### Biotech Sector Faces Continued Layoffs Amid Strategic Realignments
As biotech companies realign their research and development priorities, the sector is experiencing continued layoffs, with this week being no exception. The FDA has approved a new Mpox vaccine, the second for this viral infection, in response to rising cases in Africa. Meanwhile, a major pharmaceutical company suffered a setback when one of its blockbuster drugs failed in two late-stage clinical trials.
#### Layoffs
**BioMarin Pharmaceutical Inc. (BMRN)** disclosed in an SEC filing on August 28, 2024, that it plans to reduce its global workforce by approximately 225 employees. This restructuring aims to enhance long-term profitability for its Hemophilia A drug, ROCTAVIAN, and will see the discontinuation of the development of BMN 293, a gene therapy for hypertrophic cardiomyopathy. The workforce reduction will incur a one-time pre-tax charge of about $30 to $35 million, primarily in the latter half of 2024.
BMRN closed Friday’s trading at $91.21, down 0.18%.
**Repare Therapeutics Inc. (RPTX)** announced on Thursday that it will cut approximately 25% of its workforce, primarily impacting its preclinical group. This move is part of a strategic reprioritization to focus on its clinical oncology pipeline. The layoffs will lead to non-recurring cash payments of about $1.5 million to $2.0 million in Q3 2024, with expected annual savings of approximately $15.0 million extending its cash runway into the second half of 2026.
RPTX closed Friday’s trading at $2.91, down 3.32%.
**Genentech**, a subsidiary of Roche Holding AG (RHHBY), will terminate 93 employees at its San Francisco location effective October 8, 2024. This decision follows the company's August announcement to consolidate its Cancer Immunology department with its molecular oncology programs, aiming for 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 preventing Mpox disease in high-risk individuals. Amidst the Mpox outbreak in Africa and other regions, the company has pledged to donate 50,000 doses to affected countries in Central Africa. ACAM2000 is the second Mpox vaccine to receive FDA approval, following Bavarian Nordic’s Jynneos, which was approved in 2019.
EBS closed Friday’s trading at $8.31, down 6.73%.
The FDA granted Emergency Use Authorization on Friday for Novavax Inc.'s (NVAX) updated COVID-19 vaccine for individuals aged 12 and older. The new vaccine targets the JN.1 'parent strain' of circulating variants and has shown robust cross-reactivity against related 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)** filed for FDA approval on Thursday for its investigational drug Nipocalimab to treat generalized myasthenia gravis. Acquired through the purchase of Momenta Pharmaceuticals in 2020 for approximately $6.5 billion, Nipocalimab would compete with Argenx’s Vyvgart, approved in 2021, and UCB’s Rystiggo, approved in 2023 if granted approval.
JNJ closed Friday’s trading at $165.86, up 0.99%.
#### Deal or No Deal
Flagship Pioneering and Quotient Therapeutics announced on Wednesday an agreement to identify novel targets for treating cardiovascular and renal diseases under a strategic partnership with Pfizer (PFE). This follows Flagship’s strategic partnership with Pfizer, initially announced in July 2023. Quotient Therapeutics, founded by Flagship Pioneering in 2022, is the latest program under this partnership.
PFE closed Friday’s trading at $29.01, up 1.01%.AstraZeneca plc (AZN) and QIAGEN (QGEN), which began their collaboration in 2014 to develop diagnostic tests for lung cancer patients, announced on Thursday they are extending their partnership beyond oncology. Under the new agreement, QIAGEN will develop and validate a genotyping assay using its QIAstat-Dx syndromic testing platform. This expanded partnership also allows QIAGEN to develop and commercialize companion diagnostics for AstraZeneca's forthcoming therapies aimed at treating chronic diseases.
QGEN closed Friday's trading at $45.71, rising 0.07%.
**Clinical Trials - Breakthroughs and Setbacks**
Bristol Myers Squibb (BMY) presented new long-term follow-up results of its heart drug CAMZYOS from the EXPLORER-LTE cohort of the MAVA-Long-Term Extension study on Sunday. Even after up to 3.5 years, CAMZYOS showed 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 remains the first and only approved cardiac myosin inhibitor that targets the root cause of symptomatic obstructive hypertrophic cardiomyopathy, having received FDA approval in 2022.
BMY closed Friday's trading at $49.95, up 0.46%.
NuCana plc (NCNA) announced on Thursday that it is discontinuing its phase II NuTide:323 Study, following a planned initial analysis and recommendation from a Steering Committee. In this trial, NUC-3373 was evaluated in combination with leucovorin, irinotecan (Onivyde), and bevacizumab (Avastin) against the control regimen of 5-FU, leucovorin, irinotecan, and bevacizumab (FOLFIRI+bev) for the treatment of patients with second-line colorectal cancer. The initial analysis by the Steering Committee indicated that the combination of NUC-3373 with leucovorin, irinotecan, and bevacizumab was unlikely to achieve the primary objective of superior Progression Free Survival (PFS) as compared to the control arm.
NCNA closed Friday's trading at $3.66, down 52.65%.
Merck (MRK) revealed on Thursday that it is discontinuing two phase III trials of its blockbuster drug Keytruda in non-small cell lung cancer and cutaneous squamous cell carcinoma due to disappointing interim analysis results. The terminated trials are KEYNOTE-867, a phase III trial evaluating Keytruda in combination with stereotactic body radiotherapy (SBRT) for treating stage I or II non-small cell lung cancer patients, including those who are medically inoperable or have refused surgery; and KEYNOTE-630, a phase III trial assessing Keytruda for the adjuvant treatment of high-risk locally advanced cutaneous squamous cell carcinoma following surgery and radiation.
MRK closed Friday's trading at $118.45, up 0.84%.
