An­oth­er biotech filed to go pub­lic late Fri­day as the 2020 IPO par­ty rages on.

Ali­gos Ther­a­peu­tics, fo­cus­ing on chron­ic he­pati­tis B and NASH, sub­mit­ted its S-1 pa­per­work to the SEC with a goal of rais­ing $100 mil­lion. The com­pa­ny’s lead can­di­date is known as a STOPS mol­e­cule, or an S-anti­gen trans­port-in­hibit­ing oligonu­cleotide poly­mer, and start­ed a Phase I study for CHB in Au­gust.

Through late Au­gust, the in­dus­try as a whole had raised $11 bil­lion-plus across four dozen IPOs, per in­de­pen­dent an­a­lyst Brad Lon­car, sur­pass­ing the amount from all of 2019.

Af­ter four oth­er biotechs priced their shares last Fri­day, the to­tal num­ber of in­dus­try IPOs in 2020 reached 56, Nas­daq’s head of health­care list­ings Jor­dan Saxe told End­points News at the time. Nas­daq has count­ed $11.3 bil­lion raised for those 56 biotechs through Fri­day. Saxe’s tal­ly al­so match­es Lon­car’s to­tal from 2018, which made 2020 tied for the most biotech IPOs seen since at least 2017.

The the­o­ry be­hind the lead pro­gram, dubbed ALG-010133, is that sup­press­ing the S-anti­gen in the he­pati­tis B virus can boost the pa­tients’ com­pro­mised im­mune sys­tems and im­prove vi­ral clear­ance in chron­ic he­pati­tis B. Ali­gos’ Phase I study will mea­sure safe­ty and an­tivi­ral ac­tiv­i­ty in up to 12 week­ly dos­es, both in healthy vol­un­teers and vi­ro­log­i­cal­ly sup­pressed pa­tients with CHB.

Ac­cord­ing to a state­ment at the time, ALG-010133 will first be eval­u­at­ed as a monother­a­py but Ali­gos said it has seen some po­ten­tial that it could be used in com­bi­na­tion ther­a­pies.

Topline re­sults for some co­horts are ex­pect­ed in the sec­ond half of 2021, and the first pa­tients were dosed at a tri­al site in New Zealand. Oth­er sites across Asia and Eu­rope have not be­gun dos­ing as of yet.

Ali­gos has three oth­er pre­clin­i­cal pro­grams try­ing to hit the chron­ic he­pati­tis B in­di­ca­tion, each with dif­fer­ent mech­a­nisms of ac­tion. The first is with cap­sid as­sem­bly mod­u­la­tors, which are small mol­e­cules that in­ter­fere with HBV cap­sid dis­as­sem­bly and vi­ral repli­ca­tion. This pro­gram, called ALG-000184, is ex­pect­ed to be­gin clin­i­cal tri­als be­fore the end of the year.

The com­pa­ny’s oth­er two CHB pre­clin­i­cal pro­grams both can in­hib­it the virus’s mR­NA that en­codes S-anti­gens, Ali­gos says. These two meth­ods are through an an­ti­sense oligonu­cleotide, as well as a small in­ter­fer­ing RNA. Ad­di­tion­al­ly, the biotech’s NASH pro­gram — al­so in pre­clin­i­cal stud­ies — is a THB-be­ta ag­o­nist.

Ali­gos’ S-1 did not give much de­tail about how it ex­pects to divvy up the funds from the IPO raise, on­ly that the mon­ey would main­ly go to­wards fund­ing these five pro­grams.

Al­so on Fri­day, a 5AM Ven­tures-backed blank check com­pa­ny filed to go pub­lic, seek­ing an $80 mil­lion raise. The com­pa­ny, called 5:01 Ac­qui­si­tion, is not plan­ning on op­er­at­ing like a nor­mal SPAC in that it’s not of­fer­ing war­rants that would be­come ex­er­cis­able fol­low­ing com­ple­tion of the ini­tial busi­ness com­bi­na­tion, per Re­nais­sance Cap­i­tal.

5:01 Ac­qui­si­tion did not spec­i­fy with which biotech it plans to con­duct a re­verse merg­er.

The National Institutes of Health (NIH) has declined to use so-called “march-in” rights to lower the price of Astellas’ prostate cancer drug Xtandi even as the federal government helped to pay for its development.

NIH told prostate cancer patients Robert Sachs and Clare Love, in a letter shared with Endpoints News, the institutes’ analyses found Xtandi “to be widely available to the public” and “given the remaining patent life and the lengthy administrative process involved for a march-in proceeding, NIH does not believe that use of the march-in authority would be an effective means of lowering the price of the drug.”

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.