Finalized SUNRISE-FA 2 open-label, pivotal trial protocol and SAP for LX2006 in support of accelerated approval pathway; topline data expected in second half of 2027 Initiated SUNRISE-FA 2 with first patient enrolled into pivotal study in June; site activation efforts ongoing CLARITY-FA enrollment
Expect to report topline results for ALTITUDE-AD, a Phase 2 study to investigate sabirnetug (ACU193) for the treatment of early Alzheimer’s disease, in late 2026 Two candidates nominated for development in Acumen’s Enhanced Brain Delivery™ (EBD™) program; lead clinical candidate IND filing for the
First patient dosed in Phase 3 ALLOHA-2™ study; topline readout expected mid-2028 Shared positive initial data from Cohort C of Phase 1 ALLOHA™ study, validating internal commercial-ready manufacturing process Cash and cash equivalents fund operations into the second quarter of 2027 WALTHAM, Mass.,
– Breakthrough results from V012 dialysis access Phase 3 study, where ATEV was observed to outperform AV fistula; supplemental Biologic License Application (sBLA) for dialysis access to be filed with the Food and Drug Administration ( FDA) during the second half of 2026 – – FDA accepted IND for
Topline data from CHAPTER-3, a pivotal Phase 3 study of deucrictibant XR for the prophylaxis of HAE attacks, expected in 3Q2026 Deucrictibant IR NDA under review by the FDA with PDUFA date of April 23, 2027; MAA validated by the EMA in July 2026 Enrollment ongoing in CREAATE, a pivotal study of
Rapid, Positive Clinical Outcomes in GBS FORWARD Study Reinforce Consistency and Reproducibility of Tanruprubart Treatment Effect Demonstrated in Phase 3 and Real-World Evidence Studies; BLA Submission Expected in Q4 2026 Vonaprument Phase 3 GA Program Expanded with Month 15 / 24 Dual Primary
BRISBANE, Calif., Aug. 12, 2026 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company advancing the next generation platform of targeted immunotherapies for multiple neuroinflammatory diseases that impact nearly 10 million people worldwide, today announced the addition of a
Files six new lawsuits as company escalates fight to protect patients INDIANAPOLIS, Aug. 12, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today escalated its continued fight to protect patients from the dangerous black market for retatrutide, filing six new lawsuits against U.S.
New data presented at Digestive Disease Week (DDW) demonstrating improvement of fibrosis and inflammation following a single treatment of EP-104GI Strengthened executive team and board to bolster late-stage drug development and global commercialization capabilities.
Positive Phase 2 CRDF-004 data presented in an oral session at ASCO support advancement of 30 mg onvansertib plus FOLFIRI/bevacizumab into planned registrational program for first-line RAS-mutated mCRC Following successful End-of-Phase 2 meeting with FDA, Company aligned on key elements of
Announced positive interim Phase 1 data from the HEADLINE™ trial of ABS-201 Completed $100 million underwritten offering, including $40 million strategic investment from Eli Lilly & Company Cash, cash equivalents, and marketable securities now sufficient to fund operations into the second half of
First-in-class immune-stimulating antibody conjugate BDC-4182 Phase 1/2 study ongoing, initial clinical data expected to be released with Bolt's 3Q 2026 results Cash balance of $18.1 million as of June 30, 2026 anticipated to fund operations into 1Q 2027 REDWOOD CITY, Calif., Aug.
ROCKVILLE, MD, Aug. 11, 2026 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on developing innovative antibody-based therapeutics for the treatment of cancer, today announced that Gilead Sciences, Inc.
FDA grants RMAT designation for miv-cel in non-active secondary progressive multiple sclerosis (naSPMS) based on compelling clinical data, further expanding the therapy’s potential across neuroimmunology On track to complete rolling BLA submission for miv-cel in stiff person syndrome (SPS) in Q4
Successfully completed human factors validation study and pharmacokinetic study for Anaphylm™ (dibutepinephrine) sublingual film Remains on track to resubmit Anaphylm NDA to the FDA in Q3 2026 Continues pre-launch medical affairs activities and payer engagement On track to begin ex-U.S.
Prescription Drug User Fee Act target action date is February 12, 2027 If approved, tinlarebant would be the first-ever approved treatment for Stargardt Disease Type 1 SAN DIEGO, Aug. 11, 2026 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE) (“Belite Bio ® ” or the “Company”), a clinical-stage
Updated ERAS-0015 data in U.S. trial highlighted compelling monotherapy efficacy in 2L+ KRAS G12X PDAC and continued favorable tolerability, as well as further advancement of panitumumab CRC combination ERAS-0015 program advancing toward three potentially registration-enabling trials in pancreatic
Completed dosing in the REVEAL pivotal (N=17) and ASPIRE (N=4) trials evaluating TSHA-102 for Rett syndrome; expect to report topline data from 6 ‑ month interim analysis and FDA feedback on the BLA submission pathway in 1H 2027 TSHA-102 continues to be generally well tolerated with no severe
Expanding Phase 2 study start-up activities to support global trial of oral epetraborole in polycythemia vera Enrollment ongoing in Phase 2 investigator-initiated trial of epetraborole for M. abscessus lung disease Positive non-human primate efficacy and favorable Phase 1 clinical pharmacokinetics
Company Announcement COPENHAGEN, Denmark; August 11, 2026 – Genmab A/S (Nasdaq: GMAB) will increase its share capital by 24,592 shares as a consequence of the exercise of employee warrants. The increase is effected without any preemption rights for the existing shareholders of the Company or
JERUSALEM, Aug. 10, 2026 /PRNewswire/ Scinai Immunotherapeutics Ltd. (NASDAQ: SC NI ) ("Scinai" or t he "Company" ), a biopharmaceutical company advancing a pipeline of innovative inflammation and immunology therapeutics, today announced that its wholly owned subsidiary, Scinai Biopharma Services Ltd ....
