NEWS

Celltrion’s Eydenzelt (Biosimilar, Eylea) Receives the US FDA’s Approval to Treat Multiple Retinal Diseases

Shots: The US FDA has approved Eydenzelt, a biosimilar version of Eylea (aflibercept), to treat neovascular age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema (DME), & diabetic retinopathy Approval was supported by extensive analytical, non-clinical, & clinical data, incl. a P-III trial in DME pts (n=348) comparing Eydenzelt vs Eylea over…

October 10, 2025

Novo Nordisk to Acquire Akero Therapeutics for ~$5.2B, Expanding its MASH Portfolio

Shots: Novo Nordisk will acquire Akero Therapeutics, incl. its lead asset efruxifermin (EFX), to expand its metabolic dysfunction-associated steatohepatitis (MASH) portfolio As per the deal, Novo Nordisk will acquire Akero for $54/share in an all-cash transaction totaling ~$4.7B, along with one non-tradeable CVR of $6/share (~$0.5B) tied to EFX’s US FDA approval for compensated cirrhosis due…

October 10, 2025

Boehringer Ingelheim Reports the US FDA’s Approval of Jascayd (Nerandomilast) for Idiopathic Pulmonary Fibrosis

Shots: The US FDA has approved Jascayd (nerandomilast) for the treatment of adults with idiopathic pulmonary fibrosis (IPF); regulatory review is ongoing in China, Japan, & the EU, with further filings planned Approval was based on P-III (FIBRONEER-IPF) & P-II (Trial 2) trials, where FIBRONEER-IPF assessed Jascayd (18 or 9mg, PO, BID) vs PBO in…

October 9, 2025

Johnson & Johnson Reports P-III (ASTRO) Trial Data of SC Tremfya (Guselkumab) for Ulcerative Colitis (UC)

Shots: J&J has reported P-III (ASTRO) trial data assessing Tremfya SC induction (400mg at Wks. 0, 4 & 8) followed by maintenance dose of either Tremfya 100mg (SC, Q8W) or 200mg (SC, Q4W) vs PBO in adults (n=418) with mod. to sev. active UC At Wk. 48, trial showed improved clinical remission rates of 36.7%…

October 9, 2025

AviadoBio Enters Exclusive Option & License Agreement with UgeneX Therapeutics to Advance UGX-202

Shots: AviadoBio has entered into an exclusive option & license agreement with UgeneX Therapeutics to develop & commercialize UGX-202 As per the deal, AviadoBio will receive an option to develop & commercialize UGX-202 for retinitis pigmentosa & other indications globally (excl. Greater China), while UgeneX will receive upfront payments, r&d milestones, & sales milestone payments…

October 9, 2025

Bunkerhill Health Receives the US FDA’s 510(k) Clearance for Bunkerhill MAC to Detect and Quantify Mitral Annular Calcification

Shots: The US FDA has granted 510(k) clearance to Bunkerhill MAC algorithm for the detection & quantification of mitral annular calcification (MAC) Bunkerhill MAC, developed & tested using data from 25+ academic centers incl. Emory, Thomas Jefferson, & UCSF, automatically identify & quantify MAC on routine non-gated chest CTs using AI to standardize MAC detection &…

October 9, 2025

Ascendis Pharma Reports the EMA’s MAA Submission for TransCon CNP to Treat Achondroplasia in Children

Shots: The EMA has received MAA for TransCon CNP (navepegritide) for the treatment of children with achondroplasia; NDA is under the US FDA’s priority review (PDUFA: Nov 30, 2025) MAA is supported by 3 trials assessing TransCon CNP vs PBO & up to 3yrs. of OLE data, incl. ApproaCH trial results in children with achondroplasia,…

October 9, 2025

Regeneron Reports the US FDA’s Approval of Adjuvant Libtayo to Treat High-Risk Cutaneous Squamous Cell Carcinoma (CSCC)

Shots: The US FDA has approved Libtayo (cemiplimab-rwlc) under priority review as an adj. treatment for CSCC adults who are at high risk for recurrence after surgery & radiation; application under EMA’s review, with decision expected in H1’26 Approval was based on the P-III (C-POST) trial assessing Libtayo adj. (350mg, IV, Q3W for first 12wks.…

October 9, 2025

Eli Lilly Reports P-III (LUCENT-3) OLE Trial Data of Omvoh to Treat Ulcerative Colitis

Shots: Eli Lilly has reported long-term data from the P-III (LUCENT-3) OLE study of P-III (LUCENT-1 & LUCENT-2) trials, evaluating the efficacy & safety of Omvoh (mirikizumab-mrkz) in mod. to sev. active ulcerative colitis pts over an additional 3yrs., totaling ~4yrs. of treatment In LUCENT-3, among pts who achieved clinical remission with Omvoh at 1yr.…

October 8, 2025

Zenas BioPharma Enters ~$2B Deal with InnoCare Pharma for Three Autoimmune Product Candidates

Shots: InnoCare granted Zenas exclusive global rights to develop, manufacture, & commercialize orelabrutinib for MS & non-oncology indications (excl. Greater China & Southeast Asia), plus rights to an IL-17AA/AF inhibitor outside those regions & a brain-penetrant TYK2 inhibitor globally As per the deal, InnoCare will receive $100M in upfront & near-term milestones, incl. 2026 milestones,…

October 8, 2025

NEWS

Novo Nordisk to Acquire Akero Therapeutics for ~$5.2B, Expanding its MASH Portfolio

Boehringer Ingelheim Reports the US FDA’s Approval of Jascayd (Nerandomilast) for Idiopathic Pulmonary Fibrosis

Johnson & Johnson Reports P-III (ASTRO) Trial Data of SC Tremfya (Guselkumab) for Ulcerative Colitis (UC)

AviadoBio Enters Exclusive Option & License Agreement with UgeneX Therapeutics to Advance UGX-202

Bunkerhill Health Receives the US FDA’s 510(k) Clearance for Bunkerhill MAC to Detect and Quantify Mitral Annular Calcification

Ascendis Pharma Reports the EMA’s MAA Submission for TransCon CNP to Treat Achondroplasia in Children

Regeneron Reports the US FDA’s Approval of Adjuvant Libtayo to Treat High-Risk Cutaneous Squamous Cell Carcinoma (CSCC)

Eli Lilly Reports P-III (LUCENT-3) OLE Trial Data of Omvoh to Treat Ulcerative Colitis

Zenas BioPharma Enters ~$2B Deal with InnoCare Pharma for Three Autoimmune Product Candidates

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