Pivotal B-Well data show a significant 19% functional cure in the overall study population and 26% in patients with lower viral activity.
– Pivotal B-Well data show significant 19% functional cure rate in the overall study population and 26% in patients with lower viral activity, compared to 0% with standard of care – – 49% of bepirovirsen recipients achieved a surface antigen level of ≤100 IU/mL one year after end of treatment in
Phase 3 trial met its primary endpoint, demonstrating bioequivalent drug exposure between the currently approved BRIUMVI Day 1 and Day 15 initiation dosing and a new single infusion on Day 1 only Safety and tolerability of the consolidated first infusion were consistent with the established BRIUMVI
Up to $1.3 billion in flexible, non-dilutive capital, including up to $800 million of synthetic royalty and access of up to $500 million in senior corporate debt Combined with company's current total cash of $1.3 billion, this transaction positions Apogee to achieve a self-sustainable financial
APEX Part B met all primary and secondary endpoints with high statistical significance; mid-dose zumilokibart planned to advance into Phase 3 trials in moderate-to-severe atopic dermatitis (AD) in 2H 2026 Zumilokibart was well tolerated with a safety profile consistent with other agents in class
Webcast to be held Wednesday, May 27th at 8:00 a.m. ET SAN FRANCISCO and BOSTON, May 26, 2026 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company advancing optimized, novel biologics with potential for best-in-class profiles in the largest
New and updated clinical data to be presented from over 30 patients across systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) studies Initial data from the first multi-dose cohort of RA study to be presented Initial data from the first multi-dose cohort of velinotamig study also to
The Phase 2b LUMA study of BIIB122 in early-stage Parkinson’s disease did not meet its primary or secondary endpoints Based on data from the Phase 2b LUMA study, Biogen and Denali will discontinue development of BIIB122 in idiopathic Parkinson’s disease Denali continues to independently conduct the
The Phase 2b LUMA study of BIIB122 in early-stage Parkinson’s disease did not meet its primary or secondary endpoints Based on data from the Phase 2b LUMA study, Biogen and Denali will discontinue development of BIIB122 in idiopathic Parkinson’s disease Denali continues to independently conduct
Normalization of free light chains occurred by day 15 across all doses 100% of patients achieved a hematologic complete response (CR) at the highest tested dose Majority of patients with renal or cardiac involvement demonstrated improvement in organ function, despite short follow-up First results
Updated Phase 2 CRDF-004 data to be presented during ASCO 2026 rapid oral session on June 2, 2026; investor webcast scheduled for June 3, 2026 at 8:30 am ET to review the data SAN DIEGO, Calif., May 21, 2026 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology
REDWOOD CITY, Calif., May 21, 2026 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced that members of Revolution Medicines’ senior management team will host a
- Webcast with Hepatitis B experts to discuss new biopsy and clinical data from the ongoing ELIMINATE-B trial in chronic hepatitis B - - Webcast will be held May 27 th, 2026, at 8:00 AM EDT - DURHAM, N.C. --(BUSINESS WIRE)--May 21, 2026-- Precision BioSciences, Inc.
In TRIUMPH-1, participants on 12 mg retatrutide lost an average of 70.3 lbs (28.3%) over 80 weeks with 45.3% of participants achieving ≥ 30% weight loss, a level long associated with bariatric surgery Individuals with a baseline BMI ≥ 35 who participated in a study extension continued to lose
Favourable trends seen in stability of disability and clinically meaningful improvements in fatigue. BOSTON, May 19, 2026 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) ("Tiziana"), a biotechnology company developing its lead candidate, intranasal foralumab, a fully human, anti-CD3
Event will provide an overview of Lymphatic Malformations, the treatment landscape and the TARA-002 clinical program NEW YORK, May 18, 2026 (GLOBE NEWSWIRE) -- Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage biotechnology company committed to advancing transformative therapies for the
Sac-TMT is the first TROP2 ADC to improve OS and PFS compared to chemotherapy in patients with advanced or recurrent endometrial cancer who have progressed after platinum-based chemotherapy and anti-PD-1/L1 immunotherapy in a global Phase 3 study RAHWAY, N.J.–(BUSINESS WIRE)– Merck (NYSE:...
CARLSBAD, Calif., May 17, 2026 (GLOBE NEWSWIRE) -- Design Therapeutics, Inc. (Nasdaq: DSGN), a clinical-stage biotechnology company developing treatments for serious degenerative genetic diseases, will announce data from the ongoing Phase 1/2 RESTORE-FA trial evaluating DT-216P2 in patients with
Positive Phase III readout of National Cancer Institute sponsored SWOG S1602 randomized clinical trial demonstrating non-inferior efficacy of the Tokyo strain of BCG ( Tokyo -172 BCG) versus TICE BCG in BCG-naïve high-grade non-muscle invasive bladder cancer ImmunityBio to serve as sole U.S.
