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:
Galera Therapeutics is focused on developing and commercializing a pipeline of therapeutic candidates that have the potential to transform radiotherapy in cancer. Galera’s selective dismutase mimetic product candidate avasopasem manganese, avasopasem, or GC4419, is being evaluated for radiotherapy-induced toxicities. The company’s second product candidate, rucosopasem manganese, rucosopasem, or GC4711, is in clinical-stage development to augment the anti-cancer efficacy of stereotactic body radiation therapy in patients with non-small cell lung cancer and locally advanced pancreatic cancer.
Cellectis is a clinical-stage biotechnology company that utilizes an allogeneic approach for CAR-T immunotherapies in oncology, "pioneering the concept of off-the-shelf and ready-to-use gene-edited CAR T-cells to treat cancer patients," and a platform to make therapeutic gene editing in hemopoietic stem cells for various diseases. Cellectis is developing product candidates utilizing TALEN, its gene editing technology, and PulseAgile, its electroporation system to "harness the power of the immune system in order to treat diseases with unmet medical needs," the company says.
Achieve's focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline, a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. Cytisinicline is an investigational product candidate being developed for treatment of nicotine addiction and has not been approved by the FDA for any indication in the United States.
Eiger Biopharma is a commercial-stage biopharmaceutical company focused on the development of innovative therapies to treat Hepatitis Delta Virus, or HDV, and other serious rare diseases.
Vericel manufactures and markets two cell therapy products in the United States. MACI, or autologous cultured chondrocytes on porcine collagen membrane, is an autologous cellularized scaffold product indicated for the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults. Epicel, or cultured epidermal autografts, is a permanent skin replacement for the treatment of patients with deep dermal or full thickness burns greater than or equal to 30% of total body surface area. Vericel also holds an exclusive license for North American rights to NexoBrid, a biological orphan product containing proteolytic enzymes, which is indicated for eschar removal in adults with deep partial-thickness and/or full-thickness burns.
Recent news on these stocks:
Vericel said it expects MACI arthroscopic commercial launch in 2024. Following a Type C meeting with the FDA, the company said it is planning to initiate a human factors validation study to support expanding the MACI label to include arthroscopic administration of MACI for the treatment of cartilage defects of the knee and now anticipates an accelerated potential commercial launch of arthroscopic MACI in 2024. Additionally, it announced the FDA approval of NexoBrid on December 28, 2022 for the removal of eschar in adults with deep partial-thickness and/or full-thickness thermal burns, with U.S. commercial availability expected in the second quarter of 2023. It expects to hold a pre-IND meeting with the FDA in the first half of 2023 to discuss the MACI development program for the treatment of cartilage defects in the ankle. "We made tremendous progress advancing our pipeline and expanding our business in 2022, highlighted by an accelerated regulatory pathway for the MACI arthroscopic delivery program and the recent approval of NexoBrid," said Nick Colangelo, President and CEO of Vericel. "We also had very strong MACI performance to close the year and we look forward to building on this momentum in 2023 across both of our franchises, as we expect accelerating total revenue growth this year and further acceleration in 2024 driven by a full year of NexoBrid on the market and the planned launch of arthroscopic MACI."
Vericel said total net revenue for FY22 is expected to be approximately $164M-$165M versus a consensus of $164.62M. MACI net revenue for FY22 is expected to be approximately $132M; Burn Care net revenue for FY22 is expected to be approximately $32.5M; Q4 MACI revenue growth expected to be approximately 24% versus prior year. As of December 31, 2022, the company reported that it had approximately $140M in cash and investments and no debt.
Achieve Life Sciences announced that the final subject of the company's Phase 3 ORCA-3 trial has completed treatment in the study. Similar to the previously reported ORCA-2 trial, ORCA-3 is evaluating the smoking cessation efficacy, safety, and tolerability of 3 mg cytisinicline dosed three times daily for either 6 or 12 weeks compared with placebo. "With the milestone achieved of last ORCA-3 subject completing study treatment, we are pleased to remain on schedule for announcing data results as expected in the second quarter," stated John Bencich, CEO of Achieve. "It will be a busy and exciting year ahead with the completion of both ORCA-3 and ORCA-V1, evaluating cytisinicline for e-cigarette cessation, and the preparation for FDA filing in the U.S., which is already underway." The ORCA-3 trial randomized 792 subjects in total across 20 clinical trial locations in the United States. Participants are being monitored through 24 weeks post randomization and will receive standard behavioral support for the duration of the trial. The ORCA-3 primary endpoint is biochemically verified continuous abstinence during the last four weeks of treatment.
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 15-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.