Weekly Biotech Buzz: FGEN Cuts Jobs, FDA OKs ADAP's Groundbreaking Cell Therapy, ME Rebuffs CEO Bid

(RTTNews) - There seems to be no respite from job cuts as several companies announced workforce reductions this week as well. Meanwhile, on the research front, there was a mix of news: encouraging results emerged related to Alzheimer's drug Leqembi and antidiabetic medication Tirzepatide, while a prostate cancer drug trial unfortunately disappointed. In a significant development, the week also saw the approval of the first engineered cell therapy for a solid tumor.

Let's delve into the news in detail.

Layoffs

FibroGen Inc. (FGEN) on Tuesday announced that it is reducing its headcount in the U.S. by approximately 75% as it prepares to shutter its once-promising Pamrevlumab development program. On July 30, 2024, the company's stock went into a freefall, plummeting nearly 48%, on news of its two late-stage trials of Pamrevlumab in patients with pancreatic cancer failing to meet the primary endpoint.

FGEN closed Friday's trading at $0.42, down 8.94%.

HilleVax Inc. (HLVX), a clinical-stage biopharmaceutical company developing novel vaccines, on Wednesday announced that it is reducing its workforce by approximately 41 employees, or roughly 40%, to rein in operating expenses. The lead drug candidate is HIL-214, a virus-like particle (VLP) based vaccine candidate in development for the prevention of moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection. HIL-214 demonstrated statistically significant efficacy against moderate or severe AGE due to norovirus in a Phase 2b study in adults, dubbed NOR-211. However, in a phase IIb trial of HIL-214 in infants of approximately 5 months of age, dubbed NEST-IN1, the primary or secondary efficacy endpoints were not met. The company has decided to discontinue HIL-214's development for infants but will explore its potential application for adults.

HLVX closed Friday's trading at $1.70, down 3.95%.

Vir Biotechnology Inc. (VIR) on Thursday announced that it has initiated a strategic restructuring to focus on the highest value near-term opportunities. As part of the organizational realignment and optimization, the company has decided to phase out programs in influenza, COVID-19, and its T cell-based viral vector platform. This will also lead to a workforce reduction of approximately 25% or approximately 140 employees.

VIR closed Friday's trading at $9.21, down 5.34%.

uniQure N.V. (QURE), a gene therapy company, which recently sold its global manufacturing facility in Lexington, Massachusetts to Contract Development and Manufacturing Organization Genezen, on Thursday announced major organizational changes. In an effort to conserve capital, streamline operations, and ensure sufficient cash resources to achieve multiple potentially meaningful value creating milestones, the company has decided to eliminate approximately 65% or 300 roles across the organization, inclusive of the sale of Lexington manufacturing facility. The restructuring is expected to be completed in the fourth quarter of 2024.

QURE closed Friday's trading at $7.31, down 2.27%.

Arbutus Biopharma Corp. (ABUS) is another company that is downsizing its workforce to streamline operations. The company on Thursday announced that it is ceasing all HBV discovery efforts and discontinuing its IM-PROVE III clinical trial, a phase IIa clinical trial evaluating lead drug candidate Imdusiran and nucleos(t)ide analogue (NA) therapy in combination with intermittent low doses of approved immune checkpoint inhibitor Durvalumab in patients with chronic HBV. This would result in a reduction in workforce by 40% and extension of expected cash runway into the fourth quarter of 2026. The company will now focus on phase 2b development of Imdusiran and another drug candidate AB-101, which is under a phase Ia/Ib trial for chronic HBV.

ABUS closed Friday's trading at $3.73, down 1.97%.

Pfizer Inc. (PFE), which recently pulled the plug on its investigational gene therapy Fordadistrogene movaparvovec for Duchenne muscular dystrophy, has decided to lay off 150 employees at its Sanford facility in Lee County. The company will also lay off 60 employees in its sterile injectable facility located in Rocky Mount in Nash County, according to reports. The company is targeting at least $4 billion in net cost savings by end of this year from a previously announced cost realignment program. A new cost reduction program announced by Pfizer in May of this year is expected to deliver savings of approximately $1.5 billion by the end of 2027.

FDA Spotlight

Vertex Pharmaceuticals Inc. (VRTX) on Tuesday announced that its New Drug Application for Suzetrigine, an investigational, oral, selective NaV1.8 pain signal inhibitor, has been accepted for priority review by the FDA. Suzetrigine is proposed for the treatment of moderate-to-severe acute pain. The FDA decision is due on January 30, 2025. If approved, Suzetrigine could become the first new class of medication for treating acute pain in more than two decades.

VRTX closed Friday's trading at $494.46, down 2.24%.

Adaptimmune Therapeutics plc (ADAP) on Thursday announced that Tecelra has been granted accelerated approval by the FDA for the treatment of advanced MAGE-A4+synovial sarcoma in adults with certain human leukocyte antigen (HLA) types who have received prior chemotherapy. Tecelra becomes the first engineered cell therapy for a solid tumor cancer approved in the U.S., and the first new therapy option in more than a decade for synovial sarcoma, a rare, soft tissue cancer that most commonly impacts young adults.