The trial did not reach statistical significance for the primary endpoint of improvement in progression-free survival (PFS) A numeric improvement of 5.1 months in median PFS was observed for the high-dose fianlimab combination compared to pembrolizumab monotherapy Phase 3 head-to-head trial of the
- High CR rates at any time observed in the CIS-containing population with 85.7% and 92.3% in the ITT population and Efficacy Evaluable population, respectively - High-Grade - EFS in the overall intention-to-treat population was 96.0% at 3 months and 89.5% at 6 months - Efficacy was comparable
PRINCETON, N.J., May 15, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotechnology company focused on transforming the treatment of urothelial and specialty cancers, today announced UGN-103 achieved a 94.5% (95% CI: 86.1, 97.9) durability of response (DOR) at six months by
Phase 3 VIKTORIA-1 trial achieved primary endpoint with clinically meaningful improvement in progression-free survival in PIK3CA mutant cohort; detailed data for gedatolisib regimens will be presented at the 2026 ASCO Annual Meeting Phase 3 VIKTORIA-2 trial expanded to include a second study
Company announced positive topline results from pivotal Phase III AFFINITY DUCHENNE ® study of RGX-202 Primary endpoint achieved with high statistical significance Statistically significant correlation between RGX-202 microdystrophin expression and functional improvement (NSAA, n=9), supporting
- Based on the strength of the biomarker and efficacy data, Biogen plans to advance diranersen to registrational development; CELIA did not meet its primary endpoint assessing dose response - - Robust reductions in tau pathology were observed across all studied doses, with results generally
Achieved primary endpoint with high statistical significance; 93% of patients achieved microdystrophin expression above 10% (p
Intending to initiate rolling BLA seeking accelerated approval with submission of nonclinical and clinical modules in June 2026; submission of the final modules including the CMC module expected in second half of 2026 Cross-species nonclinical findings that support skin frataxin levels as a
CELIA did not meet its primary endpoint assessing dose response; based on the strength of the biomarker and efficacy data, Biogen plans to advance diranersen to registrational development Robust reductions in tau pathology were observed across all studied doses, with results generally consistent
In ATTAIN-MAINTAIN, participants who transitioned from a maximum tolerated dose (MTD) of Wegovy (semaglutide) to Foundayo maintained all but 0.9 kg of their previously achieved weight loss on average after one year In ATTAIN-MAINTAIN and SURMOUNT-MAINTAIN, participants who switched from Zepbound
Next anticipated Revita ® clinical data readouts are 1-year data from the REVEAL-1 Cohort in Q2 2026 and 1-year randomized data from the REMAIN-1 Midpoint Cohort in Q3 2026 Early Q4 2026 timing for topline 6-month randomized data from the REMAIN-1 Pivotal Cohort and late Q4 2026 timing for
Detailed results from RISE UP Phase 3 trial of mitapivat in sickle cell disease selected for distinguished Plenary Abstracts Session Company to host investor conference call and webcast during EHA 2026 on Saturday, June 13, at 9:00 a.m. ET ( 3:00 p.m.
Positive topline results from Phase 2/3 Study ‘302’ position VDPHL01 to potentially become the first FDA-approved oral treatment for pattern hair loss in nearly 30 years Upsized IPO and follow-on financing generated approximately $766.8 million in aggregate gross proceeds; pro forma cash expected
On track to report topline data from Phase 3 LEVEL study of TNX-103 in third quarter of 2026 Global Phase 3 LEVEL-2 clinical trial ongoing, enrollment completion anticipated by end of 2027 Strengthened leadership team with appointments of Thomas Staab as Chief Financial Officer and Timothy Healey,
– LUMRYZ Met All Primary and Key Secondary Endpoints Demonstrating Statistically Significant and Clinically Meaningful Improvements Compared to Placebo in Excessive Daytime Sleepiness and Patient-Reported Disease Severity – – Safety Profile Consistent With Known Safety Profile of LUMRYZ – DUBLIN
Compelling Phase 1 Data for SEP-631 (MRGPRX2 NAM) in Healthy Volunteers Support Phase 2b Development, Initially in Chronic Spontaneous Urticaria (CSU) in Second Half of 2026 Phase 1 Clinical Trial Initiated for SEP-479, Oral Small Molecule PTH1R Agonist for Hypoparathyroidism Cash Position of
Zumilokibart advancing across multiple indications, with Phase 3 initiation in atopic dermatitis (AD) expected later this year: - APEX Phase 2 Part A 52-week data demonstrated durable maintenance and improved efficacy over time with every 3- and 6-month dosing in moderate-to-severe AD - APEX Phase
- Data from Phase 1b/2 trial of evorpacept + zanidatamab presented at ESMO Breast Cancer 2026 showed all patients with confirmed HER2-positive disease and high CD47 expression experienced durable responses to this combination - - Evorpacept data from two independent HER2-positive trials strengthens
Reported positive results from aleniglipron Phase 2 ACCESS II study with up to 16.3% body weight loss, demonstrating highest efficacy among oral GLP-1RAs at the 44-week time point and potentially comparable efficacy to injectable GLP1-RAs Data from ACCESS OLE expected in Q3 2026; Data from the
Completion of Lead Clinical Candidate PH-762 Dose Escalation Trial for Treatment of Skin Cancer with Favorable Safety and Pathology Data Key Development Agreements Secured for Nonclinical Toxicology and U.S. cGMP Clinical Supply ManufacturingKing of Prussia, Pennsylvania--(Newsfile Corp. - May 7, 2026) - Phio Pharmaceuticals Corp. (NASDAQ:...
Soquelitinib clinical development for atopic dermatitis advancing with Phase 1 cohort 4 positive data and initiation of Phase 2 trial during the quarter New immunologic and biomarker data supporting the potential for drug-free remissions with soquelitinib to be presented at Society for
First presentation of Week 24 results from TRuE-AD4 study in adults with moderate atopic dermatitis (AD) who had an inadequate response, intolerance or contraindication to topical corticosteroids (TCSs) and topical calcineurin inhibitors (TCIs) at the 2026 EADV Symposium The vast majority of
Final UPMC Primary Endpoint Report Details Positive Data from Ovarian Cancer Clinical Trial Combining Ampligen, Pembrolizumab and Cisplatin OCALA, Fla., May 07, 2026 (GLOBE NEWSWIRE) — AIM ImmunoTech Inc. (NYSE American:...
