Rocket Pharmaceuticals Stock Surges 40% On FDA Alignment For Danon Disease Treatment

European Economic News Preview: UK GDP Data Due

Monthly GDP, industrial output and foreign trade data from the UK and industrial production from the euro area are due on Wednesday, headlining a light day for the European economic news.

At 2.00 am ET, the Office for National Statistics releases UK GDP, industrial output and foreign trade figures. The economy is forecast to shrink 0.2 percent on month, in contrast to the 0.5 percent rise in June.

The UK visible trade deficit is seen widening to GBP 16 billion in July from GBP 15.45 billion in June. Economists forecast industrial output to fall 0.6 percent reversing June’s 1.8 percent increase.

At 2.30 am ET, the Hungarian Statistical Office publishes final industrial output data for July.

At 5.00 am ET, Eurostat is scheduled to issue euro area industrial production for July. Industrial output is expected to fall 0.7 percent month-on-month, in contrast to the 0.5 percent increase in June.

At 8.00 am ET, foreign trade and current account reports are due from Poland.

Nektar Therapeutics Reports Promising Data From Phase 1b Study Of Rezpegaldesleukin

Nektar Therapeutics (NKTR) said new data from Phase 1b Study of Rezpegaldesleukin in Moderate-to-Severe Atopic Dermatitis showed that, in addition to the strong previously reported efficacy for EASI-related endpoints, rezpegaldesleukin has the potential to be a differentiated therapeutic that could greatly improve quality-of-life for patients.

Jonathan Zalevsky, Chief R&D Officer of Nektar Therapeutics, said: “We look forward to advancing rezpegaldesleukin into our robust Phase 2b study in biologic-naïve patients with moderate to severe atopic dermatitis in October of this year. We are excited to announce that we are also initiating a Phase 2a study of rezpegaldesleukin in patients with alopecia areata in early 2024.”

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Moderna Up 6% On Business And Clinical Updates

Shares of Moderna, Inc. (MRNA) saw a 6% increase on Wednesday following the announcement of business and clinical updates, as well as new development programs at the Company’s annual R&D Day.

MRNA is trading on the Nasdaq at $111.97, up 6.39% or $6.73 per share. It has traded between $95.02 and $217.25 in the past 52-week period.

Over the next five years, the company intends to launch 15 new products and conduct clinical trials for 50 mRNA medicines. Additionally, the company is focused on creating both single-virus and combination respiratory vaccines to address important public health concerns. The company’s vaccine development also includes addressing six latent and other viruses, such as cytomegalovirus, Epstein Barr virus, herpes simplex virus, varicella zoster virus, norovirus, and HIV.

The company has announced its plan to invest around $25 billion in research and development between 2024 and 2028 to support the growth of its business. Furthermore, based on current vaccination rates in the United States, the company is projecting COVID-19 sales to range between $6 billion and $8 billion in 2023.

Looking ahead to 2028, the company is aiming to expand its annual sales by $10 billion to $15 billion by introducing new products in the fields of Oncology, Rare and Latent diseases.

European Economic News Preview: Germany Industrial Output Data Due

Industrial production from Germany and house prices from the UK are due on Thursday, headlining a light day for the European economic news.

At 2.00 am ET, Destatis is scheduled to issue Germany’s industrial production for July. Output is forecast to fall 0.5 percent on month, slower than the 1.5 percent decrease in June.

In the meantime, UK Halifax house price data is due. Economists forecast house prices to drop 0.3 percent on month in August, the same pace of decrease as seen in July.

At 2.45 am ET, foreign trade and current account figures are due from France. The trade deficit is seen at EUR 6.8 billion in July compared to a shortfall of EUR 6.7 billion in June.

At 3.00 am ET, the Czech Statistical Office is set to publish retail sales for July. Sales had increased 0.3 percent on a monthly basis in June.

At 4.00 am ET, Italy’s statistical office ISTAT publishes retail sales for July. Economists forecast sales to grow 0.2 percent, offsetting the 0.2 percent fall in June.

At 5.00 am ET, revised GDP data is due from the euro area. The preliminary estimate showed that the currency bloc expanded 0.3 percent sequentially in the second quarter after remaining flat a quarter ago.

DZS Shares Surge On Securing $29.7 Mln In Financing

Shares of DZS Inc. (DZSI) are surging over 25% on Wednesday after the company announced that it had secured $29.7 million in loans.

DZSI is trading on the Nasdaq at $2.20, up 25.68% or $0.47 per share. It has traded between $1.70 and $16.25 in the past 52-week period.

This financing includes a $24.5 million 3-year term loan, with an annual interest rate of 8%, from DASAN Networks, a 29% shareholder of the company, and approximately $5.2 million of short-term loans with South Korean bank financial partners.

The company plans to use the funds to pay off its existing term debt facility and line of credit. Additionally, the company intends to establish a new ABL debt facility to propel its growth into 2024.

“The new financing from DNI will ease our financial covenants, lower our interest cost basis and, together with the additional short-term loans secured or in final process, will fully pay off our existing loans,” said Charlie Vogt, President, and CEO.

Rocket Pharmaceuticals Stock Surges 40% On FDA Alignment For Danon Disease Treatment

Shares of Rocket Pharmaceuticals, Inc. (RCKT) surged over 40% on Wednesday morning after the company announced that alignment has been reached with the FDA on the global Phase 2 pivotal trial of RP-A501 for Danon Disease.

RCKT is currently trading at $21.61, up $6.32 or 41.33%, on a huge volume of 15 million shares, above average volume of 600 thousand, on the Nasdaq. The stock opened its trading at $21.44 after closing Tuesday’s trading at $15.29. The stock has traded between $11.78 and $24.53 in the past 52-week period.

RP-A501 is Rocket’s investigational gene therapy product for the treatment of Danon Disease and the first gene therapy for a cardiovascular condition to demonstrate safety and efficacy in clinical studies.

Danon Disease is a uniformly fatal inherited cardiomyopathy that leads to mortality in the majority of male patients at age ~20 and females at age ~40, and for which there are no approved curative or disease-modifying therapies. The disease affects an estimated 15,000 to 30,000 patients in the U.S. and Europe.

The global, single-arm, multi-center Phase 2 pivotal trial will evaluate the efficacy and safety of RP-A501 in 12 patients with Danon Disease, including a pediatric safety run-in (n=2), with a natural history comparator and a dose level of 6.7 x 1013 GC/kg.