U.S. FDA lifts clinical hold on Inovio's COVID-19 vaccine trial

 Inovio Pharmaceuticals Inc said on Tuesday the U.S. Food and Drug Administration (FDA) had lifted a partial clinical hold on late-stage trial of its COVID-19 vaccine within the country.

Inovio said it now has the authorization to proceed with the trial after 14 months, sending its shares up 4.6% before the bell.

The FDA last year in September put the final-stage trial on hold as it sought more information from the company, including details on a delivery device used to inject genetic material into cells.

Following the decision, the U.S. government pulled funding for the late-stage study for Inovio's vaccine as other COVID-19 vaccines were already available in the country.

Inovio then started late-stage trials outside the United States in partnership with China's Advaccine Biopharmaceuticals.

The company is currently conducting the Phase 3 portion of its mid-to-late-stage trial in several regions including Latin America, Asia Pacific and Africa.

https://finance.yahoo.com/news/1-u-fda-lifts-clinical-131230448.html

Moderna seeks EU authorization for COVID-19 vaccine in young kids

 Moderna Inc on Tuesday sought conditional marketing authorization with the European Medicines Agency for use of its COVID-19 vaccine in children in the age-group of 6-11 years.

The vaccine was authorized for use in teens aged 12 to 17 years by the European Union in July, but several countries including Sweden have paused its use for people aged 30 and younger due to rare heart-related side-effects.

The drugmaker sought U.S. authorization of its vaccine for use in teens in June and is awaiting a decision by the U.S. Food and Drug Administration.

"This marks our first submission for the use of our vaccine in this age group," said Stéphane Bancel, Chief Executive of Moderna, adding the company will submit the data to other regulatory agencies around the world.

https://finance.yahoo.com/news/1-moderna-seeks-eu-authorization-140344081.html

Ocugen Submits EUA in US for Ages 5-18

 Conference Call and Webcast Today at 8:30 a.m. ET

• Emergency Use Authorization application filed with the U.S. FDA for the COVID-19 vaccine candidate, COVAXIN™ (BBV152), for children aged 2 – 18 years

• Investigational New Drug application filed with the U.S. FDA for COVAXIN™ (BBV152)

• Investigational New Drug application filed with the U.S. FDA for breakthrough modifier gene therapy candidate, OCU400

• Collaboration with CanSinoBIO expanded to include OCU410 for chemistry, manufacturing, and controls development and manufacturing

Conference Call and Webcast Details

Ocugen has scheduled a conference call and webcast for 8:30 a.m. eastern time today to discuss the financial results and recent business highlights. Ocugen's senior management team will host the call, which will be open to all listeners. There will also be a question-and-answer session following the prepared remarks.

The call can be accessed by dialing (844) 873-7330 (U.S.) or (602) 563-8473 (international) and providing the conference ID 8198297. To access a live audio webcast of the call on the “Investors” section of the Ocugen website, please click here. A replay of the webcast will be archived on Ocugen’s website for approximately 45 days following the call.

https://finance.yahoo.com/news/ocugen-provides-business-third-quarter-123000780.html

Biohaven, Pfizer enter up to $1.24 bln deal to market migraine drugs

 Pfizer Inc will acquire overseas marketing rights to two migraine drugs from Biohaven Pharmaceutical Holding Co for up to $1.24 billion, the companies said on Tuesday.

The deal includes an upfront payment of $500 million for the rights to Biohaven's rimegepant and zavegepant. The payment consists of $150 million in cash and $350 million for the purchase of Biohaven equity at a 25% market premium.

Biohaven will also be able to fetch another $740 million in milestone payments and receive double-digit royalties on the drugs' overseas net sales from Pfizer.

Rimegepant, marketed as Nurtec ODT in the United States, has been approved for the acute treatment of migraine attacks and the prevention of episodic migraine in adults.

The drug brought in sales of about $136 million in the quarter ended Sept. 30, a 46% jump over the previous three months.

Biohaven has applied for rimegepant's approval with the European Medicines Agency and several other regulatory authorities outside the United States.

Zavegepant is being studied as an intranasal and a soft-gel formulation in late-stage clinical trials for migraine.

https://finance.yahoo.com/news/1-biohaven-pfizer-enter-1-133143671.html

Vaccine biotech Vaxxinity sets terms for $101 million IPO

 Vaxxinity, a Phase 2 biotech developing vaccine therapies for chronic diseases using synthetic peptides, announced terms for its IPO on Friday.

