Shots:
The US FDA has received NDA of bezuclastinib under the RTOR program for the treatment of pts with GIST who were previously treated with imatinib, backed by the P-III (PEAK) trial of bezuclastinib + sunitinib vs sunitinib monotx.
Trial met its 1EP of improved PFS by 50% (mPFS: 16.5 vs 9.2mos.) & showed ORR of…
Shots:
JenaValve Technology has launched Trilogy THV System to treat ssAR in pts at high or greater surgical risk & reported successful first cases across the US
The System uses radiopaque locators to attach directly to native aortic leaflets without calcification, allowing stable implantation, precise alignment, reduced paravalvular regurgitation, & preserving future coronary access with…
Shots:
FDA has approved Foundayo along with lifestyle intervention for obese/overweight adults with weight-related medical problems; Foundayo will be available via LillyDirect beginning Apr 6, 2026
Approval was backed by the ATTAIN program, incl. ATTAIN-1, where Foundayo showed weight loss of 27.3 lbs (12.4%) vs 2.2 lbs (0.9%) with PBO at the highest dose, with…
Headlines, Trends, and the Signals Shaping the Future of Biopharma
A Quarter That Reset the Biopharma Narrative
The first quarter of 2026 did not simply continue the momentum of the global biopharmaceutical industry; it redefined its direction.
From multi-billion-dollar acquisitions and accelerating rare disease breakthroughs to AI-powered discovery collaborations and gene therapy approvals, the industry demonstrated a clear shift toward precision innovation, strategic consolidation, and next-generation…
Shots:
Axsome has entered into an asset purchase agreement with Takeda for TAK-063 (balipodect), with an intention to develop it for treating schizophrenia & Tourette syndrome (P-III trial-enabling activities for schizophrenia to begin in 2026)
As per the deal, Axsome gains global rights to develop, manufacture, & commercialize TAK-063, while Takeda receives an upfront payment,…
Shots:
The Chinese NMPA has approved Exdensur as an add-on maintenance therapy for asthma pts (≥12yrs.) characterised by an eosinophilic phenotype based on P-III (SWIFT-1: n=382) & (SWIFT-2: n=380) trials
Exdensur reduced asthma exacerbations by 58% (SWIFT-1) & 48% (SWIFT-2) over 52wks., with results in Chinese pts (n=58, SWIFT-1) consistent with the overall population. Pooled data…
Shots:
Frontier has granted LG Chem an exclusive global license to develop & commercialize FMC-220 outside of Greater China, with Frontier retaining full rights in Greater China
As per the deal, LG will handle regulatory filings, global clinical development, & commercialization in licensed regions, while Frontier may partially fund confirmatory trials & receive upfront, clinical,…
Shots:
Biogen to acquire Apellis, incl. its assets Empaveli, Syfovre & felzartamab, for $41/share plus a non-transferable CVR, representing an upfront equity consideration of ~$5.6B, with remaining shares acquired later via a second-step merger
CVR holders will receive $2/CVR if Syfovre achieves $1.5B sales (2027-2030), an additional $2 if it reaches $2B in the same…
Shots:
The US FDA has granted clearance to Elitone for Men to help restore bladder control after prostate surgery, with US availability expected in Apr 2026
Elitone for Men is a non-invasive, at-home therapy that delivers neuromuscular stimulation to strengthen pelvic floor muscles, improving bladder control, with a simple 20min. daily use enabling consistent treatment…
Shots:
Infinimmune has partnered with Merck to discover & develop antibody candidates against multiple undisclosed targets selected by Merck using Infinimmune’s human-first antibody discovery platform
As per the deal, Infinimmune will use its Anthrobody discovery platform & Glimpse antibody language model to discover & optimize antibodies from human immune repertoires, enabling large-scale B-cell screening to…

