 21, 2023 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced the introduction of Simcyp™ Biopharmaceutics software. It is designed for use by biopharmaceutic, formulation, and CMC scientists to aid in formulating complex novel and generic small molecule medicines quickly and cost effectively. Simcyp Biopharmaceutics software is part of the Simcyp Simulator... Read More
PRINCETON, N.J., Nov. 08, 2023 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today reported its financial results for the third quarter of fiscal year 2023. Third Quarter Highlights: Revenue was $85.6 million, compared to $84.7 million in the third quarter of 2022, representing growth of 1% over the third quarter of 2022. Broad based recovery in services bookings during the quarter. Net... Read More
PRINCETON, N.J, Oct. 11, 2023 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that it will release financial results for the third quarter of 2023 after the market close on Wednesday November 8 th , 2023. Company management will host a conference call to discuss financial results at 5:00PM ET. Investors interested in listening to the conference call are required to register... Read More
PRINCETON, N.J., Sept. 19, 2023 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced it has successfully supported 300 completed submissions to regulatory agencies worldwide. Submissions include those to initiate clinical trials, such as Investigational New Drug (IND) or Clinical Trial Application (CTA) and marketing applications, such as New Drug Applications (NDA), Marketing... Read More
PRINCETON, N.J., Aug. 29, 2023 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that Company management will participate in the following investor conferences: Morgan Stanley 21 st Annual Global Healthcare Conference Date and Time: Tuesday, September 12 at 5:30 p.m. ET Baird Global Healthcare Conference Date and Time: Wednesday, September 13 at 3:45 p.m. ET Live webcasts for... Read More
PRINCETON, N.J., Aug. 29, 2023 (GLOBE NEWSWIRE) -- Certara (Nasdaq: CERT), a global leader in biosimulation, today announced that the Simcyp group has been awarded two new grants from the U.S. Food and Drug Administration (FDA) to expand its predictive models for assessing drug virtual bioequivalence (VBE) and to create a formulation toolbox for topically applied drugs. These capabilities will help enable safer, faster and... Read More
PRINCETON, N.J., Aug. 09, 2023 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today reported its financial results for the second quarter of fiscal year 2023. Second Quarter Highlights: Revenue was $90.5 million, compared to $82.8 million in the second quarter of 2022, representing growth of 9% over the second quarter of 2022 on a reported basis and 10% at constant currency. Net income... Read More
PRINCETON, N.J., July 13, 2023 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that it will release financial results for the second quarter of 2023 after the market close on Wednesday, August 9 th , 2023. Company management will host a conference call to discuss financial results at 5:00PM ET. Investors interested in listening to the conference call are required to... Read More
PRINCETON, N.J., June 02, 2023 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that Company management will participate in the Jefferies Global Healthcare Conference. Company management will present at 1:30PM ET on Wednesday, June 7 th , 2023. A live webcast of the event will be available on Certara’s investor relations website at https://ir.certara.com and will be... Read More
PRINCETON, N.J., May 08, 2023 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today reported its financial results for the first quarter of fiscal year 2023. First Quarter Highlights: Revenue was $90.3 million, compared to $81.6 million in the first quarter of 2022, representing growth of 11% over the first quarter of 2022 on a reported basis and 13% at constant currency. Net income was... Read More
PRINCETON, N.J., April 27, 2023 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that 90 percent of new drug approvals by the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Review (CDER) were received by Certara’s customers in 2022. * This is the 9th consecutive year that Certara’s customers, who use the Company’s biosimulation software and... Read More
PRINCETON, N.J., April 10, 2023 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that it will release financial results for the first quarter of 2023 after the market close on Monday, May 8 th , 2023. Company management will host a conference call to discuss financial results at 5:00PM ET. Investors interested in listening to the conference call are required to register... Read More
NEW YORK , March 15, 2023 /PRNewswire/ -- S&P Dow Jones Indices will make the following changes to the S&P MidCap 400 and S&P SmallCap 600: CVR Energy Inc. (NYSE: CVI) will replace Atlas Air Worldwide Holdings Inc. (NASD: AAWW) in the S&P SmallCap 600 effective prior to the opening of trading on Tuesday, March 21 . Apollo Global Management Inc. (NYSE: APO) is acquiring Atlas Air Worldwide Holdings in a transaction expected... Read More
