Hu­mani­gen, once led by the im­pris­oned Mar­tin Shkre­li, is find­ing it­self in a sim­i­lar­ly con­fined space.

On Thurs­day, the com­pa­ny said the FDA de­clined its re­quest for an EUA for its lead drug lenzilum­ab to treat new­ly hos­pi­tal­ized Covid-19 pa­tients, send­ing shares of the com­pa­ny’s stock $HGEN down by more than 50% pre-mar­ket.

Why ex­act­ly the FDA re­ject­ed the EUA re­mains large­ly un­known as the com­pa­ny of­fered few specifics.

“In its let­ter, FDA stat­ed that it was un­able to con­clude that the known and po­ten­tial ben­e­fits of lenzilum­ab out­weigh the known and po­ten­tial risks of its use as a treat­ment for COVID-19,” the com­pa­ny said in a state­ment, while not­ing that it can sub­mit ad­di­tion­al da­ta as it be­comes avail­able.

The NIH is still test­ing lenzilum­ab in com­bi­na­tion with Gilead’s remde­sivir in its AC­TIV-5/BET-B study, which Hu­mani­gen said could pro­vide fur­ther da­ta to sup­port a new EUA re­quest.

Those re­sults will be cru­cial for the com­pa­ny, which said that as of June 30, it had cash and cash equiv­a­lents of about $121 mil­lion. The long-suf­fer­ing biotech was a pen­ny stock play­er in the OTC mar­ket when Covid-19 came along and lift­ed its prospects, fu­el­ing a steep rise in share price and re­viv­ing its prospects with in­vestors. Hu­mani­gen burned through more than $100 mil­lion in cash in the first half of 2021, com­pared to about $20 mil­lion in the first half of 2020.

Hu­mani­gen CEO Cameron Dur­rant, who took the reins of then-bank­rupt Hu­mani­gen — known pre­vi­ous­ly as Kalo­Bios — from Shkre­li, said in a state­ment, “We be­lieve the on­go­ing AC­TIV-5/BET-B tri­al, which has been ad­vanced to en­roll up to 500 pa­tients, may pro­vide ad­di­tion­al safe­ty and ef­fi­ca­cy da­ta suf­fi­cient to sup­port our ef­forts to ob­tain an EUA to treat hos­pi­tal­ized COVID-19 pa­tients.”

The re­jec­tion is an about-face for the com­pa­ny, which in March tout­ed pos­i­tive re­sults from a 520-per­son, place­bo-con­trolled study that found lenzilum­ab im­proved the odds of ven­ti­la­tor-free sur­vival by 54%.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

Leading the way to increase access to cheaper drugs worldwide, Pfizer said Wednesday it will provide all current and future patent-protected medicines and vaccines available in the US or EU on a not-for-profit basis to about 1.2 billion people in 45 lower-income countries.

Rwanda, Ghana, Malawi, Senegal and Uganda are the first five countries to sign on to this accord, which will also seek to blaze new paths for quick and efficient regulatory and procurement processes to reduce the usual delays in making new medicines and vaccines available in these countries.