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PivotalWire
Martes 13 oct 2026SEC · NASDAQ biomédico

Portada›Miércoles 5 de noviembre de 2025

Biomédicas del NASDAQ ante la SEC, miércoles 5 de noviembre de 2025

Los 121 documentos que 68 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. BNTCBenitec Biopharma Inc.424B5Nueva emisión de acciones con precioEDGAR
    En el documentoDebilidad material en el control internotexto original ▸…sales, marketing, manufacturing and distribution requirements; • greater than expected expenses, expenses relating to litigation or strategic activities; • the impact of, and our ability to remediate, the identified material weakness in our internal controls over financial reporting; • our ability to satisfy our capital needs through increasing revenue and obtaining additional financing; and • the impact of local, regional and national…
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…Form S-3 (File No. 333-277310) with the SEC registering up to $125 million of our common stock, debt securities, warrants, and units (the “February 2024 S-3 Shelf”). Subsequently, in October 2024, we entered into an open market sales agreement and filed a prospectus supplement related to an at-the-market offering of up to $75 million of our common stock registered under the February 2024 S-3 Shelf. On November 1, 2024, we filed a registration statement on Form S-3 (File No. 333-282957) with the SEC registering…
  2. MLTXMoonLake Immunotherapeutics424B5Nueva emisión de acciones con precioEDGAR
  3. ORKAOruka Therapeutics, Inc.424B5Nueva emisión de acciones con precioEDGAR
  4. RLMDRELMADA THERAPEUTICS, INC.424B5Nueva emisión de acciones con precioEDGAR
  5. BIOABioAge Labs, Inc.S-3/ACapacidad de emisión registrada (enmienda)EDGAR
  6. BIOABioAge Labs, Inc.S-3/ACapacidad de emisión registrada (enmienda)EDGAR
  7. IMAImageneBio, Inc.424B3Prospecto suplementario o de reventaEDGAR
  8. LXEOLexeo Therapeutics, Inc.S-3Capacidad de emisión registradaEDGAR
  9. ORKAOruka Therapeutics, Inc.424B3Prospecto suplementario o de reventaEDGAR
  10. UPBUpstream Bio, Inc.S-3ASRCapacidad de emisión registradaEDGAR

Participaciones y control

  1. GILDGILEAD SCIENCES, INC.SC 13D/ACambio en participación significativaEDGAR
  2. INDVIndivior Pharmaceuticals, Inc.SC 13D/ACambio en participación significativaEDGAR

Informes y hechos relevantes

  1. CMPXCompass Therapeutics, Inc.8-KResultadosEDGAR
    En el documentoEl ensayo alcanzó su objetivo principaltexto original ▸…are triggered by a pre-specified number of pooled OS events (80%). Based on a continued trend of decreased mortality in the study, top-line data are expected in late Q1 2026. In April 2025, tovecimig met the primary endpoint in the ongoing COMPANION-002 Phase 2/3 study, where tovecimig plus paclitaxel demonstrated a statistically significant improvement in overall response rate compared to paclitaxel alone. Preparations for…
  2. JAZZJazz Pharmaceuticals plc8-KResultadosEDGAR
    En el documentoAprobación acelerada de la FDAtexto original ▸…With a proven portfolio and strong financial foundation, we are well-positioned to accelerate our evolution and deliver meaningful value for patients and shareholders alike.” Key Highlights •Modeyso received accelerated approval from the FDA ahead of its PDUFA date; initiated commercial launch in August 2025 with strong initial uptake and sales of $11.0 million in 3Q25. •Zepzelca and atezolizumab combination received FDA approval…
  3. MLTXMoonLake Immunotherapeutics8-KResultadosEDGAR
    En el documentoEl ensayo alcanzó su objetivo principaltexto original ▸…sonelokimab achieving an American College of Rheumatology (ACR) 50 response and Minimal Disease Activity (MDA) at week 24. This followed the positive top-line results in November 2023, where the trial met its primary endpoint with a statistically significant greater proportion of patients treated with either sonelokimab 60mg or 120mg (with induction) achieving an ACR50 response compared to those on placebo at week 12. All…
  4. PRAXPraxis Precision Medicines, Inc.8-KResultadosEDGAR
