Shots:
Pfizer reported topline data of P-III (BREAKWATER) study assessing Braftovi (300mg, PO, QD) in untreated BRAF V600E-mutant mCRC pts, randomized to Braftovi + Erbitux (n=158), Braftovi + Erbitux + mFOLFOX6 (n=236), or CT (mFOLFOX6/ FOLFOXIRI/ CAPOX) ± Avastin (n=243)
Study showed improved PFS (1EP) & OS (2EP) along with previously reported improved cORR…
NEWS
Shots:
Algiax reported topline data from the P-IIa PoC trial assessing AP-325 (GABA-A modulator) vs PBO in 99 pts with peripheral post-surgical neuropathic pain in Germany, Spain, the Czech Republic, Belgium, & France
Data showed rapid PI-NRS reduction in <2wks., sustained effects, plus significantly higher ≥50% & ≥70% responder rates with ~25% vs. 11% pts…
Datar Cancer Genetics Launches Exacta AI to Offer Personalized Treatment Options for Cancer Patients
Shots:
Datar Cancer Genetics has introduced Exacta AI (multi-analyte platform) to provide ~10 evidence-based drug combinations as a treatment for cancer patients who have exhausted SoC options
Exacta AI integrates 360° tumor work-up with AI-driven analysis of complex tumor interactome data to assess drug interactions, toxicity, & side effects for ADCs, CPIs, targeted therapies,…
Shots:
Vanda received exclusive rights to develop, manufacture & commercialize imsidolimab which has completed 2 P-III (GEMINI-1 & GEMINI-2) trials for generalized pustular psoriasis
As per the terms, Anaptys will get $10M upfront, $5M for existing drug supply, & ~$35M in regulatory & sales milestones, plus 10% royalty on net sales, whereas Vanda will…
Shots:
The EMA received MAA of finerenone for HF pts having a left ventricular ejection fraction (LVEF) of ≥40%, i.e. mildly reduced (HFmrEF) or preserved LVEF (HFpEF). Awaits approval in US and China, with global applications planned
Application was backed by P-III (FINEARTS-HF) trial, a part of P-III (MOONRAKER, n=15000) study, where FINEARTS-HF assessed…
Shots:
The CHMP recommended label extension to SC Rybrevant (Q1W x 4wks, then Q2W) + Lazcluze for 1L advanced NSCLC harboring EGFRm exon 19 del/ exon 21 L858R substitution & as monotx. for NSCLC pts with EGFRm exon 20 insertions unresponsive to Pt-based CT
Opinion was backed by P-III (PALOMA-3) trial, evaluating SC vs…
Shots:
The CHMP has recommended Vimkunya (pre-filled syringe) against CHIKV disease in individuals (≥12yrs.), with the EC’s decision & launch expected in H1’25 for the EU, Iceland, Liechtenstein, & Norway
Opinion was based on 2 P-III studies showing a rapid immune response in 1wk. with ~97.8% of participants (n=3,500) developing neutralizing antibodies by day…
Shots:
Jupiter has partnered with Zina to support its P-IIa trial of Jotrol for assessing its safety & tolerability (1EP), and PK/PD (2EP) in Parkinson’s pts
As per the agreement, Zina will provide services for P-IIa trial such as protocol design assistance (PK, biomarkers), regulatory strategy, & trial site selection
Jotrol (micellar formulation)…
Shots:
The US FDA has approved Ozempic to reduce the risk of kidney disease worsening & CV death in adults with type 2 diabetes & CKD
Approval was based on P-IIIb (FLOW) trial assessing Ozempic (1mg, Q1W, n=1767) vs matching PBO (n=1766) in type 2 diabetes & CKD pts (N=3533)
Study met its 1EP of 24% relative…
Shots:
Anivive secured a $20M investment from Leonid to advance research of its programs, expand manufacturing, & support the marketing of its valley fever vaccine for canines
Funding follows a $33M NIAID contract with NIH to develop human vaccine for the fungus Coccidioides, which causes Valley fever, leading to ~$80M in preorders & contracts…

