Fulcrum Therapeutics(FULC)
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Fulcrum Therapeutics Announces Pricing of Upsized $175.0 Million Public Offering of Common Stock and Pre-Funded Warrants
Globenewswire· 2025-12-10 12:48
Core Viewpoint - Fulcrum Therapeutics, Inc. has announced a public offering of 11,851,853 shares of common stock priced at $13.50 per share, aiming to raise approximately $175 million in gross proceeds before expenses [1][2]. Group 1: Offering Details - The offering includes pre-funded warrants for certain investors to purchase up to 1,111,193 shares at a price of $13.499 per warrant, reflecting a slight discount from the common stock price [1]. - Fulcrum has granted underwriters a 30-day option to purchase an additional 1,944,456 shares under the same terms [1]. - The offering is expected to close around December 11, 2025, subject to customary closing conditions [3]. Group 2: Use of Proceeds - The net proceeds from the offering will primarily be used for general corporate purposes, including working capital, capital expenditures, and research and development expenses [2]. - Specific allocations may include funding clinical trials, regulatory submissions, commercialization efforts, and potential acquisitions or investments in complementary technologies or assets [2]. Group 3: Company Background - Fulcrum Therapeutics is focused on developing small molecules for patients with genetically defined rare diseases, with its lead program targeting sickle cell disease through the modulation of gene expression [7].
Fulcrum Therapeutics Announces Proposed $150.0 Million Public Offering of Common Stock
Globenewswire· 2025-12-08 21:01
Core Viewpoint - Fulcrum Therapeutics, Inc. has initiated an underwritten public offering of $150 million in common stock, with an option for underwriters to purchase an additional $22.5 million [1][2]. Group 1: Offering Details - The offering is being managed by J.P. Morgan, Leerink Partners, Cantor, Oppenheimer & Co., and Truist Securities [2]. - The shares are being offered under an effective shelf registration statement filed with the SEC on February 27, 2024, and declared effective on April 25, 2024 [3]. - A preliminary prospectus supplement and accompanying prospectus will be filed with the SEC and made available on their website [3][5]. Group 2: Use of Proceeds - The net proceeds from the offering are intended for general corporate purposes, including working capital, capital expenditures, research and development expenses, and potential acquisitions or investments [4]. Group 3: Company Overview - Fulcrum Therapeutics is focused on developing small molecules for patients with genetically defined rare diseases, with its lead program being pociredir for sickle cell disease [7]. - The company utilizes proprietary technology to identify drug targets that can modulate gene expression [7].
Fulcrum Therapeutics Stock Rally Ignited By Promising Sickle Cell Results
Benzinga· 2025-12-08 18:06
Fulcrum Therapeutics Inc. (NASDAQ:FULC) stock is surging on Monday, after the company released initial results from the ongoing 20 mg dose cohort of the Phase 1b PIONEER trial of pociredir in sickle cell disease. • Fulcrum Therapeutics shares are testing new highs. What’s driving FULC to record levels?“We are highly encouraged by these initial data from the 20 mg cohort, which show clear evidence of a dose-response and build on the strong profile established with the 12 mg cohort,” said Alex Sapir, Fulcrum’ ...
Crude Oil Falls Over 1%; Structure Therapeutics Shares Jump - Fulcrum Therapeutics (NASDAQ:FULC), Structure Therapeutics (NASDAQ:GPCR)
Benzinga· 2025-12-08 17:46
U.S. stocks traded lower midway through trading, with the Dow Jones index falling more than 200 points on Monday.The Dow traded down 0.46% to 47,733.58 while the NASDAQ fell 0.32% to 23,501.92. The S&P 500 also fell, dropping, 0.46% to 6,838.69.Check This Out: Top 3 Materials Stocks That Are Preparing To Pump In Q4Leading and Lagging SectorsInformation technology shares jumped by 0.6% on Monday.In trading on Monday, communication services stocks fell by 2.1%.Top HeadlineThe one-year-ahead median inflation e ...
