Humanigen Inc (fka HGENQ)

[cowtown jay]

Looks like they may get some help tomorrow.

PDUFA dates
Under PDUFA, the FDA is usually given 10 months to review a new drug application. However, if a drug is designated for priority review, the FDA is given six months to review that drug.

Only a select number of drugs are deemed eligible for priority review. Typically, those given priority represent significant medical breakthroughs or offer treatment where few or no other options exist. Priority review is often granted to drugs that aim to treat serious medical conditions, though drugs that treat less serious conditions are also eligible for priority review if they meet the aforementioned criteria. Review deadlines begin on the date that a new drug application is accepted by the FDA.

Though the FDA generally tries to adhere to PDUFA dates, they aren't set in stone, and it's not unheard of for the FDA to extend a PDUFA date. This generally happens when the FDA needs more time to complete the review process because of a major amendment in a new drug application.

Announcing PDUFA dates
The FDA, as a matter of policy, does not publish an official list of PDUFA dates. However, many drug companies choose to release their PDUFA dates in the hopes that doing so will lead to an increase in their stock prices. If a company gets FDA approval on a breakthrough drug, its stock price is likely to climb as a result. Similarly, stock prices might also rise in anticipation of FDA approval. Knowing that a PDUFA date is imminent can give investors an edge and help them time their upcoming stock purchases.

https://www.fool.com/knowledge-center/what-is-a-pdufa-date.aspx

It would be nice to have some good news for HGEN tomorrow, too. Even if it's just Form 4's from Black Horse or Cheval, announcing a decrease in their holdings.

Also, we should know more about the quality of Twitter's rumor murmur guy in regards to a share buyback.