This week, we highlight key Phase 3 catalysts of biotech companies expected over the next six months.

Gyre Therapeutics Inc. (NASDAQ: GYRE) has a market cap of US$846M, with cash reserves of approximately US$75.3 million. The company has yet to generate product revenue and reported a modest net loss. Its lead asset, hydronidone (F351), has received Breakthrough Therapy Designation in China.

Hydronidone is in a fully enrolled Phase 3 trial (NCT05115942) for chronic hepatitis B-associated liver fibrosis in China. This antifibrotic agent targets TGF-β signaling, a central pathway in fibrogenesis. Topline results are expected in Q2 2025, following last-patient dosing on 22 October 2024. An NDA filing is planned for 2025, making this a critical late-stage catalyst for Gyre.

Mineralys Therapeutics Inc. (NASDAQ: MLYS) is a mid-cap biotech with a market cap of US$719M and roughly US$294 million in cash. The company’s lead candidate is lorundrostat, a selective aldosterone synthase inhibitor. Mineralys reported positive Phase 3 results and has significant institutional interest given its cash position and focus on cardiometabolic diseases.

Lorundrostat is being evaluated in uncontrolled and resistant hypertension in the Launch-HTN Phase 3 trial. Topline data showed statistically significant reductions in systolic blood pressure with the 50 mg dose. The primary endpoint was met, and the full data readout is anticipated in 1H 2025. This is a major catalyst that could support regulatory filings.

PolyPid Ltd. (NASDAQ: PYPD) has a market cap of US$27.8M and is focused on developing localized drug-delivery systems to prevent surgical site infections. The company operates with limited cash and no product revenue to date.

D-PLEX100 is being studied in the SHIELD II Phase 3 trial to prevent abdominal surgical site infections. The trial completed enrollment as of March 2025, with topline data expected in Q2 2025. The product uses a novel polymer-lipid matrix for local antibiotic release. It has been positioned as a potential new standard in SSI prevention, making this readout highly consequential for PolyPid’s future.

Lyra Therapeutics Inc. (NASDAQ: LYRA) is a micro-cap biotech (US$9.3M market cap) developing therapies for chronic rhinosinusitis. The company operates with significant cash constraints and has reported substantial net losses. LYR-210 is an investigational implant delivering mometasone furoate directly to the sinonasal tissues. The ENLIGHTEN II Phase 3 trial resumed enrollment in April 2023 and expects topline data in 2Q 2025. Given the previous trial delays, this data will be pivotal for validating the company’s approach and determining its commercial viability.