Crude Oil Falls Over 1%; Structure Therapeutics Shares Jump
Benzinga· 2025-12-08 17:46
U.S. stocks traded lower midway through trading, with the Dow Jones index falling more than 200 points on Monday.The Dow traded down 0.46% to 47,733.58 while the NASDAQ fell 0.32% to 23,501.92. The S&P 500 also fell, dropping, 0.46% to 6,838.69.Check This Out: Top 3 Materials Stocks That Are Preparing To Pump In Q4Leading and Lagging SectorsInformation technology shares jumped by 0.6% on Monday.In trading on Monday, communication services stocks fell by 2.1%.Top HeadlineThe one-year-ahead median inflation e ...
Paramount Skydance, Wave Life Sciences, Ocular Therapeutix, Carvana And Other Big Stocks Moving Higher On Monday - Arcellx (NASDAQ:ACLX), Arrowhead Pharma (NASDAQ:ARWR)
Benzinga· 2025-12-08 17:33
Group 1 - U.S. stocks experienced a decline, with the Dow Jones falling over 200 points on Monday [1] - Paramount Skydance Corporation launched an all-cash tender offer to acquire Warner Bros. Discovery, Inc. for $30 per share, valuing the company at $108.4 billion [1] - Paramount aims to create a scaled Hollywood leader by merging with Warner Bros. [1] Group 2 - Paramount Skydance shares increased by 9.8% to $14.68 on Monday [2] - Other notable stocks that gained include Wave Life Sciences Ltd., which rose 129.1% to $17.16 after positive interim Phase 1 data for its obesity drug [4] - Structure Therapeutics Inc. saw a gain of 100.5% to $69.30 following the announcement of topline data from its clinical program for obesity treatment [4] Group 3 - Fulcrum Therapeutics, Inc. shares rose 62.3% to $14.44 after reporting initial results from its Phase 1b trial for sickle cell disease [4] - Kymera Therapeutics, Inc. gained 51.2% to $100.75 after reporting successful trial results for its KT-621 drug [4] - Confluent, Inc. shares increased by 29.2% to $29.89 after IBM agreed to acquire the company for $31 per share [4]
Morning Market Movers: CETX, TGL, TWG, FULC See Big Swings
RTTNews· 2025-12-08 13:20
Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential trading opportunities before the market opens [1] Premarket Gainers - Cemtrex, Inc. (CETX) has increased by 284% to $11.79 - Treasure Global Inc. (TGL) has risen by 135% to $59.83 - Top Wealth Group Holding Limited (TWG) is up 95% at $11.73 - Fulcrum Therapeutics, Inc. (FULC) has gained 49% to $13.29 - MetaVia Inc. (MTVA) is up 33% at $10.90 - Kymera Therapeutics, Inc. (KYMR) has increased by 31% to $87.58 - Confluent, Inc. (CFLT) is up 27% at $29.40 - Immix Biopharma, Inc. (IMMX) has risen by 23% to $6.85 - Nurix Therapeutics, Inc. (NRIX) is up 18% at $21.46 - SU Group Holdings Limited (SUGP) has increased by 15% to $6.44 [3] Premarket Losers - SMX (Security Matters) Public Limited Company (SMX) has decreased by 27% to $242.01 - Meihua International Medical Technologies Co., Ltd. (MHUA) is down 27% at $10.20 - Polyrizon Ltd. (PLRZ) has declined by 16% to $10.90 - Fly-E Group, Inc. (FLYE) is down 16% at $6.90 - Sensei Biotherapeutics, Inc. (SNSE) has decreased by 14% to $8.29 - Kentucky First Federal Bancorp (KFFB) is down 10% at $4.00 - Arteris, Inc. (AIP) has declined by 7% to $16.27 - Fusion Fuel Green PLC (HTOO) is down 6% at $3.89 - Kamada Ltd. (KMDA) has decreased by 5% to $6.69 - iOThree Limited (IOTR) is down 5% at $3.11 [4]
Fulcrum Therapeutics, Inc. (FULC) Discusses New Clinical Data From the Phase 1b PIONEER Trial of Pociredir in Sickle Cell Disease Transcript
Seeking Alpha· 2025-12-07 16:03
Core Viewpoint - Fulcrum Therapeutics is poised to make significant advancements in the treatment of sickle cell disease, which could greatly improve the lives of patients globally [2]. Company Overview - Alexander Sapir serves as the CEO and President of Fulcrum Therapeutics, leading the company in its mission to develop transformative therapies [1]. - The company is focused on addressing the needs of the sickle cell community, highlighting the potential impact of its drug on patient outcomes [2]. Industry Context - The presentation emphasizes the importance of innovation in the pharmaceutical industry, particularly in the development of treatments for chronic conditions like sickle cell disease [2].
