Cell/Gene Tx channel feed

In a snap­shot of its rare dis­ease da­ta, Ul­tragenyx boosts case for new sur­ro­gate bio­mark­er

Last year
R&D

Gene edit­ing start­up Metageno­mi fi­nal­ly sets IPO range, as pre­clin­i­cal biotech eyes $87M

Last year
Financing

4D Mol­e­c­u­lar Ther­a­peu­tic­s' gene ther­a­py cuts Eylea use in wet AMD pa­tients, biotech di­vulges plans for piv­otal stud­ies

Last year
R&D

Abec­ma sales dis­ap­point again as BC­MA com­pe­ti­tion ramps up, FDA ad­comm looms

Last year
Pharma

Kyver­na seeks $182M IPO as biotech runs mul­ti­ple au­toim­mune CAR-T tri­als

Last year
Financing

CMS de­tails pro­gram to use out­comes-based agree­ments to pay for sick­le cell gene ther­a­pies

Last year

Avro­bio makes way for GPCR biotech Tec­ton­ic Ther­a­peu­tic in re­verse merg­er

Last year
Startups
Deals

Gilead, Kite short­en Yescar­ta man­u­fac­tur­ing by two days in 'in­cre­men­tal' im­prove­ment

Last year
Manufacturing

CAR NK biotech Cata­ma­ran Bio to wind down, will seek part­ners for cell ther­a­pies

Last year
People

FDA fi­nal­izes CAR-T and gene ther­a­py guid­ance, of­fers sup­port for ac­cel­er­at­ed ap­provals

Last year
FDA+

Fractyl has the GUTS: Obe­si­ty and di­a­betes biotech charts $99M IPO

Last year
Financing

Shang­hai star­tup's gene ther­a­py re­stores hear­ing in five deaf chil­dren, run­ning ahead of Lil­ly and Re­gen­eron tri­als

Last year
R&D

Fol­low­ing CAR-T safe­ty la­bel changes, FDA of­fi­cials share new de­tails about sec­ondary can­cer cas­es

Last year
Pharma
FDA+

FDA up­dates Gilead­'s la­bel for CAR-T Tecar­tus with new boxed warn­ing for sec­ondary can­cer

Last year
Pharma
FDA+

Up­dat­ed: Gilead’s Tecar­tus dropped from list of CAR-Ts with up­dat­ed boxed warn­ings

Last year
Pharma
FDA+

Eli Lil­ly says its po­ten­tial gene ther­a­py 're­stored hear­ing' in 11-year-old boy

Last year
R&D

Up­dat­ed: FDA’s safe­ty re­view on CAR-Ts cul­mi­nates in new boxed warn­ings of sec­ondary can­cer

Last year
Pharma
FDA+

Au­to­lus eyes No­vem­ber for po­ten­tial US ap­proval of Tecar­tus ri­val

Last year
Pharma
FDA+

CAR NK ther­a­py looks durable in a small tri­al, giv­ing in­sight in­to large Take­da study

Last year
R&D

Graphite Bio co-founder de­buts Treg cell ther­a­py start­up with $75M, aims to ‘trick’ im­mune sys­tem in­to re­set­ting

Last year
Financing
Startups

Jaguar Gene Ther­a­py spins out man­u­fac­tur­ing with Deer­field, ARCH sup­port

Last year
Startups
Manufacturing

Re­genxbio touts pos­i­tive mid-stage da­ta for Ab­b­Vie-part­nered vi­sion-loss gene ther­a­py, but no de­tailed plans for piv­otal study

Last year
R&D

Kyver­na Ther­a­peu­tics files for IPO as au­toim­mune CAR-T space heats up

Last year
Financing
Startups

FDA ap­proves Ver­tex and CRISPR's Cas­gevy as first CRISPR-edit­ed ther­a­py for be­ta-tha­lassemia

Last year
FDA+
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