    En el documentoEl ensayo alcanzó su objetivo principaltexto original ▸…were met, including rate of disease improvement, PGI-C and CGI-S at Week 8 showing statistically significant improvement with ulixacaltamide vs placebo (p<0.001). •Study 2 (randomized withdrawal study) met its primary endpoint and first secondary endpoint: •Primary endpoint of percentage of patients maintaining response was met with 55% of patients on ulixacaltamide vs 33% of patients on placebo maintaining their response…
    En el documentoDesignación de medicamento huérfanotexto original ▸…tolerated, robust, short- and long-term improvement in motor seizures in a heavily pre-treated population, alongside maintained seizure freedom in some patients with SCN2A- and SCN8A-DEE. Relutrigine has received Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation from the FDA for the treatment of SCN2A-DEE, SCN8A-DEE and Dravet syndrome; as well as Breakthrough Therapy Designation (BTD), and ODD from the European Medicines…
  5. UPBUpstream Bio, Inc.8-KResultadosEDGAR
    En el documentoEl ensayo alcanzó su objetivo principaltexto original ▸…from the VIBRANT Phase 2 trial in CRSwNP showed statistically significant and clinically meaningful effects on multiple endpoints when administered once every 12 weeks. • In this 24-week study, VIBRANT met its primary endpoint, with verekitug dosed every 12 weeks leading to a statistically significant and clinically meaningful reduction from baseline in placebo-adjusted endoscopic nasal polyp score (NPS) of -1.8 (p<0.0001)…
  6. VERAVera Therapeutics, Inc.8-KResultadosEDGAR
    En el documentoEl ensayo alcanzó su objetivo principaltexto original ▸…further improvements in Gd-IgA1, hematuria, and proteinuria, as well as stabilization of eGFR reflecting a profile consistent with that of the general population without IgAN. The ORIGIN Phase 3 trial met the primary endpoint with a statistically significant and clinically meaningful reduction in proteinuria at week 36, in the prespecified interim analysis. Across the ORIGIN program in IgAN, the safety profile of atacicept…
    En el documentoDesignación de terapia innovadora (breakthrough)texto original ▸…reduction in proteinuria at week 36, in the prespecified interim analysis. Across the ORIGIN program in IgAN, the safety profile of atacicept appears favorable, and comparable to placebo. Atacicept has received FDA Breakthrough Therapy Designation for the treatment of IgAN, which reflects the FDA’s determination that, based on an assessment of data from the ORIGIN Phase 2b clinical trial, atacicept may demonstrate substantial improvement on a clinically…
  7. ACADACADIA PHARMACEUTICALS INC8-KResultadosEDGAR
  8. ACETAdicet Bio, Inc.8-KResultadosEDGAR
  9. ACETAdicet Bio, Inc.10-QInforme trimestralEDGAR
    En el documentoDebilidad material en el control internotexto original ▸…management, including the Chief Executive Officer (CEO) and Chief Financial Officer (CFO), as appropriate to allow timely decisions regarding required disclosure. During the fourth quarter of 2024, we identified a material weakness in internal controls over financial reporting related to unauthorized cash disbursements, as previously identified and discussed under Part II, Item 9A. of our Annual Report on Form 10-K. We fully implemented…
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…with resTORbio, Inc. In January 2024, we raised aggregate net proceeds of approximately $19.3 million through the JonesTrading ATM Program. In March 2024, we terminated the JonesTrading ATM Program and entered into the Jefferies ATM Program. As of September 30, 2025, no shares of common stock have been sold through the Jefferies ATM Program. On January 22, 2024, we entered into an underwriting agreement (the Underwriting Agreement) with…
  10. ADMAADMA BIOLOGICS, INC.8-KResultadosEDGAR
  11. ADMAADMA BIOLOGICS, INC.10-QInforme trimestralEDGAR
  12. ADPTAdaptive Biotechnologies Corp8-KResultadosEDGAR
  13. ADPTAdaptive Biotechnologies Corp10-QInforme trimestralEDGAR
  14. ALDXAldeyra Therapeutics, Inc.10-QInforme trimestralEDGAR
  15. AMGNAMGEN INC10-QInforme trimestralEDGAR
  16. AQSTAquestive Therapeutics, Inc.8-KResultadosEDGAR
