→ A herd of up­start biotechs will look to Wall Street for some ma­jor wind­falls this week as a burst of new of­fer­ings con­tin­ues to feed cash in­to the R&D sys­tem. To­day we learned that Bridge­Bio will look to raise in the neigh­bor­hood of $225 mil­lion by of­fer­ing 15 mil­lion shares for $14 to $16 each. And they have a string of joint bookrun­ners: J.P. Mor­gan, Gold­man Sachs, Jef­feries, SVB Leerink, KKR, Piper Jaf­fray, Mizuho Se­cu­ri­ties, BMO Cap­i­tal Mar­kets and Ray­mond James. If suc­cess­ful, Bridge­Bio will emerge with a mar­ket cap of around $1.7 bil­lion. There are 5 biotechs look­ing to IPO this week, in­clud­ing Akero and Pre­vail.

→ Rockville, MD-based CASI Phar­ma­ceu­ti­cals has in-li­censed an an­ti-CD19 T cell ther­a­py from Chi­na’s Ju­ven­tas. CASI is mak­ing an $11.6 mil­lion in­vest­ment in Ju­ven­tas in lieu of an up­front pay­ment. They’ll joint­ly con­tin­ue the de­vel­op­ment work.

→ Flex Phar­ma is hav­ing a lit­tle bit of trou­ble in ex­e­cut­ing its re­verse merg­er deal with Salarius Phar­ma­ceu­ti­cals. The failed biotech $FLKS says it needs to see more votes cast by share­hold­ers af­ter fail­ing to achieve a quo­rum — in per­son or proxy — at a spe­cial meet­ing. Its be­lea­guered shares dropped 24% to a mere 49 cents in pre-mar­ket trad­ing on Mon­day.

→ Ar­bu­tus Bio­phar­ma tapped William Col­lier as its next pres­i­dent and CEO. Col­lier suc­ceeds Mark Mur­ray, who is re­tir­ing on June 23. Col­lier has had over 30 years of ex­pe­ri­ence in the phar­ma­ceu­ti­cal in­dus­try. He served as pres­i­dent and gen­er­al man­ag­er, North Amer­i­ca at Vi­iV Health­care, in ad­di­tion to a stint at GSK $GSK as well. 

→ Med­ical ge­net­ics com­pa­ny, In­vi­tae Cor­po­ra­tion, is set to ac­quire Sin­gu­lar Bio to help in­crease ac­cess to ge­net­ic screen­ing in ear­ly preg­nan­cy. Sin­gu­lar Bio is “a pri­vate­ly held com­pa­ny de­vel­op­ing sin­gle mol­e­cule de­tec­tion tech­nol­o­gy that en­ables low­er costs and ex­pand­ed use of high-qual­i­ty, cell-free nu­cle­ic acid analy­sis, ini­tial­ly for ap­pli­ca­tion in non-in­va­sive pre­na­tal screen­ing (NIPS).”

→ In­cyte $IN­CY on Sat­ur­day pre­sent­ed 24-week re­sults from a mid-stage study of its JAK in­hibitor rux­oli­tinib, which showed the drug met the main goal of in­duc­ing ≥50% im­prove­ment in the fa­cial vi­tili­go. “This 24-week in­ter­val was the first part of a 3-part, 104-week study, and await 52- and 104-week da­ta to con­firm the safe­ty and ef­fi­ca­cy seen this week­end,” Cred­it Su­isse an­a­lysts wrote in a note. 

→ Calithera $CALA on Mon­day broke out da­ta from a mid-stage study test­ing its glu­t­a­m­i­nase in­hibitor, tela­gle­na­s­tat, in com­bi­na­tion with chemother­a­py everolimus. The tela­gle­na­s­tat com­bi­na­tion achieved a  me­di­an pro­gres­sion-free sur­vival (mPFS) of 3.8 months, while everolimus-treat­ed pa­tients ex­pe­ri­enced mPFS of 1.9 months. “While the top-line da­ta are en­cour­ag­ing, they do ap­pear to have de­te­ri­o­rat­ed vs. ear­li­er Phase I re­sults,” SVB Leerink an­a­lysts wrote in a note. 

→ A 15-month long sweep­ing in­ter­nal in­ves­ti­ga­tion en­com­pass­ing more than a mil­lion doc­u­ments, thou­sands of hours of se­cret video sur­veil­lance — in­stalled un­der the aus­pices of for­mer CEO Park­er “Pe­te” Pe­tit — and over 80 wit­ness­es, paint­ed a sor­did pic­ture of the scan­dalous past of the wound care com­pa­ny MiMedx in May. Ear­li­er this month, MiMedx begged its share­hold­ers not to fall for ma­ligned Pe­tit’s bid to re­turn to the com­pa­ny’s board, along with two of his busi­ness as­so­ciates. A pre­lim­i­nary vote count sug­gests stock­hold­ers have lis­tened, the com­pa­ny said on Mon­day.

Stephen Hahn went before a Senate committee Wednesday and declared he’s fighting. “Every one of the decisions we have reached has been made by career FDA scientists based on science and data, not politics,” he exclaimed, adding that “FDA will not permit any pressure from anyone to change that. I will fight for science.”

A few hours later, he was undermined by President Donald Trump when a reporter asked if he was okay with stricter vaccine guidelines that the FDA was said to be cooking up. “That has to be approved by the White House. We may or may not approve it. That sounds like a political move,” he decided.

Earlier this month, Flagship announced their big bet on the software half the industry is talking about, launching the AI and machine learning startup. Now, they and a couple other investors are gambling $100 million on a software that much of the public generally thinks of as a cool, IT afterthought: cloud computing.

The idea, says founder and Flagship partner David Berry, is one of scale: The sheer magnitude of biological data that you can store on cloud technology is unprecedented. And that size, when leveraged properly, can allow you to ask questions and form insights that are similarly unprecedented.

It’s been less than a month since Lumen Bioscience announced a $16 million Series B to engineer spirulina — a nutrient-packed super food — for diseases like traveler’s diarrhea, norovirus and C. difficile colitis. And now, the biotech has pulled in another $4 million to do the same for Covid-19.

The approach is quite similar to other gastrointestinal targets the company is pursuing, co-founders and Brian Finrow and Jim Roberts said. The Seattle-based company is working on a camelid antibody cocktail to combat GI infection common among Covid-19 patients. In a study published in the American Journal of Gastroenterology, a majority of Covid-19 patients showed GI and respiratory symptoms, and 25% had only GI symptoms.

About four months after completing an extension to its Series A, Monte Rosa Therapeutics is putting its next foot forward with another heap of cash.

The Boston-based biotech is back with $96 million in Series B financing with a goal to get its lead program ready for IND-enabling studies by the end of the year. Though Monte Rosa is keeping its specific target a secret for now, the company has been researching how to utilize its protein degradation technology in breast cancer and non-small cell lung cancer, among other areas.

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials, and could help shore up public trust in the agency and any eventual vaccine.

London Stock Exchange-listed PureTech Health announced Wednesday that it’s looking to extend to Nasdaq. But due to its “strong cash position,” the biotech says it isn’t issuing any new shares in the potential secondary listing.

The company’s shares closed at £256.50 Tuesday on the London Stock Exchange. Its candidate LYT-100 is currently in Phase I development for various indications, including lymphatic flow disorders and fibrotic and inflammatory disorders. PureTech is expecting a Phase Ib readout in lymphatic flow disorders later this year, and is also planning to launch a Phase II study for the drug to treat respiratory conditions experienced after Covid-19.