Core Viewpoint - Fulcrum Therapeutics (FULC) has experienced a significant stock decline of 58% over the past month, underperforming compared to the industry and the S&P 500, primarily due to disappointing results from a late-stage study of its candidate losmapimod for facioscapulohumeral muscular dystrophy (FSHD) [1][2][3] Company Performance - The phase III REACH study for FSHD did not meet its primary endpoint, failing to show a change from baseline in relative surface area compared to placebo at week 48, leading to the cessation of losmapimod's development in this indication [3][4] - Despite the setback with losmapimod, Fulcrum has another promising candidate, pociredir, which is being developed for sickle cell disease (SCD) [4][5] Pipeline Development - Pociredir is an investigational oral small-molecule inhibitor developed using Fulcrum's proprietary technology, FulcrumSeek, and is currently in a phase Ib study with four dosage strengths [6][7] - Early data for pociredir in SCD has shown proof-of-concept by increasing HbF levels, indicating potential benefits for patients, and it has been well-tolerated with no serious adverse events reported [7][8] Market Potential - The SCD market presents significant growth opportunities due to unmet medical needs and regulatory incentives, with pociredir already receiving Fast Track and Orphan Drug designations in the U.S. [8][12] - Competitors in the SCD market include Vertex and CRISPR Therapeutics, which have recently launched their gene therapy, highlighting the competitive landscape [9] Valuation and Earnings Estimates - Fulcrum's stock appears attractive from a valuation perspective, trading at a price/book value ratio of 0.81, below the industry average of 3.89 and its own 5-year mean of 2.25 [10] - Analysts have narrowed the loss per share estimates for Fulcrum, indicating an improving outlook, with estimates for 2024 reduced from 46 cents to 28 cents and for 2025 from $1.51 to $1.14 [11][12] Investment Consideration - Despite the recent pipeline setback, the potential of pociredir for SCD could drive growth, making Fulcrum a stock worth considering for investors looking for opportunities in the biotech sector [11][13]

FMR LLC (Trades, Portfolio) Transaction Overview - FMR LLC (Trades, Portfolio) sold 3,605,932 shares of Fulcrum Therapeutics Inc (FULC) on September 30, 2024, reducing its holdings to 1,724,014 shares [1] - The shares were traded at $3.57, reflecting a strategic adjustment in the firm's portfolio [1] - This transaction reduced FMR LLC's stake in Fulcrum Therapeutics to 2.76% [5] FMR LLC (Trades, Portfolio) Background - FMR LLC, also known as Fidelity, was established in 1946 and has a strong focus on growth potential and innovative investment strategies [2] - The firm manages a vast portfolio with significant holdings in technology and healthcare sectors, including major companies like Apple Inc and Microsoft Corp [2] - As of June 30, 2024, FMR LLC's top holdings include NVIDIA Corp ($129.0B), Microsoft Corp ($96.8B), and Apple Inc ($72.8B) [3] Fulcrum Therapeutics Inc Overview - Fulcrum Therapeutics Inc is a clinical-stage biopharmaceutical company focused on developing treatments for complex diseases such as muscular dystrophy and sickle cell disease [4] - The company went public on July 18, 2019, and currently has a market capitalization of $224.955 million [4] - Fulcrum's stock price is $3.605, significantly below its GF Value of $48.74 [4] Market Performance and Valuation of Fulcrum Therapeutics - Fulcrum Therapeutics has experienced a 50% year-to-date price decrease and a 75.14% drop since its IPO [6] - The company's GF Score is 54/100, indicating poor future performance potential [6] - Fulcrum ranks 1/10 in Profitability and 0/10 in Growth, further highlighting its challenges [6] Biotechnology Sector and FMR LLC's Strategy - FMR LLC has historically allocated a significant portion of its portfolio to the healthcare sector, with biotechnology being a key focus [7] - The recent reduction in Fulcrum Therapeutics holdings suggests a possible realignment of FMR LLC's investment strategy within the volatile biotechnology sector [7] Future Outlook for Fulcrum Therapeutics - Analysts remain cautious about Fulcrum Therapeutics' future due to its financial health and market challenges [8] - The strategic reduction by FMR LLC may indicate broader concerns about the biotechnology sector's near-term prospects [8] Conclusion - The transaction by FMR LLC represents a significant realignment of its investment in Fulcrum Therapeutics, reflecting the firm's adaptive portfolio management strategy [9] - This move is indicative of FMR LLC's response to the evolving dynamics of the biotechnology sector [9]

