Biotech Stocks Facing FDA Decision In June 2023

Lions Gate Stock Up 12% As Q4 Results Beat Street

Shares of Lions Gate Entertainment Corp. (LGF-A) were up 12% on Friday as the company reported earnings and revenue that topped analyst estimates.

LGF-A is currently trading at $11.40, up 12.05% or $1.23 per share, on the Nasdaq. It has traded between $5.46 and $11.96 in the past 52-week period.

Net loss for the fourth quarter was $96.8 million or $0.42 per share, compared to the loss of $ 104.6 million or $0.46 per share the prior year.

Adjusted net income was $ 49.2 million or $0.21 per share, compared to $3.3 million or $0.01 the prior year. This came above the analyst estimate of $0.19 per share. Analysts’ estimates typically exclude special items.

The company’s revenue for the quarter rose 16.1% to $1.08 billion from $929.9 million last year. This was above the analyst estimate of $ 868.01 million.

Oil Futures Settle Higher

Crude oil prices climbed higher on Friday after Russia played down the prospect of additional output cuts by OPEC+.

Russian Deputy Prime Minister Alexander Novak said on Thursday that he doesn’t think there will be new steps with regard to production cuts.

Oil was also supported by reports that U.S. lawmakers are closing in on a deal that would raise the government’s $31.4 trillion debt ceiling for two years while capping spending on most items.

West Texas Intermediate crude oil futures for July ended higher by $0.84 or about 1.2% at $72.67 a barrel. WTI crude futures gained about 1.6% in the week, after surging 2.2% last week.

Brent crude futures settled at $76.95 a barrel, gaining $0.69 or about 0.9%. Brent futures gained 1.8% in the week.

According to the data released by Baker Hughes, total active drilling rigs in the U.S. fell by another 9 to 711, the lowest count in a year.

Drilling rigs targeting crude oil in the U.S. fell by 5 to 570, its lowest number since last May, and gas rigs dropped by 4 to 137, the lowest since March last year. Total rigs targeting crude oil in the Permian Basin gained 1 to 347.

“The upcoming week could deliver a make-or-break moment for oil as we will see if Chinese manufacturing is rebounding, if the US labor market is reading to soften, how oil giants Exxon and Chevron address climate ambitions at their AGMs, and what if the Saudis and Russians can reach agreement on what to drive OPEC+ do with output,” says Edward Moya, Senior Market Analyst at OANDA.

Vietnam's VinFast Recalls All US EVs To Fix Software Issue

Vietnamese electric vehicle maker VinFast is reportedly recalling all of the first batch of vehicles it shipped to the US last year to fix a software issue.

According to the National Highway Traffic Safety Administration (NHTSA), 999 of VinFast’s VF 8 vehicles suffered a software error in the dashboard display that prevented critical safety information from being shown and “may increase the risk of a crash”.

VinFast is recalling certain 2023 VF8 vehicles. A software error may cause the multifunction head unit (MHU) display to go blank. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 101, “Control and Displays.”

The company will release an over-the-air software update beginning May 25, 2023, free of charge. Owner notification letters are expected to be mailed May 29, 2023.

More than 700 of the 999 units are still in VinFast’s hands and have not been delivered to customers or fleet services, the NHTSA estimated.

Antonio Simpson, 34, is suspect in Denver fatal shooting police said.

A suspect has been arrested in connection to a Denver double shooting, with one person dead, police said.

The shooting happened about 6:50 p.m. May 20 in the 800 block of Cherry Street, according to the Denver Police Department.


Responding officers found a woman and a man who were shot, the man was dead at the scene, police said. An argument led to the shooting and the suspect and the man who died were known to each other.

Antonio Simpson, 34, was arrested Thursday on investigation of first-degree murder and attempted murder, police said.


Kali Collins, 21, of Denver, suspect in fatal Aurora shooting

A suspect has been arrested in a fatal Aurora shooting involving a driver crashing in to a 7-Eleven store.

Kali Collins, 21, of Denver, was arrested Friday on investigation of first-degree murder in connection to an early morning shooting in the Centre Pointe neighborhood, police said in a news release. Officers responded to 15550 E. Mississippi Ave. and found that a driver who crashed into the store had been fatally shot.

An investigation is ongoing, anyone with information on the incident is asked to call Metro Denver Crime Stoppers at 720-913-7867 (STOP).


Mum’s horror after stranger reaches into car to touch son at school pick-up time

A mum was horrified when a stranger walked up to her car on the school run, reached in through an open window and touched the face of her son sitting in the back seat. It happened outside a school in North Somerset and has sparked a police manhunt.

More to follow…

Biotech Stocks Facing FDA Decision In June 2023

As we step into the third month of the second quarter, let’s take a quick look at the regulatory news that made headlines in May and offer you a sneak peek into the anticipated FDA decisions coming up in June.

On May 1, the FDA conditionally approved Elanco’s Varenzin-CA1, the first drug for anemia in cats with chronic kidney disease.

Arexvy, the first respiratory syncytial virus (RSV) vaccine, received regulatory approval in the U.S., for use in individuals 60 years of age and older, on May 3.

Otsuka Pharma’s Rexulti was approved by the FDA for the expanded use in treating agitation associated with dementia due to Alzheimer’s disease on May 11. This marks the first FDA-approved treatment option for this indication.

Astellas Pharma’s Veozah was granted FDA approval on May 12, for the treatment of moderate to severe hot flashes caused by menopause.

Krystal Biotech’s Vyjuvek received FDA approval on May 19, becoming the first topical gene therapy for treatment of wounds in patients with Dystrophic Epidermolysis Bullosa.

On May 22, the FDA approved Opiant Pharma’s Opvee, a prescription nasal spray to reverse opioid overdose.

Pfizer’s Paxlovid was approved by the FDA on May 26, becoming the first oral antiviral to receive regulatory nod in the U.S. for the treatment of COVID-19 in adults.

Now, let’s take a look at the biotech stocks awaiting FDA decision in June.