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: 

• Regulus Therapeutics (RGLS), 16,893% surge in interest
• Nucana (NCNA), 6,533% surge in interest
• SIGA Technologies (SIGA), 1,892% surge in interest
• Heron Therapeutics (HRTX), 449% surge in interest
• Acadia Pharmaceuticals (ACAD), 311% surge in interest
• Tracon Pharma (TCON), 270% surge in interest
• Aslan Pharmaceuticals (ASLN), 222% surge in interest
• Liquidia (LQDA), 156% surge in interest

Pipeline and key clinical candidates for these companies:

Regulus Therapeutics is a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs. Regulus has leveraged its oligonucleotide drug discovery and development expertise to develop a pipeline complemented by a rich intellectual property estate in the microRNA field.

NuCana is a clinical-stage biopharmaceutical company focused on significantly improving treatment outcomes for patients with cancer by applying its ProTide technology to transform some of the most widely prescribed chemotherapy agents, nucleoside analogs, into more effective and safer medicines.

SIGA Technologies is a commercial-stage pharmaceutical company focused on the health security market. Health security comprises countermeasures for biological, chemical, radiological and nuclear attacks, vaccines and therapies for emerging infectious diseases, and health preparedness. The company’s lead product is TPOXX, also known as tecovirimat and ST-246, an orally administered and IV formulation antiviral drug for the treatment of human smallpox disease caused by variola virus. The oral formulation of TPOXX was approved by the FDA for the treatment of smallpox in 2018, and the IV formulation was approved for the same indication in 2022.

Heron Therapeutics is a commercial-stage biotechnology company that says its “advanced science, patented technologies, and innovative approach to drug discovery and development have allowed it to create and commercialize a portfolio of products that aim to advance the standard-of-care for acute care and oncology patients.”

Acadia says it is advancing “breakthroughs in neuroscience to elevate life.” The company developed and commercialized what it identifies as “the first and only approved therapies” for hallucinations and delusions associated with Parkinson’s disease psychosis and for the treatment of Rett syndrome. Acadia’s clinical-stage development efforts are focused on treating the negative symptoms of schizophrenia, Alzheimer’s disease psychosis and neuropsychiatric symptoms in central nervous system disorders.

Tracon is a clinical-stage biopharmaceutical company that says utilizing “a cost-efficient, CRO-independent, product development platform” it is advancing its pipeline of novel targeted cancer therapeutics and partnering with other life science companies. The company’s clinical-stage pipeline includes Envafolimab, a PD-L1 single-domain antibody given by rapid subcutaneous injection that is being studied in the pivotal ENVASARC trial for sarcoma; YH001, a potential best-in-class CTLA-4 antibody in Phase 1 development; and TRC102, a Phase 2 small molecule drug candidate for the treatment of lung cancer.

Aslan Pharmaceuticals is a clinical-stage, immunology-focused biopharmaceutical company developing eblasakimab, a potential first-in-class antibody targeting the IL-13 receptor in moderate-to-severe atopic dermatitis with the potential to improve upon current biologics used to treat allergic disease, and has reported positive topline data from a Phase 2b, dose-ranging study in moderate-to-severe AD patients. Aslan is also developing farudodstat, a potent oral inhibitor of the enzyme dihydroorotate dehydrogenase, as a potential first-in-class treatment for alopecia areata in a Phase 2a, proof-of-concept trial with an interim readout expected in mid-2024.

Liquidia Corporation is a biopharmaceutical company focused on the development and commercialization of products in pulmonary hypertension and other applications of its PRINT Technology. Liquidia Technologies has developed Yutrepia inhalation powder for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. Liquidia Technologies is also developing L606, an investigational liposomal formulation of treprostinil administered twice-daily with a short-duration next-generation nebulizer, for use in North America. 

Recent news on these stocks:

March 14

H.C. Wainwright raised the firm’s price target on Liquidia to $32 from $16 and kept a Buy rating on the shares. The analyst believes the FDA’s inclusion of the pulmonary hypertension associated with interstitial lung disease indication for review with the tentatively approved new drug application for Yutrepia in pulmonary arterial hypertension reflects a critical component to facilitate near-term commercial growth for Yutrepia.

