News

NEW YORK, NY - Dec. 8, 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 advanced breast 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). The Company began a monotherapy Phase 1/2 study in December 2020 in high grade gliomas and later amended the protocol in the second quarter of 2021 to include HR+/HER2- advanced breast cancer (with and without brain metastases) and metastatic castration resistant prostate cancer (mCRPC). The Company is continuing to enroll patients in the Phase 1 dose escalation portion of the study.

AUSTIN, TX - December 6, 2020 -- Aeglea BioTherapeutics, Inc. (NASDAQ: AGLE), a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics as innovative solutions for rare metabolic diseases, today announced that the pivotal Phase 3 study, PEACE (Pegzilarginase Effect on Arginase 1 Deficiency Clinical Endpoints), met the primary endpoint with a statistically significant reduction in plasma arginine from baseline after 24 weeks of treatment with pegzilarginase (p <0.0001). Importantly, pronounced and sustained plasma arginine reduction was accompanied by a positive trend in Gross Motor Function Measure Part E (GMFM-E), a key clinical assessment of a patient's mobility, including the ability to walk, run and jump.

DUARTE, CA - Dec. 01, 2021 — Prolacta Bioscience^®, the world’s leading hospital provider of 100% human milk-based nutritional products for premature and critically ill infants, today announced the enrollment of the first baby into a Japan-based clinical trial evaluating growth and safety associated with an Exclusive Human Milk Diet including Prolacta’s 100% human milk-based fortifiers (Prolacta’s EHMD). The Japan-based study — “JASMINE: A Randomized, Controlled Study to Assess Growth and Safety of the Exclusive Human Milk Diet (EHMD) in Very Low Birth Weight (VLBW) Infants” — began in October 2021. In Japan, Prolacta’s human milk-based products will be registered as a drug.

BOSTON, MA and LOUISVILLE, KY - November 30, 2021 - Talaris Therapeutics, Inc., (Nasdaq: TALS), a late-clinical stage cell therapy company developing therapies with the potential to transform the standard of care in solid organ transplantation, certain severe autoimmune diseases, and certain severe non-malignant blood, immune and metabolic disorders, today announced the initiation of the company’s Phase 2 FREEDOM-3 trial in diffuse cutaneous systemic sclerosis (dcSSc), a severe form of the rare autoimmune disease scleroderma. This trial will explore the safety of the company’s investigational allogeneic cell therapy, FCR001, delivered with non-myeloablative conditioning, in these patients, as well as its potential to halt the progression of organ damage or induce clinical remission in individuals with dcSSc. The University of Michigan is the first FREEDOM-3 clinical site to be activated and has now begun screening for eligible patients. Additional sites are expected to be activated in 2022.

• FDA Accepts NDA for Linzagolix for the Management of Heavy Menstrual Bleeding Associated with Uterine Fibroids
• Ad hoc announcement pursuant to Art. 53 LR of the SIX Swiss Exchange

GENEVA, Switzerland - November 22, 2021 - Obseva SA (NASDAQ: OBSV; SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health,today announced that the New Drug Application (NDA) for linzagolix for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women has been accepted for review by the United States Food and Drug Administration (FDA). The submission is based on data from the two Phase 3 PRIMROSE trials. Linzagolix has a differentiated profile and if approved, would be the first and only GnRH receptor antagonist with flexible dosing options for uterine fibroids, including a low dose option to address the needs of women who cannot or do not want to take hormones.^1,4 The FDA set a target action date of September 13, 2022 for this NDA under the Prescription Drug User Fee Act (PDUFA).

DUARTE, CA - November 22, 2021 — Prolacta Bioscience^®, the world’s leading hospital provider of 100% human milk-based nutritional products for premature and critically ill infants, today announced that Dr. Anne Beal, founder and CEO of AbsoluteJOI Skincare, has been appointed as a member of its board of directors.

Palo Alto, CA, and Lugano, Switzerland - November 19, 2021 – BridgeBio Pharma, Inc. (Nasdaq: BBIO), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, and Helsinn Group, a fully integrated, global biopharma company with a diversified pipeline of innovative oncology assets and strong track record of commercial execution, announced they have entered into a strategic collaboration to co–develop and co-commercialize a potentially first-in-class inhibitor designed to target glutathione peroxidase 4 (GPX4) with the hope of providing an effective new therapy for patients with difficult-to-treat tumors. The joint collaboration for BridgeBio’s GPX4 inhibitor was established as part of a new non-exclusive collaboration framework between BridgeBio and Helsinn that allows the companies to propose co-development and co-commercialization opportunities for preclinical precision oncology programs.

MENDHAM, NJ and ROME, ITALY - November 15, 2021 – Antios Therapeutics, Inc. (“Antios”), a clinical-stage biopharmaceutical company developing innovative therapies to treat and cure chronic hepatitis B virus (HBV), and IRBM, a drug discovery and early development research institute and global contract research organization, announced today they entered into an agreement for Antios to purchase the IP rights to a novel series of fourth-generation capsid assembly modulators (CAMs) being developed for the treatment of HBV. The CAMs were originated and developed at IRBM in conjunction with Promidis/CNCCS (a subsidiary of IRBM), Istituto Nazionale Genetica Molecolare (INGM) and San Raffaele Hospital (OSR). These CAMs enable the selection of a new pipeline candidate, which will be the second molecule in Antios’ HBV portfolio. The total potential value of the deal to the Italian sellers/parties is up to $50 million, in addition to royalties.

BOSTON, MA - November 10, 2021 -- Monte Rosa Therapeutics, Inc. (NASDAQ: GLUE), a biotechnology company developing novel molecular glue-based precision medicines, today reported business highlights and financial results for the third quarter, ended Sept. 30, 2021. “This year has been marked by several exciting and significant milestones for Monte Rosa, culminating in the naming of our first development candidate, MRT-2359, selectively targeting GSPT1 for the treatment of cancers driven by one of the Myc family genes,” said Markus Warmuth, M.D., CEO of Monte Rosa. “Preclinical data recently presented at AACR-NCI-EORTC underscores the potential of our molecular glue degraders to differentially induce cell death in Myc-addicted tumors. With the selection of MRT-2359 as our lead candidate, we are now positioned to rapidly advance our clinical development plan in both solid tumors and hematological malignancies. We have initiated IND-enabling studies and look forward to submitting our first IND to the FDA in mid-2022.”

MENDHAM, NJ - November  03, 2021 — Antios Therapeutics, Inc. (“Antios”), a clinical-stage biopharmaceutical company developing innovative therapies to treat and cure chronic hepatitis B virus (HBV), today announced the successful closing of a $75 million Series B-1 financing. The financing round was co-led by GordonMD Global Investments, a firm focused on investments in private and publicly traded global growth and innovative biopharma companies primarily located in the United States, Japan, and Europe. The proceeds from this financing will be used to advance the clinical development of ATI-2173, Antios’ lead Phase 2b clinical candidate. ATI-2173 is the only Active Site Polymerase Inhibitor Nucleotide (ASPIN) in clinical development and has the potential, if approved, to become the cornerstone of a curative, once-daily HBV therapy. Pre-clinical data to date for ATI-2173, alone or combined with tenofovir disoproxil fumarate (TDF), indicate the potential for sustained HBV DNA suppression off treatment, unique among approved nucleosides and investigational anti-HBV therapies.