Portada›Lunes 29 de septiembre de 2025

Biomédicas del NASDAQ ante la SEC, lunes 29 de septiembre de 2025

Los 40 documentos que 34 empresas del sector presentaron ante la SEC ese día, agrupados por tipo y con el enlace al original en EDGAR.

← viernes 26 de septiembre de 2025 · martes 30 de septiembre de 2025 →

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

Emisiones y dilución

1. COCPCocrystal Pharma, Inc.424B3Prospecto suplementario o de reventaEDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …to continue as a going concern. In addition, our independent registered public accounting firm, in its audit report to the financial statements as of and for the year ended December 31, 2024, expressed substantial doubt about our ability to continue as a going concern. Our continued existence is dependent upon our obtaining the necessary capital to meet our expenditures, and we can provide no assurance that we will be able to raise adequate capital to meet our future…

   En el documentoAviso de incumplimiento de las reglas de cotizacióntexto original ▸

   …minimum bid requirement, we effected a 1-for-12 reverse stock split by amending our Certificate of Incorporation on October 11, 2022. Further, previously in December 2019 and again in November 2020, we received notice of failure to comply with the Nasdaq minimum bid price although were able to regain compliance without effecting a reverse stock split in those instances. In addition, a new Nasdaq rule recently took effect which precludes listed issuers that have already…

   En el documentoContrasplit de accionestexto original ▸

   …price requirement because the closing bid price of our common stock was below $1.00 per share for 30 consecutive trading days. In order to regain compliance with the Nasdaq minimum bid requirement, we effected a 1-for-12 reverse stock split by amending our Certificate of Incorporation on October 11, 2022. Further, previously in December 2019 and again in November 2020, we received notice of failure to comply with the Nasdaq minimum bid price…
2. HYPDHYPERION DEFI, INC.S-3/ACapacidad de emisión registrada (enmienda)EDGAR
   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…
3. LEXXLexaria Bioscience Corp.424B5Nueva emisión de acciones con precioEDGAR
4. MDCXMedicus Pharma Ltd.S-1Capacidad de emisión registradaEDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …brought to market, or, if it does, that it will be positively received or obtain favorable pricing, which would have a material adverse effect on our business plans and results of operations. 11 There is substantial doubt about the Company's ability to continue as a going concern and if the Company is unable to obtain additional financing from outside sources and/or eventually generate enough revenues, it may be forced to curtail or discontinue its operations. The Company's auditor…

   En el documentoDebilidad material en el control internotexto original ▸

   …precision in the review of materials used to record transactions in accordance with US GAAP, and lack of formalized or documented policies related to the overall IT system environment. Our management has concluded that, due to such material weakness, our disclosure controls and procedures were not effective as of December 31, 2024, and that such controls and procedures remained ineffective as of June 30, 2025. To address our material weaknesses,…
5. MDCXMedicus Pharma Ltd.S-1Capacidad de emisión registradaEDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …brought to market, or, if it does, that it will be positively received or obtain favorable pricing, which would have a material adverse effect on our business plans and results of operations. 11 There is substantial doubt about the Company's ability to continue as a going concern and if the Company is unable to obtain additional financing from outside sources and/or eventually generate enough revenues, it may be forced to curtail or discontinue its operations. The Company's auditor…

   En el documentoDebilidad material en el control internotexto original ▸

   …precision in the review of materials used to record transactions in accordance with US GAAP, and lack of formalized or documented policies related to the overall IT system environment. Our management has concluded that, due to such material weakness, our disclosure controls and procedures were not effective as of December 31, 2024, and that such controls and procedures remained ineffective as of June 30, 2025. To address our material weaknesses,…
6. PALIPALISADE BIO, INC.S-1Capacidad de emisión registradaEDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …material used in our clinical trial. 24 Risks Related to Our Financial Operations We have expressed substantial doubt about our ability to continue as a going concern. Management has determined that there is substantial doubt about our ability to continue as a going concern for a period of one year following the issuance of our most recent financial statements. This determination was based on conditions and events, considered in the aggregate, that raise substantial doubt…

   En el documentoContrasplit de accionestexto original ▸

   …bid price of at least $1.00. In October 2023, we were notified that we were no longer in compliance with the Minimum Bid Price Requirement and had 180 days to cure such deficiency. On April 5, 2024, we effected a 1-for-15 reverse stock split and we were notified by the Nasdaq Stock Market that as of April 19, 2024, we were back in compliance with the Minimum Bid Price Requirement. On April 30, 2025, we received the Notice from Nasdaq advising…