PRINCETON, N.J., March 09, 2023 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, is adding deep learning capabilities to D360 , a leading scientific informatics software platform. The addition of novel A.I. will enable discovery scientists to integrate multiple structured and unstructured data sources and substantially enhance predictions and analysis of content related to small molecules... Read More
PRINCETON, N.J., March 07, 2023 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced the release of Simcyp Simulator Version 22, which includes new capabilities and updated features to the Company’s population-based modeling and simulation platform. The Simcyp Simulator is the pharmaceutical industry’s most sophisticated physiologically based pharmacokinetics (PBPK) platform and... Read More
PRINCETON, N.J., March 01, 2023 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today reported its financial results for the fourth quarter and full year of 2022 and issued guidance for 2023. Fourth Quarter Highlights: Revenue was $86.6 million, compared to $75.3 million in the fourth quarter of 2021, representing growth of 15% over the fourth quarter of 2021 on a reported basis and 18% at... Read More
PRINCETON, N.J., March 01, 2023 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), announced today that John Gallagher will succeed Andrew Schemick as Chief Financial Officer, effective April 1, 2023. Mr. Schemick will transition into a newly created position as Senior Vice President, Corporate Operations and Integration, and he will be focused on supporting John’s transition, and then building operational excellence as... Read More
PRINCETON, N.J., Feb. 27, 2023 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that Company management will participate in the Barclays Global Healthcare Conference. Company management will present at 11:15AM ET on Wednesday, March 15 th , 2023. A live webcast of the event will be available on Certara’s investor relations website at https://ir.certara.com and will be... Read More
PRINCETON, N.J., Feb. 01, 2023 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that it will release financial results for the fourth quarter and full year of 2022 after the market close on Wednesday, March 1 st , 2023. Company management will host a conference call to discuss financial results at 5:00 p.m. ET. Investors interested in listening to the conference call are... Read More
PRINCETON, N.J., Jan. 04, 2023 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), today announced it has acquired Vyasa Analytics, LLC. Vyasa provides scalable deep-learning software which allows life sciences organizations to perform predictions and answer complex questions across structured and unstructured bio-medical information. The acquisition will elevate Certara’s software by bringing state-of-the-art artificial... Read More
Certara, Inc ., (Nasdaq: CERT) a global leader in biosimulation, today announced that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has renewed its licenses of Certara’s Simcyp™ Simulator, Phoenix™ biosimulation software, and Pinnacle 21™ Enterprise software. “The adoption of biosimulation and technology to advance novel drug development continues to grow in Japan,” said Certara’s CEO William Feehery, Ph.D.... Read More
Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that it will release financial results for the third quarter of 2022 after the market close on Monday, November 7 th , 2022. Company management will host a conference call to discuss financial results at 5:00 p.m. ET. Investors interested in listening to the conference call are required to register online . It is recommended to register at least... Read More
Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that Company management will participate in the following investor conferences: • Morgan Stanley 20 th Annual Global Healthcare Conference Date and Time: Tuesday, September 13 at 11:45 a.m. ET • Baird Global Healthcare Conference Date and Time: Wednesday, September 14 at 12:15 p.m. ET Live webcasts for each of the conferences will be available on... Read More
Certara, Inc. (Nasdaq: CERT) (“Certara”), a global leader in biosimulation, today announced the sale by certain stockholders (the “Selling Stockholders”), including EQT Avatar Parent L.P., in an underwritten secondary offering of 7,000,000 shares of common stock of Certara pursuant to a registration statement filed by Certara with the U.S. Securities and Exchange Commission (the “SEC”). In connection with the offering, the... Read More
Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today reported its financial results for the second quarter of fiscal year 2022 and adjusted its full year guidance. Second Quarter Highlights: Revenue was $82.8 million, compared to $70.1 million in the second quarter of 2021, representing growth of 18% over the second quarter of 2021 on a reported basis and 21% at constant currency. Excluding Pinnacle 21,... Read More
Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced the feature release 5.2.0 of Pinnacle 21 Enterprise, the Company’s flagship software for validating clinical trial data for biosimulation and regulatory submissions. It also introduced the new Pinnacle 21 Data Exchange product, an integrated module that streamlines the process of ingesting clinical trial data from external sources. “The volume... Read More
Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced a 2-year collaboration with Memorial Sloan Kettering Cancer Center (MSK) to develop new biosimulation software. Certara will be working with the MSK Innovation Hub to create a Chimeric antigen receptor (CAR) T-cell therapy biosimulation platform. CAR T-cell therapy is an immunotherapy that uses specially altered T-cells in the immune system to... Read More
Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced the appointment of Rosemary Crane to its Board of Directors, effective July 21, 2022. Her appointment brings the company’s board of directors to eleven members. “We are excited to welcome an accomplished business leader with a proven track record of success join Certara’s Board,” said William F. Feehery, PhD, CEO of Certara. “Rose’s experience in... Read More
Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced the appointment of Eran Broshy to its Board of Directors, effective July 11, 2022. His appointment brings the company’s board of directors to ten members. “Eran has a proven track record taking high-growth healthcare businesses to the next level and delivering superior results,” said William Feehery, Ph.D., CEO of Certara. “Certara is excited to... Read More
Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that it will release financial results for the second quarter of 2022 after the market close on Tuesday, August 9 th , 2022. Company management will host a conference call to discuss financial results at 5:00 p.m. ET. Investors interested in listening to the conference call are required to register online . It is recommended to register at least... Read More
Certara (Nasdaq: CERT), a global leader in biosimulation, today announced the release of Simcyp Discovery Simulator, a new software designed for scientists working in small molecule drug discovery and translational research. Derived from the industry-leading Simcyp Simulator, Simcyp Discovery increases confidence in early-stage development decisions using physiologically-based pharmacokinetic (PBPK) modeling and simulation.... Read More
Certara , a global leader in biosimulation, today announced the release of new versions of its Immunogenicity (IG), Immuno-oncology (IO) and Vaccine Simulators to help predict how drugs work and address key questions in the development of novel biologic therapies. “The latest versions of our simulators help tackle some of the toughest challenges in drug discovery and development with complex biologics,” said William F.... Read More
Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today reported its financial results for the first quarter of fiscal year 2022. First Quarter Highlights: Revenue was $81.6 million, compared to $66.7 million in the first quarter of 2021, representing growth of 22% over the first quarter of 2021. Excluding Pinnacle 21, revenue was $75.6 million, representing growth of 13% over the first quarter of 2021. Net... Read More
Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that Company management will participate in the following investor conferences: Bank of America 2022 Healthcare Conference Date and Time: Tuesday, May 10 at 3:00 p.m. ET Citi’s Biopharma Virtual Co-Panel Day Date and Time: Wednesday, May 18 at 10:00 a.m. ET Jefferies Healthcare Conference Date and Time: Wednesday, June 8 – Friday, June 10 Details... Read More
Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that it will release financial results for the first quarter of 2022 after the market close on Thursday, May 5 th , 2022. Company management will host a conference call to discuss financial results at 5:00 p.m. ET. Investors interested in listening to the conference call may do so by dialing (833) 360-0946 for domestic callers or (914) 987-7661... Read More
Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today reported its financial results for the fourth quarter and full year of 2021 and updated guidance for 2022. Fourth Quarter Highlights: Revenue was $75.3 million, compared to $64.6 million in the fourth quarter of 2020, representing growth of 17% over the fourth quarter of 2020. Excluding Pinnacle 21, revenue was $69.3 million, representing growth of 7% over... Read More
Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that the U.S. Food and Drug Administration (FDA) has licensed Certara’s Immunogenicity (IG) Simulator to research and evaluate immunogenicity in protein-based therapeutics. Certara’s IG Simulator predicts the immune response of therapeutics in development, which is important to guide clinical and regulatory decision-making. “The FDA’s decision to... Read More
Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that 90 percent of new drug approvals by the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Review (CDER) were received by Certara’s customers in 2021, excluding diagnostic agents. This is the 8 th consecutive year that Certara’s customers, who use the Company’s biosimulation software and technology-driven services, have... Read More
Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that it will release financial results for the fourth quarter and full year of 2021 after the market close on Tuesday, March 1 st , 2022. Company management will host a conference call to discuss financial results at 5:00 p.m. ET. Investors interested in listening to the conference call may do so by dialing (833) 360-0946 for domestic callers or... Read More
Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that the U.S. Food and Drug Administration (FDA) has renewed and expanded its licenses of Certara’s proprietary biosimulation software, with more than 400 user licenses of Simcyp and Phoenix software. In total, there are 12 divisions and offices of the FDA using Certara’s software for internal research and to independently analyze, verify and... Read More
Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced the feature release of Pinnacle 21 Enterprise 5.1.0, which updates the Company’s flagship software for preparing clinical trial data for biosimulation and regulatory submission. “With today’s announcement, we are just beginning to realize the compelling opportunities made possible when we welcomed Pinnacle 21 to Certara in October of this year,”... Read More
Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, will host an Investor Day on Wednesday, December 15, 2021 from 3:00 PM to 6:00 PM ET in New York City. Certara’s management team will provide updates on the Company’s strategy, differentiated software and technology-driven services, and financial guidance for 2022. There will also be a demonstration of the Simcyp™ Simulator. The live video webcast of the event,... Read More
Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced the release of Simcyp Simulator Version 21, which updates the Company’s population-based modeling and simulation platform. The Simcyp Simulator is used throughout the drug development process to evaluate new drug formulations, determine first-in-human dosing, optimize clinical study design and predict drug-drug interactions. Certara’s Simcyp... Read More
Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced the release of D360 version 21.5, an industry-leading scientific informatics software for discovery scientists to integrate many data sources and analyze small molecules and biologic drugs for fast, high-confidence go/no-go decisions. This latest release increases research efficiency with comprehensive data analysis, enhanced workflows and data... Read More
Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced the closing of its underwritten public offering of 10,000,000 shares of its common stock by certain existing stockholders at a public offering price of $31.00 per share. The selling stockholders have granted the underwriters a 30-day option to purchase up to 1,500,000 additional shares of common stock. Certara did not receive any proceeds from... Read More
Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced the pricing of its underwritten public offering of 10 million shares of its common stock by certain existing stockholders (the “selling stockholders”) at a price to the public of $31.00 per share. Additionally, the selling stockholders have granted the underwriters a 30-day option to purchase up to 1.5 million additional shares of common stock.... Read More
Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced a proposed underwritten public offering by certain selling stockholders of 10 million shares of its common stock pursuant to a registration statement filed with the Securities and Exchange Commission. Additionally, the selling stockholders intend to grant the underwriters a 30-day option to purchase up to 1.5 million additional shares of common... Read More
Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today reported its financial results for the third quarter of fiscal year 2021. Highlights: Revenue was $73.9 million, compared to $60.3 million in the third quarter of 2020, representing growth of 23% over the third quarter of 2020. Net loss was $1.8 million, compared to net income of $1.2 million in the third quarter of 2020, representing a decrease of $3.0... Read More
Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that James E. Cashman III, a current Board member, will be appointed Chairman of the Board of Directors, effective as of December 1, 2021. Jim succeeds Sherilyn McCoy, who is stepping down from the Board to focus on other professional commitments. "It has been a privilege to serve as Chairman of Certara’s Board of Directors, and I am proud of the... Read More
Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that William F. Feehery, Chief Executive Officer, and Andrew Schemick, Chief Financial Officer will participate in a fireside chat at the Piper Sandler 33rd Annual Virtual Healthcare Conference. A webcast of the fireside chat will be available beginning Monday, November 22, 2021, at 10:00 am ET on Certara’s investor relations website at... Read More
Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that the U.S. Food and Drug Administration (FDA) has awarded a five-year contract with Pinnacle 21 for ongoing software and related services support for the agency’s DataFit program. The DataFit program assesses data quality and performs data validation for standards compliance of all electronic clinical and non-clinical trial study submission... Read More
Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that its Simcyp COVID-19 Vaccine Model has won an R&D 100 Award, which recognizes the top 100 “R&D pioneers and their revolutionary ideas in science and technology” in the past year. The model, which is incorporated in Certara’s Vaccine Simulator, has been used by major pharmaceutical companies and allows researchers to study how a vaccine is... Read More
Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that it will release financial results for the third quarter of 2021 after the market close on Tuesday, November 9 th , 2021. Company management will host a conference call to discuss financial results at 5:00 p.m. ET. Investors interested in listening to the conference call may do so by dialing (833) 360-0946 for domestic callers or (914)... Read More
Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced the appointment of Patrick F. Smith, Pharm.D. as president of Integrated Drug Development (IDD), reporting to CEO William F. Feehery. Dr. Smith will lead the Company’s global drug development services team, which creates value for clients across the entire drug development life cycle using biosimulation and quantitative approaches. Dr. Smith... Read More
Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced the appointment of Drayton T. Virkler to the newly created position of Chief Commercial Officer. In this role, Mr. Virkler will drive the Company’s global commercial strategy and execution and expand the business development team. “I am pleased to welcome Drayton as our new Chief Commercial Officer,” said William F. Feehery, Ph.D., CEO of... Read More
Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced the completion of the previously announced transaction to acquire Pinnacle 21, a leading provider of SaaS solutions for clinical data fitness, regulatory compliance and submission readiness. At closing, equity holders of Pinnacle 21 received approximately $250 million in cash consideration and 2,239,717 shares of Certara restricted common stock,... Read More
Certara , a global leader in biosimulation, today announced the launch of Synchrogenix™ Writer, a new regulatory SaaS product that expedites the authoring and review of patient narratives. Patient narratives describe adverse events or adverse drug reactions and are critical to clinical study reporting across every therapeutic area throughout the clinical phases. “In today's automated and standards driven clinical and... Read More
Certara , a global leader in biosimulation, today announced that it is expanding its Integrated Drug Development (IDD) division with a new clinical science group, headed up by Philippa Marshall, M.D., Vice President of Clinical Science. The Company also appointed David Mitchell, Ph.D., as Senior Vice President of Strategic Engagement and added C. Glenn Begley M.D., Ph.D., and Colin Pillai, Ph.D., as Senior Scientific... Read More
Certara (Nasdaq: CERT), a global leader in biosimulation, today announced the Company has been awarded a grant from the U.S. Food and Drug Administration (FDA) to verify and expand biosimulation models for assessing virtual bioequivalence (VBE) to help enable safer, faster and more cost-effective generic drug product development. Bioequivalence (BE) studies ensure that the rate and extent of absorption of the investigational... Read More
Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that it closed its public offering of 23,000,000 shares of common stock at $31.00 per share. The closing includes 3,000,000 shares sold upon full exercise of the underwriters’ option to purchase additional shares of common stock. Certara sold 4,500,000 shares of its common stock, and certain selling stockholders sold 18,500,000 shares of common... Read More
Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced the pricing of its underwritten public offering of shares of its common stock by Certara and certain existing stockholders (“the selling stockholders”) at a price to the public of $31.00 per share. Certara is offering 4.5 million shares of its common stock and certain selling stockholders are offering 15.5 million shares of common stock.... Read More
Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced a proposed underwritten public offering of 20,000,000 shares of its common stock pursuant to a registration statement filed with the Securities and Exchange Commission. Certara is offering 4,500,000 shares of common stock and certain selling stockholders are offering 15,500,000 shares of common stock in the offering. Additionally, the selling... Read More
Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that Company management will participate in a fireside chat at the following virtual investor conferences: Morgan Stanley 19 th Annual Global Healthcare Conference Date and Time: Tuesday, September 14 at 9:30 a.m. ET Speakers: William Feehery, chief executive officer, and Andrew Schemick, chief financial officer Baird 2021 Global Healthcare... Read More
Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today reported its financial results for the second quarter of fiscal year 2021. Highlights: Revenue was $70.1 million, representing growth of 15% over the second quarter of 2020 Net loss was ($2.9) million, compared to a net income of $2.8 million in the second quarter of 2020 Adjusted EBITDA was $25.5 million, representing growth of 1% over the second quarter... Read More
Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced it has signed a definitive agreement to acquire Pinnacle 21 for $310 million in cash and stock. Pinnacle 21’s software tools are used to validate compliance to the Clinical Data Interchange Standards Consortium (CDISC) standards, which is required by the US Food & Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency... Read More
Certara (NASDAQ: CERT), a global leader in biosimulation, today announced that Mubadala Investment Company (Mubadala) has made an approximately $250 million investment in Certara. The investment aligns with Mubadala’s strategy of enabling innovation to address unmet clinical needs and drive cost efficiencies. Mubadala and certain existing institutional shareholders of Certara, including a shareholder affiliated with EQT,... Read More
Certara , a global leader in biosimulation, today announced that its Vaccine Simulator accurately predicted that eight weeks was the optimal timing between the first and second dose of COVID-19 vaccines. The Pitch study conducted at Oxford University in the United Kingdom confirmed Certara’s Vaccine Simulator prediction, which was released six months ago . Current dosing for the Pfizer-BioNTech and Moderna vaccines are... Read More
Certara , a global leader in biosimulation, today announced the appointments of Nancy Killefer and Cynthia Collins to its board of directors, effective August 1, 2021. The two additional appointments increase the company’s board of directors to eleven members. “It’s truly a pleasure to welcome Nancy and Cynthia to the board of directors,” said Sheri McCoy, board chairman. “Their wealth of knowledge and extensive corporate... Read More
Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that it will release financial results for the second quarter of 2021 after the market close on Thursday, August 5, 2021. Company management will host a conference call to discuss financial results at 5:00 p.m. ET. Investors interested in listening to the conference call may do so by dialing (833) 360-0946 for domestic callers or (914) 987-7661... Read More
Certara ® , a global leader in biosimulation, today announced that it has appointed Nicolette D. Sherman to the position of Chief Human Resources Officer (CHRO). Sherman joins Certara with extensive experience in the biopharmaceutical industry, leading HR strategy and implementing programs to drive business impact. “We are pleased to have Nicolette join Certara as we continue to grow our high-performing team and capabilities... Read More
Certara , a global leader in biosimulation, today announced the release of BaseCase software version 2021.06, which updates the value communication software platform to include new capabilities that can provide biopharmaceutical and medical device companies greater commercial success for new therapies and products. “In today's value-based healthcare environment, hard data guide reimbursement, prescribing, and procurement... Read More
Certara , a global leader in biosimulation, today announced that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has renewed its licenses of Certara’s Simcyp™ and Phoenix™ biosimulation software. The PMDA has been using Certara’s biosimulation software since 2014. The Simcyp Physiologically-Based Pharmacokinetic (PBPK) Simulator is used in drug development to determine first-in-human dose, design more... Read More
Certara , a global leader in biosimulation, today announced the addition of Carol Gallagher, Pharm.D., to its board of directors. Dr. Gallagher is an experienced biopharmaceutical director and operator and serves as a venture partner at New Enterprise Associates (NEA), a global venture capital firm. “We are thrilled to welcome Carol as a new independent director to the board. A proven entrepreneur and commercial leader, she... Read More
Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that William Feehery, Chief Executive Officer, and Andrew Schemick, Chief Financial Officer, will participate in the following virtual investor conferences: William Blair's 41st Annual Growth Stock Conference Fireside Chat on Tuesday, June 1 st at 11:40 a.m. ET Jefferies Virtual Healthcare Conference Fireside Chat on Friday, June 4 th at 10:00... Read More
Certara, Inc. (Nasdaq: CERT), the global leader in biosimulation, today announced the launch of new versions of its Immunogenicity (IG) and Immuno-oncology (IO) Quantitative Systems Pharmacology (QSP) Simulators to help address the challenges in the development of biologics and cancer therapies. These new versions further expand applications of QSP and advance the field of using virtual patients to conduct computer-based... Read More
Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today reported its financial results for the first quarter of fiscal year 2021. Highlights: Revenue was $66.7 million, representing growth of 16% over the first quarter of 2020. Net income was $1.1 million, compared to a net income of $1.0 million in the first quarter of 2020. Adjusted EBITDA was $23.9 million, representing growth of 20% over the first quarter... Read More
Certara, Inc. (Nasdaq: CERT), the global leader in biosimulation, today announced the launch of its Secondary Intelligence™ software, the first and only software that quantitatively predicts the risk of adverse effects and safety issues derived from secondary pharmacology that may impede the clinical development of a drug. Safety issues account for approximately one quarter of candidate attrition in drug development... Read More
Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that it will be participating in the BofA Securities 2021 Virtual Health Care Conference. William Feehery, CEO, and Andrew Schemick, CFO, are scheduled to present on Tuesday, May 11, 2021 at 2:45 p.m. ET. A live webcast will be available on Certara’s investor relations website at https://ir.certara.com and will be available for replay for 90 days... Read More
Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that it will release preliminary financial results for the first quarter of 2021 after the market close on Thursday, May 6, 2021. Company management will host a conference call to discuss financial results at 5:00 p.m. ET. Investors interested in listening to the conference call may do so by dialing (833) 360-0946 for domestic callers or (914)... Read More
Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced the closing of its underwritten public offering of 11,500,000 shares of its common stock by certain existing stockholders at a public offering price of $25.00 per share. The closing includes 1,500,000 shares sold upon full exercise of the underwriters’ option to purchase additional shares of common stock. Neither Certara nor its management team... Read More
Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced the pricing of its underwritten public offering of 10 million shares of its common stock by certain existing stockholders (“the selling stockholders”) at a price to the public of $25.00 per share. Additionally, the selling stockholders have granted the underwriters a 30-day option to purchase up to 1,500,000 additional shares of common stock.... Read More
Certara, Inc. (“Certara”), a global leader in biosimulation, today announced a proposed underwritten public offering of 17 million shares of its common stock being offered by selling stockholders. Additionally, the selling stockholders intend to grant the underwriters a 30-day option to purchase up to 2,550,000 additional shares of common stock. Certara will not receive any proceeds from the sale of shares in the offering by... Read More
TrialAssure® – a leading, global software company advancing clinical trial disclosure, data sharing, and transparency – has announced today that Certara (Nasdaq: CERT) – the global leader in biosimulation – has licensed TrialAssure’s ANONYMIZE software to anonymize clinical data. TrialAssure’s ANONYMIZE for Data provides a cutting-edge anonymization application for datasets that allows clinical trial sponsors to anonymize... Read More
Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today reported its preliminary results for the fourth quarter and full year ended December 31, 2020. Highlights: Revenue was $64.6 million in the fourth quarter of 2020, and $243.5 million for the full year, representing year-over-year growth of 20% and 17%. Reported net loss was ($54.4) million in the fourth quarter of 2020, and ($49.4) million for the full... Read More
Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that 2020 marked the seventh consecutive year where 90% of new drug and biologic approvals by the US Food and Drug Administration (FDA), excluding diagnostic agents, were received by Certara’s customers. Certara’s customers use its biosimulation software and tech-enabled services to increase confidence in decisions across the entire R&D... Read More
Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that it will release preliminary financial results for the fourth quarter and full year of 2020 after the market close on Thursday, March 4, 2021. Company management will host a conference call to discuss financial results at 5:00 p.m. ET. Investors interested in listening to the conference call may do so by dialing (833) 360-0946 for domestic... Read More
Certara, Inc. , the global leader in biosimulation, today announced the release of version 20 of its Simcyp™ Physiologically-based Pharmacokinetic (PBPK) Simulator platform. Simcyp PBPK Simulator version 20 provides new models for maternal health, virtual bioequivalence to attain biowaivers, and analysis of long-acting injectable drugs. It also delivers a newly expanded biologics module, Simcyp Biologics Simulator, that... Read More
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