MINNEAPOLIS / Apr 17, 2024 / Business Wire / DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and cardio-renal disease, today announced the first patient being dosed in DiaMedica’s relaunch of its pivotal Phase 2/3 ReMEDy2 Trial of DM199 for the treatment of acute ischemic stroke. The company continues to work closely with its contract...Read more
Data and Safety Monitoring Board (DSMB) recommends the continuation, without modifications, of the adaptive Phase 2b/3 NAVIGATE study of belapectin in metabolic dysfunction-associated steatohepatitis (MASH) liver cirrhosis Fifth positive recommendation further supports favorable tolerability and safety profile of belapectin Interim Phase 2b efficacy readout anticipated in Q4 2024 NORCROSS, Ga., April 09, 2024 (GLOBE NEWSWIRE) --...Read more
Data transferred for independent statistical analysis Top-line data expected in April 2024 RADNOR, Pa., April 8, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that the Company has achieved data-lock in its Phase 2b/3 Suicidal Treatment Resistant Bipolar Depression Study with NRX-101. With data-lock, as forecast...Read more
BASKING RIDGE, N.J. & RAHWAY, N.J. / Apr 03, 2024 / Business Wire / Daiichi Sankyo (TSE: 4568) and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the first patient has been dosed in the REJOICE-Ovarian01 phase 2/3 trial evaluating the efficacy and safety of investigational raludotatug deruxtecan (R-DXd) in patients with platinum-resistant ovarian cancer. The phase 2 portion of the trial...Read more
Early progression-free survival (PFS) trends favor GRANITE recipients with hazard ratios of 0.82 in the overall population ([95% CI, 0.34-1.67]; 62% censored) and 0.52 (48% relative risk reduction of progression or death with GRANITE vs. control) in a high-risk group, where clinical data are more mature ([95% CI, 0.15-1.38]; 44% censored); >90% of high-risk patients have liver metastases Short-term molecular response (as...Read more
45 mg once daily oral dose selected for Phase 3 Results support trial expansion to lower age group and study will now include adolescents ages 10-17 years If positive, pre-planned interim analysis at Week 48 may serve as the basis for accelerated approval in the U.S. BOSTON / Apr 01, 2024 / Business Wire / Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that inaxaplin (VX-147) has advanced into...Read more
First of its kind study in muscle-invasive urothelial cancer, with both escalation and de-escalation arms Approximately 1,000 patients will be enrolled at more than 300 sites AUSTIN, Texas / Apr 01, 2024 / Business Wire / Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, and the Alliance for Clinical Trials in Oncology, which is part of the National Clinical Trials Network (NCTN) funded by the National Cancer...Read more
HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., March 22, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that it has initiated the registration stage of the Phase II/III clinical trial of sovleplenib in adult patients with warm antibody autoimmune hemolytic anemia (“wAIHA”) in China. This follows positive data from the proof-of-concept Phase II stage of the trial and...Read more
NEW YORK, March 19, 2024 /PRNewswire/ -- Seelos Therapeutics, Inc. (Nasdaq: SEEL) ("Seelos"), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today provided an update on top-line data of the Phase 2/3 HEALEY ALS Platform trial. This study was performed in collaboration with The Sean M. Healey and AMG Center, which is viewed as an influential force...Read more
Study met primary endpoint of ACR50 at 16 weeks versus placebo with high statistical significance and is expected to be the first of two registrational trials in psoriatic arthritis Robust clinical responses achieved for the high hurdles of ACR70, PASI100, as well as composite endpoints ACR50/PASI100 and Minimal Disease Activity Favorable safety profile consistent with the IL-17A class and previous izokibep experience LOS ANGELES,...Read more
Data from the safety lead-in of the AIPAC-003 trial shows 90mg efti in combination with paclitaxel is safe and well tolerated Encouraging initial efficacy in six metastatic breast cancer patients, who exhausted all endocrine therapy including CDK4/6 inhibitors, demonstrated by a 50% overall response rate, including one complete response, and a 100% disease control rate SYDNEY, AUSTRALIA, March 05, 2024 (GLOBE NEWSWIRE) -- Immutep...Read more
