FUSN Fusion Pharmaceuticals Inc.

7.23
-0.08  -1%
Previous Close 7.31
Open 7.57
52 Week Low 6.6074
52 Week High 13.89
Market Cap $311,031,853
Shares 43,019,620
Float 42,433,573
Enterprise Value $154,912,719
Volume 41,036
Av. Daily Volume 39,788
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Upcoming Catalysts

Drug Stage Catalyst Date
FPI-1434
Solid tumors
Phase 1
Phase 1
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FPI-1966
Head and Neck and Bladder Cancers
Phase 1
Phase 1
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Drug Pipeline

Drug Stage Notes
FPI-2059
Solid tumors
Phase 1
Phase 1
IND due 1H 2022.

Latest News

  1. Single and multiple doses of FPI-1966 demonstrated therapeutic efficacy in a preclinical bladder xenograft model

    [225Ac]-FPI-2059 demonstrated superior efficacy against [177Lu]-IPN-1087 in a head-to-head comparison in a mouse xenograft model of colorectal cancer

    Data featured in oral presentation sessions at the 34th Annual EANM Congress

    HAMILTON, Ontario and BOSTON, Oct. 20, 2021 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (NASDAQ:FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced the presentation of preclinical data that provide further support of its FPI-1966 and FPI-2059 targeted alpha therapies (TATs) at the 34th Annual European Association of Nuclear…

    Single and multiple doses of FPI-1966 demonstrated therapeutic efficacy in a preclinical bladder xenograft model

    [225Ac]-FPI-2059 demonstrated superior efficacy against [177Lu]-IPN-1087 in a head-to-head comparison in a mouse xenograft model of colorectal cancer

    Data featured in oral presentation sessions at the 34th Annual EANM Congress

    HAMILTON, Ontario and BOSTON, Oct. 20, 2021 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (NASDAQ:FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced the presentation of preclinical data that provide further support of its FPI-1966 and FPI-2059 targeted alpha therapies (TATs) at the 34th Annual European Association of Nuclear Medicine Congress. These data reinforce the clinical dosing regimen of FPI-1966 and highlight the potential of FPI-2059 as an actinium-225 labelled precision medicine targeting NTSR1.

    "These data demonstrate the broad potential of our TAT platform across multiple validated targets overexpressed in a variety of solid tumors," said Chief Executive Officer John Valliant, Ph.D. "We are pleased to share preclinical efficacy and tumor uptake data resulting from the administration of FPI-1966, and we believe strongly that this data will translate into meaningful results for patients with solid tumors overexpressing FGFR3 – a population with high unmet medical need. We look forward to initiating the Phase 1 study around the end of this year."

    Data from preclinical studies of FPI-1966, a TAT designed to target and deliver actinium-225 to cancer cells expressing FGFR3, were presented in an oral presentation titled, "FGFR3 Targeted Alpha Therapeutic [225Ac]-FPI-1966 induces regression in preclinical bladder xenograft model". Outcomes demonstrated that FPI-1966 when administered with vofatamab results in high tumor delivery and low off-target uptake. Further, the data showed therapeutic efficacy of FPI-1966 at both single and multiple doses in a preclinical bladder cancer xenograft model.

    Data from preclinical studies of FPI-2059, a TAT designed to target and deliver actinium-225 to cancer cells expressing neurotensin receptor 1 (NTSR1), were presented in an oral presentation titled "NTSR1 Targeted Alpha Therapeutic [225Ac]-FPI-2059 induces regression in preclinical colorectal xenograft model". The study results include a head-to-head comparison of therapeutic efficacy obtained from FPI-2059, which delivers an alpha emitting isotope, with [177Lu]-IPN-1087, which delivers a beta emitting isotope on the same targeting molecule. Results demonstrate superior efficacy with [225Ac]-FPI-2059 in a mouse xenograft model of colorectal cancer.

    Dr. Valliant continued, "Our science is based on the belief that alpha-emitting isotopes can provide significant therapeutic advantages compared to other commonly used radioisotopes. Preclinical results from our FPI-2059 product candidate provide further validation of this belief and support the diversification of our product portfolio to comprise multiple targeting vehicle types, including small molecules. We are pleased to be advancing further preclinical studies of FPI-2059 as we approach an investigational new drug (IND) filing in the first half of 2022."

