Portada›Miércoles 1 de octubre de 2025

Biomédicas del NASDAQ ante la SEC, miércoles 1 de octubre de 2025

Los 28 documentos que 21 empresas del sector presentaron ante la SEC ese día, agrupados por tipo y con el enlace al original en EDGAR.

← martes 30 de septiembre de 2025 · jueves 2 de octubre de 2025 →

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Emisiones y dilución

1. ACOGAlpha Cognition Inc.424B5Nueva emisión de acciones con precioEDGAR
   En el documentoContrasplit de accionestexto original ▸

   …the process of abandonment. S-3 NASDAQ Listing and Reverse Stock Split On November 12, 2024, our common shares began trading on the Nasdaq Capital Market under the symbol “ACOG”. On November 5, 2024, we completed a reverse stock split of our common shares with a stock split ratio of 1-for-25 (“Reverse Stock Split”). The Reverse Stock Split is intended to allow us to meet the minimum share price requirement of the Nasdaq Capital Market…
2. AKANAKANDA CORP.424B3Prospecto suplementario o de reventaEDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the consolidated financial statements, the Company’s significant operating losses and cash outflows raise substantial doubt about its ability to continue as a going concern. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. Basis for Opinion These consolidated financial statements are the responsibility…

   En el documentoContrasplit de accionestexto original ▸

   …Nasdaq Listing Rule 5550(a)(2). It resulted from the fact that the closing bid price of the Company’s Akanda Shares was below $1.00 per share for a period of 30 consecutive business days. As a result, we implemented a 1-for-40 reverse stock split on the Akanda Shares effective May 23, 2024 in order to regain compliance. On May 14, 2024, the Company received written notification from the Listing Qualifications Department of Nasdaq, indicating that…
3. AKANAKANDA CORP.424B3Prospecto suplementario o de reventaEDGAR
   En el documentoContrasplit de accionestexto original ▸

   …37,638 (December 31, 2024 – $133,083). 15. Share Capital (a) Authorized The Company has authorized share capital of an unlimited number of common shares with no par value. On May 21, 2024, the Company implemented a 1-for-40 Reverse Stock Split on its common shares. No fractional shares were issued in connection with the Reverse Stock Split. Any fractional shares resulting from the Reverse Stock Split were rounded down to the nearest whole number…
4. APVOAptevo Therapeutics Inc.S-1Capacidad de emisión registradaEDGAR

   El 21 de mayo de 2025 el consejo aprobó una modificación del certificado de constitución para hacer un contrasplit de las acciones ordinarias en proporción de 1 por 20.

   Original en inglés · traducción automática

   On May 21, 2025, the Board approved an amendment to the Certificate of Incorporation to effect a reverse stock split of our common stock at the reverse split ratio of 1-for-20 (the “Reverse Stock Split”).

   Traducción automática (claude-sonnet-5-5). 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.

5. ARTLARTELO BIOSCIENCES, INC.424B5Nueva emisión de acciones con precioEDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …of one of our product candidates. We expect to continue to fund our operations primarily through utilization of our current financial resources and additional raises of capital. These conditions raise substantial doubt about our ability to continue as a going concern. We have evaluated the significance of the uncertainty regarding our financial condition in relation to our ability to meet our obligations, which has raised substantial doubt about our ability to continue…

   En el documentoPrograma de venta continua de acciones (ATM)texto original ▸

   …effect on our reputation, business, financial condition, results of operations, growth and ability to accomplish our strategic objectives. S-3 Table of contents Recent Developments On July 18, 2025, we entered into an At-The-Market Offering Agreement (the “Sales Agreement”) with R. F. Lafferty & Co., Inc. (“Lafferty”) under which we may offer and sell up to $6.5 million of shares of our common stock from time to time through an “at the market…
6. DWTXDogwood Therapeutics, Inc.S-3Capacidad de emisión registradaEDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …herein by reference in reliance upon such report given on the authority of such firm as experts in accounting and auditing. The report of Forvis Mazars, LLP contains an explanatory paragraph regarding substantial doubt about the Company's ability to continue as a going concern. LIMITATION ON LIABILITY AND DISCLOSURE OF COMMISSION POSITION ON INDEMNIFICATION OF SECURITIES ACT LIABILITIES Our certificate of incorporation and bylaws provide that we will indemnify our directors…
7. ENTAENANTA PHARMACEUTICALS INC424B5Nueva emisión de acciones con precioEDGAR
8. PTNPALATIN TECHNOLOGIES INCS-1Capacidad de emisión registradaEDGAR
   En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸

   …statements include, but are not limited to, statements about: ● our significant operating losses since our inception and our need to obtain additional financing has caused management to determine there is substantial doubt regarding our ability to continue as a going concern; ● our ability to obtain additional financing on terms acceptable to us, or at all, including unavailability of funds or delays in receiving funds as a result of economic disruptions; ● our expectation…

