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Martes 13 oct 2026SEC · NASDAQ biomédico

Portada›Lunes 20 de octubre de 2025

Biomédicas del NASDAQ ante la SEC, lunes 20 de octubre de 2025

Los 31 documentos que 27 empresas del sector presentaron ante la SEC ese día, agrupados por tipo y con el enlace al original en EDGAR.

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El día, bloque a bloque

¿Lo quieres en tu correo cada mañana, y solo de tus empresas? Crear una cuenta.

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

  1. ACXPAcurx Pharmaceuticals, Inc.S-1Capacidad de emisión registradaEDGAR
    En el documentoContrasplit de accionestexto original ▸…share. We are an “emerging growth company” under applicable Securities and Exchange Commission rules and, as such, we are subject to reduced public company reporting requirements. On August 4, 2025, we effected a 1-for-20 reverse stock split pursuant to which every 20 shares of our issued and outstanding common stock were reclassified as one share of common stock (the “Reverse Stock Split”). The Reverse Stock Split had no impact on the par…
  2. CLRBCellectar Biosciences, Inc.S-1Capacidad de emisión registradaEDGAR
    En el documentoAviso de incumplimiento de las reglas de cotizacióntexto original ▸…will send a deficiency notice to the company, advising that it has been afforded a “compliance period” of 180 calendar days to regain compliance with the applicable requirements. On January 30, 2025, we received a deficiency letter from Nasdaq notifying us that, for the last 30 consecutive business days, the closing bid price for our common stock was below the minimum $1.00 per share required for continued listing on Nasdaq pursuant…
    En el documentoContrasplit de accionestexto original ▸…immediately following Bruton Tyrosine Kinase inhibitor (BTKi) treatment failures regardless of line of therapy. 4 Selected Financial Data Reverse Stock Split As previously disclosed, on June 24, 2025 we effected a reverse stock split of our outstanding shares of common stock at a ratio of one-for-thirty (the Reverse Stock Split). Our periodic and current reports that are incorporated by reference, and all other documents that were…
  3. IRONDisc Medicine, Inc.424B5Nueva emisión de acciones con precioEDGAR
    En el documentoContrasplit de accionestexto original ▸…investment. Please also carefully read the section titled “Cautionary Note Regarding Forward-Looking Statements.” 7 Table of Contents SELECTED FINANCIAL DATA Reverse Stock Split On December 29, 2022, we effected a 1-for-10 reverse stock split of our common stock. The total number of authorized shares of capital stock was amended from 260,000,000 to 110,000,000. The par value per common share remained unchanged. The audited consolidated financial…
  4. NEUPNeuphoria Therapeutics Inc.424B5Nueva emisión de acciones con precioEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…unchanged. This Amendment is not complete without, and may only be delivered or utilized in connection with, the Prospectus Supplement, and any future amendments or supplements hereto or thereto. We have entered into an At The Market Offering Agreement, or the Sales Agreement, with H.C. Wainwright & Co., LLC, or Wainwright, dated November 18, 2024. Under this Sales Agreement, as updated by this Amendment, we may offer and sell common stock…
  5. PRAXPraxis Precision Medicines, Inc.424B5Nueva emisión de acciones con precioEDGAR
  6. TVRDTvardi Therapeutics, Inc.S-1/ACapacidad de emisión registrada (enmienda)EDGAR

    La situación financiera de la Compañía genera dudas sustanciales sobre su capacidad para continuar como negocio en marcha.

    Original en inglés · traducción automáticaThe Company’s financial condition raises substantial doubt as to its ability to continue as a going concern. ​ • The Company will require substantial additional capital to fund its operations.

    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.

    Cara efectuó un desdoblamiento inverso de acciones de 1 por 3 de sus acciones ordinarias y aumentó sus acciones ordinarias autorizadas a 150.000.000, y cambió su nombre a Tvardi Therapeutics, Inc.

    Original en inglés · traducción automática2025, Cara changed its name from “Cara Therapeutics, Inc.” to “Tvardi Therapeutics, Inc.” ​(“Tvardi,” the “Company,” “we,” “our,” or “us”). Pursuant to the Merger Agreement, on the Closing Date, (i) Cara effected a 1-for-3 reverse stock split of its common stock (the “Reverse Stock Split”), (ii) Cara increased its authorized shares of common stock to 150,000,000

    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.

Participaciones y control

  1. SIONSionna Therapeutics, Inc.SC 13D/ACambio en participación significativaEDGAR
  2. VORVor Biopharma Inc.SC 13D/ACambio en participación significativaEDGAR

