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CUE-221 met both primary and key secondary endpoints in a 145-patient Phase 2 study, with the 4 mg/kg dose outperforming omalizumab 12

Cue Biopharma’s CUE-221 met its Phase 2 goals in chronic hives, beating placebo and showing longer-lasting relief than Xolair after dosing stopped.

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Cue Biopharma (CUE) reported positive topline results from a Phase 2 trial of CUE-221 in 145 patients with moderate to severe chronic spontaneous urticaria inadequately controlled on H1 antihistamines.The randomized, double-blind study in China tested CUE-221 at 1, 2 and 4 mg/kg subcutaneously every 4 weeks versus placebo and omalizumab. The primary endpoint, complete resolution of hives (HSS7=0) at week 12, was dose‑responsive and met at all CUE-221 doses, with 54%, 53% and 43% responders for 4, 2 and 1 mg/kg versus 11% for placebo (p<0.005, p<0.005, p<0.05). The key secondary endpoint, complete response UAS7=0 at week 12, reached statistical significance at 4 mg/kg (46% vs 11% placebo, p<0.05). Complete hive resolution rates with CUE-221 peaked at week 22 and remained clinically meaningful up to week 28 at 4 mg/kg, including a post hoc statistically significant 36% delta versus omalizumab. CUE-221 showed a favorable safety profile with no treatment‑related serious adverse events or anaphylaxis.

Reported Sunday, Sep 20 - 10:14am EDT (TheFly subscription required to read more.)

Announced recent Investigational New Drug (IND) submission to the FDA for CUE-221 in food allergy applicationsCompleted a $50 million private placement (PIPE) to further fund clinical development and the portfolio with significant potential for value-inflectionStrengthened the leadership team with the...

Cue Biopharma (Nasdaq:CUE) reported second quarter 2026 collaboration revenue of $7.9 million, up from $3.0 million a year earlier, primarily from a Boehringer Ingelheim preclinical milestone. Operating expenses rose sharply, with R&D at $49.0 million and G&A at $46.6 million, driven largely by one-time cash and non-cash items related to the CUE-221 license from Ascendant and a strategic transformation.Other expense included a substantial non-cash loss tied to liability-classified warrants, leading to a net loss of $153.1 million versus $8.5 million in 2025. Cash and equivalents were $17.4 million at June 30, 2026, with a subsequent $50 million private placement completed. Cue submitted an IND for CUE-221 in food allergy, expects Phase 2 data in chronic spontaneous urticaria by end of Q3 2026, and plans to initiate a CUE-401 Phase 1 study by year-end. The company also added a new CMO/Head of R&D and CFO.

Cue Biopharma (Nasdaq:CUE) reported Q1 2026 collaboration revenue of $5.7 million, up from $0.4 million in Q1 2025, and a net loss of $5.2 million, reduced from $12.3 million. R&D expenses fell to $6.9 million, G&A held at $4.2 million.The company licensed CUE-221, a Phase 2 anti-IgE asset for allergic disease, and advanced CUE-401, an autoimmune candidate. Liquidity was strengthened by a $30 million private placement and a $7.5 million milestone from Boehringer Ingelheim. Shao-Lee Lin, M.D., Ph.D., was appointed President and CEO.

Cue Biopharma (NASDAQ: CUE) announced a private placement expected to raise approximately $30 million in gross proceeds via pre-funded warrants and accompanying warrants. The PIPE is expected to close on or about May 4, 2026, subject to customary conditions and stockholder approval.Proceeds are intended to advance the clinical pipeline, including acquiring and developing Ascendant-221, and for working capital and general corporate purposes. Newbridge Securities is placement agent; resale registration will be filed with the SEC.

Cue Biopharma (Nasdaq: CUE) entered an exclusive license agreement for Ascendant-221, a Phase 2 anti-IgE antibody, gaining global rights excluding mainland China, Hong Kong, Macau and Taiwan.Deal consideration includes a $15 million upfront fee, up to $676.5 million in milestone payments and tiered royalties. Ascendant-221 Phase 2 results from a China study are expected in 2H 2026; Cue plans a global Phase 2b in food allergy after data review.

Les cinq candidats à la chefferie du Nouveau Parti démocratique (NPD) croiseront le fer jeudi dans un premier débat « majoritairement » en français à Montréal.