iBIO https://ibio.org To promote, connect and engage the life sciences community Tue, 18 Feb 2020 16:41:51 +0000 en-US hourly 1 https://ibio.org/wp-content/uploads/cropped-android-chrome-512x512-32x32.png iBIO https://ibio.org 32 32 HB 3493: Prescription Drug Affordability Board https://ibio.org/hb-3493-prescription-drug-affordability-board/ https://ibio.org/hb-3493-prescription-drug-affordability-board/#respond Tue, 18 Feb 2020 16:39:57 +0000 https://ibio.org/?p=4828 iBIO Position: Oppose

Creates the Prescription Drug Affordability Act. Defines terms. Creates the Prescription Drug Affordability Board and includes provisions regarding: purpose; members; alternate members; conflict of interest; terms; additional staff; salary; compensation and reimbursement; and meetings. Creates the Prescription Drug Affordability Stakeholder Council and includes provisions regarding: purpose; members; knowledge requirements; terms; and compensation. Provides the manner in which a conflict of interest shall be disclosed. Provides that gifts or donations of services or property that indicate a potential conflict of interest may not be accepted by any member of the Board, Board staff, or third-party contractor. Includes provisions on applicability. Provides that the Board shall identify specified prescription drug products and determine whether each prescription drug product should be subject to a cost review. Provides that if the Board finds that spending on a prescription drug product creates affordability challenges, the Board shall establish an upper payment limit that applies to all purchases and payor reimbursements. Includes provisions regarding remedies and an appeal process. Creates the Prescription Drug Affordability Fund. Provides that the Board shall submit a report to the General Assembly including specified information. Includes a provision on term expiration for Board and Council members. Provides that the Board shall conduct a study of the operation of the generic drug market that includes specified information on or before June 1, 2020. Makes conforming changes in the State Finance Act. Effective immediately.

Rep. Will Guzzardi – Mary E. Flowers – Karina VillaThaddeus JonesFred CrespoRobert RitaJaime M. Andrade, Jr. and Terra Costa Howard

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HB 4362: Imported Prescription Drugs https://ibio.org/hb-4362-imported-prescription-drugs/ https://ibio.org/hb-4362-imported-prescription-drugs/#respond Tue, 18 Feb 2020 16:37:49 +0000 https://ibio.org/?p=4826 iBIO Position: Oppose

Creates the Wholesale Importation of Prescription Drugs Act. Requires the Department of Public Health to design an importation program where the State is the licensed wholesaler of imported drugs from licensed, regulated Canadian suppliers. Requires the program to address specified issues, including billing issues, cost savings issues, and safety and regulatory issues. Contains auditing and reporting requirements. Provides that the Department shall enlist the assistance of the Attorney General to identify the potential for anti-competitive behavior in industries that would be affected by an importation program. Requires the Department to submit a formal request to the Secretary of the United States Department of Health and Human Services for certification of the importation program. Requires the Department to have the program operational within 6 months after receiving the certification. Contains provisions concerning implementation requirements.

Rep. Anna Moeller – Natalie A. Manley

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SB 2499: Medicaid Clinical Trials https://ibio.org/sb-2499-medicaid-clinical-trials-support/ https://ibio.org/sb-2499-medicaid-clinical-trials-support/#respond Tue, 18 Feb 2020 16:34:56 +0000 https://ibio.org/?p=4824 Companion: HB 4314: Medicaid Clinical Trials (Support)

iBIO Position: Support

Amends the Medical Assistance Article of the Illinois Public Aid Code. Provides that the medical assistance program shall provide coverage for routine care costs that are incurred in the course of an approved clinical trial if the medical assistance program would provide coverage for the same routine care costs not incurred in a clinical trial. Defines “approved clinical trial” to mean a phase I, II, III, or IV clinical trial involving the prevention, detection, or treatment of cancer or any other life-threatening disease or condition. Defines “routine care cost” to mean the cost of medically necessary services related to the care method that is under evaluation in a clinical trial, including the cost of services related to the detection and treatment of any complications arising from the patient’s medical care and any complications related to participation in the clinical trial. Defines other terms.

