PrimeGen US to Go Public via DT Cloud Star Acquisition Corporation’s SPAC Deal

Shots: PrimeGen US has entered into a definitive business combination agreement with DT Cloud Star at an implied equity value of ~$1.5B, with closing expected in H2’26 After closing, the combined entity is expected to operate as PrimeGen US or a successor company & will be listed on Nasdaq under a new ticker symbol PrimeGen…

ByRidhi RastogiFebruary 5, 2026

NEWS

Daiichi Sankyo Reports First Patient Dosing in P-I/II Trial of DS3790 for R/R B-Cell Non-Hodgkin Lymphoma

Shots: Daiichi Sankyo has dosed the first patient with DS3790 in the P-I/II trial for pts with r/r B-cell non-Hodgkin lymphoma The trial will assess DS3790 in ~420 pts with r/r B-cell NHL, evaluating safety endpoints as well as efficacy endpoints incl. overall response, DCR, DoR, time to response, PFS, & OS DS3790 is a…

ByRidhi RastogiFebruary 5, 2026

NEWS

Hologic’s Aptima HPV Assay Receives the US FDA Approval for HPV Primary Screening

Shots: The US FDA has approved AptimaHPV Assay, an mRNA-based assay for clinician-collected HPV primary screening Approval follows completion of a real-world HPV screening study of 650,000+ women across US, showing the Aptima HPV Assay has clinically comparable sensitivity to an FDA-approved DNA-based HPV test & is effective for detecting CIN2+ & CIN3+ in primary…

ByRidhi RastogiFebruary 5, 2026

NEWS

ZipBio and MeiraGTx Partner to Advance AAV Gene Therapy for Geographic Atrophy

Shots: ZipBio has entered into an exclusive license agreement with MeiraGTx, granting MeiraGTx exclusive right to AAV gene therapy to treat Geographic Atrophy Licensing deal will combine MeiraGTx’s expertise in vector design, clinical development, & in-house genetic medicine manufacturing with ZipBio’s de novo protein therapeutics created using its COMPACT generative AI platform As per the…

ByRidhi RastogiFebruary 4, 2026

NEWS

ONWARD Medical First Patient in Empower BP Study of ARC-IM System to Treat Blood Pressure Instability in Spinal Cord Injury

Shots: ONWARD Medical has enrolled the first patient in its Empower BP study evaluating ARC-IM System for symptomatic blood pressure instability in patients with chronic spinal cord injury The global trial will assess ARC-IM System against a sham in pts with C2–T6 spinal cord injuries & injury severities of AIS A-D across ~20 centers in…

ByRidhi RastogiFebruary 4, 2026

NEWS

Relay Therapeutics’ Zovegalisib Receives the US FDA Breakthrough Therapy Designation for PIK3CA-Mutant Advanced Breast Cancer

Shots: The US FDA has granted BTD to zovegalisib + fulvestrant for the treatment of adults with PIK3CA mutant, HR+/HER2- locally advanced or metastatic breast cancer following recurrence or progression on or after treatment with a CDK4/6 inhibitor Designation was supported by P-I/II (ReDiscover) trial data of zovegalisib + fulvestrant ± CDK inhibitors, showing activity…

ByRidhi RastogiFebruary 4, 2026

NEWS

Pfizer Reports P-IIb (VESPER-3) Trial Results on PF’3944 in Weight Management

Shots: Assessing PF’3944 (QW titration to QM) in obese/overweight pts without T2D, the trial randomized pts to Arm 1 (0.4mg QW/ 0.8mg QW/ 3.2mg QM), Arm 2 (0.8mg QW/ 3.2mg QM), Arm 3 (0.4mg QW/ 0.8mg QW/ 1.2mg QW/ 4.8mg QM), Arm 4 (0.6mg QW/ 1.2mg QW/ 4.8mg QM), or Arm 5 (PBO) Trial met…

ByRidhi RastogiFebruary 4, 2026

NEWS

Quanterix Seeks US FDA Approval for Multi-Analyte Algorithmic Blood Test to Diagnose Alzheimer’s Disease

Shots: The US FDA has received 510(k) premarket notification for the multi-analyte algorithmic blood test to diagnose Alzheimer’s disease Submission was backed by data across three independent cohorts & 1,800+ pts, published in the Alzheimer’s & Dementia: Diagnosis, Assessment & Disease Monitoring The blood test uses Quanterix’s Simoa tech to integrate five AD biomarkers (p-Tau217,…

ByRidhi RastogiFebruary 4, 2026

NEWS

Zonsen PepLib Biotech and Eli Lilly Partner to Advance Peptide-Based Therapies

Shots: Zonsen PepLib Biotech has entered into a worldwide R&D and license agreement with Eli Lilly to jointly advance peptide-based drug candidates using PepLib’s robust & diverse peptide libraries & discovery platforms As per the deal, PepLib will screen & identify optimal peptide molecules using its in-house platform, while Lilly will oversee IND-enabling activities, clinical…

ByRidhi RastogiFebruary 4, 2026

NEWS

Exelixis Reports the US FDA’s NDA Acceptance of Zanzalintinib + Tecentriq for Metastatic Colorectal Cancer (mCRC)

Shots: The US FDA has accepted NDA of zanzalintinib + Tecentriq (atezolizumab) for the treatment of adults with mCRC who have been previously treated with fluoropyrimidine, oxaliplatin & irinotecan-based CT, &, if RAS wild-type, an anti-EGFR therapy (PDUFA: Dec 03, 2026) NDA was based on P-III (STELLAR-303) trial assessing zanzalintinib in combination with atezolizumab (n=451)…

ByRidhi RastogiFebruary 3, 2026

Ridhi Rastogi

PrimeGen US to Go Public via DT Cloud Star Acquisition Corporation’s SPAC Deal

Daiichi Sankyo Reports First Patient Dosing in P-I/II Trial of DS3790 for R/R B-Cell Non-Hodgkin Lymphoma

Hologic’s Aptima HPV Assay Receives the US FDA Approval for HPV Primary Screening

ZipBio and MeiraGTx Partner to Advance AAV Gene Therapy for Geographic Atrophy

ONWARD Medical First Patient in Empower BP Study of ARC-IM System to Treat Blood Pressure Instability in Spinal Cord Injury

Relay Therapeutics’ Zovegalisib Receives the US FDA Breakthrough Therapy Designation for PIK3CA-Mutant Advanced Breast Cancer

Pfizer Reports P-IIb (VESPER-3) Trial Results on PF’3944 in Weight Management

Quanterix Seeks US FDA Approval for Multi-Analyte Algorithmic Blood Test to Diagnose Alzheimer’s Disease

Zonsen PepLib Biotech and Eli Lilly Partner to Advance Peptide-Based Therapies

Exelixis Reports the US FDA’s NDA Acceptance of Zanzalintinib + Tecentriq for Metastatic Colorectal Cancer (mCRC)

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