Lyra Therapeutics recently decided to terminate all further development of its only candidate drug for the treatment of chronic sinusitis, LYR-210 , and lay off 28 employees, retaining only the CEO and CFO as caretaker managers to find a "strategic alternative." Just six months ago, this absorbable intranasal implant achieved positive results in a Phase 3 trial, but now it has been shelved by the company itself.

LYR-210 is manufactured using Lyra's proprietary XTreo platform : microcrystalline mometasone furoate is uniformly dispersed within a polylactic-co-glycolic acid copolymer backbone to form a 2-cm-long flexible filament. After simple implantation into the middle nasal meatus by a physician, it continuously releases glucocorticoids for up to 24 weeks, directly acting on the inflamed mucosa. Its target population is patients with chronic sinusitis (CRS) without nasal polyps.

In June 2025, the pivotal Phase 3 ENLIGHTEN 2 study of LYR-210 was completed. The trial was a multicenter, randomized, double-blind, sham-operated controlled trial that enrolled 400 adult patients. The primary endpoint was the change in the combined scores of the three core symptoms—nasal congestion, rhinorrhea, and facial pain/throbbing—at week 24. Results showed a significant improvement of -1.13 points in the LYR-210 group compared to the sham-operated group (P=0.0078). All key secondary endpoints were also met simultaneously , with symptom relief observed as early as week 4, and the safety profile was comparable to the control group. The company subsequently reached a Phase 3 registration agreement with the FDA: completing one more confirmatory trial of similar size would allow for NDA submission.

However, a funding gap has become a real obstacle . As of September 30, 2025, the company had $22.1 million in cash and cash equivalents, with quarterly operating expenses of approximately $9 million. Proceeding with the second Phase 3 project and simultaneously completing commercial production line validation would require a total cost of $180-220 million. In the fourth quarter of 2025, Lyra attempted to raise funds through various means, including share issuance, private placement, and partnerships, but all failed due to low valuations or stringent terms. Given the unavoidable high dilution, the board believes that continuing the project is not in the best interests of shareholders.
The failure of LYR-210 is not the first case. In the past two years, several topical drug-device hybrid products with positive Phase 3 clinical trials have been forced to shelve due to unclear commercial pathways. Analysts point out that low reimbursement rates, high learning costs for doctors, and limited peak sales ceilings are the main reasons for capital withdrawal. For patients with chronic sinusitis, the withdrawal of LYR-210 means the end of the "one-time implantation, six-month relief" non-surgical solution; for the industry, it serves as a reminder that "good data" is only the ticket to success, and any weakness in regulation, payment, distribution channels, or cash flow can turn a final push into an abrupt halt.

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