Sen. Andy Manar – Melinda Bush – Celina Villanueva – Mattie Hunter – Iris Y. MartinezJennifer Bertino-TarrantLaura EllmanOmar AquinoLaura M. MurphyLaura FinePatricia Van PeltRachelle CroweRam VillivalamJacqueline Y. CollinsScott M. BennettLinda HolmesAntonio MuñozChristopher BeltCristina CastroPatrick J. JoyceHeather A. SteansSara Feigenholtz and Kimberly A. Lightford

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HB 4314: Medicaid Clinical Trials https://ibio.org/hb-4314-medicaid-clinical-trials-support/ https://ibio.org/hb-4314-medicaid-clinical-trials-support/#respond Tue, 18 Feb 2020 16:32:06 +0000 https://ibio.org/?p=4822 Companion: SB 2499: Medicaid Clinical Trials

iBIO Position: Support

Amends the Medical Assistance Article of the Illinois Public Aid Code. Provides that the medical assistance program shall provide coverage for routine care costs that are incurred in the course of an approved clinical trial if the medical assistance program would provide coverage for the same routine care costs not incurred in a clinical trial. Defines “approved clinical trial” to mean a phase I, II, III, or IV clinical trial involving the prevention, detection, or treatment of cancer or any other life-threatening disease or condition. Defines “routine care cost” to mean the cost of medically necessary services related to the care method that is under evaluation in a clinical trial, including the cost of services related to the detection and treatment of any complications arising from the patient’s medical care and any complications related to participation in the clinical trial. Defines other terms.

Representative Camille Y. Lilly

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SB 3358: DCEO-Marching Funds Program https://ibio.org/sb-3358-dceo-marching-funds-program/ https://ibio.org/sb-3358-dceo-marching-funds-program/#respond Tue, 18 Feb 2020 16:29:19 +0000 https://ibio.org/?p=4820 iBIO Position: Support

Amends the Department of Commerce and Economic Opportunity Law of the Civil Administrative Code of Illinois. Establishes the Illinois Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Matching Funds Program to be administered by the Department of Commerce and Economic Opportunity. Provides that the Department of Commerce and Economic Opportunity may make grants to eligible businesses to match federal funds received by the business as an SBIR or STTR Phase I award and to encourage businesses to apply for Phase II awards up to a maximum of $50,000. Effective July 1, 2020.

Senator Elgie R. Sims, Jr.

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Endotronix Announces Enrollment of the First Patients in the PROACTIVE-HF Pivotal Trial https://ibio.org/endotronix-announces-enrollment-of-the-first-patients-in-the-proactive-hf-pivotal-trial/ https://ibio.org/endotronix-announces-enrollment-of-the-first-patients-in-the-proactive-hf-pivotal-trial/#respond Tue, 18 Feb 2020 15:56:50 +0000 https://ibio.org/?p=4812 Study to support U.S. FDA approval of the Cordella™ Pulmonary Artery Pressure Sensor System for the treatment of patients with chronic heart failure

Endotronix, a digital health and medical technology company dedicated to advancing the treatment of chronic heart failure (HF), today announced the enrollment of the first two patients in the PROACTIVE-HF pivotal trial. The trial is a pre-market investigational device exempt (IDE) study evaluating the safety and efficacy of the Cordella™ Pulmonary Artery (PA) Pressure Sensor System (Cordella Sensor) for the treatment of HF. The first two patients were successfully implanted with the Cordella Sensor by Drs. Navin Kapur and Michael Kiernan at Tufts Medical Center in Boston, Massachusetts and Dr. Liviu Klein at the University of California San Francisco (UCSF).

The prospective, multi-center, randomized, controlled, single-blind trial is expected to enroll over 950 New York Heart Association (NYHA) Class III heart failure patients at up to 60 sites across the U.S. The dual-arm trial design compares HF management using daily patient vital sign data versus daily vital sign plus PA pressure data. Designed to show a definitive benefit for PA pressure-guided management, the landmark trial incorporates protocolized PA pressure therapy guidelines and guideline-directed medical therapy (GDMT) for proactive HF management. Primary endpoints of the study include the reduction of HF hospitalizations and mortality. In addition, the data from this trial will support U.S. market access of the Cordella Sensor and inform a national coverage decision from the Centers for Medicare & Medicaid Services (CMS). The company also announced that last year they received Category B IDE Study approval from CMS, which will allow coverage of the Cordella Sensor and routine care services during the trial.

