Leerink Positive on Fulcrum Due to Agios Accelerated Approval Filing
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1 day ago
0mins
Should l Buy FULC?
Leerink thinks Agios Pharmaceuticals' (AGIO) announcement that it is filing mitapivat for accelerated approval in sickle cell disease has positive readthrough to Fulcrum Therapeutics (FULC) by demonstrating FDA flexibility ahead of a key regulatory update for the company expected Q2 2026. Recall Agios' Phase 3 RISE UP trial of mitapivat in SCD met the primary endpoint of hemoglobin response but technically missed statistical significance on the primary endpoint of annualized rate of sickle cell pain crises though a trend was shown, Leerink notes. Leerink says the move underscores continued FDA recognition of the high unmet need in SCD and willingness to work with sponsors to gain alignment. Leerink believes this is a positive sign for Fulcrum given they are seeking regulatory alignment on their next steps in SCD in the near term.
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Analyst Views on FULC
Wall Street analysts forecast FULC stock price to rise
11 Analyst Rating
9 Buy
1 Hold
1 Sell
Moderate Buy
Current: 7.670
Low
7.00
Averages
16.80
High
25.00
Current: 7.670
Low
7.00
Averages
16.80
High
25.00
About FULC
Fulcrum Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases in areas of high unmet medical need. The Company's lead clinical program is pociredir, a small molecule designed to increase expression of fetal hemoglobin for the treatment of sickle cell disease (SCD). It uses technology to identify drug targets that can modulate gene expression to treat the known root cause of gene mis-expression. In addition to its product candidates, the Company has developed a discovery approach that it employs to systematically identify and validate cellular drug targets that can potentially modulate gene expression to treat known root causes of genetically defined rare diseases. The Company continues to advance its program for the potential treatment of inherited aplastic anemias, such as Diamond-Blackfan anemia (DBA), Shwachman-Diamond syndrome, and Fanconi anemia.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Fulcrum Therapeutics Grants Stock Options to New Employee
- Stock Option Grant: Fulcrum Therapeutics granted 34,000 stock options to a new employee at an exercise price of $7.81 per share, reflecting the closing price on March 2, 2026, aimed at attracting talent and strengthening the company's team.
- Incentive Plan Context: This grant is made under Fulcrum's 2022 Inducement Stock Incentive Plan, complying with Nasdaq Listing Rule 5635(c)(4), demonstrating the company's commitment to attracting and retaining key talent.
- Option Structure: The options have a ten-year term and vest over four years, with 25% vesting on the first anniversary and an additional 6.25% vesting quarterly, ensuring continued employee contribution during their tenure with the company.
- Company Mission: Fulcrum focuses on developing small molecules to improve the lives of patients with genetically defined rare diseases, with its lead clinical program pociredir aimed at increasing fetal hemoglobin expression to treat sickle cell disease, highlighting the company's strategic positioning in areas of high unmet medical need.
See More
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- Weight Loss Innovation: Allurion Technologies' gastric balloon system gained FDA approval, offering a non-surgical weight loss option for patients with a BMI of 30-40, which is anticipated to expand the company's market share in the obesity sector.
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Fulcrum Therapeutics Reports Phase 1b Trial Results Amid Stock Decline
- Clinical Trial Results: Fulcrum Therapeutics reported that in its Phase 1b trial for pociredir, the 20 mg cohort showed a 12.2% increase in mean absolute fetal hemoglobin (HbF) at 12 weeks, significantly outperforming the 8.6% increase in the 12 mg cohort, indicating the drug's potential in enhancing HbF levels.
- Safety Analysis: The trial reported no serious adverse events, although one patient discontinued due to an unrelated Grade 5 serious adverse event; overall, the strong safety profile could support future registration trials.
- Future Plans: Fulcrum intends to initiate a potential registration-enabling trial in the second half of 2026 and plans to engage with the European Medicines Agency in mid-2026 for feedback on the next trial design, demonstrating a proactive approach to development.
