News

FREMONT, CA- February 08, 2022 -- Zosano Pharma Corporation (Nasdaq:ZSAN), a clinical-stage biopharmaceutical company, today announced the pricing of its previously announced underwritten public offering of 51,250,000 units, each consisting of one share of common stock and one warrant to purchase one share of common stock, at a public offering price of $0.30 per unit. The warrants have an exercise price of $0.30 per share, are immediately exercisable and will expire five years from the date of issuance. Zosano has granted the underwriter a 30-day option to purchase up to an additional 7,687,500 shares of common stock and/or additional warrants to purchase up to 7,687,500 shares of common stock.

CAMBRIDGE, MA - February 1, 2022 -- AVROBIO, Inc. (Nasdaq: AVRO), a leading clinical-stage gene therapy company with a shared purpose to free people from a lifetime of genetic disease, today announced the appointment of Sean O’Bryan as chief regulatory officer. Sean brings a wealth of experience in regulatory strategy and product development to AVROBIO, as well as keen insight into the field of cell and gene therapy, where he has spent most of his career.

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.