https://biotech-insider.com/ Biotech, pharma and life-science market news for investors. https://biotech-insider.com/ultragenyx-angelman-failure-cost-cuts/https://biotech-insider.com/ultragenyx-angelman-failure-cost-cuts/Sun, 06 Sep 2026 00:24:10 GMTA phase 3 miss in Angelman syndrome has pushed Ultragenyx into cost-cutting mode just as its newly approved drug Genglycos reaches the market. What the failure changes.Biotechnology Daily https://biotech-insider.com/gsk-hutchmed-kras-egfr-conjugate-license/https://biotech-insider.com/gsk-hutchmed-kras-egfr-conjugate-license/Sat, 05 Sep 2026 21:52:47 GMTGSK is paying $110 million upfront to license Hutchmed's KRAS-EGFR antibody conjugate, with $1.185 billion in milestones behind it — the latest Western pharma bet on Chinese oncology assets.Bio Business News https://biotech-insider.com/fda-tempo-pilot-ai-devices-reach-patients-pre-clearance/https://biotech-insider.com/fda-tempo-pilot-ai-devices-reach-patients-pre-clearance/Sat, 05 Sep 2026 20:05:43 GMTFour devices, among them generative AI tools from Cadence and Limbic, have been accepted into the FDA's TEMPO pilot, which lets digital health firms reach patients before marketing authorization is granted.Biotechnology Daily https://biotech-insider.com/superluminal-60-million-mc4r-obesity-phase-1/https://biotech-insider.com/superluminal-60-million-mc4r-obesity-phase-1/Sat, 05 Sep 2026 18:53:16 GMTSuperluminal Medicines has closed a $60 million Series B to push an MC4R-targeted obesity candidate into first-in-human testing, a field Rhythm Pharmaceuticals opened with setmelanotide.Bio Business News https://biotech-insider.com/abivax-stays-single-biotech-ma-runs-hot/https://biotech-insider.com/abivax-stays-single-biotech-ma-runs-hot/Sat, 05 Sep 2026 17:44:46 GMTBiotech dealmaking is running hot, yet France's Abivax remains independent. Valuation, the timing of obefazimod data and its own financing options all point to why the phone hasn't rung.Bio Business News https://biotech-insider.com/cityblock-116-million-digital-health-megaround-habit/https://biotech-insider.com/cityblock-116-million-digital-health-megaround-habit/Sat, 05 Sep 2026 16:41:13 GMTCityblock's $116 million August financing is the newest data point in a year-long shift: digital health dollars are pooling into a shrinking set of very large private rounds.Bio Business News https://biotech-insider.com/abbvie-etentamig-phase-3-relapsed-myeloma/https://biotech-insider.com/abbvie-etentamig-phase-3-relapsed-myeloma/Sat, 05 Sep 2026 15:27:52 GMTAbbVie's bispecific T-cell engager etentamig improved response rates and progression-free survival in relapsed/refractory multiple myeloma, the company said, pushing it toward a crowded field.Biotechnology Daily https://biotech-insider.com/novartis-pelacarsen-misses-pivotal-cardiovascular-trial/https://biotech-insider.com/novartis-pelacarsen-misses-pivotal-cardiovascular-trial/Sat, 05 Sep 2026 13:52:37 GMTNovartis said Friday its closely watched cardiovascular candidate pelacarsen failed a pivotal trial, a setback for one of the drug industry's most-anticipated late-stage readouts.Biotechnology Daily https://biotech-insider.com/novartis-lpa-drug-misses-phase-3-outcomes-test/https://biotech-insider.com/novartis-lpa-drug-misses-phase-3-outcomes-test/Sat, 05 Sep 2026 13:22:37 GMTThe first phase 3 outcomes readout for any lipoprotein(a) therapy came up short, leaving Novartis, partner Ionis and every rival in the class with a harder question to answer.Biotechnology Daily https://biotech-insider.com/adarx-files-ipo-three-drugs-clinic-abbvie/https://biotech-insider.com/adarx-files-ipo-three-drugs-clinic-abbvie/Sat, 05 Sep 2026 12:49:24 GMTSan Diego RNAi developer ADARx Pharmaceuticals, partnered with AbbVie, filed paperwork with the SEC on Friday night to list its shares, carrying three clinical-stage drugs into a reopening