Why I Was Wrong About Esperion, But Is It A Buy Now?
Mark Chapman • 11 Comments
Mark Chapman • 11 Comments
Wed, Jun. 29, 12:46 PM
Wed, Jun. 29, 11:10 AM
Wed, Jun. 29, 9:16 AM
Tue, Jun. 28, 5:37 PM
Tue, Jun. 28, 5:07 PM
- Nano cap Esperion Therapeutics (NASDAQ:ESPR) had a ugly day today despite the market's up move. Shares slumped almost 20% on more than a 35% spike in volume as informed investors ran for the exits ahead of the company's press announcement released at 4:05 pm which updated investors on the clinical development and regulatory path for lead product candidate bempedoic acid, its candidate for lowering "bad" cholesterol in patients intolerant of statins.
- The good news is that a global pivotal Phase 3 trial to assess safety and efficacy should commence in Q4 as will a cardiovascular outcomes study. Esperion says the study timelines will support a European marketing application in 2019 for patients with elevated LDL-C, including those intolerant of statins and one in 2022 for CV disease risk reduction in statin-intolerant patients.
- The bad news is the FDA's refusal to clarify a regulatory pathway for the LDL-C indication citing potential changes in their view of LDL-C lowering as a surrogate endpoint and the possibility of a shift in the future standard-of-care for statin-intolerant patients with elevated LDL-C. According to the company, if, indeed, lowering LDL-C is no longer a surrogate endpoint for approval, it will still submit a New Drug Application (NDA) for a CV disease risk reduction claim by 2022, which means potential approval is at least six years away.
- Bempedoic acid is a small molecule that lowers cholesterol without the side effects associated with statins. Once in the liver, it converts into a derivative coenzyme which directly inhibits an enzyme called ATP citrate lyase (ACL), which plays a key role in cholesterol and fatty acid synthesis.
- Update: Shares are down 24% after hours on robust volume.
Oct. 12, 2015, 9:13 AM
Oct. 12, 2015, 8:38 AM
- Eli Lilly (NYSE:LLY) is down 10% premarket on robust volume in response to its announcement that it has terminated the development of evacetrapib for the treatment of high-risk atherosclerotic cardiovascular disease due to lack of efficacy. Its decision was based on a review by the independent data monitoring committee.
- The move will result in a Q4 charge to R&D expense of up to $90M ($0.05 per share after tax). The company will incorporate the change in its 2015 guidance that it will provide during its earnings call on October 22.
- SVP and President of Lilly Bio-Medicines David Ricks says, "We're obviously disappointed in this outcome, as we hoped the evacetrapib would offer an advance in treatment for people with high-risk cardiovascular disease. We'll be working with investigators to appropriately conclude these trials. We remain confident in our pipeline as we prepare for launches in other therapeutics areas with significant unmet needs."
- Related tickers and status premarket: (NASDAQ:REGN) +4%; (NASDAQ:AMGN) +3%; (NASDAQ:ESPR) +14%; (NYSE:SNY) +1%.
Sep. 30, 2015, 9:13 AM
Sep. 29, 2015, 12:41 PM
Sep. 29, 2015, 9:14 AM
Sep. 29, 2015, 9:08 AM
- Esperion Therapeutics (NASDAQ:ESPR) is down 15% premarket on increased volume in response to the news of its Phase 3 development plan for its lead product candidate, bad cholesterol-lowering ETC-1002. The company's approach is based on the official End-of-Phase 2 Meeting Minutes it received from the FDA.
- The company plans to conduct multiple Phase 3 trials that will separately assess patients with statin intolerance and those who are inadequately treated despite maximally tolerated statin therapy. The design of the trials should be finalized in H1 2016 and will include long-term safety studies for patients on the maximum dose of statins. The length of the studies is the big question. An NDA filing could be 2018 or later, depending on the design of the trials.
- The FDA has encouraged the company to promptly initiate a cardiovascular outcomes study which would be well underway at the time of an NDA filing but would need to be completed before regulatory approval if there are concerns over ETC-1002's benefit/risk assessment. Esperion intends to start the trial by the end of the year. If final results are required for the NDA, its filing would be pushed back another couple of years.
- ETC-1002 inhibits an enzyme called ACL (ATP citrate lyase), which plays a key role in cholesterol synthesis in the liver.
Sep. 28, 2015, 5:43 PM
Aug. 18, 2015, 9:23 AM
Aug. 17, 2015, 5:37 PM
Aug. 17, 2015, 4:58 PM
- Esperion Therapeutics (NASDAQ:ESPR) jumps 11% after hours on robust volume in response to its announcement that the FDA informed it that a cardiovascular outcomes trial (CVOT) will not be necessary for the approval of its lead product candidate, ETC-1002, in certain patient populations with high cholesterol, although the company continues to plan and will initiate a CVOT prior to filing its New Drug Application (NDA) filing seeking clearance for broader label indications related to cardiovascular disease risk reduction. The FDA provided its feedback in an End-of-Phase 2 meeting with Esperion.
- The regulator confirmed that LDL-C remains an acceptable clinical surrogate endpoint for the clearance of an LDL-C-lowering therapy like ETC-1002 in patient populations who have a high unmet medical need such as patients with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) who are already taking maximally tolerated statins yet require additional LDL-C reduction.
- The company intends to start a Phase 3 study by the end of the year that will support its NDA for the above indication.
- ETC-1002 is a once-daily small molecule that inhibits the action of ATP citrate lyase (ACL), a key enzyme in the cholesterol biosynthesis pathway that supplies substrate for cholesterol and fatty acid synthesis in the liver. For certain patients, it avoids the unwanted side effects associated with statins.
Jul. 24, 2015, 2:31 PM
- Esperion Therapeutics (NASDAQ:ESPR) has taken a dive, -20.4%, as the FDA approves Praluent (alirocumab), the competing cholesterol-lowering drug developed by Regeneron (NASDAQ:REGN) and Sanofi (SNY +0.2%).
- Praluent is the first cholesterol-lowering treatment in the PCSK9 inhibitor class.
- Esperion fell sharply in June in response to a positive FDA AdComm vote for Praluent, which stands to compete against Esperion's ETC-1002 cholesterol drug candidate (provided it's approved).
- Regeneron shares remain halted.
Esperion Therapeutics, Inc. is a clinical stage biopharmaceutical company, which focuses on developing and commercializing first-in-class, oral, low-density lipoprotein cholesterol lowering therapies for the treatment of patients with hypercholesterolemia and other cardiometabolic risk markers.... More
Country: United States