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Harmony Biosciences Holdings, Inc.

https://www.harmonybiosciences.com/

Latest From Harmony Biosciences Holdings, Inc.

Keeping Track: Regeneron Ebola Antibody Cocktail Inmazeb Approved; Avenue Feels Pain From CRL; Scynexis Submits Oral Antifungal

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

Approvals Drug Approval Standards

US FDA Heads Into October With Calm Approvals Forecast

Decision on Regeneron’s Ebola virus therapy, which uses a similar monoclonal antibody cocktail approach as the company’s COVID-19 therapy candidate, stands out among the 10 user fee goal dates in the coming month.

US FDA Performance Tracker Drug Review

US FDA Oncology Applications: Real-Time Review And Breakthrough Pathway Show Durable Appeal

Recent submissions include what could be the fourth novel agent approved under the RTOR pilot.

Cancer Review Pathway

Finance Watch: 2020 Is Four Biopharma IPOs Away From Matching 2019

With 46 initial public offerings in the US by drug developers so far – including recent launches by Kymera, Inhibrx and Harmony – 2020 will easily beat last year’s 50 IPOs. In follow-on offerings and VC deals, newly public Schrodinger raised $346.5m and Tango’s $50m equity financing.

Financing Business Strategies
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