Pharma and biotech news, week of Sep 28 – Oct 4, 2026

Eli Lilly announced that the U.S. FDA has approved an expanded indication for Jaypirca (pirtobrutinib) as a first-line treatment for adults with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma without a 17p deletion. The approval was based on Phase 3 BRUIN CLL-313 trial data showing significantly improved progression-free survival compared to chemoimmunotherapy. Jaypirca is already approved for relapsed or refractory CLL/SLL and mantle cell lymphoma.AI summary

The U.S. FDA has approved AbbVie's JUVMO (tavapadon) as the first selective D1/D5 receptor agonist for adults with Parkinson's disease. Approval was supported by Phase 3 TEMPO program data demonstrating significant improvements in daily functioning and increased on-time without troublesome dyskinesia. AbbVie expects to make JUVMO available to U.S. patients in October 2026.AI summary

The FDA approved a supplemental new drug application from Bristol-Myers Squibb Company for Camzyos (mavacamten) capsules. The supplement extends the indication to pediatric patients weighing 30 kg or more with obstructive hypertrophic cardiomyopathy, adds a 1 mg capsule strength, updates US labeling with study results, and modifies the REMS. PDUFA goal date: 2026-09-30.AI summary

The FDA approved a new drug application from Rare Thyroid Therapeutics International AB for Emcitate (tiratricol) tablets. The approval provides for treating peripheral thyrotoxicosis in adult and pediatric patients with monocarboxylate transporter 8 (MCT8) deficiency. PDUFA goal date: 2026-09-28.AI summary

Vaxcyte announced it will host a webcast and conference call on October 5, 2026, to present topline data from the OPUS-1 trial. OPUS-1 is a pivotal adult Phase 3 trial evaluating the safety, tolerability, and immunogenicity of VAX-31. VAX-31 is a 31-valent pneumococcal conjugate vaccine candidate designed to prevent invasive pneumococcal disease and pneumococcal pneumonia.AI summary

Cullinan Therapeutics initiated a New Drug Application submission to the U.S. FDA for zipalertinib in combination with chemotherapy for first-line EGFR exon 20 insertion mutation NSCLC under the Real-Time Oncology Review program. The submission is based on Phase 3 REZILIENT3 trial data. Cullinan expects to complete the submission by year-end 2026.AI summary

Atara Biotherapeutics announced that its partner, Pierre Fabre Pharmaceuticals, has resubmitted the Biologics License Application (BLA) for tabelecleucel to the FDA. The resubmission follows a Type A meeting and includes updated data with additional patients and longer follow-up. Upon potential FDA approval, Atara is eligible to receive a $31 million milestone payment.AI summary

Replimune Group announced that TUDRIQEV (vusolimogene oderparepvec-wtpg) is now commercially available in the United States. The therapy is indicated in combination with nivolumab for adults with unresectable advanced cutaneous melanoma following disease progression on a PD-1-blocking regimen. Healthcare providers can now order TUDRIQEV for next-day delivery.AI summary

The European Medicines Agency has validated PolyPid's Marketing Authorization Application for D-PLEX₁₀₀, initiating formal review for the prevention of post-abdominal surgery incisional infections. The submission is backed by Phase 3 trial data showing a 60% relative risk reduction in surgical site infections. Concurrently, the drug is under FDA Priority Review with a PDUFA date of November 28, 2026.AI summary

Outlook Therapeutics has submitted an application to CMS for a permanent, product-specific HCPCS Level II J-code for LYTENAVA (bevacizumab-vikg). The submission aims to establish a consistent reimbursement pathway and streamline billing for U.S. retina practices. Outlook Therapeutics remains on track for the U.S. commercial launch of LYTENAVA before the end of 2026.AI summary

The Centers for Medicare & Medicaid Services has granted Transitional Pass-Through payment status and assigned a permanent HCPCS code for Lantheus' PYLARIFY TruVu, effective October 1, 2026. The designation provides separate reimbursement for the PSMA-targeted PET imaging agent in hospital outpatient settings. Lantheus plans to introduce PYLARIFY TruVu through a phased geographic commercial rollout.AI summary

