Last week Medicines Company announced positive results from two Phase 3 studies for its cholesterol-lowering drug, inclisiran. Topline results for the Orion-9 Phase 3 clinical study of inclisiran in patients with heterozygous familial hypercholesterolemia were positive. The company also said it saw positive topline results for the Orion-10 Phase 3 clinical study in patients with atherosclerotic cardiovascular disease, successfully completing the pivotal Phase 3 LDL-cholesterol lowering clinical trials for inclisiran. Orion-10 met all primary and secondary endpoints, and inclisiran demonstrated efficacy, tolerability and safety that were at least as favorable as observed in ORION-11, with no treatment-related liver or renal laboratory abnormalities.
The Baird team feels that the positive 9/10 Orion data could be validated by the November 16 to 18 American Heart Association meeting, and the firm’s report said this:
We had conviction that PCSK9 RNAi drug inclisiran would demonstrate efficacy and safety in the Phase 3 ORION-9/10/11 trials. Combining the complete results for ORION-11 presented at the European Society for Cardiology, and top-line results for ORION-9/10 announced last week, the existing clinical results for inclisiran across these pivotal trials almost completely validates our conviction. To that end, we look forward to late-breaking presentations for ORION-10 on November 16 and ORION-9 on November 18 at the American Heart Association (AHA) conference in Philadelphia to validate inclisiran’s profile.
Baird has set a massive $100 price objective, while the posted consensus figure is much lower at $62.36. The stock ended most recent at $48.96 per share, just over 2% lower on the day.
This is the smallest market cap play of these three, but for super-aggressive accounts it could be a huge winner. Syndax Pharmaceuticals Inc. (NASDAQ: SNDX) is a clinical-stage biopharmaceutical company that is developing an innovative pipeline of cancer therapies.
The company’s lead product candidate, entinostat, is a once-weekly, oral, small molecule, class I HDAC inhibitor that is being tested in a Phase 3 combination trial with exemestane for treatment of advanced HR+, HER2- breast cancer and has been evaluated in combination with several approved PD-1/PD-(L)1 antagonists.
The Syndax pipeline also includes SNDX-6352, a monoclonal antibody that blocks the colony-stimulating factor 1 receptor, as well as SNDX-5613, a highly selective inhibitor of the Menin–MLL binding interaction.
The Baird analysts like the clinical data and noted this in the report:
Phase 2 OS results for histone deacetylase (HDAC) entinostat plus aromatase inhibitor Aromasin in HR+ BC give us initial optimism for E2112. Combined with parallel efficacy for HDAC drug chidamide and a proprietary Bayesian analysis that conservatively gives E2112 a reasonable chance for OS benefit. We like the risk-reward for E2112, in the next interim readout guided for the fourth quarter (likely Nov-19). We recognize Street expectations for E2112 are high, particularly with SNDX’s +97% performance YTD, such that even a study continuation at the fourth quarter would be considered negative. However, we still reiterate the risk-reward opportunity heading into this readout and more generally for E2112.
The gigantic $30 Baird price target compares with a much lower $17.71 consensus target price. The stock closed at $6.91 a share on Tuesday after retreating 7.5% for the day.
These three biotech stocks have upcoming clinical data and presentations that could be huge, and they could blast the stocks higher. Note though that any delay in data, extension of trials or outright failure could have a huge impact on the share prices, so these are only suitable for accounts with a very high risk tolerance