Summit Therapeutics III期HARMONi试验达主要终点：ivonescimab联合化疗在EGFR突变NSCLC中PFS显著获益（HR 0.52），SMMT盘中涨7%后回落

Today's top gainers in the biotech and healthcare space include Summit Therapeutics, following positive Phase III HARMONi trial data; Celularity, despite a Nasdaq compliance notice; Biodesix, on strong quarterly growth; Cardiol Therapeutics, after narrowing its quarterly loss; and Edesa Biotech, following its proposed public offering.
Read on...
SMMT Jumps 7% As Ivonescimab Delivers Significant PFS Benefit
Summit Therapeutics Inc. (SMMT) shares rose 7% after Phase III HARMONi trial results showed a significant progression-free survival benefit for ivonescimab plus chemotherapy in EGFR-mutated advanced non-small cell lung cancer.
Median PFS was 6.8 months versus 4.4 months for placebo plus chemotherapy, with a hazard ratio of 0.52. Overall survival showed a positive trend but had not reached statistical significance. Grade 3-5 treatment-related hemorrhage occurred in less than 1% of patients.
SMMT shares are currently trading at $14.34, up 7%.
CELU Climbs 15% Despite Nasdaq Filing Compliance Issue
Celularity Inc. (CELU) shares gained 15% after the company disclosed a Nasdaq notification concerning delayed Form 10-Q filings for the quarters ended March 31 and June 30, 2026.
Nasdaq requested a compliance plan by September 4, 2026, while any exception could extend the compliance period through November 16, 2026. Celularity said the notice does not immediately affect the listing or trading of its common stock and that it is working to file both reports as soon as practicable.
CELU shares are currently trading at $0.924, up 15%.
BDSX Advances 8% As Diagnostic Testing Fuels Q2 Growth
Biodesix Inc. (BDSX) shares are up 8% after second-quarter revenue increased 34% year over year to $26.9 million.
Diagnostic Testing revenue rose 42% to $25.4 million, driven by a 38% increase in test volumes to 20,900. Gross margin improved to 82%, while net loss narrowed 37% to $7.3 million and Adjusted EBITDA loss improved 56% to $3.2 million.
Biodesix maintained its 2026 revenue guidance of $108 million to $114 million, with the midpoint representing approximately 25% growth over 2025.
BDSX shares are currently trading at $30.36, up 8%.
CRDL Gains 12% As Quarterly Loss Narrows
Cardiol Therapeutics Inc. (CRDL) shares rose 12% after the company reported a second-quarter net loss of C$6.08 million, compared with C$8.35 million a year earlier.
The company reported a six-month net loss of C$16.90 million, broadly in line with the prior-year period. Cardiol ended the period with C$26.08 million in cash and cash equivalents, while total assets reached C$29.36 million and total equity stood at C$24.03 million.
CRDL shares are currently trading at $2.23, up 12%.
EDSA Gains 11% After Launching Proposed Public Offering
Edesa Biotech, Inc. (EDSA) shares are up 11% after the company announced a proposed underwritten public offering of common shares, or pre-funded warrants, together with accompanying common share warrants.
The company expects to provide underwriters with a 30-day option to purchase additional shares and warrants representing up to 15% of the securities offered. Edesa plans to use the proceeds for working capital, capital expenditures, R&D and manufacturing expenses.
The offering remains subject to market conditions, with final size and terms yet to be determined.
EDSA shares are currently trading at $4.92, up 11%.
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Business News
August 21, 2026 14:42 ET The minutes of the latest policy meeting of the Federal Reserve, housing market data and manufacturing sector survey results were the main news for the U.S. economy this week. In Europe, inflation data from the U.K. was the highlight, while consumer price data from Japan drew attention in Asia.