Browsing Tag
United States Food and Drug Administration
162 posts
A small pancreatic cancer study just sent RenovoRx shares soaring. The biggest test is still ahead
RenovoRx shares surge after TAMP data show 51% targeted gemcitabine extraction. See why TIGeR-PaC survival results remain the key catalyst.
Zymeworks gets $250m boost after Ziihera wins major first-line cancer approval
FDA expands Ziihera into first-line HER2-positive gastroesophageal cancer, unlocking $250 million for Zymeworks. See why the approval matters.
Erasca’s $6.2bn valuation faces bigger test as ERAS-0015 heads toward three pivotal trials
ERAS-0015 wins FDA Fast Track status as Erasca deploys nearly $1bn behind three planned pivotal cancer trials after an early 57% response signal.
CAPR jumps 15% as FDA gives deramiocel three more months to rescue Duchenne approval bid
CAPR jumps as FDA extends deramiocel review to November 22, giving Capricor more time to support its Duchenne upper limb approval case.
Gossamer Bio (Nasdaq: GOSS) secures regulatory-linked funding as seralutinib NDA nears September
The financing can reach US$250 million, but only about US$25 million is scheduled at the initial closing; another US$125 million requires FDA acceptance of the NDA and US$100 million depends on approval-linked warrants.
Ultragenyx (Nasdaq: RARE) wins FDA approval for $2.7m Genglycos gene therapy
Genglycos becomes the first approved treatment for glycogen storage disease type Ia, but accelerated approval rests on reduced cornstarch use as a surrogate endpoint and requires confirmatory evidence.
Rein’s $57.5m financing buys LTI-03 time, but Phase 2 IPF data now carry the valuation
LTI-03 wins FDA Fast Track status as Rein deploys its $43.6m cash position behind a closely watched Phase 2 IPF readout due in 2026.
Amylyx (Nasdaq: AMLX) upsizes offering to $500m as avexitide advances
The biotechnology company is selling 14.09 million shares at $35.50 after avexitide cut severe hypoglycemic events by 55% in pivotal Phase 3 testing.
REGN rises 3.8% as Pasatru opens a new rare-disease franchise for Regeneron
Pasatru wins FDA approval after cutting new FOP lesions 90%, expanding Regeneron’s rare-disease portfolio as pediatric development approaches.
Ecopipam Priority Review puts Teva’s $700m Tourette bet on a Q1 2027 FDA clock
Ecopipam gets FDA Priority Review, putting Teva’s $700m Tourette acquisition on a late-Q1 2027 decision clock after positive Phase 3 data.