Julia Owens, Millendo

Mil­len­do braces for deep cuts af­ter its last clin­i­cal ef­fort ends in de­feat and a last search for a way to end things

Turn out the lights, the par­ty is over at Mil­len­do Ther­a­peu­tics.

Nine months af­ter pulling the plug on a piv­otal study of their lead drug, the Ann Ar­bor, MI-based biotech is shut­ter­ing its sole re­main­ing ear­ly-stage study for their NK3R an­tag­o­nist MLE-301. And they’re sound­ing a bleak note, plan­ning some deep cuts for the re­main­ing staff while the board goes about the busi­ness of find­ing a way to gain some val­ue out of this for share­hold­ers.

At the top of the al­ter­na­tive strate­gies on the ta­ble: A sale or merg­er of the com­pa­ny, or what’s left of it.

The biotech is wash­ing its hands of a drug aimed at treat­ing menopausal va­so­mo­tor symp­toms. Af­ter look­ing over the re­sults from their dose-as­cend­ing Phase I, re­searchers found lit­tle rea­son to re­main op­ti­mistic — es­pe­cial­ly giv­en the com­pet­i­tive land­scape of NK3R drugs.

This is the drug Mil­len­do — long helmed by Ju­lia Owens — turned to af­ter its Phase IIb tri­al for liv­o­le­tide went bel­ly up last spring.

The stock $ML­ND, which has erased vir­tu­al­ly all of its once high-fly­ing val­ue, dropped 14% Tues­day morn­ing,

Com­pa­ny chair­man Car­ol Gal­lagher summed it up in a state­ment:

The board has con­tin­ued to sup­port the com­pa­ny’s on­go­ing plans and ex­e­cu­tion ef­forts; how­ev­er, at this time the board be­lieves that it is in the best in­ter­est of the com­pa­ny and its share­hold­ers to ac­tive­ly seek a broad range of strate­gic al­ter­na­tives, in­clud­ing a sale or merg­er of the com­pa­ny in or­der to max­i­mize share­hold­er val­ue.

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.

What con­tro­ver­sy? Eli Lil­ly plots Alzheimer's BLA fil­ing lat­er this year as FDA taps more an­ti-amy­loid drugs as break­throughs

The FDA is keeping the good news coming for Alzheimer’s drug developers. And Eli Lilly is taking them up on it.

Amid continued controversy around whether Biogen’s new flagship drug, Aduhelm, should have been approved at all — and swelling, heated debates surrounding its $56,000 price tag — the agency had no issue handing them and their Japanese partner Eisai a breakthrough therapy designation for a second anti-amyloid beta antibody, lecanemab, late Wednesday.

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On heels of Aduhelm ap­proval, Bris­tol My­ers jumps back in­to Alzheimer's race

Bristol Myers Squibb last put major resources behind an Alzheimer’s drug nearly a decade ago, when their own attempt at targeting amyloid flamed out in mid-stage studies. They invented another molecule, a Tau-targeted antibody, but jettisoned it to Biogen in 2017 as they dropped out of neuroscience altogether.

But on Thursday, the New York pharma announced they were getting back in the game. Bristol Myers exercised an $80 million option to bring a tau-targeted antibody from Prothena into a Phase I study. The opt-in, which Bristol Myers triggered ahead of analyst expectations, opens the door for another $1.7 billion in milestones down the road.

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Alexis Borisy (file photo)

EQRx and Ex­sci­en­tia, a pair of self-styled dis­rup­tors, team up to over­turn the drug pric­ing ap­ple cart

The biotech industry has seen no shortage of innovation in recent years, but in one area — drug pricing — the field has been anything but innovative. Now, two brash startups taking different roads to upset the drug pricing model will partner up to create a sort of “super-disruptor.”

EQRx and UK-based AI specialist Exscientia will team up on a discovery-through-commercialization collaboration the partners hope will work better than the sum of its parts to bring cheaper medicines to patients faster, the companies said Thursday.

Hervé Hoppenot, Incyte CEO (Jeff Rumans)

ODAC echoes FDA con­cern over In­cyte PD-1, as Paz­dur sig­nals broad­er shift for ac­cel­er­at­ed ap­proval

After the FDA lambasted their PD-1 ahead of an adcomm earlier this week, Incyte ran into new trouble Thursday as ODAC panelists voted against an accelerated OK by a wide margin.

Members of the Oncologic Drugs Advisory Committee recommended with a 13-4 vote to defer a regulatory decision on Incyte’s retifanlimab until after more data can be collected from a placebo-controlled trial. The PD-1 therapy is due for a PDUFA date in late July after receiving priority review earlier this year.

New FDA doc­u­ments show in­ter­nal dis­sent on Aduhelm ap­proval

In a lengthy review document and a pair of memos from top officials, the FDA released on Tuesday night its most detailed argument yet for approving Biogen’s intensely controversial Alzheimer’s drug aducanumab.

The documents amount to an agency attempt to quench the firestorm their decision kindled, as outside advisors members resigned and experts warned that an unproven drug now could stretch Medicare’s budget to a breaking point. Ultimately, the documents show how CDER director Patrizia Cavazzoni and Office of New Drugs director Peter Stein both concurred with FDA neuroscience head Billy Dunn on the accelerated approval while the staff at FDA’s Office of Biostatistics did not think an approval was warranted.

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Karen Flynn, Catalent

Q&A: When the pan­dem­ic struck, Catal­en­t's CCO had just joined the team

Karen Flynn came aboard Catalent’s team just in time.

The company was going through a surge of changes, and she had been brought over from her role as CCO of West Pharmaceutical Services to serve in the same capacity for the New Jersey-based CDMO. Then a few months later, the pandemic was in full-force.

Since then, Catalent’s been in hyper-expansion mode. In early May, it acquired Promethera’s Hepatic Cell Therapy Support SA subsidiary and its 32,40-square-foot facility in Gosselies, Belgium. Prior to that, the company acquired Belgian CDMO Delphi Genetics, wrapped up the expansion of an already-existing site in Madison, WI and added an ultra-low temperature freezer partner in Sterling. As Emergent has botched millions of doses of AstraZeneca’s vaccine, the company has swooped in to move that production to its Maryland plant as well.

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Richard Pazdur (vis AACR)

FDA en­cour­ages in­clud­ing in­cur­able can­cer pa­tients in tri­als, re­gard­less of pri­or ther­a­pies

The FDA on Thursday called to include those with incurable cancers (when there is no potential for cure or for prolonged/near normal survival) in appropriate clinical trials, regardless of whether they have received existing alternative treatments.

Historically, many cancer clinical trials have required that participating patients previously received multiple therapies, according to Richard Pazdur, director of the FDA’s Oncology Center of Excellence.

Roche sev­ers ties with 4D Mol­e­c­u­lar Ther­a­peu­tics over blind­ness gene ther­a­py, mark­ing an­oth­er set­back for the field

Roche is turning its nose up over a gene therapy program targeting an inherited form of night blindness, signaling the latest setback for such treatments in eye-related diseases.

As the space continues to reel from Biogen’s major Phase III flop last week, Roche is handing back rights to a program from 4D Molecular Therapeutics, the biotech announced Thursday morning. The termination of the licensing agreement will be effective as of Sept. 16, 4DMT said.

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