Marks a major step in the development of what could be the first drug approved for Suicidal Bipolar Depression The study database is being cleaned and locked; statistical analysis and top-line data to follow shortly thereafter Study maintained 95% concordance rate between study sites and central raters on primary endpoint. No unexpected Serious Adverse Events were reported. Positive data and FDA comment would trigger the next $4...Read more
AGOURA HILLS, Calif., March 04, 2024 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc (OTCQB:OTLC) invites participation in our STOP-PC clinical trial which is now open for recruitment. Additional information can be obtained at www.stop-pc.com. An explainer video is available at https://www.youtube.com/watch?v=C4ZsE3fulIU. STOP-PC is a Randomized Phase 2b/Phase 3 Study of the TGF-β2 Targeting Antisense Oligonucleotide OT-101 in...Read more
Enrolled patients allowed to continue on study MENLO PARK, Calif. / Feb 12, 2024 / Business Wire / AN2 Therapeutics, Inc. (Nasdaq: ANTX), a clinical-stage biopharmaceutical company focused on developing treatments for rare, chronic, and serious infectious diseases with high unmet needs, today announced the company’s decision to voluntarily pause Phase 3 enrollment in the seamless Phase 2/3 clinical trial (EBO-301) evaluating...Read more
Patient Reported Outcomes (PROs) based on a May 16, 2022 data cutoff in the QUILT 3.032 trial indicate stability of physical function and global health in patients who completed PRO questionnaires and reached month 24 on-study Overall, participants with complete responses (CRs) to combination therapy with the novel interleukin-15 (IL-15) superagonist N-803 and bacillus Calmette-Guerin (BCG) reported better physical function than those...Read more
Pamrevlumab has now completed Stage 2 of the trial and topline data from this registration study in ~175 pamrevlumab treated patients is anticipated in 2Q 2024 Pamrevlumab is the first experimental arm to meet its required threshold for graduation in the seamless Phase 2/3 adaptive platform trial SAN FRANCISCO, Jan. 25, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) announced graduation and completion of the pamrevlumab...Read more
Exceeded originally target enrollment (70) with n=74 Last patient, last visit expected in approximately six weeks; data to follow shortly thereafter Positive data triggers milestone payment from Alvogen, as previously announced. RADNOR, Pa., Jan. 22, 2024 /PRNewswire/ -- NRx Pharmaceuticals,...Read more
MELBOURNE, Australia and NEW YORK, Jan. 17, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (‘Incannex’ or the ‘Company’), a pharmaceutical company developing unique medicinal cannabinoid pharmacotherapies and psychedelic medicine therapies is pleased to announce that an independent Institutional Review Board (IRB) has approved the protocol for the Company’s Phase 2/3 clinical trial to be conducted in the...Read more
Aligned with the FDA on submitted protocol for 225Ac-PSMA (FPI-2265) Phase 2/3 registrational program for patients with metastatic castration-resistant prostate cancer (mCRPC) Achieved target enrollment in ongoing TATCIST trial evaluating FPI-2265; Interim Phase 2 data expected to be presented in April 2024 FPI-1434 shows promising safety profile and early evidence of antitumor activity at 25 kBq/kg dose level Fusion's...Read more
Topline data from LIFT-AD on track for second half of 2024 Previously reported independent, unblinded interim analysis supports trial continuation and potential clinically meaningful activity of fosgonimeton Potential first-in-class approach focused on HGF modulation for treatment of neurodegenerative diseases BOTHELL, Wash., Jan. 03, 2024 (GLOBE NEWSWIRE) -- Athira Pharma, Inc. (NASDAQ: ATHA), a late clinical-stage...Read more
Anavex Announces Topline Results from Phase 2/3 EXCELLENCE Clinical Study in Pediatric Rett Syndrome Validation from Real World Evidence (RWE) of Rett Syndrome Patients under Compassionate Use Authorization NEW YORK, Jan. 02, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of...Read more
