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
CKPT,
Immunotherapy,
U.S. FDA,
Patient,
Autoimmune disease,
PDUFA,
Ira Pastan,
Oncology,
Research,
FDA,
Oliviero,
Regulation of tobacco by the U.S. Food and Drug Administration,
BLA,
Food,
D,
Pharmaceutical industry,
Cryptocurrency,
Video game WALTHAM, Mass., Aug. 14, 2023 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced financial results for the second quarter ended June 30, 2023, and recent corporate highlights.
Key Points:
- Biologics License Application for cosibelimab under review by U.S. FDA; Successful mid-cycle meeting with U.S. FDA completed; PDUFA goal date of January 3, 2024
WALTHAM, Mass., Aug. 14, 2023 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced financial results for the second quarter ended June 30, 2023, and recent corporate highlights.
- R&D Expenses: Research and development expenses for the second quarter of 2023 were $13.9 million, compared to $12.1 million for the second quarter of 2022, an increase of $1.8 million.
- General and administrative expenses for the second quarter of 2023 included $0.8 million of non-cash stock expenses, compared to $0.5 million for the second quarter of 2022.
- Net loss for the second quarter of 2023 included $1.0 million of non-cash stock expenses, compared to $0.7 million for the second quarter of 2022.
Retrieved on:
Thursday, August 10, 2023
Epilepsy,
DSM-IV codes,
Seizure,
Spinal and bulbar muscular atrophy,
IV,
Symantec Endpoint Protection,
PO,
Anterior grey column,
Schedule,
SBMA,
Pain,
U.S. FDA,
Morphine,
Patient,
Hydromorphone,
Research,
FDA,
Therapy,
Regulation of food and dietary supplements by the U.S. Food and Drug Administration,
Tramadol,
Food,
Safety,
Generalized tonic–clonic seizure,
D,
Pharmaceutical industry,
Avenue MIAMI, Aug. 10, 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 second quarter ended June 30, 2023.
Key Points:
- Additionally, we reported promising preclinical results for BAER-101 that show robust anti-seizure activity in a translational animal model of absence epilepsy.
- R&D Expenses: Research and development expenses for the second quarter of 2023 were $3.0 million, compared to $0.2 million for the second quarter of 2022.
- G&A Expenses: General and administrative expenses for the second quarter of 2023 were $0.9 million, compared to $0.5 million for the second quarter of 2022.
- Net Loss: Net loss attributable to common stockholders for the second quarter of 2023 was $4.0 million, or $0.52 per share, compared to a net loss of $0.6 million, or $0.41 per share, for the second quarter of 2022.
WORCESTER, Mass., Aug. 03, 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 that Manuel Litchman, M.D., President and Chief Executive Officer, will participate in two investor conferences in August 2023.
Key Points:
- WORCESTER, Mass., Aug. 03, 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 that Manuel Litchman, M.D., President and Chief Executive Officer, will participate in two investor conferences in August 2023.
- Details of the events are as follows:
BTIG Virtual Biotechnology Conference 2023: The company will present a corporate update on Tuesday, August 8, 2023, at 9:00 a.m.
- ET and will participate in one-on-one meetings during the conference.
- H.C. Wainwright Immune Cell Engager Virtual Conference: The company will participate in a fireside chat on Thursday, August 17, 2023, at 3:00 p.m.
MIAMI, Aug. 03, 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 BTIG Virtual Biotechnology Conference on Tuesday, August 8, 2023 at 12:00 PM ET.
Key Points:
- MIAMI, Aug. 03, 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 BTIG Virtual Biotechnology Conference on Tuesday, August 8, 2023 at 12:00 PM ET.
- The Company will also attend virtual one-on-one meetings during the conference.
- For more information or to join the conference, email [email protected] .
Epilepsy,
DSM-IV codes,
Seizure,
Generalized tonic–clonic seizure,
Human,
Deficit spending,
PO,
Ataxia,
AstraZeneca,
Eli Lilly,
Patient,
GAERS,
Addiction,
Therapy,
FAAN,
Safety,
Pharmaceutical industry,
Avenue The GAERS model mimics behavioral, electrophysiological and pharmacological features of human absence seizures.
Key Points:
- The GAERS model mimics behavioral, electrophysiological and pharmacological features of human absence seizures.
- The GAERS model is a proven, early, informative indicator of efficacy in anti-seizure drug development, with high predictability of response in humans.
- 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, tolerability and efficacy in an established translationally relevant epilepsy model support BAER-101’s continued development.
Employment,
Chronic lymphocytic leukemia,
Non-Hodgkin lymphoma,
Translation,
CAR,
CFIUS,
CGMP,
Patient,
Cancer,
Form,
Foreign investment,
Mustang,
DSM-IV codes,
Pharmaceutical industry,
Lease,
Fine chemical Unless and until the lease is transferred to uBriGene, Mustang will retain its facility lease and facility personnel, and will continue to occupy the leasehold premises and manufacture there its lead product candidate, MB-106.
