Numerous companies revealed workforce reductions this week, adding to the ongoing wave of layoffs. On the research front, there were mixed results: promising advancements involving the Alzheimer’s medication Leqembi and the antidiabetic drug Tirzepatide contrasted with disappointing findings from a prostate cancer drug trial. Additionally, a significant milestone was reached with the approval of the first engineered cell therapy for a solid tumor.Let’s examine these developments more closely.### Layoffs**FibroGen Inc. (FGEN):** On Tuesday, FibroGen Inc. announced a 75% reduction in its U.S. workforce as it winds down its once-promising Pamrevlumab program. Following two late-stage trials failing to meet the primary endpoint in pancreatic cancer patients, FibroGen’s stock plummeted nearly 48% on July 30, 2024. The stock closed Friday at $0.42, down 8.94%.**HilleVax Inc. (HLVX):** This clinical-stage biopharmaceutical company, developing novel vaccines, announced on Wednesday a workforce reduction of about 40%, or 41 employees, to manage operating expenses. HilleVax’s lead drug candidate, HIL-214, demonstrated significant efficacy in preventing moderate-to-severe acute gastroenteritis (AGE) caused by norovirus in adults during a Phase 2b study, NOR-211. However, a Phase IIb trial in infants, NEST-IN1, failed to meet primary or secondary efficacy endpoints, prompting the discontinuation of HIL-214 development in infants while exploring its potential in adults. The stock closed Friday at $1.70, down 3.95%.**Vir Biotechnology Inc. (VIR):** On Thursday, Vir Biotechnology announced a strategic restructuring to focus on high-value near-term opportunities. This includes phasing out programs for influenza, COVID-19, and its T cell-based viral vector platform, resulting in a 25% workforce reduction, affecting approximately 140 employees. The stock closed Friday at $9.21, down 5.34%.**uniQure N.V. (QURE):** Recently selling its global manufacturing facility to Genezen, uniQure announced major organizational changes on Thursday. To conserve capital and streamline operations, the company will eliminate approximately 65% of its workforce, affecting 300 roles. This restructuring is expected to be completed by the fourth quarter of 2024. The stock closed Friday at $7.31, down 2.27%.**Arbutus Biopharma Corp. (ABUS):** Arbutus Biopharma announced on Thursday a workforce reduction to streamline operations, including ceasing all HBV discovery efforts and discontinuing its IM-PROVE III clinical trial. This results in a 40% workforce reduction and extends the expected cash runway into the fourth quarter of 2026. The company will focus on the phase 2b development of Imdusiran and AB-101, currently in a phase Ia/Ib trial for chronic HBV. The stock closed Friday at $3.73, down 1.97%.**Pfizer Inc. (PFE):** Pfizer announced layoffs affecting 150 employees at its Sanford facility in Lee County and 60 employees at its sterile injectable facility in Rocky Mount, Nash County. This is part of an effort to achieve at least $4 billion in net cost savings by the end of this year, with an additional cost reduction program targeting approximately $1.5 billion in savings by the end of 2027.### FDA SpotlightFurther information on key approvals and noteworthy developments by the FDA will be discussed.### Vertex Pharmaceuticals Advances Pain Management InnovationVertex Pharmaceuticals Inc. (VRTX) announced on Tuesday that the FDA has accepted its New Drug Application for Suzetrigine, an investigational oral selective NaV1.8 pain signal inhibitor, granting it priority review status. Suzetrigine is aimed at addressing moderate-to-severe acute pain. The FDA’s decision is anticipated by January 30, 2025. If approved, Suzetrigine could mark the introduction of a new class of pain management medication, the first in over two decades. VRTX shares closed Friday at $494.46, reflecting a 2.24% decline.### Breakthrough in Synovial Sarcoma TreatmentAdaptimmune Therapeutics plc (ADAP) reported on Thursday that the FDA has granted accelerated approval for Tecelra, a therapy for advanced MAGE-A4+ synovial sarcoma in adults with specific human leukocyte antigen (HLA) types who have previously undergone chemotherapy. Tecelra represents the first engineered cell therapy for solid tumor cancer in the U.S. and is the first new treatment option for synovial sarcoma in over a decade, a rare soft tissue cancer predominantly affecting young adults. ADAP shares closed Friday at $1.17, down 7.87%.