ARTV) Soars on News FDA has granted Fast Track Designation to AlloNK

October 17, 2025 – (Investorideas.com
Newswire), a go-to investing platform covering biotech and medtech
stocks releases a news and trading alert for Artiva Biotherapeutics,
Inc. (Nasdaq: ARTV), a clinical-stage biotechnology company whose mission is to develop
effective, safe, and accessible cell therapies for patients with
devastating autoimmune diseases and cancers.

The stock is trading at $5.69, up 2.92, gaining 105.40% on volume of
over 61 Million shares. The stock had a morning high of $6.19.

News summary:

Artiva Biotherapeutics, Inc. (Nasdaq: ARTV) announced that the U.S.
Food and Drug Administration (FDA) has granted Fast Track
Designation to its investigational therapy AlloNK® (AB-101) for
treating refractory rheumatoid arthritis (RA) in combination with
rituximab, marking it as the first drug candidate in the deep B-cell
depleting category to receive this status for this indication. The
company is prioritizing refractory RA as the lead autoimmune
indication for AlloNK, targeting over 100,000 underserved U.S.
patients who remain treatment-refractory despite existing therapies,
with more than 20 patients already treated across trials and
upcoming data from over 15 refractory RA patients, including several
with six or more months of follow-up. Translational data
demonstrating uniform deep B-cell depletion and safety results
highlighting a favorable tolerability profile and outpatient-ready
regimen are expected in mid-November, followed by clinical response
data in the first half of 2026, with FDA interactions planned to
potentially advance to a pivotal trial. As CEO Fred Aslan, M.D.,
stated, “We are prioritizing refractory RA as our lead
autoimmune indication for AlloNK given the size of this underserved
population… [and] could enable AlloNK to become the first deep
B-cell depleting therapy to advance to a pivotal trial in patients
with RA.”

News:

Artiva announced that the U.S. Food and Drug Administration (FDA) has
granted Fast Track Designation to AlloNK® (also known as AB-101)
for the treatment of refractory rheumatoid arthritis (RA) in
combination with rituximab and that the Company has prioritized
refractory RA as the program’s lead indication. AlloNK is
believed to represent the first drug candidate in the deep B-cell
depleting therapeutic category to receive this designation in
refractory RA.

“We are prioritizing refractory RA as our lead autoimmune
indication for AlloNK given the size of this underserved population.
Despite the many approved therapies in RA, there are over 100,000
patients in the United States who remain treatment refractory and
could potentially benefit from a deep B-cell depleting therapy,”
said Fred Aslan, M.D., Chief Executive Officer of Artiva. “We look
forward to sharing the emerging translational and safety data in
mid-November, supporting AlloNK’s profile as an outpatient-ready
therapy capable of achieving deep B-cell depletion, followed by
clinical response data in the first half of 2026 from more than 15
refractory RA patients, several of whom will have six or more months
of follow-up. In addition, we are planning FDA interactions in the
first half of 2026 that could enable AlloNK to become the first deep
B-cell depleting therapy to advance to a pivotal trial in patients
with RA.”

AlloNK’s Clinical Opportunity in RA:

RA is a chronic autoimmune disease that affects over 1.5 million
people in the United States and can cause painful joint inflammation,
progressive joint damage, and disability, if not adequately treated.
While existing treatments such as methotrexate, TNF inhibitors, and
B-cell depleting antibodies have improved outcomes for many patients,
a significant subset becomes refractory and no longer responds to or
tolerates these options. These patients face ongoing disease activity,
increased risk of disability and joint destruction, and reliance on
steroids or immunosuppressants that have long-term toxicity. AlloNK is
designed to enhance the activity of B-cell-targeting antibodies, such
as rituximab, through antibody-dependent cellular cytotoxicity. This
mechanism of action is intended to drive deeper and more durable
B-cell depletion than antibodies alone, potentially enabling long-term
durable responses.

“I am encouraged by our early data with AlloNK in refractory RA
patients. Having contributed to the development of leading RA
therapies including Humira® and Orencia®, I have witnessed the
unmet need among patients with refractory RA who continue to suffer
from inadequate disease control,” said Subhashis Banerjee, M.D.,
Chief Medical Officer of Artiva. “Of note, most patients with RA
are treated at community rheumatology clinics rather than at large
academic medical centers. Emerging deep B-cell depleting therapies
such as CAR-T and T-cell engagers can be limited by the need for
hospitalization or specialized oncology oversight, making them
challenging for widespread use. With its infusion-ready, off-the-shelf
format, and ease of use similar to IV-administered RA drugs, AlloNK in
combination with rituximab has the potential to address this unmet
need in a scalable and broadly accessible way.”

Key Highlights:

Company is prioritizing refractory RA as its lead indication,
reflecting the opportunity to address this unmet need with a
potentially impactful therapy that can be administered and managed in
the community setting

Received FDA Fast Track Designation for AlloNK in refractory RA,
representing the first known drug candidate in the deep B-cell
depleting therapeutic category to receive this designation in RA

More than 20 patients treated with AlloNK + mAb across refractory RA,
Sjögren’s disease, systemic lupus erythematosus, lupus
nephritis, and systemic sclerosis in company-sponsored trials and an
investigator-initiated basket trial, at 1 billion and 4 billion cells
per AlloNK dose

Emerging translational and safety data expected to support
AlloNK’s profile as an outpatient-ready therapy capable of
achieving consistent and deep B-cell depletion

Depending on our regulatory interactions with the FDA, AlloNK has the
potential to become the first therapy within the emerging deep B-cell
depletion category, which includes auto-CAR-T and T-cell engagers, to
advance to a pivotal trial for patients with refractory RA

Full news

https://finance.yahoo.com/news/artiva-biotherapeutics-announces-refractory-rheumatoid-200500522.html

Research biotech and medical device/ tech stocks at
Investorideas.com 

https://www.investorideas.com/BIS/

About Investorideas.com – Big Investing Ideas

Investorideas.com is the go-to platform for big investing ideas. From
breaking stock news to top-rated investing podcasts, we cover it all

Follow us on X @investorideas

Follow us on Facebook
https://www.facebook.com/Investorideas

Follow us on YouTube
https://www.youtube.com/c/Investorideas

Contact Investorideas.com 

800-665-0411