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Friday, November 10, 2023

Celldex upped to Equal Weight from Underweight by Wells Fargo

 Target $27

https://finviz.com/quote.ashx?t=CLDX&p=d

Treace guides lower

 Treace is updating its full-year 2023 revenue guidance to $182 million to $186 million, which represents approximately 28% to 31% growth over the Company’s 2022 revenue. This compares to the prior full-year 2023 revenue guidance of $191 million to $197 million.

The Company expects positive adjusted EBITDA in the fourth quarter of 2023 and continues to expect to show modest improvement in adjusted EBITDA for full-year 2023 compared to 2022.

An investor presentation for the Company’s third quarter 2023 financial results is available in the "Investors" section of Treace's website at investors.treace.com.

https://finance.yahoo.com/news/treace-medical-concepts-reports-third-210500787.html

Novo Nordisk seeks obesity, diabetes 'bolt-on' deals

 Novo Nordisk wants to buy more companies with drugs in early- to mid-stages of development through "bolt-on" deals of up to a few billion dollars, CEO Lars Fruergaard Jorgensen told Reuters on Friday.

As the company's fortunes soar on demand for its popular weight-loss medicine Wegovy, Jorgensen said Novo sought to acquire companies working on medicines in the areas where it is already focused.

"So diabetes, obesity, cardiovascular disease, the whole cardiometabolic space, but also in the rare blood disorders, haemophilia, sickle cell, we believe that we have a stronghold there," he said in an interview.

"We will continuously be looking at smaller bolt-ons, typically early stage, phase 1 and phase 2, projects and typically of a very modest number of a few billion dollars," he added.

Novo's M&A strategy focuses on disease or therapeutic areas where the company has a "deep biological understanding", and also on "a set of technologies" the company wants to leverage, he added. He cited "protein engineering," saying the company had done that for year.

The company's research and development (R&D) engine is intact and therefore it is unlikely to do transformative deals soon, Jorgensen said.

He spoke after the company announced it would invest around $6 billion in one of its Danish production facilities in the coming years.

Last month Novo said it had agreed to buy a drug for uncontrolled hypertension that could potentially be used in cardiovascular and kidney disease, from Singapore-headquartered biotech firm KBP Biosciences for up to $1.3 billion. It was the latest in a series of similarly-sized deals the company has done this year.


Novo Nordisk invests $6 bln in Wegovy production, still far below demand -CEO

 Obesity drug maker Novo Nordisk said on Friday it will spend $6 billion to boost production in Denmark, although its chief executive warned the industry was far from being able to produce enough weight-loss drugs to meet global demand.

Novo Nordisk has had phenomenal success with its anti-obesity drug, Wegovy, but has scrambled to address shortages that have forced it to limit the number of patients.

The World Health Organization describes obesity as a "rising epidemic" and estimates that more than 1 billion adults globally will be living with obesity in 2030.

"With the capacity we're building and what competition is building, I believe we are far from getting to a billion people," CEO Lars Fruergaard Jorgensen told Reuters in an interview.

"I believe we will continuously have to invest," he added.

This week, U.S. and British regulators approved Eli Lilly's weight-loss treatment, while AstraZeneca invested in licensing an experimental pill from China's Eccogene.

Enormous demand is expected to drive annual sales of obesity drugs to $100 billion within a decade, with as many as 10 different drugs on the market, according to analysts.

Jorgensen said he welcomed competition and that the approval of Eli Lilly's drug "will further fuel market growth."

Novo said more than 42 billion Danish crowns ($6.0 billion) it will spend on expanding its Kalundborg site in Denmark will boost capacity for manufacturing active pharmaceutical ingredients (API) as well as across other parts of its supply chain, such as packaging.

This will include lifting capacity for GLP-1 products such as semaglutide, the API in Wegovy as well as the company's Ozempic diabetes treatment.

A portion of the investment was included in a 25 billion crowns capital expenditure plan announced in February. That is up from 12 billion in 2022 and 6.3 billion the year before.

