Coya Therapeutics Advances COYA 302 ALS Trial With 100th Participant

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1. Ownership and Share Structure Information

The information listed above was updated on the date this article was published and was compiled from information from the company and various other data providers.

Key Takeaways

• Coya Therapeutics has enrolled 100 of its planned 120 participants in the Phase 2/3 ALSTARS trial of COYA 302 for ALS.
• The company expects to complete enrollment in the upcoming weeks and report topline data in early Q2 2027.
• ALSTARS is testing two COYA 302 dosing regimens against placebo in a randomized, double-blind study.
• The trial measures changes in ALS disease severity using the ALSFRS-R score, along with safety, tolerability, and biological markers.
• Coya is also advancing other clinical programs and expects additional data from its ALS and Alzheimer's research in the second half of 2026.

ALSTARS Evaluates COYA 302 Against Placebo

On September 15, 2026, Coya Therapeutics Inc. (COYA:NASDAQ) announced that the 100th participant had been enrolled in its ongoing Phase 2/3 ALSTARS trial evaluating COYA 302 for the treatment of amyotrophic lateral sclerosis (ALS). According to the release, the company plans to enroll 120 participants, expecting to complete enrollment in time to report topline data in early Q2 2027.

"Enrollment of the 100^th participant in the ALSTARS trial represents a critical milestone for Coya and brings us closer to completing this important Phase 2/3 study," said Fred Grossman, DO, FAPA, President and Chief Medical Officer of Coya. "Our current screening and enrollment rates have been consistent, and we project that all 120 participants will be enrolled in the upcoming weeks and on target for a topline readout in early Q2 2027."

"We are deeply grateful to the patients, caregivers, investigators, and clinical site teams whose participation and commitment continue to make the ALSTARS trial possible. We look forward to topline data and believe that, if positive, COYA 302 has the potential to significantly alter the course of this devastating disease and offer new hope to people living with ALS and their families," Dr. Grossman concluded.

ALSTARS is a randomized, multicenter, double-blind, placebo-controlled trial evaluating COYA 302, a combination of low-dose interleukin-2 (IL-2) and CTLA-4 immunoglobulin (Ig). Participants are being randomized 1:1:1 to two pre-specified COYA 302 dosing regimens or placebo during a 24-week double-blind treatment period, followed by a 24-week blinded active-treatment extension. The study can potentially provide up to 48 weeks of treatment data.

The trial's primary endpoint is the change in disease severity from baseline through Week 24, measured using the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) total score compared with placebo. Additional objectives include evaluating the treatment's efficacy, safety, tolerability, biological activity, and biomarker levels.

Coya has also received U.S. Food and Drug Administration (FDA) Fast Track designation for COYA 302 in ALS. The company continues to enroll participants toward the approximately 120-person target, with additional participants moving into the trial's active-treatment extension phase after completing the initial 24-week treatment period.

Coya Therapeutics is a Houston, Texas-based clinical-stage biotechnology company developing proprietary treatments focused on regulatory T cells (Tregs) to target systemic inflammation and neuroinflammation.

ALS Research Continues In Attempt to Meet Treatment Needs

ALS is a progressive neurodegenerative disease that attacks motor neurons in the brain and spinal cord that control voluntary muscles, including those needed to speak, swallow, and breathe. In 2026, the U.S. government provided US$90 million in federal funding for ALS research.

Meanwhile, R&D spending among the top 16 pharmaceutical companies declined by 3.6% overall in 2025, according to BioSpace.

In February 2026, Iqvia discussed the global pharma market projection for 2026, noting that total medicine use is expected to approach four trillion defined daily doses by 2030. They wrote, "The largest drivers of medicine spending growth through the next five years will continue to be the use in developed markets of innovative therapeutics, especially in oncology, immunology, diabetes, and obesity."

On September 9, 2026, Raghuram Selvaraju, Ph.D., of H.C. Wainwright & Co. reiterated a "Buy" rating and price target of US$18 for Coya. 

Pharma sector funding fell between 2024 and 2025, according to a March 26, 2026, article for Fierce Biotech by Nick Paul Taylor.  He wrote that pharma funding had fallen from 2024 but noted that, "2025 was still the third-best year of the past decade. Similarly, overall funding was well above the pre-pandemic norm and only topped by 2020, 2021, and 2024."

At the same time, J. Edward Moreno of Sherwood News reported contradictory news on January 14, 2026, writing that, "In 2025, announced global biotech deals totaled US$228.4 billion, up from US$132.3 billion in 2024, data from Dealogic shows . . . Just two weeks into 2026, US$9.2 billion in deals have been announced."

According to Moreno, movement is expected in the sector: "As some of the most lucrative drugs lose exclusivity in the next few years, pharmaceutical giants are increasingly shopping around for biotechs to add to their portfolios — and they are more than happy to pay a hefty premium for the right company . . . For some Big Pharma companies, business development spending is now about equal to, or more than, research and development."

The shift toward business-development spending comes as some major pharmaceutical companies have reduced or reprioritized R&D spending. On March 25, 2026, BioSpace's Annalee Armstrong reported that, "R&D spending at the top 16 pharmaceutical companies declined by 3.6% overall in 2025, as many aggressively cut spending and refocused pipelines."

