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
Generalized tonic–clonic seizure,
PO,
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Epilepsy,
AES,
American Epilepsy Society,
Therapy,
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GABAA,
FAAN,
DSM-IV codes,
Patient,
Safety,
Pharmacology,
GAERS,
Pharmaceutical industry MIAMI, Dec. 01, 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 that Amy Chappell, M.D., FAAN, will be presenting preclinical in vivo data evaluating BAER-101 using the SynapCell's Genetic Absence Epilepsy Rat from Strasbourg (“GAERS”) model of absence epilepsy at the American Epilepsy Society (AES) 2023 Annual Meeting in Orlando, FL on December 2, 2023.
Key Points:
- MIAMI, Dec. 01, 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 that Amy Chappell, M.D., FAAN, will be presenting preclinical in vivo data evaluating BAER-101 using the SynapCell's Genetic Absence Epilepsy Rat from Strasbourg (“GAERS”) model of absence epilepsy at the American Epilepsy Society (AES) 2023 Annual Meeting in Orlando, FL on December 2, 2023.
- The Company's presentation details are as follows:
“We are pleased with the progress made with BAER-101, a molecule with unique pharmacology which has demonstrated that it can significantly suppress seizures in a translational animal model of absence epilepsy,” said Alexandra MacLean, M.D., Chief Executive Officer of Avenue.
- In the model, BAER-101 demonstrated full suppression of seizure activity with a minimal effective dose of 0.3 mg/kg, PO.
- The combination of safety and tolerability in hundreds of patients and the preclinical efficacy data support BAER-101’s continued development in a Phase 2a trial.
Retrieved on:
Tuesday, November 14, 2023
NDA,
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SBMA,
BLA,
Exercise,
Patient,
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Marketing,
New Drug Application,
Fortification,
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Hyperhidrosis,
PDUFA,
Dermatology,
Video game,
Pharmaceutical industry,
NFE2L2,
Avenue,
Hong Kong,
Checkpoint MIAMI, Nov. 14, 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 financial results and recent corporate highlights for the third quarter ended September 30, 2023.
Key Points:
- Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, “In the third quarter of 2023, Fortress and our partner companies and subsidiaries continued to advance our diverse portfolio of drug candidates.
- Journey Medical’s total product net revenues were $15.3 million for the third quarter of 2023, compared to third quarter 2022 total product net revenues of $16.0 million.
- Fortress’ consolidated net revenue totaled $34.8 million for the third quarter of 2023, which included $15.3 million in net product revenue generated from our marketed dermatology products.
- Consolidated selling, general and administrative expenses were $21.7 million for the third quarter of 2023, compared to $30.1 million for the third quarter of 2022.
Retrieved on:
Tuesday, November 14, 2023
Sale,
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WM,
First grade,
CRS,
IND,
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Glioblastoma,
Risk,
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Clinical trial,
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CD19,
Nature,
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University of Washington,
Chronic lymphocytic leukemia,
File,
Mustang,
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University,
Mustang Bio,
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CFIUS,
Letter,
DSM-IV codes,
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Indolent lymphoma,
Pharmaceutical industry,
Cryptocurrency,
Video game WORCESTER, Mass., Nov. 14, 2023 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (“Mustang”) (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 financial results and recent corporate highlights for the third quarter that ended September 30, 2023.
Key Points:
- WORCESTER, Mass., Nov. 14, 2023 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (“Mustang”) (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 financial results and recent corporate highlights for the third quarter that ended September 30, 2023.
- Subsequent to the end of the third quarter, Mustang raised approximately $4.4 million of gross proceeds in a registered direct offering completed in October 2023.
- Research and development expenses were $9.5 million for the third quarter of 2023, compared to $15.5 million for the third quarter of 2022.
- General and administrative expenses were $2.1 million for the third quarter of 2023, compared to $3.4 million for the third quarter of 2022.
Retrieved on:
Tuesday, November 14, 2023
The warrants are immediately exercisable at a price of $1.70 per share and expire five years from the date of issuance.
Key Points:
- The warrants are immediately exercisable at a price of $1.70 per share and expire five years from the date of issuance.
- Certain directors and officers of the Company participated in the offering and purchased an aggregate amount of approximately $2.9 million of units at the same purchase price.
- The gross proceeds from the offering, before deducting the placement agent's fees and other offering expenses, are approximately $10.0 million.
