Wel­come back to End­points Week­ly, your re­view of the week’s top bio­phar­ma head­lines. Want this in your in­box every Sat­ur­day morn­ing? Cur­rent End­points read­ers can vis­it their read­er pro­file to add End­points Week­ly. New to End­points? Sign up here.

With AS­CO be­hind us and BIO just ahead, we’re feel­ing the heat of the biotech sum­mer. Many of my col­leagues will be in San Diego next week. Safe trav­els to every­one mak­ing the trip there.

End­points News will be host­ing our first in-per­son events at BIO in two years, and we have a full slate of pan­els lined up to dis­cuss bio­phar­ma at the cross­roads. Set­ting the stage, End­points founder John Car­roll chat­ted with BIO chair Paul Hast­ings, polled the E100 group of biotech CEOs for their sen­ti­ments as well as views on hot but­ton is­sues, and asked Deal­For­ma chief Chris Doko­ma­ji­lar to crunch the num­bers a lit­tle bit ear­ly on H1 for a look at the trends in play. The spe­cial pre­view al­so fea­tures a look in­to M&A for the sec­ond half of the year, ac­cord­ing to sea­soned play­ers, and per­spec­tives from re­al es­tate de­vel­op­ers. Here’s the full line­up with more de­tails.

Over the past week­end, tens of thou­sands of physi­cians, clin­i­cal tri­al in­ves­ti­ga­tors, aca­d­e­mics, R&D sci­en­tists and bio­phar­ma lead­ers de­scend­ed up­on Chica­go for the first in-per­son AS­CO meet­ing since the pan­dem­ic on­set. And as Kyle LaHu­cik ob­served on the side­lines of the con­fer­ence, even as a suite of promi­nent drugs swept the head­lines with da­ta up­dates, min­gling face-to-face stole the spot­light as ex­ecs re­unit­ed with “50,000 of (their) clos­est friends.” Check out our full cov­er­age here.

Ahead of what may be make-or-break meet­ings for blue­bird bio, the FDA re­leased brief­ing doc­u­ments on two of its gene ther­a­pies sig­nal­ing a like­ly green light for one to treat a rare blood dis­or­der and ques­tions for the oth­er — an ex­per­i­men­tal treat­ment for cere­bral adrenoleukody­s­tro­phy — due to un­cer­tain­ty in both ben­e­fit and risk. Sur­pris­ing­ly, though, the ad­comm gave a big thumbs up to both the CALD and be­ta-tha­lassemia ther­a­pies de­spite those con­cerns.

Re­silience, the CD­MO with am­bi­tions to be­come the Fox­conn of bio­man­u­fac­tur­ing, had quite the week. It got a boost in the form of a $625 mil­lion Se­ries D, which will be used to con­tin­ue in­vest­ing in its in­fra­struc­ture through more deals, po­ten­tial ac­qui­si­tions and R&D ex­pan­sion so that it can do it all — and be ready for any­thing. Then it cracked open two part­ner­ships, first with the Uni­ver­si­ty of Texas MD An­der­son Can­cer Cen­ter then with the Park­er In­sti­tute for Can­cer Im­munother­a­py, around cell and gene ther­a­pies for can­cer.

PRE­MI­UM

David Schenkein has added a new mem­ber to GV’s still quite ex­clu­sive club of biotech CEOs-in-wait­ing. And this time the Google Ven­tures play­er is turn­ing to some­one he’d worked with for years at Agios, the com­pa­ny he built from a white sheet of pa­per. Schenkein re­cruit­ed Kevin Marks out of NI­BR, where he’s been work­ing as head of the on­col­o­gy dis­cov­ery group, a move that he says rep­re­sents the “growth mode” at GV life sci­ences. While he’s not rush­ing to join a start­up, Marks not­ed drug re­sis­tance is a key are­na he’s fo­cused on.

FI­NANC­ING

CORO­N­AVIRUS

MAR­KET­INGRX

MAN­U­FAC­TUR­ING

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

It’s one conference after the other in June. Now that #BIO22 is behind us, we’re shifting gears to Zach Brennan’s upcoming events at #DIA22 and on-the-ground coverage from Cannes Lions by Beth Snyder Bulik and Nicole DeFeudis. If you’re taking a long weekend like us — we’re off Monday in observance of Juneteenth — I hope it’s just what you need.

Unlock this story instantly and join 144,000+ biopharma pros reading Endpoints daily — and it's free.

Merck is evaluating a potential buyout of embattled Seattle biotech Seagen, according to a report from the Wall Street Journal on Friday morning.

This is the newest development for the biotech after former CEO Clay Siegall stepped down from the company — while also forfeiting his board positions at other companies such as Umoja Biopharma — following allegations of domestic violence that surfaced last month. He was initially arrested in the early hours of April 23 after a physical altercation with his wife left her with multiple bruises, according to a police report. Siegall has denied the allegations.

