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: 

• Equillium (EQ), 943% surge in interest
• scPharmaceuticals (SCPH), 788% surge in interest
• Vir Biotechnology (VIR), 333% surge in interest
• Fibrogen (FGEN), 279% surge in interest
• Madrigal Pharmaceuticals (MDGL), 194% surge in interest
• Bridgebio Pharma (BBIO), 161% surge in interest
• Adial Pharmaceuticals (ADIL), 152% surge in interest
• Viking Therapeutics (VKTX), 148% surge in interest
• Aldeyra Therapeutics (ALDX), 146% surge in interest
• Amarin (AMRN), 141% surge in interest

Pipeline and key clinical candidates for these companies:

Equillium is a clinical-stage biotechnology company working to develop novel therapeutics to treat severe autoimmune and inflammatory disorders with high unmet medical need. The company’s pipeline consists of the following novel first-in-class immunomodulatory assets and product platform targeting immuno-inflammatory pathways. EQ101: a selective tri-specific cytokine inhibitor targeting IL-2, IL-9, and IL-15; currently under evaluation in a Phase 2 proof-of-concept clinical study of patients with alopecia areata being conducted in Australia and New Zealand by Equillium’s Australian subsidiary as the trial sponsor. EQ302: an orally delivered, selective bi-specific cytokine inhibitor targeting IL-15 and IL-21; currently in pre-clinical development.

scPharmaceuticals is a pharmaceutical company focused on developing and commercializing products that are designed to reduce healthcare costs and improve health outcomes. The company develops, internally and through strategic partnerships, innovative products and solutions that aim to expand and advance the outpatient care of select acute conditions. The company’s lead program focuses on the subcutaneous, self-administration of IV-strength treatment in heart failure.

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.

FibroGen is “committed to leveraging its expertise in connective tissue growth factor biology and hypoxia-inducible factor to discovering, developing, and commercializing a pipeline of first-in-class therapeutics for the treatment of unmet needs.” Pamrevlumab, an anti-CTGF human monoclonal antibody, is in clinical development for the treatment of idiopathic pulmonary fibrosis, or IPF, locally advanced unresectable pancreatic cancer, metastatic pancreatic cancer, and Duchenne muscular dystrophy, or DMD. Roxadustat is currently approved in China, Europe, Japan, and numerous other countries for the treatment of anemia in CKD patients on dialysis and not on dialysis. Roxadustat is in Phase 3 clinical development in the U.S. and Europe for anemia associated with myelodysplastic syndromes, or MDS, and in Phase 3 clinical development in China for treatment of chemotherapy-induced anemia, or CIA.

Madrigal is a biopharmaceutical company pursuing novel therapeutics for non-alcoholic steatohepatitis, also known as metabolic dysfunction associated steatohepatitis. Madrigal has advanced its once daily, oral, liver-directed thyroid hormone receptor β-selective agonist, into multiple Phase 3 clinical trials in NASH. Based on Phase 3 results reported to date, the U.S. FDA granted accelerated approval for the therapy for the treatment of adults with NASH with moderate to advanced liver fibrosis.

BridgeBio Pharma is a commercial-stage biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. BridgeBio’s pipeline of development programs ranges from early science to advanced clinical trials, the company has stated.

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.

Viking Therapeutics is focused on the development of novel first-in-class or best-in-class therapies for the treatment of metabolic and endocrine disorders. The company’s clinical programs include VK2809, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the treatment of lipid and metabolic disorders, which is currently being evaluated in a Phase 2b study for the treatment of biopsy-confirmed non-alcoholic steatohepatitis, or NASH, and fibrosis.

Aldeyra is a clinical-stage biotechnology company whose pre-commercial product candidates are reproxalap, a potential treatment for dry eye disease and allergic conjunctivitis, and ADX-2191, a potential treatment for primary vitreoretinal lymphoma, proliferative vitreoretinopathy, and other rare sight-threatening retinal diseases. In addition, Aldeyra is developing other product candidates, including ADX-629 and chemically related molecules, for the potential treatment of systemic and retinal immune-mediated diseases.

Amarin is an “innovative pharmaceutical company leading a new paradigm in cardiovascular disease management” and is “committed to increasing the scientific understanding of the cardiovascular risk that persists beyond traditional therapies and advancing the treatment of that risk for patients worldwide.”

