We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Mallinckrodt's Roxicodone Reformulation Gets CRL From FDA
Read MoreHide Full Article
Mallinckrodt plc’s subsidiary, SpecGx LLC reported that the FDA has issued a complete response letter (“CRL”) for its new drug application (“NDA”) seeking approval of opioid analgesic candidate, MNK-812. The candidate is an abuse-deterrent, immediate-release reformulation of commonly abused opioid painkiller, Roxicodone (oxycodone hydrochloride tablets USP).
The NDA sought approval of MNK-812 for management of pain severe enough to be treated with an opioid analgesic and where alternative treatments have inadequate effect. The company had been developing the reformulation with properties designed to deter intravenous and intranasal abuse under its 505(b)2 NDA.
However, last month, the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted in favor of the candidate.
Mallinckrodt’s stock has lost 7.6% in the year so far compared with the industry’s decline of 16.1%.
The letter provides guidance on areas of further evaluation for resubmitting the NDA. The letter from the FDA was unexpected, following the positive outcome at the Advisory Committee meeting held in November. The company is evaluating the agency's guidance and will request a meeting with the FDA in the coming weeks to discuss the path forward.
The news comes as a setback for the company. Acthar, Mallinckrodt’s largest product, is being negatively impacted by the residual impact of the previously reported patient withdrawal issues. Two CRLs – for MNK-812 and stannsoporfin – have also impacted the company’s future prospects unfavorably.
Meanwhile, Mallinckrodt is focused on streamlining its business to focus better on its innovative medicines and therapies. Earlier this month, it announced its intention to spin-off its Specialty Generics/Active Pharmaceutical Ingredients business and Amitiza into a new company.
The company expects to create two independent and publicly-traded companies — one focused on innovative specialty pharmaceutical brands and the other primarily on niche specialty generic products and API manufacturing. The spin-off is expected to be completed by the second half of 2019.
Bristol-Myers’ earnings per share estimates have increased from $3.64 to $3.87 for 2018 and from $3.94 to $4.08 for 2019 over the past 60 days.
J&J’s earnings per share estimates have increased from $8.14 to $8.16 for 2018 and from $8.62 to $8.66 for 2019 over the past 60 days.
Merck’s earnings per share estimates have increased from $4.28 to $4.34 for 2018 and from $4.66 to $4.71 for 2019 over the past 60 days.
The Hottest Tech Mega-Trend of All
Last year, it generated $8 billion in global revenues. By 2020, it's predicted to blast through the roof to $47 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
Image: Bigstock
Mallinckrodt's Roxicodone Reformulation Gets CRL From FDA
Mallinckrodt plc’s subsidiary, SpecGx LLC reported that the FDA has issued a complete response letter (“CRL”) for its new drug application (“NDA”) seeking approval of opioid analgesic candidate, MNK-812. The candidate is an abuse-deterrent, immediate-release reformulation of commonly abused opioid painkiller, Roxicodone (oxycodone hydrochloride tablets USP).
The NDA sought approval of MNK-812 for management of pain severe enough to be treated with an opioid analgesic and where alternative treatments have inadequate effect. The company had been developing the reformulation with properties designed to deter intravenous and intranasal abuse under its 505(b)2 NDA.
However, last month, the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted in favor of the candidate.
Mallinckrodt’s stock has lost 7.6% in the year so far compared with the industry’s decline of 16.1%.
The letter provides guidance on areas of further evaluation for resubmitting the NDA. The letter from the FDA was unexpected, following the positive outcome at the Advisory Committee meeting held in November. The company is evaluating the agency's guidance and will request a meeting with the FDA in the coming weeks to discuss the path forward.
The news comes as a setback for the company. Acthar, Mallinckrodt’s largest product, is being negatively impacted by the residual impact of the previously reported patient withdrawal issues. Two CRLs – for MNK-812 and stannsoporfin – have also impacted the company’s future prospects unfavorably.
Meanwhile, Mallinckrodt is focused on streamlining its business to focus better on its innovative medicines and therapies. Earlier this month, it announced its intention to spin-off its Specialty Generics/Active Pharmaceutical Ingredients business and Amitiza into a new company.
The company expects to create two independent and publicly-traded companies — one focused on innovative specialty pharmaceutical brands and the other primarily on niche specialty generic products and API manufacturing. The spin-off is expected to be completed by the second half of 2019.
Mallinckrodt public limited company Price
Mallinckrodt public limited company Price | Mallinckrodt public limited company Quote
Zacks Rank & Stocks to Consider
Mallinckrodt currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the same space are Bristol-Myers Squibb Co. (BMY - Free Report) , Johnson & Johnson (JNJ - Free Report) and Merck & Co. Inc. (MRK - Free Report) . While Bristol-Myers sports a Zacks Rank #1 (Strong Buy), J&J and Merck carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Bristol-Myers’ earnings per share estimates have increased from $3.64 to $3.87 for 2018 and from $3.94 to $4.08 for 2019 over the past 60 days.
J&J’s earnings per share estimates have increased from $8.14 to $8.16 for 2018 and from $8.62 to $8.66 for 2019 over the past 60 days.
Merck’s earnings per share estimates have increased from $4.28 to $4.34 for 2018 and from $4.66 to $4.71 for 2019 over the past 60 days.
The Hottest Tech Mega-Trend of All
Last year, it generated $8 billion in global revenues. By 2020, it's predicted to blast through the roof to $47 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
See Zacks' 3 Best Stocks to Play This Trend >>