Here's a roundup of top developments in the biotech space over the last 24 hours:
Stocks In Focus
Merck's Potential Buyout Of Seagen Expected Within Next Few Weeks
Merck & Co Inc. MRK is in advanced talks to acquire Seagen Inc. SGEN. A purchase agreement is expected in the next few weeks, according to the Wall Street Journal citing people familiar with the matter.
The potential deal could be worth more than $40 billion, or above $200 a share.
FDA Institutes Clinical Hold On DiaMedica's Late-Stage Stroke Trial
The FDA placed a clinical hold on DiaMedica Therapeutics Inc.'s DMAC Phase 2/3 ReMEDy2 trial evaluating DM199 to treat acute ischemic stroke patients.
The company submitted three serious adverse event reports related to clinically significant transient hypotension (low blood pressure) occurring shortly after initiating the intravenous dose of DM199.
DMAC shares closed 36.1% lower at $1.29 during after-hours trading.
CytomX's Breast Cancer Candidate Meets Primary Goal Of Objective Response Rate
CytomX Therapeutics Inc's CTMX Phase 2 study of praluzatamab ravtansine in hormone receptor-positive/human epidermal growth factor receptor 2-non-amplified breast cancer (Arm A) met its primary efficacy endpoint of confirmed objective response rate (ORR) of more than 10%.
The ORR was 15% in 47 evaluable patients. The clinical benefit rate at 24 weeks was 40%, and the median progression-free survival was 2.6 months.
Shares closed 23.4% lower at $1.51 during after-hours trading.
FDA's Recommendation Before Clovis Submits Rubraca Application For Ovarian Cancer
Clovis Oncology Inc. CLVS recently had a Type A meeting with the FDA to discuss its plans for a supplemental marketing application for Rubraca (Rucaparib) as a first-line maintenance treatment in ovarian cancer.
The FDA recommends that the company wait for more mature overall survival data to submit the application.
If the company chooses to submit the application before receiving more mature overall survival data, it may need to be discussed at an Oncologic Drugs Advisory Committee meeting.
Adverum Biotechnologies Cuts Workforce
Adverum Biotechnologies Inc. ADVM announced a restructuring plan, including reductions in headcount and expenses, to prioritize its clinical development of ADVM-022, a single intravitreal injection for wet age-related macular degeneration.
The company is reducing its workforce by 78 (approximately 38%).
Adverum expects the workforce reduction to decrease its annual operating costs by approximately $15.3 million in direct labor costs.
Exelixis, Ryvu Ink Licensing Pact For Targeted Cancer Therapies
Exelixis Inc. EXEL and Ryvu Therapeutics S.A. have entered into an exclusive license agreement focused on targeted therapies utilizing Ryvu's STimulator of INterferon Genes technology.
Exelixis will pay Ryvu an upfront fee of $3 million in exchange for certain rights to Ryvu's STING agonist small molecules, which Exelixis will seek to incorporate into targeted therapies such as ADCs.
Exelixis will lead all research activities and be responsible for all development and commercialization activities upon selecting each development candidate.
FDA Authorizes Pharmacists to Prescribe Pfizer's COVID-19 Therapy
The FDA authorized state-licensed pharmacists to prescribe, with certain limitations, Pfizer Inc.'s PFE COVID-19 pill to eligible patients to help improve access to the treatment.
The agency said patients who tested positive for COVID-19 should bring their health records for the pharmacists to review for kidney and liver problems.
89bio Inc. ETNB: Director Rajeev Shah reported purchasing 5.6 million shares at an average price of $1.78/share in a Form 4 filing.
Shares are rising 4.52% at $3.24 during premarket trading.
On The Radar
Scholar Rock Holding Corp SRRK: E-poster presentation on the design of the company's ongoing SAPPHIRE Phase 3 trial in spinal muscular atrophy at the International Congress on Neuromuscular Diseases.
Avalo Therapeutics Inc AVTX: Reverse stock split of a 1-for-12.
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