For­get buy­er’s re­morse, Pfiz­er is like­ly feel­ing pret­ty good about its $11.6 bil­lion Bio­haven takeover deal fol­low­ing re­ports of a 57% sales boost for mi­graine med Nurtec.

Bio­haven re­port­ed in Q2 re­sults on Fri­day that it’s cleared the nec­es­sary an­titrust hur­dles to move for­ward with the sale of its cal­ci­tonin gene-re­lat­ed pep­tide (CGRP) as­sets to Pfiz­er. How­ev­er, be­cause the com­pa­ny is “fo­cused on work­streams re­lat­ed to the clos­ing” of the deal, it did not host a call with an­a­lysts and in­vestors.

The com­pa­ny’s stock $BHVN was down less than 1% on Fri­day, pric­ing in at $146.96 per share.

The Pfiz­er deal is ex­pect­ed to close by “ear­ly 2023,” ac­cord­ing to a news re­lease. Aside from snag­ging the block­buster mi­graine drug, Pfiz­er al­so gets za­veg­epant, an in­tranasal mi­graine ther­a­py, and five pre­clin­i­cal as­sets in the deal cov­er­ing the CGRP port­fo­lio.

The rest of the port­fo­lio will be spun out in­to New Bio­haven, run by CEO Vlad Coric and his crew.

Nurtec saw a boom in sales, rak­ing in $194 mil­lion in Q2, up 57% from last quar­ter and a 109% in­crease over Q2 of last year. That surge is most­ly due to in­creased pre­scrip­tion sales from its oral Nurtec ODT and “fa­vor­able pack mix per pre­scrip­tion,” Bio­haven said.

“Ad­di­tion, we con­tin­ue to see im­prove­ments in pa­tient af­ford­abil­i­ty / co­pay sup­port needs as pa­tients sat­is­fy an­nu­al de­ductible oblig­a­tions,” ac­cord­ing to the Q2 re­port.

Nurtec ODT was ini­tial­ly ap­proved in Feb­ru­ary 2020 to treat acute on­set of mi­graine, then snagged an­oth­er in­di­ca­tion as a pre­ven­ta­tive in May 2021. Last month, Bio­haven tapped re­al­i­ty star and busi­ness­woman Khloé Kar­dashi­an to help mar­ket the drug as part of its “All in One” cam­paign.

Coric al­so tout­ed an NDA fil­ing for the in­tranasal za­veg­epant, which he said has the po­ten­tial to de­liv­er “ul­tra-rapid re­lief in as ear­ly as 15 min­utes,” and ad­dress pa­tients with nau­sea or vom­it­ing who need non-oral treat­ments. The com­pa­ny is ex­pect­ing a de­ci­sion in Q1 2023.

Mean­while, Coric said Bio­haven have made “tremen­dous strides across our broad­er pipeline,” in­clud­ing a Phase I pro­gram in fo­cal epilep­sy and the Phase III talde­f­grobep al­fa pro­gram in spinal mus­cu­lar at­ro­phy (SMA).

“We are ex­cit­ed about the vast op­por­tu­ni­ties be­yond CGRP,” he said in the Q2 re­port.

How­ev­er, the New Bio­haven vi­sion be­came a lit­tle murki­er when the com­pa­ny re­vealed a Phase III flop for the glu­ta­mate reg­u­la­tor tro­r­ilu­zole in pa­tients with spin­ocere­bel­lar atax­ia. De­spite miss­ing the pri­ma­ry end­point, Bio­haven ex­ecs looked to­ward a post hoc analy­sis for a po­ten­tial path for­ward in a spe­cif­ic group of fall risk pa­tients.

Coric al­so re­vealed a net loss of $6.21 per share in Q2, in­clud­ing ac­count­ing de­riv­a­tive loss­es as a re­sult of the an­tic­i­pat­ed merg­er. “Non-GAAP ad­just­ed net loss1 for the sec­ond quar­ter was $3.82 per share,” the com­pa­ny 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:

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.

The Pharmaceutical Research and Manufacturers of America — and their fleet of drug industry lobbyists on Capitol Hill — are known for never losing.

Whenever a big drug pricing bill comes up, an army of the industry group’s lobbyists descend onto the Hill and either smash it outright or dismantle it piece by piece.

But for perhaps the largest drug pricing reforms ever enacted, after more than a decade of Congress trying and failing to allow Medicare to negotiate prescription drug prices, those same lobbyists and their biopharma clients were dealt a stunning blow on Sunday afternoon.

Days after Enhertu reeled in another FDA nod, with the first-ever green light for HER2-low breast cancer, another antibody drug conjugate biotech claims it has secured the largest preclinical ADC pact to date for a single asset.

AstraZeneca and Daiichi Sankyo made waves with their nearly $7 billion collaboration back in spring 2019, but at that point, Enhertu was already nearing the FDA’s doors with clinical data. The latest ADC tie-up to enter the biopharma fray centers around a preclinical asset, Mersana Therapeutics’ XMT-2056.

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.”