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Wednesday, January 22, 2020

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.
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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.
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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.
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Abbott Q4 earnings up 60%

Abbott Laboratories (ABT) Q4 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.
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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%.
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Jazz Pharma submits marketing application for JZP-258

Jazz Pharmaceuticals (NASDAQ:JAZZ) has submitted a New Drug Application (NDA) to the FDA seeking approval for JZP-258 for the treatment of cataplexy and excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.
The company redeemed its priority review voucher for the filing.
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Genmab earns $150M Darzalex milestone from J&J

Triggered by the achievement of $3B in global Darzalex (daratumumab) sales in 2019, Genmab A/S (NASDAQ:GMAB) earns a $150M milestone payment from Johnson & Johnson (NYSE:JNJ) unit Janssen Biotech.
It also earns royalties on net sales under the exclusive license agreement.
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