Recent news on these stocks:

June 6

Madrigal Pharmaceuticals announced results from new analyses of the Phase 3 MAESTRO-NASH trial of Rezdiffra being presented at the EASL Congress, which takes place from June 5-8, 2024 in Milan, Italy. In the pivotal Phase 3 MAESTRO-NASH biopsy trial, Rezdiffra achieved both fibrosis improvement and NASH resolution primary endpoints, and 80% of patients treated with Rezdiffra 100 mg experienced improvement or stabilization of fibrosis. Rezdiffra is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic NASH with moderate to advanced liver fibrosis. Bill Sibold, Chief Executive Officer of Madrigal, stated, “The ten abstracts Madrigal will be presenting at the EASL Congress further advance our leadership position in NASH. Our late-breaking oral presentation leverages innovative AI technology to provide deeper insight into the antifibrotic effects of Rezdiffra and the critical role of THR-beta as a suppressor of NASH disease progression. This analysis is particularly meaningful in light of emerging health economics data indicating patients with NASH can progress more rapidly than previously thought to decompensated cirrhosis. Additionally, new analyses of the MAESTRO-NASH data broaden our understanding of Rezdiffra treatment response across a range of parameters, including noninvasive measures of fibrosis and steatosis through three years of therapy and health-related quality of life. These data reinforce Rezdiffra’s role as the foundational therapy in NASH.”

June 5

Vir Biotechnology announced new preliminary data from its Phase 2 SOLSTICE hepatitis delta clinical trial evaluating tobevibart, an investigational monoclonal antibody, and elebsiran, an investigational small interfering ribonucleic acid, for the treatment of people living with chronic hepatitis delta. Preliminary data from the Phase 2 trial show treatment with tobevibart alone or in combination with elebsiran was generally well tolerated and participants achieved high rates of virologic response at weeks 12 and 24, durable virologic response through 48 weeks, and high rates of ALT normalization. These participants received 12 weeks of either tobevibart or elebsiran monotherapy and then rolled over into combination therapy. All 6 participants remain on treatment. At the time of the analysis, 5 out of the 6 participants had reached 48 weeks of combination therapy and 1 had reached 40 weeks of combination therapy. All 6 participants showed sustained virologic response at time of last visit 100% achieved HDV RNA less than limit of detection or 2 log10 IU/mL decrease from baseline; 50% achieved ALT normalization; 50% achieved the combined endpoint. Furthermore, 100% achieved HDV RNA less than the lower limit of quantification, 100% achieved HDV RNA less than LOD, and 83% achieved HDV RNA target not detected. The majority of adverse events were Grade 1-2 and transient in nature with no reported serious adverse events, no ALT flares and no Grade 2 or higher elevations in liver function tests were observed. Week 12: Among 27 participants 100% achieved HDV RNA less than LOD or 2 log10 IU/mL decrease from baseline; 44% achieved ALT normalization; 44% achieved the combined endpoint. Furthermore, 52% achieved HDV RNA less than LLOQ, 37% achieved HDV RNA less than LOD, and 15% achieved HDV RNA TND. Week 24: Among 11 participants 100% achieved HDV RNA less than LOD or 2 log10 IU/mL decrease from baseline, 64% achieved ALT normalization, 64% achieved the combined endpoint. Furthermore, 100% achieved HDV RNA less than LLOQ, 91% achieved HDV RNA less than LOD, and 55% achieved HDV RNA TND. Similar rates of virologic suppression and ALT normalization were observed in participants who are non-cirrhotic and those with compensated cirrhosis. The majority of adverse events were Grade 1-2 and transient in nature with no treatment-related serious adverse events, no ALT flares and no Grade 2 or higher elevations in LFTs were observed. Preliminary tobevibart monotherapy data demonstrated high rates of virologic suppression and ALT normalization: Week 12: Among 26 participants; 73% achieved HDV RNA less than LOD or 2 log10 IU/mL decrease from baseline; 54% achieved ALT normalization; 38% achieved the combined endpoint. Furthermore, 27% achieved HDV RNA less than LLOQ, 19% achieved HDV RNA less than LOD, and 8% achieved HDV RNA TND. Week 24: Among 11 participants 55% achieved HDV RNA less than LOD or 2 log10 IU/mL decrease from baseline; 64% achieved ALT normalization; 55% achieved the combined endpoint. Furthermore, 55% achieved HDV RNA less than LLOQ, 46% achieved HDV RNA less than LOD, and 18% achieved HDV RNA TND. The majority of adverse events were Grade 1-2 and transient in nature with no serious adverse events, no ALT flares and no Grade 2 or higher elevations in LFTs were observed. The Company is on track to report additional 24-week treatment data for all approximately 60 SOLSTICE participants in the fourth quarter of 2024.

