One analyst is putting the odds at three to one that tests of a Karuna Therapeutics Inc. (KRTX, Financial) schizophrenia drug will meet study objectives, paving the way to Food and Drug Administration approval. If that happens, Jefferies analyst Chris Howerton believes the treatment should have “no issue” topping annual sales of $1 billion, reported BioPharma Dive.
Karuna is just one of several smaller pharma companies slated to reveal the results of clinical trials of key treatments in the third quarter. In a recent article, I reviewed the drug hopefuls of members of Big Pharma, noting that their stocks are less likely to make big moves - up or down - on results of clinical trials because of the breadth and depth of their product portfolios. The same can’t be said for smaller biotechs, where trial results could make or break them.
Seagen Inc. (SGEN, Financial) has been in the news lately, and not because of the important clinical test of the company’s cancer drug Padcev with Merck & Co. Inc.’s (MRK, Financial) immunotherapy Keytruda in newly diagnosed, advanced bladder tumors. Most of the news has been centered on the potential acquisition of the company by Merck and the resignation of co-founder and longtime CEO Clay Siegall due to an investigation into his arrest for alleged domestic abuse.
Positive results from Seagen’s study of Padcev would be a big deal because it would probably support an accelerated application and a potential entry into a market worth about $7 billion. That could help boost the company’s push to profitability.
New Jersey-based IVERIC bio Inc. (ISEE, Financial), formerly known as Ophthotech, is focused on treatments for retinal diseases. Its drug Zimura is being tested for geographic atrophy, a form of blindness with no effective treatments. Phase 3 results are expected this fall.
IVERIC is trying to catch up with Apellis Pharmaceuticals Inc. (APLS, Financial), whose drug was approved just last month. Zimura already succeeded in one phase 3 trial. Hitting the mark in a second study could set it apart from the Apellis medication.
In the fourth quarter, Madrigal Pharmaceuticals Inc. (MDGL, Financial) is expected to report top-line results from the company’s phase 3 study of its treatment for nonalcoholic steatohepatitis, a fatty liver disease thought to affect millions of people. Madrigal is trying to succeed where many predecessors failed.
The drug has its skeptics, among them Raymond James analyst Steven Seedhouse, whose analysis was blunt, writing that the medication is just not good for NASH.
Also awaiting NASH data are Akero Therapeutics (AKRO) and Intercept Pharmaceuticals Inc. (ICPT, Financial).
Backers of Copenhagen-based Zealand Pharma A/S (ZEAL.CO) are hoping study results help jump-start the stock, which is selling for about half of what it was last year. That could happen if the company’s treatment for short bowel syndrome proves superior to market leader Takeda Pharmaceuticals Inc. (TAK, Financial), according to a report by Evaluate.
Fate Therapeutics Inc.’s (FATE, Financial) fate may rest upon how well its natural killer cell therapy, affects lymphoma. We’ll learn more about its efficacy when study results are made public later this year. Also developing NK cell therapies are Nkarta Inc. (NKTX, Financial) and Affimed N.V. (AFMD, Financial), the latter of which is being developed in collaboration with the MD Anderson Cancer Center.