biotech IPO market.Bio Business News https://biotech-insider.com/revolution-medicines-rasonque-approval-stock-shrugs/https://biotech-insider.com/revolution-medicines-rasonque-approval-stock-shrugs/Sat, 05 Sep 2026 00:30:42 GMTRevolution Medicines cleared the FDA with RASONQUE in pancreatic cancer, yet RVMD closed at 210.02, down 0.40%. The approval was priced in; the spending line is now the story.Market Watch https://biotech-insider.com/menarini-gan-lee-glp1-europe-deal/https://biotech-insider.com/menarini-gan-lee-glp1-europe-deal/Fri, 04 Sep 2026 21:52:08 GMTMenarini will pay Gan & Lee €62 million up front in a deal valued at up to $771 million to register and sell the GLP-1 bofanglutide across Europe, adding another Chinese-origin asset to the region's obesity race.Bio Business News https://biotech-insider.com/abbvie-pfizer-2026-buy-debate-sharpens/https://biotech-insider.com/abbvie-pfizer-2026-buy-debate-sharpens/Fri, 04 Sep 2026 20:01:17 GMTAbbVie fell 1.71% and Pfizer 1.32% in Friday trading as the two large-cap drugmakers were set against each other for 2026, with AbbVie's immunology pivot the pivotal fact.Market Watch https://biotech-insider.com/gilead-rising-dividend-one-hiv-blockbuster/https://biotech-insider.com/gilead-rising-dividend-one-hiv-blockbuster/Fri, 04 Sep 2026 18:52:41 GMTGilead's quarterly dividend keeps climbing on HIV cash flow, but the payout leans on one blockbuster with a patent clock already running. What income investors should track.Market Watch https://biotech-insider.com/neushen-series-b-80-million-brain-health-drugs/https://biotech-insider.com/neushen-series-b-80-million-brain-health-drugs/Fri, 04 Sep 2026 17:41:58 GMTNeuShen Therapeutics has closed a Series B of more than $80 million to push three clinical-stage neuroscience candidates forward, in a cross-border financing split between Shanghai and Boston.Bio Business News https://biotech-insider.com/ionis-alexander-disease-approval-shares-add/https://biotech-insider.com/ionis-alexander-disease-approval-shares-add/Fri, 04 Sep 2026 16:32:00 GMTIonis has won approval for a treatment for Alexander disease, a rare inherited brain disorder with no prior approved therapy, anchoring the company's rare-disease pipeline as IONS rose 1.24%.Biotechnology Daily https://biotech-insider.com/zilganersen-approval-ionis-neurology-franchise/https://biotech-insider.com/zilganersen-approval-ionis-neurology-franchise/Fri, 04 Sep 2026 15:21:06 GMTThe FDA cleared Ionis Pharmaceuticals' zilganersen for Alexander disease, an ultra-rare childhood neurodegenerative disorder — and the first neurology drug Ionis owns outright.Biotechnology Daily https://biotech-insider.com/pfizer-6-percent-yield-stock-slides/https://biotech-insider.com/pfizer-6-percent-yield-stock-slides/Fri, 04 Sep 2026 13:51:18 GMTPfizer's dividend yield has climbed toward 6% for the worst possible reason — a falling share price. With the CEO pledging to defend the payout, the question is what covers it.Market Watch https://biotech-insider.com/tempus-ai-personalis-cancer-vaccine-picks-shovels/https://biotech-insider.com/tempus-ai-personalis-cancer-vaccine-picks-shovels/Fri, 04 Sep 2026 13:21:12 GMTTempus AI is positioning to supply the testing layer beneath Moderna and Merck's personalized cancer vaccine push, with Personalis central to the wager. Where the money could land.Bio Business News https://biotech-insider.com/iba-h1-2026-profit-proton-therapy-ebit-guidance/https://biotech-insider.com/iba-h1-2026-profit-proton-therapy-ebit-guidance/Fri, 04 Sep 2026 12:46:45 GMTIon Beam Applications booked a EUR9.3 million first-half net result as Proton Therapy returned to sustainable profitability, and held its full-year adjusted EBIT floor at EUR32 million.Market Watch https://biotech-insider.com/pig-kidney-recipients-bridge-human-transplants/https://biotech-insider.com/pig-kidney-recipients-bridge-human-transplants/Fri, 