Celldex Positive Topline Results from Barzolvolimab Phase 2 Study in Urticaria

 Barzolvolimab met primary endpoint with clinically meaningful and statistically significant decreases in urticaria disease activity across multiple dose groups-

-Mean change from baseline to week 12 in UAS7 of -23.87 in 300 mg q8w dose group and -23.02 in 150 mg q4w dose group-
-Barzolvolimab was generally well tolerated with a favorable safety profile-
-Treatment will continue to 52 weeks; results support further development of barzolvolimab in Phase 3 CSU studies-
- Company to host webcast call today at 8:00 am ET-

The Company will host a conference call/webcast today to discuss the results at 8:00 a.m. ET. The event will be webcast live and can be accessed by going to the "Events & Presentations " page under the "Investors & Media” section of the Celldex Therapeutics website at www.celldex.com. The call can also be accessed by dialing (646) 307-1963 or (800) 715-9871 (toll free). The conference ID is 3272134.

https://www.globenewswire.com/news-release/2023/11/06/2773880/24180/en/Celldex-Therapeutics-Announces-Positive-Topline-Results-from-Barzolvolimab-Phase-2-Study-in-Chronic-Spontaneous-Urticaria.html

BioNTech Q3 Profit Falls, Trims FY23 Vaccine Revenue Outlook

BioNTech SE (BNTX) Monday announced a sharp fall in third-quarter earnings compared to the prior year, as the commercial revenues were down sharply. The company revised down its COVID-19 vaccine revenues for the full year 2023.

The quarterly earnings were 160.6 million euros or 0.67 cents, down from 1.784 billion euros or 6.98 cents in the prior year.

On average, 2 analysts polled by Thomson Reuters were looking for earnings of $0.62 per share. Analysts' views usually exclude special items.

Revenue for the quarter declined to 895.3 million euros from 3.461 billion euros a year ago. Commercial revenues were 893.7 million euros, down from 3.394 billion last year. R&D expenses surged to 497.9 million from 341.8 million euros in the prior year.

For the full year 2023, the company now expects COVID-19 vaccine revenues to be 4 billion euros compared to its March outlook of 5 billion euros. Research and Development expenses are now projected to be in the range of 1.8 to 2.00 billion euros, while the March projection was in the range of 2.4 to 2.6 billion euros.

https://www.rttnews.com/3402948/biontech-q3-profit-falls-trims-fy23-vaccine-revenue-outlook.aspx

Halozyme, Acumen in License Agreement for ENHANZE® Tech in Alzheimer's

Acumen represents thirteenth license partner for ENHANZE

https://www.prnewswire.com/news-releases/halozyme-and-acumen-pharmaceuticals-enter-global-collaboration-and-non-exclusive-license-agreement-for-the-enhanze-technology-in-alzheimers-disease-301978022.html

Bristol Myers buys Orum's blood cancer therapy for up to $180 million

 Bristol Myers Squibb has acquired Orum Therapeutics' experimental therapy to treat a type of blood cancer for a total value of up to $180 million, the privately held company said on Monday.

The therapy, ORM-6151, which helps degrade a specific protein hard to treat previously, has received the U.S. Food and Drug Administration's (FDA) clearance for an early stage study.

The deal includes an upfront payment of $100 million and milestone payments, Orum said, without disclosing further details.

https://finance.yahoo.com/news/bristol-myers-buys-orums-blood-125402629.html

Karyopharm Prelim Data in Overall Survival in Selinexor-Treated Patients with Endometrial Cancer

 Long-Term Safety and Efficacy Data from SIENDO Study in the TP53 Wild-Type Exploratory Subgroup Showed Signals of Improvement in Overall Survival  (OS) Regardless of Mismatched Repair Status (MMR)

Median OS Not Reached for Selinexor-Treated Patients Who are TP53 Wild-Type pMMR

https://www.prnewswire.com/news-releases/karyopharm-announces-new-preliminary-data-in-overall-survival-os-in-selinexor-treated-patients-with-advanced-or-recurrent-tp53-wild-type-endometrial-cancer-as-part-of-pre-specified-exploratory-subgroup-analysis-of-the-siendo-stu-301977796.html

'Childcare Entrepreneur Explains Why Preschool Is So Expensive'

 

Parents are stumping up thousands of dollars a year for childcare, but preschool workers say they're underpaid and the industry has struggled to expand.

Some 58% of working parents with children five years old and younger — about 6.38 million parents in the US — rely on childcare, according to a survey by the National Household Education. And the cost for preschool is becoming a growing problem for families — one that has gained more urgency in the aftermath of the Covid-19 pandemic. President Joe Biden has made more affordable childcare an administrative priority, announcing a series of measures last month aimed at increasing access to high-quality childcare and boosting wages for early educators.

https://www.bloomberg.com/news/articles/2023-11-06/why-preschool-is-so-expensive-a-childcare-executive-explains-the-economics

Align Technology Announces $100 Million Open Market Repurchase

 Align Technology, Inc. (“Align”) (Nasdaq: ALGN) a leading global medical device company that designs, manufactures, and sells the Invisalign® system of clear aligners, iTero™ intraoral scanners, and exocad™ CAD/CAM software for digital orthodontics and restorative dentistry, today announced that it is planning to repurchase $100 million of Align’s common stock through open market repurchases under Align’s $1.0 billion stock repurchase program that was approved by Align's Board of Directors in January 2023. This $100 million open market repurchase is in addition to the $250 repurchase of Align's common stock under an accelerated stock repurchase agreement that was announced on October 27, 2023.

https://www.businesswire.com/news/home/20231106545321/en/Align-Technology-Announces-100-Million-Open-Market-Repurchase