Company Product Description Indication Status
Aimmune Therapeutics Inc., of Vevey, Switzerland Palforzia (defatted powder of Arachis hypogaea L., semen [peanuts]) Immunomodulator Peanut allergy Approved by European Commission for use in patients, ages 4-17, in conjunction with peanut-avoidant diet
Aim Immunotech Inc., of Ocala, Fla. Ampligen (rintatolimod) TLR-3 agonist; interferon type I receptor agonist; ribonuclease stimulator; 2,5-oligoadenylate synthetase stimulator Pancreatic cancer FDA granted orphan designation
Anixa Biosciences Inc., of San Jose, Calif. Breast cancer vaccine Breast cancer vaccine Triple-negative breast cancer FDA cleared IND
Aptorum Group Ltd., of New York ALS-4 Small-molecule drug Infections caused by Staphylococcus aureus including methicillin-resistant S. aureus  Submitted CTA to Health Canada for phase I study in healthy volunteers
Bioinvent International AB, of Lund, Sweden, and Transgene SA, of Strasbourg, France BT-001 Oncolytic vaccinia virus Solid tumors Received CTA approval in Belgium for a phase I/IIa study
Janssen Pharmaceutical Cos., of Raritan, N.J., part of Johnson & Johnson, and Legend Biotech Corp., of Somerset, N.J. Ciltacabtagene autoleucel BCMA-directed CAR T therapy Relapsed and/or refractory multiple myeloma Initiated rolling BLA to FDA
Jazz Pharmaceuticals plc, of Dublin JZP-458 Recombinant Erwinia asparaginase Acute lymphoblastic leukemia or lymphoblastic lymphoma Initiated submission of BLA seeking approval for use as a component in multi-agent chemotherapeutic regimen for treating adult and pediatric patients who have developed hypersensitivity or silent inactivation to E. coli-derived asparaginase
Lumosa Therapeutics Ltd., of Taipei, Taiwan LT-1001 (Naldebain) Extended-release analgesic injection Analgesic Approved by Singapore’s Health Science Agency
Merz Therapeutics Inc., of Raleigh, N.C. Xeomin (incobotulinumtoxinA) Neuromodulator Chronic sialorrhea FDA approved supplemental BLA for treating patients 2 and older; received priority review designation 
Moebius Medical Ltd., of Tel Aviv, Israel MM-II Non-opioid intra-articular injection Pain in knee osteoarthritis FDA cleared IND for phase IIb trial
Myovant Sciences Ltd., of Basel, Switzerland Orgovyx (relugolix) Oral GnRH receptor antagonist Advanced prostate cancer Approved by FDA under priority review
Pfizer Inc., of New York, and Biontech SE, of Mainz, Germany BNT-162b2 Vaccine COVID-19 EMA’s Committee for Medicinal Products for Human Use issued positive opinion to recommend conditional marketing authorization to prevent COVID-19 caused by SARS-CoV-2 virus in individuals 16 and older
Sesen Bio Inc., of Cambridge, Mass. Vicineum Locally administered fusion protein High-risk BCG-unresponsive non-muscle invasive bladder cancer Submitted completed BLA to FDA, requesting priority review
Taysha Gene Therapies Inc., of Dallas TSHA-101 AAV9-based gene therapy GM2 gangliosidosis Queen’s University in Ontario received CTA approval from Health Canada for phase I/II study
Viiv Healthcare Ltd., of London Vocabria (cabotegravir injection and tablets) Inhibits HIV replication by preventing viral DNA from integrating into genetic material of human immune cells HIV Approved in European Union for use in combination with Rekambys (rilpivirine injection, Johnson & Johnson) for treating adults with HIV-1 infection who are virologically suppressed
Zogenix Inc., of Emeryville, Calif. Fintepla (fenfluramine) 5-HT 2c receptor modulator; 5-HT 1d receptor modulator; 5-HT 2a receptor modulator; opioid receptor sigma modulator 1 Dravet syndrome European Commission granted marketing authorization for treating seizures associated with Dravet syndrome as add-on therapy to other anti-epileptic medicines for patients 2 and older

Notes

For more information about individual companies and/or products, see Cortellis.

Notes

For more information about individual companies and/or products, see Cortellis.