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: 

• Fibrogen (FGEN), 342% surge in interest
• Fate Therapeutics (FATE), 258% surge in interest
• Palatin Technologies (PTN), 188% surge in interest
• NovaBay Pharmaceuticals (NBY), 187% surge in interest
• Y-mAbs Therapeutics (YMAB), 105% surge in interest
• Checkpoint Therapeutics (CKPT), 54% surge in interest
• Akebia Therapeutics (AKBA), 52% surge in interest
• Cellectar Biosciences (CLRB), 27% surge in interest

Pipeline and key clinical candidates for these companies:

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.

Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell-derived cellular immunotherapies to patients with cancer and autoimmune disorders. Using its proprietary iPSC product platform, “the company has established a leadership position in creating multiplexed-engineered iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products,” the company states.

Palatin is a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor systems, with targeted, receptor-specific product candidates for the treatment of diseases with significant unmet medical need and commercial potential. “Palatin’s strategy is to develop products and then form marketing collaborations with industry leaders to maximize their commercial potential,” the company says.

NovaBay Pharmaceuticals develops and sells eyecare and skincare products. NovaBay’s leading product, Avenova Antimicrobial Lid & Lash Solution, is often prescribed by eyecare professionals for blepharitis and dry-eye disease and is also available directly to eyecare consumers through online distribution channels such as Amazon.

Y-mAbs is focused on the development and commercialization of novel, antibody-based therapeutic cancer products. In addition to conventional antibodies, the company’s technologies include bispecific antibodies generated using the Y-BiClone platform and the SADA platform. The company’s product pipeline includes one FDA-approved product, Danyelza, which targets tumors that express GD2, and one product candidate at the registration-stage, Omblastys, which targets tumors that express B7-H3.

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.

Akebia Therapeutics is a fully integrated biopharmaceutical company that says its purpose is “to better the lives of people impacted by kidney disease.”

Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on the discovery and development of proprietary drugs for the treatment of cancer, independently and through research and development collaborations. The company’s core objective is to leverage its proprietary Phospholipid Drug Conjugate delivery platform to develop the next-generation of cancer cell-targeting treatments, delivering improved efficacy and better safety as a result of fewer off-target effects. The company’s product pipeline includes lead asset iopofosine, a small-molecule PDC designed to provide targeted delivery of iodine-131, proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets.

Recent news on these stocks:

January 30

Palatin Technologies announced that it has entered into a definitive agreement with healthcare-focused institutional investors for the issuance and sale of an aggregate of 1.83M shares of its common stock, at a purchase price of $5.46 per share of common stock. Palatin has also agreed to issue in a private placement warrants to purchase up to an aggregate of 1.83M shares of common stock at an exercise price of $5.46 per share. The warrants will become exercisable on the six months anniversary of the closing date and will expire on the date that is four years after the closing date. H.C. Wainwright & Co. is acting as exclusive placement agent for the offering. The closing of the offering is expected to occur on or about February 1, subject to the satisfaction of customary closing conditions. The gross proceeds from the offering are expected to be approximately $10M. Palatin intends to use the net proceeds of this offering for general corporate purposes.

Cellectar Biosciences announced the first patient has been enrolled in its Phase 1b clinical trial evaluating iopofosine I 131, a novel phospholipid radiotherapeutic conjugate, in pediatric patients with relapsed or refractory malignant high-grade gliomas, or pHGG. The open-label study will assess two dosing regimens to identify the optimal iopofosine I 131 Phase 2 recommended dose and schedule in pHGG patients and evaluate safety and tolerability. The study is supported by a $2M Fast Track SBIR grant from the National Institute of Health’s National Cancer Institute, which was awarded based in part on the promising Phase 1a trial data.

January 29

Checkpoint Therapeutics announced that it has entered into a definitive agreement with a single healthcare-dedicated institutional investor for the issuance and sale of an aggregate of 7.76M shares of its common stock at a purchase price of $1.805 per share of common stock, in a registered direct offering priced at-the-market. In addition, in a concurrent private placement, Checkpoint will issue and sell unregistered warrants to purchase up to 7.76M shares of common stock. The warrants will have an exercise price of $1.68 per share, will be exercisable immediately upon issuance and will expire five years following the issuance date. H.C. Wainwright & Co. is acting as exclusive placement agent for the offering. The closing of the offering is expected to occur on or about January 31, subject to the satisfaction of customary closing conditions. The gross proceeds from the offering are expected to be approximately $14M. Checkpoint intends to use the net proceeds of this offering for working capital and general corporate purposes, including funding the planned resubmission of its Biologics License Application for cosibelimab.

January 25

FibroGen announced graduation and completion of the pamrevlumab experimental arm in the Pancreatic Cancer Action Network’s, PanCAN, Precision Promise Phase 2/3 adaptive platform trial, which evaluates pamrevlumab in combination with the chemotherapy treatments gemcitabine and nab-paclitaxel for patients with metastatic pancreatic ductal adenocarcinoma, mPDAC. Topline data from this registration study is anticipated in the second quarter of 2024. Pamrevlumab, in Stage 1 of the trial, achieved a protocol pre-specified greater than or equal to 35% predictive probability of success for the primary endpoint of overall survival at the completion of the trial, and thus graduated to the second and final Stage of the trial in the third quarter of 2022. Pamrevlumab is the first experimental arm to meet its required threshold for graduation to Stage 2 in the adaptive platform trial. The pamrevlumab arm of the study completed Stage 2 of the trial in January 2024. “We are excited to announce the achievement of this significant milestone in Precision Promise. The graduation and completion of the pamrevlumab arm of this study brings a potential new therapy one step closer for patients with metastatic pancreatic cancer, an underserved population with limited treatment options,” said Thane Wettig, Chief Executive Officer, FibroGen. “We look forward to continuing to work with PanCAN in sharing the topline data in the coming months.”

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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.