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: 

• Adial Pharmaceuticals (ADIL), 722% surge in interest
• Stoke Therapeutics (STOK), 613% surge in interest
• Bicycle Therapeutics (BCYC), 586% surge in interest
• Merrimack Pharmaceuticals (MACK), 315% surge in interest
• Sage Therapeutics (SAGE), 198% surge in interest
• G1 Therapeutics (GTHX), 190% surge in interest
• Kalvista Pharmaceuticals (KALV), 184% surge in interest
• Omeros (OMER), 168% surge in interest
• Vir Biotechnology (VIR), 153% surge in interest
• Xeris Pharmaceuticals (XERS), 152% surge in interest

Pipeline and key clinical candidates for these companies:

Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of treatments for addictions. The company’s lead investigational new drug product, AD04, is a genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder, or AUD, in heavy drinking patients and was recently investigated in the company’s ONWARD pivotal Phase 3 clinical trial for the potential treatment of AUD in subjects with certain target genotypes identified using the company’s proprietary companion diagnostic genetic test. The company is also developing adenosine analogs for the treatment of pain and other disorders.

Stoke Therapeutics is a biotechnology company dedicated to addressing the underlying cause of severe diseases by upregulating protein expression with RNA-based medicines. Stoke’s first compound, STK-001, is in clinical testing for the treatment of Dravet syndrome, a severe and progressive genetic epilepsy. 

Bicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. The company is evaluating BT8009, a Bicycle Toxin Conjugate targeting Nectin-4, a well-validated tumor antigen; BT5528, a BTC targeting EphA2; and BT7480, a Bicycle TICA targeting Nectin-4 and agonizing CD137, in company-sponsored Phase 1/2 trials.

Sage Therapeutics is a biopharmaceutical company “fearlessly leading the way to create a world with better brain health.” The company’s mission is to “pioneer solutions to deliver life-changing brain health medicines, so every person can thrive,” Sage has stated.

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.

KalVista Pharmaceuticals is a pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors for diseases with significant unmet need. KalVista is developing sebetralstat as an oral on-demand therapy for HAE and anticipates providing data from the phase 3 KONFIDENT clinical trial in early 2024. In addition, KalVista’s oral Factor XIIa inhibitor program represents a new generation of therapies that may further improve the treatment for people living with HAE and other diseases.

Omeros is committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting immunologic disorders, including complement-mediated diseases, cancers, and addictive and compulsive disorders. Omeros’ lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application pending before FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Narsoplimab is also in multiple late-stage clinical development programs focused on other complement-mediated disorders, including IgA nephropathy, COVID-19, and atypical hemolytic uremic syndrome.

Vir Biotechnology is an immunology company focused on combining cutting-edge technologies to treat and prevent infectious diseases and other serious conditions. Vir has assembled two technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current clinical development pipeline consists of product candidates targeting hepatitis B and hepatitis delta viruses, influenza A and B, human immunodeficiency virus and COVID-19. Vir has several preclinical candidates in its pipeline, including RSV/MPV and HPV.

Xeris is committed to developing and commercializing “differentiated and innovative products across a range of therapies,” the company states. Xeris has three commercially available products: Gvoke, a ready-to-use liquid glucagon for the treatment of severe hypoglycemia; Keveyis, a proven therapy for primary periodic paralysis; and Recorlev for the treatment of endogenous Cushing’s syndrome. Xeris has a pipeline of development and partnered programs using its formulation sciences, XeriSol and XeriJect, the company adds.

Recent news on these stocks:

February 14

Sage Therapeutics reported Q4 EPS of (55c) against a consensus of ($1.28), and reported Q4 revenue of $77.97M against a consensus of $60.98M. “2023 was a pivotal year for Sage, with key accomplishments achieved across our pipeline, culminating with the recent encouraging launch of ZURZUVAE, the first-and-only once daily oral treatment for adults with postpartum depression. We are incredibly pleased with the early progress on the launch. I am proud of our team’s relentless work toward our goal of ZURZUVAE becoming the first line therapy for women with PPD and believe strongly in the potential for ZURZUVAE to make an impact in treating this devastating disease,” said Barry Greene, CEO at Sage Therapeutics. “Beyond our ongoing commercialization efforts for ZURZUVAE, we look forward to delivering on multiple anticipated catalysts in 2024, including topline data from our studies evaluating dalzanemdor and SAGE-324. We believe our work has the potential to make a difference in the lives of patients with brain health disorders, and we look forward to providing updates on our progress over the coming quarters.” Sage Therapeutics said it expects cash available will support its operations into 2026.

