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1月前
Intellia Therapeutics Shares Slip Despite Strong Phase 3 DataApril 27, 2026 11:20 AM
IH Market News
Intellia Therapeutics Inc. (NASDAQ:NTLA) declined 3% on Monday, reversing earlier gains that followed the release of positive Phase 3 results for its hereditary angioedema (HAE) therapy. The data marks the first global Phase 3 outcome for an in vivo gene editing treatment.The company said its Phase 3 HAELO trial evaluating lonvoguran ziclumeran (lonvo-z) achieved its primary endpoint along with all key secondary endpoints. Results showed that a single dose reduced HAE attack rates by 87% compared to placebo over six months, with patients experiencing a mean monthly attack rate of 0.26 versus 2.10 in the placebo group.
Trial Results Highlight Durable Efficacy
The study included 80 participants, with 52 receiving lonvo-z and 28 assigned to placebo. According to Intellia, most treated patients remained free from both HAE attacks and the need for ongoing therapy throughout the six-month evaluation period. Additionally, all individuals in the treatment group remained off long-term prophylaxis as of the February 10 data cutoff.
Regulatory Pathway and Potential Launch Timeline
Intellia has begun a rolling biologics license application submission to the U.S. Food and Drug Administration and is targeting a potential U.S. launch in the first half of 2027, pending approval. The therapy is designed as a one-time outpatient treatment that disables the KLKB1 gene, leading to sustained reductions in kallikrein and bradykinin levels.
Safety Profile and Upcoming Data Presentation
The trial also demonstrated a favorable safety and tolerability profile. The most commonly reported treatment-emergent adverse events included infusion-related reactions, headache, and fatigue. All recorded events were mild to moderate in severity, and no serious adverse events were observed in the lonvo-z group as of the data cutoff.Further findings from the HAELO study are expected to be presented at the European Academy of Allergy and Clinical Immunology Congress 2026 in June.
More about Intellia Therapeutics Inc.
Intellia Therapeutics Inc. is a clinical-stage biotechnology company focused on developing CRISPR-based gene editing therapies designed to treat genetic diseases through in vivo and ex vivo approaches.Intellia Therapeutics stock price
Original: Intellia Therapeutics Shares Slip Despite Strong Phase 3 Data
Frankestin
1月前
A rolling BLA under RMAT means the clock is already ticking — FDA can review in real time, not at the finish line. With CMC readiness and priority review on the table, this isn’t development phase anymore… this is positioning for approval. An unusually aggressive timeline: BLA completion in 2H 2026, potential approval by late 2026 or early 2027, and commercial launch as early as 1H 2027. So the market reacts like they expected approval today? Rolling BLA initiated, Phase 3 success, clear path to 2027 launch… and this is a sell?
I’ll take that opportunity — happy to keep adding here. Thanks for the discount.
Frankestin
3月前
At this point it’s almost comical. Back to $15 should be the minimum baseline — how much lower do they want to crush a company delivering 96% attack reduction, 31/32 attack-free patients, a lifted Phase III hold, and the strongest HAE data ever seen?
Goldman trims, ATM reloads, algos panic… and somehow this is supposed to trade under fair value?
Come on. You can only push a spring this far before it snaps back.
Real product cash starts rolling in around 2028 — and the market will regret every dollar it suppressed before then.
Frankestin
3月前
ANALyst:
Citizens raised its price target on Intellia Therapeutics shares (NASDAQ:NTLA) to $28
H.C. Wainwright maintains the target price at $25
Chardan raised to $27
BofA Securities raised its price target to $19
Bank of America Securities on March 2, 2026 maintained a Neutral rating on Intellia Therapeutics (NTLA) while raising its price target to $19
Goldman Sachs reiterated $8.00 price target
BC Capital raised its price target to $15
Goldman Sachs discloses 2.7% Intellia Therapeutics (NTLA) stake in filing (as of 12/31/2025).... 2026-02-12 13G/A GOLDMAN SACHS GROUP INC from 5,498,262 to 3,157,178
jondoeuk
2年前
They are opting out of an agreement with REGN to co-develop a factor IX gene editing therapy for haemophilia A and B. The agreement, which was signed in 2020, will terminate 180 days after NTLA provide written notice to REGN. They will continue to have obligations related to the co-development of gene-editing products directed to factor IX until the effective date of termination. Upon termination, NTLA will no longer be obligated for sharing 35% of the development costs, or be entitled to receive 35% of the profits, for gene-editing products directed to factor IX under the agreement.
Separately, the company would continue to support REGN with the development of gene-editing products directed to factor IX, as applicable, pursuant to a 2016 license and collaboration agreement between the companies. NTLA may be eligible to receive up to $320M in milestone payments and royalties in the high-single digits to low teens if REGN develops and commercialises gene-editing products under the terms of this license and collaboration deal.