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Fortress Biotech Reports 2023 Financial Results and Recent Corporate Highlights

Retrieved on: 
Thursday, March 28, 2024
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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.

Achieve Life Sciences Reports Financial Results for Fourth Quarter and Year-End 2023 and Provides Corporate Update

Retrieved on: 
Thursday, March 28, 2024
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Results presented from the Phase 3 participant surveys, showed that 69% of survey respondents who received cytisinicline reported quitting smoking completely.

Key Points: 
  • Results presented from the Phase 3 participant surveys, showed that 69% of survey respondents who received cytisinicline reported quitting smoking completely.
  • For those on treatment that did not achieve full smoking abstinence, 22% reported a reduction of their smoking by over half.
  • Total operating expenses for the fourth quarter and year ended December 31, 2023 were $4.4 million and $27.3 million, respectively.
  • Total net loss for the fourth quarter and year ended December 31, 2023 was $5.5 million and $29.8 million, respectively.

Applied Therapeutics Provides FDA Update on PDUFA Target Action Date for Govorestat for the Treatment of Classic Galactosemia

Retrieved on: 
Thursday, March 28, 2024
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The FDA has set a new Prescription Drug User Fee Act (PDUFA) target action date of November 28, 2024.

Key Points: 
  • The FDA has set a new Prescription Drug User Fee Act (PDUFA) target action date of November 28, 2024.
  • In February 2024, the Company announced that the FDA accepted and granted Priority Review to the NDA.
  • “While the PDUFA action date extension represents a delay, we remain confident in the potential for govorestat approval for Galactosemia and we will continue to work closely with the FDA throughout the review process,” said Shoshana Shendelman, PhD, Founder and CEO of Applied Therapeutics.
  • If approved, govorestat would be the first medication indicated for the treatment of Galactosemia and would be Applied Therapeutics’ first commercial product.

Unicycive Therapeutics Announces Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, March 28, 2024
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LOS ALTOS, Calif., March 28, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY) (the “Company” or “Unicycive”), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the year ended December 31, 2023, and provided a business update.

Key Points: 
  • LOS ALTOS, Calif., March 28, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY) (the “Company” or “Unicycive”), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the year ended December 31, 2023, and provided a business update.
  • Completed a private placement with new and existing healthcare institutional investors that generated $50 million in gross proceeds to Unicycive.
  • Cash Position: As of December 31, 2023, cash and cash equivalents totaled $9.7 million.
  • Subsequent to year end, in March 2024, Unicycive completed a private placement of preferred stock which generated $50 million in gross proceeds.

Tonix Pharmaceuticals Announces Pricing of $4.4 Million Registered Direct Offering

Retrieved on: 
Thursday, March 28, 2024
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The closing of the offering is expected to take place on or about April 1, 2024, subject to the satisfaction of customary closing conditions.

Key Points: 
  • The closing of the offering is expected to take place on or about April 1, 2024, subject to the satisfaction of customary closing conditions.
  • The gross proceeds of the offering will be approximately $4.4 million before deducting placement agent fees and other estimated offering expenses payable by the Company.
  • A.G.P./Alliance Global Partners is acting as sole placement agent for the offering.
  • This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No.

Apollomics Highlights Clinical Progress and Reports Full Year 2023 Financial Results

Retrieved on: 
Thursday, March 28, 2024
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Key Points: 
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    FOSTER CITY, Calif., March 28, 2024 (GLOBE NEWSWIRE) --  Apollomics Inc. (Nasdaq: APLM) (“Apollomics” or the “Company”), a late- stage clinical biopharmaceutical company developing multiple oncology drug candidates to address difficult-to-treat and treatment-resistant cancers, today announced financial results for the full year ended December 31, 2023, and highlighted progress of its pipeline.
  • As a result, Apollomics believes that its current capital resources will fund planned operations through the first quarter of 2025.
  • Dr. Plunkett brings to Apollomics over 25 years of strategic and financial experience within the biopharmaceutical sector, including extensive fundraising and corporate development expertise.
  • In March 2023, the Company raised $23.7 million in a private placement in public equity (PIPE) financing, before transaction expenses.

