Portada›Viernes 19 de diciembre de 2025

Biomédicas del NASDAQ ante la SEC, viernes 19 de diciembre de 2025

Los 42 documentos que 36 empresas del sector presentaron ante la SEC ese día, agrupados por tipo y con el enlace al original en EDGAR.

← jueves 18 de diciembre de 2025 · lunes 22 de diciembre de 2025 →

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

ADILADIAL PHARMACEUTICALS, INC.424B5Nueva emisión de acciones con precioEDGAR
AKTSAktis Oncology, Inc.S-1Capacidad de emisión registradaEDGAR
BDRXBiodexa Pharmaceuticals Plc424B4Nueva emisión de acciones con precioEDGAR
En el documentoContrasplit de accionestexto original ▸
…United States dollar (or units thereof); and · “£,” “pence” and “p” each refer to the British pound sterling (or units thereof). On March 27, 2023, following shareholder approval at a general meeting, we effected a one-for-20 reverse stock split of our Ordinary Shares, and our consolidated Ordinary Shares began trading on AIM, a market operated by the London Stock Exchange plc, or AIM, on a split-adjusted basis as of such date. No fractional…
CELUCelularity IncS-1Capacidad de emisión registradaEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…our inception, have no cellular therapeutic candidates approved for commercial sale and we anticipate that we will incur substantial net losses in the future. ● Our historical operating results indicate substantial doubt exists related to our ability to continue as a going concern. ● We will need substantial additional financing to develop our therapeutics and implement our operating plans. If we fail to obtain additional financing, we may be unable to complete the development…
CUECue Biopharma, Inc.424B5Nueva emisión de acciones con precioEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…believe our Immuno-STAT platform holds the promise of producing drug product candidates with the potential of establishing new standards of care in the treatment of autoimmune disease. Events that Raise Substantial Doubt About Our Ability to Continue as a Going Concern We will need to raise substantial additional capital to fund our operations and remain as a going concern. As of September 30, 2025, we had $18.7 million in cash, cash equivalents and marketable securities…
IKTInhibikase Therapeutics, Inc.424B5Nueva emisión de acciones con precioEDGAR
INMBInmune Bio, Inc.424B5Nueva emisión de acciones con precioEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…significant development and other expenses related to our ongoing operations. As a result, we are not and have never been profitable and have incurred losses in each period since our inception, resulting in substantial doubt in our ability to continue as a going concern. We reported a net loss of $30.0 million and $27.3 million for the years ended December 31, 2023 and 2022, respectively. As of December 31, 2023 and 2022, we had cash and cash equivalents of $35.8 million…
En el documentoPrograma de venta continua de acciones (ATM)texto original ▸
…neutralizing soluble tumour-necrosis factor alpha (sTNF) is a cornerstone to the treatment of neuroinflammation and immune dysfunction in these diseases. Recent Developments On August 9, 2024, the Company entered into an Amended and Restated At-The-Market Sales Agreement (the “prior sales agreement”) with RBC Capital Markets, LLC and BTIG, LLC (together, the “then-appointed agents”), pursuant to which the Company could offer and sell shares of its common stock, having…
ISPCiSpecimen Inc.S-1/ACapacidad de emisión registrada (enmienda)EDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…profitability in subsequent periods. Our prior losses and expected future losses have had and will continue to have adverse effects on our stockholders’ equity (deficit) and working capital. There is substantial doubt about our ability to continue as a going concern. Our audited financial statements included in this Annual Report include an explanatory paragraph that indicates that they were prepared assuming that we would continue as a going concern. We have suffered…
En el documentoDebilidad material en el control internotexto original ▸
…recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should we be unable to continue as a going concern. During the year ended December 31, 2024, we identified a material weakness in our internal control over financial reporting that may cause us to fail to meet our reporting obligations or result in material misstatements of our financial statements. If we fail to remediate this…
JBIOJade Biosciences, Inc.424B3Prospecto suplementario o de reventaEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…results of its operations and its cash flows for the period from June 18, 2024 (inception) to December 31, 2024 in conformity with accounting principles generally accepted in the United States of America. Substantial Doubt about the Company’s Ability to Continue as a Going Concern The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the consolidated financial statements, the Company…
En el documentoContrasplit de accionestexto original ▸
…Closing Financing were converted into shares of Common Stock in accordance with the Exchange Ratio (as defined herein). 1 Table of Contents Immediately prior to the consummation of the Merger, Aerovate effected a 1-for-35 reverse stock split of Aerovate common stock (as defined herein), which became legally effective on April 28, 2025 (the “Reverse Stock Split”). Following the Reverse Stock Split, and as a result of and upon the First Effective…
JUNSJUPITER NEUROSCIENCES, INC.424B3Prospecto suplementario o de reventaEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…price of our common stock could be subject to rapid and substantial volatility; and ● Our management’s assessment of historical losses, negative cash flows, and reliance on private equity financing raises substantial doubt about our ability to continue as a going concern, as noted in our auditor’s reports for the fiscal years ended December 31, 2023 and 2024. ● The other risk and uncertainties discussed in “Risk Factors,” elsewhere in this Registration Statement on Form…
En el documentoContrasplit de accionestexto original ▸
…incentive plans. On November 11, 2021, the Company increased the number of authorized shares of common stock, $0.0001 par value per share, to 45,000,000 from 25,000,000. On January 25, 2022, the Company effected a one-for-two (1:2) reverse stock split whereby the Company (i) decreased the number of issued and outstanding shares of common stock, $0.0001 per share, from 13,076,608 to 6,538,304 and (ii) decreased by a ratio of one-for two (1:2) the number…
NMADNOMAD POWER SOLUTIONS, INC.424B5Nueva emisión de acciones con precioEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…losses since our inception and anticipate that we will continue to incur substantial and increasing losses for the foreseeable future; ● Our independent registered public accounting firm has expressed substantial doubt about our ability to continue as a going concern; ● We need significant additional financing to fund our operations and complete the development and, if approved, the commercialization of our lead product candidate, LB-100. If we are unable to raise…
NXTCNextCure, Inc.424B5Nueva emisión de acciones con precioEDGAR
En el documentoContrasplit de accionestexto original ▸
…which have previously been filed as exhibits to the Company’s filings with the SEC. S-1 TABLE OF CONTENTS Reverse Stock Split On July 14, 2025, at 12:01 am Eastern time (the “Effective Time”), the Company effected a one-for- twelve (1:12) reverse stock split (the “Reverse Stock Split”) of the Company’s common stock. The Reverse Stock Split affected all shares of Company’s common stock outstanding immediately prior to the Effective Time. No fractional shares…
En el documentoPrograma de venta continua de acciones (ATM)texto original ▸
…Registration No. 333-273723 As filed with the Securities and Exchange Commission on December 19, 2025 PROSPECTUS SUPPLEMENT (to Prospectus dated August 4, 2023) Up to $14,500,000 Common Stock We have entered into an at the market offering agreement (the “ATM agreement”) with H.C. Wainwright & Co., LLC (“H.C. Wainwright”) relating to shares of our common stock, par value $0.001 per share (the “common stock”), offered by this prospectus…
APREAprea Therapeutics, Inc.S-3Capacidad de emisión registradaEDGAR
IVVDInvivyd, Inc.S-3/ACapacidad de emisión registrada (enmienda)EDGAR

