Intellia's Gene Therapy Trial Resumes After FDA Hold Lifted
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1d ago
0mins
Source: seekingalpha
- Trial Resumption: The FDA lifted the clinical hold on Intellia Therapeutics' nexiguran ziclumeran (nex-z) trial, allowing the MAGNITUDE-2 Phase 3 study to proceed, which is expected to positively impact the company's stock price.
- Increased Enrollment Target: Intellia raised the target enrollment for the MAGNITUDE-2 trial from 50 to 60 patients, aiming to enhance the statistical power of the trial and improve the validation of treatment efficacy.
- Regulatory Approval: The FDA's decision to lift the hold after reviewing Intellia's study modifications and mitigation measures indicates recognition of the company's research direction, potentially boosting investor confidence.
- Future Trials Pending: While the MAGNITUDE-2 trial resumes, the trial for patients with cardiomyopathy remains on hold, with Intellia planning to provide updates once a consensus is reached with the FDA, demonstrating the company's ongoing commitment to regulatory compliance.
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: 14.830
Low
4.00
Averages
16.50
High
54.00
Current: 14.830
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.
