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Upstream Bio gains FDA alignment for pivotal verekitug trials across asthma and nasal polyps
Upstream Bio sets Phase 3 plans for quarterly verekitug in severe asthma and CRSwNP. See what FDA alignment means for the biotech’s growth strategy.
Ocugen has FDA alignment and a 2028 filing target. Now OCU410 needs to prove the Phase 2 signal was real
Ocugen starts Phase 3 testing of one-time OCU410 gene therapy for geographic atrophy after a 31% Phase 2 reduction in lesion growth.
Novartis gains another potential MS growth engine after remibrutinib beats teriflunomide in two Phase III trials
Novartis shares surge after remibrutinib wins two Phase III MS trials, opening another potential growth opportunity alongside Kesimpta.
Lifeward sales are finally growing, but it has about $11m of pro forma cash. Why change CEO and CFO now?
Lifeward has appointed Josh Hexter interim CEO and Rami Aviram CFO as stronger ReWalk and AlterG sales improve commercial momentum, even as losses and a relatively small cash position keep financing discipline central to the strategy.
TScan Therapeutics is cutting 75% of its workforce after starting Phase 3. What changed?
TScan Therapeutics has cut approximately three-quarters of its workforce, paused further enrolment in its Phase 3 ALLOHA-2 trial and removed both its chief financial officer and chief medical officer as it redirects its remaining capital toward in vivo cell therapy.
Takeda’s MIMRYLO approval unlocks $275m for Protagonist and a $1bn-plus PV bet
Takeda has secured FDA approval for MIMRYLO in adults with polycythemia vera, triggering $275 million of payments to Protagonist Therapeutics and opening a launch Takeda believes could ultimately generate $1 billion to $2 billion in peak global sales.
AVT80 joins FDA review as Alvotech and Teva target both major Entyvio delivery formats
FDA accepts Alvotech’s AVT80 filing, expanding its Entyvio biosimilar strategy across subcutaneous and intravenous treatment with Teva.
Palvella Therapeutics targets first approved microcystic lymphatic malformation therapy with QTORIN filing
Palvella Therapeutics completes its QTORIN FDA filing and prepares for a potential 2027 launch in microcystic lymphatic malformations.
Vertex just completed a $10bn acquisition. Why is Jonathan Poole becoming CFO now?
Vertex Pharmaceuticals has split the operating and finance responsibilities held by Charles Wagner as it begins integrating the $10 billion Crinetics Pharmaceuticals acquisition and targets more than $5 billion of potential peak sales from its new endocrine assets.
Why ArsenalBio is cutting 99 jobs two years after its $325m Series C
Arsenal Biosciences is eliminating 99 jobs, representing a majority of employees across functions and locations, as the well-funded biotech pivots from its autologous solid-tumor CAR-T strategy toward in vivo cell therapy for blood cancers and autoimmune disease.