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Fusion Pharmaceuticals Inc. (Nasdaq: FUSN) is a clinical-stage oncology company based in Hamilton, Ontario, Canada, and Boston, focusing on the development of next-generation radioconjugates (RCs) for precision cancer treatments. The company specializes in targeted alpha therapy (TAT), leveraging their unique expertise in linking alpha particle-emitting isotopes to targeting molecules to create highly effective therapeutics.
Fusion’s lead program, FPI-2265, is designed specifically for metastatic castration-resistant prostate cancer (mCRPC). This innovative treatment targets the prostate-specific membrane antigen (PSMA) and is currently undergoing a Phase 2 clinical trial. FPI-2265 aims to improve patient outcomes by delivering a potent radioactive payload directly to cancer cells, minimizing damage to healthy tissues. The recent Phase 2 TATCIST trial results, presented at the AACR Annual Meeting 2024, demonstrated promising clinical activity and safety, with meaningful improvements in secondary endpoints for mCRPC patients.
Fusion’s pipeline includes several other promising candidates, such as FPI-1434, targeting the insulin growth factor 1 receptor (IGF1R), FPI-2059, targeting the neurotensin receptor 1 (NTSR1), and FPI-2068, a bispecific IgG-based RC targeting EGFR-cMET.
The recent acquisition of Fusion by AstraZeneca marks a significant milestone. AstraZeneca will acquire all of Fusion’s outstanding shares for $21.00 per share in cash, plus a non-transferable contingent value right of $3.00 per share, subject to achieving specific regulatory milestones. This acquisition, valued at approximately $2.4 billion, underscores Fusion's pivotal role in pioneering RCs and enhancing AstraZeneca's oncology portfolio.
Fusion operates a state-of-the-art Good Manufacturing Practice (GMP) compliant facility, ensuring the production of clinical doses for its expanding pipeline. The company has strategic actinium supply agreements with Niowave, Inc., and BWXT Medical to meet the growing demand for their therapies.
With a robust pipeline, strategic partnerships, and a strong balance sheet, Fusion is well-positioned to advance their mission of transforming cancer treatment through innovative alpha-emitting radioconjugates.
Fusion Pharmaceuticals Inc. (Nasdaq: FUSN) announced the grant of stock options totaling 80,000 shares to an employee outside its 2020 Stock Option and Incentive Plan. This award was made in accordance with Nasdaq Listing Rule 5635(c)(4), with an exercise price set at $9.41 per share, equal to the closing price on August 30, 2021. The options have a ten-year term and vest over four years. Fusion focuses on developing precision radiopharmaceuticals, with its lead program, FPI-1434, currently in a Phase 1 clinical trial.
Fusion Pharmaceuticals and TRIUMF have announced an expanded collaboration focused on the development and production of actinium-225, a key medical isotope. Fusion will invest up to $25 million CAD to enhance TRIUMF's production capabilities, gaining preferred access and pricing for the isotope. This initiative aligns with Fusion's strategy to advance its pipeline of actinium-based targeted alpha therapies for cancer treatment. The partnership signifies a significant step in securing actinium supply amidst rising demand for innovative cancer therapies.
Fusion Pharmaceuticals Inc. (Nasdaq: FUSN) announced its Q2 2021 financial results, revealing a net loss of $26.9 million, marking an improvement from a $44.7 million loss in Q2 2020. Cash reserves stood at $260.5 million, projected to sustain operations through 2023. Key highlights include progress in its Phase 1 trial of FPI-1434, with data on multi-dose safety expected in H1 2022, and FDA clearance for FPI-1966, anticipated to begin trials soon. The company also aims to submit an IND for FPI-2059 in early 2022, enhancing its pipeline of targeted therapies.
Fusion Pharmaceuticals (Nasdaq: FUSN) announced its participation in the "Hot Topic - Radiopharmaceuticals" panel at the 2021 Wedbush PacGrow Healthcare Virtual Conference on August 11, 2021, at 4:05 PM EDT. CEO John Valliant, Ph.D., will represent the company. Fusion specializes in developing precision radiopharmaceuticals, utilizing its proprietary Fast-Clear™ linker technology to target tumors selectively. Its lead program, FPI-1434, is in Phase 1 trials, supported by collaborations with AstraZeneca and Merck.
Fusion Pharmaceuticals (Nasdaq: FUSN) has received FDA clearance for its Investigational New Drug (IND) applications for the targeted alpha therapy FPI-1966 and imaging agent FPI-1967. FPI-1966 aims to deliver actinium-225 to tumors expressing FGFR3, overexpressed in various cancers, particularly head and neck and bladder cancers. A Phase 1 clinical trial will evaluate the safety and recommended dosage of FPI-1966. This approach seeks to target a broader patient population than current treatment options, potentially addressing significant unmet medical needs.
Fusion Pharmaceuticals Inc. (Nasdaq: FUSN) granted stock option awards for 90,400 shares to a new employee, as per Nasdaq Listing Rule 5635(c)(4). The exercise price is set at $8.23 per share, matching the closing price on July 6, 2021. These options vest over four years, starting with 25% vesting on the one-year anniversary. Fusion focuses on developing precision medicines using next-generation radiopharmaceuticals, with its lead program, FPI-1434, currently in a Phase 1 clinical trial aimed at targeting various tumor types.
Fusion Pharmaceuticals (Nasdaq: FUSN) announced promising preliminary results from its Phase 1 trial of FPI-1434, highlighting a favorable safety profile with no serious adverse events. The drug demonstrated significant uptake across multiple tumor types. Ongoing enrollment in multi-dosing cohorts aims to assess cumulative radiation levels for anti-tumor activity. Additionally, preclinical data revealed synergistic efficacy when FPI-1434 was combined with olaparib and immune checkpoint inhibitors, showing potential for enhanced cancer treatment strategies. These findings were presented at the SNMMI 2021 Annual Meeting.
Fusion Pharmaceuticals Inc. (Nasdaq: FUSN) has appointed Isabelle Dussault, Ph.D., as senior vice president of research. Dussault brings extensive experience in oncology, having previously served as global head of clinical biomarker strategy at EMD Serono and held roles at Bristol-Myers Squibb, Merck, and Amgen. The company granted her stock options to purchase 132,000 shares as an inducement to join Fusion. Dussault's expertise will bolster the company’s research capabilities, particularly in radiopharmaceuticals aimed at targeted alpha therapies.
Fusion Pharmaceuticals (Nasdaq: FUSN) announced a 15-year lease for a 27,000 square foot GMP-compliant radiopharmaceutical manufacturing facility in Hamilton, Ontario. This facility, set to be operational by early 2024, will support the production of the company's targeted alpha therapies (TATs). Fusion’s CEO, John Valliant, emphasized the importance of manufacturing infrastructure for the company's growth and collaboration efforts. The company also established a services agreement with the Centre for Probe Development and Commercialization for facility validation.
Fusion Pharmaceuticals Inc. (Nasdaq: FUSN) announced its participation in the Jefferies Virtual Healthcare Conference on June 3, 2021, at 11:00am EDT. The CEO, John Valliant, Ph.D., will represent the company. A live webcast will be available on the company’s website and will be archived for 30 days post-event. Fusion specializes in developing next-generation radiopharmaceuticals, including its lead program, FPI-1434, currently in Phase 1 clinical trials. The company employs proprietary technology to deliver alpha particles selectively to tumors.
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