  17. AQSTAquestive Therapeutics, Inc.10-QInforme trimestralEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…facilities are located in Portage, Indiana, and its corporate headquarters and primary research laboratory facilities are based in Warren, New Jersey. (B) Equity Transactions ATM Facility The Company established its first ATM facility in September 2019, and since inception to September 30, 2025, the Company has sold 27,315,145 shares of Common Stock under its ATM facility which has generated net cash proceeds of approximately $81,785…
  18. ARVNARVINAS, INC.8-KResultadosEDGAR
    En el documentoDesignación de vía rápida (Fast Track)texto original ▸…metastatic breast cancer previously treated with endocrine-based therapy. The U.S. Food and Drug Administration (FDA) has filed the New Drug Application (NDA) for vepdegestrant. Vepdegestrant has also been granted Fast Track designation by the FDA, underscoring the significant unmet need in this patient population and the potential for vepdegestrant to offer a meaningful new treatment option. In July 2021, Arvinas announced a global…
    En el documentoFecha de decisión de la FDA (PDUFA)texto original ▸…/human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer previously treated with endocrine-based therapy. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of June 5, 2026. •Announced agreement with Pfizer to jointly select a third party for the commercialization and potential further development of vepdegestrant, with the goal of rapidly bringing it to patients, if approved…
  19. ARVNARVINAS, INC.10-QInforme trimestralEDGAR
  20. BIAFbioAffinity Technologies, Inc.8-KOtros hechos relevantesEDGAR
  21. BOLDBoundless Bio, Inc.8-KResultadosEDGAR
  22. BOLDBoundless Bio, Inc.10-QInforme trimestralEDGAR
  23. BTMDbiote Corp.8-KResultadosEDGAR
    En el documentoRecorte de plantilla o reestructuracióntexto original ▸…filing fees were incurred during the three and nine months ended September 30, 2025. (9) Represents restructuring costs incurred during the three and nine months ended September 30, 2025 related to a workforce reduction primarily within our commercial organization. (10) Represents executive severance costs of $0.7 million and $1.2 million, strategic consulting and legal expenses related to the Chief Executive Officer…
  24. CMPXCompass Therapeutics, Inc.10-QInforme trimestralEDGAR
  25. CNTXContext Therapeutics Inc.10-QInforme trimestralEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…were approximately $100 million, before deducting offering expenses of approximately $5.2 million, and the Private Placement closed on May 6, 2024. At-the-Market Facility On December 2, 2024, the Company entered into a Sales Agreement (the “ATM Sales Agreement”) with Leerink Partners LLC (the “Agent”). Pursuant to the terms of the ATM Sales Agreement, the Company may offer and sell shares of the Company’s common stock (the “ATM Shares”), having an aggregate…
  26. CNTXContext Therapeutics Inc.8-KOtros hechos relevantesEDGAR
  27. CYTKCYTOKINETICS INC8-KResultadosEDGAR
    En el documentoFecha de decisión de la FDA (PDUFA)texto original ▸…Application (NDA) for aficamten for the treatment of patients with obstructive hypertrophic cardiomyopathy (HCM) by the U.S. Food and Drug Administration (FDA) ahead of the Prescription Drug User Fee Act (PDUFA) action date of December 26, 2025. • On September 15, 2025, the Company participated in a Late Cycle Meeting with the FDA regarding the NDA for aficamten in which the Company discussed its proposed Risk Evaluation and Mitigation Strategy…
  28. CYTKCYTOKINETICS INC10-QInforme trimestralEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…certain patents, the expiration of regulatory exclusivity for the Product in Japan, and the end of a minimum specified term. 37 Table of Contents At-the-Market Sales of Common Stock On March 1, 2023, we entered into the Amended ATM Facility, with Cantor, under which we may offer and sell, from time to time at our sole discretion, shares of the Common Stock having an aggregate offering price of up to $300.0 million through Cantor, as sales…
  29. DNTHDianthus Therapeutics, Inc. /DE/8-KResultadosEDGAR
  30. DNTHDianthus Therapeutics, Inc. /DE/10-QInforme trimestralEDGAR