- Financial Position: As of 2025, Fulcrum had $352.3 million in cash and cash equivalents, projected to sustain operations through 2029, despite a 10.01% drop in stock price following the latest announcement, reflecting market caution regarding trial outcomes.
See More
Fulcrum Therapeutics Reports Q4 Earnings and Cash Position
- Earnings Report: Fulcrum Therapeutics reported a Q4 GAAP EPS of -$0.31, aligning with market expectations, indicating stability in financial management despite ongoing losses.
- Strong Cash Position: As of 2025, Fulcrum's cash, cash equivalents, and marketable securities totaled $352.3 million, providing a cash runway into 2029, which ensures operational stability for the coming years.
- Capital Raising Strategy: The company announced the pricing of a $175 million upsized public offering of common stock and pre-funded warrants, reflecting an active approach to fundraising aimed at supporting its R&D and operational needs.
- Clinical Trial Updates: Fulcrum presented new clinical data from the Phase 1b PIONEER trial at the 44th Annual J.P. Morgan Healthcare Conference, highlighting its ongoing innovation and potential in the treatment of sickle cell disease.
See More
Fulcrum Therapeutics Grants Stock Options to New Employee
- Stock Options Granted: Fulcrum Therapeutics granted 70,000 stock options to a new employee at an exercise price of $10.72 per share, reflecting the company's commitment to attracting talent and strengthening its team to drive research and development efforts.
- Incentive Plan Context: The grant is made under the amended 2022 Inducement Stock Incentive Plan, complying with Nasdaq Listing Rule 5635(c)(4), which demonstrates the company's adherence to compliance and transparency in talent acquisition.
- Options Structure: These options have a ten-year term and vest over four years, with 25% vesting on the first anniversary and an additional 6.25% vesting quarterly, designed to incentivize long-term employee retention and enhance engagement.
- Strategic Company Positioning: Fulcrum focuses on developing small molecules to improve the lives of patients with genetically defined rare diseases, particularly its lead program pociredir for sickle cell disease, showcasing the company's strategic positioning in areas of high unmet medical need.
See More
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Fulcrum Therapeutics Grants Stock Options to New Employee
- Stock Option Grant: Fulcrum Therapeutics granted 34,000 stock options to a new employee at an exercise price of $7.81 per share, reflecting the closing price on March 2, 2026, aimed at attracting talent and strengthening the company's team.
- Incentive Plan Context: This grant is made under Fulcrum's 2022 Inducement Stock Incentive Plan, complying with Nasdaq Listing Rule 5635(c)(4), demonstrating the company's commitment to attracting and retaining key talent.
- Option Structure: The options have a ten-year term and vest over four years, with 25% vesting on the first anniversary and an additional 6.25% vesting quarterly, ensuring continued employee contribution during their tenure with the company.
- Company Mission: Fulcrum focuses on developing small molecules to improve the lives of patients with genetically defined rare diseases, with its lead clinical program pociredir aimed at increasing fetal hemoglobin expression to treat sickle cell disease, highlighting the company's strategic positioning in areas of high unmet medical need.
See More
Significant Milestones in Biotech Sector This Week
- FDA Drug Approvals: Armata Pharmaceuticals' AP-SA02 received FDA's QIDP designation, granting five years of market exclusivity and paving the way for a Phase 3 trial in 2026, which is expected to significantly enhance the company's competitive edge in the antibiotic market.
- Weight Loss Innovation: Allurion Technologies' gastric balloon system gained FDA approval, offering a non-surgical weight loss option for patients with a BMI of 30-40, which is anticipated to expand the company's market share in the obesity sector.
- Acquisition Deal: Gilead Sciences is acquiring Arcellx for $115 per share, totaling $7.8 billion, a move that will strengthen Gilead's position in cell therapy and enhance its collaboration with Kite Pharma.
