BioSpace News Archive

Femasys Inc. announced today the approval of an Investigational Device Exemption (IDE) from the United States Food and Drug Administration (FDA) to evaluate the safety and efficacy of FemBloc®, a first-of-its-kind, non-surgical, non-implant, in-office solution for permanent birth control in a pivotal clinical trial (the “FINALE” trial).

BioVie Inc. today announced that baseline data from its multicenter, randomized, placebo-controlled Phase 3 study ( NCT04669028 ) of NE3107 in patients with mild to moderate Alzheimer’s Disease (AD) was presented at the American Diabetes Association Annual Meeting.

CereVasc, Inc. and LianMedical announced a partnership focused on bringing CereVasc’s eShunt® System and related products to patients and providers in China, Hong Kong, Taiwan, and Macaw.

ALX Oncology Holdings Inc., (“ALX Oncology”) (Nasdaq: ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced that evorpacept, a next-generation CD47 blocker, has received orphan drug designation (“ODD”) from the European Commission (“EC”) for the treatment of patients with gastric cancer.

Invivyd, Inc. today announced that it has reached general alignment with the U.S. Food and Drug Administration (FDA) on a pathway to potential emergency use authorization (EUA) for VYD222 and anticipated follow-on monoclonal antibody (mAb) candidates designed to prevent symptomatic COVID-19.

Avalo Therapeutics, Inc. (Nasdaq: AVTX), today announced topline results from the Phase 2 randomized, double-blind, placebo-controlled trial (PEAK trial) evaluating AVTX-002 (anti-LIGHT mAb) in patients with poorly controlled non-eosinophilic asthma (NEA).

CollPlant Biotechnologies (NASDAQ: CLGN) today announced the achievement of a milestone with respect to the clinical phase dermal filler product, according to its agreement with AbbVie for the development of a regenerative dermal and soft tissue filler product.

OpGen, Inc. and OpGen subsidiary, Ares Genetics, which strives to become a leader in bacterial genomics and AI-powered prediction of antimicrobial resistance (AMR), announced today that one of its key patents under opposition has been successfully maintained.

Accuray Incorporated (NASDAQ: ARAY) announced today that as part of the annual reconstitution of the Russell stock indexes, the Company will be included in the Russell 2000 ® Index and the broad-market Russell 3000 ® Index, which will be effective today.

Eyenovia, Inc. announced that the company was added to the small cap Russell 2000® and broad market Russell 3000® Indexes.