Covid-19 af­flicts Eli Lil­ly’s share price and a KRAS drug gets tossed, but Jar­diance win salves the wound as an an­ti­body ef­fort ad­vances to PhII

Shares of Eli Lil­ly $LLY tum­bled close to 2% on Thurs­day in a tox­ic re­ac­tion to its mixed rev­enue per­for­mance in the face of the pan­dem­ic dur­ing Q2. But in­vestors found so­lace in a promis­ing Phase III read­out for Jar­diance, as their block­buster con­tin­ues to blaze a trail to much big­ger mar­kets.

Their SGLT2 in­hibitor beat out a place­bo in re­duc­ing the risk for the com­pos­ite of car­dio­vas­cu­lar death or hos­pi­tal­iza­tion due to heart fail­ure, when added to stan­dard of care. The drug hit the pri­ma­ry end­point, added Lil­ly, not­ing that the full da­ta read­out will come at the Eu­ro­pean So­ci­ety of Car­di­ol­o­gy (ESC) Con­gress at the end of Au­gust.

Swept out in the Q2 cleanup, though, was Lil­ly’s ear­ly stage KRAS G12C drug LY3499446. Af­ter Am­gen spurred hope for a big KRAS play, with a va­ri­ety of play­ers look­ing to make progress on a tar­get that has long been con­sid­ered un­drug­gable, added da­ta have dimmed hopes for broad ap­plic­a­bil­i­ty. And now Lil­ly, which has been steadi­ly re­work­ing its on­col­o­gy pipeline and brand un­der Loxo chief Josh Bilenker, wants out. The key is­sue was safe­ty.

Lil­ly’s state­ment to End­points News:

While we were ini­tial­ly ex­cit­ed to ex­plore the po­ten­tial of LY3499446, we saw un­ex­pect­ed tox­i­c­i­ty and de­cid­ed not to in­vest ad­di­tion­al time and re­sources in a pro­gram that may not be as clin­i­cal­ly and com­pet­i­tive­ly rel­e­vant as we hoped. We are tak­ing a very dis­ci­plined ap­proach to build­ing our pipeline and are sin­gu­lar­ly fo­cused on dis­cov­er­ing and de­vel­op­ing med­i­cines that we be­lieve will be tru­ly dif­fer­en­ti­at­ed and mat­ter to pa­tients.

The news on Jar­diance, one of their fastest grow­ing fran­chis­es at Lil­ly, will be sweet­er for in­vestors.

Vamil Di­van at Mizuho not­ed:

(I)t is clear to us that to­day’s news, com­bined with pos­i­tive news we have seen re­cent­ly from SGLT-2 in­hibitors in pa­tients with kid­ney dis­ease, is go­ing to open up large new mar­kets for the SGLT-2 class, with Jar­diance the clear mar­ket leader.

Oth­er drugs in the class, in­clud­ing Farx­i­ga from As­traZeneca, have been mak­ing their own ad­vances on the car­dio side of the med­ical equa­tion.

“The re­sults of the EM­PER­OR-Re­duced tri­al in­di­cate that SGLT2 in­hibitors have the po­ten­tial to be­come a new stan­dard of care for this dis­ease, which will be a mean­ing­ful ad­di­tion to cur­rent­ly es­tab­lished treat­ments,” not­ed Mil­ton Pack­er, chair of the ex­ec­u­tive com­mit­tee for the de­vel­op­ment pro­gram.

An­a­lysts have al­so been close­ly fol­low­ing Lil­ly’s an­ti­body de­vel­op­ment pro­gram for CoV555, part­nered with Ab­Cellera. In their Q2 state­ment, the com­pa­ny said they had com­plet­ed dos­ing in the first study and launched a Phase II tri­al, with da­ta ex­pect­ed in the fourth quar­ter.

Un­lock­ing ESG strate­gies for growth with Gilead Sci­ences

RBC Capital Markets explores what is material in ESG for biopharma companies with the ESG leads at Gilead Sciences. Gilead has long focused on sustainability but recognized a more robust framework was needed. Based on a materiality assessment, Gilead’s ESG strategy today focuses first on drug access and pricing, while also addressing D&I and climate change. Find out why Gilead’s board is “acutely aware” of the contribution that ESG makes to firm’s overall success.

Con­sor­tium of 5 drug reg­u­la­tors plot path to in­crease har­mo­niza­tion through 2024

A group of drug regulators from Australia, Canada, Singapore, Switzerland and the UK on Tuesday unveiled their strategic plans for the next three years, laying out how they’ll work together on reviewing new drugs to reduce duplication across borders.

