Horizon Pharma plc (NASDAQ:HZNP) is up 23% premarket on average volume in response its successful Phase 3 clinical trial, OPTIC, evaluating teprotumumab in patients with active thyroid eye disease (TED). The study met the primary endpoint of a statistically significant proportion of responders compared to placebo. Specifically, 82.9% of patients in the treatment group experienced meaningful improvements in proptosis (bulging eyes) (at least a 2 mm reduction) compared to 9.5% for control (p<0.001).
The company expects to file a U.S. marketing application mid-year.
Detailed results will be submitted for presentation at a future medical conference and for publication.
Teprotumumab is a fully human monoclonal antibody that binds to (inhibits) the insulin-like growth factor 1 receptor (IGF-1R). TED is a rare autoimmune disorder in which IGF-1R is overexpressed in the eye.
Ahead of this evening’s “news” set for release at 5 ET, a couple of modest items are moving Tesla (NASDAQ:TSLA) 1.1% higher in the premarket.
First, there’s a CNBC report overnight that the company is setting up about $2B in loans from Chinese banks to build its Shanghai factory.
Then there’s Baird, which puts Tesla on its “Fresh Pick” list with an Outperform rating.
Biotech movers: Pfizer Inc. (PFE), Celgene Corporation (CELG)
Pfizer Inc. (PFE) said on Thursday it received a request for documents as part of a U.S. investigation related to quality issues involving the manufacture of auto-injectors at its Meridian Medical Technologies site.
Pfizer, in a regulatory filing, said it would be producing records in response to the civil investigative demand from the U.S. Attorney’s office for the Southern District of New York.
Meridian, a unit of Pfizer that manufactures EpiPen injectors used to deliver an emergency allergy antidote, has been hit by a series of manufacturing problems in recent years. Mylan NV, which markets EpiPens, has recalled tens of thousands of the devices after complaints that some had failed to activate.
Bristol-Myers Squibb has been meeting with shareholders in Boston and New York over the last two weeks to try to salvage its $74 billion purchase of cancer drugmaker Celgene Corporation (CELG), the biggest acquisition announced so far this year.
The deal, announced in January, was hard sell to Bristol shareholders from the start. The acquisition adds about $32 billion in fresh debt to Bristol’s balance sheet while assuming $20 billion in Celgene’s debt, the companies said at the time. After factoring in debt, the acquisition was the largest health-care deal on record, according to data compiled by Refinitiv.
Now, hedge funds Wellington Management and Starboard Value say the deal doesn’t sit well with them. Bristol has sent executives to New York to meet with institutional investors several times over the last two weeks and met with investors in Boston on Wednesday and Thursday, according to a person who briefed on the meetings.
Bristol-Myers declined to comment.
Big Losers: Corbus Pharmaceuticals Holdings, Inc. (CRBP), Petróleo Brasileiro S.A. – Petrobras (PBR)
Corbus Pharmaceuticals Holdings, Inc. (CRBP)’s shares slumped as much as 16% to $6.94 on huge volume. The stock has been showing intense sell off suddenly after a bearish article on seekingalph.com by Alpha Exposure.
The article stated that Corbus has ties to investors convicted of or alleged to have committed securities fraud. We believe lenabasum has failed its major trials in SSc and CF. Lenabasum was also denied Breakthrough Therapy Designation in SSc. We believe lenabasum will fail in its pivotal SSc and Phase 2b CF trials. We are short Corbus with a price target of $0.50.
Petróleo Brasileiro S.A. – Petrobras (PBR) is expanding its ambitious divestment program and has “bold” plans for sales, the Brazilian state-run oil company’s chief executive said after the firm posted its first annual profit in five years.
On a conference call with analysts to discuss fourth-quarter results, CEO Roberto Castello Branco said selling non-core assets will be key to deleveraging.
Petrobras, as the company is known, can reduce its ratio of net debt to earnings before interest, taxes, depreciation and amortization, or EBITDA, to 1.5 or even to 1, he added.
The University of Chicago-educated CEO, who took the reins in early January, has long been vocal about the need to slim down the sprawling firm and focus on core activities such as exploration and production. Thursday’s comments were some of his most assertive on the matter.
TG Therapeutics, Inc. (TGTX), Monster Beverage (NASDAQ:MNST) Jumps Double Digit On Big News
Shares of TG Therapeutics, Inc. (TGTX)) rocketed 17% in to $6.07. The company today announced that the Marginal Zone Lymphoma (MZL) cohort of the UNITY-NHL Phase 2b pivotal trial evaluating umbralisib (TGR-1202), our novel, once daily, PI3K delta inhibitor, met the primary endpoint of Overall Response Rate (ORR) as determined by Independent Review Committee (IRC) for all treated patients (n=69). The results met the Company’s target guidance of 40-50% ORR.
Monster Beverage (NASDAQ:MNST) unveiled its quarterly earnings results for its last quarter of fiscal 2018, posting earnings and revenue that topped the mark, lifting MNST stock up 10.
The Corona, Calif.-based company has been making waves for over 15 years now with its popular energy drink, and it shows no signs of slowing down as its fourth quarter yielded net income of $239.1 million, an 18.8% gain when compared to its profit of $201.3 million from its year-ago quarter.
On a per-share basis, these figures were 43 cents and 35 cents respectively. Monster topped the Wall Street’s average earnings estimate for its quarter of 40 cents per share by 3 cents per share, according to data compiled by FactSet.
The energy beverage giant amassed total sales of $924.2 million, a 14.1% surge against its $810.4 million from the year-ago quarter. Analysts saw Monster as raking in revenue of $901 million, according to FactSet.
The company’s Monster energy drink brand tallied in sales of $853.3 million, 15.9% ahead of the $736.1 million from the year-ago quarter. Its international sales were also up about 30.4% for the period.
The Monster brand also authorized a new $500 million share repurchase program.