Celcuity announced that REVTORPYK (gedatolisib) is now commercially available in the United States for eligible patients with HR+/HER2- advanced breast cancer without a PIK3CA mutation. The therapy was previously approved by the FDA in July 2026 for use in combination with fulvestrant, with or without palbociclib. Celcuity has also submitted a supplemental New Drug Application to expand approval to PIK3CA-mutated patients.AI summary

Unicycive Therapeutics has resubmitted its New Drug Application for oxylanthanum carbonate (OLC) to treat hyperphosphatemia in patients with chronic kidney disease on dialysis. The resubmission includes CMC data from a new drug product manufacturing vendor. The company expects FDA acceptance within 30 days and a new PDUFA date assigned six months from resubmission.AI summary

Aldeyra Therapeutics announced its intent to submit a Formal Dispute Resolution Request to the FDA for reproxalap to treat dry eye disease. The submission appeals a March 16, 2026 Complete Response Letter that denied approval of the drug's New Drug Application. Aldeyra expects to submit the request and hold a meeting with the FDA's Office of New Drugs in the fourth quarter of 2026.AI summary

Mineralys Therapeutics announced that new data for lorundrostat from the Launch-HTN trial will be presented at ASN Kidney Week 2026. The oral presentation will highlight blood pressure and albuminuria reduction with lorundrostat in participants with chronic kidney disease stages 1 to 3. The presentation is scheduled for October 21-25 in Denver, Colorado.AI summary

Eli Lilly announced results from post-hoc analyses of the Phase 3 ATTAIN-1 trial evaluating Foundayo (orforglipron) in adults with obesity or overweight without diabetes. At 72 weeks, Foundayo 17.2 mg was associated with an estimated 57% reduction in predicted 10-year type 2 diabetes risk and an 18% reduction in cardiovascular disease risk compared to placebo.AI summary

AbbVie announced late-breaking Phase 3 data from its Viti-Up-1 and Viti-Up-2 studies evaluating RINVOQ in non-segmental vitiligo. Patients continuing RINVOQ 15 mg once daily showed continued facial and total body repigmentation through 76 weeks, with no new safety signals reported. A phototherapy substudy also showed numerically higher repigmentation responses with RINVOQ combined with NB-UVB phototherapy compared to RINVOQ monotherapy.AI summary

Eli Lilly announced Phase 3 ACHIEVE-4 trial results evaluating oral Foundayo (orforglipron) against insulin glargine in adults with type 2 diabetes. Foundayo met its primary endpoint for MACE-4 non-inferiority while demonstrating a 16% lower risk, alongside sustained A1C reduction and weight loss. Lilly is also evaluating the medicine in the ongoing ATTAIN-OUTCOMES Phase 3 study.AI summary

Kailera Therapeutics announced the completion of enrollment in its KaiNETIC global Phase 3 clinical program. The program encompasses three trials evaluating ribupatide injection for the treatment of people living with obesity or overweight. Topline data from KaiNETIC-1, KaiNETIC-2, and KaiNETIC-3 are now expected in mid-2028.AI summary

Vor Bio presented post hoc analysis data from a Phase 3 trial of telitacicept in adults with generalized myasthenia gravis (gMG). Over 94% of participants achieved a ≥5-point MG-ADL improvement at Week 48, with 42% achieving minimal symptom expression. Vor Bio is advancing telitacicept in global Phase 3 trials in gMG and Sjögren's disease.AI summary

Eli Lilly announced detailed Phase 3 TRIUMPH-2 results showing retatrutide delivered substantial weight loss and A1C reductions in adults with type 2 diabetes and obesity or overweight. At 80 weeks, participants taking the 12 mg dose lost an average of 20.8% of their body weight and reduced A1C by an average of 1.5%. Lilly plans to submit a Biologics License Application to the U.S. FDA in Q1 2027.AI summary

Kodiak Sciences announced that primary endpoints were met for Zenkuda and tabirafusp-ted in the Phase 3 DAYBREAK study in wet age-related macular degeneration. Both drugs achieved non-inferiority in vision gains compared to aflibercept at year one, with 54% of Zenkuda patients achieving 6-month durability. Kodiak plans to submit a BLA for Zenkuda in the fourth quarter of 2026.AI summary

