Now that Wall Street is in the second half of the year, analysts are anticipating updates and announcements about pipeline drugs from biopharmaceutical companies, including MEI Pharma Inc (NASDAQ:MEIP), Sarepta Therapeutics Inc (NASDAQ:SRPT), Novavax, Inc. (NASDAQ:NVAX), and XOMA Corp (NASDAQ:XOMA). Here is what investors should look for in the second half of the year:
MEI Pharma Inc
MEI Pharma Inc focuses on the development of new therapies for cancer. The company is currently running a Phase 1b trial for ME-344, a novel mitochondrial inhibitor, and a Phase 1 trial for PWT143, a highly selective PI3K delta inhibitor. MEI Pharma is expected to release data from both trials in the fourth quarter this year.
ME-344 targets solid tumors in cancer patients. The Phase 1b trial is testing the safety and tolerability of intravenous ME-344 in combination with Hycamtin, an FDA approved chemotherapy, in patients with solid tumors. The trial is testing up to 64 patients with expected safety and survival data to be announced in the fourth quarter.
PWT143 is “a potent and highly selective oral inhibitor of phosphatidylinositide 3-kinase (PI3K) delta, a molecular target that has been shown to play a critical role in the proliferation and survival of hematologic cancer cells,” according to MEI Pharma. The Phase 1 study is assessing the safety and tolerability of different oral doses of various formulations of PWT-143 in healthy patients. The primary completion date of the trial is expected next month.
Out of two analysts polled by TipRanks who have rated MEI Pharma within the past three months, one is bullish on the stock and the other is neutral. The average 12-month price target for MEI Pharma is $5, marking a 168.82% potential upside from where shares last closed.
Sarepta Therapeutics Inc
Sarepta Therapeutics Inc develops RNA-based therapeutics for the treatment of rare, infectious, and other life threatening diseases. The company’s pipeline drug is eterplirsen, used for the treatment of Duchenne muscular dystrophy (DMD); a genetic degenerative muscle disease.
The drug was recently granted priority review by the FDA, a status offered to drugs that treat diseases that do not have sufficient therapies, or to drugs that have more benefits than existing drugs. The FDA will make a final decision on the drug by February 26, 2016.
Sarepta is expected to announce new eteplirsen data ahead of its Advisory Committee meeting in the fourth quarter. Brian Skorney of Baird reiterated an Outperform rating on Sarepta Therapeutics on August 26 after the FDA granted priority review, expecting the drug will be “the subject of a joint Advisory Committee meeting tentatively scheduled for November 23/24. [Eterplirsen was] recently awarded Rare Pediatric Disease Designation from the FDA, setting [it] for a valuable voucher.” On average, Skorney has an overall success rate of 64% recommending stocks and a +13.0% average return per recommendation when measured over a one-year horizon and no benchmark,
Out of eight analysts polled by TipRanks who have rated Sarepta within the past three months, seven are bullish on the stock and one is neutral. The average 12-month price target on the company is $47.86, marking a 33.17% potential upside from where the stock last closed.
Novavax, Inc. is expected to release data from the Phase 2 maternal immunization study for respiratory syncytial virus, or RSV, to be available in the third quarter of 2015. RSV is contagious and can occur in anyone, but is most noticeable in young children and the elderly populations who have compromised immune systems. RSV causes infections in the lungs and breathing passages.
Novavax is testing a vaccine in healthy women in their third trimester of pregnancy in order to observe the safety and immunogenicity of the vaccine throughout the first year of the infant’s life. Last month, the company announced positive top-line data for a clinical trial of a RSV vaccine in older adults (ages 60 and older). The vaccine was well-tolerated and achieved its primary, secondary, and exploratory objectives.
According to TipRanks, two analysts have rated the Novavax in the past three months, both of whom are bullish on the stock. The average 12-month price target is $15.50, marking a 55% potential upside from current levels.
In the second half of 2015, pharmaceutical company Xoma Corp is expected to announce results from Proof of Concept of gevokizumab in non-infectious anterior scleritis; a painful condition in which the front of the eye becomes red and inflamed. Gevokizumab is a pipeline drug in testing to treat a wide variety of inflammatory conditions.
On July 22, Xoma announced results from the Phase 3 Eyeguard-B trial, testing gevokizumab in patients with Behçet’s disease uveitis; another inflammatory condition of the eye. The study did not reach its primary endpoint, but management remained optimistic, noting that the study revealed other benefits of the pipeline drug.
Wedbush analyst Liana Moussatos currently has an Outperform rating on Xoma. She was not discouraged by the disappointing Phase 3 Eyeguard trial results, noting, “Gevokizumab still holds plenty of value. Moussatos expects data from Eyeguard-A and C to be released by the end of 2015. Moussatos currently has a 42% success rate recommending stocks and a +22.5% average return per recommendation when measured over a one-year horizon and no benchmark.
Out of the six analysts polled by TipRanks in the last three months, Moussatos is bullish on the biopharmaceutical company and the other five are neutral. The average 12-month price target of the company is $1.50, marking a 92.31% potential upside from where the stock last closed.