Vice President - Clinical Development

3 takeover targets in immunology. Dealmaking in the autoimmune space is thriving as biotechs chase new targets with the potential to treat more conditions. Published Aug. 26, 2026 By Kelly Bilodeau No other drug category has reached the heady heights of GLP-1s in recent years, but immunology remains a strong contender as one of the fastest-growing areas in pharma's overall market, according to an Evaluate report. Immunology treatments are often poised to become blockbusters because they're used over the long term. They also have the ability to treat a range of diseases caused by a misfiring immune system, which turns on the body's own tissues and organs, said Betty Pio, a partner at Kearney - and their reach is expected to grow. "What's interesting about immunology is that it's multi-specialty," Pio said, pointing out that the space is expanding from its traditional fields like rheumatology and dermatology into new areas like respiratory. "I think that there will be more because we're learning so much more about other conditions and the way that inflammation affects them." The field took a major leap forward more than two decades ago with the advent of tumor necrosis factor inhibitors like AbbVie's mega blockbuster Humira. But while they were effective, they were often wielded like a big hammer with broad effects - similar to how chemotherapy is used for cancer, Pio said. Also like oncology, the field is now moving toward precision approaches. "We're learning more about different biologic processes, different types of inflammation, and the different inflammatory cascades or cytokines that are associated with inflammation," Pio said. "It's way more specific now." Even though researchers are getting more precise, today's drugs still have range. "There is a whole portfolio of diseases that could be addressed with a single mechanism," she said. For example, AbbVie's Skyrizi, a targeted injectable IL-23 antagonist, is expected to become the second-best selling drug in 2032, raking in more than $33 billion from multiple indications, including psoriasis, ulcerative colitis and Crohn's disease, according to Evaluate. One investigational target in particular, tumor necrosis factor-like ligand 1A (TL1A), has led to dealmaking by companies like Roche and Merck & Co. because of its potential to address both inflammation and fibrosis in inflammatory bowel disease. Other popular drug targets include signaling proteins that can drive inflammation, like IL-17. Drug developers are also investigating drugs that could do double duty by targeting protein signals called BAFF and APRIL, which could throw a wrench into the system that allows immune cells primed to attack the body's own tissues to survive. CAR-T cell therapies, which are being tested as a way to rid the body of the rogue immune cells driving these conditions, have also driven numerous acquisitions, including Eli Lilly's acquisition of Orna Therapeutics earlier this year. But they still need to overcome delivery and safety challenges, Pio said. When big companies are looking for new immunology assets, they're typically focused on the drug's mechanism, a multi-indication opportunity, and best-in-class or first-in-class potential, even if it's in a small or rare indication, Pio said. Immunology will likely remain an active investment area because of its commercial appeal and significant unmet need, she said, and several companies, including the three below, could be well positioned as acquisition targets. Spyre Therapeutics. Spyre Therapeutics, which was spun out from Paragon Therapeutics, has generated buzz for its pipeline of long-acting phase 2 antibodies, including two targeting TL1A. Its other programs target IL-23, α4β7 and IL-17, alone or in combination. The company recently notched a few clinical wins, including favorable results in phase 2 for its anti-TL1A drug SPY002 in ulcerative colitis, and another in phase 2 for its α4β7-targeting drug, SPY001. If SPY001 stays on track in later-stage trials, it could challenge Takeda Pharmaceutical's blockbuster drug, Entyvio, which also targets α4β7. The company is also expecting to release readouts for six "proof-of-concept" phase 2 trials in 2026.

