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All | News | Filings
Date FiledTypeDescription
06/29/2020 8-K Quarterly results
05/14/2020 8-K Other Events
03/30/2020 8-K Other Events
03/27/2020 8-K Other Events
09/27/2019 8-K Investor presentation
Docs: "Investor Presentation (September 2019)"
09/23/2019 8-K Regulation FD Disclosure, Financial Statements and Exhibits
Docs: "Xynomic Pharma Receives Fast-Track Designation from the US FDA for Abexinostat as 4L Therapy Treating Follicular Lymphoma SHANGHAI, September 23, 2019 — Xynomic Pharmaceuticals Holdings, Inc. , a clinical stage US-China oncology drug development company, today announced that the U.S. Food and Drug Administration has granted Fast-Track designation to Xynomic’ s lead drug candidate abexinostat, for use as a single agent, as a fourth-line treatment of relapsed or refractory follicular lymphoma . Fast-Track is a designation by the FDA to facilitate the development and expedite the review of drugs to treat serious or life-threatening conditions and fill an unmet medical need. According to the U.S. National Cancer Institute, FL is the most common indolent non-Hodgkin’ s lymphoma subtype in the U..."
09/20/2019 8-K Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements...
09/13/2019 8-K Quarterly results
09/06/2019 8-K Entry into a Material Definitive Agreement, Financial Statements and Exhibits
Docs: "Form of Amended and Restated Securities Purchase Agreement by and among the Company and the Purchasers"
08/30/2019 8-K Regulation FD Disclosure, Financial Statements and Exhibits
Docs: "Xynomic Pharma Reports Encouraging Interim Data from Phase 1b Study of Abexinostat Combined with Keytruda® in Multiple Solid Tumors RALEIGH, N.C. and SHANGHAI, Aug. 30, 2019 — Xynomic Pharmaceuticals Holdings, Inc. , a clinical stage US-China oncology drug development company, announced encouraging interim data from an ongoing Phase 1b study of its lead candidate abexinostat, an orally dosed, hydroxamic acid-based small molecule histone deacetylase inhibitor , in combination with Keytruda®, for the treatment of multiple solid tumors. The trial is being conducted at University of California, San Francisco. The interim data will also be presented at the 3rd World-China Immunotherapy & Gene Therapy Congress 2019 to be held in Beijing from August 30th to 31st, 2019. This Phase 1b trial explore..."
08/27/2019 8-K Submission of Matters to a Vote of Security Holders
08/16/2019 8-K Regulation FD Disclosure, Financial Statements and Exhibits
Docs: "About Xynomic Pharmaceuticals Holdings, Inc."
08/07/2019 8-K Quarterly results
08/01/2019 8-K Regulation FD Disclosure, Financial Statements and Exhibits
Docs: "Xynomic Filed Fast-Track Designation Application for Follicular Lymphoma Treatment with the U.S. FDA RALEIGH, N.C. and SHANGHAI, August 1, 2019 — Xynomic Pharmaceuticals Holdings, Inc. , a clinical stage U.S.-China oncology drug development company, announced that it has filed an application with the U.S. Food and Drug Administration seeking Fast-Track designation for its drug candidate abexinostat as a monotherapy for the treatment of relapsed or refractory follicular lymphoma . Fast-Track designation is designed to aid in the development and expedite the review of drug candidates, which show promise in treating a serious or life-threatening disease, and address an unmet medical need. A drug candidate that receives Fast-Track designation is eligible for more frequent meetings and correspo..."
07/30/2019 8-K Quarterly results
07/17/2019 8-K Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing
07/11/2019 8-K Entry into a Material Definitive Agreement, Financial Statements and Exhibits
Docs: "Form of Securities Purchase Agreement by and among the Company and the Purchasers",
"Form of Warrants"
06/21/2019 8-K Investor presentation
Docs: "Investor Presentation (June 2019)"
06/12/2019 8-K Other Events, Financial Statements and Exhibits
Docs: "Xynomic Completes Pre-IND Meeting with US FDA for XP-102, a Novel Pan-RAF Inhibitor against Colorectal Cancer and Lung Cancer RALEIGH, N.C. and SHANGHAI, June 12, 2019 -- Xynomic Pharmaceuticals Holdings, Inc. , a clinical stage US-China oncology drug development company, announced that it recently held a pre-IND meeting with the U.S. Food and Drug Administration for its pan-PAF inhibitor XP-102 for the treatment of cancers. The FDA addressed Xynomic' questions related to CMC, nonclinical and clinical protocol, and provided valuable advice on overall clinical development plan to advance this drug candidate. Xynomic is on track to file this Investigational New Drug application in the second half of 2019. XP-102 is a second generation potent and selective pan-RAF inhibitor uniquely binding t..."
