A compilation of many sources by BIO.
$BCRX
Human cells are incapable of incorporating Gali into human DNA or RNA, meaning that it is very nontoxic. This is unlike other antivirals like Favipiravir and EIDD-2801, which are mutagenic and likely carcinogenic. The Who lists Galidesivir as a high priority antiviral for Ebola.
It is effective against all RNA viruses, both positive and negative strand. Positive strand viruses are flaviviruses (e.g., Hepatitis C, West Nile, Dengue, Jap Encephalitis, Yellow Fever, TBEV, OHFV, and Zika) and coronaviruses (including MERS and SARS). Negative are filoviruses like Ebola and Marburg, arenaviruses, bunyaviruses, orthomyxoviruses, picornaviruses and paramyxoviruses (e.g., RSV). It has been suggested to work in rabies but not proven. Note that COVID19 and SARS RNA polymerases are virtually identical, so its ability to inhibit SARS will correlate with COVID19.
We have heard several reports that it is effective in vitro against COVID19—from talks given by Esper Kallas and from other sources like the University of Florida, but we await further evidence. However the cancer cell lines used to study viruses (e.g., Vero) are incapable of metabolizing Gali, so there is a lot of misinformation out there on its in vitro usefulness. In vivo studies are necessary, as discussed below.
In liver fractions of rats, dogs, mice, monkeys, and humans, it is metabolically stable for a long time.
In monkeys infected with Marburg Virus, 0 out of 6 controls survived. But 17 out of 18 treated with one low injection of BCX4430 survived. Viral loads were reduced 600 fold. All disease markers improved. Monkeys showed no toxicity or adverse local reactions.
In another monkey model infected with Ebola, 0 out of 6 controls survived but 6 out of 6 survived with one dose. Although Remdesivir showed some promise in monkeys infected with Ebola it was unable to help patients treated with it. Hence it was given up on until the COVID19 pandemic when Gilead donated it immediately to the Chinese government giving it the public attention it needed to make progress in clinical trials in the West, where it ultimately was found to be very inferior, and even the WHO and EU rejected it.
In hamsters infected with yellow fever, even 4 days after infection, a low dose of the drug reduced mortality significantly. All outcomes improved including weight loss, liver enzymes, and viremia.
Dose response curve for survival was very high for these hamsters and a mouse model of Yellow Fever, indicating these dangerous flaviviruses are all treatable by Gali at the right dose. Viral replication is completely stopped in vitro, especially West Nile. There are 200 million flavivirus infections worldwide per year, all untreatable… Hence the Yellow Fever Galidesivir trial in Brazil beginning last year.
In macaque monkeys infected with Zika virus showed that Galidesivir results in dramatic viral level reductions in blood and even in the brain, saliva, and urine generally to undetectable levels, even when the drug is given days after infection. The treated monkeys also showed induction of protective immunity. Virus levels fell to undetectable levels after 48 hours of Galidesivir treatment.
Another paper reported that it is effective in mice with Zika virus, even when given at peak viremia (all mice die with Zika virus infection, but 7 out of 8 Galidesivir-treated mice survived.
Phase I safety trials in humans show it is safe and well tolerated.
I’m not going to go into all of the publications that in silico it is an excellent inhibitor of the COVID19 polymerase.
Now we just await good news. Based on the above, the viral reduction will be striking, the survival and shortened length of stays and reductions in the ordinal scale will be very significant, and with no toxicity or side-effects. Once the data is released, which will also show some clinical efficacy, which the NIAID, which is funding the trial, is fully aware of and gave additional huge amounts of money to Biocryst in the middle of the trial, then an oral trial will be announced. This will happen quickly, as there are more than enough patients.
The drug has been manufactured at large scale in the background in the limelight. Once everyone recognizes the improvement, it will quickly be recognized as vastly superior to the available drugs and become number 1 selling drug worldwide for COVID19. This could give it 20+ billion dollars per year just for COVID19. Recall that Gilead gets 8 billion just from the US. Not including 200 million infections per year from filoviruses, 170 million from Trichomonas, and all the 30 classes of viruses it works safely and effectively against. It will also be stockpiled by countries for every foreseeable future pandemic, especially since at room temperature it exists stably for years.
Contrast that with Remdesivir, which is not even soluble, or Pfizer’s vaccine which has to be stored at -80C or Convalescent Plasma, which is not even effective unless it is very high titer and causes so many side effects. Favipiravir, Ribavirin, EIDD2801 with their likely serious liver and renal side effects. Gali will be number 1. Guaranteed. When I recognized all this in May after the disappointing Remdesivir results, I jumped in. Brace yourself for the BCRX price reset. The earthquake from the reset will shake the stock market for years to come.
And so ends this Galidesivir DD summary. It skips a lot of details, speculation, the vast amount of funding given by the NIAID and NIH to Biocryst for it, and calculations of earnings, but hopefully it exposes the soundness of the science and the high likelihood that it will turn out to be a super-drug reaching levels of sales akin to Lipitor, Aspirin, and Insulin.
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