Forward-Looking Statements This ... gene therapy product candidates under the Novartis licenses and collaboration and Neurocrine collaboration, including the anticipated initiation of clinical trials by Neurocrine for NBIB-‘223 in FA, pending successful IND clearance; the role of tau in the treatment of AD, including as a critical disease-modifying ... Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 and other federal securities laws, including, without limitation, implied and express statements about Voyager’s belief and expectations regarding the development of its product candidates and advancement of its preclinical and clinical development programs, including Voyager’s advancement of the tau silencing gene therapy program in AD, VY1706, including the timing of clinical development milestones such as Voyager’s intentions to i VY7523 (anti-tau antibody): Voyager expects tau positron emission tomography (PET) imaging efficacy data in Q4 2026 from the ongoing multiple ascending dose (MAD) clinical trial in participants with Alzheimer’s disease (AD). VY1706 (tau silencing gene therapy): The U.S. “We continue to advance our two tau-targeted programs toward potential inflection points in clinical trials for Alzheimer’s disease before the end of the year, with the tau-targeted antibody VY7523 expected to generate tau PET imaging data and the tau-targeted gene therapy VY1706 expected to begin dosing.” In July, Health Canada cleared Voyager’s Clinical Trial Application (CTA), enabling the inclusion of Canadian clinical trial sites in the study. NBIB-‘223 (Friedreich’s ataxia gene therapy): Voyager’s partner Neurocrine Biosciences has stated that it intends to initiate a clinical trial with NBIB-‘223 in H2 2026, pending successful FDA IND clearance.

/PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation... Olomorasib is currently being studied in the LOXO-RAS-20001 Phase 1/2 trial (NCT04956640) in patients with KRAS G12C-mutant NSCLC and other advanced solid tumors and in the pivotal, registrational SUNRAY-01 global study (NCT06119581) investigating olomorasib in combination with pembrolizumab with or without chemotherapy for first-line treatment of KRAS G12C-mutant advanced NSCLC, and the SUNRAY-02 (NCT06890598) global study investigating olomorasib in combination with standard of care immunotherapy in patients with resected or unresectable KRAS G12C-mutant NSCLC. For additional information about olomorasib clinical trials, please refer to clinicaltrials.gov. ... What is Breakthrough Therapy designation and why does it matter? Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. "Pancreatic cancer has historically been one of the most difficult-to-treat cancers and people whose tumors harbor a KRAS G12C mutation face limited options once their disease progresses," said Jacob Van Naarden, executive vice president, and president of Lilly Oncology. "This Breakthrough Therapy designation reflects the early potential we're seeing with olomorasib in this setting and the critical need for new treatment options. With now two Breakthrough Therapy designations across pancreatic and lung cancers, olomorasib continues to demonstrate broad potential clinical evidence across KRAS G12C-driven tumors and reflects our commitment to bringing meaningful new treatment options to patients living with these cancers." KRAS mutations account for approximately 85% of RAS-associated cancers in humans, including about 90% of pancreatic cancers, and KRAS G12C mutations occur in approximately 1% to 2% of patients with pancreatic cancer.8,9 The study includes a Phase 1a dose escalation phase of olomorasib monotherapy in KRAS G12C-mutant solid tumors and Phase 1b dose expansion and optimization phases which are evaluating olomorasib as a monotherapy and in combination with other treatments. More information can be found at clinicaltrials.gov. Where can patients find more information about the LOXO-RAS-20001 trial?

Biogen officially began reporting revenue from the $5.6 billion acquisition of Apellis in the second quarter, shaking up analysts’ consensus estimates and leading to a beat. IN PARTNERSHIP WITH ARVINAS · Life after the lead asset: Advancing an early-stage pipeline · July 30, 2026 · · 1 min read · · Jennifer C. Smith-Parker · Job Trends · New funding, new jobs: 4 biotechs hiring after series B raises · July 30, 2026 · · 4 min read · In addition to delivering two approved medicines to Biogen’s portfolio, the acquisition of Apellis Pharmaceuticals will support the future launch of the pharma’s own kidney disease asset, currently in multiple Phase 3 trials. Then in the 2030s, Biogen is looking to Alzheimer’s disease prospect diranersen—albeit cautiously given the difficult nature of the disease area—for growth. “We do not believe the beat meaningfully alters the key debates surrounding Biogen’s long-term earnings trajectory, particularly given that much of the upside was acquisition- and royalty-driven rather than indicative of a fundamental inflection in the underlying business.

Referred to the House Committee on Energy and Commerce.

Clinical trial results 17 July 2026: gedatolisib receives FDA approval for HR+/HER2- breast cancer, diranersen shows cognitive benefit in Alzheimer's, denecimig haemophilia A extension data, and bempikibart alopecia areata Phase 2a results. The remaining readouts reflect a pipeline that continues to diversify across disease biology, from antisense oligonucleotides targeting a core Alzheimer’s pathology through to engineered antibodies addressing unmet needs in rare bleeding disorders and immune-mediated hair loss. Here, Life Science Daily News brings you the most significant clinical trial results 17 July 2026. The FDA approved gedatolisib (Revtorpyk) on 14 July 2026 for the treatment of adults with hormone receptor-positive (HR+), HER2-negative, locally advanced or metastatic breast cancer without a PIK3CA mutation detected, following progression on or after at least one line of endocrine therapy in the metastatic setting. Every therapy that reaches a patient first has to clear a quieter hurdle that rarely makes headlines: finding enough of the right people to test it. That hurdle is where most clinical programs stumble. Roughly 80% of clinical trials fail to meet their enrollment... read more · The US Food and Drug Administration has approved Tregzi, a regulatory T-cell therapy developed by Orca Bio. It is the first treatment built from highly purified regulatory T cells to reach the American market. Phase 2 CELIA Data at AAIC Demonstrating Meaningful Clinical Outcomes and Robust Tau Reduction with Diranersen in Early Alzheimer's Disease · Alzheimer's Association, 14 July 2026. Detailed Phase 2 Results from the CELIA Clinical Trial of Tau-Targeting Therapy Diranersen (BIIB080) Genmab and AbbVie's epcoritamab meets its primary endpoint in a Phase 3 trial for relapsed or refractory diffuse large B-cell lymphoma, the FDA approves Orca Bio's Tregzi as the first regulatory T-cell therapy to reduce chronic graft-versus-host disease in blood... read more · This week's clinical trial results for 26 June 2026 deliver a landmark psychiatric result, a major oncology setback, and a decisive blow to one of the most watched platforms in regenerative medicine.