Fulcrum Therapeutics Inc

Fulcrum Therapeutics, Inc. is a clinical stage biopharmaceutical company. The firm develops new medicines and focuses on unlocking gene control mechanisms to develop small molecule therapies. Its product candidate includes Losmapimod and FTX-HbF. The company was founded by Michael R. Green, Danny Reinberg, Rudolf Jaenisch, Jeannie T. Lee, and Bradley E. Bernstein on August 18, 2015 and is headquartered in Cambridge, MA.

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Fulcrum Therapeutics reports promising data and financial stability in Q4

Fulcrum Therapeutics showcased positive data for FTX-6058 and financial stability in their Q4 2022 earnings call
While facing challenges with the clinical hold, the company's strong cash position and promising programs offer opportunities for growth

Fulcrum Therapeutics reports solid financials, FDA challenges, and leadership change

Fulcrum Therapeutics navigates a mixed landscape with strong financials, promising clinical trial progress, and regulatory challenges that require careful resolution.
New leadership, ongoing FDA collaborations, and a robust cash position position Fulcrum for continued growth and innovation in the biopharmaceutical space.

Fulcrum Therapeutics reports stable finances, regulatory hurdles ahead

Fulcrum Therapeutics maintains a stable financial position with a focus on advancing key pipeline candidates.
Challenges include regulatory uncertainties for FTX-6058 and ongoing R&D investment impacting financials.
Opportunities lie in upcoming data releases, resolving regulatory issues, and strategic growth initiatives.

Fulcrum Therapeutics reports Q3 loss, progresses key clinical trials

Fulcrum Therapeutics reported a mixed performance in Q3 2023, with a net loss driven by significant R&D and administrative expenses.
Despite challenges in cash burn and timeline for commercialization, the company's strong cash position and promising clinical developments highlight its potential.
Opportunities lie in advancing regulatory filings, leveraging positive clinical results, and exploring additional endpoints to showcase therapy efficacy.

Fulcrum Therapeutics advances Phase III trials, secures strong financial position

Fulcrum Therapeutics made significant progress in advancing its pipeline with successful trial enrollments and resolution of clinical holds.
Financially, the company ended 2023 on a strong note with a healthy cash position and reported financials.
Challenges lie in meeting trial endpoints and managing expenses, but opportunities exist in market reception and further data collection.
Overall, Fulcrum's proactive approach to clinical development and stakeholder engagement positions it well for future growth.

Fulcrum Therapeutics secures Sanofi collaboration, advances Phase III trials

Fulcrum Therapeutics' collaboration with Sanofi and strong financial position provide a solid foundation for future growth and development.
The company's focus on advancing Phase III trials, addressing unmet medical needs, and driving innovation through novel endpoints positions it well for success.
While facing challenges in various operational aspects, Fulcrum's strategic planning and emphasis on key appointments and market access strategies indicate a proactive approach to overcoming obstacles.

Fulcrum Therapeutics reports strong Q2 earnings and advances clinical assets

Fulcrum Therapeutics achieved a significant turnaround in financial performance with a notable increase in net income and a strong cash position, supported by collaboration revenue.
Progress in Phase III trials for losmapimod and pociredir, along with positive patient engagement, bodes well for future drug development and market potential.
While facing regulatory and competitive challenges, the company's strategic collaborations, financial stability, and ongoing trials present opportunities for growth and market expansion.

Fulcrum Therapeutics navigates workforce reduction, focuses on sickle cell treatment

Fulcrum Therapeutics faces challenges with workforce reduction and program suspension but remains focused on advancing pociredir for sickle cell disease treatment.
The company's financial position is strong, with a cash balance of $257.2 million and plans to manage cash burn effectively in 2025.
Management changes and analyst inquiries underscore the need for strategic decision-making and operational efficiency to drive future success.

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CAMBRIDGE, Mass., Oct. 01, 2021 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc. (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today announced the grant of an inducement award outside of the Company's 2019 Stock Incentive Plan to Naomi Aoki, the Company's newly appointed SVP, Communications and Investor Relations. The grant was approved by the Compensation Committee on September 10, 2021, as an inducement material to the employee entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4).

Fulcrum Therapeutics™ Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

– Presentations highlight progress in the development of losmapimod for FSHD –

Fulcrum Therapeutics™ Announces Multiple Presentations During the Virtual Congress of the World Muscle Society

FULC has multiple interesting programs with decent data.

Fulcrum Therapeutics: Multiple Interesting Programs, Needs A Better Entry Point

BioCryst Pharmaceuticals

These recent winners still have a long way to run.