Group 1 - Fulcrum Therapeutics, Inc. (FULC) has experienced significant selling pressure, resulting in a 65.6% loss over the past four weeks, but it is now considered to be in oversold territory [1] - Wall Street analysts anticipate that FULC will report better earnings than previously predicted, with a consensus EPS estimate increase of 24.8% over the last 30 days [3] - The stock's Relative Strength Index (RSI) is currently at 20.49, indicating a potential trend reversal as the heavy selling appears to be exhausting itself [3] Group 2 - FULC holds a Zacks Rank 1 (Strong Buy), placing it in the top 5% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, suggesting a strong potential for price appreciation [3]

NEW YORK, Sept. 13, 2024 (GLOBE NEWSWIRE) -- Attorney Advertising -- Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Fulcrum Therapeutics, Inc. ("Fulcrum" or "the Company") (NASDAQ: FULC). Investors who purchased Fulcrum securities are encouraged to obtain additional information and assist the investigation by visiting the firm's site: bgandg.com/FULC. Investigation Details On September 12, 2024, Fulcrum announced that "its Phase 3 REACH trial evaluating losma ...

Shares of Fulcrum Therapeutics, Inc. (FULC) plunged 61.1% on Sept. 12 after the company announced disappointing top-line data from the phase III REACH study, which evaluated its pipeline candidate, losmapimod, for treating patients with facioscapulohumeral muscular dystrophy (FSHD), a rare and debilitating disease. Currently, there are no treatments approved for the given indication. The study did not meet its primary endpoint as treatment with losmapimod failed to demonstrate a change from baseline in rela ...

Core Insights - Fulcrum Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing small molecules for genetically defined rare diseases [2] - The company will participate in investor meetings at the Wells Fargo Healthcare Conference on September 4, 2024, and the Morgan Stanley 22nd Annual Global Healthcare Conference on September 6, 2024 [1] Company Overview - Fulcrum Therapeutics specializes in small molecules aimed at improving the lives of patients with rare diseases that have high unmet medical needs [2] - The company's lead programs include losmapimod for facioscapulohumeral muscular dystrophy (FSHD) and pociredir for sickle cell disease (SCD) [2] - Fulcrum employs proprietary technology to identify drug targets that can modulate gene expression, addressing the root causes of gene mis-expression [2]

Core Viewpoint - Fulcrum Therapeutics, Inc. (FULC) shows significant upside potential with a mean price target of $16.11, indicating a 71% increase from the current trading price of $9.42 [1] Price Target Analysis - The mean estimate consists of nine short-term price targets with a standard deviation of $5.78, suggesting variability in analyst predictions [2] - The lowest estimate is $5, indicating a potential decline of 46.9%, while the highest estimate is $26, suggesting a potential increase of 176% [2] - A low standard deviation indicates strong agreement among analysts regarding the stock's price movement direction [7] Analyst Sentiment - Analysts exhibit growing optimism regarding FULC's earnings prospects, as evidenced by a positive trend in earnings estimate revisions [9] - The Zacks Consensus Estimate for the current year has increased by 61.7% over the past month, with five estimates rising and no negative revisions [10] - FULC holds a Zacks Rank 1 (Strong Buy), placing it in the top 5% of over 4,000 ranked stocks based on earnings estimates [11] Caution on Price Targets - While price targets are commonly referenced by investors, they can often mislead and should not be the sole basis for investment decisions [5][8] - Analysts may set overly optimistic price targets due to business incentives, which can inflate expectations [6]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38978 FULCRUM THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 47-4839948 (State or other juri ...

• Cash Position: As of June 30, 2024, cash, cash equivalents, and marketable securities were $273.8 million, as compared to $236.2 million as of December 31, 2023. The increase in our cash position is due to the $80.0 million upfront payment received from Sanofi in the second quarter of 2024, partially offset by cash used to fund our operating activities in 2024. • Collaboration Revenue: Collaboration revenue was $80.0 million for the three months ended June 30, 2024, as compared to $0.9 million for the thr ...

― Conference call and webcast scheduled for 8:00 a.m. ET today ― ― On track to report topline data for Phase 3 REACH trial of losmapimod in facioscapulohumeral muscular dystrophy (FSHD) by the end of October 2024 ― CAMBRIDGE, Mass., July 31, 2024 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc.® (Fulcrum) (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases, today reported financial results for ...