Associated tags: Therapy, Hospital, City, AstraZeneca, Nationwide, Fortress Biotech, Fortification, Drug development, Pharmaceutical industry, Patient, DSM-IV codes, Safety
Locations: EUROPE, MIAMI, ASIA, AUSTRALIA, WALL STREET, INDIA, NEWPORT BEACH, CITY OF HOPE, PARK AVENUE, NEW YORK, NY, US, RARE, AL, JAPAN, BAY HARBOR ISLANDS, FL, IV
Retrieved on:
Thursday, November 2, 2023
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Financial adviser MIAMI, Nov. 02, 2023 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced the closing of its previously announced public offering of an aggregate of 16,633,400 units (or pre-funded units in lieu thereof) at a public offering price of $0.3006 per unit (inclusive of the pre-funded warrant exercise price of $0.0001 per share).
Key Points:
- MIAMI, Nov. 02, 2023 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced the closing of its previously announced public offering of an aggregate of 16,633,400 units (or pre-funded units in lieu thereof) at a public offering price of $0.3006 per unit (inclusive of the pre-funded warrant exercise price of $0.0001 per share).
- The gross proceeds from the offering, before deducting the placement agent's fees and other offering expenses, are approximately $5.0 million.
- Maxim Group LLC and Lake Street Capital Markets, LLC acted as placement agents for the offering.
- The offering was made only by means of a prospectus which is a part of the effective registration statement.
Retrieved on:
Thursday, November 2, 2023
FDA,
DSM-IV codes,
Translation,
Fred Hutchinson Cancer Research Center,
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Bone marrow,
University of Washington,
Disclosure,
Chronic lymphocytic leukemia,
Waldenström,
Society,
PET-CT,
Disease,
Cancer,
Follicular lymphoma,
Mustang,
University,
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NHL,
Safety,
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Investigational New Drug,
Associate,
American Society of Hematology,
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Lymphoma,
Pharmaceutical industry,
WM MB-106 is being developed in a collaboration between Mustang and Fred Hutchinson Cancer Center (“Fred Hutch”).
Key Points:
- MB-106 is being developed in a collaboration between Mustang and Fred Hutchinson Cancer Center (“Fred Hutch”).
- All patients displayed MB-106 expansion, with peak levels between 7-14 days post-infusion, and CAR-T cell persistence is ongoing at 6 months.
- From a safety perspective, 3 patients experienced Grade 1 cytokine release syndrome and no occurrences of immune effector cell-associated neurotoxicity syndrome were reported.
- Dose-limiting toxicities (“DLT”) were monitored through day 28, and no DLTs were observed at DL1.
Retrieved on:
Tuesday, October 31, 2023
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Form S-1,
Form,
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ATTN:,
Therapy MIAMI, Oct. 31, 2023 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced the pricing of its public offering of an aggregate of 16,633,400 units at a public offering price of $0.3006 per unit.
Key Points:
- MIAMI, Oct. 31, 2023 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced the pricing of its public offering of an aggregate of 16,633,400 units at a public offering price of $0.3006 per unit.
- The gross proceeds from the offering, before deducting the placement agent's fees and other offering expenses, are expected to be approximately $5.0 million.
- Maxim Group LLC and Lake Street Capital Markets, LLC are acting as placement agents for the offering.
- The offering is being made only by means of a prospectus which is a part of the effective registration statement.
Sale,
DSM-IV codes,
Translation,
Security (finance),
Park Avenue,
Regulation D,
Form,
3rd Floor,
Prospectus,
Cancer,
Mustang In a concurrent private placement, Mustang issued unregistered warrants to purchase up to an aggregate of 2,588,236 shares of its common stock.
Key Points:
- In a concurrent private placement, Mustang issued unregistered warrants to purchase up to an aggregate of 2,588,236 shares of its common stock.
- The gross proceeds to Mustang from the offering are approximately $4.4 million, before deducting the placement agent’s fees and other offering expenses payable by the Company.
- Mustang currently intends to use the net proceeds from the offering for working capital and general corporate purposes.
- A final prospectus supplement and an accompanying base prospectus relating to the registered direct offering was filed with the SEC and is available on the SEC’s website located at http://www.sec.gov .
