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NEWS

Insulet Enrolls First Patient in the EVOLVE Study of its FCL Omnipod M System for Type 2 Diabetes

Shots:Insulet has enrolled the first patient in its EVOLVE study to evaluate safety & efficacy of its fully closed-loop (FCL) Omnipod M System, an automated insulin delivery system for T2D vs standard therapyTrial will assess the system in ~350 T2D pts (18-75yrs.) using insulin (basal-bolus or basal-only), across the US, with prior feasibility data (presented…
May 5, 2026

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Guardant Health Secures the US FDA Approval for Guardant360 CDx as a Companion Diagnostic for Arvinas’ Veppanu

Shots:The US FDA has approved Guardant360 CDx as a companion diagnostic to identify pts with ESR1mutations in ER+, HER2- advanced or metastatic breast cancer who may benefit from treatment with Arvinas’ Veppanu (vepdegestrant)Approval was supported by clinical data showing that Guardant360 CDx, a non-invasive liquid biopsy test, demonstrated clinical utility in identifying ESR1 mutations to…
May 5, 2026

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Lannett Company and Sunshine Lake Pharma Report US FDA Approval of Langlara (Biosimilar, Lantus)

Shots:The US FDA has approved Langlara, an interchangeable biosimilar to Lantus (insulin glargine), for the treatment of adults & pediatric patients with type 1 diabetes mellitus, and adults with type 2 diabetes mellitusApproval was based on the extensive data, incl. analytical, preclinical & clinical program, showing non-inferiority of Langlara to Lantus in terms…
May 5, 2026

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Mirum Pharmaceuticals
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Mirum Pharmaceuticals Reports P-IIb (VISTAS) Trial Data on Volixibat in Primary Sclerosing Cholangitis (PSC) Patients with Cholestatic Pruritus

Shots:Mirum has reported global P-IIb (VISTAS) trial data evaluating volixibat (20mg, BID) vs PBO in 158 patients with cholestatic pruritus caused by PSC, incl. 111 pts in the primary analysis cohort with mod. to sev. itch & 47 pts in the secondary cohort with mild itchIn the primary cohort, volixibat met the 1EP,…
May 5, 2026

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BioCryst Partners with Irish Affiliate of Neopharmed Gentili in ~$345M EU Commercialization Deal for Navenibart

Shots:BioCryst Pharmaceuticals has entered into a license agreement with an Irish affiliate of Neopharmed Gentili, granting the latter exclusive rights to commercialize navenibart for hereditary angioedema (HAE) in the EUAs per the deal, BioCryst will receive $70M upfront & up to $275M in regulatory & sales milestone payments as well as tiered royalties…
May 4, 2026

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Celcuity
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Celcuity Reports the P-III (VIKTORIA-1) Trial Data on Gedatolisib Combination for HR+/HER2- PIK3CA Mutant Advanced Breast Cancer

Shots:Celcuity has reported the PIK3CA mutant cohort data from P-III (VIKTORIA-1) study of gedatolisib + fulvestrant ± palbociclib vs SoC in HR+/HER2- advanced breast cancer pts who progressed on or after treatment with CDK4/6 inhibitor & an aromatase inhibitorThe trial met its 1EP, with gedatolisib triplet improving PFS vs alpelisib + fulvestrant, while…
May 4, 2026

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Rhythm Pharmaceuticals
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Rhythm Pharmaceuticals Reports the EC Approval of Imcivree (Setmelanotide) for Acquired Hypothalamic Obesity

Shots:The EC has approved label expansion of Imcivree to incl. treatment of obesity & control of hunger in pts (≥4yrs.) with acquired hypothalamic obesity (HO) due to hypothalamic injury or impairment; commercial launch is expected in 2027Approval was supported 120-patient cohort data from the global P-III (TRANSCEND) trial assessing setmelanotide (n=81) vs PBO…
May 4, 2026

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Arvinas and Pfizer Report the US FDA Approval of Veppanu (Vepdegestrant) for ESR1-Mutated Breast Cancer

Shots:FDA approved Veppanu to treat adults with ESR1-mutated ER+/HER2- advanced or metastatic breast cancer who received ≥1L of endocrine therapy, prior to PDUFA date of Jun 5, 2026; Arvinas & Pfizer plan to select a third-party partner for commercializationNDA was backed by P-III (VERITAC-2) trial assessing Veppanu alone vs fulvestrant in mentioned pts…
May 4, 2026

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NEWS

UCB to Acquire Candid Therapeutics for ~$2.2B

Shots: UCB has entered into a definitive agreement to acquire Candid Therapeutics, expanding its immunology pipeline with novel T-cell engagers (TCE)As per the deal, UCB will acquire Candid for $2B upfront & ~$200M in potential future milestone payments; closing is expected by end of Q2 or early Q3’26Acquisition will add cizutamig, a BCMA…
May 4, 2026

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