2 Soaring Biotech Stocks With More Fuel in the Tank

CAMBRIDGE, Mass., Aug. 16, 2021 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc. (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today announced closing of its previously announced underwritten public offering of 7,590,000 shares of its common stock at a public offering price of $19.00 per share, which includes 990,000 shares issued upon the exercise in full by the underwriters of their option to purchase additional shares of common stock at the public offering price, less underwriting discounts and commissions. The total gross proceeds of the offering were $144.2 million, before deducting underwriting discounts and commissions and offering expenses payable by Fulcrum. All of the shares in the offering were sold by Fulcrum.

Fulcrum Therapeutics Announces Closing of Public Offering of Common Stock and Full Exercise by Underwriters of Option to Purchase Additional Shares

CAMBRIDGE, Mass., Aug. 11, 2021 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc. (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today announced that it has priced an underwritten public offering of 6,600,000 shares of its common stock at a public offering price of $19.00 per share, for total gross proceeds of approximately $125 million, before deducting underwriting discounts and commissions and offering expenses payable by Fulcrum. All of the shares in the offering are being sold by Fulcrum. In addition, Fulcrum has granted the underwriters a 30-day option to purchase up to 990,000 additional shares of its common stock at the public offering price, less the underwriting discount and commissions. The offering is expected to close on August 16, 2021, subject to customary closing conditions.

Fulcrum Therapeutics Announces Pricing of $125 Million Public Offering of Common Stock

Compelling clinical-trial data that could validate the company's unique approach to new drug development inspired a slew of analyst upgrades.

Why Fulcrum Therapeutics Popped Again on Tuesday

Fulcrum Therapeutics Inc (NASDAQ:FULC) is trading higher again Wednesday after the stock saw positive analyst coverage following the company's better-than-expected financial results and announcement that its Phase 1 study of FTX-6058 for sickle cell disease showed proof of mechanism and proof of biology. “We are very pleased with the interim results from this clinical trial of FTX-6058, which demonstrated compelling results across all primary, secondary, and exploratory endpoints included in this study,” said Bryan Stuart, president and CEO of Fulcrum Therapeutics.

Why Are Fulcrum Therapeutics Shares Trading Higher Today?

The stock price of Fulcrum Therapeutics Inc (NASDAQ: FULC) increased 125.33%. This is why it happened.

FULC Stock Price Increased 125.33%: Why It Happened

Shares of FULC stock are skyrocketing higher today on reports of positive results for the company's sickle cell treatment trial. The post FULC Stock: The Trial News Sending Fulcrum Therapeutics Skyrocketing appeared first on InvestorPlace.

FULC Stock: The Trial News Sending Fulcrum Therapeutics Skyrocketing

Fulcrum Therapeutics Inc (NASDAQ: FULC) is surging higher Tuesday after the company reported results from its Phase 1 study of FTX-6058 for sickle cell disease showed proof of mechanism and proof of biology. “We are very pleased with the interim results from this clinical trial of FTX-6058, which demonstrated compelling results across all primary, secondary, and exploratory endpoints included in this study,” said Bryan Stuart, president and CEO of Fulcrum Therapeutics.

Why Fulcrum Therapeutics Shares Are Soaring Today

Fulcrum Therapeutics, Inc. (FULC) CEO Bryan Stuart on Q2 2021 Results - Earnings Call Transcript

A positive trial readout suggests the company's new drug discovery engine has more potential than expected.

Here's Why Fulcrum Therapeutics Stock Is Shooting Higher Today

Fulcrum Therapeutics, Inc. (FULC) delivered earnings and revenue surprises of 7.69% and 62.68%, respectively, for the quarter ended June 2021. Do the numbers hold clues to what lies ahead for the stock?

Fulcrum Therapeutics, Inc. (FULC) Reports Q2 Loss, Tops Revenue Estimates

The stock price of Fulcrum Therapeutics Inc (NASDAQ: FULC) increased by over 60% pre-market. This is why it happened.

FULC Stock Price Increases Over 60% Pre-Market: Why It Happened

Fulcrum Therapeutics Inc (NASDAQ: FULC) has announced positive interim results from the Phase 1 trial with FTX-6058 in healthy adult volunteers.  FTX-6058 is a potent and selective small-molecule inhibitor of EED designed to increase fetal hemoglobin (HbF) expression with the potential to treat hemoglobinopathies, such as sickle cell disease and beta-thalassemia.