-- Announced positive ELEVATE-44-201 Cohort 1 topline results in Duchenne muscular dystrophy showing favorable safety, tolerability and early functional benefit -- -- Company on track to report ELEVATE-45-201 Cohort 1 data in mid-2026, as well as ELEVATE-44-201 open-label period and Cohort 2 data
Phase 2a follow-up period data for RAP-219 in focal onset seizures (FOS) demonstrated sustained seizure reduction, including a 90% median reduction in clinical seizures over baseline in weeks 9-12 RAP-219 Phase 2 trial in bipolar mania topline results now expected in the fourth quarter of 2026,
-- Achieved the primary objective with favorable safety and tolerability, no discontinuations and no serious adverse events -- -- Markers of kidney function via eGFR, Cystatin C and magnesium were all within normal ranges and comparable to placebo -- -- Observed lower plasma exposure in Cohort 1
- Full Top Line Results from Phase 1a SAD/MAD Trial of ATI-052 Exceed Aclaris’ Target Profile, Validating Potential Best-in-Class Potency Advantage and Opportunity for Extended Dosing - - Unique Dual Mechanism of ATI-2138 Supports Planned Phase 2b Clinical Trial in Lichen Planus - - Strong Cash
Data contributed to the scientific and clinical rationale for RASolute 302, a pivotal Phase 3 trial in second line treatment of patients with metastatic pancreatic cancer REDWOOD CITY, Calif., May 06, 2026 (GLOBE NEWSWIRE) -- Revolution Medicines, a late-stage clinical oncology company developing
BOSTON, May 06, 2026 (GLOBE NEWSWIRE) -- Entrada Therapeutics, Inc. (Nasdaq: TRDA) will announce topline results from Cohort 1 of the double-blind, placebo-controlled, multiple ascending dose portion of the Phase 1/2 ELEVATE-44-201 clinical study of ENTR-601-44 on Thursday, May 7, 2026.
One-Year Cohort 1 Data and Initial Cohort 2 Data from RIDGE™-1 Phase 1b/2 Trial of TN-401 for PKP2-Associated ARVC to be Presented at ASGCT 2026 New Data from Both Cohorts of the MyPEAK™-1 Phase 1b/2 Trial of TN-201 for Adults with MYBPC3-Associated HCM Expected in the Second Quarter 2026
COPENHAGEN, Denmark, May 06, 2026 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced new data from a subgroup analysis showing that children with achondroplasia ≥5 years of age at enrollment treated with once-weekly TransCon CNP (navepegritide) in its pivotal ApproaCH Trial
-- Company will also report first quarter 2026 financial results and operational highlights -- ROCKVILLE, Md., May 6, 2026 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that it will host a webcast on Thursday, May 14, 2026, at 8:00 a.m.
FDA Breakthrough Therapy designation granted to zovegalisib for PIK3CA-mutant, HR+/HER2- advanced breast cancer, the Phase 3 ReDiscover-2 trial population in 2L breast cancer Presented zovegalisib doublet data at Phase 3 dose in CDK4/6-experienced patients at ESMO TAT, demonstrating 11.1-month
Conference Call and Webcast Today at 8:30 a.m. ET Positive 12-month data from the OCU410 Phase 2 ArMaDa clinical trial for geographic atrophy (GA) indicates a statistically significant (p
Announced positive topline induction data from Part A of the Phase 2 SKYLINE trial of SPY001, demonstrating best-in-class efficacy potential and a safety profile consistent with the α4β7 class Announced over-enrollment and acceleration of topline readout to the third quarter of 2026 of the
Robust B-cell depletion observed with budoprutug subcutaneous formulation in healthy volunteers, supporting continued development Budoprutug pMN, ITP, and SLE clinical trials enrolling to plan; Fast Track Designation received for pMN Initial data from ITP trial anticipated in June; initial data
- REVEAL-2 met its primary endpoint with a highly statistically significant treatment effect - - Elegrobart Q4W and Q8W achieved 50% and 54% proptosis responder rates (PRR) at week 24, respectively, versus 15% placebo, both highly statistically significant results (p 0.0001) - - Elegrobart Q4W
Dupixent showed significant and clinically meaningful improvements in both esophageal distensibility as well as disease-related structural changes and inflammation in the esophagus in adult patients with EoE at week 24 compared to placebo, in results presented at DDW These results reinforce the
In LUCENT-3, more than 60% of patients who achieved disease clearance at one year maintained it after four years of continuous Omvoh treatment Disease clearance is a high clinical bar in UC requiring simultaneous symptomatic, endoscopic and histologic remission INDIANAPOLIS, May 5, 2026
Conference Call Scheduled for Friday, May 15, 2026, at 1:00 PM ET NEEDHAM, Mass., May 04, 2026 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal immunotherapies to improve outcomes for
Conference Call Scheduled for Friday, May 15, 2026, at 1:00 PM ET NEEDHAM, Mass., May 04, 2026 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal immunotherapies to improve outcomes for
-- Data support potentially best-in-class profile of XmAb942, under evaluation in ongoing global Phase 2b XENITH-UC study on track for 12-week induction results in 2027 -- -- Novel XenLock™ format optimizes bispecifics for treatment of autoimmune diseases; first XenLock™ candidate XmAb412
Detailed data for the gedatolisib triplet and doublet regimens will be presented at a late-breaking abstract oral session at the 2026 ASCO Annual Meeting MINNEAPOLIS, May 01, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of
Positive Phase 1 data confirm MP0317’s tumor-localized CD40 activation with a favorable safety profile in patients with advanced cancer types Pharmacokinetic profile of MP0317 well suited for combination treatment settings, including checkpoint inhibitors Randomized Phase 2 investigator-initiated
- The trial achieved its primary endpoint demonstrating favorable safety and tolerability - Encouraging trends observed across multiple exploratory efficacy endpoints including improvements in measures of pain and other functional patient-reported outcomes - Results support further evaluation of
With recent FDA acceptance of the Phase 2a multidose portion of INLIGHT trial of WVE-007 (INHBE GalNAc-siRNA) in individuals with higher BMI, with and without type 2 diabetes, this portion of the trial remains on track to initiate in 2Q 2026 Combination and maintenance trials of WVE-007 on track
- Positive Full Results from Phase 1a Trial of Anti-TSLP/IL-4Rα Bispecific Antibody ATI-052 Exceed Aclaris’ Target Profile, Validating Potential Best-in-Class Potency Advantage and Opportunity for Extended Dosing - - Estimated Half-Life of Approximately 45 Days; Unlocks Opportunity for up to