04 Sep 2026 00:22:11 GMTTwo gene-edited pig kidney recipients have gone on to receive human organs, turning xenotransplantation into a bridge therapy rather than a final destination.Biotechnology Daily https://biotech-insider.com/humana-non-renewal-letters-december-31-deadline/https://biotech-insider.com/humana-non-renewal-letters-december-31-deadline/Thu, 03 Sep 2026 21:54:04 GMTHumana's Medicare Advantage non-renewal notices are in the mail. Members whose plans end December 31 and who take no action land in Original Medicare on January 1 with no drug plan.World News https://biotech-insider.com/merck-dealmaking-pace-keytruda-patent-cliff/https://biotech-insider.com/merck-dealmaking-pace-keytruda-patent-cliff/Thu, 03 Sep 2026 20:02:28 GMTRobert Davis says Merck has been striking deals "with urgency" ahead of Keytruda's loss of exclusivity — and more are coming. What that means for the pipeline and the stock.Bio Business News https://biotech-insider.com/summit-therapeutics-leaps-keytruda-head-to-head/https://biotech-insider.com/summit-therapeutics-leaps-keytruda-head-to-head/Thu, 03 Sep 2026 18:52:19 GMTSummit Therapeutics shares jumped 17.33% Thursday after its experimental cancer drug beat Merck's Keytruda in a head-to-head comparison. Merck stock barely moved.Market Watch https://biotech-insider.com/novartis-licenses-alteogen-alt-b4-cellares-cuts/https://biotech-insider.com/novartis-licenses-alteogen-alt-b4-cellares-cuts/Thu, 03 Sep 2026 17:43:21 GMTNovartis is licensing Alteogen's hyaluronidase enzyme ALT-B4, a step into subcutaneous drug delivery, while Cellares trims staff again in cell therapy manufacturing.Bio Business News https://biotech-insider.com/pfizer-shelved-seagen-adc-medicus-pharma/https://biotech-insider.com/pfizer-shelved-seagen-adc-medicus-pharma/Thu, 03 Sep 2026 16:32:45 GMTPfizer has offloaded an antibody-drug conjugate from its $43 billion Seagen purchase to Medicus Pharma in a deal worth up to more than $1 billion. MDCX fell 34.47% intraday.Bio Business News https://biotech-insider.com/abbvie-etentamig-myeloma-progression-risk-phase-3/https://biotech-insider.com/abbvie-etentamig-myeloma-progression-risk-phase-3/Thu, 03 Sep 2026 15:30:38 GMTA 60% reduction in progression or death puts AbbVie's etentamig into the middle of the myeloma T-cell engager race — and into a pipeline still being rebuilt after Humira.Biotechnology Daily https://biotech-insider.com/ivonescimab-clears-survival-bar-china-phase-3-lung-trial/https://biotech-insider.com/ivonescimab-clears-survival-bar-china-phase-3-lung-trial/Thu, 03 Sep 2026 13:24:52 GMTAkeso says updated China-only Phase 3 data show ivonescimab clearing the overall survival bar in lung cancer, a year after an interim readout knocked investor confidence in the PD-1xVEGF bispecific.Biotechnology Daily https://biotech-insider.com/ai-in-drug-discovery-market-projected-to-reach-8-52-billion-by-2030-302868297/https://biotech-insider.com/ai-in-drug-discovery-market-projected-to-reach-8-52-billion-by-2030-302868297/Thu, 03 Sep 2026 12:55:00 GMTArizton projects the global AI in drug discovery market will reach $8.52 billion by 2030 from approximately $1.71 billion in 2024, a compound annual growth rate of about 30.58%, with MindWalk Holdings Corp. reporting fiscal 2026 revenue up 46% to C$15.6 million and launching ReefIQ™ as its biological context layer on June 10, 2026.Market Watch https://biotech-insider.com/danske-denmark-growth-novo-nordisk-pharma-exports/https://biotech-insider.com/danske-denmark-growth-novo-nordisk-pharma-exports/Thu, 03 Sep 2026 12:47:52 GMTDenmark's biggest bank expects pharmaceutical exports led by Novo Nordisk to push GDP growth to a five-year high, with the expansion running into 2027 — and a single company carrying it.World News