BioSpace News Archive

Expects to report initial data from Phase 1 study of NTLA-2001, a potentially curative single-course therapy for transthyretin amyloidosis (ATTR), in 2021 On track to submit an IND or IND-equivalent in mid-2021 for NTLA-5001 for the treatment of acute myeloid leukemia (AML) Intends to submit an IND or IND-equivalent in 2H 2021 for NTLA-2002 for the treatment of hereditary angioedema (HAE)

Reaffirms plans to resubmit its New Drug Application (NDA) around the end of second quarter 2021 Received additional feedback from FDA after completion of Type A meeting and submission of revised weight based dosing regimen Anticipates an FDA action date in 2021

Humanigen, Inc . (Nasdaq: HGEN) (“Humanigen”), a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate, lenzilumab™, today announced that the Company’s management team will present and host meetings with investors at the H.C. Wainwright Global Life Sciences Conference being held from March 9-10, 2021

Cue Biopharma, Inc. (NASDAQ: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics designed to selectively engage and modulate targeted T cells within the patient’s body, announced today the appointments of renowned experts Abul K. Abbas, M.D., distinguished professor in pathology and former chair of the department of pathology at the University of California, San Francisco (UCSF)

NGM Biopharmaceuticals, Inc. (NGM) (Nasdaq: NGM), a biotechnology company focused on discovering and developing transformative therapeutics for patients, today announced that David J. Woodhouse, Ph.D., Chief Executive Officer, will present an overview of the company and provide a business update at the Cowen 41st Annual Health Care Conference on Thursday, March 4, at 11:10 am ET.

Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness and cataplexy in adults with narcolepsy, announced today that members of the Avadel management team will participate in fireside chats at the H.C. Wainwright Global Life Sciences Conference

Homology Medicines, Inc. (Nasdaq: FIXX), a clinical-stage genetic medicines company, announced today presentations at the following virtual conferences:

Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage rare pediatric liver disease company developing novel bile acid modulators, today provided a business update and reported financial results for the fourth quarter and year ended December 31, 2020.

Conference Call to Begin Today at 9:00 AM ET 4Q 2020 Afrezza Net Revenue of $10.1 million; +30% vs. 4Q 2019 • Sequential Quarter Growth +38% vs. 3Q 2020 2020 Total Revenues of $65.1 million • 2020 Afrezza Net Revenue of $32.3 million; +28% vs. 2019 • 2020 Afrezza Gross Profit $17.2 million; 53% Gross Margin $67.2 million of Cash, Cash Equivalents and Restricted Cash at December 31, 2020 Acquired QrumPharma Inc. for $12.8 million in cash and stock

Allergan, an AbbVie (NYSE: ABBV) company, today announced that it has submitted a New Drug Application to the U.S. Food and Drug Administration for investigational AGN-190584 (pilocarpine 1.25%) ophthalmic solution for the treatment of presbyopia