Welcome to our dedicated page for Mustang Bio news (Ticker: MBIO), a resource for investors and traders seeking the latest updates and insights on Mustang Bio stock.
Mustang Bio, Inc. (Nasdaq: MBIO) is a clinical-stage biopharmaceutical company developing cell therapies for difficult-to-treat cancers, and its news flow reflects both scientific progress and capital markets activity. The company focuses on CAR T-cell therapies and an HSV-1 oncolytic virus, with programs aimed at malignant glioma, recurrent glioblastoma (GBM), high-grade astrocytomas, and related brain tumors.
News about Mustang Bio often centers on pipeline milestones, including updates on MB-101, an IL13Rα2-targeted CAR T-cell therapy, and MB-108, an HSV-1 oncolytic virus. The company has reported U.S. Food and Drug Administration Orphan Drug Designations for MB-108 in malignant glioma and MB-101 in recurrent diffuse and anaplastic astrocytoma and glioblastoma. Mustang Bio also highlights the MB-109 regimen, which combines MB-101 and MB-108 to reshape the tumor microenvironment and potentially enhance CAR-T activity in recurrent GBM and high-grade astrocytomas.
Investors following MBIO news will also see listing and financing developments, such as reverse stock split announcements, Nasdaq compliance updates on minimum bid price and stockholders’ equity requirements, and details of public offerings and warrant exercises. These items provide context on Mustang Bio’s access to capital and its efforts to maintain its Nasdaq Capital Market listing.
This news page aggregates Mustang Bio’s press releases and related coverage, giving readers a single place to review regulatory designations, clinical trial updates, facility and operational changes, and securities offerings. For those tracking MBIO, revisiting this page can help monitor how Mustang Bio’s cell therapy programs and corporate actions evolve over time.
Mustang Bio, Inc. (NASDAQ: MBIO) announced that initial Phase 1 data on their PSCA-targeted CAR T therapy, MB-105, will be presented at the virtual 27th Annual Prostate Cancer Foundation Scientific Retreat from October 20-23, 2020. This therapy targets patients with PSCA-positive metastatic castration-resistant prostate cancer (mCRPC). The Phase 1 trial can enroll up to 33 patients, focusing on side effects and optimal dosing, with secondary endpoints assessing treatment response and survival outcomes. The data presentation will take place on October 23, 2020.
Mustang Bio has entered a licensing agreement with SIRION Biotech to use LentiBOOST™ technology in developing MB-207, a lentiviral gene therapy targeting patients with X-linked severe combined immunodeficiency (XSCID). The agreement includes an undisclosed upfront payment, milestone payments, and royalties on future sales. Mustang aims to file an IND with the FDA to start a pivotal Phase 2 trial for MB-207 in the coming months, building on prior clinical research. The therapy is expected to improve clinical outcomes in patients needing re-treatment post-hematopoietic stem cell transplantation.
Mustang Bio (NASDAQ: MBIO) announced that its CEO, Manuel Litchman, will participate in a fireside chat at Chardan's Virtual 4th Annual Genetic Medicines Conference on October 5, 2020, at 1:00 p.m. EDT. The live chat can be accessed via Mustang's Investor Relations page, with an archived replay available for 30 days post-event. Mustang Bio focuses on developing cell and gene therapies for hematologic cancers, solid tumors, and rare genetic diseases, collaborating with top medical institutions to advance CAR T therapies and gene therapy for XSCID.
Mustang Bio has initiated a Phase 1/2 clinical trial for its MB-102 (CD123-targeted CAR T cell therapy) on patients with relapsed or refractory blastic plasmacytoid dendritic cell neoplasm, acute myeloid leukemia, and high-risk myelodysplastic syndrome. The trial aims to assess safety, maximum tolerated doses, and efficacy, with outcomes measured at 28 days post-infusion. This marks a significant milestone for Mustang, being the first trial using cells processed in their own facility. Additional details are available on clinicaltrials.gov.
Mustang Bio (NASDAQ: MBIO) announced that the FDA granted Orphan Drug Designation to MB-207, its lentiviral gene therapy for X-linked severe combined immunodeficiency (XSCID) patients previously treated with hematopoietic stem cell transplantation (HSCT). This designation provides incentives including tax credits and market exclusivity for seven years upon FDA approval. Mustang plans to initiate pivotal clinical trials for MB-207 in Q4 2020, targeting this rare disease that affects 1 in 225,000 births. MB-207 is currently in a Phase 1/2 clinical trial.
Mustang Bio (NASDAQ: MBIO) announced that the FDA granted Rare Pediatric Disease Designation to MB-207, a lentiviral gene therapy for X-linked severe combined immunodeficiency (XSCID). This designation is for patients previously treated with hematopoietic stem cell transplantation (HSCT) who require re-treatment. If Mustang's Biologics License Application is approved, it may qualify for a priority review voucher. MB-207 is undergoing a Phase 1/2 trial for patients over two years old at the NIH, with an IND filing for a multi-center Phase 2 trial expected in Q4 2020.
Mustang Bio (NASDAQ: MBIO) reported its Q2 2020 financial results, revealing a net loss of $14.6 million or $0.32 per share, up from $10.4 million or $0.29 per share in Q2 2019. The company raised approximately $37.2 million through a public offering in June 2020. Mustang continues to advance its clinical pipeline, initiating a Phase 1/2 trial for its MB-102 CAR T cell therapy. Furthermore, the company anticipates filing for its MB-207 gene therapy trial by Q4 2020, targeting topline data in the second half of 2022. As of June 30, 2020, cash reserves totaled $86.4 million.
Mustang Bio, Inc. (NASDAQ: MBIO) announced plans for an underwritten public offering of common stock, subject to market conditions. The company will grant underwriters a 30-day option to buy up to an additional 15% of shares. Funds raised will primarily support the development of product candidates, potential acquisitions, and general corporate purposes. The offering details will be finalized based on market conditions. Cantor Fitzgerald & Co. is the sole book-running manager for the offering. Mustang focuses on innovative therapies for hematologic cancers and rare genetic diseases.
Mustang Bio, a clinical-stage biopharmaceutical company focused on cell and gene therapies, will hold its 2020 Annual Meeting of Stockholders virtually due to COVID-19 concerns. The meeting is set for June 17, 2020, at 3:00 p.m. ET. Stockholders of record as of April 20, 2020, can participate online. Attendees must access the meeting through a specific link and use a 16-digit control number for voting. Technical support will be available during the meeting. Mustang Bio aims to advance therapies for hematologic cancers, solid tumors, and rare genetic diseases.
Mustang Bio (NASDAQ: MBIO) announced its Q1 2020 financial results and corporate highlights on May 11, 2020. Key milestones included the submission of an IND application for MB-107, aimed at treating X-linked severe combined immunodeficiency (XSCID), and granting of ATMP classification by the EMA. Financially, cash reserves decreased to $56.8 million, with a net loss of $11.9 million ($0.28 per share). R&D expenses rose to $9.3 million, while general and administrative costs decreased to $2.0 million. The company remains focused on advancing its gene and CAR T cell therapies.