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Martes 13 oct 2026SEC · NASDAQ biomédico

Portada›Miércoles 29 de octubre de 2025

Biomédicas del NASDAQ ante la SEC, miércoles 29 de octubre de 2025

Los 47 documentos que 35 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. DFTXDefinium Therapeutics, Inc.424B5Nueva emisión de acciones con precioEDGAR
  2. GNPXGenprex, Inc.424B5Nueva emisión de acciones con precioEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…operations and expenses, which could have a material adverse effect on our financial position, results of operations, cash flows, and ability to achieve our intended business objectives. These matters raise substantial doubt about our ability to continue as a going concern, and if we are unable to raise required capital, we may be unable to continue the operation of our business as currently planned or to seek strategic alternative transactions. We are currently listed…
    En el documentoContrasplit de accionestexto original ▸…aggregate market value of $14,038,985 pursuant to General Instruction I.B.6. of Form S-3 during the prior 12 calendar month period that ends on, and includes, the date of this prospectus supplement. We effected a 1-for-50 reverse stock split effective as of 12:01 a.m. Eastern Time on October 21, 2025, pursuant to which every fifty shares of our issued and outstanding common stock were reclassified as one share of common stock (the “2025 Reverse…
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…to us in the ordinary course of business, for which it may receive customary fees and commissions. As previously disclosed in our Current Report on Form 8-K filed with the SEC on December 13, 2023, we entered into an At The Market Offering Agreement (the “Sales Agreement”) with the Placement Agent on December 13, 2023. Pursuant to the Sales Agreement, the Placement Agent serves as agent (the “Agent”) with respect to an at-the-market (“ATM…
  3. SNYSanofi424B5Nueva emisión de acciones con precioEDGAR
  4. SPRBSPRUCE BIOSCIENCES, INC.S-3Capacidad de emisión registradaEDGAR
    En el documentoContrasplit de accionestexto original ▸…Please also read carefully the section below titled “Special Note Regarding Forward-Looking Statements.” 5 SELECTED FINANCIAL DATA REFLECTING REVERSE STOCK SPLIT Reverse Stock Split On July 23, 2025, we completed a one-for-seventy-five (1:75) reverse stock split of our outstanding common stock, effective as of August 4, 2025, or the Reverse Stock Split. Based on such Reverse Stock Split, the total number of outstanding shares of common stock was adjusted from…
  5. SPRBSPRUCE BIOSCIENCES, INC.S-3Capacidad de emisión registradaEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…are incorporated by reference in this prospectus. These risks include the following: • We do not currently have sufficient working capital to fund our planned operations for the next twelve months and substantial doubt exists as to our ability to continue as a going concern. • We will need substantial additional financing to develop our product candidates and implement our operating plan. If we fail to obtain additional financing, we may be forced to delay, reduce or eliminate…
    En el documentoContrasplit de accionestexto original ▸…Please also read carefully the section below titled “Special Note Regarding Forward-Looking Statements.” 6 SELECTED FINANCIAL DATA REFLECTING REVERSE STOCK SPLIT Reverse Stock Split On July 23, 2025, we completed a one-for-seventy-five (1:75) reverse stock split of our outstanding common stock, effective as of August 4, 2025, or the Reverse Stock Split. Based on such Reverse Stock Split, the total number of outstanding shares of common stock was adjusted from…
  6. SVRASavara Inc424B5Nueva emisión de acciones con precioEDGAR
  7. TTRXTurn Therapeutics Inc.424B5Nueva emisión de acciones con precioEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…development. We expect to incur additional losses for the foreseeable future, and it is possible we may never achieve or maintain profitability. Our consolidated financial statements therefore express substantial doubt about our ability to continue as a going concern. ​ • We have a limited operating history and there are inherent uncertainties and risks in pharmaceutical and medical device product development and commercialization. ​ • If we fail to obtain or generate…
    En el documentoDebilidad material en el control internotexto original ▸…that competes against large, well-established companies with long-standing relationships, extensive clinical data, and recognized brands, as well as against new companies with innovative products. ​ • We identified a material weakness in our internal control over the accuracy of our financial reporting. Any failure to maintain an effective control over financial reporting may result in material misstatements of our consolidated financial…
  8. VERUVERU INC.424B5Nueva emisión de acciones con precioEDGAR
    En el documentoContrasplit de accionestexto original ▸…claims for fraud. The amended complaint also alleges that we are responsible to indemnify the Purchaser for a pre-closing tax liability of approximately $137,000. Reverse Stock Split On August 8, 2025, we effected a 1-for-10 reverse stock split (the “Reverse Stock Split”) of our issued and outstanding common stock. As a result of the Reverse Stock Split, each 10 shares of issued and outstanding common stock were automatically converted into…
  9. SILOSilo Pharma, Inc.S-1Capacidad de emisión registradaEDGAR
  10. SMMTSummit Therapeutics Inc.S-3ASRCapacidad de emisión registradaEDGAR

