Search This Blog

Wednesday, January 22, 2020

Baudax Bio up 11% ahead on FDA action date for IV meloxicam

Thinly traded nano cap Baudax Bio (NASDAQ:BXRX) is up 11% premarket on light volume on the heels of its announcement that the FDA’s action date is Thursday, February 20, for its review of its marketing application for intravenous (IV) meloxicam for the management of moderate-to-severe pain.
The company was spun out from Recro Pharma last year after the FDA rejected its IV meloxicam application a second time.

J&J forecasts weak annual profit, misses revenue estimates

Johnson & Johnson on Wednesday forecast 2020 profit below Wall Street estimates and said increased competition for its off-patent treatments could somewhat limit growth in the top-earning pharmaceuticals unit.

Shares of the healthcare conglomerate fell nearly 2% to $146.62 after it reported a rare miss on quarterly revenue, as sales of cancer drug Imbruvica and psoriasis treatment Stelara came in below lofty Wall Street estimates.
J&J’s pharmaceuticals unit, which makes up half of the company’s overall sales, has powered much of its recent growth.
However, generic competition for medicines such as prostate cancer drug Zytiga, coupled with pressure to hold down prescription drug price increases in the United States, has weighed on revenue.
Chief Financial Officer Joseph Wolk said the company still expects sales growth to accelerate in 2020, but it will “probably not be as robust as we would have thought this time last year.”
He said J&J did not take as big a hit from generic and biosimilar competition in 2019 as feared, and that the company hoped its off-patent branded products could maintain market share into 2020.
J&J expects full-year 2020 adjusted earnings of $8.95 to $9.10 per share, with a midpoint below current analysts’ average estimates at the top of the range.
Important newer drugs posted double-digit sales gains in the fourth quarter but missed analysts’ forecasts.
Stelara rose 17.7% to $1.70 billion, short of Credit Suisse’s estimate of $1.79 billion, while Imbruvica sales jumped 24.5% to $875 million, but still came up short of the brokerage’s estimate of $907 million.
Pharmaceutical sales rose 3.5% to $10.55 billion in the fourth quarter, but failed to reach Wall Street estimates of $10.63 billion, according Refinitiv data.
Overall sales rose 1.7% to $20.75 billion, below the average analyst estimate of $20.80 billion, marking the company’s first revenue miss in at least eight quarters.
The company said it will not actively participate in a U.S. Food and Drug Administration hearing early next month to discuss testing methods for talc.
“We certainly welcome any discussion around the safety and efficacy of the product… I can say that our current internal testing methods exceed that of current FDA standards for cosmetic talc,” Wolk said.
The company faces thousands of lawsuits alleging that its talc products, including baby powder, caused cancer. J&J has maintained that the products are safe and do not contain cancer-causing contaminants.
Excluding items, J&J earned $1.88 per share, beating the average analyst estimate by a cent, according to IBES data from Refinitiv.

Concert Pharma nabs new CTP-543 patent

Concert Pharmaceuticals (CNCE +4.2%) has received a Notice of Allowance from the USPTO for a patent covering the composition of lead candidate CTP-543 and methods of treating alopecia areata with CTP-543.
Phase 3 studies should commence this year.

FDA OKs generic Farxiga

The FDA has tentatively approved Biocon Limited’s (OTC:BCNQY) marketing application for a generic version of AstraZeneca’s (AZN -0.7%) type 2 diabetes med Farxiga (dapagliflozin).
Tentative approval means that Biocon’s marketing application met the requirements for approval, but patent issues need to be resolved before full approval is granted.

FDA accepts Supernus Pharma’s SPN-812 application

The FDA accepts for review Supernus Pharmaceuticals’ (NASDAQ:SUPN) marketing application seeking approval of SPN-812 for the treatment of children and adolescents with attention deficit hyperactivity disorder (ADHD).
The agency’s action date is November 8.
SPN-812 is a serotonin norepinephrine modulating agent that has been marketed for many years in Europe as an antidepressant. It has never been approved for any indication in the U.S.

Abbott Q4 earnings up 60%

Abbott Laboratories (ABTQ4 results: Revenues: $8,314M (+7.1%); Nutrition: $1,868M (+5.2%); Diagnostics: $2,058M (+5.0%); Established Pharmaceuticals: $1,174M (+7.8%); Medical Devices: $3,204M (+9.7%).
Net Income: $1,049M (+60.4%); EPS: $0.59 (+59.5%); non-GAAP Net Income: $1,705M (+18.1%); non-GAAP EPS: $0.95 (+17.3%).
2020 Guidance: GAAP EPS: $2.35 – 2.45; Non-GAAP EPS: $3.55 – 3.65.
Q1 Guidance: GAAP EPS: $0.40 – 0.42; Non-GAAP EPS: $0.69 – 0.71.

Coronavirus vaccine prospects boost Moderna

Moderna (NASDAQ:MRNA) perks up 6% premarket on light volume on the heels of the news of a coronavirus outbreak in China (SARS 2.0, so to speak). Investors perceive that it may be a player in developing a vaccine considering that it is developing the same for CMV, RSV, hMPV/PIV3, Zika and influenza H7N9.
Yesterday’s top mover, NanoViricides (NYSEMKT:NNVC), is down 54% premarket in reaction to its stock offering while Novavax (NASDAQ:NVAX) is down 16% and ImmunCell (NASDAQ:ICCC) is down 7%. On the plus side, Aethlon Medical (NASDAQ:AEMD) is up 15%, Inovio Pharmaceuticals (NASDAQ:INO) up 1%, BioCryst Pharmaceuticals (NASDAQ:BCRX) up 2% and Nabriva Therapeutics (NASDAQ:NBRV) up 1%.