“Management of chronic heart failure patients can be challenging. The Cordella Sensor and System provide a unique combination of daily patient PA pressure and vital sign data, enabling me and my team to make smarter, trend-based clinical decisions before decompensation occurs,” commented Dr. Klein, Director of the Mechanical Circulatory Support Program at UCSF and National Principal Investigator of the PROACTIVE-HF trial. “Based on my early experience, the Cordella System offers an intuitive at-home patient experience, including a seated PA pressure reading, for remote management. I’m excited for the PROACTIVE-HF trial and look forward to clearly demonstrating the benefits of hemodynamic PA-pressure guided therapy and its impact on clinical outcomes.”

“PROACTIVE-HF is a groundbreaking trial, designed to provide the highest level of clinical evidence in support of PA pressure-guided therapy,” added Harry Rowland, Chief Executive Officer of Endotronix. “Our national coverage of top implanting centers positions us for successful study enrollment to further demonstrate that the Cordella Sensor and System provides efficient HF management, improves clinical outcomes and has the potential to redefine the standard of care for patients with chronic heart failure.”

The Cordella Sensor is not available for commercial use in any geography and is under clinical investigation in Europe (SIRONA II CE Mark Trial) and the U.S. (PROACTIVE-HF IDE Trial). CAUTION – Investigational Device. Limited by Federal (or United States) Law to Investigational Use. Exclusively for clinical investigations. The Cordella System, without the sensor, is available for commercial use in the U.S. and E.U. and is currently in cardiology centers across the U.S.

About the Cordella™ Heart Failure System
The Cordella Heart Failure System (Cordella System) is designed to help patients suffering from chronic heart failure feel better and stay out of the hospital with streamlined care and remote medication titration. The system provides a comprehensive health status of the patient at home with easy-to-use tools that securely collect and share health data with healthcare providers for trend-based management. The Cordella Sensor seamlessly integrates pulmonary artery (PA) pressure data into the Cordella System. Together, they proactively deliver the information necessary to improve patient care between office visits and support reimbursement for care delivery activities.

About Endotronix
Endotronix, Inc., is a medical technology company focused on advancing the treatment of chronic heart failure. Privately held, the company is backed by world-class medtech investors including Aperture Venture Partners, BioVentures Investors, LSP, Lumira Ventures, OSF Ventures, Seroba Life Sciences, Skydeck LLC, SV Health Investors, Wanxiang Healthcare Investments, and two unnamed corporate strategic investors. Learn more at www.endotronix.com.

Cautionary Statement Regarding Forward-Looking Statements
This press release may contain predictions, estimates or other information that might be considered forward-looking statements. Such forward-looking statements are not a guarantee of future performance.

Carla Benigni
SPRIG Consulting LLC (847) 951-7430

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Guide: How to approach Life Sciences fundraising https://ibio.org/guide-how-to-approach-life-sciences-fundraising/ https://ibio.org/guide-how-to-approach-life-sciences-fundraising/#respond Mon, 17 Feb 2020 13:01:09 +0000 https://ibio.org/?p=4804 Brex, the newest addition to BIO Business Solutions®, has published a thorough guide to fundraising in the life sciences. 

The guide spans: grants, incubators/accelerators, private investment (venture capital/private equity), and partnership with pharma highlighting strategy coupled with pros/cons. We encourage everyone to read and reflect on this guide and how it may supplement your strategy. 

iBIO Members, consider using Brex to “make the funding you got stretch further”.

Read: How to approach Life Sciences fundraising

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Rosalind Franklin University Announces Research Collaboration With Exicure https://ibio.org/rosalind-franklin-university-announces-research-collaboration-with-exicure/ https://ibio.org/rosalind-franklin-university-announces-research-collaboration-with-exicure/#respond Fri, 14 Feb 2020 15:50:07 +0000 https://ibio.org/?p=4810 Rosalind Franklin University of Medicine and Science announced today a research collaboration with the Chicagoland biotech company Exicure Inc. to develop new therapeutics for genetic diseases.