Lantheus announced the first patient has been dosed in the SPARROW Phase 2/3 registrational trial for LNTH-2401. The open-label, multicenter study evaluates the investigational gallium-68-labeled PET imaging agent in prostate cancer. The trial includes an initial dose optimization phase, followed by a Phase 3 diagnostic performance period expected to enroll approximately 400 participants.AI summary

Biogen announced 52-week results from the Phase 2 part of its ongoing AMETHYST Phase 2/3 study evaluating litifilimab in cutaneous lupus erythematosus. By Week 52, 27.2% of participants receiving litifilimab achieved clear or almost clear skin. Results from the Phase 3 part of the study are expected in the first half of 2027.AI summary

Verastem Oncology announced new molecular profiling and external control arm analyses from the Phase 2 RAMP 201 trial evaluating avutometinib plus defactinib in recurrent low-grade serous ovarian cancer. In KRAS wild-type triple wild-type patients, the combination showed an 18% confirmed objective response rate and a median progression-free survival of 13 months. External control analyses demonstrated statistically significant progression-free survival improvements versus conventional care.AI summary

Regeneron announced new results from the Phase 2 COURAGE trial evaluating trevogrumab in combination with semaglutide to prevent muscle loss during weight loss in people with obesity. Lower-dose trevogrumab preserved lean mass at 26 and 52 weeks and preserved up to 71.8% of thigh muscle volume. Regeneron plans to initiate a Phase 2 trial in older adults with obesity and decreased muscle mass or strength.AI summary

Merck presented Phase 2b trial results showing tulisokibart met its primary endpoint in patients with moderate to severe hidradenitis suppurativa. High-dose and medium-dose regimens achieved 72% and 64% HiSCR50 response rates at week 16, respectively, outperforming placebo at 35%. Safety was comparable to placebo, and Merck plans to advance the drug to Phase 3.AI summary

AbbVie presented primary Phase 2 APEX Part B results for zumilokibart in moderate to severe atopic dermatitis at EADV 2026. All three dose regimens met the primary endpoint of significantly greater EASI-75 response rates compared to placebo at Week 16. AbbVie plans to advance the mid-dose regimen into Phase 3 development.AI summary

Eli Lilly announced positive results from a Phase 2b trial evaluating EloraTZP, a combination of eloralintide and tirzepatide, in adults with obesity or overweight and type 2 diabetes. At 48 weeks, participants taking EloraTZP lost up to 23.3% of their body weight and lowered A1C by up to 2.9%. Based on these results, Lilly plans to initiate Phase 3 studies of an EloraTZP co-formulation by the end of 2026.AI summary

Verastem Oncology announced the publication of two-year follow-up data from the Phase 2 RAMP 201 study in Gynecologic Oncology. The combination of AVMAPKI and FAKZYNJA demonstrated a median duration of response of 31.1 months and median progression-free survival of 12.9 months across patients with recurrent low-grade serous ovarian cancer. Verastem is currently conducting the Phase 3 RAMP 301 confirmatory trial.AI summary

Genmab announced Phase 1/2 RAINFOL-01 trial results evaluating rinatabart sesutecan (Rina-S) in patients with platinum-resistant ovarian cancer. The drug achieved a confirmed objective response rate of 45.9% and a median duration of response of 12.1 months. The findings inform Genmab's ongoing Phase 3 program for Rina-S.AI summary

Lexeo Therapeutics announced that an abstract on its gene therapy candidate LX2006 will be featured in an oral presentation at MDS 2026. The presentation will highlight previously reported data alongside new mFARS subscore analyses from Phase 1 and 2 studies in Friedreich ataxia. LX2006 is also currently being evaluated in the Phase 2 registrational SUNRISE-FA 2 trial.AI summary

Regeneron announced first Phase 1/2 results for ubamatamab in advanced low-grade serous ovarian cancer. In 11 patients treated with the highest 800 mg dose, ubamatamab demonstrated a 73% objective response rate and an 11-month median progression-free survival. Regeneron is enrolling a single-arm, potentially registrational LGSOC cohort and plans to initiate a confirmatory Phase 3 trial.AI summary

