December 1, 2025 – Talk Bio

Tessera Therapeutics Advances Gene Writing Technology with Major Funding and Strategic Partnerships

17 hours ago talkbio0Tagged alpha 1-Antitrypsin Deficiency, ARPA-H grant, CAR-T, Clinical Trials, Gene Writing, genome engineering, in vivo, Lipid Nanoparticles, Partnership, Regeneron, Tessera, TSRA-196

Tessera Therapeutics; Gene Writing; in vivo CAR-T; ARPA-H grant; Regeneron partnership; TSRA-196; alpha-1 antitrypsin deficiency; Lipid Nanoparticles; in vivo genome engineering; clinical trials

FDA’s Vinay Prasad Links 10 Child Deaths to COVID-19 Vaccines, Calls for Stricter Review Guidelines

18 hours ago talkbio0Tagged Biological Factors, COVID19 (disease), Death of child, Evaluation, Myocarditis, United States Food and Drug Administration, vaccine guidelines, vaccine regulation, Vaccine Safety, Vaccines, VAERS, Vinay Prasad

FDA; Vinay Prasad; COVID-19 vaccines; child deaths; myocarditis; vaccine safety; vaccine regulation; biologics evaluation; VAERS; stricter vaccine guidelines

Generate:Biomedicines Launches Global Phase 3 Trials for AI-Engineered Anti-TSLP Antibody GB-0895 in Severe Asthma

22 hours ago talkbio0Tagged AI-engineered antibody, Asthma, Biomedicines, Clinical Trials, GB-0895, Generate, Phase 3, Programmable Biology, Severe (severity modifier), SOLAIRIA-1, SOLAIRIA-2, thymic stromal lymphopoietin, TSLP gene

Generate:Biomedicines; GB-0895; Phase 3 clinical trials; TSLP; thymic stromal lymphopoietin; severe asthma; AI-engineered antibody; programmable biology; SOLAIRIA-1; SOLAIRIA-2

AcuCort Appoints Nomination Committee for 2026 Annual General Meeting

24 hours ago talkbio0Tagged AcuCort, annual, General Meeting, Jonmark, nomination committee, representatives, shareholder

AcuCort; nomination committee; 2026 annual general meeting; shareholder representatives; Jonas Jonmark; Zoya Invest

Cereno Scientific Secures SEK 100m in Directed Share Issue and SEK 350m Loan Financing, Targeting Milestones by Q4 2027

24 hours ago talkbio0Tagged Cardiovascular Diseases, Cereno Scientific, Clinical Development, Directed share, Histone deacetylase inhibitor, Infrequent, Loan, loan financing, milestones, portfolio, Problem, Pulmonary arterial hypertension

Cereno Scientific; SEK 100 million; Directed share issue; SEK 350 million; Loan financing; Q4 2027 milestones; HDAC inhibitor portfolio; Pulmonary arterial hypertension; Clinical development; Rare cardiovascular diseases

Recent Developments in Medical Affairs Reputation and Hemophilia A Management in the US (2025)

1 day ago talkbio0Tagged Acquired (qualifier value), Centers for Disease Control and Prevention (U.S.), federal funding, gene therapy, Health Policy, Hemophilia A, Hemophilia A Pipeline, Hemophilia Treatment Centers, HRSA, Medical Affairs, Programs - Publication Format, public health policy, reputation, U.S.

Medical Affairs; Reputation; Hemophilia A; US; 2025; Gene Therapy; Public Health Policies; Hemophilia Treatment Centers; 340B Program; Federal Funding; Acquired Hemophilia A Pipeline; Healthcare Policy; CDC; HRSA

Marengo’s invikafusp alfa shows promising monotherapy activity in PD-1 resistant gastrointestinal cancers

1 day ago talkbio0Tagged Alfa, Colorectal Carcinoma, fast-track designation, High tumor mutational burden, High-Frequency Microsatellite Instability, Immunotherapy, invikafusp, Malignant neoplasm of gastrointestinal tract, Marengo Therapeutics, PDCD1 gene, resistant tumors, United States Food and Drug Administration

Invikafusp alfa; Marengo Therapeutics; PD-1 resistant tumors; Gastrointestinal cancers; Colorectal cancer; TMB-H; MSI-H; Immunotherapy; ESMO 2025; FDA Fast Track designation

Keytruda Breaks New Ground with FDA Approval for Perioperative Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma

1 day ago talkbio0Tagged Adjuvant Therapy, Approved, Clinical Trials, Event-Free Survival, Gene Expression, KEYNOTE-689 trial, Keytruda, Neoadjuvant Therapy, PD-L1, pembrolizumab, perioperative, Squamous cell carcinoma of the head and neck, United States Food and Drug Administration

Keytruda; pembrolizumab; perioperative treatment; head and neck squamous cell carcinoma; HNSCC; FDA approval; KEYNOTE-689 trial; neoadjuvant therapy; adjuvant therapy; PD-L1 expression; event-free survival; clinical trial

Rezatapopt Shows Early Promise in TP53 Y220C-Mutant Tumors in PYNNACLE Phase II Trial

1 day ago talkbio0Tagged Familial mitral valve prolapse, ORR, ovarian neoplasm, p53 reactivator, Phase 2 Clinical Trials, PYNNACLE trial, Rezatapopt, Solid Neoplasm, Targeted Therapy, TP53 gene, Y220C mutation

Rezatapopt; TP53 Y220C mutation; PYNNACLE trial; solid tumors; phase II clinical trial; ORR; ovarian cancer; p53 reactivator; targeted therapy; PMV Pharmaceuticals