Weekly Biotech Buzz: BMRN Cuts Jobs, FDA Approves New Mpox Vaccine, MRK Halts 2 Keytruda Studies

(RTTNews) - As biotech companies reprioritize their research and development activities, the sector continues to face layoffs. Unfortunately, this week was no exception. The FDA greenlighted a new vaccine for Mpox, which is the second for this viral infection, amid increasing cases in Africa. Meanwhile, a pharma giant faced a clinical trial setback related to one of its blockbuster drugs as it failed in two late-stage studies.

Let's dive into the details.

Layoffs

BioMarin Pharmaceutical Inc. (BMRN), in a SEC filing dated Aug.28, 2024, revealed that it will implement its plan of reducing its global workforce by approximately 225 employees, with this process expected to be substantially completed by the end of 2024. This decision is driven by the company's organizational restructuring efforts, its updated strategy for its Hemophilia A drug ROCTAVIAN to enhance long-term profitability, and its choice to discontinue the development of BMN 293, a gene therapy for hypertrophic cardiomyopathy. The workforce reduction will result in a one-time pre-tax charge of approximately $30 to $35 million, with a majority of the expense expected to be incurred during the second half of 2024.

BMRN closed Friday's trading at $91.21, down 0.18%.

Repare Therapeutics Inc. (RPTX), on Thursday, announced that it is reducing its overall workforce by approximately 25%, which will primarily affect its preclinical group. The workforce reduction is part of the company's strategic reprioritization of its research and development activities to focus its resources on its clinical oncology pipeline. The company expects to incur total non-recurring cash payments of approximately $1.5 million to $2.0 million in the third quarter of 2024 associated with the workforce reduction and expects to generate annual savings of approximately $15.0 million that will extend its cash runway into the second half of 2026.

RPTX closed Friday's trading at $2.91, down 3.32%.

Roche Holding AG's (RHHBY) subsidiary Genentech is terminating 93 employees at its San Francisco site, with the layoffs set to take effect on Oct.8, 2024. Earlier in August, the company announced its plan to wind down the Cancer Immunology department and consolidate its R&D activities in this area with its molecular oncology programs, with the goal of creating a unified and expanded cancer research initiative.

RHHBY.OB closed Friday's trading at $42.35, up 0.74%.

FDA Approvals and Rejections

Emergent BioSolutions Inc.'s (EBS) smallpox vaccine ACAM2000, received FDA approval, on Thursday, for expanded use in prevention of Mpox disease in high-risk individuals. As the Mpox outbreak continues across Africa and other regions, the company has pledged to donate 50,000 doses of ACAM2000 for potential deployment across impacted countries in Central Africa. ACAM2000 is the second Mpox vaccine to receive FDA approval. Bavarian Nordic's Jynneos, approved in 2019, is the first vaccine to be approved in the U.S for the prevention of Mpox.

EBS closed Friday's trading at $8.31, down 6.73%.

The FDA, on Friday, granted Emergency Use Authorization for Novavax Inc.'s (NVAX) updated version of COVID-19 vaccine to prevent COVID-19 in individuals aged 12 and older. The updated vaccine targets JN.1, the 'parent strain' of currently circulating variants, and has shown robust cross-reactivity against JN.1 lineage viruses, including KP.2.3, KP.3, KP.3.1.1 and LB.1.

NVAX closed Friday's trading at $12.38, up 8.60%.

Johnson & Johnson (JNJ), on Thursday, filed for FDA approval of its investigational drug Nipocalimab for the treatment of people living with generalized myasthenia gravis. Nipocalimab came under JNJ's fold following the acquisition of Momenta Pharmaceuticals in 2020 for roughly $6.5 billion in cash. Nipocalimab, if granted FDA nod, would have to compete with Argenx's Vyvgart, which was approved in 2021, and UCB's Rystiggo, approved in 2023.

JNJ closed Friday's trading at $165.86, up 0.99%.

Deal or No Deal

Flagship Pioneering, a venture capital firm, and Quotient Therapeutics, on Wednesday, entered into an agreement to identify potential novel targets for the treatment of cardiovascular and renal diseases under a strategic partnership with Pfizer (PFE). Flagship's strategic partnership with Pfizer was announced in July 2023. Quotient Therapeutics was founded by Flagship Pioneering in 2022. The Quotient agreement is the most recent program initiated under Flagship Pioneering/Pfizer 2023 partnership.

PFE closed Friday's trading at $29.01, up 1.01%.

AstraZeneca plc (AZN) and QIAGEN (QGEN), which entered into collaboration in 2014 to develop diagnostic test for lung cancer patients, announced on Thursday they are expanding their partnership beyond oncology. Under the expanded agreement, QIAGEN will develop and validate a genotyping assay with its QIAstat-Dx syndromic testing platform. The new deal will also enable QIAGEN to develop and commercialize companion diagnostics for AstraZeneca's future therapies being developed to address chronic diseases.

QGEN closed Friday's trading at $45.71, up 0.07%.

Clinical Trials - Breakthroughs and Setbacks

Bristol Myers Squibb (BMY), on Sunday, announced new long-term follow-up results of its heart drug CAMZYOS from EXPLORER-LTE cohort of the MAVA-Long-Term Extension study. Even after up to 3.5 years, CAMZYOS demonstrated consistent and sustained improvements in echocardiographic measures and symptoms, with no new safety signals, in adult patients with New York Heart Association (NYHA) class II-III symptomatic obstructive hypertrophic cardiomyopathy. CAMZYOS is the first and only approved cardiac myosin inhibitor that targets the source of symptomatic obstructive hypertrophic cardiomyopathy. The drug received FDA approval in 2022.

BMY closed Friday's trading at $49.95, up 0.46%.

NuCana plc (NCNA), on Thursday, revealed that it is discontinuing its phase II NuTide:323 Study, following pre-planned initial analysis and recommendation from a Steering Committee. In the phase II NuTide:323 trial, NUC-3373 was evaluated in combination with leucovorin, irinotecan (Onivyde), and bevacizumab (Avastin) against the control arm of 5-FU, leucovorin, irinotecan and bevacizumab (FOLFIRI+bev) for the treatment of patients with colorectal cancer in the second line. The pre-planned initial analysis by the Steering Committee has found that the combination of NUC-3373 with leucovorin, irinotecan and bevacizumab was unlikely to achieve the study's primary objective of superior Progression Free Survival (PFS) compared to the control arm.

NCNA closed Friday's trading at $3.66, down 52.65%.

Merck (MRK), on Thursday, announced it is discontinuing two phase III trials of its blockbuster drug Keytruda in non-small cell lung cancer and cutaneous squamous cell carcinoma as a planned interim analysis of the trials revealed disappointing data. The trials that are being terminated are KEYNOTE-867, a phase III trial evaluating KEYTRUDA in combination with stereotactic body radiotherapy (SBRT) for the treatment of patients with stage I or II non-small cell lung cancer, including those who are medically inoperable or have refused surgery, and KEYNOTE-630, a phase III trial evaluating KEYTRUDA for the adjuvant treatment of patients with high-risk locally advanced cutaneous squamous cell carcinoma following surgery and radiation.

MRK closed Friday's trading at $118.45, up 0.84%.