A 52% increase from baseline in mean C-peptide AUC at Week 12 in patients diagnosed within 0–3 years (n=5) receiving icovamenib 200 mg, with a clear dose response observed vs 100 mg (n=6) Persistence observed through Week 52, with mean C-peptide AUC largely preserved in 200 mg group (~7% decline
WAYNE, Pa., April 27, 2026 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases, today announced that it will provide the full results from its Phase 1a single and
Conference call and live webcast today at 4:30 PM Eastern Time SAN DIEGO, April 27, 2026 (GLOBE NEWSWIRE) -- Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK
DURHAM, N.C., April 27, 2026 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced that it will host a virtual key opinion leader (KOL) event on
Tovecimig (a DLL4 x VEGF-A bispecific antibody) in combination with paclitaxel demonstrated a highly statistically significant improvement versus paclitaxel alone in the key secondary endpoint of median progression-free survival (PFS) of 4.7 months versus 2.6 months, providing a 56% reduction in
SAN DIEGO, April 27, 2026 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced that the Company will host a key opinion leader (KOL) webinar to discuss data
VDPHL01, a novel orally-administered extended-release minoxidil formulation, met all primary and all key secondary endpoints with high statistical significance in both active treatment arms evaluating once-daily (QD) and twice-daily (BID) administration of VDPHL01 Rapid and robust hair growth was
Conference call will take place on Monday, April 27, 2026 at 8:00 am ET NEW HAVEN, Conn. --(BUSINESS WIRE)--Apr. 26, 2026-- Veradermics, Incorporated (NYSE: MANE), a dermatologist-founded, late-stage biopharmaceutical company focused on developing innovative therapeutics for pattern hair loss,
MENLO PARK, Calif., April 26, 2026 (GLOBE NEWSWIRE) -- Oruka Therapeutics, Inc. (“Oruka”) (Nasdaq: ORKA), a clinical-stage biotechnology company developing novel biologics designed to set a new standard for the treatment of chronic skin diseases, today announced it will report Week 16 data for
Webcast scheduled for Monday, April 27, 2026 at 8:00am ET. BOSTON, April 24, 2026 (GLOBE NEWSWIRE) -- Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases,
RNS Number: 4332B PureTech Health PLC 22 April 2026 22 April 2026 PureTech Health plc PureTech Reports Positive Topline Data from Phase 1b Trial of LYT-200 in Relapsed/Refractory (R/R) High-Risk (HR) Myelodysplastic Syndrome (MDS) and R/R Acute Myeloid Leukemia (AML) Phase 1b dataset with
EMP-01 demonstrated a large, clinically meaningful reduction in patient-reported SAD symptoms at Day 43: placebo-adjusted LSMD -11.5 points (p=0.002) on SPIN; placebo-adjusted LSMD -15.6 points (p=0.004) on SAFE - a 38% and 32% reduction, respectively Patient-perceived global improvement: 49% PGI-C
Late-breaking Phase III FENhance 1 and 2 study results showed superiority of investigational fenebrutinib compared to teriflunomide in reducing relapses and brain lesions in relapsing multiple sclerosis (RMS) Both studies showed positive trends in reducing disability progression with fenebrutinib compared to teriflunomide Fenebrutinib could become a...
Single-dose of miv-cel achieved robust and durable improvements in mobility, reversed disability scores, and eliminated the need for chronic immunotherapies – outcomes not previously observed in SPS Data underscore potential for miv-cel to become the first and only approved treatment for SPS,
Phase III METEOROID study met its primary endpoint in patients with myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) MOGAD is a rare autoimmune disease of the central nervous system characterised by unpredictable attacks of the optic nerves, spinal cord or brain that are often severe and debilitating Data will be submitted to...
As published in The Lancet and presented at AAN, NIMBLE trial met its primary and key secondary endpoints at week 24, demonstrating potential best-in-class efficacy and convenience in gMG U.S. regulatory application submitted; cemdisiran could be the first siRNA to be approved for the treatment
Two oral presentations including late-breaker at SID Data will cover Phase 1 clinical trial of soquelitinib for atopic dermatitis, including new immunologic and biomarker data supporting drug-free remissions Investor and analyst meeting scheduled for 1:30 pm ET ( 12:30 pm CT) on May 14, 2026
120 mg and newly announced 60 mg once-daily doses each achieved ≥85% median hsCRP reductions in participants with obesity and elevated baseline inflammation BGE-102 was well tolerated across all dose levels Phase 2 proof-of-concept trial in cardiovascular risk planned to initiate mid-2026, with
This is the first release of 36-week symptom response & tissue health data for the highest dose (Cohort 9) from the dose escalation portion of Eupraxia’s RESOLVE trial. At 36 weeks, patients in Cohort 9 (n=3) demonstrated a robust response in both tissue health and symptom response compared to
21 April 2026 Ultomiris demonstrated statistically significant and clinically meaningful reduction of proteinuria in adults with immunoglobulin A nephropathy in I CAN Phase III trial Ultomiris delivered rapid reduction in proteinuria as early as week 10 Results show potential for terminal C5 complement inhibition with Ultomiris as a disease-modifying...
100% of patients achieved rapid, sustained improvements across MG-ADL and QMG at 24 weeks, further increasing confidence in Phase 3 trial Totality of efficacy and safety data reinforces miv-cel’s differentiated and potential best-in-class profile for delivering durable, drug-free, disease-free
29% and 31% of patients in the 18 µg/kg and 24 µg/kg extension arms, respectively, achieved new SALT Score ≤20 from week 36 to week 52 with continued twice-monthly treatment Increasing proportions of patients achieved clinically meaningful hair growth thresholds across numerous SALT measurements
20 April 2026 Tozorakimab met primary endpoint in Phase III MIRANDA trial in patients with COPD Third positive pivotal Phase III clinical trial of AstraZeneca's IL-33-targeting biologic further demonstrates its benefits in COPD Positive high-level results from the pivotal Phase III MIRANDA trial showed potential first-in-class tozorakimab demonstrated a...