Spyre Therapeutics announces launch of SPY772 program and initiation of Phase 2 SKYLIGHT trial in Hidradenitis Suppurativa. August 10, 2026 SPY772 program aims to deliver best-in-indication efficacy and convenience in Hidradenitis Suppurativa through dual inhibition of TL1A and IL-17A/F in a long-acting coformulation Phase 2 SKYLIGHT trial designed to provide clinical proof-of-concept for TL1A and IL-17A/F inhibition in Hidradenitis Suppurativa; site activation has begun with topline Week 16 HiSCR75 data planned for late 2027 or early 2028 WALTHAM, Mass., Aug. 10, 2026 (GLOBE NEWSWIRE) - Spyre Therapeutics, Inc. (NASDAQ: SYRE), a clinical-stage biotechnology company committed to developing next-generation therapies that elevate the standard in immunology by delivering more complete disease control, greater durability, and a simpler treatment experience for patients, today announced the launch of SPY772, a new combination program comprising SPY072, a long-acting anti-TL1A antibody, and SPY007, a novel long-acting anti-IL-17A/F antibody in preclinical development. To test the hypothesis of the SPY772 program, the company also announced the initiation of SKYLIGHT, a randomized Phase 2 proof-of-concept trial evaluating dual inhibition of TL1A and IL-17A/F in Hidradenitis Suppurativa (HS). "Combination therapy has demonstrated the ability to meaningfully improve efficacy without apparent safety downsides in multiple autoimmune conditions. We believe our differentiated strategy of developing long-acting antibody coformulations against validated targets appears increasingly likely to deliver indication-leading product profiles," said Sheldon Sloan, M.D., Chief Medical Officer. "Expanding our portfolio to include long-acting IL-17A/F broadens the potential for our pipeline to improve outcomes across some of the largest gastrointestinal, dermatologic, and rheumatic diseases with substantial remaining unmet medical need." "HS is a chronic, painful disease that can profoundly affect patients' quality of life, and many patients do not achieve adequate disease control with available therapies. We believe targeting complementary inflammatory pathways has the potential to raise the efficacy ceiling in HS," said Josh Friedman, M.D., Ph.D., SVP of Clinical Development and SKYLIGHT study lead. "SKYLIGHT will evaluate whether adding SPY072 (anti-TL1A) to bimekizumab (anti-IL-17A/F) can improve outcomes beyond bimekizumab alone. Positive SKYLIGHT results would support advancement of our long-acting SPY772 combination (SPY072 and SPY007) in HS. We are also excited to potentially explore other indications with this combination pending our SKYWAY trial results." SKYLIGHT is a randomized, placebo-controlled Phase 2 proof-of-concept study expected to enroll approximately 150 adults with moderate-to-severe HS. Participants will receive background bimekizumab therapy and either SPY072 or placebo. The primary endpoint is the proportion of patients achieving a HiSCR75 response at Week 16. Topline results are expected in late 2027 or early 2028. About Spyre Therapeutics Spyre Therapeutics is a clinical-stage biotechnology company committed to developing next-generation therapies that elevate the standard in immunology by delivering more complete disease control, greater durability, and a simpler treatment experience for patients. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, IL-23, and IL-17A/F as well as rational combination programs. Forward-Looking Statements Certain statements in this press release, other than purely historical information, may constitute "forward-looking statements" within the meaning of the federal securities laws, including for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding: Spyre's ability to achieve the expected benefits or opportunities with respect to its product candidates and combinations thereof, including its ability to develop next-generation therapies that elevate the standard in immunology by delivering more complete disease control, greater durability, and a simpler treatment experience for patients and its ability to develop long-acting antibody coformulations against validated targets to deliver indication-leading product profiles; the potential for SPY772 to provide best-in-indication efficacy and convenience in Hidradenitis Suppurativa through dual inhibition of TL1A and IL-17A/F in a long-acting coformulation; the potential of raising the efficacy ceiling in HS by targeting complementary inflammatory pathways; and Spyre's ongoing and future pre-clinical and clinical development activities, including Spyre's plans for and timing of data readouts and clinical enrollment for the SKYLIGHT trial, preclinical development of the SPY007 program and the potential expansion of the SPY772 program to indications outside of HS. The words "opportunity," "potential," "milestones," "pipeline," "strategy," "anticipate," "believe," "could," "estimate," "expect," "may," "might," "plan," "possible," "predict," "should," "will," "would," "can, " "likely," "aim," and similar expressions (including the negatives of these