- Clinical Trial Developments: Novo Nordisk's CagriSema missed key goals in its trial against Zepbound, although it demonstrated a favorable safety profile, which may influence future market strategies.
See More
Fulcrum Therapeutics Reports Phase 1b Trial Results Amid Stock Decline
- Clinical Trial Results: Fulcrum Therapeutics reported that in its Phase 1b trial for pociredir, the 20 mg cohort showed a 12.2% increase in mean absolute fetal hemoglobin (HbF) at 12 weeks, significantly outperforming the 8.6% increase in the 12 mg cohort, indicating the drug's potential in enhancing HbF levels.
- Safety Analysis: The trial reported no serious adverse events, although one patient discontinued due to an unrelated Grade 5 serious adverse event; overall, the strong safety profile could support future registration trials.
- Future Plans: Fulcrum intends to initiate a potential registration-enabling trial in the second half of 2026 and plans to engage with the European Medicines Agency in mid-2026 for feedback on the next trial design, demonstrating a proactive approach to development.
- Financial Position: As of 2025, Fulcrum had $352.3 million in cash and cash equivalents, projected to sustain operations through 2029, despite a 10.01% drop in stock price following the latest announcement, reflecting market caution regarding trial outcomes.
See More
Fulcrum Therapeutics Reports Q4 Earnings and Cash Position
- Earnings Report: Fulcrum Therapeutics reported a Q4 GAAP EPS of -$0.31, aligning with market expectations, indicating stability in financial management despite ongoing losses.
- Strong Cash Position: As of 2025, Fulcrum's cash, cash equivalents, and marketable securities totaled $352.3 million, providing a cash runway into 2029, which ensures operational stability for the coming years.
- Capital Raising Strategy: The company announced the pricing of a $175 million upsized public offering of common stock and pre-funded warrants, reflecting an active approach to fundraising aimed at supporting its R&D and operational needs.
- Clinical Trial Updates: Fulcrum presented new clinical data from the Phase 1b PIONEER trial at the 44th Annual J.P. Morgan Healthcare Conference, highlighting its ongoing innovation and potential in the treatment of sickle cell disease.
See More
Fulcrum Therapeutics Grants Stock Options to New Employee
- Stock Options Granted: Fulcrum Therapeutics granted 70,000 stock options to a new employee at an exercise price of $10.72 per share, reflecting the company's commitment to attracting talent and strengthening its team to drive research and development efforts.
- Incentive Plan Context: The grant is made under the amended 2022 Inducement Stock Incentive Plan, complying with Nasdaq Listing Rule 5635(c)(4), which demonstrates the company's adherence to compliance and transparency in talent acquisition.
- Options Structure: These options have a ten-year term and vest over four years, with 25% vesting on the first anniversary and an additional 6.25% vesting quarterly, designed to incentivize long-term employee retention and enhance engagement.
- Strategic Company Positioning: Fulcrum focuses on developing small molecules to improve the lives of patients with genetically defined rare diseases, particularly its lead program pociredir for sickle cell disease, showcasing the company's strategic positioning in areas of high unmet medical need.
See More
BMO Initiates Medline Coverage with $45 Price Target
- Medline Coverage Initiation: BMO Capital analyst Sean Dodge initiated coverage on Medline Inc (NASDAQ:MDLN) with an Outperform rating and a price target of $45, indicating an approximate 11% upside from the current share price of $40.52, reflecting confidence in the company's growth prospects.
- Hims & Hers Rating Update: Evercore ISI Group analyst Mark Mahaney initiated coverage on Hims & Hers Health Inc (NYSE:HIMS) with an In-Line rating and a price target of $33, suggesting a stable growth outlook as the current share price stands at $31.69.
- Andersen Group Coverage Initiation: UBS analyst Kevin Mcveigh initiated coverage on Andersen Group Inc (NYSE:ANDG) with a Buy rating and a price target of $28, indicating significant upside potential from the current price of $24.29, reflecting optimism about its market performance.
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See More
