BioSpace News Archive

Leap Therapeutics, Inc. announced that the FDA has granted Fast Track designation to DKN-01 for the treatment of patients with gastric and gastroesophageal junction adenocarcinoma whose tumors express high Dickkopf-1 protein, following disease progression on or after prior fluoropyrimidine- and platinum- containing chemotherapy and if appropriate, human epidermal receptor growth factor /neu-targeted therapy.

Project includes funding for preliminary engineering work on facility to manufacture over 1 billion doses per year

Taysha Gene Therapies, Inc. (“Taysha”), a patient-centric gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system in both rare and large patient populations, today announced the pricing of its initial public offering of 7,869,566 shares of common stock at a price to the public of $20.00 per share. The shares are expecte

Encompass Health Corp. (NYSE: EHC) today announced it will report results for its third quarter ending Sept. 30, 2020 , after the market closes on Oct. 28, 2020 . The Company will host an investor conference call at 9 a.m. ET on Oct. 29, 2020 , to discuss its results.

Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, today announced the U.S. Food and Drug Administration (FDA) has cleared a new Investigational New Drug (IND) application for the initiation of an Investigator Sponsored Phase 1 clinical study of ADXS-504,

Inspire Medical Systems, Inc. (NYSE: INSP) (“Inspire”), a medical technology company focused on the development and commercialization of innovative and minimally invasive solutions for patients with obstructive sleep apnea, today announced that it will release financial results for the third quarter 2020 after the close of trading on Monday, November 2.

Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, today announced that the CMS Molecular Diagnostics Program (MOLDX) has issued a draft local coverage determination (LCD) to provide expanded coverage for circulating tumor DNA (ctDNA) tests that detect MRD in patients with a history of cancer.

Axcella (Nasdaq: AXLA) is a clinical-stage biotechnology company focused on leveraging endogenous metabolic modulators (EMMs) to pioneer a new approach for treating complex diseases and improving health. The company’s product candidates are comprised of EMMs and their derivatives that are engineered in distinct combinations and ratios to simultaneously impact multiple biological pathways. Axcella’s pipeline includes lead therapeutic can

André Calantzopoulos, CEO of Philip Morris International (PMI) (NYSE: PM), today delivered high-level remarks at the 2020 Concordia Annual Summit.

Apellis Pharmaceuticals , Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in targeted C3 therapies, today announced that the company will present at Stifel’s 2020 Immunology and Inflammation Virtual Summit on Thursday, October 1, 2020 at 9:00 a.m. ET. Cedric Francois, M.D., Ph.D., co-founder and chief executive officer of Apellis, will participate in a panel discussion titled “The Evolution of Complement Targeted Therap