While understanding that the biopharma industry is truly global, the group, known collectively as the Access Consortium, seeks to better align their respective regulatory and policy approaches for pharmaceuticals, with an aim to facilitate faster access to high quality, safe and effective health products.

On the hunt for the next Mod­er­na, in­vestors have pumped 'plat­form plays' with cash. Can any­thing slow the run­away train?

It didn’t take an expert to see that mRNA platforms could be huge.

Julie Sunderland partnered with both Moderna and BioNTech about a decade ago while she was running program-related investments for the Bill & Melinda Gates Foundation — and even then the potential for their platforms was obvious despite some well-founded concerns about whether the next-gen tech would ever cross the finish line.

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Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

Mer­ck­'s Keytru­da blazes a path in first-line cer­vi­cal can­cer, mak­ing good on drug­mak­er's push for ear­li­er pa­tients

In the years since I/O wonder drug Keytruda’s initial approval, Merck has struck an aggressive clinical trial program, which is now firmly focused on earlier lines of therapy. The drugmaker has scored some success there so far, and now it’s earned one of its biggest wins yet.

Keytruda plus chemotherapy with or without background Avastin significantly extended patients’ lives over those dosed with a placebo control in first-line patients with persistent, recurrent or metastatic cervical cancer, according to top-line data from the Phase III KEYNOTE-826 study revealed Tuesday.

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Neu­rona Ther­a­peu­tics is dash­ing to the clin­ic with its cell ther­a­py for epilep­sy — but first, an­oth­er ven­ture round

Six years ago, a band of neuroscientists from the University of California, San Francisco combined decades of research and jumped into the hunt for an off-the-shelf cell therapy. Now, that team is sprinting toward the clinic with a treatment for epilepsy — but first, it’s making a pit stop at the venture well.

Neurona Therapeutics unveiled a $41.5 million round on Tuesday morning, bringing the San Francisco-based biotech’s total raise to $135 million. The cash will be used to advance the company’s pipeline, including an upcoming Phase I/IIa for its lead candidate, NRTX-1001, in chronic focal epilepsy.

Sen. Ron Wyden (D-OR) with reporters in the Senate Subway (Graeme Sloan/Sipa via AP Images)

Top Wyden pri­or­i­ty for drug price re­forms: Medicare ne­go­ti­a­tions

As the Biden administration tries to wrangle the details of its infrastructure bill, Senate Finance Committee Chair Ron Wyden (D-OR) took a concrete step forward on drug pricing reforms on Tuesday and unveiled five principles for such reforms, including providing Medicare with the ability to negotiate prices.

“Allowing the Secretary of HHS to negotiate the price Medicare will pay creates a much needed mechanism to achieve fairer prices when the market has failed to do so,” Wyden wrote.

End­points News is now 5 years old. Here's how you can sup­port us for the next phase of growth

Endpoints News turned five years old over the weekend. I wanted to mark the happy occasion by extending our deepest gratitude to Endpoints’ premium subscribers while outlining several other ways to support us as we go broader and get bigger this year and beyond.

Same as any business, we’ve got to create value and get paid for delivering it. So if you depend on Endpoints to stay abreast on biopharma developments, we depend on you too.

Emma Walmsley, GlaxoSmithKline CEO (Credit: Fang Zhe/Xinhua/Alamy Live News)

Ac­tivist in­vestor El­liott in talks with oth­er Glax­o­SmithK­line in­vestors about re­plac­ing Em­ma Walm­s­ley, spin­ning off vac­cine busi­ness — re­port

As Emma Walmsley reveals details this Wednesday about the upcoming split of GlaxoSmithKline’s pharma and consumer units, some tough questions may be coming her way.

Elliott Management, the activist investor that’s previously threatened an attack on GSK (but eventually backed off), is floating more radical changes like replacing the CEO, further breaking up the company and spinning out the vaccine unit, or reviewing the focus on cancer drugs, the Financial Times reported.

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Fred Upton and Diana DeGette

New DARPA-like NIH agency preps for re­al­i­ty as E&C un­veils bi­par­ti­san Cures 2.0 draft bill

House Energy & Commerce leaders Fred Upton (R-MI) and Diana DeGette (D-CO) on Tuesday released new draft legislation with wide-ranging implications for public health, the FDA, NIH, and that would create a new, $6.5 billion federal advanced research agency under NIH, with an aim to cure cancer, Alzheimer’s and other difficult diseases.

Similar to DARPA, the new NIH division to be known as ARPA-H, would be run by a small group of program managers with more latitude to pursue high-risk, high-reward projects that other government agencies would likely shy away from.

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