Senhwa's Pidnarulex Receives US FDA Fast Track Designation for the Treatment of Solid Tumors with BRCA1/2, PALB2 and other HR Gene Mutations
TAIPEI and SAN DIEGO, Jan. 25, 2022 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, announced today that the US Food and Drug Administration (FDA) has granted Fast Track...
Senhwa Clinical Data Abstract for Silmitasertib in Patients with Advanced Basal Cell Carcinoma Accepted for 2022 AAD Annual Meeting
TAIPEI and SAN DIEGO, Dec. 16, 2021 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, announced that an abstract highlighting preliminary clinical data for their lead drug...
Senhwa Biosciences Announces Abstract Accepted for Presentation at the 2022 ASCO Gastrointestinal Cancers Symposium
TAIPEI and SAN DIEGO, Nov. 15, 2021 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, announced that an abstract highlighting clinical design for their lead drug candidate...
Senhwa Presents Positive Initial Data from Phase 2 Clinical Trial of Silmitasertib (CX-4945) in Moderate COVID-19 Patients At the ISIRV-WHO Conference
* Statistically significant 133% faster time to COVID-19 clinical symptoms recovery versus standard of care (SOC)/best supportive care. * Statistically significant 114% faster time to reach EQ-5D-5L Q6 ≥ 90% versus SOC/best supportive care. * Statistically significant 57% faster time to norm...
Senhwa Announces First Patient Successfully Dosed in Phase 1b Expansion Study of Pidnarulex to Treat Solid Tumors with Specific Homologous Recombination Gene Mutations
TAIPEI and SAN DIEGO, Sept. 10, 2021 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, announced t hat their first patient has been successfully dosed, in a Phase1b c...
Senhwa's Silmitasertib, COVID-19 Drug Candidate, Receives Positive Interim Review from Data Monitoring Committee to Proceed
TAIPEI and SAN DIEGO, Aug. 31, 2021 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focused on first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, today announced that its oral new drug, Silmitasertib, had received a positive feedbac...
Senhwa Biosciences Announces Dose Escalation Initiation of the Phase I Trial of Pidnarulex as a Treatment for Advanced Hematological Malignancies
TAIPEI and SAN DIEGO, Aug. 25, 2021 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focused on first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, today announced the initiation of Dose Escalation within the Phase I Investigator Init...
Senhwa Completes Enrollment of a Phase 2 Investigator Initiated Trial of Silmitasertib as Novel Oral Drug for COVID-19
TAIPEI and SAN DIEGO, Aug. 16, 2021 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a new drug development company focused on human efficacy and innovation of first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, today announced that its novel oral drug, Silmita...
Senhwa Signs Agreement with Taiwan's CDE for COVID-19 Program Guiding Development of Silmitasertib
TAIPEI and SAN DIEGO, Aug. 13, 2021 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focused on first-in-class therapeutics for oncology, rare diseases, and coronaviruses, today announced that its novel oral drug, Silmitasertib, has been included inTaiwan's Center...
Senhwa Announces IND Submission to India's CDSCO of a Phase II Clinical Study for Silmitasertib as a Potential COVID-19 Treatment
TAIPEI and SAN DIEGO, June 23, 2021 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a clinical-stage biopharmaceutical company focused on developing first-in-class therapeutics for the treatment of cancer, rare conditions, and novel coronaviruses, today announced that it has submitted an I...
Senhwa Announces the First Patient Enrolled in an Investigator Initiated Trial Of Silmitasertib as a Treatment for Patients with Severe COVID-19
TAIPEI and SAN DIEGO, Jan. 21, 2021 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a clinical-stage biopharmaceutical company focused on next generation DNA Damage Response (DDR) therapeutics for the treatment of cancer, today announced that the first patient has enrolled into an investi...
Senhwa Biosciences Presents Positive Cholangiocarcinoma Data
TAIPEI and SAN DIEGO, Jan. 15, 2021 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a clinical-stage biopharmaceutical company focused on next generation DNA Damage Response (DDR) therapeutics for the treatment of cancer, today announces that promising clinical data from their global phase...
Senhwa Biosciences Receives US FDA 'Study May Proceed' Letter to Treat BRCA2+ or PALB2+ Solid Tumors With CX-5461
TAIPEI and SAN DIEGO, Dec. 23. 2020 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a clinical-stage biopharmaceutical company focused on next-generation DNA Damage Response (DDR) therapeutics for the treatment of cancer, today announced that it has received a "Study May Proceed" letter fr...
Senhwa Biosciences's Positive Topline Cholangiocarcinoma Data Abstract Accepted by 2021 ASCO Gastrointestinal Cancers Symposium
TAIPEI and SAN DIEGO, Dec. 13, 2020 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a clinical-stage biopharmaceutical company focused on next generation DNA Damage Response (DDR) therapeutics for the treatment of cancer , announced their Abstract on Cholangiocarcinoma treatment with Silmit...
Senhwa Announces the First Patient Enrolled in an Investigator Initiated Trial Of Silmitasertib as a Treatment for COVID-19
Highlights: * The first hospitalized patient with severe COVID-19, treated under an eIND was discharged in 5 days after being treated with Silmitasertib. * The first patient with moderate COVID-19 has enrolled into this clinical trial at the Center for Advanced Research and Education (CARE),G...
Senhwa Announces Multiple IND Application Submissions to US FDA and Health Canada for the Treatment of Solid Tumors with BRCA2 or PALB2 Mutations
TAIPEI and SAN DIEGO, Nov. 25, 2020 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a clinical-stage biopharmaceutical company focused on next-generation DNA Damage Response (DDR) therapeutics for the treatment of cancer, today announced that it has submitted multiple Investigational New D...
CARE GA Receives Study May Proceed Letter from US FDA to Initiate Phase II Clinical Trial of Senhwa's Silmitasertib in COVID-19 Patients
TAIPEI and SAN DIEGO, Nov. 6, 2020 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a clinical-stage biopharmaceutical company focused on next generation DNA Damage Response (DDR) therapeutics for the treatment of cancer, today announced its clinical partner- Center for Advanced Research an...
Senhwa Announces Multiple IND application submissions to U.S. FDA for Silmitasertib as a Potential Treatment for COVID-19
TAIPEI and SAN DIEGO, Nov. 2, 2020 /PRNewswire/ -- Senhwa Biosciences, Inc.
(TPEx: 6492), a clinical-stage biopharmaceutical company focused on
next-generation DNA Damage Response (DDR) therapeutics for the treatment of
cancer, today announced that it has submitted an Investigational New Drug
Coronavirus Breakthrough: Senhwa Reports First eIND Silmitasertib Treated Severe COVID-19 Patient - Discharged Following Five Days of Treatment
TAIPEI and SAN DIEGO, Sept. 11, 2020 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a clinical-stage biopharmaceutical company focused on next generation DNA Damage Response (DDR) therapeutics for the treatment of cancer, announced today that the first patient with severe COVID-19 demonst...
Senhwa Biosciences's Silmitasertib Receives Rare Pediatric Disease Designation from U.S. FDA for Treatment of Recurrent Sonic Hedgehog Medulloblastoma
TAIPEI and SAN DIEGO, July 7, 2020 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a clinical-stage biopharmaceutical company focused on Next Generation DNA Damage Response (DDR) therapeutics for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) ...