Why Reata Pharma Shares Are Trading Lower After Q2 Earnings Update

 

• Reata Pharmaceuticals Inc (NASDAQ: RETA) completed a mid-cycle communication meeting with the FDA regarding the marketing application review status for omaveloxolone for Friedreich's ataxia.

• The FDA stated that it had not identified any new significant issues, but it continues to have concerns regarding the strength of the efficacy evidence.

• The agency did not identify any significant clinical safety issues.

• The FDA stated that the safety review is ongoing, and they are continuing to evaluate the cardiac safety of omaveloxolone in patients with Friedreich's ataxia, a rare genetic disease that causes difficulty walking.

• They have not identified any other major safety concerns at this stage of their review.

• The regulatory agency has assigned Priority Review for the application and set a PDUFA target action date of November 30.

• Results of the updated Delayed-Start Analysis from the March 2022 data cut-off demonstrated that the between-group difference in Friedreich's ataxia scale was observed at the end of the placebo-controlled MOXIe Part 2 treatment preserved at MOXIe Extension Week 72 in the delayed-start period.

• The threshold for non-inferiority was met at Extension Week 120.

• Reata held a cash balance of $481.5 million.

https://finance.yahoo.com/news/why-reata-pharma-shares-trading-141612453.html

Karuna’s Schizophrenia-Trial Data Are ‘Best Case Scenario’

 New data from Karuna Therapeutics on the schizophrenia treatment KarXT sent shares of the biotech up more than 60% as analysts said the results were strong enough that the drug could be the go-to treatment once it is approved.

Investors were expecting a difference of 7 or 8 points between the study group and people who took a placebo in reduction of schizophrenia symptoms, as measured by a tool known as the Positive and Negative Syndrome Scale, according to a note out Monday by Mizuho analyst Uy Ear.

https://www.barrons.com/articles/karuna-stock-schizophrenia-trial-51659973608?siteid=yhoof2

BioNTech Announces Second Quarter 2022 Financial Results and Corporate Update

 

• Second quarter revenues of €3.2 billion¹, net profit of €1.7 billion and fully diluted earnings per share of €6.45 ($6.87²) as well as first half 2022 revenues of €9.6 billion, net profit of €5.4 billion and fully diluted earnings per share of €20.69 ($18.92²)
• Reiterates BioNTech COVID-19 2022 vaccine revenue guidance of €13 billion to €17 billion
• Preparing for potential launch of two variant-adapted bivalent COVID-19 vaccines containing the original strain and Omicron BA.1 or BA.4/5 spike protein as recommended by U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and other regulators; expect to be able to begin delivering Omicron-adapted vaccines as early as October 2022, subject to regulatory approval
• Signed agreement with U.S. government to provide additional 105 million doses of COVID-19 vaccine with option for another 195 million doses
• Received U.S. Emergency Use Authorization (EUA) for COVID-19 vaccine in children six months through four years of age and for a booster dose in children five through 11 years of age
• Continued pipeline expansion with initiation of two new Phase 1 clinical trials (BNT116 and BNT142) to 18 clinical-stage oncology programs in 23 ongoing clinical trials; BNT211, first-in-class CAR-T program targeting CLDN6, receives EMA Priority Medicines (PRIME) designation
• Commenced construction of first BioNTainer mRNA vaccine manufacturing facility in Africa

Conference call and webcast scheduled for August 8, 2022, at 8:00 am ET (2:00 pm CET)

BioNTech invites investors and the general public to join a conference call and webcast with investment analysts on the same day at 8.00 a.m. EDT (2.00 p.m. CEST) to report its financial results and provide a corporate update for the second quarter of 2022.

To access the live conference call via telephone, please register via this link. Once registered, dial-in numbers and a pin number will be provided. It is recommended to register at least a day in advance.
The slide presentation and audio of the webcast will be available via this link.

Participants may also access the slides and the webcast of the conference call via the “Events & Presentations” page of the Investor Relations section of the Company’s website at https://biontech.de/. A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.

https://www.biospace.com/article/releases/biontech-announces-second-quarter-2022-financial-results-and-corporate-update/

FDA OKs additional indication of darolutamide-docetaxel combo for prostate cancer

 Orion’s collaboration partner Bayer today announced the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for the oral androgen receptor inhibitor (ARi) darolutamide in combination with docetaxel for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC).

