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: 

• Rapt Therapeutics (RAPT), 7,206% surge in interest
• Sol-Gel Technologies (SLGL), 5,771% surge in interest
• Puma Biotechnology (PBYI), 653% surge in interest
• Anavex (AVXL), 329% surge in interest
• Phio Pharmaceuticals (PHIO), 328% surge in interest
• Oncolytics (ONCY), 279% surge in interest
• Fibrogen (FGEN), 150% surge in interest
• Aclaris Therapeutics (ACRS), 145% surge in interest

Pipeline and key clinical candidates for these companies:

Rapt Therapeutics is focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in inflammatory diseases and oncology. Rapt has discovered and advanced two unique drug candidates, RPT193 and FLX475, each targeting C-C motif chemokine receptor 4, for the treatment of inflammation and cancer, respectively. The company is also pursuing a range of targets that are in the discovery stage of development.

Sol-Gel Technologies is a dermatology company focused on identifying, developing and commercializing or partnering drug products to treat skin diseases. Sol-Gel developed Twyneo which is approved by the FDA for the treatment of acne vulgaris in adults and pediatric patients nine years of age and older; and Epsolay, which is approved by the FDA for the treatment of inflammatory lesions of rosacea in adults.

Puma Biotechnology is focused on the development and commercialization of products to enhance cancer care. Puma in-licenses the global development and commercialization rights to PB272 — neratinib, oral; PB272 — neratinib, intravenous; and PB357. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX, neratinib, tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting.

Anavex Life Sciences is a biopharmaceutical company dedicated to the development of novel therapeutics for the treatment of neurodegenerative, neurodevelopmental, and neuropsychiatric disorders, including Alzheimer’s disease, Parkinson’s disease, schizophrenia, Rett syndrome, and other central nervous system diseases, pain, and various types of cancer. Anavex’s lead drug candidate, ANAVEX 2-73, has successfully completed a Phase 2a and a Phase 2b/3 clinical trial for Alzheimer’s disease, a Phase 2 proof-of-concept study in Parkinson’s disease dementia, and both a Phase 2 and a Phase 3 study in adult patients and one Phase 2/3 study in pediatric patients with Rett syndrome.

Phio Pharmaceuticals is a clinical stage biotechnology company whose proprietary INTASYL RNAi technology is designed to make immune cells more effective in killing tumor cells. “INTASYL is the only self-delivering RNAi technology focused on immuno-oncology therapeutics. INTASYL drugs precisely target specific proteins that reduce the body’s ability to fight cancer, without the need for specialized formulations or drug delivery systems,” the company has stated.

Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated “promising” results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer, the company says. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype — turning “cold” tumors “hot” — through innate and adaptive immune responses to treat a variety of cancers.

FibroGen is “committed to leveraging its expertise in connective tissue growth factor biology and hypoxia-inducible factor to discovering, developing, and commercializing a pipeline of first-in-class therapeutics for the treatment of unmet needs.” Pamrevlumab, an anti-CTGF human monoclonal antibody, is in clinical development for the treatment of idiopathic pulmonary fibrosis, or IPF, locally advanced unresectable pancreatic cancer, metastatic pancreatic cancer, and Duchenne muscular dystrophy, or DMD. Roxadustat is currently approved in China, Europe, Japan, and numerous other countries for the treatment of anemia in CKD patients on dialysis and not on dialysis. Roxadustat is in Phase 3 clinical development in the U.S. and Europe for anemia associated with myelodysplastic syndromes, or MDS, and in Phase 3 clinical development in China for treatment of chemotherapy-induced anemia, or CIA.

Aclaris Therapeutics is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of drug candidates powered by a robust R&D engine exploring protein kinase regulation.

Recent news on these stocks:

December 23

Rapt Therapeutics and Shanghai Jemincare Pharmaceutical, a subsidiary of Jiangxi Jemincare Group, announced they have entered into an exclusive license agreement for JYB1904, a clinical-stage, half-life extended anti-immunoglobulin E monoclonal antibody. Under the terms of the license agreement, Rapt is granted worldwide rights excluding mainland China, Hong Kong, Macau and Taiwan to develop and commercialize RPT904. As consideration for the license, Jemincare receives a $35M upfront license fee, up to $672.5M in additional payments upon the achievement of various regulatory and commercial milestones, and royalties on future sales of RPT904 outside the Jemincare Territory. RAPT plans to pursue development of RPT904 initially in food allergy. Separately, Jemincare is conducting Phase 2 clinical trials of JYB1904 in China in asthma and CSU.

Puma Biotechnology announced that the National Comprehensive Cancer Network, or NCCN, Clinical Practice Guidelines in Oncology for Cervical Cancer were updated to include an addition involving neratinib. The updated NCCN Practice Guidelines for Cervical Cancer include neratinib monotherapy for use as second-line or subsequent therapy for recurrent or metastatic disease as an option for patients with HER2-mutated tumors with a designation of Category 2A. The NCCN Guidelines Category of Preference is designated as “useful in certain circumstances” as a treatment option for patients with HER2-mutated tumors.

Anavex Life Sciences announced that the European Medicines Agency, EMA, has accepted for review the Marketing Authorization Application, MAA, for blarcamesine, ANAVEX 2-73, an investigational drug for the treatment of Alzheimer’s disease. The Company is looking forward to working with the EMA. “The EMA filing acceptance for blarcamesine to review the Marketing Authorization Application potentially brings us a step closer offering broader patient access to a new treatment option in Europe, and we look forward to continued engagement with the EMA,” said Juan Carlos Lopez-Talavera, MD, PhD, Head of Research and Development of Anavex. “Through our clinical development program, we have seen that blarcamesine has the potential to slow the progression of this relentless and ultimately fatal disease.”

H.C. Wainwright upgraded Aclaris Therapeutics to Buy from Neutral with a $20 price target after the company entered into an exclusive license agreement with privately-held Biosion. The “transformative” licensing transaction revitalizes the company’s pipeline with renewed focus on biologic candidates, the analyst tells investors in a research note. The firm ascribes a 30% probability of approval to BSI-045B in chronic asthma and a 20% probability of approval to this candidate in atopic dermatitis. It also believes Aclaris’ legacy pipeline programs may generate additional value.

December 16

FibroGen announced the appointment of David DeLucia to CFO, effective December 16, 2024. The company previously announced that Juan Graham would step down on December 15, 2024. Reporting to CEO, Thane Wettig, DeLucia will lead and oversee FibroGen’s global finance organization. He has most recently served as FibroGen’s Vice President, Head of Corporate Financial Planning and Analysis, Investor Relations, and Treasury.

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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.