Intellia Therapeutics, Inc - NTLA STOCK NEWS

Intellia Therapeutics (NASDAQ:NTLA) reported positive Phase 2 results for NTLA-2002 in hereditary angioedema (HAE), meeting primary and secondary endpoints. The company plans to initiate a Phase 3 trial in 2H 2024 with the selected 50 mg dose. Rapid enrollment continues in the Phase 3 MAGNITUDE trial of NTLA-2001 for ATTR amyloidosis with cardiomyopathy. Intellia expects to dose the first patient in the Phase 1/2 study of NTLA-3001 for alpha-1 antitrypsin deficiency in 2H 2024. The company ended Q2 2024 with $939.9 million in cash, expected to fund operations into late 2026. Q2 financial results show collaboration revenue of $7.0 million, R&D expenses of $114.2 million, and a net loss of $147.0 million.

Intellia Therapeutics (NASDAQ:NTLA), a leading clinical-stage gene editing company focused on CRISPR-based therapies, has announced its upcoming second quarter 2024 earnings call. The conference call is scheduled for August 8, 2024, at 8 a.m. ET. During this call, the company will present its Q2 2024 financial results and provide operational highlights.

Investors and interested parties can join the call by dialing 1-833-316-0545 (U.S.) or 1-412-317-5726 (international). A live webcast will also be available. A replay of the call will be accessible through Intellia's website after 12 p.m. ET on the same day.

Intellia Therapeutics (NASDAQ:NTLA) has received authorization from the UK's MHRA to initiate a Phase 1/2 clinical trial for NTLA-3001, a potential one-time CRISPR-based gene editing treatment for alpha-1 antitrypsin deficiency (AATD)-associated lung disease. NTLA-3001 aims to normalize AAT protein levels by inserting a healthy copy of the SERPINA1 gene, potentially halting disease progression and eliminating the need for weekly infusions or lung transplants.

The study will enroll up to 30 adult patients and evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics. Intellia plans to dose the first patient in the second half of 2024. This trial marks Intellia's first wholly owned in vivo targeted gene insertion candidate to enter clinical stages, validating their modular gene insertion platform for addressing various protein deficiency diseases.

Intellia Therapeutics (NASDAQ:NTLA), a leading clinical-stage gene editing company, has announced inducement grants for its new Executive Vice President and Chief Financial Officer, Edward Dulac. The grants, awarded on July 22, 2024, include:

96,219 non-qualified stock options with an exercise price of $25.33 per share, vesting over three years; 66,324 time-based restricted stock units (RSUs) vesting annually over three years; 33,162 performance-based RSUs tied to total stockholder return over three years; and 30,000 performance-based RSUs (at target) linked to development milestones over three years.

These grants were made outside of Intellia's stockholder-approved equity incentive plans, under the 2024 Inducement Plan adopted in June 2024, in accordance with Nasdaq Listing Rule 5635(c)(4).

Intellia Therapeutics (NASDAQ:NTLA) announced the appointment of Edward Dulac as the new Executive Vice President, Chief Financial Officer (CFO), and Treasurer, effective July 22, 2024. Dulac will replace Glenn Goddard, who steps down on June 30, 2024. Dulac brings over 20 years of experience in finance, business development, and corporate strategy from roles at Fate Therapeutics, Celgene (now Bristol Myers Squibb), Barclays Capital, Lehman Brothers, and Pfizer. Intellia's CEO, John Leonard, expressed confidence in Dulac's ability to drive the company's future commercial success and thanked Goddard for his contributions. This leadership transition marks a significant step as Intellia continues to advance its CRISPR-based therapies.

Intellia Therapeutics has announced positive clinical data demonstrating the potential for redosing with its proprietary CRISPR-based therapy, NTLA-2001. In a Phase 1 study, a follow-on 55 mg dose led to a 90% median reduction in serum TTR at day 28 among three patients who previously received the lowest dose. This redosing capability, enabled by Intellia's non-viral lipid nanoparticle (LNP) delivery platform, is not currently planned for the NTLA-2001 program but shows promise for future therapies requiring additive effects. The 55 mg follow-on dose was well tolerated, with only one mild infusion-related reaction reported. The NTLA-2001 program is part of a collaboration with Regeneron. The promising results will inform Phase 3 trials for ATTR-CM and ATTRv-PN.

Intellia Therapeutics (NASDAQ: NTLA) will present groundbreaking clinical data on redosing patients with its investigational CRISPR gene editing therapy, NTLA-2001, at the Peripheral Nerve Society Annual Meeting from June 22-25, 2024, in Montreal, Canada.

The Phase 1 study data, featuring redosing of three patients initially administered 0.1 mg/kg followed by a 55 mg dose, will provide insights into the safety and pharmacodynamics of this approach.

While repeat dosing is not planned for NTLA-2001 in treating transthyretin amyloidosis (ATTR), it could benefit future therapies using Intellia’s lipid nanoparticle (LNP) delivery platform by enabling additional dosing where needed.

Dr. Jorg Taubel will present these findings on June 25, 2024.

Intellia Therapeutics, a clinical-stage gene editing company, announced the appointment of Brian Goff to its board of directors. Goff, who is the current CEO of Agios Pharmaceuticals, brings over three decades of experience in commercialization, operations, and sales and marketing. He has held senior roles at Alexion Pharmaceuticals, Neurovance, Baxalta, Baxter Healthcare, Novartis Pharmaceuticals, and Johnson & Johnson. Intellia's CEO, John Leonard, highlighted Goff's expertise in rare disease product launches as critical for the company's transition to a commercial organization, especially as it prepares to commercialize its first CRISPR-based therapies.

Intellia Therapeutics announced positive long-term data from the Phase 1 study of NTLA-2002, a CRISPR-based gene editing therapy for hereditary angioedema (HAE). The data showed that eight out of ten patients remained attack-free following a 16-week primary observation period and continued to show positive results for over two years. A single dose of NTLA-2002 led to a 98% reduction in monthly HAE attacks. All patients who stopped prophylaxis treatment remained free from chronic treatment. The therapy demonstrated a favorable safety profile with mild adverse events. The company plans to begin a Phase 3 trial in the second half of 2024.