Key Points:
- Unless and until the lease is transferred to uBriGene, Mustang will retain its facility lease and facility personnel, and will continue to occupy the leasehold premises and manufacture there its lead product candidate, MB-106.
- The amended asset purchase agreement provides that Mustang will continue to work with uBriGene to secure the assignment of its manufacturing facility lease, which would complete the transfer of its facility to uBriGene as originally planned.
- At closing, Mustang and uBriGene also entered into a manufacturing services agreement, under which Mustang contracted uBriGene to manufacture Mustang’s lead product candidates.
- Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, commented, “We are very pleased to have closed this strategic transaction with uBriGene.
Park,
Checkpoint,
Telephone,
CKPT,
SEC filing,
Sale,
Prospectus,
S-3,
Series,
Form,
Security (finance) H.C. Wainwright & Co. is acting as exclusive placement agent for the offering.
Key Points:
- H.C. Wainwright & Co. is acting as exclusive placement agent for the offering.
- The closing of the offering is expected to occur on or about July 31, 2023, subject to the satisfaction of customary closing conditions.
- The gross proceeds from the offering are expected to be approximately $10 million.
- The securities offered in the registered direct offering are being offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.
DSM-IV codes,
Spinal and bulbar muscular atrophy,
Neurodegenerative disease,
Clinical trial,
Biomarker,
Anterior grey column,
SBMA,
MRI,
NRF1,
Oxidative stress,
Patient,
NFE2L2,
Therapy,
AR,
Safety,
Pharmaceutical industry,
Medical imaging,
Avenue MIAMI, July 27, 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 the first patient has been dosed in the Phase 1b/2a clinical trial of AJ201 for the treatment of spinal and bulbar muscular atrophy (“SBMA”), also known as Kennedy's Disease.
Key Points:
- MIAMI, July 27, 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 the first patient has been dosed in the Phase 1b/2a clinical trial of AJ201 for the treatment of spinal and bulbar muscular atrophy (“SBMA”), also known as Kennedy's Disease.
- “We are excited to announce that the first patient has been dosed in our Phase 1b/2a clinical trial evaluating AJ201 for the treatment of SBMA, a progressive and devastating neurodegenerative disease that currently has no approved treatments available,” said Alexandra MacLean, M.D., Chief Executive Officer of Avenue.
- “We are encouraged by the Phase 1 clinical data of AJ201 that demonstrate the drug’s excellent safety profile in healthy volunteers.
- The primary endpoint of the study is to assess safety and tolerability of AJ201 in subjects with clinically and genetically defined SBMA.
Radiation,
Neoplasm,
Immunotherapy,
Autoimmunity,
Prescription Drug User Fee Act,
Ira Pastan,
Patient,
Autoimmune disease,
PD-1,
Oncology,
Regulation of food and dietary supplements by the U.S. Food and Drug Administration,
BLA,
PD-L1,
FC,
Food,
Safety,
Pharmaceutical industry WALTHAM, Mass., July 27, 2023 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced new, longer-term data for cosibelimab from its pivotal studies in locally advanced and metastatic cutaneous squamous cell carcinoma (“cSCC”). These results demonstrate a deepening of response over time, resulting in substantially higher complete response rates than previously reported. Furthermore, responses continue to remain durable over time with the median duration of response not yet reached in either group. Results determined by independent central review by treatment group were as follows:
Key Points:
- “We are excited to see the substantial increases in the rate of patients experiencing a complete response of their cSCC tumors with further cosibelimab treatment in both our locally advanced and metastatic pivotal trials,” said James Oliviero, President and Chief Executive Officer of Checkpoint.
- Mr. Oliviero continued, “Unlike PD-1 inhibitors, cosibelimab does not interrupt the body’s PD-1/PD-L2 pathway, which we believe results in cosibelimab’s low rates of autoimmunity.
- The application is filed and under review with a Prescription Drug User Fee Act (“PDUFA”) goal date of January 3, 2024.
- Checkpoint plans to present these updated results at an upcoming medical conference.
Epilepsy,
DSM-IV codes,
Partnership,
IV,
Element,
Schedule,
Pain,
Morphine,
Patient,
Physician,
Hypoventilation,
Norepinephrine,
Hydromorphone,
Serotonin,
FDA,
Therapy,
Tramadol,
Regulation of food and dietary supplements by the U.S. Food and Drug Administration,
Food,
Safety,
Pharmaceutical industry,
Avenue The agreed upon non-inferiority study is designed to assess the theoretical risk of opioid-induced respiratory depression related to opioid stacking on IV tramadol compared to IV morphine.
Key Points:
- The agreed upon non-inferiority study is designed to assess the theoretical risk of opioid-induced respiratory depression related to opioid stacking on IV tramadol compared to IV morphine.
- The study will randomize post bunionectomy patients to IV tramadol or IV morphine for pain relief administered during a 48-hour post-operative period.
- Of note, IV tramadol demonstrated safety and efficacy in this same surgical model in a Phase 3 efficacy trial.
- We remain committed to Avenue’s mission of delivering impactful therapies to treat patients with neurologic diseases, while building shareholder value,” said Dr. MacLean.
