December 28, 2016
By Mark Terry, BioSpace.com Breaking News Staff
With the end of 2016 only a few days away, there’s still some potential big changes in biopharma stocks. Wayne Duggan, writing for Benzinga, cites nine companies with potential catalysts before the end of the year.
1. Cempra
On November 4, Cempra announced that the majority, with a vote of 7 to 6, of the U.S. Food and Drug Administration (FDA)’s Antimicrobial Drugs Advisory Committee (AMDAC) found that its solithromycin antibiotic’s efficacy data outweighed the risks for the treatment of community-acquired bacterial pneumonia (CABP).
The PDUFA dates for the drug are December 27 and 28.
Cempra is currently trading for $5.82.
In September, Agios Pharmaceuticals , with Celgene announced plans to submit a new drug application (NDA) to the FDA for AG-221 (enasidenib) in relapsed and/or refractory (R/R) acute myeloid leukemia (AML) with an IDH2 mutation by the end of the year. If that schedule remains, there should be some news this week.
Agios is currently trading for $42.22.
Too late! This one already happened today. The company’s Sollpura in cystic fibrosis (CF) patients with exocrine pancreatic insufficiency failed a Phase III trial, although it was a near-miss, and the company is going to conduct an additional trial with more flexibility for dosing starting the first quarter of 2017.
Anthera Pharmaceuticals is currently trading down at $0.70.
Aviragen Therapeutics ' BTA585 is being developed to treat respiratory syncytial virus. It is currently in a Phase II clinical trial and top-line data is expected soon.
Aviragen is currently trading for $1.24.
Coherus Biosciences is expected to complete its Phase III confirmatory trial of CHS-1420 to treat psoriasis by the end of the year. In August, it reported topline results from its ongoing Phase III trial of its biosimilar to Humira (adalimumab), which met its primary endpoint.
Coherus is currently trading for $28.80.
Nektar Therapeutics is evaluating its Cipro DPI as a treatment of bronchiectasis in a Phase III clinical trial. It is expected to finish that trial by the end of the year.
Nektar is currently trading for $12.29.
7. Opko Health
Opko Health just announced on December 19 that it was added to the Nasdaq Biotechnology Index (NBI). Opko is expected to release data from its Phase III trial of HGH-CTP in adults with growth hormone deficiency by the end of the year.
Opko is currently trading for $11.53.
At its third-quarter financial reporting Raul Rodriguez, Rigel ’s president and chief executive officer, said, “We believe that the collective data from the FIT Phase III clinical program of fostamatinib support a clear treatment effect, a sustained clinical benefit and a positive benefit-risk profile. We look forward to discussing the top-line FIT program results with the FDA in the very near future, and obtaining their feed-back on our plan to submit an NDA. Assuming a successful discussion, we expect to submit the NDA in the first quarter of 2017.”
Rigel is currently trading for $2.46.
On November 29, TRACON Pharmaceuticals closed on its underwritten public offering of common stock. It is expected to report Phase II trial data on its TRC105 to treat soft tissue sarcomas very soon.
TRACON is currently trading for $5.10.
