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

Rubius Therapeutics (RUBY), 630% surge in interest
Nanoviricides (NNVC), 621% surge in interest
Soligenix (SNGX), 306% surge in interest
Sesen Bio (SESN), 190% surge in interest
Acasti Pharma (ACST), 177% surge in interest

Pipeline and key clinical candidates for these companies:

Rubius Therapeutics is a biopharmaceutical company developing "an entirely new class of cellular medicines" called Red Cell Therapeutics for the treatment of cancer and autoimmune diseases.

NanoViricides is a development stage company that is creating special purpose nanomaterials for antiviral therapy. The company's novel nanoviricide class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. Their lead drug candidate is NV-CoV-2 for the treatment of COVID-19 disease caused by SARS-CoV-2 coronavirus. Their other advanced candidate is NV-HHV-1 for the treatment of Shingles. The company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The company is currently focused on advancing NV-CoV-2 into Phase I/II human clinical trials.

Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases. Their Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma. Development programs in this business segment also include expansion of synthetic hypericin into psoriasis, their first-in-class innate defense regulator technology, dusquetide for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate for the prevention/treatment of gastrointestinal disorders characterized by severe inflammation including pediatric Crohn's disease.

Sesen Bio is a late-stage clinical company focused on targeted fusion protein therapeutics for the treatment of patients with cancer. Sesen Bio’s most advanced product candidate, Vicineum, also known as VB4-845, is a locally-administered targeted fusion protein for the treatment of non-muscle invasive bladder cancer. On July 15, 2022, Sesen Bio made the strategic decision to voluntarily pause further development of Vicineum in the U.S. Sesen Bio has turned its primary focus to assessing potential strategic alternatives with the goal of maximizing shareholder value. Additionally, Sesen Bio intends to seek a partner for the further development of Vicineum.

Acasti is a late-stage specialty pharma company with drug delivery technologies and drug candidates addressing rare and orphan diseases. Acasti's three lead clinical assets have each been granted Orphan Drug Designation by the FDA, which provide the assets with seven years of marketing exclusivity post-launch in the United States, and additional intellectual property protection with over 40 granted and pending patents.

Recent news on these stocks:

February 14

Soligenix announced that the FDA has provided the company with a Refusal to File letter for its HyBryte new drug application, or NDA, in the treatment of early stage cutaneous T-cell lymphoma, a rare cancer and area of unmet medical need affecting over 25,000 patients in the U.S. Upon preliminary review, the FDA determined that the NDA, submitted on December 14, 2022, was not sufficiently complete to permit substantive review. Soligenix first learned of the RTF decision via this letter and is reviewing its contents to determine the appropriate next steps, which includes, but is not limited to, requesting a Type A meeting with the FDA to clarify and respond to the issues identified in the letter and to seek additional guidance concerning information that the agency would require for a resubmitted NDA to be deemed acceptable to file.

Sesen Bio and Carisma Therapeutics announced that the companies have reached a voting and support agreement with Bradley Radoff and Michael Torok, The Investor Group, which beneficially owns approximately 8.7% of Sesen Bio's outstanding common stock, has committed to vote its shares in support of the pending merger. Sesen Bio and Carisma have further amended the previously amended merger agreement to increase the one-time special cash dividend expected to be paid to Sesen Bio stockholders to $75M, or 36c per share. This represents an increase from the expected special cash dividend of approximately $70M, or approximately 34c per share, under the first amendment to the merger agreement, and an increase from the up to $25M special cash dividend under the terms of the original merger agreement.

Acasti reported Q3 earnings. Jan D'Alvise, CEO of Acasti, said "Significant progress was made over the past few months on all three of our clinical programs. We ended calendar 2022 in a very strong fashion with the completion of two successful clinical trials, and we announced important pharmacokinetic study results for both GTX-101 and GTX-102 in late December. In both cases, the preliminary topline results met all outcome measures. These positive results allow us to advance both programs to the next stage of clinical development in 2023. We expect 2023 to be very exciting for Acasti with two of our drug candidates ready to enter Phase 3. We look forward to receiving clarifying guidance from the FDA in calendar Q1 2023 on the Phase 3 study design for our lead program, GTX-104, a novel formulation of nimodipine for continuous IV infusion in patients suffering from subarachnoid hemorrhage. We are hopeful that this FDA feedback will confirm our 505(b)(2) regulatory strategy and allow us to finalize the study protocol, paving the way for the initiation of our Phase 3 safety study later this year."

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.