Azetukalner data show significant reductions in seizure frequency across weekly, monthly and multi-year time points X-TOLE2 data featured in Late-breaking Science session show 53.2% reduction in monthly seizure frequency in 25 mg group vs. 10.4% for placebo and increasing rates of 100% seizure
SAN FRANCISCO, April 19, 2026 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR), a clinical-stage biotechnology company focused on development of novel immunology therapies, today announced it will host an investor call and live webcast to review 52-week topline results from the 16-week extension
First study of agenT-797, botensilimab (BOT) and balstilimab (BAL) in gastroesophageal cancer shows disease control rate (DCR) in 77% of patients and long-term survival beyond 20 months in a subset of patients Induction strategy linked to improvement in PFS (HR 0.19; p=0,015) and survival rates at
Data from subset analysis of cabozantinib-pretreated patients support potential to overcome resistance and resensitize tumors to VEGF TKI therapy 44% ORR and 94% DCR in ccRCC patients previously treated with cabozantinib, with tumor shrinkage observed in 75% of patients Responses observed in
In ACHIEVE-4, Foundayo met the primary objective of non-inferiority vs. insulin glargine with a 16% lower risk of MACE-4 events and a 23% lower risk of MACE-3 events In a pre-planned analysis, the risk of all-cause death was 57% lower for Foundayo vs.
Trial met all primary and key secondary endpoints, including progression-free survival and overall survival Company intends to include these data in a future New Drug Application submission to the U.S. Food and Drug Administration and to other global regulatory authorities REDWOOD CITY, Calif.,
SPY001 met its primary endpoint with a statistically significant reduction of 9.2 points (p
BRUIN CLL-322 is the first Phase 3 readout in CLL to utilize and outperform a venetoclax-containing control arm This trial predominantly enrolled a patient population previously treated with covalent BTK inhibitors, highly relevant to current practice These results mark the fourth positive Phase 3
Promising efficacy and safety profile supports start of five pivotal phase III trials in 2026.
Trastuzumab pamirtecan, an investigational HER2-targeted antibody-drug conjugate, met the primary efficacy endpoint in a Phase 2 cohort of heavily pre-treated patients with HER2-expressing, recurrent endometrial cancer, an area of high unmet medical need Data demonstrated clinically meaningful
WALTHAM, Mass., April 10, 2026 (GLOBE NEWSWIRE) -- Spyre Therapeutics, Inc. (NASDAQ: SYRE), a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease (IBD) and rheumatic diseases, today
SOUTH SAN FRANCISCO, Calif., April 10, 2026 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, today announced the Company will host a
EMERYVILLE, Calif., April 09, 2026 (GLOBE NEWSWIRE) -- Kyverna Therapeutics, Inc. (Kyverna, Nasdaq: KYTX), a late-stage clinical biopharmaceutical company focused on developing cell therapies for patients with autoimmune diseases, today announced it will host a conference call on Wednesday, April
Data build on findings presented at ESMO 2025 and support potential of darlifarnib to overcome resistance and resensitize tumors to VEGFR TKI therapy Virtual investor call on April 17, 2026, at 7:30 a.m. PT / 10:30 a.m. ET / 4:30 p.m. CEST SAN DIEGO, April 09, 2026 (GLOBE NEWSWIRE) -- Kura
- Unprecedented improvements in arm span observed with TransCon CNP and TransCon hGH combination therapy, a measure highly meaningful to the achondroplasia community - Enhanced improvements in spinal canal dimensions observed with TransCon CNP and TransCon hGH combination therapy compared to
66.7% of participants achieved an antidepressant response by Day 2 following a single intranasal dose of BPL-003 in both the 10 mg (n=6) and 12 mg (n=6) cohorts Durable responses observed at Day 85: 83% (5/6) (10 mg) and 66.7% (4/6) (12 mg) BPL-003 received FDA Breakthrough Therapy Designation in
Trial extension completed as planned with three-year clinical efficacy data expected to be presented in the second half of 2026 The trial has already yielded encouraging one- and two-year data including a 75% Objective Response Rate COPENHAGEN, Denmark, April 7, 2026 - Evaxion A/S (NASDAQ: EVAX)
Primary and Key Secondary Endpoints Met 77% of Patients Achieved Highly Statistically Significant Proptosis Response Study Showed Clinically Meaningful Reduction in Proptosis; Greater Than 3 mm THOUSAND OAKS, Calif., April 6, 2026 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced positive
Elsunersen demonstrated placebo-adjusted seizure reduction from baseline of 77% (p=0.015) 71% of elsunersen-treated patients achieved >50% seizure reduction by period 6, with sustained benefit observed in the open-label extension for up to one year 100% of elsunersen patients - and none on placebo
Deupirfenidone 825 mg TID monotherapy significantly slowed lung function decline versus placebo at 26 weeks in people with idiopathic pulmonary fibrosis (adjusted mean FVC difference 91 mL; p=0.02), approaching the lung function change expected in normal, healthy aging First industry-sponsored IPF
Lichen planopilaris (LPP) is a highly morbid inflammatory scalp disorder that causes generally irreversible scarring hair loss, often accompanied by profound pain, itch, and burning sensations; no FDA-approved therapies exist for LPP, highlighting a critical unmet therapeutic need LPP marks the
2 April 2026 Imfinzi plus Imjudo combined with lenvatinib and TACE demonstrated a statistically significant and clinically meaningful improvement in progression-free survival in embolisation-eligible unresectable liver cancer in EMERALD-3 Phase III trial Imfinzi plus Imjudo combined with lenvatinib and transarterial chemoembolisation (TACE) showed trend...