Dyne Therapeutics announced additional one-year clinical data from the Phase 1/2 ACHIEVE trial evaluating z-basivarsen in myotonic dystrophy type 1. A pooled dose group demonstrated functional improvements across multiple measures, including myotonia, strength, and patient-reported outcomes compared to baseline, placebo, and a natural history cohort. Dyne expects topline data from the registrational expansion cohort in Q1 2027 to support a potential U.S. Accelerated Approval submission in Q3 2027.AI summary

Arrowhead Pharmaceuticals announced it will host an R&D webinar on October 14, 2026, to discuss its central nervous system pipeline. The event will feature interim clinical data from the Phase 1/2a study of investigational therapy ARO-MAPT for Alzheimer's disease and other tauopathies. Presentations will include details on the proprietary TRiM CNS delivery platform and study results.AI summary

Arvinas has dosed the first patient in its Phase 1/2 clinical trial of ARV-6723, an oral HPK1 PROTAC degrader for advanced solid tumors. The trial will evaluate the drug's safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity as a monotherapy and with pembrolizumab. Initial monotherapy cohorts are enrolling adults who previously received an immune checkpoint inhibitor.AI summary

Life Biosciences announced it will present initial interim data from its Phase 1 clinical trial of ER-100 in patients with glaucoma. The presentation will take place during an oral session at Eyecelerator @ AAO 2026 on October 8, 2026. The trial is evaluating the safety, tolerability, and visual function impact of ER-100 in patients with optic neuropathies.AI summary

Roswell Park Comprehensive Cancer Center and Generate Biomedicines have dosed the first patient in a Phase 1 clinical trial evaluating GB-5267 for ovarian cancer. GB-5267 is an autologous IL-18 armored CAR T-cell therapy targeting MUC16. The trial will evaluate the drug's safety and tolerability in patients whose disease recurred or failed to respond to platinum-based chemotherapy.AI summary

Arvinas announced that novel biomarker and oculomotor data from a Phase 1 clinical trial of ARV-102 in participants with Parkinson’s disease will be presented at the 2026 MDS Congress. ARV-102 is an investigational, orally bioavailable PROTAC degrader designed to target LRRK2. The presentations are scheduled as late-breaking oral and poster sessions on October 7, 2026.AI summary

Monte Rosa Therapeutics reported positive results from the GFORCE-1 Phase 1 trial evaluating MRT-8102 in 108 obese subjects at elevated cardiovascular disease risk. The drug demonstrated robust NEK7 degradation, reduced ASCVD drivers to normal physiological levels, and was safe and well tolerated. The company plans to initiate multiple Phase 2 trials across coronary artery disease, gout, and hidradenitis suppurativa.AI summary

Kailera Therapeutics presented Phase 1 data at EASD 2026 showing that ribupatide injection maintains similar plasma drug exposure across upper arm, thigh, and abdominal injection sites. Partner Hengrui Pharma also presented Phase 1 data where tri-agonist HRS-4729 achieved up to 16.0% mean weight loss at Week 12. Kailera plans to initiate a Phase 1 trial for KAI-4729 outside China in 2026.AI summary

AbbVie presented detailed Phase 1 MAD data for its investigational long-acting amylin analog, ABBV-295, at EASD 2026. The therapy showed meaningful body weight reductions ranging from -7.8% to -9.8% across various dosing schedules alongside favorable tolerability. The findings support advancing ABBV-295 into Phase 2 development for chronic weight management.AI summary

Tectonic Therapeutic announced favorable topline Phase 1a results for TX2100 in healthy volunteers, demonstrating single ascending doses were generally safe and well-tolerated. The FDA cleared the IND application and granted Fast Track designation for TX2100 in HHT. Tectonic plans to initiate a Phase 1b trial by year-end 2026 and a Phase 2 trial in early 2027.AI summary

Attovia Therapeutics announced it will present new clinical, translational, and preclinical data for ATTO-1310 and ATTO-2306 at upcoming medical conferences. The presentations include Phase 1a healthy volunteer data, Phase 1b interim results in high-itch atopic dermatitis or chronic pruritus for ATTO-1310, and preclinical characterization data for ATTO-2306. Post-congress presentations will be available on Attovia's website.AI summary

