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Lunes 12 oct 2026SEC · NASDAQ biomédico

Portada›Martes 16 de diciembre de 2025

Biomédicas del NASDAQ ante la SEC, martes 16 de diciembre de 2025

Los 28 documentos que 24 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

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. CVKDCadrenal Therapeutics, Inc.424B5Nueva emisión de acciones con precioEDGAR
  2. CVKDCadrenal Therapeutics, Inc.424B5Nueva emisión de acciones con precioEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…Existing Warrants”) in exchange for our issuance of new unregistered warrants, such number of new warrants equal to 200% of the number of shares issued upon exercise of the Existing Warrants. We have entered into an At the Market Offering Agreement, dated March 11, 2024 (the “sales agreement”), with the Placement Agent relating to the sale of shares of Common Stock, from time to time through or to the Placement Agent, acting as sales agent…
  3. DMRADamora Therapeutics, Inc.S-3Capacidad de emisión registradaEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…audited by EY Godkendt Revisionspartnerselskab, independent registered public accounting firm, as set forth in their report thereon (which contains an explanatory paragraph describing conditions that raise substantial doubt about the Company’s ability to continue as a going concern as described in Note 1 to the consolidated financial statements), included therein, and incorporated herein by reference. Such consolidated financial statements are incorporated herein by reference in…
  4. HUMAHumacyte, Inc.424B5Nueva emisión de acciones con precioEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…Stock Purchase Agreement will not be sufficient to fund our operations, as currently planned, for more than one year beyond the filing date of this registration statement, we have determined that there is substantial doubt regarding our ability to continue as a going concern. If we do not raise sufficient funds through one or more offerings under this prospectus or through other means, then in connection with the future filing of our Annual Report on Form 10-K for the year…
  5. LEXXLexaria Bioscience Corp.424B5Nueva emisión de acciones con precioEDGAR
  6. SCLXScilex Holding CoS-1Capacidad de emisión registradaEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…additional funding, which may not be available to us on acceptable terms, or at all. 14 Table of Contents • Our recurring losses from operations, negative cash flows and substantial cumulative net losses raise substantial doubt about our ability to continue as a going concern. Risks Related to our Commercial Operations and Product Development • We obtain, or historically have obtained, our commercial supply of certain of our products, the clinical supply of our product candidates…
    En el documentoContrasplit de accionestexto original ▸…Warrants”. Our Common Stock is listed on the Nasdaq Capital Market under the symbol “SCLX”. On December 12, 2025, the last reported sales price per share of our Common Stock was $16.63. On April 15, 2025, we effected a reverse stock split of our Common Stock at a ratio of 1-for-35 (the “Reverse Stock Split”). Unless otherwise noted, the share and per share information in this prospectus reflects the effect of the Reverse Stock Split. We…
    En el documentoDebilidad material en el control internotexto original ▸…timely and accurately report ourfinancial results and such material weaknesses may result in a material misstatement of our financial statements.” above for additional information regarding a previously identified material weakness. These reporting and other obligations place significant demands on our management and administrative and operational resources, including accounting resources. In addition, changing laws, regulations…
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…Riley Purchase Agreement. On, and effective as of, February 16, 2024, we and B. Riley mutually agreed to terminate the B. Riley Purchase Agreement. At-the-Market Sales Agreement On December 22, 2023, we entered into a Sales Agreement (the “ATM Sales Agreement”) with B. Riley Securities, Inc., Cantor Fitzgerald & Co. and H.C. Wainwright & Co., LLC (the “Sales Agents”), which agreement was voluntarily terminated by us effective as of March 5, 2025. Pursuant…
  7. CELZCREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC.424B3Prospecto suplementario o de reventaEDGAR
  8. FBIOFortress Biotech, Inc.S-1Capacidad de emisión registradaEDGAR

Participaciones y control

  1. SKYESkye Bioscience, Inc.SC 13D/ACambio en participación significativaEDGAR
  2. TVGNTevogen Inc.SC 13D/ACambio en participación significativaEDGAR

