Mesoblast (NASDAQ:MESO) has received A$29.6M (US$21.7M) from Mallinckrodt (NYSE:MNK) under their equity purchase agreement related to the development and commercialization of product candidates MPC-06-ID (low back pain) and MSC-100-IV (graft versus host disease). Mesoblast issued 20.04 ordinary shares to Mallinckrodt in the transaction.
Mallinckrodt has nine months to finalize the agreements for the candidates.
"Ultimately, we want the same thing as the president-elect," tweets Allergan (AGN -2.2%) CEO Brent Saunders. "1) Supportive environment for innovation 2) Patient access and affordability for healthcare 3) Smart people with good U.S. jobs."
Also on the move post-Trump: Mylan (MYL -4.2%), Perrigo (PRGO -7.5%), Valeant (VRX -5.5%), Bristol-Myers Squibb (BMY -5%), Mallinckrodt (MNK -6.7%), BioMarin (BMRN -4.6%)
Mallinckrodt (NYSE:MNK) will acquire 20.04M of Mesoblast's (NASDAQ:MESO) ordinary shares at A$1.4761 (4.99% stake) for the exclusive right to negotiate a development and commercialization agreement for two of MESO's top product candidates.
The assets are MPC-06-ID for the prevention of moderate-to-severe low back pain and MSC-100-IV for the treatment of acute graft versus host disease. Both are in Phase 3 development.
Under the terms of the equity purchase agreement, MNK has an exclusive period of up to nine months to finalize the agreements for the two candidates worldwide except Japan and China.
Philip van Doorn and team at Marketwatch put together a list of 18 S&P 500 names with consensus sell-side price targets at least 30% above the current price.
Ten of the 18 stocks are in healthcare, which has been roughed up by a combination of Obamacare, Clinton's talk about drug pricing (back when all thought she would be the next POTUS), and now Trump joining in the bashing.
Mallinckrodt (NYSE:MNK) fell 9.1% in today's trade, tumbling to the bottom of the S&P 500, despite reporting better than expected FQ4 earnings and revenues.
In the earnings conference call, CEO Mark Trudeau said MNK's specialty generics segment fell 19% in the quarter, and management expects "significant downward pressure on this segment to persist."
MNK also has experienced temporary "production issues" with a third-party manufacturer supporting its Therakos immunotherapy platform, and the company says the situation could continue into Q2 2017.
The company's decision to withhold FY 2017 guidance also troubled investors, which caused concerns about lack of sales visibility for Acthar, generics and the hospital franchise to weigh on shares, Guggenheim analyst Louise Chen says.
Barclays is one of several firms that remain optimistic, saying MNK's selloff was "outsized considering much of the disclosure on the call was largely expected, including specialty generics weakness and the 2017 outlook, which seemed relatively mild."
Mallinckrodt (NYSE:MNK) announces plans to initiate a Phase 2 clinical trial in the first half of next year to assess H.P. Acthar Gel (repository corticotropin injection) in patients with amyotrophic lateral sclerosis (ALS), a Fast Track designation by the FDA.
The eight-week open-label study will evaluate four different dosing regimens of Acthar. An optional 28-week open-label extension phase will follow.
Deutsche Bank analyst Gregg Gilbert says Mallinckrodt (NYSE:MNK) did not intentionally mislead investors relative to Acthar's exposure to Medicare. He adds that yesterday's sell-off creates an "interesting" entry point. He reiterates his Buy rating and $78 (29% upside) price target.
Mallinckrodt (NYSE:MNK) plunged 12% in today's trade after short seller Andrew Left accused CEO Mark Trudeau of committing securities fraud.
"Trudeau has been caught red handed committing securities fraud - exposed by none other than the newly released Medicare drug-spending dashboard," according to Citron Research editor Left, who called into question MNK's Acthar Gel sales derived from government sources such as Medicaid and Medicare.
Leerink analysts say the report attempts to question whether the government should be paying Acthar’s average $80K-$100K net price per patient per year and calling it to the attention of government figures who have been targeting excessive drug pricing issues, in the type of issue that became a major headache for Mylan recently with EpiPen.
The source doesn't have the most reliable reputation, but nevertheless Depomed (DEPO +3.8%) is on the move as Interconomia.com reports Mallinckrodt (MNK +2.1%) as having won the bidding for the company with a $2.6B offer.
Mallinckrodt (NYSE:MNK) and Lannett Company (NYSEMKT:LCI) are tussling with the FDA over its withdrawal of previously approved abbreviated New Drug Applications (ANDAs) for generic versions of Janssen Pharmaceuticals' (NYSE:JNJ) CONCERTA (methylphenidate HCl) for the treatment of attention deficit hyperactivity disorder (ADHD).
The agency pulled the approvals due to the lack of bioequivalence. Although bioequivalence was the basis for the original approvals, field reports of insufficient therapeutic effect surfaced after the products were launched. In an analysis of reports from the FDA's adverse event reporting system, FAERS, the reported therapeutic failures of the generics in question were almost 10x higher than Actavis' (NASDAQ:TEVA) generic version, the reference drug. Further analyses showed differences in the rates of drug release and absorption. Specifically, the companies' products delivered the active ingredient at a slower rate 7 - 12 hours after dosing.
Lannett has requested a hearing with the FDA on the matter. Mallinckrodt will have to do the same after an appeals court removed its pending litigation with the agency from its oral argument calendar. It has filed a Motion to Reconsider in an attempt to be put back on the docket. Both firms insist that their generic versions are safe and effective.