Portada›Viernes 9 de enero de 2026
Biomédicas del NASDAQ ante la SEC, viernes 9 de enero de 2026
Los 46 documentos que 40 empresas del sector presentaron ante la SEC ese día, agrupados por tipo y con el enlace al original en EDGAR.
← jueves 8 de enero de 2026 · lunes 12 de enero de 2026 →
Va en color lo que cambia el capital o avisa de un riesgo: las emisiones con precio (424B1, 424B2, 424B4 y 424B5), los 8-K con item 1.02, 1.03, 2.04, 3.01, 3.02 y 4.02, y cualquier documento en el que haya aparecido una frase vigilada, que va citada debajo. Lo demás va en tinta normal. Una cita marcada «por primera vez» es una frase que no estaba en el informe previo del mismo tipo de esa empresa. La etiqueta del formulario lleva a su explicación.
Emisiones y dilución
- ACONAclarion, Inc.424B5Nueva emisión de acciones con precioEDGAR
Aclarion presentó un suplemento de prospecto para ofrecer 200.000 acciones ordinarias y 1.800.000 warrants prefinanciados para comprar acciones adicionales.
Original en inglés · traducción revisada
200,000 Shares of Common Stock 1,800,000 Pre-Funded Warrants to Purchase Shares of Common Stock 1,800,000 Shares of Common Stock Issuable Upon Exercise of the Pre-Funded Warrants
Traducción automática (claude-sonnet-5), con la cita comprobada contra el documento y revisada por una persona.
- AKTSAktis Oncology, Inc.424B4Nueva emisión de acciones con precioEDGAR
- ARWRARROWHEAD PHARMACEUTICALS, INC.424B5Nueva emisión de acciones con precioEDGAR
- ARWRARROWHEAD PHARMACEUTICALS, INC.424B5Nueva emisión de acciones con precioEDGAR
- CGCCanopy Growth CorpS-3Capacidad de emisión registradaEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…paragraph that states that the Company’s material debt obligations coming due in the short-term, recurring losses from operations and the requirement for additional capital to fund its operations raise substantial doubt about the Company’s ability to continue as a going concern. The 2023 consolidated financial statements do not include any adjustments that might result from the outcome of that uncertainty. Canopy Growth Corporation has agreed to indemnify and hold KPMG harmless…
- CLNNClene Inc.424B5Nueva emisión de acciones con precioEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…2024 SSCP Notes”), we are required to maintain unrestricted cash and cash equivalents of at least $2.0 million to avoid acceleration of the full balance of the 2024 SSCP Notes. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. To mitigate our funding needs, we plan to raise additional funding, including exploring equity financing and offerings, debt financing, licensing or collaboration arrangements with third parties, as…
En el documentoContrasplit de accionestexto original ▸
…Inc. On the Closing Date, Chelsea Worldwide Inc. changed its name to Clene Inc. and listed its shares of common stock, par value $0.0001 per share (“common stock”), on Nasdaq under the symbol “CLNN.” We effected a 1-for-20 reverse stock split of our common stock beginning with the opening of trading on July 11, 2024 (the “Reverse Stock Split”). As a result, every 20 shares of our common stock issued and outstanding were automatically combined…
- DRUGBRIGHT MINDS BIOSCIENCES INC.424B5Nueva emisión de acciones con precioEDGAR
- EIKNEikon Therapeutics, Inc.S-1Capacidad de emisión registradaEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…products approved for commercial sale, have never generated revenue from product sales, and may never achieve or maintain profitability. • Our recurring losses from operations and financial condition raise substantial doubt about our ability to continue as a going concern. • Even if this offering is successful, we will require substantial additional capital to finance our operations and achieve our business objectives. If we are unable to raise such capital when needed…
- GLUEMonte Rosa Therapeutics, Inc.424B5Nueva emisión de acciones con precioEDGAR
- GRIGRI Bio, Inc.424B5Nueva emisión de acciones con precioEDGAR