    About FPI-1966

    [225Ac]-FPI-1966 is a targeted alpha therapy designed to target and deliver an alpha emitting medical isotope, actinium-225, to cancer cells expressing FGFR3; a receptor that is overexpressed on several tumor types, including head and neck and bladder cancers. FPI-1966 utilizes Fusion's Fast-Clear™ linker to connect vofatamab, the human monoclonal antibody that targets FGFR3, with actinium-225. Vofatamab was previously evaluated as a therapeutic agent in a Phase 1b/2 trial and was reportedly well-tolerated. FPI-1966 is advancing to a Phase 1 study following the recent investigational new drug (IND) clearance

    About FPI-2059

    FPI-2059 is a targeted alpha therapy combining actinium-225 with IPN-1087, for development as a targeted alpha therapy for various solid tumors. The molecule targets NTSR1, a promising target for cancer treatment, that is overexpressed in multiple solid tumors. IPN-1087 was in Phase 1 clinical development as a lutetium-177-based radiopharmaceutical for pancreatic ductal adenocarcinoma, colorectal cancer and gastric cancers expressing NTSR1. Fusion expects to submit an IND for FPI-2059 in the first half of 2022.

    About Fusion

    Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Employing a proprietary Fast-Clear™ linker technology, Fusion connects alpha particle emitting isotopes to various targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion's lead program, FPI-1434 targeting insulin-like growth factor 1 receptor, is currently in a Phase 1 clinical trial. The pipeline includes FPI-1966, targeting the fibroblast growth factor receptor 3 (FGFR3), advancing to a Phase 1 study following the recent investigational new drug (IND) clearance; and FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1). In addition to a robust proprietary pipeline, Fusion has a collaboration with AstraZeneca to jointly develop novel targeted alpha therapies (TATs) and combination programs between Fusion's TATs and AstraZeneca's DNA Damage Repair Inhibitors (DDRis) and immuno-oncology agents. Fusion has also entered into a collaboration with Merck to evaluate FPI-1434 in combination with Merck's KEYTRUDA® (pembrolizumab) in patients with solid tumors expressing IGF-1R. Fusion and Hamilton, Ontario-based McMaster University are building a current Good Manufacturing Practice (GMP) compliant radiopharmaceutical manufacturing facility designed to support manufacturing of the Company's growing pipeline of TATs.

    Forward Looking Statements

    This press release contains "forward-looking statements" for purposes of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995, including but not limited to the statements regarding Fusion Pharmaceuticals Inc.'s (the "Company") future business and financial performance. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words "expect," "plans," "anticipates," "intends," "will," and similar expressions are also intended to identify forward-looking statements, as are expressed or implied statements with respect to the uncertainties inherent in the drug development process, including FPI-1966 and FPI-2059 early stage of development; the ability to move in-licensed targets forward in the clinic;  the process of designing and conducting preclinical and clinical trials; the regulatory approval processes; the timing of regulatory filings; and the challenges associated with manufacturing drug products generally and radiopharmaceuticals specifically. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. These and other risks which may impact management's expectations are described in greater detail under the heading "Risk Factors" in the Company's quarterly report on Form 10-Q for the quarter ended June 30, 2021 as filed with the SEC and in any subsequent periodic or current report that the Company files with the SEC. All forward-looking statements reflect the Company's estimates only as of the date of this release (unless another date is indicated) and should not be relied upon as reflecting the Company's views, expectations or beliefs at any date subsequent to the date of this release. While Fusion may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, even if the Company's estimates change.

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/fusion-pharmaceuticals-announces-presentation-of-preclinical-data-supporting-its-fpi-1966-and-fpi-2059-targeted-alpha-therapies-301405060.html

    SOURCE Fusion Pharmaceuticals Inc.