Unlock this story instantly and join 144,000+ biopharma pros reading Endpoints daily — and it's free.

The amyloid beta theory that has driven billions of dollars in failed Alzheimer’s research has taken yet another body blow.

Roche — and specifically its big sub Genentech — conceded defeat overnight for its closely watched Phase II API-ADAD trial of crenezumab in Alzheimer’s prevention. This follows twin Phase III failures — CREAD 1 and CREAD 2 in 2019 — and may well effectively mark the end of the line for a drug in-licensed from Switzerland’s AC Immune 16 years ago.

Unlock this story instantly and join 144,000+ biopharma pros reading Endpoints daily — and it's free.

A panel of the FDA’s outside experts voted 9-3 that Acadia Pharmaceuticals’ drug doesn’t appear to be effective at treating patients with Alzheimer’s-related psychosis.

The drug, Nuplazid, is already indicated for Parkinson’s-related psychosis, but Acadia has tried — and failed last year — to get another green light in Alzheimer’s psychosis. The drug never panned out in the clinic for patients with depression or schizophrenia, causing Acadia multiple R&D headaches over the years.

Unlock this story instantly and join 144,000+ biopharma pros reading Endpoints daily — and it's free.

The member countries of the World Trade Organization negotiated late into last night, finally offering up a compromised and watered-down way for some low-income countries to waive the intellectual property around certain Covid-19 vaccine ingredients and manufacturing processes, potentially paving the way for compulsory licensing for these vaccines.

While only in effect initially for five years, the waiver would hypothetically allow low-income countries to bypass certain Pfizer and Moderna patents to produce more Covid-19 vaccines.

Another OK, another 2,000 potential patients.

On Thursday, Rhythm Pharmaceuticals received its second FDA green light for its obesity management drug for those with ultra-rare genetic diseases, this time for Bardet-Biedl syndrome, a disease that impacts a number of organs but with early-onset obesity as a major symptom. And the company also engineered a royalty deal netting it up to $100 million.

The FDA approved the drug, known as setmelanotide and marketed as Imcivree, for patients 6 years and up after Phase III data in 31 Bardet-Biedl patients showed it decreased BMI by around 8% compared to placebo. Rhythm chairman and CEO David Meeker noted that while BMI was not a perfect measurement, the company opted to use it over weight because its study included pediatric patients who were still growing.

One month after telling the SEC it would lay off about a fourth of its staff, Scholar Rock is following the blueprint laid out by other public biotechs during the bear market: raising some big cash on the heels of a data readout.

The Cambridge, MA-based company announced Friday morning it plans to raise $205 million in a public offering after touting two-year Phase II data in spinal muscular atrophy as positive, also on Friday. The figure represents more money than Scholar Rock’s market cap at Thursday’s closing, which clocked in at $171.6 million.

Unlock this story instantly and join 144,000+ biopharma pros reading Endpoints daily — and it's free.

More than 18 months after adults were able to start receiving Pfizer-BioNTech’s and Moderna’s Covid-19 vaccines, kids as young as six months are on the verge of being able to get inoculated against the pandemic virus.

The FDA authorized the Pfizer-BioNTech and Moderna vaccines Friday morning under EUA after the agency’s outside advisors unanimously favored (21-0) administering the shots. Parents and caregivers just have to wait for the CDC to sign off before the youngest of America’s kids can get the vaccine.

A couple of weeks after being told by the powers that be at Nasdaq that it will need to get its battered share price out of penny stock territory if it wants to keep its listing, Mereo BioPharma has picked up some steam today with the rumor that AstraZeneca has come calling to see about an acquisition.

If it’s accurate, AstraZeneca — which has developed into a powerhouse oncology player with a very select appetite for high-dollar deals — is shopping the bargain basement on Wall Street after the biotech bear market eviscerated Mereo’s market cap.

Unlock this story instantly and join 144,000+ biopharma pros reading Endpoints daily — and it's free.

Bioscience & Technology Business Center The University of Kansas Lawrence, Kansas

If you're already an Endpoints subscriber, enter your email below for a magic link that lets you log in quickly without using a password. Please note the magic link is one-time use only and expires after 24 hours.

We'll e-mail you a link to set a new password. Please note this link is one-time use only and is valid for only 24 hours.

ENDPOINTS NEWS Daily at 11:30 AM ET

EARLY EDITION Daily at 7:15 AM ET

ENDPOINTS PHARMA Daily at 2 PM ET

ENDPOINTS MARKETING RX Tue at 2 PM ET

ENDPOINTS FDA+ Wed at 2 PM ET

ENDPOINTS MANUFACTURING Thu at 2 PM ET

ENDPOINTS WEEKLY Sat at 6 AM ET