- HCWBHCW Biologics Inc.S-1Capacidad de emisión registradaEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…terminate our product development efforts or other operations. Raising additional capital may dilute our existing shareholders, restrict our operations or cause us to relinquish valuable rights. There is substantial doubt regarding our ability to continue as a going concern based only on the cash and cash equivalents as of September 30, 2025. We continuously evaluate whether there are conditions and events, considered in the aggregate, which raise substantial doubt about…
En el documentoContrasplit de accionestexto original ▸
…) for a bladder cancer indication in 2024. Reverse Stock Split of Our Common Stock On March 31, 2025, at a Special Meeting of the Stockholders (the “Special Meeting”), the stockholders of the Company approved a reverse stock split of all outstanding shares of the Common Stock, and the Board approved 3 Table of Contents a reverse stock split of the Common Stock at a final ratio of one-for-forty (1:40) (the “Reverse Stock Split”…
- HYPDHYPERION DEFI, INC.424B3Prospecto suplementario o de reventaEDGAR
En el documentoContrasplit de accionestexto original ▸
…notified by Nasdaq that we had regained compliance with the Minimum Bid Price Rule. Nasdaq Listing Rule 5810(c)(3)(A)(iv) states that any listed company that fails to meet the Minimum Bid Price Rule and has effected a reverse stock split over the prior one-year period, or has effected one or more reverse stock splits over the prior two-year period with a cumulative ratio of 250 shares or more to one, will not be eligible for an automatic…
- LABTLakewood-Amedex Biotherapeutics Inc.S-1Capacidad de emisión registradaEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…to continue as a “going concern.” Our audited financial statements for the year ended December31, 2024 include an explanatory paragraph from our independent registered public accounting firm expressing substantial doubt about our ability to continue as a going concern. As of June30, 2025, we had cash of approximately $1.3million and a working capital deficit of approximately $0.8million. Further, we have incurred and expect to continue to incur significant costs in…
En el documentoContrasplit de accionestexto original ▸
…notes payable of $250,000 to current stockholders. Reverse Stock Split On August18, 2025, the Company’s Board of Directors approved, and in September 2025 a majority of the Company’s common stockholders approved by written consent, a reverse stock split of the Company’s common stock at a ratio of one-for-5.92 (1:5.92) shares (the “Reverse Split”). The Reverse Split became effective on September29, 2025. The Reverse Split was implemented to meet the Nasdaq…
- ADAGAdagene Inc.424B3Prospecto suplementario o de reventaEDGAR
- IMMXImmix Biopharma, Inc.S-3Capacidad de emisión registradaEDGAR
Participaciones y control
- GLUEMonte Rosa Therapeutics, Inc.SC 13D/ACambio en participación significativaEDGAR
- HUMAHumacyte, Inc.SC 13D/ACambio en participación significativaEDGAR
- XCUREXICURE, INC.SC 13D/ACambio en participación significativaEDGAR
Informes y hechos relevantes
- APVOAptevo Therapeutics Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
En el documentoDesignación de medicamento huérfanotexto original ▸
…is currently being evaluated in RAINIER, a two-part Phase 1b/2 trial for the treatment of frontline acute myeloid leukemia in combination with standard-of-care venetoclax + azacitidine. Mipletamig has received orphan drug designation ("orphan status") for AML according to the Orphan Drug Act. ALG.APV-527, a bispecific conditional 4-1BB agonist, designed to only be active upon simultaneous binding to 4-1BB and 5T4, is being co-developed…
- NTLAIntellia Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
La FDA impuso una suspensión clínica a las solicitudes de nuevo fármaco en investigación para los ensayos de fase 3 MAGNITUDE y MAGNITUDE-2 de nex-z.
Original en inglés · traducción automática
the United States Food and Drug Administration (the “FDA”) subsequently placed a clinical hold on the Investigational New Drug applications for the MAGNITUDE and MAGNITUDE-2 Phase 3 clinical trials of nex-z.