https://biotech-insider.com/teva-celiac-antibody-gluten-challenge-topline/https://biotech-insider.com/teva-celiac-antibody-gluten-challenge-topline/Thu, 03 Sep 2026 00:22:13 GMTTeva reported topline data showing one injection of an experimental antibody significantly cut intestinal damage in celiac patients eating gluten daily. Shares closed up 3.59%.Biotechnology Daily https://biotech-insider.com/ultragenyx-angelman-therapy-fails-phase-3/https://biotech-insider.com/ultragenyx-angelman-therapy-fails-phase-3/Wed, 02 Sep 2026 21:51:56 GMTUltragenyx's experimental Angelman syndrome therapy missed against sham control in Phase 3, removing a late-stage asset from one of rare disease's busiest pipelines.Biotechnology Daily https://biotech-insider.com/uniqure-files-huntingtons-approval-shares-slip/https://biotech-insider.com/uniqure-files-huntingtons-approval-shares-slip/Wed, 02 Sep 2026 20:05:24 GMTuniQure's Huntington's gene therapy cleared a key regulatory checkpoint with the FDA, yet QURE shares fell 3.41% on Wednesday to 46.23 while the broad market rose.Market Watch https://biotech-insider.com/novartis-130-basel-job-cuts-biologics-rethink/https://biotech-insider.com/novartis-130-basel-job-cuts-biologics-rethink/Wed, 02 Sep 2026 18:52:08 GMTNovartis has told staff that around 130 roles in Basel are at risk as it reshapes biologics technical development and production, with the shares little changed at 161.54 in Wednesday trade.Bio Business News https://biotech-insider.com/fda-official-overrode-reviewers-replimune-tudriqev/https://biotech-insider.com/fda-official-overrode-reviewers-replimune-tudriqev/Wed, 02 Sep 2026 17:45:17 GMTNewly released FDA documents show CBER clinical evaluation director Asha Das overruled the agency's review team to grant Replimune's melanoma drug Tudriqev accelerated approval.Biotechnology Daily https://biotech-insider.com/novartis-alteogen-3-22-billion-subcutaneous-drug-deal/https://biotech-insider.com/novartis-alteogen-3-22-billion-subcutaneous-drug-deal/Wed, 02 Sep 2026 16:30:49 GMTNovartis has struck a $3.22 billion agreement with Alteogen for platform technology that converts IV biologics into under-the-skin injections, with payouts hinging on milestones across multiple products.Bio Business News https://biotech-insider.com/mhra-halts-tavneos-sales-uniqure-huntingtons-filing/https://biotech-insider.com/mhra-halts-tavneos-sales-uniqure-huntingtons-filing/Wed, 02 Sep 2026 15:22:54 GMTBritain's MHRA has suspended sales of Tavneos after the EMA acted first, while UniQure moves its Huntington's gene therapy into the regulatory queue. QURE fell 2.97%.Biotechnology Daily https://biotech-insider.com/boehringer-owkin-ai-oncology-immunology-deal/https://biotech-insider.com/boehringer-owkin-ai-oncology-immunology-deal/Wed, 02 Sep 2026 13:29:47 GMTGermany's Boehringer Ingelheim will apply Owkin's AI model to cancer and immunology drug discovery, becoming the third large drugmaker to sign with the French startup after AstraZeneca and Sanofi.Bio Business News https://biotech-insider.com/vertex-names-jonathan-poole-cfo-wagner-coo/https://biotech-insider.com/vertex-names-jonathan-poole-cfo-wagner-coo/Wed, 02 Sep 2026 12:54:36 GMTVertex Pharmaceuticals will hand the CFO job to Jonathan Poole in January 2027 while Charles Wagner Jr. takes on a chief operating officer role, splitting finance from operations at the cystic fibrosis leader.Bio Business News https://biotech-insider.com/oral-wegovy-germany-novo-gf-value-discount/https://biotech-insider.com/oral-wegovy-germany-novo-gf-value-discount/Wed, 02 Sep 2026 00:23:09 GMTNovo Nordisk has made Germany the first EU market for the Wegovy pill, arriving with the shares near 58% below GF Value and Eli Lilly widening its own oral push.Market Watch https://biotech-insider.com/house-stopgap-bill-halts-white-house-research-grants/https://biotech-insider.com/house-stopgap-bill-halts-white-house-research-grants/Tue, 01 Sep 