Associated tags: Therapy, Hospital, City, AstraZeneca, Nationwide, Fortress Biotech, Fortification, Drug development, Pharmaceutical industry, Patient, DSM-IV codes, Safety
Locations: UNITED STATES, CHECKPOINT, MASSACHUSETTS, ALABAMA, LOS ANGELES, SPAIN, BOSTON, MA, AZ, SCOTTSDALE, HONG KONG, NEW YORK CITY, IV, CAR, MCLEAN, PARK, GABA, BAY HARBOR ISLANDS, NEW ORLEANS, NEW YORK, NY, US, AL, MALAYSIA, TAIWAN, JAPAN, INDONESIA, SINGAPORE, VIETNAM, PHILIPPINES, LAOS, MACAU, BRUNEI, CAMBODIA, THAILAND, MYANMAR, FL, CALIFORNIA
H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.
Key Points:
- H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.
- The gross proceeds from the offering, before deducting the placement agent's fees and other offering expenses payable by the Company, and prior to any potential warrant exercises, were approximately $4 million.
- The Company intends to use the net proceeds from this offering for working capital and general corporate and other purposes.
- The offering was made only by means of a prospectus, including a prospectus supplement, forming part of the effective registration statement.
Retrieved on:
Wednesday, April 24, 2024
The reverse stock split is intended to bring the Company into compliance with Nasdaq’s $1.00 per share minimum bid price requirement for continued listing.
Key Points:
- The reverse stock split is intended to bring the Company into compliance with Nasdaq’s $1.00 per share minimum bid price requirement for continued listing.
- After the effectiveness of the reverse stock split, the number of outstanding shares of common stock will be reduced from approximately 44.7 million to approximately 0.6 million, subject to adjustment to give effect to the treatment of any fractional shares that stockholders would have received in the reverse stock split.
- Avenue’s transfer agent, VStock Transfer, LLC, is acting as the exchange agent for the reverse stock split.
- Avenue does not expect that stockholders holding their shares in book-entry form or through a bank, broker or other nominee need to take any action in connection with the reverse stock split.
AstraZeneca,
Exercise,
Fortification,
New Drug Application,
Patient,
GBM,
CRL,
NDA,
Menkes,
Minocycline,
Therapy,
Marketing,
Radiation,
CKPT,
Rosacea,
Investigational New Drug,
Erythema,
Safety,
BLA,
Fortress Biotech,
Food,
Red,
Amyloidosis,
Dermatology,
Carcinoma,
FDA,
Hyperhidrosis,
Mustang Bio,
Menkes disease,
PDUFA,
Pharmaceutical industry MIAMI, March 28, 2024 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”), an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty revenue, today announced financial results and recent corporate highlights for the full-year ended December 31, 2023.
Key Points:
- Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, “In 2023, we built a significant amount of momentum to position our Company to achieve multiple milestones in 2024.
- In March 2024, the FDA accepted the NDA and has set a PDUFA goal date of November 4, 2024.
- In December 2023, the FDA issued a complete response letter (“CRL”) for the cosibelimab BLA.
- Fortress’ consolidated net revenue totaled $84.5 million for the full year ended December 31, 2023, which included $59.7 million in net revenue generated from our marketed dermatology products.
Mustang,
Rheumatoid arthritis,
Rituximab,
Chronic lymphocytic leukemia,
Patient,
DSM-IV codes,
CD20,
Cancer,
Translation,
NHL,
B cell,
Clinical trial,
Society,
Waldenström macroglobulinemia,
Hematology,
Health,
Lymphoma,
Waldenström,
Autoimmune disease,
Pharmaceutical industry WORCESTER, Mass., March 28, 2024 (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 its expansion into autoimmune diseases with MB-106, a personalized CD20-targeted, 3rd-generation autologous CAR T-cell therapy. MB-106 is being developed in a collaboration between Mustang and Fred Hutchinson Cancer Center (“Fred Hutch”). Mustang and Fred Hutch are in preliminary discussions to explore a potential Phase 1 investigator-sponsored clinical trial to evaluate MB-106 for the treatment of autoimmune diseases.
Key Points:
- MB-106 is being developed in a collaboration between Mustang and Fred Hutchinson Cancer Center (“Fred Hutch”).
- Mustang and Fred Hutch are in preliminary discussions to explore a potential Phase 1 investigator-sponsored clinical trial to evaluate MB-106 for the treatment of autoimmune diseases.
- “MB-106’s observed safety profile, encouraging efficacy data, and our robust manufacturing capabilities have the potential to translate to improved outcomes for patients with autoimmune diseases.
- Several antibody therapies targeting CD20 on B-cells have successfully transitioned from cancer to autoimmune diseases, such as rituximab for both lymphoma and rheumatoid arthritis.
ALS,
Disease,
KOL,
University,
Anterior grey column,
Therapy,
DSM-IV codes,
Division,
Medical laboratory,
Pathology,
Pharmaceutical industry MIAMI, March 25, 2024 (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 it will host a virtual key opinion leader (“KOL”) event highlighting expert perspectives on spinal bulbar muscular atrophy (“SBMA”), also known as Kennedy's Disease, on Thursday, April 4, 2024 at 11:00am ET.
