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LaNova gets a buyer (and it’s not Merck) Read in browser
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top stories
1.
in focus
The Trump administration disbanded a newborn screening panel. Advocates now face a harder path
2. Merck's PD-1/VEGF partner LaNova gets snapped up for $951M
3. Updated: After Phase 3 obesity success, Hengrui plans China approval filing for Kailera-partnered drug
4.
news briefing
Otsuka buys immunology drugs; JCR, Acumen team up on Alzheimer’s program
5. FDA employees let go in April receive final termination notices
6. FDA chief calls for lower user fees as negotiations begin for eighth round of PDUFA
more stories
 
Jaimy Lee
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Rare disease advocacy groups are grappling with newborn screening guidelines after the Trump administration scrapped a committee that used to guide states on which diseases to screen for. “It is already causing concern and confusion,” one advocate told Jared Whitlock. “How will states decide what new disorders to consider?” Be sure to read Jared’s story examining the fallout.

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Jaimy Lee
Deputy Editor, Endpoints News
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A nurse puts a blood sample from a newborn onto a file card for a rare disease screening. (Photo by: Arno Burgi/picture-alliance/dpa/AP Images)
Endpoints In Focus
1
by Jared Whitlock

Pa­tient groups face a hard­er and un­pre­dictable path go­ing state-by-state to boost screen­ing for rare but treat­able con­di­tions af­ter the Trump ad­min­is­tra­tion dis­band­ed a fed­er­al ad­vi­so­ry com­mit­tee on new­born screen­ing.

In April, the Ad­vi­so­ry Com­mit­tee on Her­i­ta­ble Dis­or­ders in New­borns and Chil­dren was shut down fol­low­ing an ex­ec­u­tive or­der signed by Pres­i­dent Don­ald Trump to elim­i­nate “un­nec­es­sary” fed­er­al func­tions, an HHS spokesper­son said. The com­mit­tee guides states on which dis­eases to screen for at birth.

Rare dis­ease ad­vo­cates are still push­ing to sal­vage the com­mit­tee, but for now say they have no re­al al­ter­na­tive but to shift to­ward a de­cen­tral­ized strat­e­gy.

The im­pact of the pan­el's ter­mi­na­tion, which is start­ing to be felt, threat­ens to de­lay ac­cess to ear­ly de­tec­tion that’s crit­i­cal for pa­tients who are el­i­gi­ble for new ther­a­pies from com­pa­nies like Or­chard Ther­a­peu­tics and Mirum Phar­ma­ceu­ti­cals.

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2
by Max Gelman

One of Mer­ck’s most promi­nent part­ners just got ac­quired.

LaNo­va Med­i­cines is be­ing bought out by Hong Kong-based Sino Bio­phar­ma­ceu­ti­cal for $950.9 mil­lion, Sino an­nounced Tues­day morn­ing. Sino took a 4.91% stake in the Shang­hai-based biotech in No­vem­ber, be­fore say­ing Tues­day that it plans to ac­quire the re­main­ing 95.09% of the shares.

LaNo­va was found­ed in 2019, but it’s al­ready made a mark thanks to one of its lead drugs, for­mer­ly LM-299, now called MK-2010. It’s a PD-1/VEGF bis­pe­cif­ic an­ti­body that's part of a bur­geon­ing sec­tor in im­muno-on­col­o­gy. LaNo­va put MK-2010 in­to a Phase 1 tri­al in Chi­na last Oc­to­ber. A month lat­er, Mer­ck paid LaNo­va $588 mil­lion up­front to li­cense the drug. It al­so promised LaNo­va up to $2.7 bil­lion in po­ten­tial mile­stones.

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2025'S BREAKOUT STARTUPS. WHO'S ON THE LIST?
The biotech companies everyone will be talking about in 2025 get revealed live in Boston this September. Endpoints 11 isn’t just any list — it’s where industry insiders gather to see which bold bets might pay off. Find out who wins in real time at the State Room — reserve your spot now and save with the Early Bird rate.
Ron Renaud, Kailera CEO
3
by Elizabeth Cairns

Jiang­su Hen­grui Phar­ma­ceu­ti­cals’ in­ject­ed GLP-1/GIP ag­o­nist helped obese pa­tients in a Chi­na-based tri­al lose around 18% of their weight af­ter around 11 months’ treat­ment, Hen­grui and its US part­ner Kail­era Ther­a­peu­tics said Tues­day.

On a cross-tri­al ba­sis, this is not bad, mar­gin­al­ly beat­ing what Eli Lil­ly’s sim­i­lar­ly act­ing Zep­bound showed at one year in its own piv­otal Chi­na tri­al.

In Phase 2, a high­er dose of Hen­grui’s drug, called HRS9531, post­ed weight loss of 22.8% af­ter just eight months.

Ad­just­ed for place­bo, weight loss in the Phase 3 tri­al was 16.3%, again bet­ter than the 15.2% seen with the high dose of Zep­bound.

A pre­spec­i­fied sup­ple­men­tary analy­sis found that the high­est dose, 6 mg week­ly, al­lowed pa­tients to lose 19.2% of their weight, or 17.7% when ad­just­ed for place­bo.

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News Briefing: Quick hits from the biopharma web
4
by ENDPOINTS

Plus, news about UTEC, Sel­l­as and On­co­ma­tryx Bio­phar­ma:

Ot­su­ka ac­quires im­munol­o­gy drugs from Can­tar­gia: The agree­ment will send ear­ly-stage CAN10 and pre­clin­i­cal 3G5 to Ot­su­ka for $33 mil­lion up­front. Both pro­grams are de­signed to tar­get IL-1RAP. CAN10 is cur­rent­ly in a Phase 1 study in healthy vol­un­teers. Can­tar­gia can al­so get up to an­oth­er $580 mil­lion in mile­stones. — Max Gel­man

JCR, Acu­men part­ner on Alzheimer’s pro­gram: The deal cen­ters on a pro­gram called sabir­ne­tug, which is an an­ti­body de­signed to cross the blood-brain bar­ri­er and tar­get tox­ic sol­u­ble amy­loid be­ta oligomers. JCR will get $40 mil­lion up­front and can ob­tain up to an ad­di­tion­al $515 mil­lion in mile­stones. — Max Gel­man

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