(US) Applied Genetic Technologies Corp. is a clinical stage biotechnology company, which engages in the development of gene therapy platform to develop transformational genetic therapies for patients suffering from rare and debilitating diseases. It has clinical trials in the field of ophthalmology, optogenetics, adrenoleukodystrophy, and otology. The company was founded by Richard Jude Samulski, Nicholas Muzyczka, William W. Hauswirth, Terence R. Flotte, and Barry J. Byrne on January 19, 1999 and is headquartered in Alachua, FL.
(IL) Pluristem Therapeutics, Inc. is a clinical stage company, which engages in cell therapy development. It develops placenta-based cell therapy product candidates for the treatment of multiple ischemic, inflammatory and hematologic conditions. The firm focuses on the development, clinical trials and manufacturing of cell therapeutics and related technologies. Its products include Clinical Pipeline, PLX-Immune, PLX-PAD, and PLX-R18. The company was founded by Doron Shorrer on May 11, 2001 and is headquartered in Haifa, Israel.
Cytokinetics, Inc. operates as a biopharmaceutical company, which focuses on the discovery and development of muscle activators as potential treatment for debilitating diseases. It conducts a Phase 2 clinical trials program for tirasemtiv, including a Phase 2b clinical trial in patients with ALS, known as BENEFIT-ALS (Blinded Evaluation of Neuromuscular Effects and Functional Improvement with Tirasemtiv in ALS). The company was founded on August 5, 1997 and is headquartered in South San Francisco, CA.
(US) Regulus Therapeutics, Inc. is a biopharmaceutical company, which engages in the discovery and development of drugs targeting microRNAs. Its two lead product candidates, RG-012 and RGLS4326, are in clinical development. RG-012 is an anti-miR targeting miR-21 in Phase II clinical trial for the treatment of Alport syndrome, a life-threatening kidney disease. RGLS4326 is an anti-miR targeting miR-17 in Phase I clinical trial for the treatment of autosomal dominant polycystic kidney disease. The firm is also developing a pipeline of preclinical drug product candidates in renal, hepatic, and central nervous systems diseases. The company was founded in September 2007 and is headquartered in San Diego, CA.
Catalent, Inc. operates as a holding company, which engages in the provision of delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. It operates through the following segments: Softgel and Oral Technologies, Biologics, Oral and Specialty Delivery, and Clinical Supply Services. The Softgel and Oral Technologies segment provides formulation, development, and manufacturing services for soft capsules or softgels, as well as large-scale manufacturing of oral solid dose forms for pharmaceutical and consumer health markets, and supporting ancillary services. The Biologics segment provides biologic cell-line, cell therapy and viral vector gene therapy development and manufacturing; formulation, development, and manufacturing for parenteral dose forms, which include prefilled syringes, vials, and cartridges; and analytical development and testing services for large molecules. The Oral and Speciality Delivery segment provides advanced formulation, development, and manufacturing across a range of technologies along with integrated downstream clinical development and commercial supply solutions. The Clinical Supply Services segment provides manufacturing, packaging, storage, distribution, and inventory management for drugs and biologics in clinical trials. The company was founded in 1933 and is headquartered in Somerset, NJ.
(FR) DBV Technologies SA is a clinical-stage biopharmaceutical company, which engages in the research and development of epicutaneous immunotherapy products. It focuses on the development of Viaskin, an electrostatic patch, which may offer a convenient, self-administered, and non-invasive immunotherapy to patients. It also designs a robust clinical development program that includes ongoing clinical trials of Viaskin peanut, and Viaskin milk as well as pre-clinical development of Viaskin egg. The company was founded by Pierre-Henri Benhamou, Stéphane Benhamou, Bertrand Dupont, Christophe Dupont and Pierre-Yves Vannerom on March 29, 2002 and is headquartered in Montrouge, France.
(US) Tenax Therapeutics, Inc., is a specialty pharmaceutical company focused on identifying, developing, and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need. The company has a world-class scientific advisory team, including recognized global experts in pulmonary hypertension. The company owns North American rights to develop and commercialize levosimendan and has recently released topline data regarding its Phase 2 clinical trial for the use of levosimendan in the treatment of Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction (PH-HFpEF). The company was founded on May 26, 1967 and is headquartered in Morrisville, NC.
(United States) Veru, Inc. is an oncology and urology biopharmaceutical company. It develops medicines for prostate cancer treatment and prostate cancer supportive care as well as urology specialty pharmaceuticals. Its oncology drug candidates includes VERU-111, an oral alpha and beta tubulin inhibitor, which is in a phase 1b/2 study for the treatment of metastatic castration resistant prostate cancer; Zuclomiphene citrate, which is in a phase 2 clinical trial for the treatment of hot flashes in men undergoing prostate cancer hormonal therapies; and VERU-100, a long-acting GnRH antagonist 3 month subcutaneous depot, planned phase 2 clinical trial for the treatment of hormone sensitive advanced prostate cancer. The company’s urology specialty pharmaceutical drug candidate is TADFIN, a tadalafil and finasteride combination oral capsule, for the treatment of men with benign prostatic hyperplasia. Its commercial products include the FC2 Female/Internal condom for prevention of pregnancy and sexually transmitted infections and PREBOOST 4% benzocaine wipes for the prevention of premature ejaculation marketed as Roman Swipes by getroman.com. The company was founded by William R. Gargiulo Jr. and O.B. Parrish in 1996 and is headquartered in Miami, FL.
BeyondSpring Inc., a clinical stage biopharmaceutical company, focuses on the development and commercialization of immuno-oncology cancer therapies. The company's lead asset is the Plinabulin that is in late stage clinical trials as an anti-cancer agent in combination with docetaxel in advanced non-small cell lung cancer (NSCLC) for the prevention of high and intermediate risk chemotherapy-induced neutropenia. It is also developing Plinabulin in combination with various immuno-oncology agents, including nivolumab for the treatment of NSCLC; and programmed cell death protein 1 and CTLA-4 antibodies to treat small cell lung cancer. In addition, the company engages in the development of three small molecule immune agents in preclinical stages; and a drug development platform using ubiquitin mediated protein degradation pathway. BeyondSpring Inc. has collaboration agreements with the University of Washington and the Fred Hutchinson Cancer Research Center. The company was founded by Lan Huang and Lin Qing Jia in 2013 and is headquartered in New York, NY.
Olema Pharmaceuticals, Inc. operates as a clinical-stage biopharmaceutical company. It focuses on the discovery and development of targeted therapies for women's cancers. The company also focuses on OP-1250, a complete estrogen receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD) that is being studied in a Phase 1/2 clinical trial for the treatment of metastatic or locally advanced ER-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Olema Pharmaceuticals was founded by Cyrus L. Harmon and Peter J. Kushner on August 7, 2006 and is headquartered in San Francisco, CA.