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: 

• Avid Bioservices (CDMO),487% surge in interest
• CNS Pharmaceuticals (CNSP), 329% surge in interest
• Ardelyx (ARDX), 186% surge in interest
• Emergent BioSolutions (EBS),154% surge in interest
• Heron Therapeutics (HRTX), 146% surge in interest
• Coherus Biosciences (CHRS), 69% surge in interest
• Checkpoint Therapeutics (CKPT), 124% surge in interest
• Arcturus Therapeutics (ARCT), 98% surge in interest

Pipeline and key clinical candidates for these companies:

Avid Bioservices is a dedicated contract development and manufacturing organization, or CDMO, focused on development and CGMP manufacturing of biologics. Avid’s services include CGMP clinical and commercial drug substance manufacturing, bulk packaging, release and stability testing and regulatory submissions support. For early-stage programs, the company provides a variety of process development activities, including upstream and downstream development and optimization, analytical methods development, testing and characterization.

CNS Pharmaceuticals is a clinical-stage pharmaceutical company developing a pipeline of anti-cancer drug candidates for the treatment of primary and metastatic cancers of the brain and central nervous system. The company’s lead drug candidate, Berubicin, is a novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier. Berubicin is currently in development for the treatment of a number of serious brain and CNS oncology indications including glioblastoma multiforme, or GBM, an aggressive and incurable form of brain cancer.

Ardelyx says it was founded with “a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs.” Ardelyx’s first approved product, Ibsrela is available in the United States and Canada. Ardelyx is developing Xphozah, a novel product candidate to control serum phosphorus in adult patients with chronic kidney disease on dialysis, which has completed three successful Phase 3 trials. Ardelyx has a Phase 2 potassium lowering compound, RDX013, for the potential treatment of elevated serum potassium, or hyperkalemia, a problem among certain patients with kidney and/or heart disease and an early-stage program in metabolic acidosis, a serious electrolyte disorder in patients with CKD.

Emergent BioSolutions provides solutions for complex and urgent public health threats through a portfolio of vaccines and therapeutics that the company develops and manufactures for governments and consumers. Emergent also offers a range of integrated contract development and manufacturing services for pharmaceutical and biotechnology customers.

Heron Therapeutics is a commercial-stage biotechnology company that says it is developing “novel, patient-focused solutions that apply its innovative science and technologies to already-approved pharmacological agents for patients suffering from pain or cancer.”

Coherus is a commercial-stage biopharmaceutical company focused on the research, development and commercialization of immunotherapies to treat cancer. Coherus’ immuno-oncology pipeline includes multiple antibody immunotherapy candidates focused on enhancing the innate and adaptive immune responses to enable a robust immunologic response and enhance outcomes for patients with cancer.

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.

Arcturus Therapeutics is a late-stage clinical mRNA medicines and vaccines company whose pipeline of RNA therapeutic and vaccine candidates includes mRNA vaccine programs for COVID-19 and Influenza, and other programs to potentially treat ornithine transcarbamylase, or OTC, deficiency, and cystic fibrosis, or CF. The company’s partnered programs include glycogen storage disease type III and hepatitis B virus.

Recent news on these stocks:

July 2

Avid Bioservices reported Q4 adjusted EPS of (7c), consensus (4c), and reported Q4 revenue of $42.98M, consensus $42.14M. “The fourth quarter of fiscal 2024 was a high point for the company,” stated Nick Green, president and CEO of Avid Bioservices. “We generated the highest quarterly revenues in Avid’s history, meeting our current revenue expectations for the year. During the period we signed multiple new project agreements, and we continue to see positive signs for business development in the year ahead. Given our strong backlog and robust proposal pipeline we are looking ahead to a promising 2025, and are providing 2025 full fiscal year revenue guidance of between $160M-$168M, representing 17% growth year-over-year at the midpoint.”

Ardelyx announced that, in an effort to preserve patient access to its phosphate absorption inhibitor XPHOZAH, the company has chosen not to apply to include XPHOZAH in the Centers for Medicare & Medicaid Services End-Stage Renal Disease Prospective Payment System Transitional Drug Add-on Payment Adjustment. Ardelyx’s analysis of the CMS policy to include oral-only medicines in the PPS and the Calendar Year 2025 ESRD PPS Proposed Rule released on June 27, 2024, revealed that the policy and the manner in which CMS intends to implement it are likely to cause significant restrictions on the use of XPHOZAH for all patients, irrespective of insurance coverage, because it interferes with the essential and appropriate shared decision-making between healthcare professionals and their patients.