PureTech Health plc PureTech Founded Entity Seaport Therapeutics Announces Positive Proof of Concept Topline Results from Ongoing Phase 1 Trial of GlyphAgo TM in Healthy Volunteers PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a hub-and-spoke biotherapeutics company
Prestigious Publication Reinforces risto-cel’s Durable, Differentiated Clinical Data for the Treatment of SCD with Severe Vaso-occlusive Crises (VOCs) Initially Presented at ASH, Data from 31 Patients with SCD Demonstrated Deep Resolution of Red Blood Cell Dysfunction and Reduced Time in Hospital
In 2025, muzastotug showed 29% confirmed overall response rate (ORR) among 21 patients with MSS CRC in the 20 mg/kg dose cohorts Median overall survival (OS) for the 10 mg/kg cohorts was 19.4 months, with a median follow-up of 17.8 months 4% overall discontinuation rate, no dose limiting
– Released positive topline data from Phase 1 study of IV rademikibart in patients with asthma or COPD – – Results from Phase 3 study of rademikibart in moderate-to-severe AD presented in late-breaking research session at AAD – – Recruitment ongoing for Phase 2 Seabreeze STAT studies for acute
This announcement contains inside information 31 March 2026 Efzimfotase alfa demonstrated positive results from global Phase III clinical programme in hypophosphatasia MULBERRY randomised, placebo-controlled trial showed efzimfotase alfa demonstrated statistically significant and clinically meaningful improvement in bone health in treatment-na•ve paediatric...
– PGN-EDODM1 was generally well-tolerated with all adverse events mild or moderate and no serious adverse events reported – – Mean splicing correction of 7.3% observed with PGN-EDODM1 (n=6) versus 6.8% with placebo (n=2); Excluding one outlier patient, treatment group demonstrated mean splicing
PALI-2108 demonstrated favorable safety and tolerability with no serious adverse events after two weeks of treatment in a difficult-to-treat population Phase 1b data demonstrate endoscopic improvement, with a 47.5% reduction in SES-CD score and 40% of patients achieving endoscopic response and 40% of patients achieving endoscopic remission Pharmacokinetic...
- REVEAL-1 met the primary endpoint of Q4W proptosis responder rate (PRR) with a highly statistically significant treatment effect - - Elegrobart Q4W and Q8W achieved clinically meaningful 54% and 63% PRR versus 18% placebo at week 24 - - Complete resolution of diplopia in 51% of patients treated
72.2% Probability of Remaining Event-Free at 24 Months by Kaplan-Meier Analysis After Achieving Complete Response at Three Months (79.6%) PRINCETON, N.J., March 30, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative
– Rademikibart achieved rapid, durable efficacy results across all key endpoints through 52 weeks, with near ‑ maximal responses achieved in ~90% of patients – – Rademikibart was well tolerated with safety comparable to placebo – – Data presented during late-breaking oral presentation at 2026
– Rademikibart administered as a single 300 mg 2-minute IV push to asthma and chronic obstructive pulmonary disease ( COPD) patients produced rapid improvement in FEV 1 with many patients experiencing improvements in airway function of ≥200 mL as early as 15 minutes post-dosing – – The rapid
New data for NMRA-511 supports unsurpassed clinical effect in a pre-specified population comparable to Rexulti and Auvelity pivotal studies KOASTAL-2 and -3 fully enrolled in the first quarter of 2026; on track for topline readout in the second quarter of 2026 NMRA-898 selected as lead program in
Basel, March 29, 2026 – Novartis today announced final two-year results from the Phase III APPLAUSE‑IgAN study of Fabhalta ® (iptacopan) in IgA nephropathy (IgAN). Fabhalta demonstrated a statistically significant, clinically meaningful improvement in estimated glomerular filtration rate (eGFR) slope, a key marker of kidney function, compared with placebo 1...
Results from the Phase 3 VELA clinical trials in adults with moderate-to-severe hidradenitis suppurativa (HS) show that clinical responses continue to improve to Week 40, with 62% of patients treated with sonelokimab (SLK) achieving HiSCR75 and up to 32% of patients achieving HiSCR100 An analysis
The results of the Phase 3 VALOR trial were published in the New England Journal of Medicine, underscoring the practice-changing potential of brepocitinib 30 mg once-daily in dermatomyositis Brepocitinib 30 mg was superior to placebo on the primary and all nine key secondary endpoints, with
In the Phase 2 part of the AMETHYST study, litifilimab met the primary endpoint of reduction of disease activity in people living with CLE at Week 16, with more litifilimab participants achieving clear / almost clear skin Following positive Phase 2 LILAC results, litifilimab is the only
Envudeucitinib achieved robust PASI responses by Week 16, with significant continued improvements by Week 24 in PASI 90 (68.0%, 62.1%) and PASI 100 (41.0%, 39.5%) Quality‑of‑life improvements and itch relief emerged ahead of PASI 90 skin clearance, and clear or almost clear scalp psoriasis emerged
Company to host a conference call and webcast on Tuesday, March 31, 2026 at 4:30 pm ET SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, March 27, 2026 (GLOBE NEWSWIRE) -- ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms
This announcement contains inside information 27 March 2026 Tozorakimab met primary endpoint in both OBERON and TITANIA Phase III trials in patients with COPD First-ever IL-33-targeting biologic to demonstrate statistically significant and highly clinically meaningful reductions in COPD exacerbations in two replicate Phase III clinical trials Positive...
BAAR, Switzerland --(BUSINESS WIRE)--Mar. 26, 2026-- Novocure (NASDAQ: NVCR) announced positive results today from the Phase 2 PANOVA-4 trial of Tumor Treating Fields (TTFields) therapy concomitant with atezolizumab (Tecentriq ®), gemcitabine and nab-paclitaxel (gem/nab-pac) as a first-line
Building on the success of GLOW1 and with all patients on a 6-month dosing interval, Zenkuda (tarcocimab tedromer) demonstrated superiority to sham with 62.5% of Zenkuda-treated patients achieving a ≥2-step improvement in diabetic retinopathy severity score (DRSS) compared to 3.3% of sham-treated
In early clinical results, Sarepta’s αvβ6 integrin-targeted siRNA approach achieves high muscle concentrations without dose limiting toxicity for FSHD1 and DM1 Company to host investor call on March 25, 2026, at 8:30 a.m. Eastern time CAMBRIDGE, Mass. --(BUSINESS WIRE)--Mar.