Participaciones y control

  1. CMPSCOMPASS Pathways plcSC 13D/ACambio en participación significativaEDGAR
  2. EVOEvotec SESC 13D/ACambio en participación significativaEDGAR
  3. GDTCCytoMed Therapeutics LtdSC 13D/ACambio en participación significativaEDGAR
  4. NMRANeumora Therapeutics, Inc.SC 13D/ACambio en participación significativaEDGAR
  5. PMNProMIS Neurosciences Inc.SC 13DCambio en participación significativaEDGAR
  6. XFORX4 Pharmaceuticals, IncSC 13D/ACambio en participación significativaEDGAR

Informes y hechos relevantes

  1. CABACabaletta Bio, Inc.8-KOtros hechos relevantesEDGAR
    En el documentoEl ensayo alcanzó su objetivo principaltexto original ▸…exclusion criteria as the Phase 1/2 trial FDA alignment on registrational design anticipated for systemic sclerosis and SLE/LN in 4Q25, MG in 1H26 Myositis: All DM/ASyS patients with ≥16 weeks f/u who met inclusion criteria achieved the registrational primary endpoint SSc: All patients with ≥3 mo. f/u achieved an rCRISS-25 response off all immunomodulators and steroids Lupus: In patients with ≥3 mo. f/u, 3/4 SLE achieved DORIS (4th with CRR) and 3/4 LN achieved renal…
  2. DBVTDBV Technologies S.A.8-KResultadosEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…sufficient to fund its operations into the third quarter of 2026. As such, cash and cash equivalents are not sufficient to fund operations for the next 12 months, and these conditions and events raise substantial doubt about the Company’s ability to continue as a going concern. Management is actively pursuing financing options including additional sales under the ATM Program, potential warrant exercises, and strategic transactions. Our Condensed Consolidated Financial Statements…
  3. GNPXGenprex, Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
    En el documentoDesignación de medicamento huérfanotexto original ▸…treatment for NSCLC and SCLC. Each of Genprex’s lung cancer clinical programs has received a Fast Track Designation from the FDA for the treatment of that patient population, and Genprex’s SCLC program has received an FDA Orphan Drug Designation. Genprex’s diabetes gene therapy approach is comprised of a novel infusion process that uses an AAV vector to deliver Pdx1 and MafA genes directly to the pancreas. In models of Type 1 diabetes, GPX-002…
    En el documentoDesignación de vía rápida (Fast Track)texto original ▸…lead product candidate, Reqorsa® Gene Therapy (quaratusugene ozeplasmid), is being evaluated in two clinical trials as a treatment for NSCLC and SCLC. Each of Genprex’s lung cancer clinical programs has received a Fast Track Designation from the FDA for the treatment of that patient population, and Genprex’s SCLC program has received an FDA Orphan Drug Designation. Genprex’s diabetes gene therapy approach is comprised of a novel infusion…
  4. IMAImageneBio, Inc.8-KFin de acuerdo materialEDGAR
  5. MPLTMapLight Therapeutics, Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
  6. NTLAIntellia Therapeutics, Inc.8-KOtros hechos relevantesEDGAR

    El 29 de octubre de 2025 la FDA informó verbalmente a la Compañía que había colocado una suspensión clínica sobre las solicitudes de nuevo fármaco en investigación para los ensayos de Fase 3 MAGNITUDE y MAGNITUDE-2 de nexiguran ziclumeran.

    Original en inglés · traducción automáticaOn October 29, 2025, the United States Food and Drug Administration (the “FDA”) verbally informed the Company that the FDA has placed a clinical hold on the Investigational New Drug applications for the MAGNITUDE and MAGNITUDE-2 Phase 3 clinical trials for nexiguran ziclumeran (“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.