BCG talked about trends biopharma companies need to be aware of in 2026 in order to stay competitive, saying, "Near term, companies need to continue to innovate to decrease the complexity and cost of these therapies, and governments can find ways to incentivize and pay for them. The longer-term challenge for companies is to factor operational and economic considerations into R&D decision making earlier, ensuring that trial designs match real-world usage, indication sequences match opportunity, and endpoints enable market access."

Analysts Focus on Coya's 2027 ALS Data Readout

Roth's Boobalan Pachaiyappan, Ph.D., of Roth wrote about the company on August 23, 2026, stating, "We continue to view Coya as a relatively well-funded, high-risk, high-reward story that is strategically supported by the commercial partner." The analyst reiterated a "Buy" rating and price target of US$12, then said: "We believe a 2.5-point ALSFRS-R improvement (or 2.0-pt + secondary benefits) could lead to a BLA filing in 2H27."

On September 9, 2026, Raghuram Selvaraju, Ph.D., of H.C. Wainwright & Co. reiterated a "Buy" rating and price target of US$18 for Coya. He argued, " In our view, positive data from the ALSTARS trial and the Phase 2a trial in FTD could position COYA 302 to enter pivotal development in ALS late in 2027 and possibly a Phase 2b/3 program in FTD either in late 2027 or early 2028."

Then, Chad Messer, Ph.D., of Lake Street followed on September 15, 2026, stating that results had strengthened the company's investment thesis. After reiterating a "Buy" rating and US$17 price target, Messer wrote, "The combination of imminent full enrollment, a Phase 2/3 designation, and Fast Track Designation strengthens our thesis into a near-term catalyst." Messer then followed by saying that "we note that our valuation did not explicitly credit the Phase 2/3 pathway and may be conservative if a successful readout shortens the timeline to commercialization."

Newsletter Writer Chen Lin Weighs In

Chen Lin of What is Chen Buying? What is Chen Selling? weighed in on the company on September 17, saying: "I had a good meeting with COYA. They just announced 100 patients enrolled. They are enrolling 4-5 patients per week now, [and] the 120 patients will be enrolled mid-October."

For competitor context, Lin offered: "Yesterday, Novartis halted ALS drug development due to Phase 2 failure. If COYA can be successful in their Phase 2/3 trial, this will be huge." Lin then cautioned that the stock has an uncertain future until further results come in. "COYA will need to raise money immediately after the data," he said.

Coya Advances Toward 2026 and 2027 Clinical Catalysts

Coya has a busy 2H 2026 planned. Ideally, the company hopes to report additional single-cell proteomics data from completed ALS and Alzheimer's investigator-initiated trials. A potential publication of COYA 303 in vivo data in an inflammatory animal model may be released in 2H 2026, and the company expects a topline readout for the ALSTARS trial in early Q2 2027.

Finally, investors are watching for a potential FDA approval and launch of COYA 302 in 2028.

Ownership Information & Share Structure¹

Coya Therapeutics Inc. has a market cap of US$111.66 million, with 23.46 million shares outstanding. The company's 52-week range is US$3.71-US$7.75. Institutions own 33.23% of shares, while Strategic Investors own 13.69%. Management & Insiders own 1% of shares, and the remaining 52.08% of shares are Retail.

Frequently Asked Questions

Q: What is COYA 302?
A: COYA 302 is an investigational therapy being evaluated by Coya for ALS. It combines low-dose interleukin-2 (IL-2) with CTLA-4 immunoglobulin (Ig).

Q: How is COYA 302 being tested?
A: Participants are being randomized in a 1:1:1 ratio to receive one of two pre-specified COYA 302 dosing regimens or placebo.

Q: What does randomized mean in a clinical trial?
A: Randomized means participants are assigned to treatment groups using a predefined process rather than allowing researchers or participants to choose the treatment.

Q: What does double-blind mean?
A: In a double-blind trial, neither the participants nor the relevant study personnel know which treatment each participant is receiving during the blinded portion of the study.

Q: What is a placebo-controlled trial?
A: A placebo-controlled trial compares an investigational treatment with a placebo, which is designed to resemble the treatment but does not contain the active therapy being studied.

Q: How long does the ALSTARS treatment period last?
A: The initial double-blind treatment period lasts 24 weeks. Participants can then enter a 24-week blinded active-treatment extension, potentially providing up to 48 weeks of treatment data.

Q: What is the primary endpoint of ALSTARS?
A: The primary endpoint is the change in disease severity from baseline through Week 24, measured using the ALS Functional Rating Scale-Revised (ALSFRS-R) total score compared with placebo.

Q: What is the ALSFRS-R?
A: The ALS Functional Rating Scale-Revised is a clinical scale used to measure changes in physical function in people with ALS, including areas such as movement, speech, swallowing, and breathing.

Q: What else will the ALSTARS trial evaluate?
A: The trial will also assess COYA 302's efficacy, safety, tolerability, biological activity, and biomarker levels.

Q: What is interleukin-2 (IL-2)?
A: Interleukin-2 is a signaling protein involved in regulating the immune system. Low-dose IL-2 is being studied in several settings for its potential effects on immune regulation.

Q: What is CTLA-4 immunoglobulin?
A: CTLA-4 immunoglobulin is an investigational immune-modulating component designed to affect T-cell activity. It is one of the two components of COYA 302.

Q: What is a biomarker?
A: A biomarker is a measurable biological characteristic that can provide information about a disease, biological process or response to treatment.