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Stephen Hahn steps down as CEO of Flagship biotech Read in browser
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15 August, 2025
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top stories
1. RFK Jr. says he’s not running for president in 2028, defends top aide
2. Pfizer's sickle cell drug candidate fails Phase 3 trial
3.
peer review
Stephen Hahn steps down as CEO of Flagship biotech; A new era at AbbVie partner Gubra
4. Scoping the VEGF bispecific landscape: Which large pharma might make the next move?
5. Precigen’s rare disease therapy gets full approval from the FDA
more stories
 
in focus
Alexis Kramer
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Vinay Prasad’s FDA profile page is back up today, about a week after he made his return to the agency. It appears that he still has all three of his titles. Prasad also made a statement yesterday about the new approval of Precigen’s rare disease therapy, Papzimeos.

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Alexis Kramer
Editor, Endpoints News
HHS Secretary Robert F. Kennedy, Jr. (George Walker IV/AP Images)
1
by Max Bayer

HHS Sec­re­tary Robert F. Kennedy Jr. on Fri­day shut down ru­mors that he was in the ear­ly stages of an­oth­er pres­i­den­tial cam­paign, writ­ing on so­cial me­dia that "I am not run­ning for pres­i­dent in 2028."

He al­so de­fend­ed a top aide who was fac­ing mount­ing crit­i­cism from al­lies of Pres­i­dent Don­ald Trump.

Kennedy's post on X aimed to ad­dress re­cent me­dia re­ports about his po­lit­i­cal am­bi­tions and al­leged dys­func­tion at the top of the agency he over­sees.

News re­ports have spec­u­lat­ed on a loom­ing run for a few weeks, af­ter Ax­ios in Ju­ly re­port­ed on an or­ga­niz­ing call led by a po­lit­i­cal ac­tion com­mit­tee be­hind Kennedy's Make Amer­i­ca Healthy Again move­ment. Kennedy on Fri­day ac­cused “DC lob­by­ing shops” of “push­ing the flat-out lie” that he was work­ing on an­oth­er pres­i­den­tial cam­paign. Kennedy ran in 2024 as an in­de­pen­dent be­fore drop­ping out and back­ing Trump.

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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.
2
by Nicole DeFeudis

A sick­le cell can­di­date from Pfiz­er’s $5.4 bil­lion ac­qui­si­tion of Glob­al Blood Ther­a­peu­tics failed a Phase 3 study, the phar­ma gi­ant an­nounced on Fri­day.

In­clacum­ab didn’t sig­nif­i­cant­ly re­duce the rate of painful com­pli­ca­tions called va­so-oc­clu­sive crises com­pared to place­bo in pa­tients 16 years and old­er, miss­ing the tri­al’s pri­ma­ry end­point. The study was one of two late-stage tri­als in Pfiz­er’s THRIVE pro­gram test­ing in­clacum­ab for those com­pli­ca­tions. Pfiz­er ter­mi­nat­ed the oth­er tri­al last year due to slow en­roll­ment.

Pa­tients in the com­plet­ed tri­al were giv­en in­clacum­ab every 12 weeks over 48 weeks. Pfiz­er said the drug was “gen­er­al­ly well-tol­er­at­ed.”

A Pfiz­er spokesper­son told End­points News that the com­pa­ny is con­tin­u­ing to re­view the da­ta and “will pro­vide up­dates on our next steps as ap­pro­pri­ate.”

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Peer Review: Weekly biopharma job report
3
by Alex Hoffman, Kathy Wong, Kyle LaHucik

→ For­mer FDA Com­mis­sion­er Stephen Hahn has hand­ed the reins to board mem­ber Ajit Singh at Flag­ship’s ear­ly can­cer de­tec­tion biotech Har­bin­ger Health. Hahn was named CEO of Har­bin­ger in De­cem­ber 2021 and will be “CEO emer­i­tus and spe­cial ad­vi­sor,” the com­pa­ny said in a re­lease. He will stay on the board of di­rec­tors.

Dur­ing his two decades with Siemens, Singh was pres­i­dent and CEO of the dig­i­tal ra­di­ol­o­gy and med­ical in­for­mat­ics busi­ness, as well as pres­i­dent and CEO for the on­col­o­gy care sys­tems group. He then be­came CEO of BioIm­a­gene, a dig­i­tal pathol­o­gy com­pa­ny that he sold to Roche. Since 2011, Singh had been a part­ner/man­ag­ing di­rec­tor at Ar­ti­man Ven­tures.

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4
by Elizabeth Cairns

Sum­mit Ther­a­peu­tics li­censed its PD-1xVEGF bis­pe­cif­ic an­ti­body ivonescimab from the Chi­nese com­pa­ny Ake­so back in 2022. But an­a­lysts be­lieve that the US biotech needs to find an­oth­er, even big­ger part­ner to bring the can­cer drug to mar­ket.

Any list of po­ten­tial al­lies is un­like­ly to in­clude Bris­tol My­ers SquibbPfiz­er and Mer­ck, which have all al­ready paid big mon­ey for the rights to their re­spec­tive VEGF bis­pecifics. So, which com­pa­nies might buy in­to this area by snap­ping up the rights to ivonescimab?

End­points News lis­tened to sev­er­al bio­phar­ma earn­ings calls and combed through Al­phaSense tran­scripts to find some clues.

A pu­ta­tive col­lab­o­ra­tor would like­ly al­ready have a port­fo­lio of can­cer prod­ucts. One goal of a part­ner­ship would be to com­bine ivonescimab with oth­er mech­a­nisms to cre­ate even more ef­fec­tive ther­a­pies.

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5
by Lei Lei Wu

The FDA grant­ed an un­ex­pect­ed full ap­proval to Pre­ci­gen's treat­ment for a rare dis­ease caused by hu­man pa­pil­lo­mavirus, or HPV.

Thurs­day's de­ci­sion al­so came ear­li­er than an­tic­i­pat­ed, at a time when the agency’s han­dling of rare dis­ease ther­a­pies is un­der scruti­ny.

Known as zopa­po­gene imade­n­ovec, the treat­ment is an im­munother­a­py that will be mar­ket­ed as Pa­pz­imeos. The ther­a­py was ap­proved to treat adults with re­cur­rent res­pi­ra­to­ry pa­pil­lo­mato­sis, which are wart-like growths on or around the vo­cal cords that re­turn even af­ter they are re­moved. The dis­ease is caused by in­fec­tion with chron­ic HPV 6 or 11, and is es­ti­mat­ed to af­fect around 27,000 adults in the US.

A spokesper­son said the price of Pa­pz­imeos would be dis­closed dur­ing Mon­day's in­vestor call.