Biotech Alert: Searches spiking for these stocks today

Stay ahead of biotech stocks seeing a surge in interest from retail and financial professional investors with this exclusive recap from The Fly

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

• Outlook Therapeutics (OTLK), 353% surge in interest
• Paratek Pharmaceuticals (PRTK), 300% surge in interest
• Akero Therapeutics (AKRO), 286% surge in interest
• G1 Therapeutics (GTHX), 286% surge in interest
• PDS Biotechnology (PDSB), 279% surge in interest

Pipeline and key clinical candidates for these companies:

Outlook Therapeutics is working to develop and launch ONS-5010, or Lytenava, as the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD, DME and BRVO. The FDA accepted Outlook Therapeutics’ BLA submission for ONS-5010 to treat wet AMD with a PDUFA goal date of August 29, 2023. If ONS-5010 ophthalmic bevacizumab is approved, Outlook Therapeutics expects to commercialize it as the first and only FDA-approved ophthalmic formulation of bevacizumab for use in treating retinal diseases in the United States, United Kingdom, Europe, Japan, and other markets.

Paratek Pharmaceuticals is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use. The company’s lead commercial product, Nuzyra, is a once-daily oral and intravenous antibiotic available in the United States for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights. Paratek is also conducting a Phase 2b study with Nuzyra in a rare disease, nontuberculous mycobacterial pulmonary disease, caused by Mycobacterium abscessus complex.

Akero Therapeutics says it is developing "transformational treatments for patients with serious metabolic diseases marked by high unmet medical need," including NASH, a disease without any approved therapies. Akero’s lead product candidate, EFX, is a differentiated Fc-FGF21 fusion protein that has been engineered to mimic the balanced biological activity profile of native FGF21, an endogenous hormone that alleviates cellular stress and regulates metabolism throughout the body. EFX is currently being evaluated in two Phase 2b clinical trials: the HARMONY study in patients with pre-cirrhotic NASH and the SYMMETRY study in patients with cirrhotic NASH. EFX is also being evaluated in an expansion cohort of the SYMMETRY study, comparing the safety and tolerability of EFX to placebo when added to an existing GLP-1 receptor agonist in patients with pre-cirrhotic NASH and Type 2 diabetes.

G1 Therapeutics is a commercial-stage biopharmaceutical company whose first commercial product is Cosela, or trilaciclib. G1 is executing a tumor-agnostic development plan evaluating trilaciclib in a variety of solid tumors, including colorectal, breast, lung, and bladder cancers.

PDS Biotech is a clinical-stage immunotherapy company developing a pipeline of targeted cancer and infectious disease immunotherapies based on its proprietary Versamune and Infectimune T cell-activating technology platforms. To date, its lead Versamune clinical candidate, PDS0101, has demonstrated the potential to reduce tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV-positive cancers in multiple Phase 2 clinical trials.

Recent news on these stocks:

June 6

Paratek Pharmaceuticals announced it has entered into a definitive agreement to be acquired by Gurnet Point Capital and Novo Holdings in a transaction valued at approximately $462 million, including the assumption of debt and assuming full payment of a Contingent Value Right (CVR). Debt financing of $175 million for this transaction will be provided by funds managed by Oaktree Capital Management. Under the terms of the merger agreement, Gurnet Point, a leading healthcare investment firm, and Novo Holdings, a holding and investment company responsible for managing the assets and wealth of the Novo Nordisk Foundation, will acquire all outstanding shares of Paratek for $2.15 per share in cash, plus a CVR of $0.85 per share payable upon the achievement of $320 million in U.S. NUZYRA net sales in any calendar year ending on or prior to December 31, 2026. The upfront payment at closing represents a premium of 41% over the closing price of Paratek’s common stock as of May 31, 2023, which was the last full trading day prior to market speculation regarding a potential sale of the company. The transaction, which the Paratek Board of Directors has unanimously approved, is expected to close in the third quarter of 2023, subject to customary closing conditions, including approval by Paratek shareholders and receipt of regulatory approvals. Following completion, Paratek will become a private company and will no longer be subject to the reporting requirements of the Securities Exchange Act of 1934, as amended, nor be traded on Nasdaq Global Market.

June 5

Akero Therapeutics released topline data from an expansion cohort of the Phase 2b SYMMETRY study known as Cohort D. The primary aim of the 12-week study was to assess safety and tolerability of Akero’s lead product candidate, efruxifermin, compared to placebo when added to an existing GLP-1 receptor agonist in patients with Type 2 diabetes and F1-F3 liver fibrosis due to non-alcoholic steatohepatitis. EFX was reported to be generally well tolerated in Cohort D with comparable results for the EFX and placebo groups. The overall tolerability profile was similar to that observed in Akero’s BALANCED and HARMONY studies. The most frequent adverse events for EFX-treated patients were grade 1 or 2 gastrointestinal events. One patient treated with EFX discontinued due to nausea and one EFX-treated patient discontinued after withdrawing consent. There were no drug-related serious adverse events. Cohort D also met all key secondary endpoints, including relative reduction of liver fat and proportion of patients whose absolute liver fat level normalized to 5 percent or less. We believe these data, together with statistically significant improvements across many other key NASH-related measures, show that EFX could be an important treatment for patients with NASH who are being treated with GLP-1 for T2D or obesity. In July of 2021, Akero initiated the SYMMETRY main study, a Phase 2b trial in biopsy-confirmed NASH patients with compensated cirrhosis, Child-Pugh class A. Akero expects to report results from the ongoing study in the fourth quarter of 2023.

June 4

G1 Therapeutics presented results from 24 patients enrolled in its Phase 2, single arm mechanism of action study of trilaciclib administered as a single agent to patients with early-stage triple-negative breast cancer, or TNBC, prior to receiving trilaciclib and neoadjuvant therapy. The company said that these results highlight the potential for trilaciclib to enhance long term immune surveillance by increasing T cell function and generation of certain memory T cells and demonstrate gene expression profiles that may be associated with improved clinical outcome. The data also support earlier findings from this Phase 2 trial demonstrating an increase in the ratio of CD8+ T cells to regulatory T cells; a high ratio of CD8+ T cell to Tregs is predictive of overall survival and is associated with pathologic complete response. As expected, high rates of pCR were observed in patients with PD-L1(+) tumors and in patients with inflamed tumor immune microenvironments. Data generated across multiple preclinical and clinical studies to date show that trilaciclib has the greatest effect on longer term endpoints including OS rather than earlier efficacy measures such as objective response rate, pCR, and progression free survival, consistent with other immunotherapies like checkpoint inhibitors. These results suggest that this is likely due to trilaciclib’s immune-mediated mechanism of action that protects the immune system from damage caused by cytotoxic therapy and enhances long-term immune surveillance by increasing the generation of certain memory T cells. This dual benefit may provide important longer-term benefits for patients by improving their ability to generate robust immune responses, particularly when treated with future subsequent therapies. Trilaciclib continues to show a strong tolerability profile. Trilaciclib in combination with anthracycline/ cyclophosphamide/paclitaxel (AC/T) +/- pembrolizumab +/- carboplatin in the neoadjuvant setting for early-stage TNBC has a similar safety and tolerability profile as standard neoadjuvant regimens. There were no adverse events leading to discontinuation of trilaciclib.

Hear more from InvestingChannel by signing up for The Spill.

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.

Keywords: biotech, biotech sector, biotech alert, investingchannel, XBI, SPDR S&P Biotech ETF