The approval is based on positive results of the Phase III ARASENS trial that demonstrated darolutamide plus androgen deprivation therapy (ADT) and docetaxel significantly reduced the risk of death by 32.5% in patients with metastatic hormone-sensitive prostate cancer (mHSPC) compared to ADT plus docetaxel. These results were recently published in The New England Journal of Medicine.¹ Darolutamide is approved in more than 70 markets around the world, including the U.S., the European Union (EU), Japan and China, under the brand name Nubeqa®, for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease. The compound is also being investigated in further studies across various stages of prostate cancer.

https://www.biospace.com/article/releases/u-s-fda-approves-additional-indication-of-darolutamide-in-combination-with-docetaxel-for-the-treatment-of-metastatic-hormone-sensitive-prostate-cancer-mhspc-/

HUTCHMED: Fruquintinib Phase III Met Primary Endpoint in Metastatic Colorectal Cancer

 — Trial met primary endpoint of overall survival and all secondary endpoints —

— Overall safety consistent with fruquintinib known profile —

— Plans for regulatory submissions underway in the U.S., Europe and Japan —

— Results to be submitted to an upcoming medical meeting —

https://www.globenewswire.com/news-release/2022/08/08/2493507/0/en/HUTCHMED-Announces-that-Fruquintinib-Global-Phase-III-FRESCO-2-Study-Has-Met-Its-Primary-Endpoint-in-Metastatic-Colorectal-Cancer.html

Down on Vitamin D? It could be the cause of chronic inflammation

 Inflammation is an essential part of the body's healing process. But when it persists, it can contribute to a wide range of complex diseases including type 2 diabetes, heart disease, and autoimmune diseases.

Now, world-first genetic research from the University of South Australia shows a direct link between low levels of vitamin D and high levels of inflammation, providing an important biomarker to identify people at higher risk of or severity of chronic illnesses with an inflammatory component.

The study examined the genetic data of 294,970 participants in the UK Biobank, using Mendelian randomization to show the association between vitamin D and C-reactive protein levels, an indicator of inflammation.

Lead researcher, UniSA's Dr Ang Zhou, says the findings suggest that boosting vitamin D in people with a deficiency may reduce chronic inflammation.

"Inflammation is your body's way of protecting your tissues if you've been injured or have an infection," Dr Zhou says.

"High levels of C-reactive protein are generated by the liver in response to inflammation, so when your body is experiencing chronic inflammation, it also shows higher levels of C-reactive protein.

"This study examined vitamin D and C-reactive proteins and found a one-way relationship between low levels of vitamin D and high levels of C-reactive protein, expressed as inflammation.

"Boosting vitamin D in people with deficiencies may reduce chronic inflammation, helping them avoid a number of related diseases."

Supported by the National Health and Medical Research Council and published in the International Journal of Epidemiology the study also raises the possibility that having adequate vitamin D concentrations may mitigate complications arising from obesity and reduce the risk or severity of chronic illnesses with an inflammatory component, such as CVDs, diabetes, and autoimmune diseases.

Senior investigator and Director of UniSA's Australian Centre for Precision Health, Professor Elina Hyppönen, says these results are important and provide an explanation for some of the controversies in reported associations with vitamin D.

"We have repeatedly seen evidence for health benefits for increasing vitamin D concentrations in individuals with very low levels, while for others, there appears to be little to no benefit." Prof Hyppönen says.

"These findings highlight the importance of avoiding clinical vitamin D deficiency, and provide further evidence for the wide-ranging effects of hormonal vitamin D."

Story Source:

Materials provided by University of South Australia. Note: Content may be edited for style and length.

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Journal Reference:

1. Ang Zhou, Elina Hyppönen. Vitamin D deficiency and C-reactive protein: a bidirectional Mendelian randomization study. International Journal of Epidemiology, 2022; DOI: 10.1093/ije/dyac087

https://www.sciencedaily.com/releases/2022/08/220807161657.htm

UPS Nears Deal to Buy Italian Healthcare-Logistics Provider Bomi Group

 United Parcel Service Inc.

UPS 1.15%

is nearing a deal to acquire Italy’s Bomi Group, according to people familiar with the matter, as the transportation giant looks to bolster its medical-product-distribution business.

The deal, worth several hundred million dollars, could be finalized as soon as Monday assuming the talks don’t break down at the last minute, the people said.

Founded in 1985, closely held Bomi distributes a range of medical products such as biological samples and pharmaceutical imagings to hospitals, clinics, laboratories as well as to patients’ homes. It operates in Europe and Latin America, according to the company’s website.

A deal for Bomi would expand Atlanta-based UPS’s operations in those regions and underscore the growing importance of the transport of medical supplies and equipment in the wake of the covid-19 pandemic,

In June, an investment group led by global buyout firm

EQT

EQT -2.89%

AB agreed to acquire Sweden-based medical-freight provider Envirotainer AB for close to $3 billion,

Bomi would represent a relatively small acquisition for UPS, which has a market value of close to $172 billion.

UPS is acquiring the business from French buyout firm ArchiMed, which together with Bomi’s founding Ruini family purchased the company in 2019 in a €100 million ($102 million) deal. Since then, the logistics company has acquired more than six rivals, cementing its position as Italy’s largest transport and warehouse operator for the healthcare industry and expanding its operations in Brazil, the UK and Spain.

ArchiMed manages over €5 billion in assets that are concentrated across the healthcare sector. It focuses its investments on areas such as biopharmaceutical products and services, life-science tools and medical devices and technologies.

https://netionaldastak.com/ups-nears-deal-to-buy-italian-healthcare-logistics-provider-bomi-group/