H.C. Wainwright raised the firm’s price target on Vir Biotechnology to $110 from $85 and kept a Buy rating on the shares. The company appears well positioned for the coming chronic hepatitis B virus infection “boom,” the analyst told investors in a research note. The firm increased its revenue estimates for Vir’s chronic hepatitis B virus franchise, which is the primary driver of the price target increase.

February 13

Adial Pharmaceuticals announced it has been awarded an important patent which expands the estate covering the combination of the company’s proprietary genetic diagnostic to identify patients with specific genotypes for genetically targeted treatment of alcohol use disorder and drug dependencies, such as opioid use disorder, with the company’s lead investigational new drug product AD04.

Merrimack reported that Ipsen (IPSEY) issued a press release announcing the FDA has approved the supplemental new drug application for Onivyde plus 5 fluorouracil/leucovorin and oxaliplatin as a first-line treatment for people living with metastatic pancreatic ductal adenocarcinoma. Under the terms of the 2017 Asset Purchase Agreement between Ipsen and Merrimack, previously approved by Merrimack’s stockholders, this FDA approval triggers a $225M milestone payment from Ipsen to Merrimack which is due on or before March 29, 2024. “Today’s announcement is the culmination of nearly seven years of clinical trials and regulatory approval efforts by Ipsen following its 2017 purchase of the Onivyde technology from Merrimack. The company has received several payments from the Ipsen Agreement including: a $575M payment in 2017, a $5.7M working capital adjustment payment later that year, and a $5M milestone payment in 2019” said Gary Crocker, chairman of Merrimack’s board. “The Board of Merrimack plans to hold a Special Meeting of Stockholders to approve a plan for a corporate dissolution and followed by a distribution of the proceeds to our stockholders from this new $225M milestone payment, plus residual cash, net of corporate taxes and interest charges accruing under IRS installment sale rules, and other expenses.”

KalVista Pharmaceuticals announced positive results from the phase 3 KONFIDENT clinical trial demonstrating statistically and clinically significant efficacy of sebetralstat as oral on-demand therapy for hereditary angioedema. KONFIDENT was the largest and most representative trial ever conducted in HAE, and included adolescents, patients using long-term prophylaxis, and all attack severities and locations. The clinical trial met all primary and key secondary endpoints and demonstrated a favorable safety profile. HAE attacks treated with both 300 mg and 600 mg of sebetralstat achieved the primary endpoint of beginning of symptom relief significantly faster than placebo. The median time to beginning of symptom relief was 1.61 hours with sebetralstat 300 mg, 1.79 hours with sebetralstat 600 mg, and 6.72 hours with placebo. Consistent with previous studies, sebetralstat was well-tolerated, with a safety profile similar to placebo. There were no patient withdrawals due to any adverse event and no treatment-related serious adverse events were observed. Treatment-related adverse event rates were 2.3% for 300 mg sebetralstat, 2.2% for 600 mg sebetralstat, and 4.8% for placebo.

February 12

G1 Therapeutics announced that the independent Data Monitoring Committee, or DMC, recommended continuation of the pivotal Phase 3 PRESERVE 2 trial evaluating trilaciclib in combination with gemcitabine and carboplatin for the first line treatment of metastatic triple negative breast cancer, or mTNBC, to the final analysis. This final analysis evaluating Overall Survival, or OS, is estimated to occur in the third quarter of 2024 and will be conducted on the intent-to-treat, or ITT, population. “The DMC did not express any concerns regarding safety or recommend any other changes to the study. G1 remains blinded to all data as the early stopping criteria were not met during the interim analysis,” the company stated. “We remain confident in the ability of trilaciclib to ultimately achieve the OS primary endpoint based on the robust survival benefit demonstrated in the prior randomized Phase 2 study, which continued to meaningfully increase over time as patients received subsequent therapies, as well as the increased statistical power for the final analysis of this pivotal study. While a positive interim analysis would have enabled us to bring this therapy to patients in need sooner, we look forward to completing the study and potentially making this meaningful new treatment option available to patients with this highly aggressive form of breast cancer as early as next year,” added Jack Bailey, CEO at G1 Therapeutics.

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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.