RFU’s Center for Genetic Diseases is working to understand the mechanisms of dysfunction in inherited disorders and to discover treatments using small molecule and nucleic acid-based approaches. It will work closely with Exicure, which is developing a new class of immunomodulatory and gene-silencing drugs against validated targets.

It is estimated that more than 10,000 rare diseases that strike millions of people across the globe are caused by an error in a single gene in the human DNA, according to the World Health Organization. Many of these disorders have no effective treatment.

“Tomorrow’s treatments begin with today’s research,” said RFU Executive Vice President for Research Dr. Ronald Kaplan. “We are strongly encouraged by the novel research underway in our Center for Genetic Diseases. Our collaboration with Exicure builds on both group’s expertise in the field of oligonucleotides as a solution to these often deadly diseases.”

Center Director Dr. Michelle Hastings, an expert in RNA biology and regulation of gene expression, has developed patented antisense oligonucleotide technologies for disorders such as Usher syndrome, which causes hearing and vision loss, and the devastating childhood disorders, Batten disease and cystic fibrosis. Antisense technology is based on a therapeutic platform that has potential applications to a large number of human conditions, several of which are under investigation in the Hastings lab.

“New genetic diseases are being discovered at a rapid rate,” Dr. Hastings said. “Our goal is to deliver treatment options for people diagnosed with or at risk for a genetic disease.”

The initial partnership will focus on genetic diseases using Exicure’s spherical nucleic acid (SNA™) architecture, designed to unlock the potential of therapeutic oligonucleotides in a wide range of cells and tissues.

Exicure CEO Dr. David Giljohann said the company is fortunate to collaborate with RFU, a leading expert in the field of genetic diseases.

“We’re fortunate to be working with a world leader in genetic medicines, so close to our research hub in Chicago, to drive new pathways to innovation and the identification of successful new therapeutics,” Dr. Giljohann said.

About Rosalind Franklin University
Rosalind Franklin University of Medicine and Science is committed to serving humanity through the interprofessional education of health and biomedical professionals and the discovery of knowledge dedicated to improving wellness. Founded in Chicago in 1912, RFU embodies the spirit of inquiry and excellence modeled by its namesake Dr. Rosalind Franklin, whose Photo 51 was crucial to solving the structure of DNA. Recognized for its research in areas including neuroscience, brain-related diseases, inherited disorders, diabetes, obesity, and gait and balance, the university encompasses the Chicago Medical School, College of Health Professions, College of Pharmacy, School of Graduate and Postdoctoral Studies and the Dr. William M. Scholl College of Podiatric Medicine. Learn more at rosalindfranklin.edu.

About Exicure Inc.
Exicure Inc. (NASDAQ: XCUR) is a clinical-stage biotechnology company developing therapeutics for immuno-oncology, inflammatory diseases and genetic disorders based on our proprietary Spherical Nucleic Acid, or SNA technology. Exicure believes that its proprietary SNA architecture has distinct chemical and biological properties that may provide advantages over other nucleic acid therapeutics and may have therapeutic potential to target diseases not typically addressed with other nucleic acid therapeutics. Exicure’s lead program is in a Phase 1b/2 trial in patients with advanced solid tumors. The company is based outside of Chicago, IL, and in Cambridge, MA.

Office of Marketing and Communications

SOURCE Rosalind Franklin University of Medicine and Science

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Gov. Pritzker Highlights Vision for Innovation and Economic Development with $500 Million Commitment to IIN and DPI https://ibio.org/gov-pritzker-highlights-vision-for-innovation-and-economic-development-with-500-million-commitment-to-iin-and-dpi/ https://ibio.org/gov-pritzker-highlights-vision-for-innovation-and-economic-development-with-500-million-commitment-to-iin-and-dpi/#respond Wed, 12 Feb 2020 16:09:44 +0000 https://ibio.org/?p=4817 Technology hub will support 48,000 new economy jobs, with $19 billion economic impact over the next 10 years; University of Illinois Board of Trustees Chairman Edwards and his wife, Anne also give $10 Million to University, half of which will go to IIN and DPI

Highlighting his dynamic, long-term vision for economic development built on state-of-the-art technology, robust higher education and private partnerships, Gov. JB Pritzker on Wednesday announced that the State of Illinois is moving forward with $500 million in capital funding for the University of Illinois System’s Illinois Innovation Network (IIN) and Discovery Partners Institute (DPI) – a network of research and innovation hubs that will serve as a magnet for technology and talent.