    En el documentoContrasplit de accionestexto original ▸…completion of the Reverse Merger. The Company was incorporated in June 2015 and Former Dianthus was incorporated in May 2019. Immediately prior to the effective time of the Reverse Merger, the Company effected a 1-for-16 reverse stock split of its common stock (the “Reverse Stock Split”). Unless noted otherwise, all references herein to share and per share amounts reflect the Reverse Stock Split. At the effective time of the Reverse Merger…
  31. DSGNDesign Therapeutics, Inc.8-KResultadosEDGAR
  32. DSGNDesign Therapeutics, Inc.10-QInforme trimestralEDGAR
  33. DYNDyne Therapeutics, Inc.10-QInforme trimestralEDGAR
  34. DYNDyne Therapeutics, Inc.8-KResultadosEDGAR
    En el documentoDesignación de terapia innovadora (breakthrough)texto original ▸…living with genetically driven neuromuscular diseases, today reported financial results for the third quarter of 2025 and recent business highlights. “Our lead programs in DMD and DM1 have now each been granted Breakthrough Therapy Designation by the FDA and are advancing toward anticipated U.S. Accelerated Approval submissions, as we aim to further validate the potential of our FORCE platform to safely and effectively deliver multiple drug…
  35. EOLSEvolus, Inc.8-KResultadosEDGAR
  36. EOLSEvolus, Inc.10-QInforme trimestralEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…of the allotted option shares. The net proceeds to the Company from the sale of the option shares, after deducting the underwriters’ discounts and commissions, was $4,169. On March 8, 2023, the Company entered into an “at-the-market” sales agreement (the “ATM Sales Agreement”) and filed a shelf registration statement on Form S-3 and corresponding prospectus with the Securities and Exchange Commission (“SEC”) to permit sales under the ATM Sales Agreement…
  37. FHTXFoghorn Therapeutics Inc.8-KResultadosEDGAR
  38. FHTXFoghorn Therapeutics Inc.10-QInforme trimestralEDGAR
  39. GERNGERON CORP8-KResultadosEDGAR
  40. GNLXGENELUX Corp10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…recurring losses from operations since inception and incurred a net loss of $22.9 million and used cash in operations of $19.1 million during the nine months ended September 30, 2025. These factors raise substantial doubt about the Company’s ability to continue as a going concern. In addition, the Company’s independent registered public accounting firm, in its report on the Company’s December 31, 2024 financial statements, has expressed substantial doubt about the Company’s ability…
  41. GOSSGossamer Bio, Inc.10-QInforme trimestralEDGAR
  42. GOSSGossamer Bio, Inc.8-KResultadosEDGAR
  43. HALOHALOZYME THERAPEUTICS, INC.8-KNuevo acuerdo materialEDGAR
  44. IBRXImmunityBio, Inc.8-KResultadosEDGAR
  45. IBRXImmunityBio, Inc.10-QInforme trimestralEDGAR
  46. IMAImageneBio, Inc.8-KCambio en el consejo o la direcciónEDGAR
  47. INVAInnoviva, Inc.8-KResultadosEDGAR
    En el documentoFecha de decisión de la FDA (PDUFA)texto original ▸…Infectious Disease Society of America’s IDWeek 2025 annual meeting. o Zoliflodacin is currently under Priority Review by the U.S. Food and Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) target action date of December 15, 2025. o Subsequent to the New Drug Application (NDA) acceptance in June 2025, the FDA indicated in its Day-74 letter that it did not plan to hold an Advisory Committee meeting to discuss the zoliflodacin NDA…
  48. INVAInnoviva, Inc.10-QInforme trimestralEDGAR
  49. JAZZJazz Pharmaceuticals plc10-QInforme trimestralEDGAR
  50. KROSKeros Therapeutics, Inc.8-KResultadosEDGAR
  51. KROSKeros Therapeutics, Inc.10-QInforme trimestralEDGAR
  52. LENZLENZ Therapeutics, Inc.8-KResultadosEDGAR
  53. LENZLENZ Therapeutics, Inc.10-QInforme trimestralEDGAR
  54. LRMRLarimar Therapeutics, Inc.8-KResultadosEDGAR
  55. LRMRLarimar Therapeutics, Inc.10-QInforme trimestralEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…per share. The Company received net proceeds of approximately $65.0 million, after deducting underwriting discounts, commissions and other offering expenses. ATM Agreement In November 2022, the Company entered into a sales agreement (the “2022 ATM Agreement”) with Guggenheim Securities, LLC in connection with the establishment of an “at-the-market” offering program under which the Company could sell up to an aggregate of $50.0 million of shares of common…