Adicet Bio reported positive Phase 1 data for prula-cel in patients with systemic lupus erythematosus with or without lupus nephritis. At 12 months, 54% of evaluable patients achieved DORIS remission and 50% achieved a complete renal response, while all discontinued immunosuppressants. Adicet plans to initiate start-up activities for a pivotal lupus nephritis study in the fourth quarter of 2026.AI summary

Vera Therapeutics announced that the final efficacy analysis of the ORIGIN 3 trial of TRUTAKNA (atacicept-vymj) in IgA nephropathy will be presented at ASN Kidney Week 2026. The presentation will feature as a late-breaking oral session during the opening plenary. Additionally, interim results from the PIONEER trial will be presented.AI summary

Mineralys Therapeutics announced that five abstracts featuring data on lorundrostat will be presented at the American Heart Association Hypertension Scientific Sessions 2026. The presentations include findings from the Phase 2 Explore-OSA trial and the global Phase 3 Launch-HTN trial. Nonclinical data and analyses of spironolactone and mineralocorticoid receptor antagonist utilization will also be presented.AI summary

AbbVie announced it will present 60 abstracts showcasing data from its dermatology portfolio at the 2026 EADV Congress. The presentations cover approved therapies SKYRIZI and RINVOQ alongside investigational compounds lutikizumab and zumilokibart across multiple immune-mediated skin diseases. Key data include late-breaking Phase 2 results for zumilokibart in atopic dermatitis and Phase 3 upadacitinib data in non-segmental vitiligo and alopecia areata.AI summary

Sarepta Therapeutics presented new data demonstrating durable, clinically meaningful functional benefits of ELEVIDYS (delandistrogene moxeparvovec) in older ambulatory Duchenne muscular dystrophy patients aged 8–12 compared to external controls. Analysis of children aged 2 to under 3 showed robust micro-dystrophin expression at 12 weeks. Investigators will continue following patients to assess long-term functional outcomes.AI summary

Neurocrine Biosciences announced it will present research on Prader-Willi syndrome and VYKAT XR at the FPWR 2026 Annual Research Symposium & Family Conference from October 7-10. Presentations will highlight real-world and clinical evidence, including data from the PWS-VISTA and BRAVE-PWS observational studies, long-term efficacy, and adverse event profiles.AI summary

Eli Lilly presented results from an indirect treatment comparison showing that Zepbound 10 mg and 15 mg delivered greater weight loss than Wegovy HD in adults with obesity. Using the treatment-regimen estimand at 72 weeks, Zepbound 15 mg and 10 mg demonstrated 4.5% and 3.2% greater weight loss, respectively. The data offers additional comparative evidence for physicians making treatment decisions.AI summary

Eli Lilly announced results from a new indirect treatment comparison evaluating Foundayo (orforglipron) 17.2 mg against oral semaglutide 25 mg in adults with type 2 diabetes. At 52 weeks, Foundayo demonstrated 1.5% greater weight loss and a 0.3% greater A1C reduction. Orforglipron continues to be studied across multiple conditions, including type 2 diabetes.AI summary

argenx presented new data for VYVGART, empasiprubart, and adimanebart across its neuromuscular portfolio at the AANEM and MGFA meetings. The presentations highlighted sustained efficacy and safety for VYVGART in myasthenia gravis and chronic inflammatory demyelinating polyneuropathy, alongside positive pipeline results. The company continues to advance these programs across multiple rare neuromuscular indications.AI summary

Achieve Life Sciences will present 52-week efficacy data for cytisinicline in cigarette smoking and e-cigarette cessation at CHEST 2026 on October 20, 2026. The open-label ORCA-OL study enrolled 475 adults from ORCA-2, ORCA-3 or ORCA-V1 who were actively smoking cigarettes and/or vaping daily; they received cytisinicline 3 mg three times daily for 52 weeks with behavioral support.AI summary

