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.
CytoDyn Inc (OTCMKTS:CYDY) Regains Momentum After The Big Announcement
Now that the market seems to be coming back into his elements, it could be time for investors to start looking into penny stocks more closely. These stocks may often be risky, but if one makes the right choice, then the rewards could be enormous. One penny stock that could be put into the watch list at this point in time is that of CytoDyn Inc (OTCMKTS:CYDY).
The late-stage biotechnology company, which is developing the coronavirus medicine leronlimab, announced last week that it had filed a comprehensive application for uplisting on NASDAQ. The company announced that it believes that its application satisfies the myriad listing requirements of the NASDAQ Capital Market.
The Chief Executive Officer and President of the company Nader Pourhassan stated that while it is true that the entire process is expected to take many weeks, CytoDyn is hopeful of success in this matter.
He went on to state that a listing on NASDAQ will not only provide shareholders with more liquidity but also give CytoDyn much bigger access to fresh capital. It is a significant development for the company, and the market participants realized it as well. After the announcement was made, the stock rallied by as much as 50%. Investors could do well to keep an eye on the stock this week.
While the rally following this announcement was a welcome relief for the company, it is important to point out that earlier on in the week, the stock has fallen considerably following a setback. Last Monday, the company announced that the United States Food and Drug Administration handed CytoDyn a refusal to file a letter with regards to the usage of leronlimab to treat HIV.
However, at the same time, investors should be noted that the company did announce that it is confident of furnishing the agency with all the further details that have been demanded. It is one of the penny stocks that have performed remarkably well this year so far, and investors could keep an eye on it.
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.