News

GENEVA, Switzerland - December 20, 2021 - ObsEva SA (NASDAQ: OBSV; SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health, today announced it has been selected for addition to the NASDAQ Biotechnology Index (Nasdaq: NBI), effective as of market open on Monday, December 20, 2021.

SAN DIEGO, CA -  December 20, 2021 -- Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage biopharmaceutical company utilizing proprietary genetic engineering platform technologies to create cell and gene therapeutics with the capacity to cure, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for P-MUC1C-ALLO1, the Company's allogeneic CAR-T product candidate targeting multiple solid tumor indications. "We are excited to begin the P-MUC1C-ALLO1 trial, an evaluation of a fully allogeneic CAR-T product candidate with the potential to treat a wide range of solid tumors, including breast, ovarian and other cancers," said Eric Ostertag, M.D., Ph.D., Chief Executive Officer of Poseida Therapeutics. "The genetic edits in P-MUC1C-ALLO1 have been shown to reduce or fully eliminate alloreactivity, and our proprietary manufacturing process, which includes our booster molecule, has the potential to treat many patients from a single manufacturing run. We look forward to beginning this trial and to presenting initial clinical data in 2022."

PLYMOUTH MEETING, PA - December 17, 2021-- Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced that it has been selected for addition to the NASDAQ Biotechnology Index (NBI). Harmony's addition to the NBI will become effective prior to market open on Monday, December 20, 2021.

SAN DIEGO, CA - December 16, 2021 -- Viracta Therapeutics, Inc. (Nasdaq: VIRX), a precision oncology company targeting virus-associated malignancies, today announced that it has been selected for addition to the Nasdaq Biotechnology Index (Nasdaq: NBI), effective prior to market open on Monday, December 20, 2021.

NEW YORK, NY - December 15, 2021 -- Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to NUV-422, a cyclin-dependent kinase (CDK) 2/4/6 inhibitor, for the treatment of patients with high-grade gliomas, including glioblastoma multiforme. NUV-422 received Orphan Drug Designation for the treatment of patients with malignant gliomas from the FDA in the first quarter of 2021.

MENDHAM, NJ and WARMINSTER, PA -  December 14, 2021 - Antios Therapeutics, Inc. (“Antios”) and Arbutus Biopharma Corporation (Nasdaq: ABUS) today announced that the first patient has been dosed in a triple combination treatment in patients with chronic hepatitis B virus (HBV) infection. A single cohort in the ongoing Antios Phase 2a SAVE-1 (Sustained Anti-Viral Efficacy) clinical trial will evaluate a triple combination of Antios’ proprietary active site polymerase inhibitor nucleotide (ASPIN), ATI-2173, Arbutus’ proprietary GalNAc delivered RNAi therapeutic, AB-729, and tenofovir disoproxil fumarate (TDF), a nucleotide reverse transcriptase inhibitor. The multi-center, double-blind, combination clinical trial plans to enroll 40 patients including a cohort of 10 patients with chronic HBV infection assigned 8:2 to active drugs (ATI-2173+AB-729) or matching placebos. The active drugs (ATI-2173+AB-729) or placebos will be administered in combination with 300 mg of tenofovir disoproxil fumarate. ATI-2173 and tenofovir disoproxil fumarate will be administered orally and by injections once daily for 90 days. AB-729 will be administered by subcutaneous injection at Day 28 and Day 90. Following this 90-day treatment period, patients will be followed-up for safety and sustained antiviral responses for six additional months.

MENDHAM, NJ and WARMINSTER, PA - December 14, 2021 – Antios Therapeutics, Inc. (“Antios”) and Arbutus Biopharma Corporation (Nasdaq: ABUS) today announced that the first patient has been dosed in a triple combination treatment in patients with chronic hepatitis B virus (HBV) infection. A single cohort in the ongoing Antios Phase 2a SAVE-1 (Sustained Anti-Viral Efficacy) clinical trial will evaluate a triple combination of Antios’ proprietary active site polymerase inhibitor nucleotide (ASPIN), ATI-2173, Arbutus’ proprietary GalNAc delivered RNAi therapeutic, AB-729, and tenofovir disoproxil fumarate (TDF), a nucleotide reverse transcriptase inhibitor.

NEW YORK, NY - Dec. 13, 2021 -- Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to evaluate NUV-422, a cyclin-dependent kinase (CDK) 2/4/6 inhibitor, for the treatment of prostate cancer. The FDA accepted the Company's first IND application for NUV-422 in October 2020 for the treatment of patients with high-grade gliomas, including glioblastoma multiforme (GBM), and a second IND for the treatment of advanced breast cancer in December 2021.

WALTHAM, MA - December 11, 2021 -- Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced updated positive data from its Phase 1/2 trial of axatilimab in patients with recurrent or refractory chronic graft-versus-host disease (cGVHD) despite two or more prior lines of therapy. Axatilimab is the Company's anti-CSF-1R monoclonal antibody. The data are being featured during an oral session at the 63rd American Society of Hematology (ASH) Annual Meeting on Saturday, December 11, 2021 at 3:05 p.m. ET. "There exists an urgent need for novel and effective therapies in patients with cGVHD," said Michael Meyers, M.D, M.P.H., Chief Medical Officer of Syndax. "The broad activity and tolerability observed underscores axatilimab's potential to play a meaningful role in the cGVHD treatment landscape, and further supports the importance of the ongoing AGAVE-201 trial."

WALTHAM, MA - December 09, 2021 --  Syndax Pharmaceuticals, Inc. (Nasdaq: SNDX) announced today that the Hart-Scott-Rodino (HSR) antitrust waiting period had expired and that the parties closed the exclusive worldwide collaboration and license agreement between Syndax and Incyte to develop and commercialize axatilimab, Syndax's anti-CSF-1R monoclonal antibody. In connection with closing, Incyte paid Syndax the $117 million upfront initial license fee, and Syndax closed on Incyte's $35 million equity investment in the company.