terms) may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements are based on current expectations and beliefs and involve a number of risks and uncertainties, many of which are beyond Spyre's control, and other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, uncertainties and risks arising from regulatory feedback, including potential disagreement by regulatory authorities with the Company's interpretation of data and the Company's clinical trials for its product candidates; the potential for interim data not being delivered within expected time frames or final data not being consistent with or different than the topline or interim data reported for its programs; the potential impact of Trump Administration policies and changes in law on its business; and those uncertainties and factors described in Spyre's most recent Annual Report on Form 10-K, as supplemented and updated by subsequent Quarterly Reports on Form 10-Q and any other filings that Spyre has made or may make with the SEC from time to time. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Spyre does not undertake or accept any duty to make any updates or revisions to any forward-looking statements. For Investors: Eric McIntyre, Spyre Therapeutics SVP of Finance and Investor Relations [email protected]

Assessing Spyre Therapeutics (SYRE) valuation after expanded SPY003 license with Paragon. June 03, 2026 Spyre Therapeutics (SYRE) stock is back in focus after the company amended its SPY003 license with Paragon Therapeutics, expanding rights beyond inflammatory bowel disease to broader uses while keeping clear dosing limits for non IBD indications. The expanded SPY003 license and recent conference appearance come after a sharp run, with the stock's 90 day share price return of 68.68% and a very large 1 year total shareholder return. However, the 7 day share price return is down 6.10% as some investors reassess risk around execution on the broader pipeline rights. If this kind of biotech re rating has your attention, it could be a good moment to look beyond a single stock and review 39 healthcare AI stocks With Spyre's shares up 68.68% over 90 days and the stock trading at a discount to the US$95.20 consensus target, investors now have to ask: is there still a reasonable entry point here, or is future growth already priced in? Price-to-Book of 11.7x: is it justified? Spyre Therapeutics trades on a P/B of 11.7x, which sits close to a peer average of 12.2x but far above the wider US biotech group. P/B compares the market value of the equity to the accounting value of net assets. This often matters for early stage biotechs that have little or no revenue and where earnings-based metrics are less useful. At a last close of $69.16, investors are tying a relatively high equity value to a business that reports no meaningful revenue and a net loss of $148.703m. The key question is what that premium is really reflecting. Spyre is currently unprofitable, is forecast to remain unprofitable over the next 3 years, and earnings are expected to decline by an average of 17% per year over that period. On top of that, shareholders have been substantially diluted in the past year and the company reports a negative return on equity of 26.75% with all liabilities coming from higher risk sources of funding rather than customer deposits. Compared with the broader US Biotechs industry average P/B of 2.6x, Spyre's 11.7x multiple is far richer, which signals that the market is pricing in a very optimistic view on the pipeline relative to current fundamentals. However, against its closer peer set, the same 11.7x sits only slightly below the 12.2x average. This suggests the stock is roughly in line with companies that investors consider similar on key characteristics. Result: Price-to-book of 11.7x (ABOUT RIGHT) However, there are still clear pressure points, including ongoing losses of $148.703m and reliance on higher risk funding sources that could quickly challenge today's premium valuation. Next steps. With sentiment pulled between clear risks and meaningful upside potential, it makes sense to move quickly and test the numbers yourself rather than rely on headlines. To see both sides set out clearly, start with the 1 key reward and 4 important warning signs Looking for more investment ideas? If you are serious about building a stronger portfolio, do not stop at a single biotech stock. Use targeted screens to quickly surface other opportunities that fit your style. * Spot potential turnaround candidates with room to run by scanning 24 elite penny stocks with strong financials. * Hunt for quality at a reasonable price by checking out 46 high quality undervalued stocks. * Balance return potential with resilience by reviewing the 63 resilient stocks with low risk scores. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. New: manage all your stock Portfolios in one place. - Connect an unlimited number of Portfolios and see your total in one currency - Be alerted to new Warning Signs or Risks via email or mobile - Track the Fair Value of your stocks Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]