Welcome to our dedicated page for Fulcrum Therapeutics news (Ticker: FULC), a resource for investors and traders seeking the latest updates and insights on Fulcrum Therapeutics stock.
Fulcrum Therapeutics, Inc. (Nasdaq: FULC) is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients with genetically defined rare diseases. The company focuses on developing small molecules to regulate gene expression and treat the root causes of these diseases.
Fulcrum's lead programs include losmapimod and pociredir (formerly known as FTX-6058). Losmapimod is a selective p38α/β mitogen-activated protein kinase (MAPK) inhibitor licensed from GSK, aimed at treating facioscapulohumeral muscular dystrophy (FSHD). Clinical trials have shown promising results, including slowed disease progression and improved muscle function. Losmapimod has received Fast Track and Orphan Drug Designations from the U.S. FDA and is currently in a Phase 3 multi-center randomized, double-blind, placebo-controlled study.
Pociredir is an investigational oral small-molecule inhibitor of Embryonic Ectoderm Development (EED), targeting sickle cell disease (SCD) and other hemoglobinopathies. It works by increasing the expression of fetal hemoglobin, combating the genetic causes of these diseases. Clinical trials have demonstrated proof-of-concept and an increase in fetal hemoglobin levels. Pociredir also holds Fast Track and Orphan Drug Designations from the FDA.
Fulcrum's proprietary technology platform, FulcrumSeek™, identifies drug targets capable of modulating gene expression, allowing for the development of breakthrough therapies. The company's robust pipeline is supported by strong financial health, with sufficient funding expected to cover operating expenses and capital expenditure requirements into mid-2025. Strategic partnerships, such as the collaboration with Sanofi for the commercialization of losmapimod outside the U.S., further enhance its global reach and capabilities.
Recent News Highlights:
- Completion of patient enrollment for the Phase 3 REACH trial of losmapimod, with topline data expected in Q4 2024.
- Resolution of the FDA clinical hold on pociredir, with plans to resume enrollment for the Phase 1b PIONEER trial.
- Collaboration and license agreement with Sanofi for the global commercialization of losmapimod.
- Publication of Phase 2b clinical trial results of losmapimod in The Lancet Neurology, validating its therapeutic potential.
- Conference calls and webcasts to provide updates on financial results and business highlights.
Fulcrum Therapeutics (Nasdaq: FULC) announced the granting of stock options for 6,180 shares to a new employee as inducement awards under its 2022 Inducement Stock Incentive Plan. The options, issued on October 3, 2022, have an exercise price of $8.16 per share, equal to the closing stock price on that date. These options will vest over four years, with a quarter vesting after the first year and the remainder in quarterly installments. Fulcrum focuses on developing treatments for genetically defined rare diseases with significant unmet medical needs.
Fulcrum Therapeutics (NASDAQ: FULC) announced the granting of 59,500 non-statutory stock options to three new employees on September 6, 2022. These options serve as inducement awards outside the 2019 Stock Incentive Plan. The exercise price is set at $7.47 per share, corresponding to the closing price on the grant date. Each option has a ten-year term with a four-year vesting period, allowing 25% to vest after the first year and the remainder in quarterly installments. Fulcrum focuses on developing treatments for genetically defined rare diseases.
Fulcrum Therapeutics (Nasdaq: FULC) is set to participate in key investor conferences, including the H.C. Wainwright 24th Annual Global Investment Conference on September 13, 2022, and the Morgan Stanley 20th Annual Global Healthcare Conference, which will feature a fireside chat on September 14, 2022, at 10:00 a.m. ET. The Morgan Stanley chat will be available live via the Fulcrum Investor Relations website, with a recording accessible for 30 days afterward. Fulcrum focuses on rare genetic diseases and has two lead programs in development: losmapimod for facioscapulohumeral muscular dystrophy and FTX-6058 for sickle cell disease.
Fulcrum Therapeutics, Inc. (Nasdaq: FULC) announced participation in a fireside chat at the Stifel 2022 Biotech Summer Summit on August 17, 2022, at 11:30 a.m. ET. The company focuses on developing treatments for genetically defined rare diseases, with lead programs including losmapimod for facioscapulohumeral muscular dystrophy and FTX-6058 targeting sickle cell disease. Fulcrum's proprietary platform, FulcrumSeek™, aims to address gene expression issues to tackle the root causes of these diseases. For more details, visit www.fulcrumtx.com.
Fulcrum Therapeutics (Nasdaq: FULC) announced a public offering of 9,590,792 shares of common stock at $7.82 per share, aiming to raise $75 million before expenses. The offering is led by Goldman Sachs and SVB Securities, with a 30-day option for underwriters to purchase an additional 1,438,618 shares. The closing date is projected for August 18, 2022. The shares are offered under an effective shelf registration statement with the SEC, ensuring compliance for the transaction. This move supports Fulcrum's focus on developing therapies for rare genetic diseases.
Fulcrum Therapeutics (Nasdaq: FULC) announced an underwritten public offering of $75 million in common stock, with an additional $11.3 million option for underwriters. Led by Goldman Sachs & Co. LLC and SVB Securities, the offering is subject to market conditions and may not guarantee completion. Shares will be offered under an effective shelf registration statement filed with the SEC, and a preliminary prospectus supplement will be available at SEC’s website. The funds will support Fulcrum’s clinical programs targeting rare diseases, including FSHD and sickle cell disease.
NextRNA Therapeutics announces the appointment of Dominique Verhelle, PhD, MBA, as CEO, effective immediately. Verhelle, a co-founder of the company, has spearheaded its scientific and corporate strategy since its inception. Under her leadership, NextRNA secured $56M in financing to advance its unique platform aimed at developing small molecule drugs targeting non-coding RNA interactions. Additionally, Jason Katz has been appointed as VP and Head of Drug Discovery, bringing extensive drug discovery experience from IFM Therapeutics and Merck.
Fulcrum Therapeutics (FULC) reported key advancements in clinical trials and a strategic realignment to enhance operational efficiency. Initial data from the Phase 1b trial of FTX-6058 in sickle cell disease showed promising increases in hemoglobin F (HbF), while the Phase 3 REACH trial for losmapimod in facioscapulohumeral muscular dystrophy has begun enrolling patients. The company plans to cut operating expenses by $40-50 million and extend its cash runway into mid-2024. As of June 30, 2022, cash and equivalents totaled $169 million, down from $218 million at the end of 2021.
Fulcrum Therapeutics, Inc. (Nasdaq: FULC) will release its second quarter 2022 financial results on August 11, 2022, before the U.S. markets open. The company, focused on treating genetically defined rare diseases, will host a conference call at 8:00 a.m. ET for discussions regarding the results and recent developments. Key programs include losmapimod for facioscapulohumeral muscular dystrophy and FTX-6058 for sickle cell disease. A webcast will also be available for those unable to join live.
Fulcrum Therapeutics (Nasdaq: FULC) announced the granting of non-statutory stock options to four new employees, totaling 162,700 shares. The options have an exercise price of $5.26 per share, matching the closing stock price on August 1, 2022. The options will vest over four years, commencing with 25% on the first anniversary and then 6.25% quarterly. This action is part of Fulcrum's strategy to attract talent while adhering to Nasdaq Listing Rule 5635(c)(4). Fulcrum focuses on treating rare genetically defined diseases, with lead programs targeting muscular dystrophy and sickle cell disease.
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