Merck and SciBrunch Therapeutics have entered into an exclusive global license agreement for SPR2015, an investigational preclinical oral KRAS G12D (ON) inhibitor. Under the agreement, SciBrunch receives an upfront payment of $400 million and is eligible for potential milestone payments, bringing the total transaction value up to $2.13 billion. Merck gains exclusive global rights to develop, manufacture, and commercialize the candidate worldwide.AI summary

AstraZeneca has agreed to make a $2.0 billion strategic equity investment in Summit Therapeutics through the purchase of convertible preferred shares. In addition, the companies entered into a clinical collaboration to evaluate Summit's ivonescimab with AstraZeneca's sonesitatug vedotin in gastrointestinal cancers, with plans to initiate studies imminently. The parties also executed a non-binding memorandum of understanding to evaluate ivonescimab alongside other AstraZeneca cancer medicines.AI summary

AstraZeneca has agreed to invest $2 billion in equity in Summit Therapeutics and enter a clinical collaboration. The partnership will evaluate sonesitatug vedotin in combination with ivonescimab in gastrointestinal cancers. The companies intend to initiate clinical trials under the collaboration imminently.AI summary

Regeneron and Sanofi have expanded their immunology collaboration to add four new long-acting antibodies, including clinical-stage REGN20423. Under the agreement, Regeneron receives $1 billion upfront with potential for up to $7 billion in milestone payments, and the companies will split development costs and future profits equally. Regeneron also holds an option to include Sanofi's lunsekimig following Phase 3 trials.AI summary

Viking Therapeutics has closed its concurrent upsized public offerings of common stock and 2.00% convertible senior notes, yielding gross proceeds of approximately $575.0 million. Net proceeds are estimated at approximately $547.8 million after deducting underwriting discounts, commissions, and expenses. The company intends to use the funds for the clinical development, advancement, and commercialization of its VK2735 and VK3019 programs, as well as general corporate purposes.AI summary

CSL and Alentis Therapeutics have entered an exclusive global collaboration agreement to co-develop and co-promote lixudebart for rare kidney and liver diseases. Alentis will receive an initial payment of US$355 million and up to US$1.2 billion in commercial milestones. The companies will advance lixudebart in ANCA-associated vasculitis with rapidly progressive glomerulonephritis, focal segmental glomerulosclerosis, and primary sclerosing cholangitis.AI summary

Biotechnology company. Total offering $352M; first sale 2026-09-17. Form D is filed up to 15 days after the first sale.

Zymeworks Inc. has completed its acquisition of Theravance Biopharma, adding YUPELRI to its portfolio. The transaction was financed partly through a $350 million non-recourse note from OMERS, with Theravance shareholders receiving $17.00 per share in cash. Zymeworks updated its 2026 financial guidance, projecting total revenue between $278 million and $292 million.AI summary

Breye Therapeutics has closed an over-subscribed €67.5 million Series A financing round co-led by Mission BioCapital and Novo Holdings. The funds will be used to advance its lead oral asset, danegaptide, into a randomized Phase 2 trial for Non-Proliferative Diabetic Retinopathy in 2027. Proceeds will also mature Breye's wider pipeline, including a P2X7 receptor antagonist for intermediate age-related macular degeneration.AI summary

AnaCardio completed a €62.5 million Series B financing co-led by Novo Holdings and the Ljungström family office. The proceeds will fully fund the Phase 2b GOAL-HF2 trial of lead candidate AC01 in patients with chronic advanced heart failure with reduced ejection fraction. The study is scheduled to begin enrollment in Q4 2026 to advance AC01 toward Phase 3 readiness by 2028.AI summary

ai3Bio has launched with $48 million in Series A funding led by founding investors UPMC Enterprises and Ziff Capital Partners. The company is developing its STARx and T Deplete platforms to eliminate disease-causing Th17 cells in vivo. Capital will be used to advance both platforms, including IND-enabling studies ahead of first-in-human trials in autoimmune disease.AI summary

Biotechnology company. Total offering $16M; first sale 2026-08-04. Form D is filed up to 15 days after the first sale.

Biotechnology company. Total offering $45M; first sale 2026-09-17. Form D is filed up to 15 days after the first sale.