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  2. HAMILTON, ON and BOSTON, Sept. 28, 2021 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (NASDAQ:FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced the appointment of Mohit Rawat as President and Chief Business Officer. Mr. Rawat brings to Fusion more than 15 years of experience in the biopharmaceutical industry, with expertise in corporate strategy, business development and commercial execution, including product development, launch planning and commercialization.

    "We are delighted to welcome Mohit to Fusion during a period of rapid growth for the Company, with plans to have a third program in the clinic by the middle of 2022, and in a time of expanding interest in radiopharmaceuticals as precision medicines," said Chief Executive Officer John Valliant, Ph.D. "We have used our platform and partnerships to build a deep pipeline of targeted alpha therapies with an emphasis on creating differentiated radiopharmaceuticals. As we progress, we look forward to leveraging Mohit's corporate strategy, business development, and commercial leadership experience acquired from his previous positions at multiple large pharmaceutical companies. Mohit will focus on advancing Fusion's agenda by capitalizing on our efforts to create first-in class radiopharmaceuticals and establish global strategic partnerships while planning ahead for pipeline and commercial success."

    Mr. Rawat was most recently vice president and global disease lead for the $3 billion CML franchise (including asciminib/ABL001 and TASIGNA) at Novartis Oncology where he helped bring forward for approval and potential blockbuster success the FDA-designated priority review STAMP inhibitor asciminib. Prior to this role, he was the U.S. marketing director for COSENTYX, where he led multiple commercial and strategic efforts for Novartis' top product with more than $4 billion in sales; and executive director, early-stage pipeline, for NASH, cardiovascular, renal and metabolism, also at Novartis.  Before joining Novartis, Mr. Rawat was asset team lead, senior director, immunology and neuroscience at AbbVie Pharmaceuticals. Prior to that, he was with McKinsey and Company, where he was a leader in the biopharmaceutical practice and led client teams on business development, research and development, product commercialization and strategy projects. Earlier in his career, Mr. Rawat held several positions of increasing responsibility within Novartis Pharmaceuticals, across marketing and sales, drug development and portfolio planning.

    Mr. Rawat holds an M.B.A. from Harvard Business School, an M.S. in chemical engineering from Massachusetts Institute of Technology (MIT), a certificate in finance from Sloane School of Management at MIT, and M. Tech. and B. Tech. degrees in chemical engineering from Indian Institute of Technology (IIT).

    Inducement Equity Awards

    Fusion's Compensation Committee of the Board of Directors approved a grant of stock options to Mr. Rawat to purchase 257,000 of Fusion's common shares. Each option was granted as an inducement equity award outside Fusion's 2020 Stock Option and Incentive Plan and was made as an inducement material to Mr. Rawat's acceptance of employment with Fusion. The options have an exercise price of $8.26 per share, which is equal to the closing price of Fusion's common stock on September 27, 2021. Each option has a ten-year term and vests over four years, with 25% of the original number of shares vesting on the one-year anniversary of the grant date and then in equal monthly installments for 36 months thereafter, subject to Mr. Rawat's continued service with Fusion through the applicable vesting dates.

    About Fusion

    Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Employing a proprietary Fast-Clear™ linker technology, Fusion connects alpha particle emitting isotopes to various targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion's lead program, FPI-1434 targeting insulin-like growth factor 1 receptor, is currently in a Phase 1 clinical trial. The pipeline includes FPI-1966, targeting the fibroblast growth factor receptor 3 (FGFR3), advancing to a Phase 1 study following the recent investigational new drug (IND) clearance; and FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1). In addition to a robust proprietary pipeline, Fusion has a collaboration with AstraZeneca to jointly develop novel targeted alpha therapies (TATs) and combination programs between Fusion's TATs and AstraZeneca's DNA Damage Repair Inhibitors (DDRis) and immuno-oncology agents. Fusion has also entered into a collaboration with Merck to evaluate FPI-1434 in combination with Merck's KEYTRUDA® (pembrolizumab) in patients with solid tumors expressing IGF-1R. Fusion and Hamilton, Ontario-based McMaster University are building a current Good Manufacturing Practice (GMP) compliant radiopharmaceutical manufacturing facility designed to support manufacturing of the Company's growing pipeline of TATs.

