News

Palo Alto and Solana Beach, CA – March 8, 2022 — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio), a commercial-stage biopharmaceutical company that focuses on genetic diseases and cancers, and Sentynl Therapeutics, Inc. (Sentynl), a U.S.-based biopharmaceutical company focused on bringing innovative therapies to patients living with rare diseases owned by Zydus Lifesciences Ltd. (formerly known as Cadila Healthcare Ltd.), today announced the execution of an asset purchase agreement (the Agreement) for the sale of BridgeBio’s NULIBRY™ (Fosdenopterin) for Injection. NULIBRY is approved by the U.S. Food and Drug Administration (FDA) to reduce the risk of mortality in patients with molybdenum cofactor deficiency (MoCD) Type A, an ultra-rare, life-threatening pediatric genetic disorder. The closing of the asset purchase is subject to customary closing conditions.

RAMSEY, NJ and BOCA RATON, FL and CONYERS, GA - March 07, 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 fifth ADMA BioCenters plasma collection facility located in Conyers, Georgia. This plasma collection facility commenced operations and initiated source plasma collection in the third quarter of 2021. With the approval announced today, this facility is now FDA-approved to collect and introduce into interstate commerce, human source plasma for further manufacturing in the U.S.

Lugano, Switzerland and Palo Alto, CA – March 3, 2022 — Helsinn Group (Helsinn), a fully integrated, global biopharma company with a diversified pipeline of innovative oncology assets and strong track-record of commercial execution, and BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio), a commercial-stage biopharmaceutical company that focuses on genetic diseases and cancers, today announced an update to their existing strategic collaboration to develop, manufacture and commercialize infigratinib for oncology indications. Under the terms of the amended and restated agreement, Helsinn will gain an exclusive license to commercialize infigratinib in the U.S. and will be responsible for developing, manufacturing and commercializing infigratinib in oncology indications worldwide except for achondroplasia or any other skeletal dysplasias and except in mainland China, Hong Kong and Macau. BridgeBio will be eligible to receive regulatory and commercial milestone payments as well as tiered royalties on adjusted net sales from Helsinn. BridgeBio will retain all rights to develop, manufacture and commercialize infigratinib in skeletal dysplasia, including achondroplasia

SAN CARLOS, CA - March 03, 2022 -- Atreca, Inc. (Atreca) (NASDAQ: BCEL), a clinical-stage biotechnology company focused on developing novel therapeutics generated through a unique discovery platform based on interrogation of the active human immune response, today announced financial results for the fourth quarter and full-year ended December 31, 2021, and provided updated clinical data from the ongoing Phase 1b trial of ATRC-101 in select solid tumors.

NEW YORK, NY - February 28, 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 reported financial results for the fourth quarter and full year ended December 31, 2021, and provided a business update.“In 2021, the Nuvation Bio team made significant progress for our lead cyclin-dependent kinase 2/4/6 inhibitor program in the clinic. NUV-422 received FDA Fast Track Designation for the treatment of high-grade gliomas, including glioblastoma multiforme, and clearance of two IND applications for the treatment of advanced breast cancer and prostate cancer,” said David Hung, M.D., founder, president, and chief executive officer of Nuvation Bio. “We are well positioned to build upon this momentum in 2022 and expect to achieve additional milestones across our broad pipeline of novel oncology therapeutic candidates for difficult-to-treat cancers. We look forward to sharing clinical development updates this year.”

SAN DIEGO, CA - February 23, 2022 -- 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 Company plans to highlight its clinical and preclinical pipeline progress during a virtual R&D Day to be held today beginning at 10:00am ET / 7:00am PT. "R&D Day is a time for us to showcase not only our progress in the clinic but our redefining work in cell and gene therapy using our proprietary genetic engineering technologies in new and innovative ways," said Eric Ostertag, M.D., Ph.D., Executive Chairman of Poseida Therapeutics. "Today we are excited to share new data demonstrating the promise of our platforms. For the first time, we will highlight our capabilities in site-specific transposon-based DNA delivery, which is a technology that could revolutionize gene therapy by allowing insertion of large therapeutic transgenes into potentially any site in nearly any cell type or tissue." Presentations will cover updates on both platforms and product candidates and will be delivered by the Company's executive leadership, scientists, clinical team members, and key opinion leaders including Scientific Advisory Board member Dr. Luca Gattinoni, Director of the Division of Functional Immune Cell Modulation at the Leibniz Institute for Immunotherapy, whose research focuses on T-cell-based immunotherapies with an emphasis on T-cell differentiation; and Dr. Susan Slovin, the Associate Vice Chair, Academic Administration, Department of Medicine at Memorial Sloan Kettering, an oncologist with expertise in prostate cancer, clinical immunology, and other genitourinary malignancies and a clinical investigator on Poseida' s P-PSMA-101 clinical trial.

HOUSTON, TX - February, 16, 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 an update on the Company’s clinical programs, manufacturing processes and pipeline.

SAN DIEGO, CA - February 14, 2022 -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s Investigational New Drug (IND) application for its lead flu drug-Fc conjugate (DFC), CD388 – a highly potent, long-acting antiviral immunotherapy designed to deliver universal prevention and treatment of seasonal and pandemic influenza. Cidara intends to initiate a Phase 1 study in healthy volunteers before the end of the current quarter.

GENEVA, Switzerland – February 10, 2022 – ObsEva SA (NASDAQ: OBSV; SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies for women’s health, today announced a strategic licensing agreement with Theramex, a leading global pharmaceutical company specializing in women’s health, to support the commercialization and market introduction of linzagolix across global markets outside of the U.S., Canada and Asia.

CAMBRIDGE, MA - February 9, 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 reported interim data from a collaborator-sponsored, ongoing Phase 1/2 clinical trialⁱ of AVR-RD-04, an investigational gene therapy for cystinosis, at the 18^th Annual WORLDSymposium™ in San Diego. The first three patients infused with AVR-RD-04 remain off oral cysteamine, with follow up durations ranging between 12- and 26-months post-gene therapy infusion. Sustained engraftment has been observed in each of these patients, as demonstrated by stable vector copy number (VCN) levels. A fourth patient was infused in November 2021. No adverse events related to the drug product have been reported in the four patients infused to date.