Shots:
Biomica (Evogene’s subsidiary) & Shanghai Lishan Biopharmaceuticals have entered into an exclusive worldwide licensing agreement for BMC128, currently in P-I trial
As per the deal, Lishan Biotech will receive exclusive rights to develop, manufacture, & commercialize BMC128, with Biomica receiving development milestone payments & royalties on future commercial sales
Lishan Biotech is planning to…
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Alvotech reported positive top-line data from the AVT80-GL-P01 PK study comparing AVT80 with Entyvio in healthy adults
The study met all 1EP, demonstrating PK similarity between AVT80 & Entyvio following a single 108mg/0.68mL SC dose, supporting AVT80’s biosimilar profile
Alvotech is developing AVT16 (IV) & AVT80 (SC) as Entyvio’s biosimilars, with the AVT80-GL-P01 study…
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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…
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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…
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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…
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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…
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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…
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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…
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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…
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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,…