   En el documentoContrasplit de accionestexto original ▸

   …Restated Certificate of Incorporation with the Secretary of State of Delaware to effect a 1-for-50 reverse stock split of the outstanding shares of our common stock. The Company’s stockholders previously approved the Reverse Stock Split at our annual meeting of stockholders held on July 25, 2025. The Reverse Stock Split became effective after market on August 11, 2025 with the Company’s Common Stock trading on the OTCQB on a split-adjusted…
9. SILOSilo Pharma, Inc.424B5Nueva emisión de acciones con precioEDGAR
10. PTNPALATIN TECHNOLOGIES INCS-1/ACapacidad de emisión registrada (enmienda)EDGAR

Participaciones y control

1. FBIOFortress Biotech, Inc.SC 13D/ACambio en participación significativaEDGAR
2. KALAKALA BIO, Inc.SC 13D/ACambio en participación significativaEDGAR
3. OPKOPKO HEALTH, INC.SC 13D/ACambio en participación significativaEDGAR
4. SPRYARS Pharmaceuticals, Inc.SC 13D/ACambio en participación significativaEDGAR

Informes y hechos relevantes

1. JAGXJaguar Health, Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
2. KALAKALA BIO, Inc.8-KAceleración de deudaEDGAR
3. MGXMetagenomi Therapeutics, Inc.8-KFin de acuerdo materialEDGAR
   En el documentoAcuerdo de licencia o colaboracióntexto original ▸

   …on the one year anniversary of the Effective Date and each twelve month anniversary thereafter until such time as the first patient is dosed in a Phase 1 study for a licensed product under the Acuitas License Agreement; (ii) milestone payments in the low to mid seven figures upon certain regulatory and commercialization milestones; and (iii) royalties in the low mid-single digit percentage of net sales. The Acuitas License Agreement…
4. SCLXScilex Holding Co8-KVenta de acciones no registrada (colocación privada)EDGAR
5. SILOSilo Pharma, Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
6. ARTLARTELO BIOSCIENCES, INC.8-KNuevo acuerdo materialEDGAR
7. AVTXAvalo Therapeutics, Inc.8-KCambio en el consejo o la direcciónEDGAR
8. BCRXBIOCRYST PHARMACEUTICALS INC8-KNuevo acuerdo materialEDGAR
9. CCCCC4 Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
10. CLYMClimb Bio, Inc.8-KCambio en el consejo o la direcciónEDGAR
    En el documentoCambio en la dirección de la empresatexto original ▸

    …proceeding arising out of her service to and activities on behalf of the Company. There is no arrangement or understanding between Dr. Altschuller and any other person pursuant to which Dr. Altschuller was appointed as Chief Financial Officer of the Company. There are no related party transactions between the Company and Dr. Altschuller reportable under Item 404(a) of Regulation S-K and no family relationships between Dr. Altschuller and any…
11. ENTAENANTA PHARMACEUTICALS INC8-KOtros hechos relevantesEDGAR
12. FBIOFortress Biotech, Inc.8-KOtros hechos relevantesEDGAR
    En el documentoDesignación de medicamento huérfanotexto original ▸

    …copies of the copper transporter that is defective in patients with Menkes disease, and to be used in combination with CUTX-101; AAV-ATP7A gene therapy is currently in pre-clinical development and has received FDA Orphan Drug Designation. Cyprium was founded by, and is a majority-owned subsidiary of, Fortress Biotech, Inc. (Nasdaq: FBIO). For more information, visit www.cypriumtx.com. ​ About Fortress Biotech Fortress Biotech, Inc. (…

    En el documentoRevisión prioritaria de la FDAtexto original ▸

    …PRV”), and Cyprium will also be eligible to receive royalties on net sales of CUTX-101 and up to $129 million in aggregate development and sales milestones from Sentynl. ​ The CUTX-101 NDA was initially granted Priority Review by the FDA and is supported by positive topline clinical efficacy results for CUTX-101, demonstrating significant improvement in overall survival for Menkes disease subjects who received early treatment…
13. LGVNLongeveron Inc.8-KCambio en el consejo o la direcciónEDGAR
    En el documentoDesignación de medicamento huérfanotexto original ▸

    …pursuing four pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer’s disease, Pediatric Dilated Cardiomyopathy (DCM) and Aging-related Frailty. Laromestrocel development programs have received five distinct and important FDA designations: for the HLHS program - Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation; and, for the AD program - Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation. For more information, visit…
14. VNDAVanda Pharmaceuticals Inc.8-KOtros hechos relevantesEDGAR
    En el documentoFecha de decisión de la FDA (PDUFA)texto original ▸

    …for the treatment of motion sickness by November 26, 2025. The FDA will continue its review of Vanda’s New Drug Application (NDA) for this indication, with the existing Prescription Drug User Fee Act (PDUFA) target action date of December 30, 2025. •The FDA will conduct an expedited re-review of Vanda’s supplemental New Drug Application (sNDA) for HETLIOZ® for the treatment of jet lag disorder by January 7, 2026, including consideration of alternative…

← martes 30 de septiembre de 2025 · jueves 2 de octubre de 2025 →

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