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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 (Nasdaq: FUSN) announced on November 9, 2022, that its Board of Directors granted stock option awards for 104,000 shares to four new employees as an inducement for their hiring. The stock options have an exercise price of $1.98 per share, equivalent to the closing price on November 7, 2022. The options will vest over four years, with 25% vesting after one year. Fusion is focused on developing next-generation radiopharmaceuticals and has a robust pipeline, including collaborations with AstraZeneca and Merck.
Fusion Pharmaceuticals (Nasdaq: FUSN) reported third quarter 2022 financial results, showing a net loss of $24.0 million, down from $19.4 million in Q3 2021. The company holds $205.5 million in cash and investments, sufficient to fund operations into Q3 2024. Clinical developments include updates on FPI-1434 and FPI-1966 trials, with promising advancements in targeted alpha therapy. The FPI-1434 Phase 1 data is on track for early 2023, and patient enrollment for FPI-1966 is ongoing. New CMO Dmitri Bobilev has been appointed to enhance clinical strategy.
Fusion Pharmaceuticals (Nasdaq: FUSN) has appointed Dmitri Bobilev, M.D., as its new chief medical officer, effective November 7, 2022. With extensive experience in clinical development and radiation oncology, Dr. Bobilev aims to advance Fusion's novel targeted alpha therapy (TAT) programs amid a collaboration with AstraZeneca. The company has granted him 550,000 stock options with an exercise price of $1.98, set to vest over four years. Fusion is focused on developing precision medicines through innovative radiopharmaceuticals targeting cancer.
On September 13, 2022, Fusion Pharmaceuticals (Nasdaq: FUSN) announced the granting of stock options for 197,200 shares to 10 employees as an inducement for joining the company. The options, priced at $2.83 per share, match the closing stock price on September 12, 2022, and have a ten-year term with a four-year vesting schedule. Fusion is focused on developing next-generation radiopharmaceuticals, with several programs in clinical trials, including FPI-1434 and partnerships with AstraZeneca and Merck to advance targeted alpha therapies.
Fusion Pharmaceuticals (Nasdaq: FUSN) announced its participation in the Morgan Stanley 20th Annual Global Healthcare Conference on September 14, 2022, at 12:55 p.m. ET. CFO John Crowley and CTO Eric Burak will represent the company. Investors can access a live webcast on the Company’s website, with a replay available for 60 days post-event. Fusion specializes in next-generation radiopharmaceuticals targeting tumors using alpha particle emitting isotopes. Current clinical trials include FPI-1434, FPI-1966, and FPI-2059, alongside collaborations with AstraZeneca and Merck.
Fusion Pharmaceuticals Inc. (Nasdaq: FUSN) announced the first patient dosing in a Phase 1/2 study of FPI-1966 for advanced solid tumors expressing FGFR3. This innovative therapy uses actinium-225 linked to the antibody vofatamab, targeting cancers like bladder and ovarian. The study evaluates safety and efficacy through a dose escalation design. Initial results on pharmacokinetics and safety data will be provided after patient screening. Fusion aims for FPI-1966 to establish a new treatment paradigm in precision medicine.
Fusion Pharmaceuticals Inc. (Nasdaq: FUSN) announced the FDA's clearance of its FPI-2059 investigational new drug application, expanding its clinical portfolio with targeted alpha therapy. Financial results for Q2 2022 showed a net loss of $19.1 million ($0.44 per share) and cash holdings of $198.4 million, expected to fund operations into Q1 2024. Key developments include collaborations for actinium-225 production and promising early imaging data for FPI-1434 presented at SNMMI 2022. The company anticipates further updates on clinical trials in 2023.
Fusion Pharmaceuticals Inc. (Nasdaq: FUSN) announced stock option awards for 44,800 shares to two new employees, compliant with Nasdaq Listing Rule 5635(c)(4). The options have an exercise price of $2.36 per share, equal to the closing price on August 1, 2022, and will vest over four years. Fusion, a clinical-stage oncology company, is advancing its pipeline of radiopharmaceuticals targeting various cancer-related receptors and is collaborating with AstraZeneca and Merck for drug development and manufacturing capabilities.
Fusion Pharmaceuticals (Nasdaq: FUSN) announced on July 7, 2022, that its Board of Directors approved stock option grants totaling 37,200 shares to a new employee, in accordance with Nasdaq Listing Rule 5635(c)(4). The options have an exercise price of $2.46 per share, matching the closing stock price on July 5, 2022. They vest over four years, with 25% vesting after the first year. Fusion specializes in developing precision radiopharmaceuticals, with a focus on innovative oncology therapies, including ongoing Phase 1 trials for its lead product, FPI-1434.
Fusion Pharmaceuticals (Nasdaq: FUSN) announced FDA clearance for IND applications regarding 225Ac]-FPI-2059 and 111In]-FPI-2058, their targeted alpha therapies aimed at treating solid tumors with high unmet needs. FPI-2059 targets neurotensin receptor 1 (NTSR1), potentially beneficial for patients with colorectal and neuroendocrine differentiated prostate cancers. The company plans to initiate a Phase 1 clinical trial to assess safety and pharmacokinetics, focusing on six solid tumor types. This marks Fusion's third clinical program and aims to improve treatment efficacy at significantly lower doses.
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