Sign inThe Phase 2b study of envudeucitinib failed on its primary and secondary endpoints overall, though patients with high interferon signature responded well, and Alumis plans to pursue Phase 3.
SEC filing
New filing adds royalty rates, supply terms, and clinical and market figures behind RedHill's $12 million acquisition from Ferring.
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The company also disclosed FDA clearance of an IND for a new solid tumor cell therapy and outlined plans for an in vivo CAR-T pipeline.
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Telix Pharmaceuticals completed enrollment of 350 patients in its Phase 3 BiPASS study of Illuccix and Gozellix and reached agreement with the FDA on a New Drug Application route for pre-biopsy imaging use.
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After a Type D meeting on July 28, 2026, the FDA and Cadrenal agreed on the primary endpoint definition and use of a placebo control for the planned registrational study.
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Updated interim data from the PYNNACLE Phase 2 pivotal trial support plans for a first-quarter 2027 NDA submission seeking accelerated approval.
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The Israeli biotech priced ADSs and pre-funded warrants at $2.78, with a concurrent private placement of additional warrants covering more than 1.2 billion underlying ordinary shares.
SEC filing (2)
The filing covers a proposed interchangeable biosimilar to vedolizumab in prefilled syringe and autoinjector form, adding to Alvotech's intravenous candidate AVT16.
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The company paid $42.6 million upfront to NQ Project Phoebus, L.P. and reduced its maximum obligation under the agreement from $125 million to $65 million.
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Lifeward said Grant's exit follows a separation agreement and is unrelated to any dispute with the company, while Oramed executive Hexter steps in as interim CEO.
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The notes carry a 1.875% coupon and mature in 2032, with proceeds slated for general corporate purposes and a $225 million share buyback.
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Ascendis will pay BioMarin royalties on Yuviwel sales in the U.S., EU, Brazil and South Korea under a binding term sheet signed August 30, 2026.
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iSpecimen's board appointed Behroyan effective August 26, 2026, under an independent contractor agreement paying $350,000 annually.
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Gill succeeds Dr. Mark Nelson, who had served as interim Chair and will stay on the board as a Non-Executive Director.
SEC filing
A prospectus supplement filed alongside the priced offering adds interim TNBC trial results and updated share counts, while confirming warrant terms tied to two future data readouts.
SEC filing (4)
The MASH drug developer said Benecchi will oversee launch preparations for lanifibranor ahead of Phase 3 data expected in the fourth quarter of 2026.
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Oragenics disclosed a stockholders' equity shortfall triggering a listing compliance deadline, alongside continued Phase IIa dosing for ONP-002 and an ongoing FDA review of its Type B meeting package.
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An 8-K/A filed August 28, 2026 shows Lokahi had $53,186 in cash at June 30, 2026 and an accumulated deficit of $8.8 million, with auditors citing substantial doubt about its ability to continue.
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The August 28, 2026 amendment adjusts RSU treatment, adds pre-funded warrant mechanics, and changes the vote threshold for a share authorization increase.
SEC filing
The once-daily TYK2/JAK1 inhibitor becomes the first targeted therapy approved for the rare autoimmune disease, with commercial availability starting ahead of prior guidance.
SEC filing (2)
PTC will pay Sangamo $111 million at closing and could owe up to $100 million more tied to FDA approval milestones for ST-920.
SEC filing
Leonard will be assigned through a consulting firm as interim CFO Robert Dickey departs at the end of August.
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Quoin Pharmaceuticals paired its financing with interim Phase 2/3 results showing QRX003 met its primary endpoint in six patients.
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The registration also covers 38,240 shares tied to placement agent warrants held by Laidlaw & Company, as Adaptin advances its lead brain cancer program.
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Spero entered a sales agreement with Jefferies for up to $100 million in stock sales and terminated its prior arrangement with Cantor Fitzgerald, both effective August 28, 2026.
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The company confirmed pricing and warrant terms for shares and pre-funded warrants sold alongside private placement warrants, with closing set for August 28, 2026.
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The clinical-stage biotech seeks Nasdaq listing under "ETRA" as it advances ipsoprubart through a global registrational trial after strong early Phase 1b results.
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The August 28, 2026 prospectus supplement sets up an at-the-market equity program with no fixed timeline or minimum sales amount.
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iBio said it advanced its myostatin and Activin E antibody programs through fiscal year 2026 and ended the period with about $88 million in cash and investments.
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The company had existing warrant holders exercise their warrants for cash while issuing new warrants in exchange, according to an August 28, 2026 SEC filing.
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Dr. Andrew Keller informed Sunshine Biopharma on August 25, 2026 that he does not plan to stand for another term on its board.
SEC filing
The company registered 25,477,133 shares underlying warrants issued in a February 2024 offering to require cash exercise going forward.
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The clinical-stage biopharma can sell up to $500 million in shares through TD Cowen under a prospectus dated August 27, 2026, with an amended sales agreement.
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The clinical-stage TIL cell therapy company, formed through mergers completed August 3, 2026, registers shares for selling stockholders while reporting $34.4 million in cash as of June 30, 2026.
SEC filing
Trinity Biotech will request a Nasdaq hearing after failing to regain compliance with the exchange's market value requirement by August 18, 2026, while reporting progress across its diagnostics pipeline.
SEC filing