Retrieved on:
Thursday, October 26, 2023
Sale,
DSM-IV codes,
Translation,
Security (finance),
Park Avenue,
Regulation D,
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3rd Floor,
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Mustang The offering is expected to close on or about October 30, 2023, subject to the satisfaction of customary closing conditions.
Key Points:
- The offering is expected to close on or about October 30, 2023, subject to the satisfaction of customary closing conditions.
- H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.
- The gross proceeds to Mustang from the offering are expected to be approximately $4.4 million, before deducting the placement agent’s fees and other offering expenses payable by the Company.
- Mustang currently intends to use the net proceeds from the offering for working capital and general corporate purposes.
Retrieved on:
Thursday, October 26, 2023
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Birmingham School of Law,
GBM,
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Translation,
DSM-IV codes,
Food,
UAB,
Regulation of food and dietary supplements by the U.S. Food and Drug Administration,
City,
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American Association for Cancer Research,
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Pharmaceutical industry WORCHESTER, Mass., Oct. 26, 2023 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (“Mustang” or the “Company”) (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for difficult-to-treat cancers and rare genetic diseases, today announced that the U.S. Food and Drug Administration (“FDA”) has accepted the Company’s Investigational New Drug (“IND”) application of MB-109 for the treatment of recurrent glioblastoma (“GBM”) and high-grade astrocytoma. Mustang is planning to initiate a Phase 1 multicenter clinical trial at City of Hope (“COH”) and the University of Alabama at Birmingham (“UAB”) to assess the safety, tolerability and efficacy of MB-109, a novel combination of MB-101 (COH-developed IL13Rα2‐targeted CAR-T cell therapy) and MB-108 [Nationwide Children’s Hospital- (“Nationwide”) developed HSV-1 oncolytic virus] in adult patients with recurrent GBM and high-grade astrocytomas that express IL13Rα2 on the surface of the tumor cells.
Key Points:
- As previously reported, preclinical data presented at the American Association for Cancer Research (“AACR”) Annual Meeting in 2022 supported this combination therapy to potentially optimize results to treat recurrent GBM.
- The combination leverages MB-108 to reshape the tumor microenvironment (“TME”) and make cold tumors “hot,” thereby potentially improving the efficacy of MB-101 CAR-T cell therapy.
- Data presented separately on MB-101 and MB-108 showed that administration of these therapies was well tolerated in recurrent GBM patients.
- Recurrent GBM remains a major challenge to treat, with a median overall survival rate of 6 months.
Retrieved on:
Wednesday, October 18, 2023
Patient,
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Immunodeficiency,
PDUFA,
Food,
Immunotherapy,
Safety,
Society for Immunotherapy of Cancer,
PD-1,
Regulation of food and dietary supplements by the U.S. Food and Drug Administration,
HIV disease progression rates,
Journal,
CKPT,
JITC,
Radiation,
ORR,
Biologics license application,
Oncology,
Immunology,
Society,
Toxicity,
Ira Pastan,
Vaccine,
Pharmaceutical industry,
Neoplasm,
Cancer WALTHAM, Mass., Oct. 18, 2023 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced the publication of results from the multicenter, multiregional, pivotal trial evaluating cosibelimab, a differentiated and potential best-in-class anti-PD-L1 antibody, in patients with metastatic cutaneous squamous cell carcinoma (“cSCC”), in the Journal for ImmunoTherapy of Cancer (JITC), the peer-reviewed, online journal of the Society of Immunotherapy of Cancer. The paper, entitled, “Efficacy and Safety of Cosibelimab, an Anti–PD-L1 Antibody, in Metastatic Cutaneous Squamous Cell Carcinoma” (doi:10.1136/jitc-2023-007637), describes safety and efficacy results from 78 patients with metastatic cSCC enrolled at clinical sites in eight countries.
Key Points:
- Patients received cosibelimab 800 mg every two weeks as an intravenous infusion until disease progression or unacceptable toxicity.
- The study’s primary endpoint was objective response rate (“ORR”) assessed by independent central review using Response Evaluation Criteria in Solid Tumors, v.1.1.
- As of the pre-specified data cutoff date, the primary endpoint was met with highly clinically meaningful results.
