The NASH par­ty is over at No­var­tis-backed Cona­tus. And this time they’re turn­ing off the lights.

More than 2 years af­ter No­var­tis sur­prised the biotech in­vest­ment com­mu­ni­ty with its $50 mil­lion up­front and promise of R&D sup­port to part­ner with the lit­tle biotech on NASH — ig­nit­ing a light­ning strike for the share price — Cona­tus $CNAT is back with the lat­est bit­ter tale to tell about em­ri­c­as­an, which once in­spired con­fi­dence at the phar­ma gi­ant.

Steven Men­to Cona­tus

Not on­ly did the topline re­sults for the EN­CORE-LF Phase IIb clin­i­cal tri­al fail to reach sta­tis­ti­cal sig­nif­i­cance, the ex­ten­sion study of the EN­CORE-PH study al­so flopped. EN­CORE-LF is now be­ing wrapped up.

This is Cona­tus’ fourth strike, fol­low­ing a se­ries of set­backs that elim­i­nat­ed any se­ri­ous hope in its fu­ture. The com­pa­ny is now lay­ing off 40% of its staff. And in an SEC fil­ing, the biotech not­ed that it will now search out its “strate­gic al­ter­na­tives,” which are se­vere­ly lim­it­ed.

The biotech stood up and took the bul­let, read­ing the last rites for this one: “Cona­tus will con­tin­ue to work with its part­ner No­var­tis on en­sur­ing that all re­main­ing oblig­a­tions re­lat­ed to the em­ri­c­as­an pro­gram are ful­filled.”

“We de­signed the EN­CORE pro­gram to give em­ri­c­as­an an op­por­tu­ni­ty to achieve its po­ten­tial through a se­ries of clin­i­cal tri­als tai­lored to spe­cif­ic pa­tient pop­u­la­tions en­com­pass­ing a broad range of chron­ic liv­er dis­ease,” said a straight­for­ward Steven Men­to, CEO and co-founder of Cona­tus, in a state­ment. “We are dis­ap­point­ed that em­ri­c­as­an failed to meet the ex­pec­ta­tions es­tab­lished in pri­or pre­clin­i­cal and clin­i­cal stud­ies, but con­fi­dent that the EN­CORE tri­als pro­vid­ed a fair eval­u­a­tion of em­ri­c­as­an’s lack of ef­fi­ca­cy in these pa­tient pop­u­la­tions.”

Back in late 2016, though, it was a dif­fer­ent sto­ry as No­var­tis shocked the mar­ket by pro­vid­ing an up­front that equaled Cona­tus’ mar­ket cap at the time. It’s in much worse shape now, with its pen­ny stock slashed more than 60% af­ter the mar­ket closed, drop­ping be­low the 40 cent mark in ex­tinc­tion ter­ri­to­ry.

NASH has proven to be a grave­yard for a num­ber of small and not-so-small biotechs. But with a mar­ket pro­ject­ed to reach the tens of bil­lions of dol­lars, the hunt con­tin­ues.

So­cial im­age: Shut­ter­stock

Peter Marks appeared before a virtual SVB Leerink audience yesterday and said that his staff at FDA’s CBER is on the verge of working around the clock. Manufacturing inspections, policy work and sponsor communications have all been pushed down the to-do list so that they can be responsive to Covid-related interactions. And the agency’s objective right now? “To save as many lives as we can,” Marks said, likening the mortality on the current outbreak as equivalent to “a nuclear bomb on a small city.”

It’s another day of hauling cash in the biopharma world as four more IPOs priced Friday and a fifth filed its initial paperwork.

The biggest offering comes from PMV Pharma, an oncology biotech focusing on p53 mutations, which raised $211.8 million after pricing shares at $18 apiece. Prelude Therapeutics, developing PRMT5 inhibitors for rare cancers, was next with a $158 million raise, pricing shares at $19 each. Graybug Vision raised $90 million after pricing at $16 per share for its wet AMD candidates, and breast cancer biotech Greenwich Lifesciences brought up the rear with a small, $7 million raise after pricing shares at $5.75.

Days after J&J dosed the first participants of its Phase III ENSEMBLE trial, the pharma giant has detailed the early-stage data that gave them confidence in a single-dose regimen.

Testing two dose levels either as a single dose or in a two-dose schedule spaced by 56 days in, the scientists from Janssen, the J&J subsidiary developing its vaccine, reported that the low dose induced a similar immune response as the high dose. The interim Phase I/IIa results were posted in a preprint on medRxiv.

Sitting atop the executive branch, President Donald Trump is the ultimate authority at the FDA. He can fast track any vaccine to approval himself. If it came to that, of course.

What he can’t do is unilaterally order the legislative branch to loosen the Treasury’s coffers for $6.6 billion. Nor can he command pharmaceutical companies to pay for $200 vouchers sent to 33 million Medicare beneficiaries for prescription drugs before the election.

Palladio Biosciences just took one step further in its quest to topple Otsuka’s Samsca with its own — it hopes safer — autosomal dominant polycystic kidney disease (ADPKD) drug.

The Pennsylvania-based biotech announced a $20 million Series B on Friday, which will fund a 10-person Phase III trial of its vasopressin V2 receptor agonist, lixivaptan. CEO Alex Martin expects to read out data in the first half of next year, then launch straight into a larger pivotal Phase III study with about 1,200 participants.

The concerns keep mounting over President Donald Trump’s politicization of the FDA and other federal agencies guiding the development of a safe and effective vaccine. And today, the telegenic New York governor Andrew Cuomo appeared to introduce even more politics into the matter — latest in an ongoing series of incidents that have cast the proudly independent FDA in starkly political terms.

During his daily press conference Cuomo said that the state will review any coronavirus vaccines approved by the federal government, citing a lack of trust in the Trump administration. The announcement comes one day after Trump accused the FDA of making an “extremely political” move in proposing stricter vaccine guidance.