Two years ago, Akero Ther­a­peu­tics laid out what one an­a­lyst called the “best-in-class NASH da­ta so far” in a field lit­tered with tri­al fail­ures and am­bigu­ous read­outs. Fol­low­ing those in­ter­im Phase II re­sults, Akero em­barked on a larg­er Phase II tri­al that is sup­posed to re­port out lat­er this year.

But things weren’t look­ing up for the San Fran­cis­co-based biotech when it re­vealed in its Q1 earn­ings re­port that it had just a year and a half of cash left — not enough to push its drug in­to piv­otal Phase III clin­i­cal tri­als that would sup­port an FDA ap­proval.

En­ter Pfiz­er and Her­cules Cap­i­tal.

Pfiz­er will in­vest $25 mil­lion via its Break­through Growth Ini­tia­tive to buy ap­prox­i­mate­ly 6.7% of Akero, and Pfiz­er’s VP of dis­cov­ery & de­vel­op­ment Jeff Pf­ef­fer­ko­rn will get a seat on Akero’s new­ly formed sci­en­tif­ic ad­vi­so­ry board. Along­side Pfiz­er, ven­ture lend­ing com­pa­ny Her­cules will loan up to $100 mil­lion to Akero, with $10 mil­lion avail­able im­me­di­ate­ly.

Jef­feries an­a­lyst Michael Yee (who was al­so the one who deemed Akero best-in-class in 2020) called Pfiz­er’s in­vest­ment “an in­cre­men­tal pos­i­tive.” Yee not­ed that Pfiz­er’s pre­vi­ous Break­through Growth Ini­tia­tive in­vest­ments were in ear­ly-stage com­pa­nies pri­or to key read­outs:

But the fo­cus, in our view, is PFE sees [po­ten­tial] in AKRO and an op­por­tu­ni­ty to in­vest in a promis­ing as­set, help sup­port and dri­ve for­ward a po­ten­tial im­por­tant drug, and can watch and fol­low the da­ta care­ful­ly as a pas­sive in­vestor with 7% stake.

That ex­tra cash should be enough to keep Akero afloat un­til the third quar­ter of 2024, which is two years be­yond its up­com­ing read­out of its Phase II study, it said in a press re­lease. In ad­di­tion to fin­ish­ing out its two Phase II tri­als, Akero will use the mon­ey to man­u­fac­ture a drug-de­vice com­bo and ini­ti­ate a Phase III tri­al to test that com­bo.

The fi­nanc­ing news caused Akero’s stock $AKRO to jump some 14% this morn­ing to over $9, though it is still a far cry from its peak days at $37 fol­low­ing that first Phase II an­nounce­ment.

Akero’s drug can­di­date for NASH — a dis­ease in which fat builds up in the liv­er and caus­es in­flam­ma­tion and scar­ring — is an old Am­gen drug known as efrux­ifer­min. It mim­ics FGF21, a liv­er hor­mone that reg­u­lates sug­ar up­take. In the 2020 Phase II study, near­ly half of pa­tients who re­spond­ed to the treat­ment and were biop­sied saw their NASH re­solve with­out their liv­er scar­ring wors­en­ing.

Pfiz­er it­self has al­so been work­ing to­ward a treat­ment for NASH, but with mixed re­sults. In 2018, the phar­ma dropped a Phase I can­di­date that in­hibits the fat­ty acid en­zyme DGAT2. How­ev­er, Pfiz­er is now test­ing a dif­fer­ent DGAT2 in­hibitor, er­vo­ga­s­tat, in con­junc­tion with cle­saco­stat, an in­hibitor of an­oth­er key fat­ty acid en­zyme, with re­sults ex­pect­ed in 2024.

Though Decibel Therapeutics has largely pivoted toward gene therapies for the inner ear, its lead clinical candidate simply aims to protect cancer patients from chemotherapy-induced hearing loss. On Tuesday, the biotech presented its first efficacy data for the program, and execs like what they see.

Decibel reported interim results from a Phase Ib study showing the experimental drug, dubbed DB-020, largely protected a small group of patients from losing their hearing. Researchers used a particularly unique study design, administering the compound in one of each patients’ ears before they received cisplatin chemotherapy and placebo in the other.

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

Amidst recently broader vaccine manufacturing initiatives from the EU and European companies, the G7 summit in the mountains of Bavaria has brought about some positive news for closing vaccine and medical product manufacturing gaps around the globe.

According to a statement from the White House, the G7 leaders have formally launched the partnership for global infrastructure, PGII. The effort will aim to mobilize hundreds of billions of dollars to deliver infrastructure projects in several sectors including the medical and pharmaceutical manufacturing space.

In November, Pfizer disclosed it’s spun out the Phase II dual JAK1/TYK2 inhibitor to a startup formed in collaboration with an unnamed, experienced partner.

We now know who the partner is. And as Pfizer and Roivant officially take the wraps off Priovant Therapeutics, the companies reveal that they have started two registrational trials of the drug, brepocitinib, as part of a broader plan to develop a big, first-in-class franchise spanning multiple orphan and specialty autoimmune diseases.