News

SAN DIEGO, CA - January 31, 2022 -- Viracta Therapeutics, Inc. (Nasdaq: VIRX), a precision oncology company targeting virus-associated malignancies, today announced that the first patient has been dosed in the multinational Phase 1b/2 trial of its all-oral combination product, Nana-val (nanatinostat and valganciclovir), in patients with Epstein-Barr virus-positive (EBV⁺) recurrent or metastatic nasopharyngeal carcinoma (R/M NPC) and other advanced EBV⁺ solid tumors. The trial is designed to evaluate the safety and preliminary efficacy of Nana-val alone and in combination with the PD-1 inhibitor pembrolizumab.

PALO ALTO, CA – January 27, 2022 — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced that the first patient has been dosed in ADventure, its Phase 1/2 clinical trial of BBP-631, an investigational adeno-associated virus (AAV) 5 gene therapy for the treatment of classic congenital adrenal hyperplasia (CAH). CAH is one of the most prevalent genetic diseases, with more than 75,000 cases estimated in the United States and European Union.

REDWOOD CITY, CA - January 25, 2022 -  Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), today announced that the first patient has been dosed in its Phase I clinical trial evaluating BMF-219, the company’s irreversible covalent menin inhibitor, in patients with relapsed/refractory (r/r) acute leukemias, including those with MLL1/KMT2A gene rearrangements or NPM1 mutations.

BOSTON, MA and REHOVOT, Israel - January 25, 2022  -- Monte Rosa Therapeutics, Inc. (NASDAQ: GLUE), a biotechnology company developing novel molecular glue degrader medicines, announced a license and research collaboration agreement with Dr. Nir London and the Yeda Research and Development Company Ltd., the commercial arm of the Weizmann Institute of Science, which aims to accelerate the discovery and development of novel covalent molecular glue degraders leveraging CoLDR (covalent ligand-directed release) technology.

LONDON and RALEIGH, NC - January 24, 2022 -- Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), a clinical-stage biopharmaceutical company focused on respiratory diseases, today announces it has completed patient enrollment with more than 800 subjects randomized in the ENHANCE-2 trial, evaluating ensifentrine for the maintenance treatment of chronic obstructive pulmonary disease (“COPD”). Top-line data are expected in the third quarter of 2022.

“Completing enrollment in the Phase 3 ENHANCE-2 trial with more than 800 subjects is an important accomplishment for Verona Pharma,” said David Zaccardelli, Pharm. D., President and Chief Executive Officer. “We are pleased to achieve our recruitment targets during the ongoing global pandemic.”

NEW YORK, NY - January 20, 2022 -- 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-868, a BD2-selective oral small molecule bromodomain and extra-terminal (BET) inhibitor, for the treatment of advanced solid tumors, including ovarian cancer, pancreatic cancer, metastatic castration resistant prostate cancer (mCRPC), and triple negative breast cancer (TNBC).

HOUSTON, TX - January 19, 2022 -- MARKER THERAPEUTICS, INC. (NASDAQ:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today announced that the United States Food and Drug Administration (FDA) Office of Orphan Products Development has granted Orphan Drug designation to MT-601, a multi-tumor-associated antigen (MultiTAA)-specific T cell product optimized for the treatment of patients with pancreatic cancer.

RAMSEY, NJ, BOCA RATON, FL  and GOOSE CREEK, SC - January 18, 2022 -- ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA”), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today announced that it has received U.S. Food and Drug Administration (“FDA”) approval for its fourth ADMA BioCenters plasma collection facility located in Goose Creek, South Carolina. In conjunction, the facility was issued a compliance certification from the International Quality Plasma Program (“IQPP”), confirming the center meets facility and donor criteria for IQPP Certification. This plasma collection facility commenced operations and initiated source plasma collection in the second quarter of 2021. With today’s approval, this facility is now FDA-licensed to collect and introduce into interstate commerce, human source plasma for further manufacturing in the U.S.

PALO ALTO, CA – January 13, 2022 — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced a non-exclusive clinical collaboration with Amgen Inc. (Amgen) to evaluate the combination of BBP-398, a potentially best-in-class SHP2 inhibitor with LUMAKRAS® (sotorasib), a KRAS^G12C inhibitor, in patients with advanced solid tumors with the KRAS G12C mutation. The Phase 1/2 study will include a dose escalation period followed by dose expansion and optimization, and is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of BBP-398 in combination with LUMAKRAS. Under the terms of the non-exclusive collaboration, BridgeBio will sponsor the study and Amgen will provide a global supply of LUMAKRAS.

DUBLIN, Ireland and FORT WASHINGTON, PA -  January 10, 2022 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, announced a business update today and preliminary, unaudited financial results for the fourth quarter of 2021. “We made excellent progress in 2021 in spite of the COVID pandemic and are poised for continued growth in 2022,” commented Ted Schroeder, Chief Executive Officer of Nabriva Therapeutics. “We had a strong close to 2021 for SIVEXTRO, which contributed to extending our cash runway well into the fourth quarter of 2022 and we continue to propel the product back to historical prescription trends through our promotional efforts.” Mr. Schroeder continued, “while our commercialization efforts for XENLETA have faced significant headwinds due to the global pandemic, we remain focused on maximizing the value of this novel, first-in-class antibacterial agent in the U.S. through our focused commercial investments, and outside the U.S. by expanding our partnerships globally.”