Re­al-world ev­i­dence on Gilead­'s HIV com­bo Bik­tarvy con­firms high ef­fi­ca­cy; Dig­i­tal ther­a­peu­tics firm to trade on Nas­daq

Gilead on Fri­day an­nounced in­ter­im re­sults from an on­go­ing, re­al-world tri­al for its HIV drug Bik­tarvy, con­firm­ing its ef­fec­tive­ness in more than 1,100 peo­ple liv­ing with HIV, and an­a­lyz­ing pa­tient-re­port­ed out­comes too.

The FDA ap­proved Bik­tarvy in 2018, based on da­ta from four Phase III stud­ies.

In this lat­est ob­ser­va­tion­al study, treat­ment with Bik­tarvy oc­curred be­tween June 2018 and Sep­tem­ber 2020, and af­ter 12 months of Bik­tarvy, the vast ma­jor­i­ty of treat­ment-naive adults and treat­ment-ex­pe­ri­enced adults liv­ing with HIV — 97% and 96%, re­spec­tive­ly —  achieved and main­tained vi­ro­log­ic sup­pres­sion (HIV-1 RNA <50 copies/mL).

Par­tic­i­pants in­clud­ed adults 50 years of age or old­er, cis­gen­der women, and late pre­sen­ters (CD4 <200 cells/μl and/or ≥1 AIDS-defin­ing event at base­line).

“De­spite ad­vances in an­ti­retro­vi­ral ther­a­py, peo­ple liv­ing with HIV ex­pe­ri­ence bur­den­some mul­ti­di­men­sion­al symp­toms and con­cerns re­quir­ing per­son-cen­tered care,” said Gilead’s VP of med­ical af­fairs in HIV, Fer­nan­do Bog­nar. “The pa­tient-re­port­ed out­comes ob­served in the BIC­STaR study pro­vide a first-hand as­sess­ment of the im­pact of HIV treat­ment and care on the qual­i­ty of life that peo­ple liv­ing with HIV ex­pe­ri­ence.”

Dig­i­tal ther­a­peu­tics-fo­cused Bet­ter Ther­a­peu­tics merged with SPAC to list on Nas­daq

Dig­i­tal ther­a­peu­tics com­pa­ny Bet­ter Ther­a­peu­tics is now list­ed on Nas­daq.

The firm just an­nounced its merg­er with a SPAC this morn­ing — and now the com­bined com­pa­ny start­ed trad­ing this morn­ing at $BT­TX with an open­ing price of $10.04 a share.

The com­pa­ny merged with Moun­tain Crest Ac­qui­si­tion Corp II, whose share­hold­ers ap­proved the merg­er on Wednes­day. The new com­pa­ny will be led by Bet­ter Ther­a­peu­tics’ pre­vi­ous man­age­ment team.

“The com­ple­tion of this trans­ac­tion and the cap­i­tal raised will be in­stru­men­tal in help­ing our team lead the way in this trans­for­ma­tion, be­gin­ning with car­diometa­bol­ic dis­eases,” said Bet­ter Ther­a­peu­tics co-founder and CEO Kevin Ap­pel­baum.

The pro­ceeds will be used to ad­vance Bet­ter Ther­a­peu­tics’ lead prod­uct for type 2 di­a­betes treat­ment — BT-001 — through clin­i­cal tri­als and sub­mis­sion for FDA ap­proval, and to ad­vance its PDT pipeline for oth­er car­diometa­bol­ic con­di­tions.

The trans­ac­tion gen­er­at­ed close to $70 mil­lion in gross pro­ceeds — and  the new com­bined com­pa­ny has ac­cess to an ad­di­tion­al $40 mil­lion from the Her­cules Cap­i­tal cred­it fa­cil­i­ty. That $40 mil­lion will be sub­ject to cer­tain mile­stones, ac­cord­ing to a com­pa­ny state­ment.

Ar­ma­ta Phar­ma­ceu­ti­cals in­fused with $7M to de­vel­op a CF drug

Bac­te­rio­phage-fo­cused biotech Ar­ma­ta Phar­ma­ceu­ti­cals an­nounced a $3 mil­lion eq­ui­ty in­vest­ment yes­ter­day from the Cys­tic Fi­bro­sis Foun­da­tion — fol­low­ing a $5 mil­lion award from the foun­da­tion back in March.

Just two and a half months af­ter for­mer CEO Todd Patrick re­tired and gave the biotech’s reigns to Bri­an Var­num, the biotech al­so re­ceived a $4 mil­lion eq­ui­ty in­vest­ment from health­care in­vest­ment firm and share­hold­er In­no­vi­va’s sub­sidiary In­no­vi­va Strate­gic Op­por­tu­ni­ties.

The mon­ey will be used to fur­ther a drug can­di­date the biotech cur­rent­ly has in a Phase Ib/IIa clin­i­cal tri­al — AP-PA02 for chron­ic Pseudomonas aerug­i­nosa res­pi­ra­to­ry in­fec­tions in those with cys­tic fi­bro­sis.

Alexander Lefterov/Endpoints News

A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Bahija Jallal, Immunocore CEO

BREAK­ING: FDA hur­ries up a quick ap­proval for the world's first TCR -- af­ter a 14-year R&D trek

Over the 14 years since Immunocore was spun out of MediGene in a quest to develop a gamechanging cancer med, the biotech has raised record sums and undergone a major shakeup on a long roller coaster ride of valuations for investors. But they survived and thrived and today they’re popping the champagne corks to celebrate an FDA approval of their first TCR drug.

Immunocore flagged the FDA’s green light for tebentafusp Wednesday morning by highlighting a series of firsts.

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Dominic Borie, Kyverna Therapeutics CEO

Well-con­nect­ed, Gilead-backed biotech gets an­oth­er stack of cash to pur­sue CAR-Ts for au­toim­mune dis­ease

Almost exactly two years after its debut at the 2020 JP Morgan confab — and on the heels of a new partnership with the gene editing experts at Intellia — a Gilead-backed, autoimmune disease-focused startup has returned to the well with a clearer outline of just what it plans to do with its CAR-T platform.

Kyverna brought in $85 million in its oversubscribed Series B, the company announced Wednesday. Northpond Ventures led the round, and Westlake Village BioPartners, Vida Ventures, Gilead and Intellia all contributed as well.

Days af­ter Gilead yanks PI3K drug, In­cyte with­draws NDA for its own PI3K — say­ing con­fir­ma­to­ry tri­als would take too long

The FDA’s intensifying scrutiny on accelerated approvals isn’t just putting pressure on drugmakers with marketed products. It is also subtly reshaping the regulatory dynamics.

Case in point: Incyte announced late Tuesday that it has made the “business decision” to withdraw an NDA for parsaclisib, its oral PI3Kδ inhibitor, after deciding that running the confirmatory studies the agency was asking for to support an accelerated approval wouldn’t be worth it.

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Dan O'Day (Getty Images)

In a set­back, FDA or­ders Gilead to hit the brakes on their late-stage, $5B can­cer play

Gilead’s $5 billion drug magrolimab has run into a serious setback.

The FDA ordered Gilead to halt enrollment on their studies of the drug in combination with azacitidine after investigators reports revealed an “apparent imbalance” in the suspected unexpected serious adverse reactions between study arms. And the halt is raising questions about Gilead’s plans for a quick pitch to regulators.

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Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.