Adial Pharmaceuticals announced that the first patient has been dosed in a pharmacokinetics study of AD04, the company’s lead investigational genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder in heavy drinking patients. The study is expected to take 6 months to complete and is intended to produce data which will help the company to optimize study design elements needed for the upcoming Phase 3 clinical trial of AD04. Cary Claiborne, President and CEO of Adial commented, “Dosing our first patient is an important milestone, marking the beginning of clinical activity in this previously planned and pre-budgeted study. Our goal is to obtain data we need to design a more precise and informed Phase 3 trial protocol, including evaluating the optimal dosing regimen to maximize the efficacy and safety of AD04 in patients with AUD. Completion of this study is in accord with previous guidance provided by the FDA and is intended to enhance the likelihood of success in our upcoming Phase 3 trial. This relatively short and low-cost study is also a key element of our strategy to advance ongoing partnership discussions. The study will also provide data necessary to support an application for approval of AD04 under a 505(b)(2) regulatory pathway with FDA. Looking ahead, we plan to engage with the FDA in Q4 2024 to discuss the results of this pharmacokinetics study and obtain feedback to refine the Phase 3 study design. This meeting will help establish the final protocol and ensure that it aligns with FDA expectations, further advancing AD04 towards regulatory approval.”

June 4

Equillium announced topline data from its Phase 2, single dose, proof-of-concept, or PoC, study of EQ101 in adult patients with moderate, severe or very-severe alopecia areata, or AA, an autoimmune disease driven by an immune cell attack of the hair follicles that causes hair loss. The primary objectives of the study were to evaluate the safety and tolerability profile of EQ101, as well as signs of efficacy using Severity of Alopecia Tool, or SALT, scores, where a score of 100 represents total scalp hair loss and a score of 0 represents no scalp hair loss. Results from the study demonstrated a favorable safety and tolerability profile with no serious adverse events, or SAEs, and improvements in SALT scores above the published historically low placebo response rates. Of all subjects that completed 24 weeks of treatment, 20% achieved a SALT score of less than or equal to 20 by week 24. Of those subjects with moderate to severe AA at baseline that completed 24 weeks of treatment, 29% achieved a SALT score of less than or equal to 20 by week 24, and a mean SALT improvement from baseline of 18%. Throughout 24 weeks of treatment and 4 weeks of follow up, EQ101 was well tolerated with no SAEs and no notable changes in safety laboratory, electrocardiogram, vital signs, or physical exam findings were reported. The majority of adverse events were Grade 1 or 2, with the most common being upper respiratory tract infection, headache and fatigue. The two Grade 3 events in two subjects considered related to study treatment were a case of transient lymphocytopenia and fatigue.

BridgeBio Pharma announced sustained positive results from PROPEL 2, a Phase 2 trial of the investigational therapy infigratinib in children with achondroplasia, demonstrating continued potential best-in-class efficacy and an encouraging safety profile. Infigratinib is an oral small molecule designed to inhibit FGFR3 signaling and target achondroplasia and hypochondroplasia at their source. To date, key results from the Cohort 5 dose escalation cohort in PROPEL 2 trial include: Sustained and statistically significant mean increase in AHV of +2.51cm/year from baseline at 12 months, and +2.50 cm/yr at 18 months; Statistically significant improvement in body proportionality, from 2.02 at baseline to 1.88 at Month 18; A continued well-tolerated safety profile, with no treatment-related adverse events assessed as related to infigratinib.

