Last Updated on June 21, 2019 by Kevin Douglass
Leave a comment and click here to sub for MS article alerts and our newsletter!
What Happened Last Week?
- APTX falls -67% after failing to meet primary endpoint in trial
- ADMP rallied last week on news of an epipen alternative
- LPCN gains on news of promising results in interim results of a study targeting NASH
- GALT 10x Fund LP (GALTS largest institutional holder) converted all of their series B convertible preferred stock into common stock.
Things To Watch
The end of January brings us two PDUFA decisions. Both SNY (decision date 1/28/19 for sBLA) and AQST (PDUFA decision date 1/29/19) are scheduled to receive their decisions early next week. SNY was the fifth largest Pharma company as of 2013 based on prescription sales, with revenues in excess of 35 billion euros FY17. The decision on 1/28/19 will take a look at their influenza vaccine candidate intended for children 6-35 months old. More information on the drug can be found here.
AQST is awaiting decision on APL-130277, targeting Parkinson’s disease with motor fluctuations. Recently Aquestive Therapeutics received an acceptance of their NDA with private partner Sunovion. The PDUFA will be through Sunovion and has received some optimism with quotes such as “We are encouraged that the FDA has accepted our NDA for apomorphine sublingual film,” being in their NDA press release.
The government shutdown continues, effecting hundreds of thousands of government employees and the biotech industry. The shutdown has effected the FDAs ability to review new drugs and has positioned companies in a challenging place. Many applications continue to get pushed through, but this doesn’t extend to blood and allergenic products. Among the effected is AIMT who recently paid the $2.5m filing fee in December. They were informed that the process would not begin until after a resolution has been reached by the government. FDA commissioner Scott Gottlieb, informed investors in a tweet; “For products not covered by a user fee program, like most blood and allergenic extract products, FDA does not have carryover user fee funding to continue reviewing pending or accepting new applications.” In addition, the FDA will not be accepting any new applications during the shutdown. For the time being, biotech companies outside the impacted scope of the FDA are out of harms way, but the continuation of the shutdown will impact them significantly as well. This is a risk for many companies as deadlines are pushed etc, but can serve as an advantage for some who stand to gain from competitors experiencing delays in their process. MS will be keeping a close eye on the opportunities and risks this environment presents.