Participaciones y control

DBVTDBV Technologies S.A.SC 13D/ACambio en participación significativaEDGAR
GMABGENMAB A/SSC 13DCambio en participación significativaEDGAR
KODKodiak Sciences Inc.SC 13D/ACambio en participación significativaEDGAR

Informes y hechos relevantes

INABIN8BIO, INC.8-KVenta de acciones no registrada (colocación privada)EDGAR
MIRMMirum Pharmaceuticals, Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
ONCBeOne Medicines Ltd.8-KFin de acuerdo materialEDGAR
ALTAltimmune, Inc.8-KOtros hechos relevantesEDGAR
En el documentoPrograma de venta continua de acciones (ATM)texto original ▸
…2025 Agreement, we provided notice to Leerink Partners LLC, Piper Sandler & Co. and Stifel, Nicolaus & Company, Incorporated (the “February Sales Agents”), to terminate the Equity Distribution Agreement entered into with the February Sales Agents on February 27, 2025 (the “February 2025 ATM Program”). Following September 30, 2025 and through the date hereof, the Company has sold 13,547,341 shares of common stock for net proceeds of approximately $54.6 million pursuant to the February 2025 ATM Program…
BIAFbioAffinity Technologies, Inc.8-KOtros hechos relevantesEDGAR
BMRNBIOMARIN PHARMACEUTICAL INC8-KNuevo acuerdo materialEDGAR
CUECue Biopharma, Inc.8-KNuevo acuerdo materialEDGAR
CYTKCYTOKINETICS INC8-KOtros hechos relevantesEDGAR
GALTGALECTIN THERAPEUTICS INC8-KNuevo acuerdo materialEDGAR
IKTInhibikase Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
INMBInmune Bio, Inc.8-KNuevo acuerdo materialEDGAR
IRDOpus Genetics, Inc.8-KOtros hechos relevantesEDGAR
MIRMMirum Pharmaceuticals, Inc.8-KOtros hechos relevantesEDGAR
MTVAMetaVia Inc.8-KOtros hechos relevantesEDGAR
NXTCNextCure, Inc.8-KOtros hechos relevantesEDGAR
En el documentoPrograma de venta continua de acciones (ATM)texto original ▸
…complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨ Item 8.01 Other Events. On December 19, 2025, NextCure, Inc. (the “Company”) entered into an at the market offering agreement (the “ATM Agreement”) with H.C. Wainwright & Co., LLC (the “Agent”), pursuant to which the Company may sell, from time to time, up to an aggregate sales price of $14,500,000 of its common stock…
OTLKOutlook Therapeutics, Inc.8-KResultadosEDGAR
En el documentoFecha de decisión de la FDA (PDUFA)texto original ▸
…commitment remains focused on providing patients and physicians with access to an approved ophthalmic formulation of bevacizumab.” Upcoming Near Term Milestone · U.S. Food and Drug Administration (FDA) PDUFA goal date for ONS-5010 is December 31, 2025. About ONS-5010 / LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma) ONS-5010/LYTENAVA™ is an ophthalmic formulation of bevacizumab produced in the United States for the treatment of wet AMD. LYTENAVA™…
OTLKOutlook Therapeutics, Inc.10-KInforme anualEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…products to become profitable. If we are unable to successfully complete development and obtain regulatory approval for ONS-5010/LYTENAVA outside the EU and UK, our business will be harmed. There is substantial doubt about our ability to continue as a going concern. We will need to raise substantial additional funding to complete the development of ONS-5010/LYTENAVA outside the EU and UK and support our operations until we are able to generate sufficient revenue…
En el documentoPrograma de venta continua de acciones (ATM)texto original ▸
…Note was converted into 1,607,093 shares of our common stock. On March 13, 2025, we used the proceeds from the March 2025 Note (as defined below) to pay off the December 2022 Note. On May 16, 2023, we entered into an At-the-Market Sales Agreement with BTIG, LLC, or BTIG, as sales agent, as amended, the ATM Agreement or the ATM Offering, under which we may issue and sell shares of our common stock having an aggregate offering price of up to $100…
PCVXVaxcyte, Inc.8-KCambio en el consejo o la direcciónEDGAR
QTTBQ32 Bio Inc.8-KCambio en el consejo o la direcciónEDGAR
RYTMRHYTHM PHARMACEUTICALS, INC.8-KCambio en el consejo o la direcciónEDGAR
SNDXSyndax Pharmaceuticals Inc8-KCambio de estatutosEDGAR
SPROSpero Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
SRPTSarepta Therapeutics, Inc.8-KNuevo acuerdo materialEDGAR
VSTMVerastem, Inc.8-KCambio en el consejo o la direcciónEDGAR
VTVTvTv Therapeutics Inc.8-KCambio de estatutosEDGAR

← jueves 18 de diciembre de 2025 · lunes 22 de diciembre de 2025 →

Esto mismo, cada mañana y solo de tus empresas. Sigue a las que te interesen y recibe en tu correo lo que presenten ante la SEC, en castellano. Crear una cuenta. ¿Ya tienes cuenta? Entrar.

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