HONG KONG, Shanghai and FLORHAM Park, N.J., Dec. 12, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (Nasdaq/AIM:HCM, HKEX:13) (“HUTCHMED”) today announces that it has completed enrollment of its Phase II/III trial of fruquintinib in combination with sintilimab as second-line treatment for locally advanced or metastatic renal cell carcinoma (“RCC”) in China. The study is a randomized, open-label, active-controlled study to evaluate...Read more
MELBOURNE, Australia and NEW YORK, Dec. 06, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (‘Incannex’ or the ‘Company’), a pharmaceutical company developing unique medicinal cannabinoid pharmacotherapies and psychedelic medicine therapies for unmet medical needs, is pleased to provide the following update on its proprietary IHL-42X drug candidate. Obstructive sleep apnea (OSA) is characterised by a narrowing or...Read more
STELLAR-305 is Exelixis’ first pivotal study in squamous cell carcinoma of the head and neck Trial will evaluate the potential of inhibition of VEGF, MET and AXL, which are elevated in these tumors ALAMEDA, Calif. / Dec 04, 2023 / Business Wire / Exelixis, Inc. (Nasdaq: EXEL) today announced the initiation of STELLAR-305, a phase 2/3 pivotal trial evaluating zanzalintinib in combination with pembrolizumab versus...Read more
LOS ANGELES, Nov. 27, 2023 (GLOBE NEWSWIRE) -- ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today provided an update on its izokibep clinical development program, including its ongoing global Phase 2b/3 trial for izokibep in psoriatic arthritis (“PsA trial”). Background In September 2023, ACELYRIN disclosed top-line...Read more
No safety or tolerability issues in open-label, safety lead-in phase evaluating the higher 90mg dose of efti in combination with weekly paclitaxel in the first 6 patients Good safety profile allows for lead-in phase to be closed early and the randomized Phase II portion of study will now proceed SYDNEY, AUSTRALIA, Nov. 06, 2023 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a...Read more
BERWYN, Pa. / Oct 30, 2023 / Business Wire / Annovis Bio, Inc. (NYSE: ANVS), announces the positive safety review by the Data and Safety Monitoring Board (DSMB) for its phase 2/3 trial of buntanetap, a drug candidate for moderate to mild Alzheimer’s Disease (AD) patients. The DSMB recommended that Annovis Bio continue the trial as originally designed. The feedback from the DSMB was: no drug-related SAEs (Serious Adverse Events) each AE...Read more
Phase 2 data presented at ASBMR 2023 show treatment with setrusumab resulted in 67% reduction in annualized fracture rate associated with continuous and meaningful improvements in bone mineral density (BMD) Ultragenyx hosting Analyst Day on Monday, October 16 at 8:30 a.m. ET NOVATO, Calif., VANCOUVER, British Columbia and LONDON, Oct. 14, 2023 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) and Mereo BioPharma...Read more
NORCROSS, Ga., Oct. 03, 2023 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin-3, today reported the positive outcome of its fourth data and safety monitoring board (DSMB) meeting for NAVIGATE, its seamless, adaptive, Phase 2b/3 study of belapectin in patients with portal hypertension caused by non-alcoholic steatohepatitis (NASH) liver cirrhosis. NAVIGATE is...Read more
NEW YORK, Sept. 14, 2023 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders announced today that a follow-on analysis of the landmark Phase 2b/3 study to treat early Alzheimer’s disease with the investigational drug blarcamesine (ANAVEX®2-73) did...Read more
Company announces Phase 2 part of the EBO-301 trial is now fully enrolled with 80 patients; Topline Phase 2 trial results expected in summer 2024 Over 100 sites across four countries (U.S., Japan, S. Korea & Australia) as epetraborole enters Phase 3 portion of EBO-301; expected to enroll ~230 patients MENLO PARK, Calif. / Sep 13, 2023 / Business Wire / AN2 Therapeutics, Inc. (Nasdaq: ANTX), a clinical-stage biopharmaceutical...Read more
Single-arm clinical trial was a success and showed the HAV had higher rates of patency, and lower rates of amputation and infection, compared to historic synthetic graft benchmarks BLA planned to be filed with FDA in 4th Quarter 2023 Conference call and live webcast with Key Opinion Leaders at 8:00 a.m. ET today DURHAM, N.C., Sept. 12, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage...Read more
