Healthcare Business

8 Major Biopharma Events Coming Later in 2016 and in 2017

Ultragenyx Pharmaceutical

Of the multiple clinical trial results Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) has expected in the near future, all are viable according to analysts. First the company expects Phase 2 interim data of KRN23 for tumor-induced osteomalacia to be reported by mid-2016, as well as Phase 3 data of rhGUS for mucopolysaccharidosis 7 (MPS7).

Phase 2 seizure study data in glucose transporter 1 deficiency syndrome (Glut1 DS) patients are expected in the second half of 2016. Jefferies sees a favorable risk/reward profile for this company concerning its KRN23 study, and that there is likely meaningful reduction in seizures from triheptanoin Phase 2 data in Glut1 DS based on optimized protocol and data from investigator sponsored trials.

Ultragenyx last closed at $56.81, with a consensus price target of $99.07 and a 52-week range of $49.00 to $137.05. Currently the company does not have any revenues.

GW Pharmaceuticals

After being on a roller-coaster of late, the rest of the year could be incredible for GW Pharmaceuticals PLC (NASDAQ: GWPH), based on its results. Previously Epidiolex achieved its primary endpoint of median reduction in seizure frequency in patients with Dravet syndrome, setting up for potentially positive top-line results before the end of 2016.

Other results for Epidiolex are expected for Lennox-Gastaut syndrome by mid-2016. Analysts are considering the reaction to previous results as a positive catalyst for this stock for the rest of 2016, with Merrill Lynch seeing this as potentially doubling. Also GW Pharma is reporting its Phase 2 data of GWP42004 in the first half of 2016 for the treatment of type 2 diabetes. The Phase 2 results from GWP42004 in the treatment of epilepsy are expected in the fourth quarter of 2016.

Shares last traded at $76.99, with a consensus price target of $148.83 and a 52-week range of $35.83 to $133.98. Analysts see nearly $22 million in revenues for 2016.


Puma Biotechnology

Puma Biotechnology Inc. (NYSE: PBYI) expects to continue to return value to shareholders in 2016 with neratinib. It is submitting a New Drug Application (NDA) to the FDA by mid-2016, which was delayed from what was expected to be a first quarter of 2016 filing. It is also reporting additional data from the Phase 2 trial of neratinib as an extended adjuvant treatment in HER2-positive early stage breast cancer using loperamide prophylaxis during the first half of 2016.

Expect even more data when the company reports its Phase 2 data from an investigator sponsored trial of neratinib in patients with HER2-negative breast cancer who have a HER2 mutation in mid-2016. By the end of 2016, we can expect Phase 2 data from PB272 Summit trial and for HER2 non-amplified breast cancer. In either the fourth quarter of 2016 of the first quarter of 2017, the company expects to present Phase 3 data of PB272 for third-line HER2-positive metastatic breast cancer.

Shares of Puma were last seen at $35.37, with a consensus price target of $112.83 and a 52-week range of $34.71 to $244.90. This company currently does not have any revenue.

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