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Tivic Health Systems (NasdaqCM:TIVC) Conference Transcript
2026-01-22 22:12
Summary of Tivic Health Conference Call Company Overview - **Company**: Tivic Health - **Ticker Symbol**: TIVC (Nasdaq) - **Focus**: Transitioning into a biopharmaceutical company with late-stage assets, particularly in radiation treatment and oncology [1][2] Core Points and Arguments - **Transformation**: Tivic Health has completed a major overhaul, focusing on harnessing the immune system to improve clinical outcomes, particularly in radiation treatment [2] - **Intolamod**: - Licensed drug with significant prior investment ($140 million) and government support ($36 million) aimed at treating acute radiation syndrome [3] - Potential applications in oncology, with a well-characterized mechanism of action supported by over 40 studies [4] - **Market Opportunity**: - Current standard of care in the acute radiation syndrome market is valued at $9.4 billion, primarily addressing blood disorders from radiation exposure [5] - Intolamod could replace existing G-CSF drugs and provide protective benefits while supporting regeneration of fast-growing cells [6] - **Commercialization Milestones**: - Successful scaling of manufacturing from small batch to 200x, maintaining or exceeding purity and potency levels [8] - Plans to file a Biologics License Application (BLA) with the FDA, with Fast Track and Orphan Drug Designation already secured [8] - **Government Interest**: Significant interest from the U.S. government as a medical countermeasure for nuclear disasters, alongside oncology applications [9] - **Strategic Moves**: - Acquisition of manufacturing assets to bring production in-house, ensuring cGMP manufacturing access and reducing time to market [10] - Establishment of a contract development and manufacturing organization (CDMO) for phase one and two biologics, creating an additional revenue stream [11] - **Financial Position**: Recently closed a financing package allowing access to up to $75 million, targeting multiple high-value therapeutic inflection points within the next 18 to 24 months [12] Additional Important Content - **Regulatory Pathway**: The company is drafting its BLA and anticipates starting investigator-led trials in oncology applications this year [9] - **Partnership Opportunities**: Intolamod's unique position in both acute radiation syndrome and oncology creates real partnering opportunities as the company progresses [10] - **Location Advantage**: The San Antonio facility is strategically positioned to serve U.S. government requirements, with proximity to military bases and airports for emergency product transport [11]
RedHill Biopharma(RDHL) - Prospectus(update)
2026-01-22 21:04
Israel 2834 Not Applicable (Primary Standard Industrial Classification Code Number) As filed with the Securities and Exchange Commission on January 22, 2026 Registration No. 333-292528 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 TO FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 REDHILL BIOPHARMA LTD. (Exact name of Registrant as specified in its charter) Not Applicable (Translation of Registrant's name into English) (State or other jurisdiction o ...
Arcutis to Report Fourth Quarter and Full Year 2025 Financial Results and Present at Upcoming Investor Conference
Globenewswire· 2026-01-22 21:00
Fourth quarter and full year 2025 investor conference call scheduled for February 25, 2026 at 4:30 p.m. ETArcutis management to present at the Guggenheim Emerging Outlook: Biotech Summit on February 11, 2026 WESTLAKE VILLAGE, Calif., Jan. 22, 2026 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that it will report its fourth quarter and full year 2025 financial r ...
Psyence BioMed Announces Adjournment of Annual and Special Shareholder Meeting on January 22, 2026
Globenewswire· 2026-01-22 18:42
NEW YORK, Jan. 22, 2026 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd. (Nasdaq: PBM) (“Psyence BioMed” or the “Company”) today announced that it adjourned its annual and special meeting of shareholders (the “Meeting”) until February 12, 2026. The Meeting will now be held on February 12, 2026, at 9:00 a.m. New York Time/4:00 p.m. Cape Town time at Venture Workspace Riverlands, Office Building 4, Riverlands, 51 Gogosoa Street, Observatory, Cape Town, 7935, South Africa. The adjournment is a result of the requisi ...
Trevi Therapeutics Announces Publication of Data from the Phase 2b IPF Chronic Cough Trial of nalbuphine ER in the Journal of the American Medical Association (JAMA)
Prnewswire· 2026-01-22 17:30
Patient-reported outcome measure of cough frequency was consistent with reduction observed with objective cough monitoring NEW HAVEN, Conn., Jan. 22, 2026 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy oral nalbuphine ER for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease (non-IPF ILD), and refractory chronic cough (RCC), today announced that the ...
Plus Therapeutics, Inc. (PSTV) Discusses Business Update, REYOBIQ Clinical Program Progress, and Recent Financial Offering Transcript
Seeking Alpha· 2026-01-22 16:34
PresentationI would now like to turn the conference over to Vivian Cervantes, CORE Investor Relations. Please go ahead.Good day, and welcome to the Plus Therapeutics January 22, 2026, Business Update Conference Call. [Operator Instructions] Please note that this event is being recorded.Vivian Cervantes Thank you, Chloe. Good morning, and thank you for participating in today's conference call. Earlier this morning, the company released a business update and outline of progress in its REYOBIQ clinical program ...
Portnoy Law Firm Announces Class Action on Behalf of Vistagen Therapeutics, Inc. Investors
Globenewswire· 2026-01-22 14:52
LOS ANGELES, Jan. 22, 2026 (GLOBE NEWSWIRE) -- The Portnoy Law Firm advises Vistagen Therapeutics, Inc., (“Vistagen” or the "Company") (NASDAQ: VTGN) investors of a class action on behalf of investors that bought securities between April 1, 2024 and December 16, 2025, inclusive (the “Class Period”). Vistagen investors have until March 16, 2026 to file a lead plaintiff motion. Investors are encouraged to contact attorney Lesley F. Portnoy, by phone 844-767-8529 or email: lesley@portnoylaw.com, to discuss the ...
Hoth Therapeutics Delivers 100% Clinical Response with ~50% Reduction in Disease Severity in Open-Label PK Cohort of EGFR-Treated Cancer Patients
Prnewswire· 2026-01-22 13:13
Primary endpoint ARIGA improved by ~50% from baseline by Week 6, with all evaluable patients reaching low-severity disease; additional endpoints demonstrated ~34% improvement in oncology toxicity (CTCAE) and ~37% reduction in patient-reported pruritus. NEW YORK, Jan. 22, 2026 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company focused on advancing innovative therapies for cancer patients with significant unmet needs, today announced positive interim results fr ...
Incannex Healthcare Announces Formation of Clinical Advisory Board for PSX-001 Program
Globenewswire· 2026-01-22 13:00
Strengthens clinical and regulatory guidance as PSX-001 advances to its next phase of developmentMELBOURNE, Australia and NEW YORK, Jan. 22, 2026 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), a clinical-stage biopharmaceutical company developing innovative combination therapies, announces the formation of a Clinical Advisory Board (CAB) to support the continued advancement of its PSX-001 development program in generalized anxiety disorder. The newly established CAB has been formed to provide ...
Hansa Biopharma has won the 2025 SwedenBIO Award
Prnewswire· 2026-01-22 12:38
About Hansa Biopharma Hansa Biopharma AB is a pioneering commercial-stage biopharmaceutical company developing and commercializing novel immunomodulatory therapies to transform care for patients with acute or complex immune disorders. Hansa's proprietary IgG-cleaving enzyme technology platform to address serious unmet medical needs in transplantation, gene therapy and autoimmune diseases. The company's portfolio includes imlifidase, a first-in-class immunoglobulin G (IgG) antibody-cleaving enzyme therapy, w ...