   En el documentoDebilidad material en el control internotexto original ▸

   …profitability. Failure to remediate a material weakness in internal controls over financial reporting could result in material misstatements in our consolidated financial statements. Our management has identified a material weakness in our internal control over financial reporting. The material weakness was due to a lack of controls in the financial closing and reporting process, including a lack of segregation of duties and the…
7. QUREuniQure N.V.424B5Nueva emisión de acciones con precioEDGAR
8. SCLXScilex Holding Co424B3Prospecto suplementario o de reventaEDGAR
   En el documentoContrasplit de accionestexto original ▸

   …Our Public Warrants are listed on the Nasdaq Capital Market under the symbol “SCLXW.” On September 25, 2025, the closing sale price per warrant of our Public Warrants was $0.28. 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 the Prospectuses and this prospectus supplement reflects the effect…
9. SCLXScilex Holding Co424B3Prospecto suplementario o de reventaEDGAR
   En el documentoContrasplit de accionestexto original ▸

   …Our Public Warrants are listed on the Nasdaq Capital Market under the symbol “SCLXW.” On September 25, 2025, the closing sale price per warrant of our Public Warrants was $0.28. 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 the Prospectuses and this prospectus supplement reflects the effect…
10. SCLXScilex Holding Co424B3Prospecto suplementario o de reventaEDGAR
    En el documentoContrasplit de accionestexto original ▸

    …Our Public Warrants are listed on the Nasdaq Capital Market under the symbol “SCLXW.” On September 25, 2025, the closing sale price per warrant of our Public Warrants was $0.28. 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 the Prospectuses and this prospectus supplement reflects the effect…
11. ENVBEnveric Biosciences, Inc.S-3Capacidad de emisión registradaEDGAR
12. TLPHTALPHERA, INC.424B7Prospecto de reventa de tenedoresEDGAR

Informes y hechos relevantes

1. CURXCuranex Pharmaceuticals Inc8-KVenta de acciones no registrada (colocación privada)EDGAR
2. DWTXDogwood Therapeutics, Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
   En el documentoDesignación de vía rápida (Fast Track)texto original ▸

   …including the neuropathic pain associated with chemotherapy treatment. Halneuron® is the focus of an ongoing Phase 2b CINP trial with interim data readout projected for December of 2025. Halneuron® has been granted fast track designation from the Food and Drug Administration (“FDA”) for the treatment of CINP. About Dogwood Therapeutics Dogwood Therapeutics (Nasdaq: DWTX) is a development-stage biopharmaceutical company focused on developing…
3. ELABPMGC Holdings Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
4. KALAKALA BIO, Inc.8-KOtros hechos relevantesEDGAR
   En el documentoEl ensayo NO alcanzó su objetivo principaltexto original ▸

   …tm2527340d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 KALA BIO Announces Topline Results from CHASE Phase 2b Clinical Trial Evaluating KPI-012 for the Treatment of Persistent Corneal Epithelial Defect (PCED) Did Not Meet Primary Endpoint -- Study did not meet primary endpoint of complete healing of PCED at Week 8; secondary endpoints also did not achieve statistical significance -- -- KPI-012 was well-tolerated with no treatment-related…
5. LEXXLexaria Bioscience Corp.8-KVenta de acciones no registrada (colocación privada)EDGAR
6. MLTXMoonLake Immunotherapeutics8-KOtros hechos relevantesEDGAR
   En el documentoEl ensayo alcanzó su objetivo principaltexto original ▸

   …the FDA and as well as positive feedback from its interactions with the EMA announced in February 2024. In June 2023, topline results of the MIRA trial (NCT05322473) at 12 weeks showed that the trial met its primary endpoint, the Hidradenitis Suppurativa Clinical Response (HiSCR) 75, which is a higher measure of clinical response versus the HiSCR50 measure used in other clinical trials, setting a landmark milestone. In October…
7. AKTXAkari Therapeutics Plc8-KOtros hechos relevantesEDGAR
8. ANABANAPTYSBIO, INC8-KOtros hechos relevantesEDGAR
9. CLYMClimb Bio, Inc.8-KOtros hechos relevantesEDGAR
10. CUECue Biopharma, Inc.8-KCambio en el consejo o la direcciónEDGAR
    En el documentoCambio en la dirección de la empresatexto original ▸