Key Points:
- MIAMI, March 25, 2024 (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 it will host a virtual key opinion leader (“KOL”) event highlighting expert perspectives on spinal bulbar muscular atrophy (“SBMA”), also known as Kennedy's Disease, on Thursday, April 4, 2024 at 11:00am ET.
- The virtual event will focus on the potential of AJ201 in SBMA, including KOL perspectives on the SBMA treatment landscape, an overview of the Phase 1b/2a study evaluating AJ201 for the treatment of SBMA and outcome considerations for the upcoming topline data read-out for the Phase 1b/2a trial expected in the second quarter of 2024.
- To access the conference call, please register using the audio conference link here .
- A webcast replay of the event will be available on the Events page of Avenue’s website at https://avenuetx.com/ .
Research,
Epilepsy,
PO,
Seizure,
Partnership,
Risk,
Patient,
Tramadol,
Acquisition,
American Epilepsy Society,
GABAA,
Enrollment,
NRF1,
SBMA,
Schedule,
Hydromorphone,
Society,
Therapy,
DSM-IV codes,
Safety,
GAERS,
Morphine,
Pain,
FDA,
AES,
Annual general meeting,
Food,
Pharmaceutical industry MIAMI, March 18, 2024 (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 year ended December 31, 2023.
Key Points:
- “We made considerable progress across our pipeline of differentiated neurologic therapies in 2023," said Alexandra MacLean, M.D., Chief Executive Officer of Avenue.
- Pending additional financing, we look forward to progressing BAER-101 and IV tramadol for patients facing great unmet need.
- R&D Expenses: Research and development expenses for the full year 2023 were $6.1 million, compared to $2.7 million in 2022.
- G&A Expenses: General and administrative expenses for the full year 2023 were $4.2 million, compared to $5.3 million in 2022.
Internal medicine,
Circulatory system,
Certification,
CKPT,
FASN,
Biotechnology,
FACP,
Research,
University,
Nephrology,
Society,
Marketing,
Hematology,
Alexion,
Bayer,
Health,
Hypertension,
Pharmaceutical industry WALTHAM, Mass., March 18, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced the appointment of Amit Sharma, M.D., FACP, FASN, FNKF, to its Board as an independent, non-executive director, effective immediately.
Key Points:
- WALTHAM, Mass., March 18, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced the appointment of Amit Sharma, M.D., FACP, FASN, FNKF, to its Board as an independent, non-executive director, effective immediately.
- Prior to joining Alexion, he served as Vice President of Medical Affairs for the Cardiovascular and Renal Division of Bayer Pharmaceuticals.
- “We are pleased to welcome Dr. Sharma to our Board of Directors,” said James F. Oliviero, President and Chief Executive Officer of Checkpoint.
- “He is a highly accomplished life sciences executive, with leadership experience in many facets of both patient care and the research, development, approval and commercialization of pharmaceutical products.
MIAMI, March 15, 2024 (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 by decision dated March 11, 2024, the Nasdaq Hearings Panel granted the Company’s request for an extension to evidence compliance with all applicable criteria for continued listing on The Nasdaq Capital Market, including the $1.00 bid price and $2.5 million stockholders’ equity requirements, through May 20, 2024.
Key Points:
- MIAMI, March 15, 2024 (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 by decision dated March 11, 2024, the Nasdaq Hearings Panel granted the Company’s request for an extension to evidence compliance with all applicable criteria for continued listing on The Nasdaq Capital Market, including the $1.00 bid price and $2.5 million stockholders’ equity requirements, through May 20, 2024.
- The Company is considering all available options that may enable it to timely evidence compliance with the continued listing criteria and maintain its listing on Nasdaq; however, there can be no assurance that the Company will be able to do so.
MIAMI, March 12, 2024 (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 participate in a fireside chat at the 36th Annual ROTH Conference on Monday, March 18, 2024, at 2:00 p.m. PT in Dana Point, California.
Key Points:
- MIAMI, March 12, 2024 (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 participate in a fireside chat at the 36th Annual ROTH Conference on Monday, March 18, 2024, at 2:00 p.m. PT in Dana Point, California.
- The Company will also attend one-on-one meetings during the conference.
- A webcast of the fireside chat will be available on the Events page under the News & Media section of Fortress’ website: www.fortressbiotech.com for approximately 30 days following the meeting.
Receptor (biochemistry),
DSM-IV codes,
FAAN,
GAERS,
Safety,
Society,
PO,
Generalized tonic–clonic seizure,
Therapy,
Patient,
Epilepsy,
Human,
Pharmaceutical industry MIAMI, March 11, 2024 (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 epilepsy at the American Society for Experimental Neurotherapeutics (ASENT) 2024 Annual Meeting on Wednesday, March 13, 2024.
Key Points:
- The Company's presentation details are as follows:
Title: BAER-101, a Selective Potentiator of α2- and α3-containing GABAA Receptors, Fully Suppresses Spontaneous Cortical Spike-Wave Discharges in Genetic Absence Epilepsy
BAER-101 underwent preclinical in vivo evaluation in SynapCell's GAERS model of absence epilepsy.
- In the model, BAER-101 demonstrated full suppression of seizure activity with a minimal effective dose of 0.3 mg/kg, PO.
- The effect was fast in onset and stable throughout the duration of testing.
- 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.