- “We are encouraged by recently revealed longer-term data from our pivotal studies of cosibelimab, which demonstrate a deepening of response over time.
Patent,
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Engineering,
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California Institute for Regenerative Medicine,
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Research,
Drug resistance,
Trial of the century,
Cytomegalovirus,
Criticism of the Food and Drug Administration,
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Gene,
HIV-1,
Aaron,
Safety,
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HIV,
HCT,
Survival,
ART,
City,
Vaccination,
City of Hope,
Non-Hodgkin lymphoma,
Regenerative medicine,
Bone marrow,
Virus,
CAR,
Leukemia,
Fortress Biotech,
DSM-IV codes,
2004 California Proposition 71,
San Diego,
CIRM,
Division of Acquired Immunodeficiency Syndrome,
Patient,
CMV,
Vaccine,
Triplex,
Hope MIAMI, Oct. 16, 2023 (GLOBE NEWSWIRE) -- Helocyte, Inc. (“Helocyte”), a subsidiary company of Fortress Biotech, Inc. (“Fortress”) (Nasdaq: FBIO), today announced that it executed an exclusive option agreement with City of Hope for patent rights to use Triplex, a cytomegalovirus vaccine, in combination with cytomegalovirus (“CMV”)-specific, Anti-Human Immunodeficiency Virus (“HIV”) Chimeric Antigen Receptor (“CAR”) (collectively, CMV/HIV-CAR) T Cells for the treatment of adults living with HIV. Triplex was initially developed by City of Hope, one of the largest cancer research and treatment organizations in the United States, and exclusively licensed to Helocyte in 2015.
Key Points:
- Triplex was initially developed by City of Hope , one of the largest cancer research and treatment organizations in the United States, and exclusively licensed to Helocyte in 2015.
- Additionally, the California Institute for Regenerative Medicine (“CIRM”) recently awarded a $11.3 million grant to City of Hope to fund a Phase 1 clinical trial.
- The trial will initially enroll at City of Hope and University of California at San Diego.
- The study illustrated the potential long-term durability of the combination therapy, which induced therapeutic immune cells to take hold in bone marrow.
MIAMI, Oct. 09, 2023 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress” or the “Company”), an innovative biopharmaceutical company focused on efficiently acquiring, developing and commercializing or monetizing promising therapeutic products and product candidates, announced that it will effect a 1-for-15 reverse stock split of its issued and outstanding common stock.
Key Points:
- MIAMI, Oct. 09, 2023 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress” or the “Company”), an innovative biopharmaceutical company focused on efficiently acquiring, developing and commercializing or monetizing promising therapeutic products and product candidates, announced that it will effect a 1-for-15 reverse stock split of its issued and outstanding common stock.
- Fortress’ common stock will continue to trade on the Nasdaq Capital Market under the symbol “FBIO” following the reverse stock split, with a new CUSIP number of 34960Q307.
- After the effectiveness of the reverse stock split, the number of outstanding shares of common stock will be reduced from approximately 134.1 million to approximately 8.9 million, subject to adjustment to give effect to the treatment of any fractional shares that stockholders would have received in the reverse stock split.
- Fortress’ transfer agent, VStock Transfer, LLC, is acting as the exchange and paying agent for the reverse stock split.
Retrieved on:
Thursday, October 5, 2023
MIAMI, Oct. 05, 2023 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”), an innovative biopharmaceutical company focused on efficiently acquiring, developing and commercializing or monetizing promising therapeutic products and product candidates, today announced that Lindsay A. Rosenwald, M.D., Chairman, President and Chief Executive Officer, will present a corporate overview at the ROTH MKM 2023 Healthcare Opportunities Conference in New York City on Thursday, October 12, 2023, at 11:00 a.m.
Key Points:
- MIAMI, Oct. 05, 2023 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”), an innovative biopharmaceutical company focused on efficiently acquiring, developing and commercializing or monetizing promising therapeutic products and product candidates, today announced that Lindsay A. Rosenwald, M.D., Chairman, President and Chief Executive Officer, will present a corporate overview at the ROTH MKM 2023 Healthcare Opportunities Conference in New York City on Thursday, October 12, 2023, at 11:00 a.m.
- ET.