Informes y hechos relevantes

  1. NEUPNeuphoria Therapeutics Inc.8-KOtros hechos relevantesEDGAR
    En el documentoEl ensayo NO alcanzó su objetivo principaltexto original ▸…PRESS RELEASE, DATED OCTOBER 20, 2025 Exhibit 99.1 Neuphoria Therapeutics Provides Update on AFFIRM-1 Phase 3 Trial Evaluating BNC210 for the Acute Treatment of Social Anxiety Disorder AFFIRM-1 trial did not meet primary endpoint or secondary endpoints Company to conduct strategic review of portfolio and business operations Burlington, Mass., October 20, 2025 (GLOBE NEWSWIRE) -- Neuphoria Therapeutics Inc. (Nasdaq: NEUP) (“Neuphoria…
  2. PLRXPLIANT THERAPEUTICS, INC.8-KFin de acuerdo materialEDGAR
  3. SMMTSummit Therapeutics Inc.8-KResultadosEDGAR
    En el documentoEl ensayo alcanzó su objetivo principaltexto original ▸…combined with platinum- based chemotherapy vs. tislelizumab, a PD-1 inhibitor, with the same chemotherapy in patients with locally advanced or metastatic squamous NSCLC, regardless of PD-L1 expression. met its primary endpoint of PFS. Yesterday, additional HARMONi-6 data were presented as part of the Presidential Symposium at the European Society for Medical Oncology 2025 Congress (ESMO 2025) and featured in a manuscript published…
    En el documentoDesignación de vía rápida (Fast Track)texto original ▸…by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was initially approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting. About Summit Therapeutics Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on the discovery,…
  4. ARVNARVINAS, INC.8-KOtros hechos relevantesEDGAR
    En el documentoDesignación de vía rápida (Fast Track)texto original ▸…vepdegestrant for its use as a monotherapy in the treatment of adults with ER+/HER2- ESR1-mutated advanced or metastatic breast cancer previously treated with endocrine-based therapy. Vepdegestrant has also been granted Fast Track designation by the FDA, underscoring the significant unmet need in this patient population and the potential for vepdegestrant to offer a meaningful new treatment option. About Arvinas Arvinas (Nasdaq: ARVN) is a…
  5. BIAFbioAffinity Technologies, Inc.8-KOtros hechos relevantesEDGAR
  6. CNTXContext Therapeutics Inc.8-KOtros hechos relevantesEDGAR
  7. CRBPCorbus Pharmaceuticals Holdings, Inc.8-KOtros hechos relevantesEDGAR
  8. CRMDCorMedix Inc.8-KResultadosEDGAR
  9. CYPHCYPHERPUNK TECHNOLOGIES INC.8-KOtros hechos relevantesEDGAR
  10. IDYAIDEAYA Biosciences, Inc.8-KOtros hechos relevantesEDGAR
  11. IRONDisc Medicine, Inc.8-KResultadosEDGAR
  12. KALAKALA BIO, Inc.8-KCambio en el consejo o la direcciónEDGAR
    En el documentoCambio en la dirección de la empresatexto original ▸…Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. ​ On October 19, 2025, in connection with the Reduction, the Board terminated without cause the employment of Todd Bazemore, the Company’s President and Chief Executive Officer, effective immediately. Mr. Bazemore will continue to serve as a director of the Company and act as the Company’s principal executive officer. ​ Item 8.01. Other Events ​ As described above, on October…
  13. OLMAOlema Pharmaceuticals, Inc.8-KOtros hechos relevantesEDGAR
  14. PRAXPraxis Precision Medicines, Inc.8-KOtros hechos relevantesEDGAR
  15. REPLReplimune Group, Inc.8-KOtros hechos relevantesEDGAR
    En el documentoFecha de decisión de la FDA (PDUFA)texto original ▸EX-99.1 2 tm2529069d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Replimune Announces FDA Acceptance of BLA Resubmission of RP1 for the Treatment of Advanced Melanoma Prescription Drug User Fee Act (PDUFA) target action date set for April 10, 2026 WOBURN, Mass., October 20, 2025 - Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that the U…
  16. SMMTSummit Therapeutics Inc.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…do not currently have sufficient working capital to fund our planned operations for the next twelve months. There is uncertainty regarding our ability to raise additional capital and as such, there is substantial doubt regarding our ability to continue as a going concern. Our unaudited financial statements have been prepared under the assumption that we would continue as a going concern. However, we have concluded that there is substantial doubt about our ability to continue…
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…resale of the Shares. The Company filed the registration statement on September 19, 2024, which was automatically effective upon filing. At-the-Market Offering (ATM Offering) On May 13, 2024, the Company entered into an at-the-market (“ATM”) sales agreement (the “Original Distribution Agreement”) pursuant to which the Company may, subject to the terms and conditions set forth in the agreement offer and sell, from time to time, through or to the agents, acting…
  17. TELOTelomir Pharmaceuticals, Inc.8-KNuevo acuerdo materialEDGAR
  18. VRDNViridian Therapeutics, Inc.\DE8-KNuevo acuerdo materialEDGAR
  19. VSTMVerastem, Inc.8-KOtros hechos relevantesEDGAR

Juntas de accionistas

  1. BMRABIOMERICA INCDEF 14AConvocatoria de junta de accionistasEDGAR
  2. DWTXDogwood Therapeutics, Inc.DEF 14AConvocatoria de junta de accionistasEDGAR
  3. QCLSQ/C TECHNOLOGIES, INC.DEF 14AConvocatoria de junta de accionistasEDGAR
    En el documentoContrasplit de accionestexto original ▸…Incorporation, as amended (the “Charter”), to effect, at the discretion of the board of directors (the “Board”) of the Company but prior to the one-year anniversary of the date on which the reverse stock split is approved by the Company’s stockholders at the Special Meeting, a reverse stock split of all of the outstanding shares of Common Stock, at a ratio in the range of 1-for-2 to 1-for-250, with such ratio to be determined by the Board in its discretion and included in a public announcement…
  4. XLOXilio Therapeutics, Inc.DEF 14AConvocatoria de junta de accionistasEDGAR

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