As the for­mer glob­al brand leader of Mer­ck’s an­ti­fun­gal busi­ness, Francesco Maria Lavi­no knows his facts: There are on­ly three class­es of an­ti­fun­gals.

But F2G, the biotech where he’s now CEO, is con­fi­dent that it can soon bring a fourth an­ti­fun­gal class to the mar­ket. And it’s closed $70 mil­lion in new fi­nanc­ing to get there.

The com­pa­ny has yet to un­veil da­ta from its open Phase IIb study in pa­tients with rare and re­sis­tant molds — it plans to do so at a con­fer­ence in Oc­to­ber — but the re­sults are ap­par­ent­ly pos­i­tive enough to ce­ment an FDA fil­ing by the end of the year. The agency has al­ready grant­ed its com­pound, named olo­rofim, des­ig­na­tions as a break­through ther­a­py, qual­i­fied in­fec­tious dis­ease prod­uct and or­phan drug.

Lavi­no, a self-de­scribed “com­mer­cial per­son,” joined F2G more than a year ago and, work­ing out of New York City, has been build­ing out a team in the US to pre­pare for mar­ket launch some­time next year pend­ing FDA ap­proval. The biotech keeps its R&D op­er­a­tions in Man­ches­ter, UK, and has a small of­fice in Vi­en­na, bring­ing the to­tal head­count to about 55.

For­bion and Sofinno­va co-led the round, which fol­lows a re­cent Eu­rope and Asia deal with Sh­iono­gi that al­ready poured $100 mil­lion cash in­to F2G’s bank, with promis­es of more in mile­stones.

Nan­na Lüneborg

Nan­na Lüneborg, For­bion gen­er­al part­ner, re­mem­bers do­ing due dili­gence on the com­pa­ny more than a decade ago while she was still at No­vo Hold­ings. For her, the draw to F2G is “straight­for­ward.” Rare fun­gal in­fec­tions like in­va­sive as­pergillo­sis typ­i­cal­ly af­fect can­cer pa­tients whose im­mune sys­tems are com­pro­mised from treat­ment, and drug-drug in­ter­ac­tions mean ex­ist­ing an­ti­fun­gals can­not be used to­geth­er with many of the stan­dard-of-care can­cer treat­ments these days.

“A lot of pa­tients don’t have any suit­able treat­ment op­tions,” she said. She is join­ing F2G’s board along­side Sofinno­va’s Joe An­der­son.

So while F2G will en­cour­age doc­tors to use an azole when it’s ap­pro­pri­ate, Lavi­no be­lieves olo­rofim will have a siz­able role to play in sal­vage — with a price to re­flect that.

“We are not try­ing to dis­place gener­ic drugs that work,” he said. “We are say­ing when you re­al­ly have no op­tion, this is a drug that could save your pa­tient’s life.”

The com­pa­ny is con­duct­ing a sep­a­rate Phase III head-to-head com­par­ing olo­rofim to an ex­ist­ing op­tion dubbed Am­Bi­some. The cash re­serves could al­so fund life­cy­cle man­age­ment, Lavi­no added, such as de­vel­op­ing an in­haled ver­sion of olo­rofim. Fur­ther down the line, the CEO sees F2G po­ten­tial­ly bring­ing in more drugs.

“At the mo­ment we don’t want to be — we don’t be­lieve we will be an an­ti-in­fec­tive com­pa­ny ac­tu­al­ly, we want to be a rare dis­ease com­pa­ny,” he said.

Months after Novavax celebrated its first profitable quarter as a commercial company, the Gaithersburg, MD-based company is back in the red.

Sales for Novavax’s Covid-19 vaccine slipped to $55 million last quarter, down from $586 million in Q1, CEO Stanley Erck revealed on Monday after market close. The company’s stock $NVAX plummeted more than 32% in after-hours trading.

Upon kicking off the call with analysts and investors, Erck addressed the elephant in the room:

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, less than two weeks after its supplemental BLA was accepted. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.