Im­muno­core spent much of 2019 deal­ing with the fall­out of the Neil Wood­ford scan­dal, as the for­mer star in­vestor’s fall crashed the biotech’s val­u­a­tion out of uni­corn range. Now it turns out that the com­pa­ny spent 2020 deal­ing with an­oth­er in­ter­nal scan­dal.

The long­time UK biotech dar­ling dis­closed in their IPO fil­ing last week that they had fall­en vic­tim to an al­leged kick­back scheme in­volv­ing one of their em­ploy­ees. Af­ter a whistle­blow­er came for­ward, they said in their F-1, they spent the sum­mer and spring in­ves­ti­gat­ing, find­ing fraud on the part of an em­ploy­ee and two out­side ven­dors.

Im­muno­core of­fered sparse de­tails, but es­ti­mat­ed the scheme cost them be­tween £1.1 mil­lion to £1.8 mil­lion ($1.5 mil­lion to $2.6 mil­lion). They said they ter­mi­nat­ed the re­main­ing con­tract they had with one of the ven­dors and the em­ploy­ee re­signed. The com­pa­ny was able to re­cov­er £1.8 mil­lion in court in De­cem­ber, they said, but ac­knowl­edged that the events point­ed to “a ma­te­r­i­al weak­ness in our in­ter­nal con­trols” in del­e­gat­ing au­thor­i­ty and procur­ing equip­ment.

The de­tails were first re­port­ed by The Times in the UK.

Ref­er­ences to the scheme ap­pear through­out the com­pa­ny’s S-1, as man­age­ment cau­tions that their es­ti­mates for how much they lost are pre­lim­i­nary.

Still, the de­tails are un­like­ly to im­pede their IPO. At a time when com­pa­nies years away from the clin­ic are fil­ing S-1s at mul­ti-bil­lion dol­lar val­u­a­tions, CEO Bahi­ja Jal­lal has wait­ed un­til rel­a­tive­ly late in the game to take Im­muno­core pub­lic. As a re­sult, she comes to Wall Street with a rare as­set for a hith­er­to pri­vate biotech: Phase III da­ta.

In No­vem­ber, Im­muno­core an­nounced its T cell re­cep­tor ther­a­py im­proved over­all sur­vival in a rare form of melanoma. The com­pa­ny has larg­er in­di­ca­tions on the hori­zon, but Jal­lal tout­ed the re­sults as the first piv­otal ev­i­dence that TCR ther­a­pies work, as well as the first suc­cess­ful bis­pe­cif­ic T cell en­gager for sol­id tu­mors.

It al­so pro­vid­ed vin­di­ca­tion for the in­vestors who poured over $650 mil­lion in­to the biotech since its found­ing and may now be poised to cash in.

Four years ago, when Arena CEO Amit Munshi cut its ties to a troubled weight drug and doubled down on the pipeline, a cannabinoid receptor 2 agonist figured prominently in the biotech’s future. On Tuesday evening, however, Munshi’s high hopes for the drug took a nasty hit after it failed a Phase IIb study for patients with irritable bowel syndrome pain.

Put through a randomized pace with 273 patients, researchers said it flat failed the primary endpoint among the large group with abdominal pain. But they quickly went on to highlight subgroup data, always a tricky and controversial ploy, where they spotlighted a positive p value for patients with moderate to severe pain who received the high dose of the drug — one of 3 provided in the study.

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.

FibroGen will likely have to delay its US rollout for roxadustat once again.

In an unexpected move, the FDA is convening its Cardiovascular and Renal Drugs Advisory Committee to review the NDA in an advisory committee meeting. The date is yet to be confirmed.

Just a few weeks ago, SVB Leerink analyst Geoffrey Porges predicted that the roxa approval could come ahead of the PDUFA date on March 20 — effusive despite already being let down once by the FDA’s extension of its review back in December. AstraZeneca, which is partnered with FibroGen on the chronic kidney disease-related anemia drug, disclosed regulators had requested further clarifying analyses of clinical data.

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.