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 therapy Trial 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

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

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 mellitus Approval was based on the extensive data, incl. analytical, preclinical & clinical program, showing non-inferiority of Langlara to Lantus in terms…

May 5, 2026

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 itch In the primary cohort, volixibat met the 1EP,…

May 5, 2026

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 EU As per the deal, BioCryst will receive $70M upfront & up to $275M in regulatory & sales milestone payments as well as tiered royalties…

May 4, 2026

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 inhibitor The trial met its 1EP, with gedatolisib triplet improving PFS vs alpelisib + fulvestrant, while…

May 4, 2026

ARCHIMED to Acquire Esperion Therapeutics for ~$1.1B

Shots: Esperion Therapeutics & ARCHIMED have entered a definitive agreement under which ARCHIMED-managed funds will acquire Esperion, delisting it from NASDAQ As per the deal, Esperion’s shareholders will receive $3.16/share in cash, plus the right to participate in CVR of ~$100M tied to future sales, valuing the transaction at up to ~$1.1B in fully diluted…

May 4, 2026

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 2027 Approval was supported 120-patient cohort data from the global P-III (TRANSCEND) trial assessing setmelanotide (n=81) vs PBO…

May 4, 2026

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 commercialization NDA was backed by P-III (VERITAC-2) trial assessing Veppanu alone vs fulvestrant in mentioned pts…

May 4, 2026

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 Q3’26 Acquisition will add cizutamig, a BCMA…

May 4, 2026

NEWS

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

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

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

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

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

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

ARCHIMED to Acquire Esperion Therapeutics for ~$1.1B

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

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

UCB to Acquire Candid Therapeutics for ~$2.2B

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