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/fusion-pharmaceuticals-appoints-mohit-rawat-as-president-and-chief-business-officer-301387005.html

    SOURCE Fusion Pharmaceuticals Inc.

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  3. HAMILTON, ON and BOSTON, Sept. 23, 2021 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (NASDAQ:FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced that the Company will present at the 2021 Cantor Fitzgerald Virtual Global Healthcare Conference on Wednesday, September 29, 2021 at 2:40pm ET. Presenting on behalf of Fusion will be Chief Executive Officer John Valliant, Ph.D.

    A live webcast of the event will be available on the "Events and Presentations" page in the "Investors & Media" section of the Company's website at https://ir.fusionpharma.com/events-webcasts. A replay of the webcast will be archived on the Company's website for 90 days following the presentation.  

    About Fusion

    Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Employing a proprietary Fast-Clear™ linker technology, Fusion connects alpha particle emitting isotopes to various targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion's lead program, FPI-1434 targeting insulin-like growth factor 1 receptor, is currently in a Phase 1 clinical trial. The pipeline includes FPI-1966, targeting the fibroblast growth factor receptor 3 (FGFR3), advancing to a Phase 1 study following the recent investigational new drug (IND) clearance; and FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1). In addition to a robust proprietary pipeline, Fusion has a collaboration with AstraZeneca to jointly develop novel targeted alpha therapies (TATs) and combination programs between Fusion's TATs and AstraZeneca's DNA Damage Repair Inhibitors (DDRis) and immuno-oncology agents. Fusion has also entered into a collaboration with Merck to evaluate FPI-1434 in combination with Merck's KEYTRUDA® (pembrolizumab) in patients with solid tumors expressing IGF-1R. Fusion and Hamilton, Ontario-based McMaster University are building a current Good Manufacturing Practice (GMP) compliant radiopharmaceutical manufacturing facility designed to support manufacturing of the Company's growing pipeline of TATs.

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/fusion-pharmaceuticals-to-present-at-the-2021-cantor-fitzgerald-virtual-global-healthcare-conference-301384279.html

    SOURCE Fusion Pharmaceuticals Inc.

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  4. HAMILTON, ON and BOSTON, Sept. 21, 2021 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (NASDAQ:FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced the appointment of Eric S. Hoffman, Ph.D. as senior vice president, business development.

    "The field of radiopharmaceuticals is experiencing a resurgence of interest and excitement, and Fusion is well-positioned with a platform to create differentiated targeted alpha therapies (TATs) from a wide range of targeting molecules, including antibodies and small molecules," said Fusion Chief Executive Officer John Valliant, Ph.D. "With the expansion of our pipeline of TATs through both proprietary and partnered programs, expanding our leadership team is a key part of our strategy to meet the growth opportunities in front of us. To that end, Eric brings to our team deep business development and corporate strategy experience, combined with a scientific and finance background."

    Dr. Hoffman has more than 15 years' experience in the biotechnology industry, most recently acting as chief business officer at Vicarius Pharma, where he led successful business development efforts to in-license European commercialization rights for oncology and other products. Prior to Vicarius, he was chief business officer of Genocea Biosciences where he led business development, alliance management and commercial operations. Prior to Genocea, he was vice president of corporate and business development and executive director of investor relations and corporate communications at Idenix Pharmaceuticals until the acquisition by Merck & Co. Dr. Hoffman was previously director of corporate and business development and director of investor relations at Biogen Idec. He also previously worked for more than five years on Wall Street as a biotechnology equity analyst at JPMorgan Securities and a biotechnology research associate at Bear Stearns International.

    Dr. Hoffman was a post-doctoral research associate in the Department of Immunobiology at King's College in London. He holds a Ph.D. in molecular, cellular and developmental biology with a focus on T cell immunology from Yale University, and a B.S. in biology from Trinity University.