The primary endpoint of HiSCR75 at week 16 did not meet statistical significance in the Non-Responder Imputation (NRI) primary analysis. HiSCR75 did meet statistical significance at week 16 in a Last Observation Carried Forward sensitivity analysis. HiSCR response rates of izokibep 160mg weekly (QW) were consistent with Part A open label results, demonstrating early onset of HiSCR100 at week 4, increasing through week 12 to 38%...Read more
AGOURA HILLS, Calif., Aug. 23, 2023 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc (OTCQB:OTLC) ("Oncotelic", the "Company" or "We" or “Our”), announced today its joint venture partner, GMP Biotechnology Limited’s wholly owned subsidiary – Sapu Bioscience, LLC (“Sapu”), together with with Cromos Pharma, LLC (“Cromos”), a US-based international contract research organization (“CRO”), to conduct Sapu’s registrational trial for OT-101 in...Read more
Top-line results planned to be released in third quarter 2023 Trial results are intended to support Biologics License Application (BLA) planned for fourth quarter 2023 DURHAM, N.C., July 26, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced completion of enrollment of its Phase...Read more
Patient-Reported Outcomes From the CAPELLA Trial Align With the Demonstrated Safety and Tolerability Profile of Lenacapavir Analyses Show Oral Bridging Maintains Virologic Suppression When Subcutaneous Lenacapavir Doses are Missed FOSTER CITY, Calif. / Jul 24, 2023 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today presented new data reinforcing the efficacy, safety, and tolerability profile of lenacapavir, including...Read more
Highlights: Incannex has engaged Fortrea as the contract research organisation (‘CRO’) to manage the IND opening Phase 2/3 clinical trial investigating IHL-42X for treatment of OSA. The Phase 2/3 clinical trial will assess the safety and efficacy of IHL-42X in people with OSA who are intolerant, non-compliant, or naïve to continuous positive airway pressure (‘CPAP’). The extensive trial will be conducted across 45 sites, including...Read more
Data from ongoing FIREFISH study confirm long-term efficacy and safety profile of Evrysdi in children with Type 1 SMA Ninety-one percent of children were alive at month 48 More than 95% maintained the ability to swallow - without treatment they would have required feeding support and majority would have died within 2 years Evrysdi is now approved in 99 countries with more than 8,500 patients treated...Read more
MINNEAPOLIS / Jun 21, 2023 / Business Wire / DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and kidney diseases, announced today that the U.S. Food and Drug Administration (FDA) has removed the clinical hold placed on the investigational new drug application for its ReMEDy2 phase 2/3 clinical trial studying DM199 in the treatment of...Read more
MELBOURNE, Australia, June 16, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), (‘Incannex’ or the ‘Company’) a clinical-stage pharmaceutical company developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for unmet medical needs, is pleased to announce that it has recruited two highly experienced lead principal investigators (PIs) for the IND opening Phase 2/3...Read more
NEW YORK, June 06, 2023 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) disorders, today announced the completion of dosing of all...Read more
Pediatric data show substantial induction of bone production in 1 week and a large increase in bone formation within 3 months of initiating monthly setrusumab treatment Phase 3 sites beginning to screen patients Conference call to discuss data planned for 5 p.m. Eastern Time NOVATO, Calif. and LONDON, June 05, 2023 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) and Mereo BioPharma Group plc (NASDAQ: MREO) today...Read more
SYDNEY, AUSTRALIA, May 25, 2023 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces the first patient has been enrolled and safely dosed at a European clinical site for its integrated Phase II/III AIPAC-003 trial in metastatic breast cancer. AIPAC-003 is evaluating...Read more
Immix Biopharma is a clinical-stage biopharmaceutical company pioneering a novel class of CAR-T cell therapies and Tissue-Specific Therapeutics targeting oncology and immuno-dysregulated diseases with >75 patients treated to-date. Our lead cell therapy asset is NXC-201...
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