Informes y hechos relevantes

  1. ALDXAldeyra Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
    En el documentoEl ensayo NO alcanzó su objetivo principaltexto original ▸…CSR) for the dry eye disease field trial of reproxalap, for which top-line results were announced on May 5, 2025. The field trial, which was supportive of the activity of reproxalap relative to vehicle, did not meet the primary endpoint of improvement in dry eye symptoms relative to the vehicle control. Prior to submitting the NDA in June, the field trial was discussed with the FDA. At the December 12 meeting, the FDA made no other requests…
    En el documentoFecha de decisión de la FDA (PDUFA)texto original ▸…and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) target action date for the reproxalap New Drug Application (NDA) for the treatment of dry eye disease. The extended PDUFA target action date is March 16, 2026. Following submission on June 16, 2025, the NDA was accepted for review as a “complete class 2 response” by the FDA on July 16, 2025, with a target PDUFA action date of December 16, 2025. On December…
  2. CVKDCadrenal Therapeutics, Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
  3. DBVTDBV Technologies S.A.8-KOtros hechos relevantesEDGAR
    En el documentoEl ensayo alcanzó su objetivo principaltexto original ▸…Exhibit 99.1 Châtillon, France, December 16, 2025 DBV Technologies Announces Positive Topline Results from Phase 3 VITESSE Trial of VIASKIN® Peanut Patch in Peanut Allergic Children Aged 4-7 Years • VITESSE met its primary endpoint: the lower bound of the 95% confidence interval (CI) of the difference between treatment arms was 24.5%, exceeding the prespecified threshold of 15% • 46.6% of children treated with the VIASKIN® Peanut…
    En el documentoDesignación de terapia innovadora (breakthrough)texto original ▸…been possible. Thanks to the food allergy community, we are one step closer to delivering on our mission to transform the lives of children and families living with peanut allergy.” The FDA previously granted Breakthrough Therapy Designation for VIASKIN Peanut patch, and the Company expects the BLA may be eligible for priority review. Investor Conference Call and Webcast DBV management will host an investor conference call and webcast today…
  4. LEXXLexaria Bioscience Corp.8-KVenta de acciones no registrada (colocación privada)EDGAR
  5. MBRXMoleculin Biotech, Inc.8-KOtros hechos relevantesEDGAR
    En el documentoAviso de incumplimiento de las reglas de cotizacióntexto original ▸…exchange on which registered Common Stock, par value $.001 per share MBRX The NASDAQ Stock Market LLC Item 8.01 Other Events. As previously reported, on June 27, 2025, Moleculin Biotech, Inc. (the “Company”) received a deficiency letter from the Listing Qualifications Department (the “Staff”) of the Nasdaq Stock Market (“Nasdaq”) notifying the Company that for the last 30 consecutive business days the bid price for the Company’s common…
  6. NKTRNEKTAR THERAPEUTICS8-KOtros hechos relevantesEDGAR
    En el documentoEl ensayo alcanzó su objetivo principaltexto original ▸EX-99.1 2 d24251dex991.htm EX-99.1 Exhibit 99.1 REZOLVE-AA Phase 2b Study of Rezpegaldesleukin Establishes Proof-of-Concept in Patients with Severe-to-Very-Severe Alopecia Areata Achieved target product profile on the primary endpoint, with a mean percent reduction in SALT score at 36 weeks of 28.2% in the 24 µg/kg arm versus 11.2% in placebo Mean percent reduction in SALT scores at 36 weeks was 30% for both treatment arms versus 6…
    En el documentoDesignación de vía rápida (Fast Track)texto original ▸…immune cells known as regulatory T cells. By activating these cells, rezpegaldesleukin may act to bring the immune system back into balance. In February 2025, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for rezpegaldesleukin for the treatment of adult and pediatric patients 12 years of age and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription…
  7. NXTSNexentis Technologies Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
  8. PMNProMIS Neurosciences Inc.8-KOtros hechos relevantesEDGAR
    En el documentoAviso de incumplimiento de las reglas de cotizacióntexto original ▸…listing on the Nasdaq Capital Market (“Nasdaq”) pursuant to NASDAQ Listing Rule 5550(a)(2) (“Bid Price Rule”) and that the matter is now closed. ​ As previously disclosed, on January 8, 2025, the Company received a deficiency letter from Nasdaq notifying the Company that, for the 30 consecutive business days prior to the date of the deficiency letter, the closing bid price for the Company’s common stock was trading below the minimum…
  9. CYPHCYPHERPUNK TECHNOLOGIES INC.8-KCambio en el consejo o la direcciónEDGAR
  10. GLUEMonte Rosa Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
  11. HUMAHumacyte, Inc.8-KNuevo acuerdo materialEDGAR
  12. INBXInhibrx Biosciences, Inc.8-KOtros hechos relevantesEDGAR
  13. KALAKALA BIO, Inc.8-KOtros hechos relevantesEDGAR
    En el documentoCambio en la dirección de la empresatexto original ▸…of $1.8 million. The closing for the Series AA Preferred Shares occurred on November 24, 2025 (the “Series AA Preferred Share Closing”). In accordance with the Securities Purchase Agreement the Board appointed David Lazar as the Chief Executive Officer (and principal executive officer) of the Company, effective as of immediately following the Series AA Preferred Share Closing and as the principal financial officer of the Company, effective as of the…
  14. LPCNLipocine Inc.8-KOtros hechos relevantesEDGAR
  15. PLRXPLIANT THERAPEUTICS, INC.8-KCambio en el consejo o la direcciónEDGAR
  16. TNXPTonix Pharmaceuticals Holding Corp.8-KOtros hechos relevantesEDGAR
  17. TRAWTraws Pharma, Inc.8-KCambio en el consejo o la direcciónEDGAR
  18. VIRVir Biotechnology, Inc.8-KNuevo acuerdo materialEDGAR

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