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: 

• PTC Pharmaceuticals (PTCT), 2,231% surge in interest
• Iovance Biotherapeuctics (IOVA), 204% surge in interest
• Apellis Pharmaceuticals (APLS), 64% surge in interest
• Cara Therapeutics (CARA), 45% surge in interest

Pipeline and key clinical candidates for these companies:

PTC is a biopharmaceutical company that says it is “focused on the discovery, development and commercialization of clinically differentiated medicines that provide benefits to patients with rare disorders.” The company adds: “PTC’s ability to innovate to identify new therapies and to globally commercialize products is the foundation that drives investment in a robust and diversified pipeline of transformative medicines. PTC’s mission is to provide access to best-in-class treatments for patients who have little to no treatment options.”

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.”

Apellis Pharmaceuticals says the company “ushered in the first new class of complement medicine in 15 years” with the approval of the first and only targeted C3 therapy. Apellis is advancing this science to “continually develop transformative medicines for people living with rare, retinal, and neurological diseases,” it stated.

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.

Recent news on these stocks:

September 15

PTC Therapeutics announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, has given a negative opinion on the conversion of the conditional marketing authorization to full marketing authorization of Translarna for the treatment of nonsense mutation Duchenne muscular dystrophy, or nmDMD. The negative opinion also applies to the renewal of the existing conditional authorization. PTC plans to submit a request for re-examination per EMA guidelines. Translarna will remain on the market and available to patients with nmDMD until the re-examination process is completed. Based on CHMP procedural guidance, the opinion following the re-examination process would be expected to occur in January 2024, with EC ratification of the opinion within the following 67 days. “We are surprised and extremely disappointed by the CHMP decision, given the well-established and favorable safety and efficacy profile of Translarna,” said Matthew B. Klein, M.D., Chief Executive Officer, PTC Therapeutics. “Of course, this decision is most devastating for the hundreds of boys and young men in Europe with nonsense mutation DMD, for whom no other approved therapies are available. We will be submitting a request for re-examination to the CHMP to reverse this opinion, as we have done previously in the regulatory history of Translarna in Europe.”

Wells Fargo upgraded Apellis Pharmaceuticals to Overweight from Equal Weight with a price target of $64, up from $34. The analyst likes the stock’s risk/reward into the Q3 earnings report and thinks Syfovre is on track to beat consensus estimates. In addition, J-code starting in October and stabilizing RV rates should accelerating utilization, the analyst told investors in a research note.

September 14

Iovance Biotherapeutics announced that the FDA, because of resource constraints, requires additional time to complete the Priority Review of Iovance’s Biologics License Application for lifileucel. The BLA is seeking accelerated approval of lifileucel for patients with advanced melanoma. The FDA extended the new target action date for a decision under the Prescription Drug User Fee Act to February 24, 2024, but agreed to work with Iovance to expedite the remaining review for a potentially earlier approval date. The FDA recently notified Iovance that they had insufficient resources to review a recent response to an information request for the ongoing BLA review prior to the planned late-cycle review meeting scheduled for September 11, 2023. In a meeting with the FDA held on September 14, 2023, the FDA acknowledged the resource constraints and agreed to work closely with Iovance to expedite the remaining review. The overall BLA process continues under Priority Review with several recent positive status updates. The FDA reiterated there are no major review issues, and there are no plans to hold an advisory committee meeting. In addition, all pre-approval inspections of clinical sites. internal and external manufacturing and testing facilities have been successfully completed. The FDA is also engaged and has expressed no concerns on the status of the TILVANCE-301 confirmatory trial in frontline advanced melanoma, which remains on track to be well underway by the PDUFA date.

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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.