Investors must wait until summer for the details about a pair of serious adverse events (SAEs) that caused Intercept Pharmaceuticals Inc.’s shares to lose altitude after skyrocketing on phase IIb data with obeticholic acid (OCA) in nonalcoholic steatohepatitis (NASH).

Uncertainty meanwhile, though, did nothing to stop the New York-based firm from padding its coffers to the tune of $183.3 million, the net amount from the sale of 1 million shares sold at $320 each, as Intercept gears up to file for a new drug application in the U.S. and a marketing authorization application in Europe for OCA in a separate indication, primary biliary cirrhosis (PBC).

Shares of Intercept (NASDAQ:ICPT) closed Friday at $290.89, down $30.92, still a distance from the $407.16 at which the stock closed on the day the SAEs from the NASH trial known as FLINT (Farnesoid X Receptor [FXR] Ligand Obeticholic Acid in NASH Treatment Trial) were disclosed. The price had jumped more than 600 percent since Intercept disclosed that the FLINT trial was stopping early because efficacy had been achieved. (See BioWorld Today, Jan. 10, 2014, and March 18, 2014.)

SAEs that may have tainted the FLINT trial (which the National Institute of Diabetes and Digestive and Kidney Diseases is conducting) involved cardiovascular (CV) problems in a pair of subjects who had other medical complications. The first, a 73-year-old woman with type 2 diabetes and other conditions, developed congestive heart failure and pulmonary edema before she had a stroke and died. The second, a 59-year-old woman, had a history of surgeries, hyperlipidemia, abnormally elevated liver enzymes, diabetes, obesity and hypertension. She died of an apparent heart attack about two weeks after her final trial visit, which was about 60 weeks after starting OCA therapy.

Given the drug’s mechanism of action – it’s an agonist of FXR – and previous clinical experience, the CV trouble seems unlikely an effect of the drug, in Intercept’s view. But whatever happens with FLINT, Intercept is going ahead with plans for PBC approvals. A study called POISE in that indication showed that OCA, at the 10-mg dose and at the 5-mg dose titrated to 10 mg, beat placebo in achieving a reduction in serum alkaline phosphate after 12 months of therapy, with 47 percent of patients in the 10-mg group and 46 percent in the titration group hit the endpoint vs. 10 percent in the placebo group.

POISE, which enrolled 217 patients, also hit secondary endpoints, including a range of biochemical liver function parameters. Full results are expected at the International Liver Congress of the European Association for the Study of the Liver meeting next week in London.

OCA could become the first new treatment approved for PBC is almost two decades. An autoimmune liver disease that can progress to cirrhosis and liver failure, PBC typically affects women – about one in 1,000 older than age 40. The only approved drug for it, ursodiol, doesn’t work especially well, with up to half of PBC patients not responding adequately.

And whither OCA in NASH, another indication that cries out for a reliable treatment? The regulatory path is foggy, though the FDA set up a workshop last September, which brought industry and academia together to share ideas. NASH is a serious chronic buildup of fat in the liver that can lead to cirrhosis and death. In the range of 2 percent to 5 percent of the U.S. population is afflicted with the severest forms, with 10 percent to 20 percent more having the largely benign “fatty liver” condition. Biopsy determines which of those prevails, after the patient’s blood test raises suspicion in a doctor. Intercept CEO Mark Pruzanski has termed NASH “the coming tsunami of liver disease.”

Before the waves hit, others also are working to build figurative towers on higher ground. Companies take varied approaches to the tricky condition, the etiology of which is unknown, though it’s understood to occur and worsen with a much better characterized epidemic: obesity. Thomson Reuters Cortellis Clinical Trials Intelligence lists 30 mechanisms of action being tried by biotech and pharma firms against NASH, with insulin sensitizers by far the most popular. (See BioWorld Insight, March 31, 2014.)

One company to make news this week with a NASH strategy is San Diego-based Lumena Pharmaceuticals Inc., which filed last week for a $75 million initial public offering. The firm in-licensed one of its assets, LUM002, from Sanofi SA, of Paris, which had the sodium-dependent bile acid transporter in development to lower cholesterol, too. Lumena plans a phase II trial in the second half of this year with the oral, once-daily therapy. (See BioWorld Today, April 4, 2014.)

In the offering by Intercept, which is expected to close next week, 600,000 shares were sold by the company, and the rest by stockholders. BofA Merrill Lynch, Citigroup, Goldman, Sachs & Co. and Deutsche Bank Securities are acting as joint bookrunning managers and underwriters for the offering. BMO Capital Markets is serving as lead manager, with co-managers Needham & Co. LLC, Oppenheimer & Co., Wedbush PacGrow Life Sciences, JMP Securities LLC and Summer Street Research Partners.

In other financings news:

Applied Genetic Technologies Corp., of Gainesville, Fla., closed its initial public offering of about 4.1 million shares at $12 each, and reported the exercise in full by the underwriters of their option to purchase 625,000 additional shares of common stock, which closed on April 3, 2014. Proceeds are about $51.8 million. (See BioWorld Today, March 28,2014.)

Cyclacel Pharmaceuticals Inc., of Berkeley Heights, N.J., priced an underwritten public offering of about 2.8 million shares of its common stock to institutional and other investors at a price to the public of $3.50 per share. The company granted underwriters a 30-day option to purchase up to 428,571 more shares to cover overallotments, if any. Cyclacel expects to receive gross proceeds of about $10 million. Laidlaw & Co. is the sole book-running manager for the offering. The deal is expected to close April 9, 2014.