IIN and DPI are expected to create or fill 48,000 new-economy jobs over the next decade, according to the latest economic impact study conducted by the Boston Consulting Group. In all, IIN and DPI are expected to have an economic impact of $19 billion over the next 10 years, a return of nearly 40 times the original state investment.

“With this announcement today of Discovery Partners Institute and the Illinois Innovation Network, we are launching a new era for Chicago as  an extraordinary focal point for an unparalleled tech workforce and research and development that will attract talent to our state from around the world, strengthening Illinois’ long-term economic vitality for generations to come,” said Governor JB Pritzker. “Illinois’ nexus of partnerships, innovation hubs, public and private universities, national laboratories, and international research programs is the foundation for a technology ecosystem that will rival any location in the world. And through the Illinois Innovation Network, DPI’s success will radiate across the state to 15 hubs from Chicago to Rockford to Peoria to Edwardsville. We are investing in workforce development, innovation and R&D all across our state.”

IIN and DPI are focused on preparing students and workers to step into lucrative, high-tech jobs, and increasing funding for the applied research and development that will create more of those life-changing careers. At the same time, IIN and DPI will emphasize inclusivity to increase the diversity of the state’s new economy workforce. Together, IIN and DPI are designed to develop, attract and retain talent, providing a hive of technological research and innovation that combines the power of students, faculty and companies to propel Illinois toward a future as a leading tech destination.

The funding committed by Gov. Pritzker will allow DPI and other hubs of the IIN across the state to begin architectural design work while attracting more private funding from both corporate partnerships and philanthropy. Under Gov. Pritzker’s leadership, the university dramatically accelerated its private fundraising, and has raised roughly $230 million to date from private donors.

Adding to that momentum, the governor also announced a new gift from University of Illinois Board of Trustees Chairman Don Edwards and his wife, Anne. Edwards is giving $10 million to the University of Illinois at Urbana-Champaign, $5 million of which will be dedicated to IIN and DPI. Board of Trustees Chairman Edwards’ $10 million gift is the largest ever by a University of Illinois trustee.

Edwards, who is a graduate of the university, said dedicating half of that gift to IIN and DPI is a demonstration of his belief in their academic impact and economic potential.

“My wife Anne and I are thrilled to make this $10 million gift to DPI and IIN and to the university that transformed both of our lives,” Edwards said. “Like Governor Pritzker, I hope and believe that today’s events will catalyze even more support for pioneering initiatives that have the potential to truly reinvent our economy here in Chicago and across Illinois.”

“Chicago is thrilled to be taking this important next step with DPI, Governor Pritzker and Related Midwest in developing a state-of-the-art innovation hub that will drive cutting-edge technology advancements and propel growth and opportunity throughout our city and entire region,” said Mayor Lori E. Lightfoot. “DPI’s decision to anchor in Chicago is a vote of confidence in the talent of our people and strength of our diverse, local economy, and we look forward to collaborating with them on our shared goals of developing inclusive, long-term economic growth through an array of investments that will create jobs, start companies, and help shape the future of our city for generations to come.”

In addition to the $500 million in state funding, the University System has pledged to secure $500 million in corporate and philanthropic funding. So far, $230 million has been raised, spurred by Gov. Pritzker’s early commitment to IIN and DPI. Another $224 million in non-state funding has been secured by the U of I System and its universities in Urbana-Champaign and Chicago, as well as Northern Illinois University, Southern Illinois University-Carbondale, the University of Illinois at Chicago (UIC) Health Sciences campus in Rockford and Eastern Illinois University.

“With Gov. Pritzker’s leadership and commitment, and the support and encouragement of Chicago Mayor Lori Lightfoot, DPI is now poised to become the major hub of innovation, technology development, and job creation that we all envision for Chicago, the State of Illinois, and the world. This investment by the state adds real fuel to the economic engines of DPI and IIN,” said University of Illinois System President Tim Killeen. “We are grateful for Gov. Pritzker’s vision, and his belief in what we are determined to create – an ever-more vibrant innovation ecosystem serving all the people of our state.”

