Clene submits NDA for ALS treatment candidate.
Clene Inc. filed a New Drug Application with the FDA seeking accelerated approval of CNM-Au8 for ALS, a significant regulatory milestone for the company.
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Clene Inc. filed a New Drug Application with the FDA seeking accelerated approval of CNM-Au8 for ALS, a significant regulatory milestone for the company.
The FDA accepted the supplemental NDA with a target action date of Q1 2027, supported by the ReSPECT Phase III trial. This milestone marks a significant regulatory step toward addr…
Disc Medicine announced bitopertin met all primary and secondary endpoints in the APOLLO Phase 3 trial for erythropoietic protoporphyria, signaling a potential breakthrough treatme…
Topline results from the LUCIA phase 3 trial for DURAVYU failed to meet the primary endpoint for statistical non-inferiority, while demonstrating a successful safety profile and a …
OpenWorld Inc. (OWRD) filed an 8-K to amend its certificate of incorporation, expanding authorized shares from 500 million to 1.25 billion to facilitate future capital needs and gr…
Apollo announced the voluntary delisting of its common stock from the NYSE and the formation of a Maryland Liquidating Trust to complete its planned wind-down and dissolution.
Eaton Corp filed an 8-K because it incorporated by reference independent registered public accounting firm reports dated October 16, 2026. This is standard disclosure for a large i…
Altus Group U.S. Inc. provided a consent for the description of their role in the NAV valuation process to be included in Hines' related S-3 Registration Statement.
The Federal Reserve Board terminated its enforcement actions against Gardner Bancshares, Inc. and Small Business Bank.
Hawkeye Digital posted a confidential business presentation for potential investors, outlining its strategy as a merchant banking firm. The filing serves as a public disclosure and…
Stepstone SPV Facility III LLC amended its credit facility by Amendment No. 5, modifying key terms with its administrative and collateral agents. The filing confirms the structurin…
WithumSmith+Brown, a public accounting firm, has confirmed receipt and read a Form 8-K, which the company believes reaffirms their relationship and professional services.
Fractyl Health announced topline 6-month data showing Revita maintained 80% of GLP-1 induced weight loss versus 67% in sham controls. This neuroendocrine intervention offers a new …
Independent valuation advisor Altus Group U.S. Inc. provided a consent to its reference in a current SEC filing. The filing relates to the calculation of the NAV per share as of Se…
First Amendment to Amended and Restated Credit Agreement amended fee structures and floors, with effective date October 15, 2026.
Anavex received FDA clearance for its IND application evaluating blarcamesine for Fragile X syndrome, marking progress toward clinical trials for the condition with no approved tre…
Boumarang Inc.'s auditor, Lao Professionals, confirmed the October 12, 2026 Form 8-K statements and requested to reactivate its PCAOB registration, effective October 15, 2026.
Gulf Resources Inc. received government approval to resume operations at two bromine factories, expecting impact on revenue and capacity by 2027.
Quantum-Si received notice that it has regained compliance with the Nasdaq minimum bid price requirement after the stock closed above $1.00 for 10 consecutive days, bringing an end…
Jasper Therapeutics has completed the enrollment of the first IgAN cohort of its Phase 2 study evaluating vensobafusp alfa. The company anticipates reporting initial interim data b…