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

Janet Woodcock may have one of the most historically long and drug-intense tenures in FDA history, but her new role is outside of all things pharma and the once-acting FDA commissioner isn’t looking back.

“No I really don’t look back,” Woodcock told Endpoints News via email on Monday morning. “Yes I will be transitioning. Longer discussion on infrastructure needed.”

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.

The area of Ireland famous for Blarney Castle and its cliffsides along the Atlantic Ocean is seeing Merck KGaA expand its commitment there.

The German drug manufacturer is expanding its membrane and filtration manufacturing capabilities in Ireland. The company will invest approximately €440 million ($470 million) to increase membrane manufacturing capacity in Carrigtwohill, Ireland, and build a new manufacturing facility at Blarney Business Park, in County Cork, Ireland.

Twenty House Democrats, including Reps. Katie Porter of California and Susan Wild of Pennsylvania, are calling on Senate leaders to move quickly with a reconciliation bill (meaning they only need a simple majority for passage) with prescription drug pricing reforms, and to include adding new authority for Medicare to negotiate drug prices.

They also called on the Senate to specifically follow suit with the House passage of a $35 per month insulin cap (as Senate Majority Leader Chuck Schumer’s deadline for a vote on that provision has come and gone), and to cap Medicare Part D costs at $2,000 per year for seniors.