ADAP closed Friday's trading at $1.17, down 7.87%.

Zevra Therapeutics Inc. (ZVRA) on Friday announced that an FDA panel has voted 11-5 recommending approval of its lead drug candidate Arimoclomol for the treatment of patients with Niemann-Pick disease type C (NPC). The FDA's final decision is due on September 21, 2024. Niemann-Pick disease type C (NPC) is an ultra-rare, progressive, and neurodegenerative lysosomal storage disorder, marked by an inability of the body to transport cholesterol and other lipids within the cell, leading to an accumulation of these substances in various tissues and organs, including the brain.

ZVRA closed Friday's trading at $6.30.

Deal or No Deal

23andMe Holding Co. (ME) on Friday turned down the take-private proposal of Anne Wojcicki, Chief Executive Officer, Co-Founder, and Chair of the Board of Directors of the company. Anne offered to acquire all of the outstanding shares of 23andMe not owned by her or her affiliates or any other stockholder that she invites to roll over their shares for cash consideration of $0.40 per share of Class A Common Stock or Class B Common Stock. The Special Committee of the Board of Directors of the company, which reviewed the CEO's proposal, said it is "disappointed with the proposal for multiple reasons, including because it provides no premium to the closing price per share on Wednesday, July 31st, it lacks committed financing, and it is conditional in nature."

ME closed Friday's trading at $0.38, down 0.26%.

Breakthroughs and Setbacks

Eisai Co. Ltd/Biogen Inc.'s (BIIB) Alzheimer's drug Leqembi showed improved cognition and function in patients with early Alzheimer's disease who received continuous treatment with the drug for over three years, revels a global phase III study, dubbed Clarity AD. Moreover, no additional safety concerns were observed with the extended Leqembi treatment over a three-year period. Leqembi was granted traditional FDA approval in July 2023 for use as an intravenous (IV) infusion in patients with mild cognitive impairment due to Alzheimer's disease and mild AD dementia. The company is also developing a subcutaneous injection formulation of Leqembi to enhance convenience for patients. It should be noted that last month, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended against approving Leqembi for Alzheimer's disease. The committee concluded that the drug's benefits do not outweigh the risks of serious side effects, such as brain swelling and potential bleeding, observed in patients who received the treatment.

BIIB closed Friday's trading at $205.66, down 2.39%.

Eli Lilly and Co.'s (LLY) antidiabetic medication Tirzepatide has shown to reduce the risk of heart failure outcomes - heart failure urgent visit or hospitalization, oral diuretic intensification or cardiovascular death - by 38% compared to placebo in a phase III trial in adults with heart failure with preserved ejection fraction (HFpEF) and obesity, with or without type 2 diabetes. In the trial, dubbed SUMMIT, the drug also significantly improved heart failure symptoms and physical limitations and led to 15.7% weight loss in a combined population of people with and without type 2 diabetes. Tirzepatide was approved by the FDA as Mounjaro for adults with type 2 diabetes to improve glycemic control on May 13, 2022, and as Zepbound for adults with obesity or those who are overweight who also have a weight-related comorbid condition on November 8, 2023. Both Mounjaro and Zepbound are approved as an adjunct to diet and exercise.

LLY closed Friday's trading at $804.46, down 3.36%.

Agios Pharmaceuticals Inc.'s (AGIO) blood disorder drug Pyrukynd has failed to meet the primary endpoint of transfusion reduction response in a phase III study in children aged 1 to less than 18 years with pyruvate kinase (PK) deficiency who are regularly transfused, dubbed ACTIVATE-KidsT. Although the primary endpoint was not met, the results were clinically meaningful, according to the company. A phase III trial of Pyrukynd in children with PK deficiency who are not regularly transfused, dubbed ACTIVATE-kids, is ongoing, with topline data anticipated in 2025. Pyrukynd is approved for the treatment of hemolytic anemia in adults with pyruvate kinase deficiency in the U.S., EU and Great Britain.

AGIO closed Friday's trading at $43.96, down 1.21%.

Shares of MacroGenics Inc. (MGNX) have been on a downward spiral since the company provided an update on its TAMARACK trial in May of this year. TAMARACK is a phase II study evaluating the company's investigational drug Vobra duo in metastatic castration-resistant prostate cancer. On May 9, 2024, the company revealed that a total of five patient deaths occurred in the TAMARACK study. After a review of accumulated study data, MacroGenics in late July, agreed with the study's Independent Data Monitoring Committee's (IDMC) recommendation that study treatment should be discontinued for the remaining metastatic castration-resistant prostate cancer study participants who potentially could have received additional doses.

MGNX closed Friday's trading at $3.83, down 4.25%.