Fulcrum Therapeutics (NasdaqGM:FULC) Update / Briefing Transcript
2025-12-07 13:02
Fulcrum Therapeutics Conference Call Summary Company Overview - **Company**: Fulcrum Therapeutics (NasdaqGM: FULC) - **Focus**: Development of treatments for sickle cell disease, particularly through fetal hemoglobin induction Key Industry Insights - **Sickle Cell Disease**: A debilitating condition affecting over 7 million individuals globally, with around 100,000 cases in the U.S. [13] - **Unmet Need**: Patients face significant health challenges, including painful vaso-occlusive crises (VOCs), chronic anemia, and reduced life expectancy by over 20 years compared to the general population [14] Core Drug Insights - **Drug**: Pociredir - **Mechanism**: Inhibits EED subunit of PRC2, leading to increased fetal hemoglobin (HbF) levels by reducing BCL11A activity [17][18] - **Clinical Data**: - **20 mg Cohort**: Showed a 9.9% mean absolute increase in HbF at week six, exceeding the 12 mg cohort's results [10][11] - **Efficacy**: 58% of patients achieved HbF levels greater than or equal to 20% [10][47] - **Induction**: 3.75-fold increase in HbF induction observed [11][47] - **Safety**: Generally well tolerated with no discontinuations due to adverse events [43][46] Patient Population and Study Design - **Study Population**: 13 patients enrolled, predominantly with severe genotypes, ages 18 to 65 [25] - **Adherence**: 97% adherence rate documented using an AiCure app [28] - **Endpoints**: Focused on safety, tolerability, HbF induction, hemolysis, and anemia [26] Clinical Outcomes - **HbF Induction**: Absolute increase of 16.9% HbF at day 42, compared to 16.2% at 12 weeks for the 20 mg cohort [31] - **VOCs**: Only five VOCs observed in four patients during the treatment period, with 67% of patients reporting no VOCs [42] - **Hemolysis Markers**: Significant reductions in lactate dehydrogenase (LDH) and indirect bilirubin levels, indicating improved hemolysis [37] Future Directions - **Next Steps**: Completion of the 20 mg cohort and preparation for an end-of-phase meeting with the FDA planned for early 2026 [55] - **Open Label Extension Study**: Expected to begin enrolling patients in the first half of next year [55] - **Registrational Study**: Plans to initiate a registrational study in the second half of next year, pending regulatory feedback [55] Additional Insights - **Potential for Cure**: Discussion on the possibility of achieving functional cures for some patients through high levels of HbF induction [58][59] - **Market Expansion**: Consideration of expanding the patient population to include those with less severe symptoms, as the disease progresses even without acute pain [94] Conclusion - Fulcrum Therapeutics is making significant strides in the treatment of sickle cell disease with promising data from the Pociredir trials, indicating potential for transformative patient outcomes and a pathway towards regulatory approval.
Fulcrum Therapeutics (NasdaqGM:FULC) Earnings Call Presentation
2025-12-07 12:00
Pociredir PIONEER Study: 20 mg Cohort ASH Data Release December 7, 2025 Disclaimer and Notice This presentation contains "forward-looking statements" of Fulcrum Therapeutics, Inc. (Fulcrum or Fulcrum Therapeutics) within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties, including express or implied statements regarding regarding the significance of initial results from the 20 mg cohort, Fulcrum's goals for pociredir, pociredir's best-in-cla ...