Adds analyst comment in paragraph 5-6
By Jacob Gronholt-Pedersen
COPENHAGEN, Feb 6 (Reuters) - Shares in Danish drugmaker Novo Nordisk NOVOb.CO gained 5.4% on Friday, recovering some of the previous two sessions' steep losses, after the U.S. Food and Drug Administration (FDA) pledged to address mass-marketing of unapproved drugs.
The stock plunged nearly 8% on Thursday after telehealth company Hims and Hers Health HIMS.N launched a significantly cheaper $49 compounded version of Novo Nordisk's FDA-approved Wegovy weight-loss pill.
Novo's shares, which are near their lowest since Wegovy was introduced in June 2021, were 5.4% higher at 1341 GMT.
Late on Thursday, FDA Commissioner Marty Makary said on X that the agency would "take swift action" against companies mass-marketing illegal copycat drugs. "The FDA cannot verify the quality, safety or effectiveness of non-approved drugs," he said without naming any companies.
Despite the FDA statement, Bernstein analyst Christian Moore said he wasn't holding his breath for U.S. authorities to take decisive action.
"We do think people will still buy it, and don’t think the government will do anything to stop it, based on precedent," he said.
The FDA and individual states share regulatory authority over compounding pharmacies. In September, it launched a new tracker to show when ingredients were coming from FDA-inspected facilities. It also sent letters that month to companies it said were practicing deceptive direct-to-consumer advertising, including Hims, Novo, and rival Eli Lilly LLY.N.
Novo, which on Wednesday flagged unprecedented price pressure that saw its stock plunge 17%, said on Thursday it would take "legal and regulatory action" in response to Hims' announcement but declined to elaborate further on Friday.
Eli Lilly, which is awaiting a U.S. regulatory decision on its weight-loss pill orforglipron, was also critical of the launch announcement.
"Patients deserve better than untested knockoffs that are sold without clinical evidence that they even work," a Lilly spokesperson said in an email to Reuters on Thursday before Makary's public post.
A Hims spokesperson said on Thursday the company had not compromised on safety or efficacy and used a technology based on liposomes intended to support absorption, in response to similar criticisms from Novo.
Lilly's shares, which had ended the prior session down about 8%, rose 3.8% in premarket trading.
($1 = 6.3327 Danish crowns)
(Reporting by Jacob Gronholt-Pedersen and Mrinalika Roy; Editing by David Goodman and Shailesh Kuber, Kirsten Donovan)
((Louisebreusch.rasmussen@tr.com; +45 21 27 97 79;))