    …Officers; Compensatory Arrangements of Certain Officers. Chief Executive Officer Appointment and Resignation On September 26, 2025, the Board of Directors (the “Board”) of Cue Biopharma, Inc. (the “Company”) appointed Usman Azam as President and Chief Executive Officer and as a member of the Board, in each case effective as of September 29, 2025 (the “Effective Date”). Dr. Azam will succeed Daniel R. Passeri whose retirement and resignation as Chief Executive Officer…
11. ENTAENANTA PHARMACEUTICALS INC8-KOtros hechos relevantesEDGAR
    En el documentoDesignación de vía rápida (Fast Track)texto original ▸

    …acute RSV infection who are at high risk of complications including the elderly and/or those with congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD) or asthma. Zelicapavir, which received Fast Track designation from the U.S. Food and Drug Administration (FDA), is a novel N-protein inhibitor in development as a once-daily oral treatment for RSV. This proof-of-concept study was designed to understand the antiviral…
12. ESLAEstrella Immunopharma, Inc.8-KOtros hechos relevantesEDGAR
13. HROWHARROW, INC.8-KNuevo acuerdo materialEDGAR
14. HYPDHYPERION DEFI, INC.8-KCambio en el consejo o la direcciónEDGAR
    En el documentoCambio en la dirección de la empresatexto original ▸

    …Hyperliquid. He shares my conviction that all asset classes will ultimately migrate on-chain, and his leadership will help ensure Hyperion Defi is at the forefront of that transformation." Mr. Knox, newly named Chief Financial Officer stated, "I'm pleased to join Hyperion DeFi at this pivotal moment for the Company. My experience building scalable financial platforms and structuring innovative capital solutions will help Hyperion DeFi…
15. INKTMiNK Therapeutics, Inc.8-KCambio en el consejo o la direcciónEDGAR
16. IXHLIncannex Healthcare Inc.10-KInforme anualEDGAR
    En el documentoDebilidad material en el control internotexto original ▸

    …financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis. Management has concluded that we did not maintain effective disclosure controls and procedures due to the material weakness in internal control over financial reporting which existed as of June 30, 2025, relating to the documentation of accounting policies and procedures, particularly relating to the correct application of…
17. LNAILunai Bioworks Inc.10-KInforme anualEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

    …across all subsidiaries. ● We have incurred substantial losses since our inception and anticipate that we will continue to incur substantial and increasing losses for the foreseeable future. ● There is substantial doubt about our ability to continue as a going concern, which may hinder our ability to obtain future financing. ● We will require substantial additional financing to achieve our goals, and a failure to obtain this necessary capital when needed could force…
18. LRMRLarimar Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
19. NEUPNeuphoria Therapeutics Inc.10-KInforme anualEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸

    …92 June 30, 2024 included $16.4 million of gross proceeds from the sale and issuance of shares and warrant, partially offset by equity issuance costs of $0.4 million. On November 18, 2024, the Company entered into an At The Market Offering Agreement (the “Sales Agreement”) with H.C. Wainwright & Co., LLC (the “Sales Agent”). Pursuant to the Sales Agreement, the Sales Agent will act as the Company’s agent with respect to an offering and…
20. OTLKOutlook Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
21. PPCBPropanc Biopharma, Inc.10-KInforme anualEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

    …years ended June 30, 2025 and 2024. In addition, we have convertible debt that is past maturity that we are currently negotiating with lenders in order to amend the maturity dates. The foregoing raises substantial doubt about our ability to continue as a going concern for a period of 12 months from the issue date of this report. Our ability to continue as a going concern is dependent on our ability to execute our strategy and on our ability to raise additional funds…
22. QUREuniQure N.V.8-KNuevo acuerdo materialEDGAR
23. RCKTROCKET PHARMACEUTICALS, INC.8-KCambio en el consejo o la direcciónEDGAR
24. RMTIROCKWELL MEDICAL, INC.8-KCambio en el consejo o la direcciónEDGAR
25. SEPNSepterna, Inc.8-KCambio en el consejo o la direcciónEDGAR
26. SNGXSOLIGENIX, INC.8-KNuevo acuerdo materialEDGAR
27. SPRYARS Pharmaceuticals, Inc.8-KNuevo acuerdo materialEDGAR
28. TNXPTonix Pharmaceuticals Holding Corp.8-KOtros hechos relevantesEDGAR

← viernes 26 de septiembre de 2025 · martes 30 de septiembre de 2025 →

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