Enrollment on track for Phase 3 UPSTREAM MG trial of telitacicept in generalized myasthenia gravis patients with topline results anticipated in 1H27 Enrollment ongoing for Phase 3 UPSTREAM SjD of telitacicept in primary Sjögren’s disease Pro-forma cash and investment balance of $514.5 million
Findings further validate Cingulate’s Precision Timed Release™ (PTR™) platform and its trimodal drug delivery approach KANSAS CITY, Kan., Aug. 11, 2026 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company advancing next-generation pharmaceutical products through its
Patient dosing is ongoing in the Phase 1b/2 study of TH103; preliminary data anticipated in 1H 2027 Potential Phase 3 clinical trials remain on track for initiation by year-end 2027 $93.5 million in cash, cash equivalents and marketable securities as of June 30, 2026 is expected to fund operations
Expect to complete enrollment of the BCG-Unresponsive registrational cohort of the ADVANCED-2 trial in 4Q 2026 The ADVANCED-3 trial is being redesigned as an exploratory trial to expand into and accelerate data in high-grade, high-risk BCG-Naïve and BCG-Exposed CIS (± Ta/T1) patients and papillary
TibuSHIELD enrollment complete, exceeding initial enrollment target with 247 participants randomized in HS; topline data expected Q4 2026 TibuSURE enrollment complete, exceeding initial enrollment target with 91 participants randomized in SSc; topline data expected H1 2027 Zura plans to initiate a
Phase 3 clinical trial of denifanstat in moderate to severe acne patients for the U.S. on track to initiate in second half of 2026 First-in-human Phase 1 clinical trial of FASN inhibitor TVB-3567 ongoing Secured equity financing with gross proceeds of $175.0 million in April 2026 Cash, cash
Data from Phase 1/2 trial of NGN-401 for Rett syndrome showed 100% of participants improved in CGI-I score and gained ≥1 developmental milestone, with an average of 4.7 milestones per participant; no plateau and no milestone loss observed as of data cutoff date of June 16, 2026 Milestones gained in
Positive topline results from open-label Phase 2 Study ‘207’ evaluating VDPHL01 in female pattern hair loss demonstrated rapid onset and consistent hair growth Completion of patient enrollment for Phase 2/3 Study ‘306’, a 556 participant, registration-directed trial evaluating VDPHL01 in female
~ 2026 Second Quarter Net Product Sales of $17.1 Million, Up 78% Year over Year ~ ~ 2026 Second Quarter Non-GAAP Adjusted EBITDA of $2.8 Million ~ ~ Record PEDMARK ® Demand Carried into Third Quarter 2026 as Field Sales Expansion Efforts Continue to Validate Commercial Growth Strategy ~ ~
– Company rapidly advancing toward Q1 2027 initiation of Phase 3 trials designed to deliver best-in-class efficacy with convenient quarterly dosing in both severe asthma and CRSwNP; End-of-Phase 2 interactions with FDA on track – – Completed enrollment in Phase 2 trial in COPD; data expected in the
Company reports AUCATZYL® (obecabtagene autoleucel; obe-cel) net product revenue of $45.7 million in Q2 2026, an increase of 119% year-over-year FY 2026 net product revenue guidance increased to $140 - $150 million Gross margin increased in Q2 2026, driven by growing volumes and cost reduction
Company continues to prepare for late-stage clinical advancement of vopimetostat in combination with daraxonrasib for pancreatic cancer following positive Phase 1/2 data Phase 1/2 data from combination study of vopimetostat + RAS(ON) inhibitors in pancreatic cancer to be presented at 2026 ESMO
PH-894 protection for chemical structure, genetic sequencing and broad application for proliferative and infectious diseases in U.S. King of Prussia, Pennsylvania--(Newsfile Corp. - August 11, 2026) - Phio Pharmaceuticals Corp. (NASDAQ:...
Phase 3 CoMpass trial fully enrolled with 108 patients, exceeding enrollment target; on track for topline data in 2H 2027 Strategic operating plan refined to focus on development of bel-sar in ocular oncology Interim NMIBC data reinforce bel-sar’s potential for durable efficacy and favorable safety
AC Immune Receives FDA Fast Track Designation for Anti-Alpha-synuclein Active Immunotherapy, ACI-7104, to Treat Early Parkinson’s Disease (PD) Ongoing Phase 2 VacSYn study to expand to sites in USA with Investigational New Drug (IND) clearance Recent positive interim results showed safety and
– Leadership Team Expanded with Key Executive Appointments, Including Chief Executive Officer, Chief Medical Officer and Chair of the Board of Directors, to Support Clinical Development, as well as NDA and Commercial Readiness – – Pivotal Phase 3 ENSURE Trials of Vidofludimus Calcium in Relapsing Multiple Sclerosis on Track, with Top-Line Data Expected by...