FDA Lifts Clinical Hold on Intellia's IND for ATTRv-PN Trial
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 2d ago
0mins
Source: Benzinga
- Clinical Hold Lifted: The FDA lifted the clinical hold on Intellia Therapeutics' MAGNITUDE-2 Phase 3 trial, allowing the company to proceed with its investigational new drug application for hereditary transthyretin amyloidosis (ATTRv-PN), which is expected to positively impact future R&D progress.
- Increased Enrollment Target: Intellia has raised the target enrollment for the MAGNITUDE-2 trial from approximately 50 to 60 patients, aiming to enhance the reliability of study results and bolster market confidence in its treatment approach.
- Positive Efficacy Data: In the ongoing Phase 1 study, patients receiving a one-time dose of 0.3 mg/kg or higher (n=33) showed a 92% mean reduction in serum TTR levels at 24 months, indicating the long-term efficacy of nexiguran ziclumeran, which may boost investor confidence in Intellia.
- Enhanced Safety Monitoring: Intellia has agreed with the FDA to implement enhanced safety monitoring measures for liver laboratory tests in the MAGNITUDE-2 trial, addressing previous safety events and providing stronger safety assurances for future clinical trials.
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Analyst Views on NTLA
Wall Street analysts forecast NTLA stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for NTLA is 16.50 USD with a low forecast of 4.00 USD and a high forecast of 54.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
22 Analyst Rating
9 Buy
12 Hold
1 Sell
Moderate Buy
Current: 13.820
Low
4.00
Averages
16.50
High
54.00
Current: 13.820
Low
4.00
Averages
16.50
High
54.00
About NTLA
Intellia Therapeutics, Inc. is a clinical-stage gene editing company focused on developing medicine with CRISPR-based therapies. CRISPR is a gene editing technology which is also sometimes referred to as CRISPR/Cas or CRISPR/Cas9 when referring to the use of CRISPR technology with the Cas9 enzyme. Its in vivo product candidates address genetic diseases by deploying its technologies, including CRISPR/Cas9 delivered by LNPs, as the therapy for diseases with high unmet need. Its lead in vivo product candidates, nexiguran ziclumeran (nex-z or NTLA-2001) for the treatment of transthyretin (ATTR) amyloidosis and NTLA-2002 for the treatment of hereditary angioedema (HAE), are the first CRISPR-based therapy candidates to be administered systemically, via intravenous (IV) infusion, for precision editing of a gene in a target tissue in humans. For its ex vivo product candidates, it applies its technologies to create engineered cell therapies to address immuno-oncology and autoimmune diseases.
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.
FDA Lifts Clinical Hold on Intellia's IND for ATTRv-PN Trial
- Clinical Hold Lifted: The FDA lifted the clinical hold on Intellia Therapeutics' MAGNITUDE-2 Phase 3 trial, allowing the company to proceed with its investigational new drug application for hereditary transthyretin amyloidosis (ATTRv-PN), which is expected to positively impact future R&D progress.
- Increased Enrollment Target: Intellia has raised the target enrollment for the MAGNITUDE-2 trial from approximately 50 to 60 patients, aiming to enhance the reliability of study results and bolster market confidence in its treatment approach.
- Positive Efficacy Data: In the ongoing Phase 1 study, patients receiving a one-time dose of 0.3 mg/kg or higher (n=33) showed a 92% mean reduction in serum TTR levels at 24 months, indicating the long-term efficacy of nexiguran ziclumeran, which may boost investor confidence in Intellia.
- Enhanced Safety Monitoring: Intellia has agreed with the FDA to implement enhanced safety monitoring measures for liver laboratory tests in the MAGNITUDE-2 trial, addressing previous safety events and providing stronger safety assurances for future clinical trials.
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FDA Lifts Clinical Hold on Intellia's Phase 3 Trial
- Clinical Trial Advancement: The FDA has lifted the clinical hold on Intellia's Phase 3 trial for a rare nerve disease following safety updates, marking a significant breakthrough in the company's critical R&D phase and potentially accelerating the path to market.
- Heart Disease Program Review: While the FDA has removed the hold on the Phase 3 trial, the review of Intellia's heart disease program continues, which may impact the company's market entry timeline and strategic positioning in the cardiovascular sector.
- Safety Update Impact: Intellia's safety updates have been recognized by the FDA, indicating effective measures taken to ensure patient safety during trials, which not only boosts investor confidence but may also attract more partners to its R&D initiatives.
- Market Reaction Expectations: With the FDA's positive developments, Intellia's stock price is likely to experience a favorable impact, as investors are optimistic about its future commercial potential and market performance, especially in the competitive landscape of rare disease treatments.
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