1. Tesaro
Based in Waltham, Mass., Tesaro (TSRO) has been rumored to be the target of an acquisition for a while, but they have warmed up recently. The company was granted Priority Review for its niraparib New Drug Application (NDA) in December by the U.S. Food and Drug Administration (FDA). Niraparib is a PARP inhibitor, a new form of drug treatment. It is being evaluated for patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer after response to platinum-based chemotherapy. The PDUFA date is June 30, 2017. It is currently being evaluated in three pivotal trials.
Tesaro stock is currently trading for $178.20.
2. Agile Therapeutics
Based in Princeton, NJ, Agile Therapeutics (AGRX) is focused on developing new prescription contraception products. Its lead product, Twirla (AG200-15) is a once-weekly prescription contraceptive patch. It also has other transdermal contraceptive products in its pipeline. On January 3, 2017, it announced positive top-line results from its Phase III SECURE clinical trial of Twirla.
Agile stock is currently trading for $2.14.
3. Kite Pharma
Kite Pharma (KITE) is the leader in CAR-T therapies for cancer treatment. On February 28, 2017, the company reported that its CAR-T candidate axicabtagene ciloleucel (KTE-C19) met the primary endpoints of its Phase III trial. It is being studied in chemorefractory aggressive B-cell non-Hodgkin lymphoma (NHL). There have been three deaths associated with the study. Two were believed to be related to the therapy, one hemophagocytic lymphohistiocytosis and one cardiac arrest. The third, a pulmonary embolism, was determined to be unrelated.
Kite stock is currently trading for $73.90.
4. Juno Therapeutics
Juno Therapeutics (JUNO) is also a CAR-T company, but it’s been lagging behind Kite. In late January, its stock got jittery over social media rumors of a potential buyout. Prior to July 2016, Juno was the leader in CAR-T, but because of three patient deaths, the FDA placed its Phase II trial of JCAR015 on clinical hold. They were eventually cleared, but the delay pushed its approval back from 2017 to the first half of 2018.
5. Acceleron Pharma
Headquartered in Cambridge, Mass., Acceleron Pharma (XLRN) focuses on rare diseases. Its luspatercept is being studied in Phase III trials for hematologic diseases, myelodysplastic syndromes (MDS) and beta-thalassemia under a global partnership with Celgene (CELG). It also has clinical programs in oncology and neuromuscular diseases, and preclinical work in fibrotic and other serious diseases. On December 22, 2016, it announced it had treated its first patient in a Phase II trial of ACE-083 in facioscapulohumeral muscular dystromphy (FSHD).
Acceleron stock is currently trading for $28.51.
6. Aurinia Pharmaceuticals
Based in Victoria, British Columbia, Aurinia Pharmaceuticals (AUPH) announced on March 1 top-line results from its Phase IIb AURA-LV trial in lupus nephritis (LN). At 48 weeks, the trial met endpoints for complete and partial remission.
Aurinia stock is currently trading for $5.59.
7. Geron Corporation
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