The Dallas, TX-based company plans to raise $101 million by offering 6.7 million shares at a price range of $14 to $16. At the midpoint of the proposed range, Vaxxinity would command a fully diluted market value of $2.1 billion.

Vaxxinity's vision is to disrupt the existing treatment paradigm for chronic diseases, and believes its synthetic peptide vaccine platform (Vaxxine Platform) has the potential to enable a new class of therapeutics. Its Vaxxine Platform is designed to harness the immune system to convert the body into its own "drug factory," stimulating the production of antibodies with a therapeutic or protective effect. Its current pipeline consists of five chronic disease candidates from early to late-stage development across multiple therapeutic areas including Alzheimer's Disease (AD), Parkinson's Disease, migraine, and hypercholesterolemia. Its most advanced candidate, UB-311, targets toxic forms of aggregated amyloid-b in the brain to fight AD. The company expects to initiate a Phase 2b early AD efficacy trial in 2022. Vaxxinity is also developing a candidate for COVID-19 prevention.

Vaxxinity was founded in 2014 and plans to list on the Nasdaq under the symbol VAXX. BofA Securities, Jefferies, and Evercore ISI are the joint bookrunners on the deal.

Relevant Profile: VAXX

https://www.renaissancecapital.com/IPO-Center/News/88274/Vaccine-biotech-Vaxxinity-sets-terms-for-$101-million-IPO

Childcare provider KinderCare sets terms for $503 million IPO

 KinderCare Learning Companies, the largest private provider of early childhood education and care services in the US, announced terms for its IPO on Monday.

The Portland, OR-based company plans to raise $503 million by offering 25.8 million shares at a price range of $18 to $21. At the midpoint of the proposed range, KinderCare Learning Companies would command a market value of $2.7 billion.

KinderCare is the largest private provider of early childhood education and care services in the US by center capacity. The company serves children ranging from 6 weeks to 12 years of age across its market leading footprint of 1,490 early childhood education centers with capacity of more than 195,000 children and contracts for more than 650 before- and after-school sites located in 40 states and the District of Columbia as of October 2, 2021. KinderCare operates all of its centers under the KinderCare brand and utilizes a consistent curriculum and operational approach.

KinderCare Learning Companies was founded in 1969 and booked $1.7 billion in revenue for the 12 months ended September 30, 2021. It plans to list on the NYSE under the symbol KLC. Barclays, Morgan Stanley, Jefferies, BofA Securities, Goldman Sachs, Baird, Citi, Credit Suisse, and Macquarie Capital are the joint bookrunners on the deal. It is expected to price during the week of November 15, 2021.

Relevant Profile: KLC

https://www.renaissancecapital.com/IPO-Center/News/88329/Childcare-provider-KinderCare-sets-terms-for-$503-million-IPO

U.S. Tells Court That Blocking COVID-19 Vaccine Rule to Cost Lives

 The Biden administration told a court on Monday it has clear authority to impose a COVID-19 vaccine rule on employers with at least 100 staff and that a court's order on Saturday blocking the rule could cost dozens or even hundreds of lives daily.

People are increasingly returning to work and they risk accelerating the spread of COVID-19 without the rule, said the filing in the U.S. 5th Circuit Court of Appeals by government lawyers.

"With the reopening of workplaces and the emergence of the highly transmissible Delta variant, the threat to workers is ongoing and overwhelming," said the filing.

The Occupational Safety and Health Administration (OSHA) last week announced the rule, which also provides for a testing and masking alternative to vaccination and a Jan. 4 deadline. The agency said it was necessary to prevent 250,000 hospitalizations.

Republican governors, trade groups, private employers and religious organizations sued in various federal courts of appeal, arguing the administration overstepped its authority.

On Saturday, the 5th U.S. Circuit Court of Appeals in New Orleans suspended the rule, citing "grave statutory and constitutional" issues.

The government filing was in response to a request by the plaintiffs for an injunction permanently blocking the rule. The government lawyers said that request was a premature.

The government lawyers noted that various cases that have been filed must be consolidated in one venue and it remains unclear which court will hear the cases.

A White House press secretary on Monday urged employers to push ahead with vaccinations despite the legal challenges.

https://www.usnews.com/news/top-news/articles/2021-11-08/us-says-covid-19-vaccine-mandate-lawsuits-belong-in-court-picked-randomly