Of the 160 biopharma deals tracked by BioWorld during the month of April, 36% are for collaborations focusing on the development of therapeutics and vaccines for COVID-19.
Sunovion Pharmaceuticals Inc.’s apomorphine sublingual film (APL-130277), a dopamine agonist the company will market as Kynmobi, has won FDA approval for the acute intermittent treatment of motor fluctuations (off episodes) associated with Parkinson’s disease.
Representing the highest amount ever raised by a public biopharma company on a U.S. exchange, Moderna Inc. priced a $1.34 billion follow-on offering to help fund worldwide manufacturing and distribution of its mRNA-1273 vaccine for COVID-19.
While a significant number of clinical trial delays occurred during the month of April, it was business as usual from a regulatory standpoint for companies with late-stage therapies ready for the market and for those targeting underserved patient populations.
Three biopharma drugs are up for FDA approval this week, including one new chemical entity, dasotraline, from Sunovion Pharmaceuticals Inc. to treat binge eating disorder, and two other candidates that are part of supplemental filings for expanded indications.
While COVID-19 dominated the clinical data news during the month of April, with 45% due to trial delays, suspensions and terminations, and another 12% focused on therapeutic and vaccine development targeting the deadly infection, a number of companies still posted positive phase III data for other indications and are preparing for regulatory filings and commercialization.
Despite a global pandemic that is wreaking havoc on the overall economy, biopharma financings and grants during the month of April have shown solid numbers.
Respiratory complications caused by COVID-19 can propel a patient from a mild cough one day to a ventilator and an ICU only 10 days later. As countries around the world work to stockpile ventilators and citizens continue social distancing measures, biopharma companies are tackling the development of fast-acting therapeutics to disrupt a dire disease trajectory in hospitalized patients. An industry-wide frantic race has ensued. On March 5, BioWorld reported that there were approximately 30 therapeutics and vaccines in development for COVID-19. As of April 28, there were 343 total: 249 therapeutics and 94 vaccines.
The FDA approved Urogen Pharma Ltd.’s mitomycin gel, an orphan drug branded Jelmyto, on April 15, offering patients the first non-surgical option for low-grade upper tract urothelial cancer (LG-UTUC) and granting the Princeton, N.J.-based company with its first marketed product.
Princeton, N.J.-based Urogen Pharma Ltd. is transforming itself into a commercial operation in anticipation of an FDA approval for UGN-101 this week. Wall Street also apparently expects a positive decision by the April 18 PDUFA date, as listed in BioWorld’s Drugs on Deck record. Urogen’s stock (NASDAQ:URGN) has climbed 40% since the month began, and 11.31%, or $2.41, on April 13, closing out the day at $23.71.