06/06/2019 8-K Other Events, Financial Statements and Exhibits
Docs: "Xynomic Dosed First Patient in Phase 1/2 Lymphoma Trial RALEIGH, N.C. and SHANGHAI, June 6, 2019 -- Xynomic Pharmaceuticals Holdings, Inc. , a clinical stage US-China oncology drug development company, announced that Xynomic has dosed the first patient in a Phase 1/2 trial that combines abexinostat with ibrutinib in patients with relapsed/refractory mantle cell lymphoma or relapsed/refractory diffuse large B-cell lymphoma at Memorial Sloan Kettering Cancer Center . This trial will enroll approximately 40 patients to assess the safety and efficacy of the combination in patients with r/r MCL or r/r DLBCL. This trial will also explore the biologic predictors of response and resistance to dual B-cell receptor and histone deacetylase inhibition. Janssen Biotech, Inc. is providing ibrutinib as p..."
05/21/2019 8-K Other Events, Financial Statements and Exhibits
Docs: "Xynomic Pharma To Present Long-Term Follow Up Data Showing Abexinostat, Combined with Pazopanib, has Durable Responses in Patients with Pre-Treated Kidney Cancer"
05/20/2019 8-K Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing
05/15/2019 8-K Acquisition/merger/asset purchase announced
Docs: "Certificate of Incorporation of the Company, effective on May 14, 2019",
"Amended and Restated Certificate of Incorporation of the Company, effective on May 15, 2019",
"Bylaws of the Company, effective as of May 15, 2019",
"Amended and Restated Registration Rights Agreement",
"Escrow Agreement",
"Form of Indemnification Agreement with each director and office",
"Insider Trading Policy",
"Resignation of Peixin Xu",
"Subsidiaries of Registrant",
"Audited Financial Statements of Xynomic Pharmaceuticals, Inc"
04/29/2019 8-K Quarterly results
04/04/2019 8-K Entry into a Material Definitive Agreement, Financial Statements and Exhibits
Docs: "Third Amendment to Agreement And Plan Of Merger"
03/22/2019 8-K Entry into a Material Definitive Agreement, Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year, Submiss...
Docs: "Amended and Restated Memorandum of Association and Articles of Association",
"Amendment No. 1 to Trust Agreement, by and between Bison Capital Acquisition Corp. and Continental Stock Transfer & Trust Company"
03/20/2019 8-K Regulation FD Disclosure, Financial Statements and Exhibits
Docs: "Xynomic Pharmaceuticals, Inc. Will Present at ASCO 2019 Annual Meeting, Will Sponsor an EU Investigator Meeting for Potentially Pivotal Kidney Cancer Trial, and Appoints Interim Chief Accounting Officer"
03/18/2019 8-K Regulation FD Disclosure, Financial Statements and Exhibits
Docs: "Xynomic Pharma Achieves Important Regulatory Milestones in China and EU in Potentially Pivotal Kidney Cancer and Lymphoma Trials RALEIGH, N.C. and SHANGHAI, March 16, 2019 /PRNewswire/ - Xynomic Pharma, a clinical stage US-China oncology drug development company, and Bison Capital Acquisition Corp. , today jointly announced that China, Spain and Poland authorities have approved Xynomic’ s application to conduct potentially pivotal Phase 3 trial using Xynomic’ s abexinostat, in combination with pazopanib, in patients with renal cell carcinoma . Xynomic plans to initiate this trial in China, Spain, Poland and additional European countries in the first half of 2019. The same trial is currently ongoing in the United States and South Korea. According to a June 2018 research report by Grand View..."
03/04/2019 8-K Other Events
02/27/2019 8-K Entry into a Material Definitive Agreement, Regulation FD Disclosure, Financial Statements and Exhibits
Docs: "Second Amendment to Agreement And Plan Of Merger",
"Xynomic Pharma Doses First South Korean Patient in Phase 3 Renal Cell Carcinoma Trial and Hires Senior Executive Dr. Sophia Paspal to Head Regulatory Affairs and Quality Assurance"
02/12/2019 8-K Quarterly results
12/28/2018 8-K Submission of Matters to a Vote of Security Holders
10/18/2018 8-K Quarterly results
09/19/2018 8-K Regulation FD Disclosure, Financial Statements and Exhibits
Docs: "Investor Presentation—September 2018"
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