Loyal Receives FDA Acceptance of Reasonable Expectation of Effectiveness for Senior Dog Lifespan Extension

SAN FRANCISCO--(BUSINESS WIRE)--Feb 26, 2025--

Loyal, a clinical-stage animal health company developing longevity drugs for dogs, announced today that the FDA’s Center for Veterinary Medicine has accepted the Reasonable Expectation of Effectiveness (RXE) section of its conditional approval application for LOY-002. The drug aims to extend the lifespan of senior dogs and maintain their quality of life as they age, building on the company’s previous RXE acceptance for a longevity drug specifically targeting the short lifespan of large breed dogs.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250226676005/en/

The company also announced it has raised a $22M million B-2 round from Valor Equity Partners and Collaborative Fund, among others, in addition to its $45M Series B in 2024. This brings total investment in Loyal’s to over $150M.

“Everything we do is in service of helping dogs live longer, healthier lives,” said Loyal Founder and CEO Celine Halioua. “These two milestones represent our ongoing commitment to that mission through years of diligence and hard work. Proving efficacy is one of the most challenging parts of developing a novel drug. While we still have significant work to do, RXE increases the probability that dogs will soon have access to our longevity drugs.”

A New Preventive Paradigm

The FDA's Center for Veterinary Medicine has determined that Loyal's data provides reasonable expectation of LOY-002's intended effect of extending canine lifespan, marking a significant milestone in the company's pursuit of conditional approval.

LOY-002, a daily flavored tablet developed for dogs aged 10 and older weighing at least 14 pounds, represents a groundbreaking approach to canine longevity by targeting metabolic dysfunction, one of the key underlying mechanisms of aging. This preventive therapy aims to reduce the incidence and severity of age-associated diseases that diminish senior dogs' quality of life, offering a practical alternative to established longevity interventions like caloric restriction.

The FDA's acceptance of RXE demonstrates confidence in Loyal's innovative approach, and the company anticipates completion of the manufacturing and safety requirements for Expanded Conditional Approval (XCA) from the FDA by the end of 2025.

“Loyal’s progress in bringing their products to market continues to impress, especially since they are breaking new regulatory ground,” said Dr. Linda Rhodes, VMD, PhD, a veterinarian and experienced animal health executive who serves on Loyal’s Board of Directors.

As the company pursues its XCA application, Loyal is simultaneously running its groundbreaking clinical trial, the STAY study. The STAY study is LOY-002’s pivotal efficacy study that dosed its first dog in December 2023 and will take place over approximately four years. It is the first and only FDA-concurred clinical trial for longevity and is the largest veterinary trial in history, recruiting over 1,000 dogs from 70 veterinary clinics across the country.

“Achieving RXE acceptance is a testament to the ongoing importance of the STAY study,” said Dr. Ellen Ratcliff, VP of Clinical and Veterinary Medicine at Loyal. “Completing enrollment and seeing what the data shows over the next several years is critical, but this is an important step in the process. We now have validation from one of the highest quality regulatory agencies in the world that the drug we’re testing has a reasonable expectation of extending a dog’s life.”

B-2 Fundraising Round

In addition to achieving RXE for its second drug program, Loyal successfully completed a $22M B-2 funding round, led by Valor Equity Partners and Collaborative Fund, among others. Along with his investment in Loyal, Jonathan Shulkin, Partner and Co-President at Valor Equity Partners, is joining the company’s Board of Directors.

This raise represents a significant premium on the Loyal’s Series B last year and will support the company’s execution of key go-to-market efforts to bring LOY-002 to veterinarians and dog owners soon, in addition to advancing the other drugs in development across its portfolio: LOY-001 and LOY-003, which are designed to extend the healthy lifespan of large-breed dogs.

About Loyal

Loyal is an animal health company developing the first drugs intended to help dogs live longer, healthier lives. By targeting the underlying mechanisms of aging, Loyal hopes to extend the lifespan of dogs and improve their quality of life as they age. Loyal’s work is based on decades of research, and their team of experts in dog health and longevity is dedicated to furthering this research and developing better ways to quantify and improve the aging process in dogs. It currently has three drugs in development and is making progress toward approval from the FDA’s Center for Veterinary Medicine.

For more information, please visit loyal.com.

An overview of Loyal's three drugs in development: LOY-001, LOY-002, and LOY-003 (Photo: Business Wire)

NEW YORK (AP) — U.S. stock indexes are falling on Wednesday following mixed profit reports from several big banks.

