FDA Imposes Partial Hold On DBV Technologies’ Phase III VITESSE Study

Palatin Technologies Inc. Q4 Loss decreases, but misses estimates

Palatin Technologies Inc. (PTN) revealed Loss for fourth quarter that decreased from the same period last year but missed the Street estimates.

The company’s bottom line came in at -$12.767 million, or -$1.34 per share. This compares with -$13.934 million, or -$1.47 per share, in last year’s fourth quarter.

Analysts on average had expected the company to earn -$0.81 per share, according to figures compiled by Thomson Reuters. Analysts’ estimates typically exclude special items.

The company’s revenue for the quarter rose 340.0% to $0.770 million from $0.175 million last year.

Palatin Technologies Inc. earnings at a glance (GAAP) :

-Earnings (Q4): -$12.767 Mln. vs. -$13.934 Mln. last year.
-EPS (Q4): -$1.34 vs. -$1.47 last year.
-Analyst Estimates: -$0.81
-Revenue (Q4): $0.770 Mln vs. $0.175 Mln last year.

Manchester United Posts Narrower Adj. Loss In Q4; Total Revenue Up 26.1%

Manchester United (MANU) reported a fourth quarter adjusted loss of 20.2 million pounds compared to a loss of 33.7 million pounds, previous year. Adjusted loss per share was 12.38 pence compared to a loss of 20.67 pence. Adjusted EBITDA was negative at 8.4 million pounds, an improvement of 20.0%.

Pretax loss was 91.8 million pounds compared to a loss of 42.1 million pounds, prior year. Loss per share was 43.46 pence compared to a loss of 66.08 pence.

Fourth quarter revenue from contracts with customers increased to 118.45 million pounds from 94.01 million pounds, last year. Commercial revenue was 63.4 million pounds, an increase of 22.4%. Broadcasting revenue was 33.7 million pounds, a decrease of 15.5%.

For fiscal 2023, the company expects total revenues to be in a range of 580 million pounds to 600 million pounds, and adjusted EBITDA to be in a range of 100 million pounds to 110 million pounds.

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Correction: FactSet Guides FY23 Adj. EPS In Line With Estimates; Q4 Adj. EPS Misses View

correction: corrects headline to say Q4 misses estimates

While reporting financial results for the fourth quarter on Thursday, FactSet Research Systems, Inc. (FDS) initiated its earnings and revenue outlook for the full-year 2023.

For fiscal 2023, the company now projects earnings in a range of $12.70 to $13.10 per share and adjusted earnings in a range of $14.50 to $14.90 per share on revenue between $2.100 billion and $2.115 billion.

On average, analysts polled by Thomson Reuters expect the company to report full-year earnings of $14.76 per share on revenues of $2.04 billion for the year. Analysts’ estimates typically exclude special items.

For the fourth quarter, net income increased to $104.42 million or $2.69 per share from $101.06 million or $2.63 per share in the prior-year quarter. Excluding items, net income was $3.13 per share, compared to $2.88 per share last year.

Revenue for the quarter increased 21.2 percent to $499.30 million from $411.89 million in the same quarter last year. Organic revenues grew 9.8 percent to $452.5 million.

The Street was looking for earnings of $3.20 per share on revenues $487.81 million for the quarter.

European Economics Preview: BoE, SNB Monetary Policy Announcements Due

The monetary policy announcements from the Bank of England and Swiss National Bank are the major events due on Thursday.

The Monetary Policy Committee of the BoE is expected to raise the benchmark rate for the seventh straight month. Markets expect at least a 50 basis-point rate hike after the U.S. Federal Reserve raised its key rate by 75 basis points on Wednesday. The BoE releases the monetary policy summary and the minutes at 7.00 am ET.

The Swiss National Bank is widely expected to lift its interest rate to positive territory today. The interest rate is likely to be raised by 75 basis points to -0.50 percent from -0.25 percent. The announcement is due at 3.30 am ET.

Other economic reports due for the day are as follows

At 2.45 am ET, the French statistical office Insee publishes business confidence survey results. The business sentiment index is seen at 102 in September versus 104 in August.

At 3.00 am ET, the Turkish Statistical Institute releases consumer confidence data. In the meantime, unemployment figures are due from Hungary.

At 4.00 am ET, Norges Bank announces it monetary policy decision. The bank is forecast to lift the key rate to 2.25 percent from 1.75 percent.

At 7.00 am ET, Turkey’s central bank releases the outcome of its monetary policy meeting. The bank is set to hold its key one-week repo rate at 13.00 percent.

FDA Imposes Partial Hold On DBV Technologies’ Phase III VITESSE Study

DBV Technologies’ (DBVT) phase III study of modified Viaskin Peanut 250 µg patch, dubbed VITESSE, has been slapped with a partial clinical hold by the FDA.

VITESSE is a phase III, double-blind, placebo-controlled, randomized study to assess the efficacy and safety of epicutaneous immunotherapy with the modified Viaskin Peanut 250 µg patch in peanut-allergic children ages 4 to 7 years.

The company has not yet begun the screening or recruitment of subjects in the VITESSE study.

The partial hold has been imposed following changes to elements of the VITESSE protocol with the intent for the trial to support a future BLA submission.

The modifications address design elements of the study, including the statistical analysis of adhesion, minimum daily wear time and technical alignments in methods of categorizing data, to meet study objectives as well as the total number of trial participants on active treatment, noted the company.

DBVT is currently down over 9% trading at $2.