Treatment with 60 mg of BEAM-302 Led to Mean Steady-state Total AAT Level of 16.1 µM and All Patients Consistently and Durably Above the 11 µM Protective AAT Threshold with up to 12 Months of Follow-up Corrected M-AAT Comprised 94% of Total AAT with a Concomitant 84% Reduction in Mutant Z-AAT
CAMBRIDGE, Mass. --(BUSINESS WIRE)--Mar. 24, 2026-- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that on Wed., March 25, 2026, at 8:30 am Eastern Time, the Company will host a webcast and conference call to present the early
Optimal dose intended for Phase 3 demonstrates statistically significant reduction in lesion growth (31%) versus control at 12 months (p 0.05) Potential 2X treatment benefit compared to 15% and 22% reductions reported for currently approved therapies at 12 and 24 months, respectively No serious
~ Delivered Record Annual Revenue with Full-Year Net PEDMARK ® Product Sales of $44.6 Million, Representing 50% Year-Over-Year Growth, and Q4 2025 Net Product Sales of $13.8 Million, Representing 75% Growth Over Q4 2024 Net Product Sales ~ ~ Executed on 2025 Clinical Data Strategy to Expand
Vaccine candidate PF-07307405 (LB6V) demonstrated more than 70% efficacy in preventing Lyme disease in individuals aged five years and above The investigational vaccine candidate was well tolerated with no safety concerns identified at time of analysis Overall, results strengthen confidence in the vaccine candidate and Pfizer is planning submissions to...
MALVERN, Pa., March 23, 2026 (GLOBE NEWSWIRE) -- Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that it will host a conference call and live webcast with key opinion leaders (KOLs) and Ocugen
APEX Part A data demonstrated durable maintenance of response at 52-weeks for every 3- and 6-months dosing, respectively, including: - 75% and 85% patients maintained EASI-75 - 86% and 78% patients maintained vIGA 0/1 Deepening of response was observed across all lesional and itch endpoints with
Webcast to be held Monday, March 23rd at 8:00 a.m. ET SAN FRANCISCO and BOSTON, March 22, 2026 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company advancing optimized, novel biologics with potential for best-in-class profiles in the largest
Based on the Strength of Unprecedented Results from the Positive Phase 1/2 Study in Adults Aged 50 and Older, Vaxcyte Advanced VAX-31 High Dose into Comprehensive Phase 3 Adult Program; Topline Data from the OPUS-1 Pivotal Noninferiority Trial Expected in the Fourth Quarter of 2026 At All Doses
Phase 1 APOLLO data update demonstrated encouraging clinical activity with a 66% objective response rate in relapsed non-Hodgkin lymphoma, including 50% complete responses Research published in Nature Medicine highlighted promising results of multi-antigen targeted T cells in pancreatic cancer
– Phase 3 data presentation highlighting results from the ONWARD1 and ONWARD2 clinical trials of envudeucitinib – – Phase 2 STRIDE e-poster presentation to describe disease biomarker activity of envudeucitinib – – Alumis to host investor webcast on Sunday, March 29, 2026, at 5:00 pm MDT / 7:00 pm
– ARV-102 reduced endolysosomal and neuroinflammatory biomarkers implicated in Parkinson’s disease and progressive supranuclear palsy – – ARV-102 was well tolerated across all dose levels following 28 days of once-daily dosing – – Data support further development of ARV-102 in additional
- Annualized height velocity of 9.05 cm/year (LS mean) for TransCon hGH-treated children was similar at Week 52 to daily somatropin-treated children - TransCon hGH showed a safety and tolerability profile comparable to daily somatropin with no occurrences of slipped capital femoral epiphysis
Extended long-term survival observed after an additional year of follow-up in ongoing phase 2a clinical trial, with 50% of 46 patients with advanced non-small cell lung cancer (NSCLC) treated with aglatimagene besadenovec (aglatimagene or CAN-2409) surviving beyond 24 months, despite prior
Extended long-term survival observed after an additional year of follow-up in ongoing phase 2a clinical trial, with 50% of 46 patients with advanced non-small cell lung cancer (NSCLC) treated with aglatimagene besadenovec (aglatimagene or CAN-2409) surviving beyond 24 months, despite prior
For the first time, Eupraxia is reporting 24-week data on symptom response from the highest dose cohort in the open label, Phase 1b/2a portion of the RESOLVE trial. The data is important because it is from one of the two doses that are being studied in the placebo-controlled Phase 2b portion of the
Phase 2/3 Duravelo-2 pivotal trial evaluating zelenectide pevedotin (zelenectide) plus pembrolizumab in metastatic urothelial cancer (mUC) successfully identifies 6mg/m 2 zelenectide two weeks on, one week off dose (6mg dose) as optimal, demonstrating response rates comparable to published rates
NEW YORK, March 17, 2026 (GLOBE NEWSWIRE) -- AtaiBeckley Inc. (NASDAQ: ATAI) (“AtaiBeckley” or “Company”), a clinical-stage biotechnology company on a mission to transform patient outcomes by developing rapid-acting, durable and convenient mental health treatments, today announced the peer-reviewed
- Announced Positive Data from Phase 1 Dose Expansion Study of varsetatug masetecan (“Varseta-M”) EpCAM PROBODY ® ADC in Patients with Advanced Colorectal Cancer (CRC) - - FDA interactions targeted for mid-year with goal to align on potential Varseta-M registrational trial design in late line CRC -
Placebo-adjusted mean weight loss of 16.3% (39 lbs) at 180 mg and 16.0% (37 lbs) at 240 mg at 44 weeks with no evidence of weight loss plateau in ACCESS II, demonstrating highest efficacy among oral GLP-1RAs and comparable efficacy to injectable GLP1-RAs Continued weight loss up to 16.2% (40.5 lbs)
