Shots:
BioNTech has entered into a definitive purchase agreement to acquire CureVac in an all-stock transaction, strengthening its mRNA tech & capabilities
As per the deal, each CureVac share will be exchanged for ~$5.46 in BioNTech ADSs, implying a total equity value of ~$1.25B, with a collar-adjusted exchange ratio (0.04318 if BioNTech’s 10-day VWAP >$126.55; 0.06476…
Shots:
The CVMP has recommended Zenrelia (ilunocitinib) for the treatment of pruritus linked to allergic dermatitis & clinical symptoms of atopic dermatitis in dogs
Opinion was based on clinical data demonstrating quality, safety, efficacy, & a favorable benefit-risk profile incl. a non-inferiority study conducted as a part of the EU approval process
Elanco plans to…
Shots:
The US FDA has approved Zusduri (mitomycin) for the treatment of adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC); expected to be available in the US by Jul 1, 2025
Approval was based on P-III (ENVISION) trial assessing Zusduri (QW, intravesical) in ~240 LG-IR-NMIBC pts across 56 sites, which showed 78% pts…
Shots:
The US FDA has approved mRESVIA (mRNA-1345) to prevent lower respiratory tract disease caused by RSV in individuals (18-59yrs.) at risk; expected to be available in US for the 2025–2026 respiratory virus season
Approval was based on P-III trial assessing safety & immunogenicity of mRESVIA in adults (18-59yrs.) at increased risk for RSV-associated lower…
Shots:
Novartis has reported P-IIIb (APPULSE-PNH) trial data assessing Fabhalta (iptacopan; 200mg, BID, PO) for 24wks. in 52 PNH adults with Hb levels ≥10g/dL who switched from anti-C5 therapies (eculizumab or ravulizumab)
Trial showed a 2.01 g/dL mean Hb increase, with 92.7% pts achieving ≥12g/dL & no transfusions over 24wks. It also depicted improved fatigue…
Shots:
The US FDA has granted 510(k) clearance to the next generation NEUROMARK system for pts with chronic rhinitis
The new system optimizes posterior nasal nerve treatment by providing real-time feedback for accurate electrode placement & confirming treatment delivery, with a flexible shaft & atraumatic leaflets that conform to pts anatomy for maximizing treatment coverage…
Shots:
The P-IIIb (APEX) trial assessed Tremfya (Q4W or Q8W) vs PBO for 24wks. in biologic-naïve PsA pts with inadequate response to SoCs, followed by a 24wk. active treatment period then a 12wk. safety follow-up; pts could enter a 2yr. extension phase prior to the final safety follow-up
Trial showed reduced joint damage progression per…
Shots:
The US FDA has approved label expansion of Mavyret (glecaprevir/pibrentasvir) to treat pts (≥3yrs.) with acute or chronic HCV infection, without cirrhosis or with compensated cirrhosis
Label expansion was supported by P-III (M20-350) trial assessing Mavyret (QD, PO) in 286 treatment-naïve adults with acute HCV infection for 8wks. & then followed for 12wks.
Trial…
Shots:
Deep Apple & Novo have partnered to discover, develop, & commercialize oral small molecules targeting novel non-incretin GPCRs for cardiometabolic diseases, incl. obesity, using Deep Apple’s drug discovery tech
Novo will gain exclusive global rights to develop, manufacture, & commercialize assets discovered & optimized by Deep Apple for ~$812M in upfront, research costs, &…
Shots:
The US FDA has approved Ibtrozi (taletrectinib) for treating locally advanced or metastatic ROS1+ NSCLC
Approval was based on the P-II [TRUST-I (China) & TRUST-II (global)] studies assessing Ibtrozi monotx. in 173 & 164 pts with ROS1+ NSCLC, respectively
TRUST-I showed a cORR of 90% in TKI-naïve pts, with longest DoR of 46.9mos. &…