Together, IIN and DPI are pioneering a new model for driving economic vitality in the state. With its planned headquarters in Related Midwest’s The 78, a 62-acre mixed-use development in downtown Chicago, DPI will be a key piece of a dynamic commercial and residential space along the Chicago River.

“Our vision for The 78 is to create Chicago’s next great neighborhood,” said Curt Bailey, president of Related Midwest. “With a dynamic Phase 1 plan that includes DPI as its centerpiece, we’re showing how a 21st-century neighborhood, created from the ground-up and connected to so many culturally-significant areas, will bring new opportunities to all of Chicago. DPI’s organizational model will drive long-term innovation across critical growth industries and draw corporate tenants, entrepreneurs and venture capitalists — from across Chicago and around the globe — to The 78, where they will find top talent, groundbreaking research, and new technologies that support future expansion.”

From that location, DPI will serve as a thriving nexus for students, university faculty and Illinois corporations. The IIN hubs will provide entry to communities across the state for ideas and innovations generated at DPI, while also leveraging the strengths of Illinois’ public universities to ignite the state’s economy.

DPI has already begun to work closely with Chicago’s business leaders, particularly through its relationship with P33 and its CEO, Brad Henderson. P33 is a nonprofit created to strengthen ties between Chicago and the global technology and innovation community.

“This marks an exciting moment for our region and the coming together of months of collaboration and partnership,” Henderson said. “DPI will become a hive of technology activity connecting Chicagoland’s world class strengths in data science and advanced analytics to our strong industry base – a huge unlock for our region. P33 is proud and honored to continue our partnership with DPI to solve some of the most pressing challenges facing our city, our state and beyond.”

Since their creation, the development of IIN and DPI has also been picking up speed through the building of a leadership team, the beginning of the first programs at DPI’s downtown Chicago headquarters, and early initiatives at IIN hubs across the state. Some of those steps include:

In January, William C. Jackson was named to lead DPI. He is a former president at Johnson Controls and an alumnus of the University of Illinois at Urbana-Champaign, and brings deep ties to industry. He is focused on building industry partnerships, as well as identifying research interests with university partners to attract federal and private funding; working to add internships, research experiences, and workshops for both university and K-12 students and advancing plans for the center’s permanent headquarters.

IIN’s group of hubs – including DPI – now numbers 15, linking every public university in the state and U of I College of Medicine locations in Peoria and Rockford, to reach every corner of the state. Projects planned at the IIN hubs will apply technology to address challenges and create new opportunities related to agriculture and food systems, manufacturing, transportation, health and wellness, the environment, and entrepreneurship.

Partnerships have also been established with 12 universities and research institutes in the United States and abroad, including Argonne National Laboratory, Cardiff University, The Hebrew University of Jerusalem, all three U of I System universities, Illinois Institute of Technology, the University of Chicago, MS Ramaiah Medical College, Northwestern University, National Taiwan University and Tel Aviv University.

IIN and DPI were announced in 2017. They are led by the U of I System and its three universities in Urbana-Champaign, Chicago and Springfield.

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Northwestern’s Chemistry of Life Processes Institute Hatches IPO of the Decade https://ibio.org/northwesterns-chemistry-of-life-processes-institute-hatches-ipo-of-the-decade/ https://ibio.org/northwesterns-chemistry-of-life-processes-institute-hatches-ipo-of-the-decade/#respond Fri, 31 Jan 2020 12:55:21 +0000 https://ibio.org/?p=4792 What happens when a highly interdisciplinary and integrated team of scientists, business leaders and students work together across fields of fundamental science, discovery, development, and finance? In the case of Monopar Therapeutics, a Chemistry of Life Processes Institute-affiliated spin-out, it leads to a record-breaking initial public offering.

Last month, Monopar (MNPR), a clinical stage biopharmaceutical company that develops proprietary therapeutics for cancer, experienced the “best first-day pop for an IPO since Baidu in 2005,” according to Nasdaq News. The company’s stock price rocketed 231 percent from its initial offering, reaching a market valuation of $289 million on its first day.

“It’s been a remarkable journey from the start,” says Chandler Robinson, MD, CEO of Monopar, and member of CLP’s Executive Advisory Board.

Read the rest of this article.

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