China Medical System （867.HK）2023 Annual Results: Despite of the Temporary Financial Performance Pressure Fresh Catalysts Emerged from Successive Innovation Breakthroughs

Retrieved on: 
Thursday, March 28, 2024
Sclerotherapy, RMB, Conditional sentence, NDA, IND, Creativity, Small RNA, Marketing, Gastroenterology, Central nervous system, FIC, City, BIC, CMS, NRDL, Injection, Dermatology, CDMO, Commercialization, Tablet, Pharmacy, Methotrexate, Hospital, Acquisition, Gonadotropin-releasing hormone, RCT, VBP, Rheumatoid arthritis, Growth, Varicose veins, Ecosystem, Blue, Government, Ophthalmology

SHENZHEN, CHINA, March 27, 2024 (GLOBE NEWSWIRE) -- On March 27, 2024, China Medical System (“CMS” or the “Company”) released its 2023 annual results.

Key Points: 
  • SHENZHEN, CHINA, March 27, 2024 (GLOBE NEWSWIRE) -- On March 27, 2024, China Medical System (“CMS” or the “Company”) released its 2023 annual results.
  • Based on above, CMS has successfully entered into its “New Period” of innovation and internationalization development.
  • 4 innovative drugs have started large-scale clinical application, unveiling CMS’s first year of commercialization era of innovative drugs.
  • Under its compliant and efficient commercialization system, the Company's innovative products and exclusive drugs will grow steadily.

Galera Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Corporate Updates

Retrieved on: 
Thursday, March 28, 2024
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We are continuing to explore strategic options to maximize value to our shareholders, including a potential development path for avasopasem.

Key Points: 
  • We are continuing to explore strategic options to maximize value to our shareholders, including a potential development path for avasopasem.
  • The Prescription Drug User Fee Act (PDUFA) target date assigned by the FDA for the NDA was August 9, 2023.
  • Research and development expenses were $3.2 million in the fourth quarter of 2023, compared to $8.1 million for the same period in 2022.
  • General and administrative expenses were $2.0 million in the fourth quarter of 2023, compared to $5.0 million for the same period in 2022.

Iterum Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Thursday, March 28, 2024
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DUBLIN, Ireland and CHICAGO, March 28, 2024 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today reported financial results for the fourth quarter and year ended December 31, 2023.

Key Points: 
  • Iterum reported positive top-line data in January 2024 and plans to resubmit its NDA early in the second quarter of 2024.
  • In connection with this strategic process, Iterum has engaged a financial advisor to assist management and the board in evaluating strategic alternatives.
  • In addition, during the fourth quarter of 2022, a change in the discount rate impacted the fair value of the Royalty-Linked Notes.
  • Iterum will host a conference call today, Thursday, March 28, 2024 at 8:30 a.m. Eastern Time.

Milestone Pharmaceuticals Announces Resubmission of New Drug Application for Etripamil for Treatment in Paroxysmal Supraventricular Tachycardia

Retrieved on: 
Thursday, March 28, 2024
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MONTREAL and CHARLOTTE, N.C., March 28, 2024 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced the resubmission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for etripamil, the Company’s lead investigational product for the management of paroxysmal supraventricular tachycardia (PSVT).

Key Points: 
  • MONTREAL and CHARLOTTE, N.C., March 28, 2024 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced the resubmission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for etripamil, the Company’s lead investigational product for the management of paroxysmal supraventricular tachycardia (PSVT).
  • “We appreciate FDA’s guidance through the resubmission process.
  • We believe we have addressed all the issues raised in the Refusal to File letter and look forward to working with the Agency as it reviews our application,” said Joseph Oliveto, President, and Chief Executive Officer of Milestone Pharmaceuticals.
  • The resubmission package included restructured data sets that captured timing of reported AEs and certain data files reformatted to facilitate FDA’s analyses.