Doximity guidance, stock buyback

 Doximity is providing guidance for its fiscal third quarter ending December 31, 2023 as follows:

  • Revenue between $127 million and $128 million.
  • Adjusted EBITDA between $61 million and $62 million.

Doximity is updating guidance for its fiscal year ending March 31, 2024 as follows:

  • Revenue between $460 million and $472 million.
  • Adjusted EBITDA between $207 million and $219 million.

Stock Repurchase Program

Doximity’s board of directors authorized another program to repurchase up to $70 million of the Company’s Class A common stock. The repurchases are expected to be executed from time to time over the next 12 months, subject to general business and market conditions and other investment opportunities, through open market purchases or privately negotiated transactions, including through Rule 10b5-1 plans. All prior repurchase programs were completed as of October 2023.

Conference Call Information

Doximity will host a webcast today at 2:00 p.m. Pacific Time (5:00 p.m. Eastern Time) to discuss these financial results. To listen to a live audio webcast, please visit the Company’s Investor Relations page at https://investors.doximity.com. The archived webcast will be available on the Company’s Investor Relations page shortly after the call.

https://www.businesswire.com/news/home/20231109485823/en/

Thursday, November 9, 2023

Harassment for Covid Mask Request Gets Review in Fifth Circuit

 The Equal Employment Opportunity Commission will try to revive its lawsuit accusing a Texas pharmacy of disciplining, humiliating, and threatening an asthmatic worker for seeking to wear a mask at the start of the Covid-19 pandemic.

The EEOC is set to appear at oral argument Wednesday at the US Court of Appeals for the Fifth Circuit to challenge a lower court’s ruling that the former US Drug Mart Inc. worker experienced an isolated incident of verbal harassment that didn’t amount to a hostile work environment under the Americans with Disabilities Act.

The case gives the appeals court an opportunity to clarify what sort of employer conduct gives rise to a legitimate claim of a hostile work environment.

Almost all circuit courts have said hostile work environment claims are available for disability-related bias and follow the same legal standard as those brought under Title VII of the 1964 Civil Rights Act, said Nicole Buonocore Porter, a disability law scholar who directs the Martin H. Malin Institute for Law & the Workplace at Chicago-Kent College of Law.

The federal judge who threw out the EEOC’s lawsuit against US Drug Mart cited both ADA and Title VII cases.

https://news.bloomberglaw.com/daily-labor-report/harassment-for-covid-mask-request-gets-review-in-fifth-circuit

FDA Clears First COVID-19 Home Antigen Test

 The U.S. Food and Drug Administration cleared for marketing the first over-the-counter (OTC) antigen test for COVID-19. ACON Laboratories' Flowflex COVID-19 Antigen Home Test, originally authorized for emergency use in 2021, is now the second home COVID-19 test to successfully complete a traditional FDA premarket review pathway, and the first indicated for use in children under 18. Today's announcement follows clearance of a molecular home test earlier this year.

"This marks the latest step forward in our efforts to help test developers provide Americans with continued options for safe and effective COVID tests that can be performed entirely at home," said Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health. "The FDA continues to proactively work with test developers that desire to market their products beyond emergency use authorities. This is part of the FDA's broader effort to advance the development and availability of at-home tests for a variety of medical conditions to expand patient access to testing."

The Flowflex COVID-19 Antigen Home Test is a visually-read test cleared for OTC home use by symptomatic individuals within six days of symptom onset. It is cleared for individuals aged 14 years or older testing themselves, or adults testing individuals aged two years or older. In a study reviewed by the FDA, this test correctly identified 89.8% of positive and 99.3% of negative samples in individuals with signs and symptoms of upper respiratory infection.

As with antigen tests authorized for emergency use, this test is intended to be used at least twice over three days with at least 48 hours between tests. This means that a symptomatic individual with an initial negative test result should be re-tested once between 48 and 72 hours after the first test using an antigen test for COVID-19 or followed up with a molecular COVID-19 test.