Traducción automática (claude-sonnet-5). Lo comprobado es la cita: está literal en el documento y sus cifras cuadran con las de la frase. Todavía no la ha leído una persona.
- TPSTTempest Therapeutics, Inc.8-KAviso de incumplimiento de cotizaciónEDGAR
- ACONAclarion, Inc.8-KNuevo acuerdo materialEDGAR
- ALMSALUMIS INC.8-KResultadosEDGAR
- ANABANAPTYSBIO, INC8-KResultadosEDGAR
- APREAprea Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
- AQSTAquestive Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
En el documentoFecha de decisión de la FDA (PDUFA)texto original ▸
…gather further information about the deficiencies presently identified by the FDA in the New Drug Application (NDA) for Anaphylm, with the goal of addressing those deficiencies prior to the scheduled PDUFA action date of January 31, 2026, once disclosed to the Company. The FDA has indicated that the review remains ongoing and further clarified that a Discipline Review Letter will not be issued, while information requests are possible…
- ARWRARROWHEAD PHARMACEUTICALS, INC.8-KNuevo acuerdo materialEDGAR
- ATOSATOSSA THERAPEUTICS, INC.8-KResultadosEDGAR
- CGONCG Oncology, Inc.8-KOtros hechos relevantesEDGAR
- EOLSEvolus, Inc.8-KResultadosEDGAR
- GLUEMonte Rosa Therapeutics, Inc.8-KNuevo acuerdo materialEDGAR
- GNPXGenprex, Inc.8-KOtros hechos relevantesEDGAR
- GRIGRI Bio, Inc.8-KOtros hechos relevantesEDGAR
- IMCRImmunocore Holdings plc8-KResultadosEDGAR
- IOVAIOVANCE BIOTHERAPEUTICS, INC.8-KOtros hechos relevantesEDGAR
- LONALeonaBio, Inc.8-KCambio en el consejo o la direcciónEDGAR
- MPLTMapLight Therapeutics, Inc.8-KResultadosEDGAR
- NAMSNewAmsterdam Pharma Co N.V.8-KResultadosEDGAR
- PDSBPDS Biotechnology Corp8-KOtros hechos relevantesEDGAR
- RYTMRHYTHM PHARMACEUTICALS, INC.8-KResultadosEDGAR
En el documentoFecha de decisión de la FDA (PDUFA)texto original ▸
…Upcoming Milestones Setmelanotide Acquired Hypothalamic Obesity (HO) Launch IMCIVREE in the United States for the treatment of acquired hypothalamic obesity pending FDA approval; the FDA’s assigned PDUFA goal date is March 20, 2026; Announce topline data in the 12-patient Japanese cohort of the setmelanotide Phase 3 trial in acquired HO in the first quarter of 2026. Congenital HO Complete enrollment in the setmelanotide Phase…
- TENXTENAX THERAPEUTICS, INC.8-KCambio en el consejo o la direcciónEDGAR
- XBIOXenetic Biosciences, Inc.8-KOtros hechos relevantesEDGAR
- ZNTLZentalis Pharmaceuticals, Inc.8-KOtros hechos relevantesEDGAR
Juntas de accionistas
- DCOYDecoy Therapeutics Inc.DEF 14AConvocatoria de junta de accionistasEDGAR
En el documentoContrasplit de accionestexto original ▸
…stock outstanding and entitled to vote. Each outstanding share of our common stock is entitled to one vote on each matter considered at the Special Meeting, As previously disclosed, on August 15, 2025, we effected a reverse stock split of our issued and outstanding Common Stock at a ratio of 1-for-15 with the filing of a Certificate of Amendment to our amended and restated certificate of incorporation with the Secretary of State of…
- KPTIKaryopharm Therapeutics Inc.DEF 14AConvocatoria de junta de accionistasEDGAR
- VBIOValion Bio, Inc.DEF 14AConvocatoria de junta de accionistasEDGAR
← jueves 8 de enero de 2026 · lunes 12 de enero de 2026 →
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