Biotech Alert: Searches spiking for these stocks today

These names in the biotech sector are seeing a substantial increase in search activity today, as determined by InvestingChannel. They include: 

• Cara Therapeutics (CARA), 460% surge in interest
• Checkpoint Therapeutics (CKPT), 133% surge in interest
• Prothena (PRTA), 100% surge in interest

Pipeline and key clinical candidates for these companies:

Cara Therapeutics is a commercial-stage biopharmaceutical company that notes that its Kapruvia injection is “the first and only” MHRA-approved treatment for moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis. The company is developing an oral formulation of difelikefalin and has Phase 3 programs ongoing for the treatment of pruritus in patients with non-dialysis dependent advanced chronic kidney disease and atopic dermatitis. In addition, the company has initiated a Phase 2/3 program of oral difelikefalin for the treatment of moderate-to-severe pruritus in patients with notalgia paresthetica.

Checkpoint Therapeutics is focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers. Checkpoint is evaluating its lead antibody product candidate, cosibelimab in an ongoing global, open-label, multicohort Phase 1 clinical trial in checkpoint therapy-naive patients with selected recurrent or metastatic cancers, including ongoing cohorts in locally advanced and metastatic cutaneous squamous cell carcinoma, or “cSCC,” intended to support one or more applications for marketing approval. Checkpoint is evaluating its lead small-molecule, targeted anti-cancer agent, olafertinib, formerly CK-101, as a potential new treatment for patients with EGFR mutation-positive non-small cell lung cancer.

Prothena Corporation is a late-stage clinical biotechnology company with expertise in protein dysregulation and a pipeline of investigational therapeutics with the potential to change the course of devastating neurodegenerative and rare peripheral amyloid diseases. Prothena is advancing a pipeline of therapeutic candidates for a number of indications and novel targets. Prothena’s pipeline includes both wholly-owned and partnered programs being developed for the potential treatment of diseases including AL amyloidosis, ATTR amyloidosis, Alzheimer’s disease, Parkinson’s disease and a number of other neurodegenerative diseases.

Recent news on these stocks:

December 18

Cara Therapeutics announced the outcome from the dose-finding Part A of the KIND 1 study evaluating the efficacy and safety of oral difelikefalin as adjunct therapy to topical corticosteroids for moderate-to-severe pruritus in adult patients with atopic dermatitis. Oral difelikefalin as adjunct to TCS did not demonstrate a meaningful clinical benefit compared to TCS alone, resulting in the Company’s decision to discontinue its clinical program in pruritus associated with atopic dermatitis. KIND 1 was a Phase 3, two-part, multicenter, randomized, double-blind, controlled study to evaluate the efficacy and safety of oral difelikefalin as adjunct therapy to TCS for moderate-to-severe pruritus in adults with AD. In Part A, patients were randomized to receive oral difelikefalin 0.25 mg tablets twice a day plus TCS, difelikefalin 0.5 mg tablets BID plus TCS, placebo tablets BID plus TCS or placebo tablets BID plus vehicle. The primary endpoint was the proportion of patients with a greater than or equal to4-point improvement at Week 12 from baseline in the worst itch NRS. Oral difelikefalin as adjunct therapy to TCS did not demonstrate a meaningful clinical benefit compared to TCS alone. Oral difelikefalin was generally well tolerated with a safety profile similar to prior trials.

Checkpoint Therapeutics announced that the FDA has issued a complete response letter for the cosibelimab biologic license application for the treatment of patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or radiation. The CRL only cites findings that arose during a multi-sponsor inspection of Checkpoint’s third-party contract manufacturing organization as approvability issues to address in a resubmission. The CRL did not state any concerns about the clinical data package, safety, or labeling for the approvability of cosibelimab. “As the only deficiencies relate to the FDA’s inspection of our third-party contract manufacturing organization, we believe we can address the feedback in a resubmission to enable marketing approval in 2024,” said James Oliviero, President and CEO of Checkpoint. “We are committed to working closely with our third-party manufacturer and the FDA on our resubmission in order to make cosibelimab available to patients living with cSCC.”

December 11

Deutsche Bank initiated coverage of Prothena with a Buy rating and $62 price target. With the selloff over the last few months, the analyst thinks the share price is justified by just birtamimab, cash, and projected milestone payments from collaborations. As such, Prothena’s risk/reward into the Phase 1b MAD data for PRX012 is “fundamentally skewed to the upside,” the analyst told investors in a research note.

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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.