The Daily Biotech Pulse: Novavax COVID Shot Authorized In Australia, Zymeworks Restructures, Orphan Drug Designation For Marker's Pancreatic Cancer Drug

Here's a roundup of top developments in the biotech space over the last 24 hours:

Stocks In Focus

Eisai Announces Publication Of Positive Data On Lenvima-Keytruda Combo In Endometrial Cancer

Eisai Co. Ltd. ESALY and Merck & Co., Inc. MRK announced the publication in the New England Journal of Medicine of positive results from the Phase 3 Study 309/KEYNOTE-775 trial that evaluated the Lenvima-Keytruda combo versus chemotherapy for patients with advanced endometrial carcinoma following at least one prior platinum-based regimen in any setting.

The combination demonstrated statistically significant improvements in the dual primary endpoints of overall survival and progression-free survival compared to chemotherapy.

BeiGene Says Chinese Regulator Accepted For Review Application To Expand Label Of Rare Blood Cancer Drug

BeiGene Co. Ltd. BGNE announced the Center for Drug Evaluation of the China National Medical Products Administration has accepted a supplemental new drug application for BeiGene's BTK inhibitor Brukinsa as a treatment for adult patients with Waldenström's macroglobulinemia.

Brukinsa has been approved in the U.S. and Europe for the same indication.

Novavax COVID-19 Vaccine Granted Provisional Approval In Australia

Novavax, Inc. NVAX announced that Australia's Therapeutic Goods Administration has granted approval for provisional registration of NVX-CoV2373, its COVID-19 vaccine for active immunization to prevent coronavirus disease 2019 caused by SARS-CoV-2 in individuals 18 years of age and older. The vaccine will be supplied to Australia under the brand name Nuvaxovid.

Last week, the vaccine was OK'ed in South Korea.

The shares were up 2.89% at $95.

Omeros Submits Response To FDA's CRL For Narsoplimab, Requests Type A Meeting

Omeros Corporation OMER confirmed that earlier this month it submitted to the U.S. Food and Drug Administration its response to the agency's complete response letter for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy.

Omeros said it has concurrently requested a Type A meeting with FDA to resolve any outstanding items.

Amgen Gets Approval For Lumakras To Treat Lung Cancer In Japan

Amgen, Inc. AMGN announced that Lumakras has been approved in Japan for the treatment of KRAS G12C-mutated positive, unresectable, advanced and/or recurrent non-small cell lung cancer that has progressed after systemic anticancer therapy.

Related Link: The Week Ahead In Biotech (Jan 16-22): Focus On Data Presentations And IPOs In Holiday-Shortened Week

Argenx Myasthenia Gravis Treatment Approved In Japan

argenx SE ARGX announced that Japan's Ministry of Health, Labour and Welfare has approved Vyvgart intravenous infusion for the treatment of adult patients with generalized myasthenia gravis who do not have sufficient response to steroids or non-steroidal immunosuppressive therapies.

The stock was adding 2.85% to $286.65 in premarket trading.

Marker's MT-601 Granted Orphan Drug Designation For Treating Pancreatic Cancer

Marker Therapeutics, Inc. MRKR said the FDA's Office of Orphan Products Development has granted orphan drug designation to MT-601, a multi-tumor-associated antigen-specific T cell product optimized for the treatment of patients with pancreatic cancer.
The stock was jumping 14.97% to 96.53 cents in premarket trading.

Zymeworks Slips Amid Announcement Of Restructuring Initiatives

Zymeworks Inc. ZYME shares came under pressure after it issued a corporate update and announced strategic objectives and outlook for 2022. The biopharma announced a cost-cutting initiative, including an immediate workforce reduction of 50% of the former senior management team and company-wide reduction of at least 25% by year-end 2022.

The company said it expects cash, cash equivalents and short-term investments of approximately $250 million, as of Dec. 31, 2021, and reiterated its guidance on a financial runway to fund current operations through at least late 2022.

Click here to access Benzinga's FDA Calendar.

On The Radar

Clinical Readouts/Presentations

American Society of Clinical Oncology Gastrointestinal Cancers Symposium Presentations

Alkermes plc ALKS: clinical data related to advanced GI cancers from ARTISTRY-1, a phase 1/2 study evaluating the tolerability and efficacy of nemvaleukin administered intravenously as a monotherapy and in combination with Merck and preclinical data from the study of nemvaleukin in combination with novel agents in GI cancers.

Related Link: Attention Biotech Investors: Mark Your Calendar For January PDUFA Dates