  56. LXEOLexeo Therapeutics, Inc.8-KResultadosEDGAR
  57. LXEOLexeo Therapeutics, Inc.10-QInforme trimestralEDGAR
  58. MCRBSeres Therapeutics, Inc.8-KResultadosEDGAR
    En el documentoDesignación de terapia innovadora (breakthrough)texto original ▸…FDA approval. • The Company received constructive feedback from the FDA during the third quarter and is working to finalize the planned Phase 2 study protocol for SER-155 in allo-HSCT, which previously received Breakthrough Therapy designation. The study is expected to enroll approximately 248 participants and incorporate an adaptive design and an interim data analysis when approximately half of the enrolled participants have reached the primary…
  59. MCRBSeres Therapeutics, Inc.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…commercialization efforts, or pursue other alternatives, which could include seeking relief under the U.S. Bankruptcy Code or winding down our operations. 3 • We have identified conditions and events that raise substantial doubt regarding our ability to continue as a going concern. • We are a clinical-stage company and have incurred significant losses since our inception. We expect to incur losses for the foreseeable future and may never achieve or maintain profitability. • The…
    En el documentoContrasplit de accionestexto original ▸…subsidiaries. All intercompany transactions have been eliminated in consolidation. The condensed consolidated financial statements have been prepared in conformity with U.S. GAAP. On April 21, 2025, the Company effected a 1-for-20 reverse stock split of the Company’s common stock. All share and per share amounts in the financial statements and notes thereto have been retroactively adjusted for all periods presented to give effect to this reverse stock…
  60. MLTXMoonLake Immunotherapeutics8-KNuevo acuerdo materialEDGAR
  61. MLTXMoonLake Immunotherapeutics10-QInforme trimestralEDGAR
  62. MNKDMANNKIND CORP8-KResultadosEDGAR
    En el documentoFecha de decisión de la FDA (PDUFA)texto original ▸…Completed acquisition of scPharmaceuticals on October 7, accelerating MannKind’s revenue growth with FUROSCIX® • Program updates: o sBLA for Afrezza® in pediatric population accepted for FDA review; PDUFA date of May 29, 2026 o FUROSCIX ReadyFlow™ Autoinjector sNDA submitted to the FDA o MNKD-101 NTM global Phase 3 trial (ICoN-1) achieved interim enrollment target ahead of schedule o MNKD-201 IPF Phase 2 trial (INFLO) initiated…
  63. MNKDMANNKIND CORP10-QInforme trimestralEDGAR
  64. MRKRMarker Therapeutics, Inc.8-KCambio en el consejo o la direcciónEDGAR
  65. MXCTMAXCYTE, INC.8-KResultadosEDGAR
  66. NAMSNewAmsterdam Pharma Co N.V.10-QInforme trimestralEDGAR
  67. NAMSNewAmsterdam Pharma Co N.V.8-KResultadosEDGAR
    En el documentoAcuerdo de licencia o colaboracióntexto original ▸…in revenue for the quarter ended September 30, 2025, compared to $29.1 million in the same period in 2024. The decrease was primarily attributable to the recognition of $27.3 million of revenue from a license agreement with Menarini related to a clinical development milestone which was earned in the quarter ended September 30, 2024 while there were no clinical milestones earned in the quarter ended September 30, 2025. • Research and Development (“R&D”) Expenses: R&D expenses…
  68. NERVMinerva Neurosciences, Inc.10-QInforme trimestralEDGAR
  69. NXTCNextCure, Inc.8-KResultadosEDGAR
  70. NXTCNextCure, Inc.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…29.1 million. The Company's expectation to incur additional operating losses and negative operating cash flows in the future and the need for additional funding to support its planned operations raise substantial doubt regarding the Company’s ability to continue as a going concern for a period of one year after the date that these unaudited financial statements are issued. See Note 2, Summary of Significant Accounting Policies for a futher assessment of liquidity. 2. Summary of…
  71. OCGNOcugen, Inc.8-KResultadosEDGAR
