Don't Forget To
Rate This Article

Get the Latest Investment Ideas Delivered Straight to Your Inbox. Subscribe


FDA Grants Approval for Drug Improving Kidney Function
Trending Company

Share on Stocktwits


Shares of Mallinckrodt Plc. traded 28% higher yesterday after the company reported that the U.S. FDA has issued approval for its Terlivaz® (terlipressin) for injection for use in treating hepatorenal syndrome, a serious and life-threatening condition that is accompanied by rapid reduction in kidney function.

Global specialty pharmaceutical firm Mallinckrodt Plc. (MNKPF:OTC), which makes investments in and develops specialty therapeutics for use in treating autoimmune and rare diseases in the areas of nephrology, neurology, rheumatology, ophthalmology, pulmonology, and several additional areas, Wednesday announced that "the U.S. Food and Drug Administration (FDA) approved Terlivaz® (terlipressin) for injection."

The company stated that Terlivaz is currently the only medicine to receive approval from the FDA for use in treating hepatorenal syndrome (HRS) with rapid reduction in kidney function. The firm noted that HRS is an acute, life-threatening condition that requires immediate medical attention and admission to a hospital. The company advised that it expects that Terlivaz will be available in the U.S. in the coming weeks.

Mallinckrodt's Siggi Olafsson, President and CEO Siggi Olafsson commented, "The FDA approval of Terlivaz is a significant milestone for Mallinckrodt as it brings an important treatment option to these critically ill patients requiring hospitalization and to U.S. physicians who historically have had limited treatment interventions."

"We're excited to bring Terlivaz to U.S. patients and physicians and plan to launch the product in the coming weeks," Olafsson added.

The company advised that Terlipressin has been widely studied and has been approved by medical regulatory agencies outside of the U.S. for over 30 years.

The firm indicated that the FDA issued its approval in part based on the data obtained in the Phase 3 CONFIRM trial. The CONFIRM study enrolled a total of 300 HRS type 1 (HRS-1) patient subjects in the U.S. and Canada. The study was designed to evaluate the safety and efficacy of terlipressin and was successful in meeting its primary endpoint, which was identified as verified HRS reversal. The company listed that in the trial verified HRS reversal was defined as "renal function improvement, avoidance of dialysis and short-term survival."

The company's EVP and Chief Scientific Officer Steven Romano, M.D., remarked, "Diagnosing and treating HRS can be challenging, and every minute counts when managing patients who have it. Terlivaz gives U.S. physicians the first FDA-approved option for treating HRS patients with rapid reduction in kidney function that may help them improve kidney function and lessen the associated need for renal replacement therapy, such as dialysis."

The company explained that "HRS involving rapid reduction in kidney function is an acute and life-threatening condition that occurs in people with advanced liver disease." The condition affects 30,000-40,000 people in the U.S. each year. There are two distinct types of HRS, acute and chronic, which are both serious conditions. The company added that "if left untreated, HRS with rapid reduction in kidney function has a median survival time of approximately two weeks and greater than 80 percent mortality within three months."

Mallinckrodt is a specialty pharmaceutical company headquartered in Dublin, Ireland. The firm is engaged in investing in, developing, and commercializing medical treatments for autoimmune and rare diseases.

Mallinckrodt Plc. began yesterday with a market cap of around US$1.19 billion, with approximately 84.78 million shares outstanding. MNKPF shares opened nearly 11% higher yesterday at US$15.50 (+US$1.50, +10.71%) over the previous day's US$14.00 closing price. The stock traded yesterday between US$15.50 and US$18.00 per share and closed for trading at US$17.95 (+US$3.95, +28.21%). It is currently trading at US$17.95.

Want to be the first to know about interesting Biotechnology / Pharmaceuticals investment ideas? Sign up to receive the FREE Streetwise Reports' newsletter. Subscribe

1) Stephen Hytha wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.

2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees. As of the date of this article, an affiliate of Streetwise Reports has a consulting relationship with None. Please click here for more information. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.

3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.

4) This article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.

5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.

6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

Want to read more about Biotechnology / Pharmaceuticals investment ideas?
Get Our Streetwise Reports Newsletter Free and be the first to know!

A valid email address is required to subscribe