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Belite cuts lesion growth in Stargardt – Phase 3 hit
Belite Bio announced positive top-line results from its 104-patient Phase 3 Dragon study: oral tinlarebant met the primary endpoint by significantly slowing the growth rate of retinal lesions in...
Janux down... market overreacts to prostate T‑cell engager data
Janux Therapeutics saw a steep stock decline after releasing an updated cut of early clinical data for its masked T‑cell engager JANX007 in metastatic castration-resistant prostate cancer. The...
FDA pares monkey tests: draft guidance cuts nonclinical monkey use for some mAbs
The FDA issued draft recommendations allowing biopharma companies to reduce or omit nonhuman primate testing for certain monoclonal antibodies during development. The guidance offers pathways to...
Prasad memo rattles markets: vaccine policy debate dents developers’ stocks
A leaked FDA internal memo from CBER leadership triggered a market reaction as vaccine developers’ shares dipped after investors digested proposals that could tighten evidence requirements for...
Top FDA drug regulator Pazdur to retire — sudden exit adds agency uncertainty
Richard (Rick) Pazdur, the director of the FDA’s Center for Drug Evaluation and Research (CDER), filed paperwork to retire at month-end, marking another abrupt leadership change at the agency....
Profluent raises $106m to scale AI‑driven protein design
Profluent closed a $106 million Series B to expand its AI-driven protein design platform across therapeutics, agriculture and biomanufacturing applications. The round was co-led by Altimeter...
CDER chief Pazdur set to depart — agency leadership shaken
Richard Pazdur has filed paperwork to retire as director of the FDA’s Center for Drug Evaluation and Research (CDER) after only weeks in the role. Multiple reports indicate Pazdur notified CDER...
FDA drafts guidance to curb primate testing for some antibodies
The FDA released draft recommendations aimed at reducing or eliminating the use of nonhuman primates for certain monoclonal antibody safety testing. The agency’s plan outlines circumstances where...
Regeneron plunks down $150M on Tessera gene writing — one-and-done bets
Regeneron and Tessera Therapeutics struck a deal worth $150 million to co-develop TSRA-196, Tessera’s near-clinic in vivo gene-writing candidate for alpha-1 antitrypsin deficiency (AATD)....
Belite’s oral Stargardt drug meets Phase 3 goal — path to first approval
Belite Bio reported positive top-line results from the Phase 3 DRAGON trial: tinlarebant reduced the growth rate of retinal lesions in Stargardt disease type 1 by a clinically meaningful margin...
Protego secures $130M to push first-in-class AL amyloidosis program
Protego Biopharma closed an oversubscribed $130 million Series B to advance PROT-001, its oral candidate for AL (light-chain) amyloidosis, toward a pivotal study. The financing was led by...
Janux shares tumble after prostate T‑cell engager data update
Janux Therapeutics’ stock plunged after the company released a new early-stage data cut showing a lower-than-expected response rate for JANX007, its masked T-cell engager in metastatic...
SMA gene therapy cleared as DMD drug faces new limits — regulatory seesaw
Novartis received FDA approval to expand delivery of its SMA gene therapy (Itvisma) via an intrathecal route, widening patient eligibility and affirming gene-replacement approaches for...
U.K.-U.S. trade deal lifts NICE threshold — U.K. to pay more for medicines
The U.K. and U.S. reached a trade agreement that locks in zero tariffs on pharmaceutical exports to the U.S. for three years in exchange for pricing concessions by the U.K. government. The deal...
Generate:Biomedicines advances TSLP antibody into Phase 3 — AI‑driven program scales
Generate:Biomedicines announced it is launching two Phase 3 trials for its lead TSLP-blocking antibody, marking a major clinical inflection for a company that integrates AI into therapeutic...
Recursion names Najat Khan CEO — AI drug firm shifts toward clinic
Recursion announced a leadership transition: Najat Khan, the company’s chief R&D and commercial officer, will assume the CEO role effective January 1. The change comes as Recursion pivots from...
Regeneron backs Tessera: $150M bet on gene writing
Regeneron agreed to a multi‑million dollar collaboration with Tessera to advance a near‑clinic gene‑writing program for alpha‑1 antitrypsin deficiency (AATD). Public filings and press reports show...
Pazdur plans exit — Prasad memo fuels agency turmoil
Richard Pazdur, the FDA’s Center for Drug Evaluation and Research director, filed paperwork to retire at month‑end amid a flurry of internal controversy tied to a vaccine‑policy memo from CBER...
U.K. will pay more for meds to avoid U.S. tariffs — deal struck
The U.K. and U.S. reached a trade arrangement that removes tariffs on British pharmaceutical exports in exchange for looser U.K. drug‑pricing constraints and a higher NICE cost‑effectiveness...
Tinlarebant slows Stargardt lesions — Belite posts Phase III success
Belite Bio reported positive top‑line results from its Phase III DRAGON trial: oral tinlarebant produced a statistically significant reduction in retinal lesion growth versus placebo in Stargardt...