    En el documentoAcuerdo de licencia o colaboracióntexto original ▸…BLA) filing with 50% enrollment completed to date o European Medicines Agency provided acceptability of a single U.S.-based trial for submission of a Marketing Authorization Application (MAA) ● Executed licensing agreement with Kwangdong Pharmaceutical for exclusive rights in South Korea to OCU400 o Sales milestones of $1.5 million for every $15 million of sales in South Korea, projected to reach $180 million or more in first 10 years of commercialization and royalties equaling 25% of net sales ● Closed $20 million…
  72. OCGNOcugen, Inc.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…affected. As a result of these factors, together with the anticipated continued spending that will be necessary to continue to research, develop, and commercialize the Company's product candidates, there is substantial doubt about the Company's ability to continue as a going concern within one year after the date that these condensed consolidated financial statements are issued. The condensed consolidated financial statements do not contain any adjustments that might result from…
  73. PAHCPHIBRO ANIMAL HEALTH CORP10-QInforme trimestralEDGAR
  74. PAHCPHIBRO ANIMAL HEALTH CORP8-KResultadosEDGAR
  75. PRAXPraxis Precision Medicines, Inc.10-QInforme trimestralEDGAR
  76. PVLAPALVELLA THERAPEUTICS, INC.8-KOtros hechos relevantesEDGAR
  77. QDELQuidelOrtho Corp8-KResultadosEDGAR
  78. RAREUltragenyx Pharmaceutical Inc.10-QInforme trimestralEDGAR
  79. RLMDRELMADA THERAPEUTICS, INC.8-KNuevo acuerdo materialEDGAR
  80. RPRXRoyalty Pharma plc8-KResultadosEDGAR
  81. RPRXRoyalty Pharma plc10-QInforme trimestralEDGAR
  82. RVMDRevolution Medicines, Inc.8-KResultadosEDGAR
    En el documentoDesignación de medicamento huérfanotexto original ▸…clinical trial of daraxonrasib as adjuvant treatment for patients with resectable PDAC, and remains on track to initiate RASolute 303 for patients with first line metastatic PDAC this year • Daraxonrasib has received FDA Breakthrough Therapy Designation, Orphan Drug Designation and a Commissioner’s National Priority Voucher • New leadership appointments strengthened global development and commercialization capabilities • Revolution Medicines to hold webcast today at 4:30 p.m…
    En el documentoDesignación de terapia innovadora (breakthrough)texto original ▸…clinical trial of daraxonrasib as adjuvant treatment for patients with resectable PDAC, and remains on track to initiate RASolute 303 for patients with first line metastatic PDAC this year • Daraxonrasib has received FDA Breakthrough Therapy Designation, Orphan Drug Designation and a Commissioner’s National Priority Voucher • New leadership appointments strengthened global development and commercialization capabilities • Revolution Medicines to hold…
  83. RVMDRevolution Medicines, Inc.10-QInforme trimestralEDGAR
  84. RXRXRECURSION PHARMACEUTICALS, INC.8-KResultadosEDGAR
    En el documentoCambio en la dirección de la empresatexto original ▸…President, and appointed Christopher Gibson, Ph.D., the Company’s Chief Executive Officer and President, as Chair of the Board, both effective as of January 1, 2026. Also on November 4, 2025, Dr. Gibson stepped down as the Company’s Chief Executive Officer and President, effective as of January 1, 2026. Dr. Khan, age 42, has served as our Chief Research and Development Officer and Chief Commercial Officer since July 2024 and as a member of our Board since…
  85. RXRXRECURSION PHARMACEUTICALS, INC.10-QInforme trimestralEDGAR
  86. SCYXSCYNEXIS INC10-QInforme trimestralEDGAR
  87. SDGRSchrodinger, Inc.8-KResultadosEDGAR
    En el documentoDesignación de medicamento huérfanotexto original ▸…care therapies. The company is completing the Phase 1 package and continues to explore strategic opportunities to advance the development of SGR-1505. In October, the U.S. Food and Drug Administration granted SGR-1505 Orphan Drug Designation for the treatment of Waldenström macroglobulinemia. Additionally, Schrödinger scientists recently published research in the Journal of Medicinal Chemistry highlighting the power of integrating physics…
  88. SDGRSchrodinger, Inc.10-QInforme trimestralEDGAR