Emergent BioSolutions has received more than $250M in contract modifications from the Administration for Strategic Preparedness and Response – ASPR – at the U.S. Department of Health and Human Services, to deliver millions of doses of four medical countermeasures. These contract modifications will help ensure continued supply/stockpiling of critical MCMs to address biological threats and emergencies against anthrax, smallpox and botulism.

Heron Therapeutics announced that the FDA acknowledged the receipt of the company’s Prior Approval Supplement, PAS, application for ZYNRELE extended-release solution VAN. The FDA has assigned a PDUFA goal date of September 23, 2024. If approved, the introduction of the VAN will replace the current vented vial spike and has the potential to simplify aseptic preparation, while also significantly reducing ZYNRELEF’s withdrawal time from up to three minutes down to between twenty and forty-five seconds. The user-friendly “container-like” design of the VAN may enhance the safe use of ZYNRELEF, increase adoption, and improve the preparation process. If approved, the VAN is expected to be available for use in Q4 of this year.

Checkpoint Therapeutics has completed the resubmission of its Biologics License Application, BLA, to the FDA for cosibelimab, its anti-programmed death ligand-1 antibody, as a potential new treatment for patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation. The BLA resubmission follows Checkpoint recently reaching alignment with the FDA on its BLA resubmission strategy to potentially address all approvability deficiencies outlined in the complete response letter received last December, in which FDA only cited findings that arose during a multi-sponsor inspection of Checkpoint’s third-party contract manufacturing organization as approvability issues to address in a BLA resubmission. The CRL did not state any concerns about the clinical data package, safety, or labeling for the approvability of cosibelimab.

July 1

Arcturus Therapeutics said it “is providing mid-year updates for ARCT-810, an investigational mRNA therapeutic to treat ornithine transcarbamylase deficiency, and ARCT-032, an investigational inhaled mRNA therapeutic to treat cystic fibrosis. The double blind ARCT-810 Phase 2 study in the EU and UK has completed enrollment of eight (8) subjects, including adolescents and adults, at the 0.3 mg/kg dose level. The participants in this group are randomized 3:1 and receive 6 doses of ARCT-810 or placebo administered every 14 days. Treatment and follow-up are ongoing with the safety and complete set of biomarker data expected later this year. ARCT-810 is expanding the company’s clinical program in the U.S. by enrolling patients with more severe disease. Patient screening has been initiated and the company expects the Phase 2 clinical program to be completed in the United States. More details pertaining to the U.S. trial expansion and interim data will be provided later this year. The company plans to submit an IND application in the next 60 days for an ARCT-032 Phase 2 multiple ascending dose study designed to identify a safe and effective dose in Class I (null) and other CF participants who do not benefit from CFTR modulators. This study is supported by safety and tolerability data collected in healthy volunteers and the ongoing two-administration Phase 1b study. No serious adverse events (SAEs) have been observed in any clinical trial participants to date. No febrile reactions have been observed within the target dose range of the planned Phase 2 study. The Phase 1b study is ongoing with the seventh and final participant scheduled to be dosed soon. Of the seven total CF participants in Phase 1b, six are receiving CFTR modulator treatment while one subject has Class I mutations and therefore does not benefit from modulator therapy. The Class I CF subject had low lung function at baseline and showed an improvement of 4% in ppFEV1 on Day 8, after receiving two well-tolerated administrations, with no febrile reactions.”

June 27

Coherus BioSciences agreed to divest YUSIMRY to Hong Kong King-Friend Industrial for up-front all-cash consideration of $40 million. The closing of the transaction occurred on June 26, 2024. Meitheal Pharmaceuticals, a wholly owned subsidiary of HKF, will continue to commercialize YUSIMRY in the U.S. Coherus’ oncology assets include LOQTORZI, an FDA-approved, next-generation PD-1 inhibitor, the UDENYCA franchise, with three FDA-approved presentations; and an innovative clinical-stage, immuno-oncology portfolio focused on the tumor microenvironment.

June 26

CNS Pharmaceuticals has entered into securities purchase agreements with health-care focused institutional investors for the purchase and sale of 568,000 shares of common stock in a registered direct offering and warrants to purchase up to 568,000 shares of common stock in a concurrent private placement at a combined purchase price of $2.45 per share. The warrants issued pursuant to the concurrent private placement will have an exercise price of $2.32 per share, will be exercisable immediately following the date of issuance and will expire 5 years from the initial exercise date. The closing of the offering is expected to occur on or about June 27, subject to the satisfaction of customary closing conditions. The gross proceeds from the offering are expected to be approximately $1.39M before deducting financial advisory fees and other offering expenses payable by the company. The company intends to use the net proceeds from the offering for working capital and general corporate purposes.

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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.