### FDA Panel Recommends Approval for Rare Disease TreatmentZevra Therapeutics Inc. (ZVRA) has announced that an FDA panel has voted 11-5 in favor of recommending approval for its lead drug candidate, Arimoclomol, for treating Niemann-Pick disease type C (NPC). The final FDA decision is expected by September 21, 2024. NPC is a rare, progressive, neurodegenerative disorder characterized by the body’s inability to transport cholesterol and other lipids within cells, resulting in their accumulation in various tissues and organs, including the brain. ZVRA shares closed Friday at $6.30.### Deal or No Deal23andMe Holding Co. (ME) has declined a take-private proposal from its CEO, Co-Founder, and Chair of the Board, Anne Wojcicki. Wojcicki proposed acquiring all outstanding shares not owned by her or her affiliates for $0.40 per share of Class A or Class B Common Stock. The Special Committee of the Board of Directors reviewed the proposal and cited several reasons for their disappointment, including the fact that the offer provides no premium to the closing price, lacks committed financing, and is conditional. ME shares closed Friday at $0.38, down 0.26%.### Breakthroughs and Setbacks in Alzheimer’s and Heart Failure ResearchEisai Co. Ltd and Biogen Inc.’s (BIIB) Alzheimer’s drug Leqembi has demonstrated improved cognition and function in early Alzheimer’s disease patients who received the drug continuously for over three years, according to a global phase III study named Clarity AD. No additional safety concerns were identified during the extended treatment period. Leqembi received traditional FDA approval in July 2023 as an intravenous (IV) infusion for patients with mild cognitive impairment due to Alzheimer’s disease and mild AD dementia. A subcutaneous injection formulation is also in development for enhanced patient convenience. However, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recently recommended against approving Leqembi due to concerns about the risks of serious side effects, including brain swelling and potential bleeding. BIIB shares closed Friday at $205.66, down 2.39%.Eli Lilly and Co.’s (LLY) antidiabetic medication Tirzepatide has shown significant results in reducing heart failure outcomes by 38% compared to a placebo in a phase III trial involving adults with heart failure with preserved ejection fraction (HFpEF) and obesity, irrespective of the presence of type 2 diabetes. The trial, known as SUMMIT, also reported significant improvements in heart failure symptoms, physical limitations, and a notable 15.7% reduction in weight. Tirzepatide, marketed as Mounjaro and Zepbound, is FDA-approved for improving glycemic control in adults with type 2 diabetes (as Mounjaro) and for managing obesity or overweight conditions with comorbidities (as Zepbound). LLY shares closed Friday at $804.46, marking a 3.36% decrease.—By refining and detailing the language, the meaning and information are preserved while elevating the tone to a professional level.Agios Pharmaceuticals Inc. (AGIO) recently announced that its blood disorder medication, Pyrukynd, did not achieve the primary endpoint of transfusion reduction response in the Phase III ACTIVATE-KidsT trial. This study involved children aged 1 to under 18 years with pyruvate kinase (PK) deficiency who require regular transfusions. Despite not meeting the primary endpoint, the company emphasized that the results were clinically meaningful. Agios is continuing its Phase III trial, ACTIVATE-Kids, for children with PK deficiency who are not regularly transfused, with results expected in 2025. Pyrukynd is already approved for treating hemolytic anemia in adults with PK deficiency in the U.S., EU, and Great Britain.AGIO shares ended Friday’s trading session at $43.96, reflecting a 1.21% decline.Meanwhile, MacroGenics Inc. (MGNX) has seen a significant decrease in its share price following updates on its TAMARACK trial in May. This Phase II study is assessing the investigational drug Vobra duo for metastatic castration-resistant prostate cancer. On May 9, 2024, the company disclosed that five patient deaths had occurred during the trial. Subsequently, after reviewing the accumulated data, MacroGenics, in agreement with the Independent Data Monitoring Committee (IDMC) in late July, decided to discontinue the study treatment for the remaining participants who might have received further doses.MGNX shares closed at $3.83 on Friday, down by 4.25%.The material has been provided by InstaForex Company – www.instaforex.com
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