    En el documentoDebilidad material en el control internotexto original ▸…public accounting firm. For example, in connection with the audit of our consolidated financial statements for the year ended December 31, 2022, we and our independent registered public accounting firm identified a material weakness in our internal control over financial reporting. While we remediated 102 Table of Contents this material weakness as of December 31, 2023, we cannot assure you that there will not be material weaknesses…
  89. SIONSionna Therapeutics, Inc.8-KResultadosEDGAR
  90. SIONSionna Therapeutics, Inc.10-QInforme trimestralEDGAR
  91. TECHBIO-TECHNE Corp8-KResultadosEDGAR
    En el documentoDesignación de vía rápida (Fast Track)texto original ▸…solutions extended its growth momentum and Spatial Biology stabilized while showing early signs of accelerating growth going forward. In Cell Therapy, we are very excited that a few of our largest customers received Fast Track Designation by the FDA, enabling shortened clinical development and approval timelines. However, these advancements have resulted in short- and intermediate-term order timing headwinds for our GMP proteins business…
  92. TECHBIO-TECHNE Corp10-QInforme trimestralEDGAR
  93. TGTXTG THERAPEUTICS, INC.10-QInforme trimestralEDGAR
    En el documentoContrasplit de accionestexto original ▸…price of $0.77 per share. The Company paid a premium for the shares which was recorded in research and development expense as part of the cost of the Precision License Agreement. Precision subsequently implemented a 30-to-1 reverse stock split in February 2024. On January 7, 2025, the Company made a one-time payment to Precision equal to $2.5 million (the Deferred Precision Stock Payment), as an equity investment, for the purchase of 220,712…
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…securities, or other securities that the Company may issue and sell from time to time. The 2025 WKSI Shelf is currently the Company's only active shelf registration statement. The at-the-market program established under the Company's prior shelf registration statement on Form S-3 pursuant to the At-the-Market Issuance Sales Agreement, dated September 2, 2022, with Cantor Fitzgerald & Co. and B. Riley Securities, Inc. has expired. The Company may offer and sell securities registered under the 2025 WKSI Shelf in one or more offerings…
  94. TPSTTempest Therapeutics, Inc.8-KResultadosEDGAR
  95. TPSTTempest Therapeutics, Inc.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…and Corporate Secretary, transitioned to consulting agreements with the Company, pursuant to which they will continue to serve the Company in their respective executive roles. The above conditions raise substantial doubt regarding our ability to continue as a going concern for a period of 12 months from the date of the issuance of the unaudited condensed financial statements included elsewhere in this Quarterly Report on Form 10-Q. Reverse Stock Split On April 8, 2025,…
    En el documentoContrasplit de accionestexto original ▸…with the Secretary of State of the State of Delaware to affect the one-for-thirteen (1:13) reverse stock split of its outstanding common stock (the "Reverse Stock Split"). On April 8, 2025, the Company effected the Reverse Stock Split. Pursuant to their terms, a proportionate adjustment was made to the per share exercise price and number of shares issuable under all of the Company’s outstanding options and warrants, and the number…
  96. TYRATyra Biosciences, Inc.8-KResultadosEDGAR
  97. TYRATyra Biosciences, Inc.10-QInforme trimestralEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…Stock Purchase Plan 1,951,705 1,491,195 Pre-funded warrants issued and outstanding 6,381,950 8,382,187 Total common stock reserved for future issuance 23,868,251 23,387,099 On October 3, 2022, the Company entered into an ATM Sales Agreement (the 2022 Sales Agreement) with Virtu Americas LLC (the 2022 Agent), under which the Company could have, from time to time, sold shares of its common stock having an aggregate offering price of up to…
  98. UPBUpstream Bio, Inc.10-QInforme trimestralEDGAR
  99. VERAVera Therapeutics, Inc.10-QInforme trimestralEDGAR
  100. VIRVir Biotechnology, Inc.8-KResultadosEDGAR
