These names in the biotech sector are seeing a substantial increase in search activity today, as determined by InvestingChannel. They include:
Pipeline and key clinical candidates for these companies:
Akebia Therapeutics is a fully integrated biopharmaceutical company that says its purpose is "to better the lives of people impacted by kidney disease."
Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company that says it is "pioneering the development of ITK inhibition as a new approach to immunotherapy for a broad range of cancer and immune diseases." The company's lead product candidate is CPI-818, an investigational, oral, small molecule drug that selectively inhibits ITK and is in a mid-stage clinical trial for patients with T cell lymphoma. Its other clinical-stage candidates are being developed for a variety of cancer indications.
Mirati Therapeutics is focused on bringing forward therapies that address areas of high unmet medical need, including lung cancer, and advancing a pipeline of novel therapeutics targeting the genetic and immunological drivers of cancer.
Iovance Biotherapeutics is focused on developing and delivering tumor infiltrating lymphocyte, or TIL, therapies for patients with cancer. Its lead late-stage TIL product candidate, lifileucel for metastatic melanoma, "has the potential to become the first approved one-time cell therapy for a solid tumor cancer," said the company, adding that its TIL platform has "demonstrated promising clinical data across multiple solid tumors."
Coherus is a commercial-stage biopharmaceutical company focused on the research, development and commercialization of innovative immunotherapies to treat cancer and the commercialization of our portfolio of FDA-approved therapeutics. Coherus’ strategy is to build a leading immuno-oncology franchise funded with cash generated through net sales of its diversified portfolio of FDA-approved therapeutics.
Recent news on these stocks:
In a regulatory filing, Akebia Therapeutics disclosed that on May 30, Keryx Biopharmaceuticals, a wholly owned subsidiary of Akebia, and Panion & BF Biotech entered into a settlement and license agreement with Zydus. This settlement resolves patent litigation brought by Keryx and Panion in response to Zydus' Paragraph IV certification notice letter regarding their Abbreviated New Drug Application, or "ANDA," seeking approval to market a generic version of Auryxia tablets prior to the expiration of the applicable patents. "Pursuant to the terms of the agreement and, consistent with Keryx's prior ANDA settlements with Teva Pharmaceuticals USA, Inc., Watson Laboratories, Inc., Par Pharmaceutical, Inc., Lupin Atlantis Holdings SA, Chemo Research S.L., and Mylan Pharmaceuticals Inc., Keryx and Panion will grant Zydus a license to market a generic version of Auryxia in the United States beginning on March 20, 2025, subject to U.S. Food and Drug Administration approval, or earlier under certain circumstances customary for settlement agreements of this nature. Additionally, in accordance with the agreement, the parties will terminate all ongoing litigation among Keryx, Panion and Zydus regarding Auryxia patents pending in the United States District Court for the District of Delaware. The agreement is confidential and subject to review by the U.S. Federal Trade Commission and the U.S. Department of Justice. Keryx and Panion have now entered into settlement and license agreements resolving all patent litigation proceedings brought by Keryx and Panion in response to ANDAs filed by third parties seeking approval to market generic versions of Auryxia tablets prior to the expiration of the applicable patents," the filing stated
Coherus Biosciences announced that it plans to launch its Humira biosimilar, Yusimry, with a list price of $995 per carton, which is the lowest price announced to date of any Humira biosimilar in the United States, H.C. Wainwright wrote in a research note. The analyst said the "steep discount" shows Coherus is prepared to be low-cost provider in the market for Humira biosimilars. With Humira currently priced at $6,922 per carton of two autoinjectors, Coherus' represents about an 85% discount from the originator, says H.C. Wainwright. It notes that by discounting so steeply, Yusimry is going to avoid the specialty tier and therefore avoid the 20%-30% copays that accompany those drugs. "By coming to market at such a steep discount, we expect Coherus is going to get the attention of payers," wrote Wainwright. The firm's market intelligence suggests that Abbvie's (ABBV) contracting strategy will not exclude Coherus as long as Humira is at parity and not disadvantaged through a prior authorization.
Piper Sandler upgraded Akebia to Overweight from Neutral with a price target of $4, up from $2, after the company received a response from the FDA on a path forward for vadadustat. The stock's risk/reward skews positive after the FDA outlined information to be included in a new drug application resubmission, which did not include the generation of additional clinical data, the analyst tells investors in a research note. Given the news, the firm is layering the U.S. vadadustat opportunity back into its model with end-user revenue approaching $375M by fiscal year 2028.
Ladenburg raised the firm's price target on Corvus Pharmaceuticals to $10 from $4 and keeps a Buy rating on the shares. The analyst believes CPI-818's demonstrated efficacy so far will not be limited to T-cell lymphoma only, but will likely be applicable further in a number of solid tumors.
Iovance Biotherapeutics announced that the U.S. Food and Drug Administration accepted its Biologics License Application for lifileucel for patients with advanced melanoma. The FDA granted lifileucel Priority Review and assigned November 25, 2023 as the target action date for a decision under the Prescription Drug User Fee Act. The FDA is not currently planning to hold an advisory committee meeting to discuss this application and, after a preliminary review, has not at this time identified any potential review issues. Lifileucel is a TIL therapy intended for patients with advanced melanoma who progressed on or after prior anti-PD-1/L1 therapy and targeted therapy, where applicable. There are no FDA approved therapies in this treatment setting.
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About “Biotech Alert”
The Fly will report on a selection of biotech stocks seeing a surge in interest from retail and financial professional investors, based on data from InvestingChannel.
This Fly exclusive recap reveals the biotech stocks that are seeing a spike in searches among the 20-plus million retail and financial professional investors through InvestingChannel's online financial news media ecosystem.
This increased attention from the investors may be in response to, or advance of, outsized moves for stocks in the biotech sector, which tend to be volatile and prone to sharp swings in share price around binary events such as clinical study results and FDA approvals.