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A new non-opioid drug for osteoarthritis pain being developed by Pfizer Inc. (PFE) and Eli Lilly & Co. (LLY) had positive early results in a phase 3 clinical trial, the companies announced on Wednesday. Patients who received two doses of the drug had a statistically significant improvement in pain, physical function and their own assessment of their osteoarthritis, relative to patients on the placebo. More information about progressive osteoarthritis seen in patients is still needed, though, said EvercoreISI analyst Umer Raffat, and the companies in particular "likely [need] longer follow up before being more definitive" about tanezumab's safety.
The treatment, tanezumab, belongs to an investigational category of pain medications that target nerve growth factor, a protein involved in the growth of nerve cells, and is also being evaluated to treat chronic lower back and cancer pain. U.S. regulators in 2015 lifted a hold on trials of medicines targeting the protein due to concerns they could worsen osteoarthritis in a small percentage of patients. Pfizer's shares were marginally up at $37.79 in premarket trade.
An experimental osteoarthritis drug developed by Pfizer Inc and Eli Lilly and Co achieved its main goal of lowering pain in a late stage trial, the companies said on Wednesday, potentially offering a safer alternative to opioids. The treatment, tanezumab, belongs to an investigational category of pain medications that target nerve growth factor, a protein involved in the growth of nerve cells, and is also being evaluated to treat chronic lower back and cancer pain. U.S. regulators in 2015 lifted a hold on trials of medicines targeting the protein due to concerns they could worsen osteoarthritis in a small percentage of patients.
In July, the FDA accepted Bausch + Lomb’s NDA (New Drug Application) for sub-micron loteprednol etabonate for the treatment of patients who have undergone ocular surgery and are showing symptoms of post-operative inflammation and pain.
The FDA defers decision regarding label expansion application to include cardiovascular indication on the label of J&J's (JNJ) diabetes drug Invokana.
Here is a look at the 10 biggest venture-backed IPOs and acquisitions from the first half of what has been a very active year for such exits.
Endo International’s (ENDP) U.S. Branded – Sterile Injectables segment includes branded sterile injectable products such as Vasostrict, Adrenalin, and Aplisol, and generic sterile injectable products such as ephedrine sulphate injection and neostigmine methylsulfate injection. Revenues from this segment increased from $172.17 million in Q1 2017 to $215.85 million in Q1 2018.
Under Endo International’s (ENDP) established products, Percocet sales increased from $30.94 million in Q1 2017 to $31.97 million in Q1 2018. The increase was attributable to higher prices, partially offset by a decline in volume. Voltaren gel sales, on the other hand, decreased from $14.27 million in Q1 2017 to $11.32 million in Q1 2018 due to lower prices resulting from generic competition. Sales from other established products also decreased, from $64.48 million in Q1 2017 to $45.03 million in Q1 2018.
Endo International (ENDP) generated revenues of $700.5 million in the first quarter compared to $1.04 billion in Q1 2017. Endo International incurred a cost of revenues of $403.59 million in the first quarter compared to $668.96 million in Q1 2017. Its gross profit was $296.93 million in the first quarter compared to $368.64 million in Q1 2017.
Endo International’s (ENDP) net interest expense increased from $111.9 million in Q1 2017 to $123.9 million in Q1 2018. While the company received an income tax benefit of $11.9 million in Q1 2017, it had an income tax expense of $15.49 million in Q1 2018. That led to an increase in its net loss from $173.83 million in Q1 2017 to $505.48 million in Q1 2018. That translated to a net loss per share of $2.26 in Q1 2018 compared to a net loss per share of $0.78 in Q1 2017.
Of the 19 analysts covering Endo International (ENDP) stock in July, four of them have given the stock a “buy” or higher rating, 14 have given it a “hold,” and one has given it a “sell.” The mean rating for the stock is 2.74 with a target price of $8.53. Sixteen of the 20 analysts covering Abbott Laboratories (ABT) in July have given the stock a “buy” or higher rating, and four have given it a “hold.” The mean rating for the stock is 1.8 with a target price of $69.
We want researchers to cure disease. But the honest truth is that you could potentially make a fortune by betting against drugmakers in this indication.
The last time we checked in with DnB, it had sold more than half of its investment in Intel. Norway’s largest and oldest private financial institution (established 1822) slashed its holdings in Intel (INTC) to 1.7 million shares from 3.8 million shares in the first quarter. DnB seemed to have a rethink in the second quarter, however, buying 537,300 more shares of the chip giant and raising its investment to 2.3 million shares as of June 30.
Pfizer (NYSE:PFE) was the target of a Presidential tweet tantrum Monday over its second price hike of the year but investors shrugged it off.
On Friday, Biogen (NASDAQ:BIIB) shares soared on news that one of its Alzheimer’s drug trials was showing tremendous promise. Specifically, BIIB stock jumped nearly 20% after an update on BAN-2401, a phase 2 drug that showed a statistically significant slowdown in the memory loss associated with Alzheimer’s. BAN-2401, an antibody that takes aim at the amyloid plaque in the brain that’s thought to be a key cause of Alzheimer’s, was cast into a questionable light late last year.
Incyte’s (INCY) product portfolio includes targeted therapies and immuno-therapies for oncology and non-oncology diseases. Incyte’s product portfolio includes 17 molecular targets and 19 clinical candidates. The chart below shows its revenues from collaborations since the first quarter of 2017.
Incyte Corporation (INCY) reported revenues of $382.3 million during the first quarter, a marginal decline in YoY (year-over-year) revenues compared to $384.1 million during the first quarter of 2017. These revenues include the product revenues from sales of Jakafi and Iclusig, royalty revenues from Jakavi and Olumiant, and milestone and contract revenues. The chart below compares the revenues for Incyte since the first quarter of 2017.
On July 6, Zoetis (ZTS) and Abaxis (ABAX) announced the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.
The last change in the short interest score occurred more than 1 month ago and implies that there has been little change in sentiment among investors who seek to profit from falling equity prices. Over the last one-month, outflows of investor capital in ETFs holding ENDP totaled $3.08 billion.