2026 21:53:47 GMTHouse lawmakers passed a short-term funding bill carrying language that suspends a White House plan to hand political appointees more authority over federal research grants.World News https://biotech-insider.com/gemini-zocdoc-booking-ai-healthcare-front-door/https://biotech-insider.com/gemini-zocdoc-booking-ai-healthcare-front-door/Tue, 01 Sep 2026 20:03:10 GMTGoogle's Gemini can now book appointments through Zocdoc, and Solv has tied up with Amazon. For digital health firms, the booking screen is moving inside someone else's assistant.Bio Business News https://biotech-insider.com/nine-drugmakers-trump-pricing-deals/https://biotech-insider.com/nine-drugmakers-trump-pricing-deals/Tue, 01 Sep 2026 18:52:07 GMTTrump's drug pricing push widened Monday with nine new voluntary agreements — the first to reach companies outside the group he named in letters last summer.World News https://biotech-insider.com/unitedhealth-rises-prior-authorization-drops-30-percent-services/https://biotech-insider.com/unitedhealth-rises-prior-authorization-drops-30-percent-services/Tue, 01 Sep 2026 17:41:11 GMTUnitedHealthcare will start dropping prior-authorization rules on October 1 for cardiology, lab testing, therapy and some musculoskeletal care — a targeted 30% of services. UNH rose 1.48%.Market Watch https://biotech-insider.com/merck-ranks-7-analyst-pick-dow-blue-chips-slip/https://biotech-insider.com/merck-ranks-7-analyst-pick-dow-blue-chips-slip/Tue, 01 Sep 2026 16:32:55 GMTA tally of major brokerage ratings puts Merck seventh among the Dow's 30 members and above the S&P 500 median. MRK rose 0.74% on a day the Dow 30 ETF fell 0.73%.Market Watch https://biotech-insider.com/a-wave-of-weight-loss-drugs-is-quietly-creating-a-multi-billion-dollar-opportunity-that-aesthetic-medicine-is-racing-to-/https://biotech-insider.com/a-wave-of-weight-loss-drugs-is-quietly-creating-a-multi-billion-dollar-opportunity-that-aesthetic-medicine-is-racing-to-/Tue, 01 Sep 2026 15:37:00 GMTConexeu Sciences Inc. (NASDAQ: CNXU), a preclinical regenerative-tissue company, is developing collagen-based scaffold technology for medical aesthetics applications including facial rejuvenation and body restoration, positioned to capture demand from patients undergoing GLP-1 weight-loss drug treatments who seek aesthetic follow-up procedures.Market Watch https://biotech-insider.com/gsk-mrna-flu-vaccine-phase-3-new-formulation/https://biotech-insider.com/gsk-mrna-flu-vaccine-phase-3-new-formulation/Tue, 01 Sep 2026 15:21:53 GMTGSK is taking its mRNA seasonal flu vaccine into late-stage testing with a reformulated candidate after Phase 2 data showed stronger immune responses than conventional shots.Biotechnology Daily https://biotech-insider.com/alumis-lupus-trial-miss-tyk2-phase-3/https://biotech-insider.com/alumis-lupus-trial-miss-tyk2-phase-3/Tue, 01 Sep 2026 13:51:24 GMTAlumis' phase 2b lupus study of envudeucitinib failed its primary and secondary endpoints, but the biotech is taking the TYK2 inhibitor to phase 3 anyway. Shares fell 53.74%.Market Watch https://biotech-insider.com/fda-clears-stryker-surgical-cockpit-apple-vision-pro/https://biotech-insider.com/fda-clears-stryker-surgical-cockpit-apple-vision-pro/Tue, 01 Sep 2026 13:21:59 GMTStryker has won FDA clearance for a "surgical cockpit" that runs on Apple's Vision Pro headset, giving the device its most consequential medical role yet in the operating room.Biotechnology Daily https://biotech-insider.com/novartis-rhapsido-clears-two-ms-trials-relapse-rates/https://biotech-insider.com/novartis-rhapsido-clears-two-ms-trials-relapse-rates/Tue, 01 Sep 2026 12:50:40 GMTNovartis' Rhapsido, an approved chronic itch pill, hit its mark in two identical Phase 3 multiple sclerosis trials, cutting annualized relapse rates with a safety profile that looks cleaner than rival BTK drugs.Biotechnology Daily