Lundbeck Reports Topline P-IIb (PROCEED) Trial Results on Bocunebart in Migraine Prevention

Shots: Lundbeck has reported P-IIb (PROCEED) trial results evaluating bocunebart (SC/IV; QM for 3mos.) vs PBO in migraine patients with prior failure of 1-4 preventive therapies, with the IV arm randomizing 431 pts across 14 countries Trial met its 1EP in the multiple IV dosing arm, showing a statistically significant reduction in monthly migraine days…

ByRidhi RastogiFebruary 16, 2026

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Novartis Reports Final P-III (ALIGN) Trial Data on Vanrafia (Atrasentan) in IgA Nephropathy (IgAN)

Shots: The global P-III (ALIGN) trial assessed Vanrafia (0.75mg, QD, PO) vs PBO for 132wks. in 340 IgAN pts at risk of progressive loss of kidney function. An additional 64 pts received an SGLT2 inhibitor alongside a RAS inhibitor for at least 12wks. In the trial, Vanrafia showed a 2.39 mL/min/1.73m² difference in eGFR change…

ByRidhi RastogiFebruary 13, 2026

NEWS

AstraZeneca Reports P-III (LOGOS & KALOS) Trial Findings on Breztri Aerosphere for Uncontrolled Asthma

Shots: The P-III (LOGOS & KALOS) trials evaluated Breztri Aerosphere (BGF; 320/28.8/9.6μg or 320/14.4/9.6μg) vs PT009 (ICS/LABA via Aerosphere) & Symbicort pressurized metered-dose inhaler (pMDI) in pts with uncontrolled asthma; Regulatory filings in asthma are under review in all major regions In pooled analysis, Breztri improved lung function by 76 mL in morning pre-dose trough…

ByRidhi RastogiFebruary 13, 2026

NEWS

Adlai Nortye Doses First Patient in the P-I Trial of AN9025 to Treat Solid Tumors Harboring RAS Mutations

Shots: Adlai Nortye has dosed the first patient in the US with AN9025 in its ongoing P-I trial for the treatment of advanced or metastatic solid tumors harboring RAS mutations Trial is being conducted by Adlai Nortye with ASK Pharm as a multi-regional study under a license agreement granting Adlai Nortye ex-China rights to AN9025,…

ByRidhi RastogiFebruary 12, 2026

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Merck Receives the FDA Approval for Keytruda and Keytruda Qlex, Plus CT ± Avastin to Treat PD-L1+ Pt-Resistant Ovarian Carcinoma

Shots: The US FDA has approved Keytruda/Keytruda Qlex + paclitaxel ± Avastin for the treatment of adults with PD-L1+ (CPS ≥1) Pt-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma, who have received 1 or 2 prior systemic therapy Approval was based on the P-III (KEYNOTE-B96/ENGOT-ov65) trial data assessing Keytruda (400mg, IV, Q6W) with CT…

ByRidhi RastogiFebruary 12, 2026

NEWS

Upstream Bio Reports Topline P-II (VALIANT) Trial Data on Verekitug in Severe Asthma

Shots: The global P-II (VALIANT) trial data assessed Verekitug vs PBO in 478 pts with severe asthma for ~60wks., with a minimum of 24wks. of treatment. Eligible pts could then enroll in the VALOUR LTE trial Trial met its 1EP, reducing annualized asthma exacerbation rates by 56% (100mg; Q12W) & 39% (400mg, Q24W), with FEV1…

ByRidhi RastogiFebruary 11, 2026

NEWS

OrsoBio Reports P-IIa Trial Data on TLC-2716 in Severe Hypertriglyceridemia and Metabolic Liver Disease

Shots: OrsoBio has reported topline P-IIa PoC trial data assessing TLC-2716 (6 or 12mg, QD, PO) vs PBO in 30 overweight pts with severe hypertriglyceridemia & metabolic dysfunction–associated steatotic liver disease (MASLD) The study met its 1EP, showing statistically significant reductions in fasting triglycerides & remnant cholesterol, plus improved liver fat by MRI-PDFF, with stronger lipid…

ByRidhi RastogiFebruary 11, 2026

NEWS

Zenas BioPharma Presents P-II (MoonStone) Trial Data on Obexelimab in Relapsing Multiple Sclerosis (RMS) at ACTRIMS Forum 2026

Shots: The P-II trial of obexelimab (250mg, SC, QW) vs PBO in RMS, met its 1EP with a 95% relative reduction in cumulative new Gd-enhancing T1 lesions over wks. 8 & 12, with near-complete suppression by wk. 8 sustained through wk. 12. Adjusted mean new lesions was 0.01 vs 0.23, only 2 vs 19 total…

ByRidhi RastogiFebruary 10, 2026

NEWS

MannKind Reports Initiation of P-II (INHALE-1st) Trial of Afrezza in Pediatric Patients with Newly-Diagnosed Type 1 Diabetes

Shots: MannKind has enrolled the first patient in the P-II (INHALE-1st) trial assessing initiation of Afrezza(insulin human) Inhalation Powder in pediatric pts shortly after their type 1 diabetes diagnosis Trial will evaluate Afrezza over 13wks., followed by an optional extension phase for pts continuing to use Afrezza with basal insulin up to 26wks., assessing the proportion…

ByRidhi RastogiFebruary 9, 2026

NEWS

Genentech Presents the P-III (FENtrepid) Trial Data on Fenebrutinib for Primary Progressive Multiple Sclerosis (PPMS) at ACTRIMS Forum 2026

Shots: Genentech has reported the P-III (FENtrepid) trial data assessing fenebrutinib (QD, PO) with IV Ocrevus-matching PBO vs Ocrevus & oral fenebrutinib-matching PBO in 985 adults with PPMS Trial met its 1EP, showing a 12% reduction in disability progression (cCDP12) with curves separating by wk. 24 & consistent benefit across subgroups & duration. The strongest effect was…

ByRidhi RastogiFebruary 9, 2026

Lundbeck Reports Topline P-IIb (PROCEED) Trial Results on Bocunebart in Migraine Prevention

Novartis Reports Final P-III (ALIGN) Trial Data on Vanrafia (Atrasentan) in IgA Nephropathy (IgAN)

AstraZeneca Reports P-III (LOGOS & KALOS) Trial Findings on Breztri Aerosphere for Uncontrolled Asthma

Adlai Nortye Doses First Patient in the P-I Trial of AN9025 to Treat Solid Tumors Harboring RAS Mutations

Merck Receives the FDA Approval for Keytruda and Keytruda Qlex, Plus CT ± Avastin to Treat PD-L1+ Pt-Resistant Ovarian Carcinoma

Upstream Bio Reports Topline P-II (VALIANT) Trial Data on Verekitug in Severe Asthma

OrsoBio Reports P-IIa Trial Data on TLC-2716 in Severe Hypertriglyceridemia and Metabolic Liver Disease

Zenas BioPharma Presents P-II (MoonStone) Trial Data on Obexelimab in Relapsing Multiple Sclerosis (RMS) at ACTRIMS Forum 2026

MannKind Reports Initiation of P-II (INHALE-1st) Trial of Afrezza in Pediatric Patients with Newly-Diagnosed Type 1 Diabetes

Genentech Presents the P-III (FENtrepid) Trial Data on Fenebrutinib for Primary Progressive Multiple Sclerosis (PPMS) at ACTRIMS Forum 2026

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