  7. AMRNAMARIN CORP PLC\UK8-KResultadosEDGAR
    En el documentoRecorte de plantilla o reestructuracióntexto original ▸…development expenses decreased $0.3 million, or 7%, compared with Q3 2024. Restructuring: In Q3 2025, the Company recognized $9.4 million in restructuring charges related to the implementation of the Global Restructuring Plan associated with the execution of the Recordati Licensing Agreement announced on June 24, 2025, which resulted in the elimination of commercial roles in the Company’s European operations. Total Operating…
  8. AMRNAMARIN CORP PLC\UK10-QInforme trimestralEDGAR
    En el documentoAviso de incumplimiento de las reglas de cotizacióntexto original ▸…traded below $1.00 for 30 consecutive business days. In January 2024, we regained compliance with the Nasdaq listing requirements as our ADSs had traded above $1.00 for 10 consecutive business days. We received an additional deficiency letter in May 2024, as our ADSs had traded below $1.00 for 30 consecutive business days. On November 22, 2024, we received notice Nasdaq granted the Company an additional 180 calendar days, or until May 19,…
  9. AVTXAvalo Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
  10. BBIOBridgeBio Pharma, Inc.8-KOtros hechos relevantesEDGAR
    En el documentoDesignación de vía rápida (Fast Track)texto original ▸…investigational, orally administered small molecule under investigation to treat ADH1, that is designed to selectively negatively modulate the calcium sensing receptor, targeting ADH1 at its source. Encaleret has received Fast Track Designation by the U.S. FDA and Orphan Drug Designation in the U.S., European Union, and Japan. About BridgeBio Pharma, Inc. BridgeBio Pharma, Inc. (BridgeBio) is a new type of biopharmaceutical company founded to…
  11. BBIOBridgeBio Pharma, Inc.8-KResultadosEDGAR
    En el documentoDesignación de medicamento huérfanotexto original ▸…hypochondroplasia, consistent with its activity in achondroplasia, highlighting robust preclinical efficacy across FGFR3-driven skeletal dysplasias (Demuynck et al., JBMR, 2025). •In achondroplasia, infigratinib has received Breakthrough Designation from the FDA, Orphan Drug Designation, Fast Track Designation, and Rare Pediatric Disease Designation. To date, in hypochondroplasia, infigratinib has received Fast Track Designation and Orphan Drug Designation from the FDA and EMA. •If successful…
    En el documentoDesignación de terapia innovadora (breakthrough)texto original ▸…achondroplasia expects topline results in early 2026. Infigratinib has previously demonstrated best-in-class improvements in annualized height velocity and upper-to-lower body proportionality and was granted Breakthrough Therapy Designation by the FDA -BridgeBio continues to grow potential impact of its medicines, with plans to share data from the Phase 3 portion of the ACCEL 2/3 study in hypochondroplasia in 2026, initiate clinical trials…
    En el documentoDesignación de vía rápida (Fast Track)texto original ▸…hypochondroplasia, consistent with its activity in achondroplasia, highlighting robust preclinical efficacy across FGFR3-driven skeletal dysplasias (Demuynck et al., JBMR, 2025). •In achondroplasia, infigratinib has received Breakthrough Designation from the FDA, Orphan Drug Designation, Fast Track Designation, and Rare Pediatric Disease Designation. To date, in hypochondroplasia, infigratinib has received Fast Track Designation and Orphan Drug Designation from the FDA and EMA. •If successful, infigratinib…
  12. BBIOBridgeBio Pharma, Inc.10-QInforme trimestralEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…statement on Form S-3 (the “2023 Shelf”) with the SEC in relation to the registration of common stock, preferred stock, debt securities, warrants and units or any combination thereof. We also concurrently entered into an Equity Distribution Agreement (the “ATM Agreement”) with Goldman Sachs & Co. LLC and SVB Securities LLC (collectively, the “ATM Sales Agents”), with respect to an “at-the-market” offering program under which we may issue and sell, from time to time at…
  13. BCDABioCardia, Inc.10-Q/AInforme trimestral (enmienda)EDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…management believes our cash and cash equivalents of $980,000 as of June 30, 2025 are not sufficient to fund our planned expenditures and meet our obligations beyond October 2025. These factors raise substantial doubt about our ability to continue as a going concern beyond one year from the date these financial statements are issued. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. 10 Our ability to continue…
    En el documentoContrasplit de accionestexto original ▸…Equivalents Exercise Price Balance as of December 31, 2024 2,467,104 $ 3.10 Warrants for common stock sold 681,514 1.92 Balance as of June 30, 2025 3,148,618 $ 2.84 Reverse Stock Split - On May 30, 2024, we effected a 1-for-15 reverse stock split of our common stock and reduced the authorized common shares from 100,000,000 to 50,000,000. The par value was not adjusted as a result of the reverse stock split. All issued and outstanding common stock…
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…our application of our CardiAMP Cell Therapy System. The gross proceeds of the Offering were $570,000, with associated issuance costs of $9,000. At-the-Market (ATM) Offerings – On December 6, 2023, we entered into an “At The Market” offering agreement (the Sales Agreement) with H.C. Wainwright & Co., LLC (HCW). Under the Sales Agreement, we may offer and sell our common stock, from time to time having an aggregate offering amount of up to…
  14. CMPSCOMPASS Pathways plc8-KCambio en el consejo o la direcciónEDGAR
  15. CRVOCervoMed Inc.8-KCambio en el consejo o la direcciónEDGAR
  16. DFTXDefinium Therapeutics, Inc.8-KResultadosEDGAR
  17. FULCFulcrum Therapeutics, Inc.8-KResultadosEDGAR
    En el documentoRecorte de plantilla o reestructuracióntexto original ▸…and/or earlier-stage clinical trials; obtaining, maintaining or protecting intellectual property rights related to its product candidates; managing expenses; realizing the anticipated benefits of the workforce reduction and strategic realignment and managing risks associated therewith; and raising the substantial additional capital needed to achieve its business objectives, among others. For a discussion of other risks…
    En el documentoDesignación de medicamento huérfanotexto original ▸…of the 12 mg dose cohort, pociredir was demonstrated to be generally well-tolerated in people with SCD with up to three months of exposure, with no treatment-related SAEs reported. Pociredir has been granted FDA Fast Track designation and Orphan Drug Designation for the treatment of SCD. To learn more about clinical trials of pociredir please visit ClinicalTrials.gov. About Sickle Cell Disease SCD is a genetic disorder of the red blood cells caused by a mutation…
    En el documentoDesignación de vía rápida (Fast Track)texto original ▸…of the 12 mg dose cohort, pociredir was demonstrated to be generally well-tolerated in people with SCD with up to three months of exposure, with no treatment-related SAEs reported. Pociredir has been granted FDA Fast Track designation and Orphan Drug Designation for the treatment of SCD. To learn more about clinical trials of pociredir please visit ClinicalTrials.gov. About Sickle Cell Disease SCD is a genetic disorder of the red blood…
  18. FULCFulcrum Therapeutics, Inc.10-QInforme trimestralEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…equity capital, which could in turn have an adverse effect on our business, including current operations, future growth, revenues, net income and the market prices of our common stock. In February 2024, we established a new ATM offering program to sell shares of our common stock having an aggregate offering price of up to $100.0 million from time to time. Given the overall volatility in the capital markets, we may not be willing or able…
  19. HRTXHERON THERAPEUTICS, INC. /DE/8-KCambio en el consejo o la direcciónEDGAR
  20. IONSIONIS PHARMACEUTICALS INC10-QInforme trimestralEDGAR