Viking Therapeutics announced positive 52-week histologic data from its Phase 2b VOYAGE study of VK2809, the company’s novel liver-selective thyroid hormone receptor beta agonist, in patients with biopsy-confirmed non-alcoholic steatohepatitis – NASH -. The study successfully achieved its primary endpoint, with patients receiving VK2809 experiencing statistically significant reductions in liver fat content from baseline to Week 12 as compared with placebo. Results highlight achievement of secondary endpoints evaluating histologic changes assessed by hepatic biopsy after 52 weeks of treatment with VK2809. On the secondary endpoint of NASH resolution with no worsening of fibrosis, VK2809-treated patients demonstrated NASH resolution ranging from 63% to 75%, vs. 29% for placebo. Across the combined VK2809 treatment groups, 69% achieved NASH resolution. On the secondary endpoint evaluating improvement in fibrosis with no worsening of NASH, VK2809-treated patients demonstrated improvement in fibrosis ranging from 44% to 57% vs. 34% for placebo. Across the combined VK2809 treatment groups, 51% achieved improvement in fibrosis with no worsening of NASH. On the secondary endpoint evaluating the proportion of patients experiencing both resolution of NASH and improvement in fibrosis, VK2809-treated patients demonstrated improvement ranging from 40% to 50% vs. 20% for placebo. Across the combined VK2809 treatment groups, 44% achieved this endpoint. Study results were consistent under various sensitivity analyses. Patients receiving VK2809 demonstrated statistically significant reductions in liver fat at Week 12, which was the primary endpoint in VOYAGE. Patients receiving VK2809 continued to demonstrate statistically significant reductions in liver fat content at Week 52. Patients receiving VK2809 demonstrated placebo-adjusted reductions in LDL-C ranging from 20% to 25%, as well as reductions in triglycerides and atherogenic proteins and apolipoprotein C-III, all of which have been correlated with cardiovascular risk. VK2809 demonstrated encouraging safety and tolerability in this study through 52 weeks of treatment, with minimal differences compared with the previously reported results at 12 weeks. 94% of treatment related adverse events among patients receiving VK2809 were reported as mild or moderate.

Amarin Corporation announced that the company’s board appointed Aaron Berg, currently Amarin’s executive VP and president of the U.S. Business, as president and CEO. The appointment of Berg follows the resignation of Patrick Holt as president & CEO of the company. Berg joined Amarin in November 2012 and has more than 30 years of biopharmaceutical industry experience.

In a regulatory filing, Amarin disclosed that the company has been informed by “a large national pharmacy benefit manager,” or “PBM,” that, effective July 1, the PBM intends to no longer cover Vascepa as the exclusive icosapent ethyl product for its Commercial national formularies and will be transitioning Vascepa to not covered as of July 1, 2024. “Currently, Vascepa volume through these formularies represents approximately 25% of aggregate U.S. Vascepa prescription volume. This decision does not impact Vascepa coverage within Medicare Part D formularies of the PBM,” the company stated.

June 3

FibroGen announced that the FDA has cleared the company’s Investigational New Drug of FG-3165, a galectin-9 targeted monoclonal antibody under development for treatment of solid tumors characterized by high Gal9 levels of expression. “The FDA’s IND clearance is an important achievement for us, and we are pleased to advance another product from our promising oncology pipeline into the clinic,” said Thane Wettig, CEO of FibroGen. “To date, FG-3165 has demonstrated anti-tumor activity with improved survival in combination with other immune modulatory therapies in mouse cancer models and has shown excellent tolerability in nonclinical safety studies. We are excited to begin enrollment in a Phase 1 trial in the second half of this year and explore the potential of FG-3165 in enhancing anti-tumor immune responses in the tumor microenvironment.” The FDA IND clearance enables FibroGen to initiate a Phase 1 clinical trial evaluating the safety and efficacy of FG-3165 in patients with select solid tumors. The trial is anticipated to begin enrollment in the second half of 2024

FibroGen announced a clinical trial supply agreement with Regeneron Pharmaceuticals (REGN) to evaluate FibroGen’s immuno-oncology assets, FG-3165 and FG-3175, in combination with Regeneron’s anti-PD-1 therapy, LIBTAYO or cemiplimab, in patients with solid tumors. “We are very excited to collaborate with Regeneron Pharmaceuticals to evaluate two separate novel combination approaches to treat patients with select solid tumors,” said Deyaa Adib, M.D., Chief Medical Officer of FibroGen. “We believe that the mechanisms of action for both FG-3165 and FG-3175 have the potential to be synergistic with cemiplimab, providing the possibility for an improvement in clinical outcomes for patients. We look forward to building a collaborative relationship with Regeneron, who is a leader in oncology therapeutic products development and commercialization.” FG-3165 targets Gal9, which binds multiple immune checkpoints on lymphocytes that suppress T and natural killer NK cell activation. FG-3175 targets CCR8, a receptor frequently over-expressed on T regulatory cells in solid tumors. Both FG-3165 and FG-3175 have demonstrated complementary mechanisms of action with PD-1 inhibitors preclinically, and the Company believes that combining LIBTAYO with either FG-3165 or FG-3175 may result in added clinical benefit for patients.

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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.