Fulcrum Shares Are Trading Higher As Candidate For Inherited Blood Disorders Shows Proof Of Mechanism, Biology In Early-Stage Study

–  Reported positive interim results from ongoing Phase 1 trial in healthy adult volunteers with FTX-6058 for sickle cell disease demonstrating proof of mechanism and proof of biology –

Fulcrum Therapeutics Reports Recent Business Highlights and Second Quarter 2021 Financial Results

CAMBRIDGE, Mass., Aug. 10, 2021 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc.  (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today announced positive interim results from the ongoing single- and multiple-ascending dose (SAD and MAD) Phase 1 trial with FTX-6058 in healthy adult volunteers. FTX-6058 is an investigational, potent, and selective small molecule inhibitor of EED designed to increase the expression of fetal hemoglobin (HbF) with the potential to treat hemoglobinopathies, such as sickle cell disease and beta-thalassemia. Results from the MAD portion of the trial demonstrated proof of biology as evidenced by a dose proportional induction in HBG mRNA and accompanying increases in HbF-containing reticulocytes (F-reticulocytes). At 10mg, the highest dose studied to date, the mean changes were 4.5-fold and 4.2-fold, respectively. The increases in F-reticulocytes indicate that the HBG mRNA increases observed with FTX-6058 treatment are translating to HbF protein production.

Fulcrum Therapeutics Announces Positive Interim Results from Phase 1 Healthy Adult Volunteer Trial of FTX-6058 for Sickle Cell Disease

Fulcrum Therapeutics, Inc. (FULC) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

Will Fulcrum Therapeutics, Inc. (FULC) Report Negative Q2 Earnings? What You Should Know

CAMBRIDGE, Mass., June 24, 2021 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc.  (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today announced results from the company's Phase 2b trial, ReDUX4, in people with facioscapulohumeral muscular dystrophy (FSHD). Results being presented with losmapimod at the FSHD International Research Congress today showed clinically relevant and statistically significant* benefits versus placebo on multiple measures of structural and functional FSHD disease progression and patient reported outcomes at 48 weeks. Losmapimod was generally well-tolerated, with no drug-related serious adverse events reported. Consistent with the previously reported interim analyses the primary endpoint was not met. Changes in DUX4-driven gene expression, which were included in the trial as an experimental biomarker endpoint, could not be demonstrated, the Company believes due to several technical and biologic variables with the endpoint. Based on today's results, the Company plans to meet with health authorities, including the U.S. Food and Drug Administration (FDA), in the second half of 2021 to determine the regulatory path for losmapimod in FSHD.

Fulcrum Therapeutics Announces Results from ReDUX4 Trial with Losmapimod in Facioscapulohumeral Muscular Dystrophy (FSHD) Demonstrating Slowed Disease Progression and Improved Function

– Fulcrum to host conference call on June 24, 2021 at 8:00am ET to present results from Phase 2b ReDUX4 trial with losmapimod in facioscapulohumeral muscular dystrophy (FSHD) – – Fulcrum to host conference call on June 24, 2021 at 8:00am ET to present results from Phase 2b ReDUX4 trial with losmapimod in facioscapulohumeral muscular dystrophy (FSHD) –

Fulcrum Therapeutics Announces Multiple Presentations at the 28th Annual FSHD Society International Research Congress (IRC)

Evofem Biosciences Inc

The FDA has granted Fast Track designation to Fulcrum Therapeutics Inc's (NASDAQ: FULC) losmapimod for the potential treatment of facioscapulohumeral muscular dystrophy (FSHD). Fulcrum is on track to report full data from the ReDUX4 Phase 2b trial at the virtual FSHD International Research Congress to be held next month.

Fulcrum Therapeutics, Evofem Biosciences Drug Candidates Receive FDA Fast Track Designation

CAMBRIDGE, Mass., May 12, 2021 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc.  (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to losmapimod for the potential treatment of facioscapulohumeral muscular dystrophy (FSHD).

Fulcrum Therapeutics Announces U.S. Food and Drug Administration Grants Fast Track Designation to Losmapimod for the Potential Treatment of Facioscapulohumeral Muscular Dystrophy (FSHD)

Fulcrum Therapeutics, Inc. (FULC) CEO Bryan Stuart on Q1 2021 Results - Earnings Call Transcript

CAMBRIDGE, Mass., May 07, 2021 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc.  (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today announced that management will present a corporate overview at the BofA Securities 2021 Virtual Health Care Conference on Thursday, May 13, 2021 at 11:00 a.m. ET.

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