- The offering was made only by means of a prospectus supplement which is a part of the effective registration statement.
Retrieved on:
Monday, November 13, 2023
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Checkpoint WALTHAM, Mass., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced financial results for the third quarter ended September 30, 2023, and recent corporate highlights.
Key Points:
- Biologics License Application for cosibelimab under review by U.S. FDA; PDUFA goal date of January 3, 2024
WALTHAM, Mass., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced financial results for the third quarter ended September 30, 2023, and recent corporate highlights.
- In July 2023, Checkpoint announced new, longer-term data for cosibelimab from its pivotal studies in locally advanced and metastatic cSCC.
- Also in July 2023, Checkpoint completed a registered direct offering priced at-the-market under Nasdaq rules for total gross proceeds of $10 million.
- Net loss for the third quarter of 2023 included $0.9 million of non-cash stock expenses, compared to $0.8 million for the third quarter of 2022.
Retrieved on:
Monday, November 13, 2023
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Avenue,
MIAMI MIAMI, Nov. 13, 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 reported financial results and recent corporate highlights for the third quarter ended September 30, 2023.
Key Points:
- “In the third quarter, Avenue continued to successfully execute across our pipeline of innovative CNS treatments," said Alexandra MacLean, M.D., Chief Executive Officer of Avenue.
- Topline data for the Phase 1b/2a clinical trial of AJ201 in SBMA are expected in the second quarter of 2024.
- R&D Expenses: Research and development expenses for the third quarter of 2023 were $0.9 million, compared to $0.2 million for the third quarter of 2022.
- G&A Expenses: General and administrative expenses for the third quarter of 2023 were $1.2 million, compared to $0.5 million for the third quarter of 2022.
Retrieved on:
Friday, November 10, 2023
Certain directors and officers of the Company participated in the offering and purchased an aggregate amount of approximately $2.9 million of units at the same purchase price.
Key Points:
- Certain directors and officers of the Company participated in the offering and purchased an aggregate amount of approximately $2.9 million of units at the same purchase price.
- The gross proceeds from the offering, before deducting the placement agent's fees and other offering expenses, are expected to be approximately $10.0 million.
- The offering is expected to close on or about November 14, 2023, subject to the satisfaction of customary closing conditions.
- The offering is being made only by means of a prospectus which is a part of the effective registration statement.
Retrieved on:
Thursday, November 9, 2023
All of the shares of common stock, pre-funded warrants and accompanying warrants are being offered by Fortress.
Key Points:
- All of the shares of common stock, pre-funded warrants and accompanying warrants are being offered by Fortress.
- Certain directors and officers of the Company may participate in the offering.
- Roth Capital Partners is acting as exclusive placement agent for the offering on a reasonable best-efforts basis.
- The offering is being made only by means of a prospectus which is a part of the effective registration statement.
Retrieved on:
Wednesday, December 6, 2023
NDA,
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Disease,
Patient,
U.S. FDA,
FDA,
Menkes disease,
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Death,
Parent,
Pharmaceutical industry,
Menkes,
Cyprium SOLANA BEACH, Calif. and AHMEDABAD, India, Dec. 6, 2023 /PRNewswire/ -- Sentynl Therapeutics, Inc. (Sentynl), a U.S.-based biopharmaceutical company wholly-owned by Zydus Lifesciences, Ltd. (Zydus Group), today announced the execution of an Assignment and Assumption Agreement with Cyprium Therapeutics, Inc. (Cyprium), a Fortress Biotech, Inc. (Nasdaq: FBIO) (Fortress) subsidiary company. Under the agreement, Cyprium completed the transfer of its worldwide proprietary rights and U.S. FDA documents pertaining to CUTX-101, the copper histidinate product candidate for the treatment of Menkes disease, to Sentynl.
Key Points:
- Under the agreement, Cyprium completed the transfer of its worldwide proprietary rights and U.S. FDA documents pertaining to CUTX-101, the copper histidinate product candidate for the treatment of Menkes disease, to Sentynl.
- Sentynl now assumes full responsibility for the development and commercialization of CUTX-101.
- In 2021, Sentynl and Cyprium reported positive results from a safety and efficacy analysis of data integrated from two completed pivotal studies in patients with Menkes disease treated with CUTX-101.
- This novel, breakthrough therapy could unlock possibilities for the treatment of the life threatening Menkes disease."
Retrieved on:
Friday, November 17, 2023
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