Blueprint Medicines Corp. gained the FDA’s nod for Ayvakit (avapritinib) to treat systemic mastocytosis (SM), adding another indication to the KIT inhibitor’s label. For the first time, patients have available a targeted therapy designed to block D816V mutant KIT, the central driver of the disease.
The hefty $107.5 million series B financing disclosed June 10 by Synthekine Inc. underscored Wall Street’s interest in engineered cytokines, where an army of companies is developing prospects at varying stages – including Bright Peak Therapeutics Inc., which pulled down a series B in almost exactly the same amount as Synthekine, and on the same day.
Rapt Therapeutics Inc. CEO Brian Wong said RPT-193 monotherapy in atopic dermatitis (AD) “looks really promising, but there’s still quite a bit to learn” about the small molecule, designed to inhibit the migration of Th2 cells into inflamed tissues by blocking CCR4. Investors saw enough to push the shares of South San Francisco-based Rapt up 115.5%, or $21.45, to close at $40.02, after trading as high as $41.99 during the day.
Data from a prospective study rolled out by Allakos Inc. last month at the Digestive Disease Week meeting made the case for broader prevalence than previously believed of eosinophilic gastritis and/or eosinophilic duodenitis – and the Redwood City, Calif.-based firm may have just the drug for the conditions in lirentelimab (AK-002).
Phase II data from Iovance Biotherapeutics Inc. in advanced melanoma at the recent meeting of the American Society of Clinical Oncology turned up an important relationship between previous anti-PD-1 therapy exposure and the durability of treatment response. Findings added weight to the idea that tumor-infiltrating lymphocytes (TILs) should be deployed earlier in therapy.
During a conference call with investors, Biogen Inc. officials defended the price of Aduhelm (aducanumab) for Alzheimer’s disease (AD), with CEO Michel Vounatsos saying the $56,000 per year price tag was based on “the value it is expected to bring to patients, caregivers, and society.”
By granting accelerated approval for Biogen Inc.’s Aduhelm (aducanumab) for Alzheimer’s disease (AD), the FDA is “essentially confirming that the beta-amyloid hypothesis has been validated,” Mizuho analyst Salim Syed said in an alert to investors. Shares of Cambridge, Mass.-based Biogen (NASDAQ:BIIB) closed $395.85, up $109.71, or 38.3%, as Wall Street hailed the first new AD therapy to reach the market since 2003.
In February 2020, when Redhill Biopharma Ltd. acquired the peripherally acting mu-opioid receptor antagonist (PAMORA) Movantik (naloxegol) from Astrazeneca plc, new prescriptions were dropping. But that picture has turned around after about nine months of promotion, with strong reimbursement trends for the product, and Redhill may have positioned itself to become a leader in the gastrointestinal (GI) space.
Amgen Inc.’s Merdo Gordon, head of commercial global operations, said just-approved Lumakras (sotorasib) is “priced very well compared to other targeted medicines available in the market” for cancers driven by specific mutations. “Just characterizing the launch broadly, look, it’s really hard to tell because of the variability of our reach to customers right now” – a result of the COVID-19 pandemic.
Well ahead of the assigned Aug. 16 PDUFA date, Amgen Inc. bagged accelerated clearance from the FDA for Lumakras (sotorasib), the first targeted therapy for adults with KRAS G12C-mutated locally advanced or metastatic non-small-cell lung cancer (NSCLC), as determined by an FDA-approved test.