March 13

Wells Fargo raised the firm’s price target on Regulus to $3 from $2 and kept an Equal Weight rating on the shares. The firm noted that Regulus announced topline data from Cohort 2 of the Phase 1b MAD study evaluating RGLS8429 in ADPKD patients. Following the data release, the company announced an oversubscribed $100M PIPE at a purchase price of $1.60/share. The raise extends cash runway into the first half of 2026 with proceeds going towards increasing the size of Cohort 4 to further evaluate the impact of RGLS8429 on cystic volume. Wells thinks Cohort 2 data are interesting, but given the small sample size and potential variability, it looks to mid-year data from Cohort 3 for confirmation of effects on PD biomarkers and correlation b/t PC1/PC2 changes and total kidney volume change.

March 12

Siga Technologies reported Q4 EPS of $1.01 vs. (1c) last year, and reported Q4 revenue of $116.5M vs. $11.4M last year. “In 2023, SIGA had approximately $131M in product revenues and approximately $84 million of pre-tax operating income,” stated CEO Diem Nguyen. “These financial results represent a significant increase over the 2022 financial results; product revenues increased 51% over the corresponding 2022 amount, and pre-tax operating income year increased 96% over the corresponding 2022 amount. The overall financial performance, and growth over prior-year financial results, highlight the strength, resilience and growth potential of SIGA’s business model and are a testament to SIGA’s long-standing leadership within the public health sector. We look forward to continuing our strong performance and sector leadership in 2024.”

Heron Therapeutics reported Q4 EPS (7c) against a consensus of (16c), and reported Q4 revenue of $34.23M vs. 30.03M last year. “In the Q4, Heron saw continued positive momentum and an increased sales trajectory in both our acute care and oncology care franchises, illustrating how the strategic decisions made over the past year have positioned the Company for long-term success and profitability,” said Craig Collard, CEO. “I am pleased to share this quarterly update and look forward to building upon what we achieved in the Q4, providing substantial value and meaningful solutions in the acute care and oncology care settings.”

Aslan Pharmaceuticals announced that it has entered into a definitive agreement for the purchase and sale of 5M of the company’s American Depositary Shares, or ADSs, each ADS representing twenty-five ordinary shares, at an offering price of $1.00 per ADS in a registered direct offering. In addition, in a concurrent private placement, the company will issue unregistered warrants to purchase up to 5M ADSs. The warrants have an exercise price of $1.00 per ADS, will be exercisable upon issuance, and will expire five years following issuance. The closing of the offering is expected to occur on or about March 14, subject to the satisfaction of customary closing conditions. The gross proceeds to the company from this offering are expected to be $5M, before deducting the placement agent’s fees and other offering expenses. Aslan intends to use the net proceeds from this offering to fund new and other ongoing research and development activities, working capital and other general corporate purposes. H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

