BioSpace News Archive

Orphan drug designation applies to patients with primary mitochondrial myopathy due to nuclear DNA mutations (nPMM) in the NuPower Phase 3 clinical trial.

Sarepta Therapeutics, Inc., the leader in precision genetic medicine for rare diseases, granted equity awards on May 31, 2022 that were previously approved by the Compensation Committee of its Board of Directors under Sarepta’s 2014 Employment Commencement Incentive Plan, as a material inducement to employment to 70 individuals hired by Sarepta in May 2022.

Antengene Corporation Limited (“Antengene” SEHK: 6996.HK), today announced that an abstract titled “A phase I/II study of onatasertib, a dual TORC1/2 inhibitor, combined with the PD-1 antibody toripalimab in patients with advanced solid tumors (TORCH-2)” will be presented as a poster during the 2022 American Society of Clinical Oncology (ASCO 2022).

Overall survival (OS) for patients with metastatic, microsatellite stable colorectal cancer (MSS-CRC) who had two prior lines of therapy and had molecular response as presented at ESMO 2021 will now exceed 18 months.

Aadi Bioscience, Inc. announced the appointment of Marcy Graham to the new position of Senior Vice President, Investor Relations and Corporate Communications.

Denali Therapeutics Inc. (NASDAQ: DNLI), and Biogen Inc. (NASDAQ:BIIB) today announced that dosing has commenced in the global Phase 2b LUMA study to evaluate the efficacy and safety of BIIB122 (DNL151), as compared to placebo in approximately 640 participants with early-stage Parkinson’s disease.

Eargo, Inc. announced that it received a letter from The Nasdaq Stock Market LLC dated May 26, 2022 informing Eargo that the Company’s filing delinquency for the period ended March 31, 2022 has been cured, that the scheduled hearing on June 16, 2022 has been cancelled, that the Nasdaq matter regarding the listing of Eargo’s securities is now closed and that Eargo’s stock will continue to be listed and traded on Nasdaq.

PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune ® and Infectimune™ T-cell activating technologies, announced the acceptance of its Clinical Trial Application (CTA) from the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom.

Outlook Therapeutics, Inc. (Nasdaq: OTLK), today announced that the U.S. Food and Drug Administration (FDA) has requested additional information in order to complete the filing of the Company’s Biologics License Application (BLA) for ONS-5010/ LYTENAVA™ (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD).

Stand-alone therapy with PD1 checkpoint inhibitors has shown limited efficacy against ovarian cancer, with response rates in prior clincical trials ranging from 7-15%.