Biotechnology company. Total offering $15M; first sale 2026-08-12. Form D is filed up to 15 days after the first sale.

Biotechnology company. Total offering $12M; first sale 2026-09-17. Form D is filed up to 15 days after the first sale.

AstraZeneca and Daiichi Sankyo entered into a clinical collaboration agreement with Summit Therapeutics to evaluate Datroway in combination with ivonescimab across multiple tumour types. Each company will contribute their medicine and share trial costs while retaining their respective rights. The companies intend to begin with a Phase III trial in 1st-line triple-negative breast cancer.AI summary

Axogen has completed its acquisition of BioCircuit Technologies, adding NerveTape to its product portfolio. BioCircuit is expected to contribute approximately $6 million to fourth-quarter 2026 revenue and approximately $34 million to 2027 revenue. Axogen expects these additions to enable and unlock NerveTape's full commercial potential.AI summary

PolyPid and ADVANZ PHARMA have mutually agreed to terminate their 2022 license agreement for D-PLEX₁₀₀ in Europe. As a result, the exclusive European commercialization rights for the drug have reverted to PolyPid. The company believes this opens opportunities for new multinational commercialization partnerships in Europe and other large markets.AI summary

Microsoft Research introduced Quine, an AI research system that combines a multimodal world model of biology with an interactive harness. In collaboration with Broad Institute researchers, the system prioritized compounds predicted to drive tumor-state shifts, which were validated in wet-lab assays. Microsoft is launching the Quine Fellows program to grant scientists access to the system for research.AI summary

AbbVie has entered into a new collaboration with Valkai to deploy purpose-built AI capabilities across clinical development. The partnership aims to improve efficiency in targeted areas of clinical research, generate insights faster, and support opportunities to reduce development timelines.AI summary

Jade Biosciences announced preclinical data characterizing JADE301, a half-life-extended anti-IFN-β monoclonal antibody in development for dermatomyositis. In non-human primates, subcutaneous JADE301 was well tolerated and demonstrated an approximately 25-day half-life. Jade expects to initiate a Phase 1 trial in healthy volunteers in the fourth quarter of 2026, with interim data anticipated in the second half of 2027.AI summary

Google introduced SynthID Bio, a technology for watermarking AI-generated proteins while preserving their biological function. In wet-lab testing across targets like VEGF-A, SARS-CoV-2 spike protein RBD, and PD-L1, watermarked designs successfully matched the performance of unwatermarked versions. The company is open-sourcing code and releasing model weights to advance biosecurity and biological data tracking.AI summary

Evotec SE announced that Chief Scientific Officer Dr. Cord Dohrmann will step down effective September 30, 2026, by mutual consent between Dr. Dohrmann and the company. Dr. Dohrmann has served as Chief Scientific Officer and Member of the Management Board since 2010. The search for his replacement is ongoing.AI summary

Pharming Group N.V. announced that Chief Executive Officer Fabrice Chouraqui has stepped down by mutual agreement, effective immediately. The Board of Directors appointed Chief Commercial Officer Leverne Marsh and Chief Financial Officer Kenneth Lynard as Interim Co-CEOs. The Board has initiated a formal search for a permanent successor.AI summary

Caspian Therapeutics and Kura Oncology presented preclinical data at EASD for KO-7246, a potential best-in-class menin inhibitor for diabetes. In preclinical models, the compound regenerated functional β-cell mass, demonstrated durable glycemic control, and enhanced activity in combination with semaglutide. Caspian is currently advancing KO-7246 through IND-enabling development toward initial clinical evaluation.AI summary

Iovance Biotherapeutics has raised its full year 2026 total revenue guidance to between $410 million and $420 million. Driven by strong U.S. demand for Amtagvi and Proleukin, the updated outlook reflects a $55 million increase at the midpoint over previous estimates. The company expects to report its third quarter 2026 financial results in early November 2026.AI summary

Eton Pharmaceuticals announced the U.S. commercial availability and relaunch of IMPAVIDO (miltefosine) capsules. Eton holds exclusive commercialization rights for the therapy in the United States. The company has integrated its Eton Cares patient support program and centralized distribution through Anovo Specialty Pharmacy.AI summary