    La FDA determinó que los riesgos de seguridad identificados en el programa de desarrollo clínico de WAYLIVRA superaban los beneficios esperados de la reducción de triglicéridos en pacientes con FCS.

    Original en inglés · traducción automáticathe FDA determined that the safety concerns identified with WAYLIVRA in our clinical development program outweighed the expected benefits of triglyceride lowering in patients with FCS.

    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.

  21. IONSIONIS PHARMACEUTICALS INC8-KResultadosEDGAR

    TRYNGOLZA generó 32 millones de dólares en ventas netas de producto durante el tercer trimestre de 2025.

    Original en inglés · traducción automáticaTRYNGOLZA®generated $32 million in net product sales in the third quarter 2025

    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.

    ION582 recibió la designación de Terapia Innovadora de la FDA para el tratamiento del síndrome de Angelman.

    Original en inglés · traducción automáticaION582 granted Breakthrough Therapy designation from FDA for the treatment of Angelman syndrome

    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.

  22. OPKOPKO HEALTH, INC.8-KResultadosEDGAR
  23. OPKOPKO HEALTH, INC.10-QInforme trimestralEDGAR
  24. PDSBPDS Biotechnology Corp8-KOtros hechos relevantesEDGAR
  25. RXRXRECURSION PHARMACEUTICALS, INC.8-KOtros hechos relevantesEDGAR
  26. SVRASavara Inc8-KNuevo acuerdo materialEDGAR
  27. UTHRUNITED THERAPEUTICS Corp10-QInforme trimestralEDGAR
  28. UTHRUNITED THERAPEUTICS Corp8-KResultadosEDGAR
  29. VNDAVanda Pharmaceuticals Inc.8-KResultadosEDGAR
    En el documentoFecha de decisión de la FDA (PDUFA)texto original ▸…Financial Results •Fanapt® Q3 2025 net product sales increased by 31% to $31.2 million compared to Q3 2024 •BysantiTM (milsaperidone) NDA for bipolar I disorder and schizophrenia under review by the FDA; PDUFA target action date of February 21, 2026 •Tradipitant NDA for motion sickness under review by the FDA; PDUFA target action date of December 30, 2025 •Imsidolimab BLA in generalized pustular psoriasis expected to be submitted in Q4 2025 •Vanda…
  30. VTGNVistagen Therapeutics, Inc.8-KCambio en el consejo o la direcciónEDGAR
  31. WVEWave Life Sciences, Inc.8-KOtros hechos relevantesEDGAR

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