    Inducement Equity Awards

    Fusion's Compensation Committee of the Board of Directors approved a grant of stock options to Dr. Hoffman to purchase 151,000 of Fusion's common shares. Each option was granted as an inducement equity award outside Fusion's 2020 Stock Option and Incentive Plan and was made as an inducement material to Dr. Hoffman's acceptance of employment with Fusion. The options have an exercise price of $8.56 per share, which is equal to the closing price of Fusion's common stock on September 20, 2021. Each option has a ten-year term and vests over four years, with 25% of the original number of shares vesting on the one-year anniversary of the grant date and then in equal installments for 36 months thereafter, subject to Dr. Hoffman's continued service with Fusion through the applicable vesting dates.

    About Fusion

    Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Employing a proprietary Fast-Clear™ linker technology, Fusion connects alpha particle emitting isotopes to various targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion's lead program, FPI-1434 targeting insulin-like growth factor 1 receptor, is currently in a Phase 1 clinical trial. The pipeline includes FPI-1966, targeting the fibroblast growth factor receptor 3 (FGFR3), advancing to a Phase 1 study following the recent investigational new drug (IND) clearance; and FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1). In addition to a robust proprietary pipeline, Fusion has a collaboration with AstraZeneca to jointly develop novel targeted alpha therapies (TATs) and combination programs between Fusion's TATs and AstraZeneca's DNA Damage Repair Inhibitors (DDRis) and immuno-oncology agents. Fusion has also entered into a collaboration with Merck to evaluate FPI-1434 in combination with Merck's KEYTRUDA® (pembrolizumab) in patients with solid tumors expressing IGF-1R. Fusion and Hamilton, Ontario-based McMaster University are building a current Good Manufacturing Practice (GMP) compliant radiopharmaceutical manufacturing facility designed to support manufacturing of the Company's growing pipeline of TATs.

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/fusion-pharmaceuticals-appoints-eric-s-hoffman-phd-as-senior-vice-president-business-development-301381345.html

    SOURCE Fusion Pharmaceuticals Inc.

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  5. HAMILTON, ON and BOSTON, Sept. 2, 2021 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (NASDAQ:FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced that the Company will participate in two upcoming virtual investor conferences.

    • The Morgan Stanley 19th Annual Global Healthcare Conference – The fireside chat will take place on Thursday, September 9, 2021 at 11:00am ET. Presenting on behalf of Fusion will be Chief Executive Officer John Valliant, Ph.D., and Chief Financial Officer John Crowley.



    • The H.C. Wainwright 23rd Annual Global Investment Conference – A recording of the presentation will be made available for on-demand viewing on Monday, September 13, at 7:00am ET. Presenting on behalf of Fusion will be Chief Executive Officer John Valliant, Ph.D.

    Webcasts of each event will be available on the "Events and Presentations" page in the "Investors & Media" section of the Company's website at https://ir.fusionpharma.com/events-webcasts. Replays of the webcasts will be archived on the Company's website for 90 days following their respective presentation dates.  

    About Fusion

    Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Employing a proprietary Fast-Clear™ linker technology, Fusion connects alpha particle emitting isotopes to various targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion's lead program, FPI-1434 targeting insulin-like growth factor 1 receptor, is currently in a Phase 1 clinical trial. The pipeline includes FPI-1966, targeting the fibroblast growth factor receptor 3 (FGFR3), advancing to a Phase 1 study following the recent investigational new drug (IND) clearance; and FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1). In addition to a robust proprietary pipeline, Fusion has a collaboration with AstraZeneca to jointly develop novel targeted alpha therapies (TATs) and combination programs between Fusion's TATs and AstraZeneca's DNA Damage Repair Inhibitors (DDRis) and immuno-oncology agents. Fusion has also entered into a collaboration with Merck to evaluate FPI-1434 in combination with Merck's KEYTRUDA® (pembrolizumab) in patients with solid tumors expressing IGF-1R. Fusion and Hamilton, Ontario-based McMaster University are building a current Good Manufacturing Practice (GMP) compliant radiopharmaceutical manufacturing facility designed to support manufacturing of the Company's growing pipeline of TATs.

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/fusion-pharmaceuticals-to-participate-in-upcoming-investor-conferences-301368697.html

    SOURCE Fusion Pharmaceuticals Inc.

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