March 11

Aslan Pharmaceuticals has begun to enroll patients in the U.S. under an updated protocol in the ongoing TREK-DX trial, studying eblasakimab in dupilumab-experienced patients with moderate-to-severe atopic dermatitis. TREK-DX is the first randomized, double-blind, placebo-controlled trial to be conducted in AD patients who have been previously treated with dupilumab, a market estimated to reach $10B by 2029. Based on findings from the TREK-AD study which highlighted the changing AD patient population in the US, the TREK-DX inclusion criteria have been tightened to enroll patients with a baseline Eczema Area and Severity Index score of at least 18, instead of 16. In conjunction with this, independent reviewer confirmation of baseline EASI scores has also been implemented. U.S. sites are now enrolling patients according to the updated criteria and additional sites in Europe are on track to open in the first half of 2024. TREK-DX will enroll approximately 75 patients who have discontinued dupilumab treatment for any reason, including inadequate control of AD, loss of access or an adverse event, and treat them with either 400mg eblasakimab or placebo once weekly for 16 weeks. At the time of the data cut off for this preliminary review of blinded data from 22 patients enrolled under the original inclusion criteria, who were randomized 2:1 active to placebo, 17 patients completed the 16 week treatment period and 5 patients discontinued before the completion of the 16 week treatment period. At 16 weeks or the last visit, EASI score decreased at least 90% in 10 patients, or 45%, and 11 patients, or 50%, achieved a validated Investigator Global Assessment score of 0 or 1. Of the 9 patients who previously had an inadequate response to dupilumab, 5 patients achieved EASI-90 and 5 patients a vIGA score of 0 or 1. Treatments have been well-tolerated to date and no new safety signals were identified. There have been no reports of conjunctivitis and no reports of injection site reactions. Topline unblinded data from the full dataset is expected at the end of 2024. Translational data demonstrates differentiated effects of targeting IL-13R versus IL-4R, suggesting eblasakimab has the potential to be effective even in instances where dupilumab is not: Eblasakimab targets the IL-13 receptor subunit of the Type 2 receptor, preventing signaling through both interleukin 4 and interleukin 13. Both are key drivers of inflammation in AD, however, recently published translational data highlighted the advantages of targeting IL-13R by eblasakimab over the IL-4 receptor, the target of dupilumab, in AD patient peripheral blood mononuclear cells4. IL-13R blockade resulted in more efficient reduction of cytokines implicated in Type 2-driven inflammation compared to IL-4R blockade, as well as lower levels of Type 1 pro-inflammatory cytokines. Additional data from head-to-head studies between eblasakimab and dupilumab in skin biopsies from AD patients confirmed the differentiated effects of targeting IL-13R versus IL-4R5. In this study, eblasakimab reduced localized secretion of pro-inflammatory Type 2 cytokines by the skin tissue more efficiently than dupilumab, suggesting eblasakimab could have the potential to be effective in AD patients that do not achieve an adequate response to dupilumab.

Piper Sandler said the firm is “confident” that a partner or potential acquirer will see the value and differentiation of monthly eblasakimab versus every other week Dupixent, including in the growing patient population of Dupixent inadequate responders, and expects a partner or potential acquirer will likely develop eblasakimab in other allergic indications beyond atopic dermatitis, or AD, such as COPD. The firm reiterated an Overweight rating and $15 price target on Aslan Pharmaceuticals after the company announced that it has begun to enroll patients in the U.S. under an updated protocol in the ongoing TREK-DX trial, studying eblasakimab in dupilumab-experienced patients with moderate-to-severe AD.

Acadia Pharmaceuticals “announced top-line results from the Phase 3 ADVANCE-2 trial evaluating pimavanserin for the treatment of negative symptoms of schizophrenia. Pimavanserin did not demonstrate a statistically significant improvement over placebo on the study’s primary endpoint, the change from baseline to week 26 on the Negative Symptom Assessment-16 total score. The safety and tolerability profile of pimavanserin was consistent with previous clinical trials, showing a low rate of adverse events. ADVANCE-2 was a 26-week double-blind, randomized, placebo-controlled study of 34 milligram pimavanserin in 454 adult patients with predominant negative symptoms of schizophrenia who had achieved control of positive symptoms with their ongoing antipsychotic treatment. ADVANCE-2 used the NSA-16 scale, designed to measure change on the wide range of predominant negative symptoms that patients experience, which looks at 16 different items in five subscales and covers symptoms such as blunted affect, poor socialization and lack of motivation. The change from baseline observed in the pimavanserin arm of ADVANCE-2 was similar to the change from baseline observed at the 34 milligram dose in ADVANCE-1 (-11.8 vs. -11.6); however, the placebo effect in ADVANCE-2 was higher than the placebo effect observed in ADVANCE-1”. CEO Steve Davis states: “We are disappointed the trial did not meet its primary endpoint given the significant unmet need in patients with negative symptoms of schizophrenia. We will continue to analyze these data with our scientific advisors, but we do not intend to conduct any further clinical trials with pimavanserin. We want to thank the patients, their families, and the investigators for their contributions in this important study.”

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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.