- Confirmed response rates in expansion cohorts of 32% at 10 mg/kg Q3W dose and 20% at 8.6 mg/kg Q3W - - Estimated progression free survival of 7.1 months at 10 mg/kg and 6.8 months at 8.6 mg/kg - - Grade 3 diarrhea rate of 10% in ongoing dose optimization cohorts - - FDA interactions targeted for
Groundbreaking First-in-Human Study Demonstrates Potential to Treat Type 1 Diabetes by Transplanting Insulin-Secreting Cells Without Immunosuppression 14-Month Follow-up Data Show Hypoimmune (HIP)-Modified Islets are Safe, Evade Detection by the Immune System, Survive Long-Term, and Continue to
Announced data from cohort 4 of soquelitinib atopic dermatitis Phase 1 trial demonstrating positive safety and efficacy results, including in patients who have received prior systemic therapy Initiated soquelitinib atopic dermatitis Phase 2 trial Completed public offering raising net proceeds of
Statistically significant improvements in primary endpoint of ammonia control compared with placebo at 36 weeks Clinically important changes observed in patient global impression scale for overall OTC symptoms, OTC deficiency symptoms, and OTC impact on daily living DTX301 was well tolerated with
As previously presented, gedatolisib + palbociclib + fulvestrant (“gedatolisib triplet”) and gedatolisib + fulvestrant (“gedatolisib doublet”) reduced the risk of disease progression or death versus fulvestrant by 76% and 67%, respectively MINNEAPOLIS, March 09, 2026 (GLOBE NEWSWIRE) -- Celcuity
Compelling Phase 1 Data for SEP-631 (MRGPRX2 NAM) in Healthy Volunteers Support Phase 2b Development, Initially in Chronic Spontaneous Urticaria (CSU) in Second Half of 2026 Advancing SEP-479 (PTH1R Agonist) Toward Phase 1 Initiation in First Half of 2026 Cash Runway Expected to Support Operating
• Phase 2b study demonstrated greater reductions in inflammatory acne lesions with Ameluz ® PDT versus vehicle • 3-hour incubation regimen identified as the most promising protocol for further clinical development • Acne vulgaris represents a promising poten...
X-TOLE2 met primary endpoint in both dose groups, including -53.2% median percent change (MPC) from baseline in monthly FOS frequency with 25 mg dose compared with -10.4% for placebo (p=0.000000000006) X-TOLE2 outperformed Phase 2b X-TOLE study, with a placebo-adjusted MPC of -42.7% in 25 mg group
VIS-101, purpose-designed to be best-in-class for retinal vascular diseases, is a tetravalent, dual VEGF-A X ANG-2 inhibitor Topline Phase 2a data show VIS-101 provides rapid, robust and durable treatment responses in wet AMD VIS-101 demonstrated mean BVCA improvements of >10 ETDRS letters and
persevERA Breast Cancer study did not meet the primary objective of a statistically significant improvement in progression-free survival, but a numerical improvement was observed Giredestrant plus palbociclib was well tolerated and adverse events were consistent with the known safety profiles of each individual treatment Roche is committed to transforming...
NEW YORK and WALTHAM, Mass., March 08, 2026 (GLOBE NEWSWIRE) -- Dianthus Therapeutics, Inc. (Nasdaq: DNTH), a clinical-stage biotechnology company dedicated to developing next-generation therapies to transform the treatment of severe autoimmune diseases, today announced a conference call and
VANCOUVER, British Columbia and BOSTON, March 08, 2026 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq: XENE), a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development and commercialization of life-changing therapeutics for patients in need, will
Phase 3 pivotal program initiation for BPL-003 in treatment-resistant depression remains on track for Q2 2026 following successful End‑of‑Phase 2 meeting with the U.S. Food and Drug Administration On-track for VLS-01 Phase 2 Elumina trial topline data readout anticipated in H2 2026 Exploratory
Treatment Phase for Lead Clinical Candidate PH-762 Dose Escalation Trial is Complete with Favorable Safety, Tolerability and Pathology Data 2025 Financings and Warrant Exercises Strengthen Balance Sheet with $23.7 Million in Net Proceeds, Extending Cash Runway into the First Half of 2027King of Prussia, Pennsylvania--(Newsfile Corp....
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BXCL501 demonstrated clinical benefits and favorable tolerability profile for treatment of opioid withdrawal symptoms Results from this NIDA-funded study support potential future development of BXCL501 in opioid withdrawal Opioid use disorder is a global health crisis, affecting approximately
CALABASAS, Calif., March 04, 2026 (GLOBE NEWSWIRE) -- NeOnc Technologies Holdings, Inc. (Nasdaq: NTHI) (“NeOnc” or the “Company”), a multi-Phase 2 clinical-stage biopharmaceutical company developing novel therapies for central nervous system (CNS) cancers, today announced data from the
Shared 12-month clinical results of ongoing UP421 type 1 diabetes study showing that hypoimmune-modified pancreatic islet cells transplanted without immunosuppression are safe and well-tolerated, evade detection by the immune system, and continue to function one year post-transplant New England
VIS-101, purpose-designed to be a best-in-class dual VEGF-A/ANG-2 inhibitor, has the potential to provide more effective and durable treatment than the current standard of care for patients with wet AMD, DME and RVO Visara, a NovaBridge Majority-Owned Subsidiary, Holds Global Rights to VIS-101
SEP-631 Demonstrated Robust, Dose-Dependent Inhibition of Icatibant-Induced Skin Wheal Formation, with Complete Inhibition Observed at Doses as Low as 10 mg Once-Daily Well-Tolerated Across All Doses Studied with an Adverse Event Profile Comparable to Placebo; Pharmacokinetic Profile Supports