The S&P 500 sank 0.8% and was on track for a second straight loss after setting its all-time high. The Dow Jones Industrial Average was down 177 points, or 0.4%, as of 2:18 p.m. Eastern time, and the Nasdaq composite was 1.5% lower.

Wells Fargo helped pull the market lower after falling 5%. The San Francisco-based bank reported weaker profit and revenue for the latest quarter than expected, with analysts citing lower trading fees and other miscellaneous items.

Bank of America fell 4.3% despite reporting a stronger profit than analysts expected, with some consternation about the size of its upcoming expenses. Citigroup, which is in the midst of a turnaround under Chair and CEO Jane Fraser, fell 4.2% following its own profit report.

Companies across industries need to report strong growth in profits to justify how high their stock prices have run recently. Analysts are looking for businesses across the S&P 500 to report earnings per share for the final three months of 2025 that are roughly 8% higher than a year earlier, according to FactSet.

Biogen sank 5.2% after the biotechnology company said it expects to take a hit to its profit for the fourth quarter of 2025 due to research and development expenses and other costs that it acquired.

The heaviest weights on the market were tech stocks, which gave back some of their huge gains made over recent years from the frenzy around artificial-intelligence technology. Nvidia fell 2.1%, and Broadcom sank 4.6%.

Still, nearly as many stocks on Wall Street rose as fell, and the strongest forces keeping the S&P 500 from steeper losses were Exxon Mobil and other oil companies.

Exxon Mobil rose 3.5%, and Chevron climbed 2.7% as the price of a barrel of benchmark U.S. crude added 1.3% to bring its gain for the year to more than 7%.

Oil prices have rallied as protests have swept Iran, which is a member of the OPEC group that helps set crude prices. The protests could lead to disruptions in production and squeeze supplies of crude.

Besides the rise in oil prices, gold's price also rose 0.9% toward a record in another signal of nervousness across financial markets.

In the bond market, Treasury yields sank as investors sought investments seen as safer. Several reports on the U.S. economy also came in mixed.

One said that shoppers spent more at U.S. retailers in November than economists expected. That could be an encouraging signal about the main engine of the U.S. economy, but economists pointed to some concerning signals were underneath the surface.

A separate report said prices rose modestly at the U.S. wholesale level in November. It followed a report on Tuesday that said inflation at the U.S. consumer level was close last month to economists’ expectations, though it remained above the Federal Reserve’s 2% target.

A third report said sales of occupied homes were stronger last month than economists expected. Taken altogether, the data did little to change Wall Street's expectation that the Federal Reserve will cut its main interest rate at least twice this year to shore up the job market, likely beginning around June, according to CME Group.

The yield on the 10-year Treasury fell to 4.14% from 4.18% late Tuesday.

In stock markets abroad, Japan’s Nikkei 225 rallied 1.5% to another record expectations grew that Prime Minister Sanae Takaichi may call general elections soon.

Indexes were mixed elsewhere. Stocks rose 0.6% in Hong Kong but fell 0.3% in Shanghai after a report showed China’s trade surplus surged 20% in 2025 to a record despite President Donald Trump’s tariffs.

AP Business Writers Yuri Kageyama and Matt Ott contributed.

Specialist Michael Pistillo works at his post on the floor of the New York Stock Exchange, Friday, Jan. 2, 2026. (AP Photo/Richard Drew)

A dealer watches computer monitors near the screens showing the foreign exchange rates at a dealing room of Hana Bank in Seoul, South Korea, Wednesday, Jan. 14, 2026. (AP Photo/Lee Jin-man)

The screens show the Korea Composite Stock Price Index (KOSPI), left, and the foreign exchange rate between U.S. dollar and South Korean won are seen at a dealing room of Hana Bank in Seoul, South Korea, Wednesday, Jan. 14, 2026. (AP Photo/Lee Jin-man)

A dealer walks past near the screen showing the Korea Composite Stock Price Index (KOSPI) at a dealing room of Hana Bank in Seoul, South Korea, Wednesday, Jan. 14, 2026. (AP Photo/Lee Jin-man)

A dealer stands near the screens showing the Korea Composite Stock Price Index (KOSPI), left, and the foreign exchange rate between U.S. dollar and South Korean won at a dealing room of Hana Bank in Seoul, South Korea, Wednesday, Jan. 14, 2026. (AP Photo/Lee Jin-man)