Press Releases

Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced the U.S. Food and Drug Administration (FDA) has acknowledged that the resubmission to its New Drug Application (NDA) for vadadustat as a treatment for anemia due to chronic kidney disease (CKD) in adult patients on dialysis, was complete. The FDA has classified this as a class 2 response, which results in a six-month review perio

Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced that the U.S. Patent and Trademark Office has granted the Company U.S. Patent No. 11,793,813 (“the ‘813 patent”) entitled “Pemetrexed Formulations.” Eagle has submitted the patent for listing in the U.S. Food and Drug Administration’s Orange Book.1 The ‘813 patent is directed to pemetrexed formulations, including the FDA-approved commercial fo

NexImmune, Inc. (Nasdaq: NEXI) announces the extension of the research partnership between NexImmune, Yale and JDRF to explore the use of NexImmune’s AIM nanoparticles in combination with an anti-CD3 mAb to tolerize, deplete or modulate diabetes antigen-specific T cells. The extension includes an additional $300,000 grant, funded by JDRF to Yale, as a part of its Cures research portfolio, which includes therapies for the prevention of type 1 diabetes (T1D). “We are excit

Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company developing an innovative drug delivery technology that leverages a patient’s own biology to deliver rare disease therapeutics, announced the successful completion of its acquisition of EryDel S.p.A., a privately-held, late-stage biotech company. Quince’s newly acquired Phase 3 lead asset, EryDex, targets a rare neurodegenerative disease, Ataxia-Telangiectasia (A-T). Currently, there are no approved treatm

Certa Therapeutics (Certa), a biotechnology company developing innovative precision therapies for patients with inflammatory and fibrotic diseases, today announces that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for its investigational therapy FT011 for the treatment of systemic sclerosis (scleroderma). Orphan Drug Designation is granted by the FDA to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,

Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as 'Zydus') today announced that the U.S. Food and Drug Administration (FDA) approved its New Drug Application (NDA) for ZITUVIO™ (Sitagliptin) tablets, 25 mg, 50 mg, and 100 mg. ZITUVIO™ contains active ingredient Sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mel

Numab Therapeutics AG (Numab), a clinical stage biotechnology company advancing a proprietary pipeline of immunology and oncology therapeutics, announced today that the first patient has been dosed in the multiple ascending dose (MAD) study of the Phase 1a/b clinical trial of NM26, a first-in-class bi-specific antibody for the treatment of moderate-to-severe atopic dermatitis (AD). The MAD study in AD patients is a planned continuation of the Company’s ongoing single ascending do

LSL Pharma Group Inc. (TSXV: LSL), (the “Company” or “LSL Pharma Group”), a Canadian integrated pharmaceutical company, announced today that it has entered into an exclusive agreement with Fera Pharmaceuticals, LLC (“Fera”), a U.S. specialty pharmaceutical company, to provide Erythromycin ophthalmic ointment USP (5mg/g) for the treatment of newborns in U.S. hospitals. Given the scarcity of Erythromycin ophthalmic ointment south of the border, the

Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today that it has entered into an asset purchase agreement with privately owned Gravitas Therapeutics Inc. for GR-2397, a clinical-stage antifungal compound with a novel mechanism of action, targeting invasive mold infections caused by Aspergillus species. David Veitch, Chief Executive Officer

Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies, today announced the clearance of an Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) to evaluate NKX019, its allogeneic, CD19-directed CAR NK cell therapy candidate, for the treatment of lupus nephritis. “We believe that NKX019, as an NK cell-based approach, has the potential to distinguish itself in the growing field of ce