  101. VIRVir Biotechnology, Inc.10-QInforme trimestralEDGAR
  102. VRDNViridian Therapeutics, Inc.\DE8-KResultadosEDGAR
    En el documentoDesignación de terapia innovadora (breakthrough)texto original ▸…Veligrotug Commercial Launch • Biologics License Application Submitted. In October, Viridian successfully submitted the veligrotug BLA to the U.S. FDA, including a request for Priority Review. Veligrotug was granted Breakthrough Therapy Designation in May 2025, which supports eligibility for Priority Review. If approved and Priority Review is granted, Viridian expects a U.S. commercial launch in mid-2026. • Marketing Authorization Application (MAA…
    En el documentoRevisión prioritaria de la FDAtexto original ▸…Veligrotug Commercial Launch • Biologics License Application Submitted. In October, Viridian successfully submitted the veligrotug BLA to the U.S. FDA, including a request for Priority Review. Veligrotug was granted Breakthrough Therapy Designation in May 2025, which supports eligibility for Priority Review. If approved and Priority Review is granted, Viridian expects a U.S. commercial launch in mid-2026. • Marketing Authorization Application (MAA). Viridian is on track to submit a Marketing Authorization…
  103. VRDNViridian Therapeutics, Inc.\DE10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…statements are issued. The Company is required to make certain additional disclosures if it concludes substantial doubt exists and it is not alleviated by the Company’s plans or when its plans alleviate substantial doubt about the Company’s ability to continue as a going concern. The Company’s evaluation entails, among other things, analyzing the results of the Company’s clinical development efforts, license and collaboration agreements as well as the entity’s current financial…
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…vote. The holders of common stock are entitled to receive dividends when and as declared or paid by its board of directors. Common Stock Sales Agreements - Jefferies LLC In September 2022, the Company entered into an Open Market Sale AgreementSM (the “September 2022 ATM Agreement”) with Jefferies, pursuant to which the Company may offer and sell shares of its common stock having an aggregate offering price of up to $175.0 million from time to time at prices and on terms to be…
  104. XFORX4 Pharmaceuticals, Inc8-KResultadosEDGAR
    En el documentoRecorte de plantilla o reestructuracióntexto original ▸…expressions that concern X4’s expectations, strategy, plans, or intentions. Forward-looking statements include, without limitation, implied or express statements regarding the expected cost savings from the workforce reduction, the expected results of the restructuring of business operations, the sufficiency of the Company’s cash resources and its expected cash runway, the potential addressable market for moderate and severe…
  105. XFORX4 Pharmaceuticals, Inc10-QInforme trimestralEDGAR
    En el documentoContrasplit de accionestexto original ▸…upon Senior Securities 35 ITEM 4: Mine Safety Disclosures 35 ITEM 5: Other Information 35 ITEM 6: Exhibits 37 Signatures 39 EXPLANATORY NOTE On April 28, 2025, X4 Pharmaceuticals, Inc. (the “Company”), effected a 1-for-30 reverse stock split of its common stock (the “Reverse Stock Split”). Unless otherwise noted, all references to common stock share and per share amounts in this Quarterly Report on Form 10-Q have been retroactively adjusted…
  106. XNCRXencor Inc8-KResultadosEDGAR
  107. XNCRXencor Inc10-QInforme trimestralEDGAR
  108. ZVRAZEVRA THERAPEUTICS, INC.8-KResultadosEDGAR
  109. ZVRAZEVRA THERAPEUTICS, INC.10-QInforme trimestralEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…its approved products and the continued development of its product candidates, and for other general corporate purposes. 10 Table of Contents Entry into 2024 ATM Agreement On July 12, 2024, the Company entered into an equity distribution agreement (the “2024 ATM Agreement”) with Citizens JMP Securities LLC (“Citizens JMP”) under which the Company may offer and sell, from time to time at its sole discretion, shares of its common stock having an aggregate offering price…

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