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: 

• Assembly Biosciences (ASMB), 7,900% surge in interest
• ESSA Pharma (EPIX), 2,588% surge in interest
• Aldeyra (ALDX), 2,224% surge in interest
• Mereo Biopharma (MREO), 1,662% surge in interest
• Evelo Biosciences (EVLO), 1,653% surge in interest
• Prothena (PRTA), 1,454% surge in interest
• Summit Therapeutics (SMMT), 1,306% surge in interest
• Omeros Corp (OMER), 579% surge in interest
• Daré Bioscience (DARE), 488% surge in interest
• Ultragenyx Pharmaceutical (RARE), 483% surge in interest

Pipeline and key clinical candidates for these companies:

Assembly Biosciences is a biotechnology company that says it is “dedicated to the development of innovative small molecule antiviral therapeutics designed to change the path of serious viral diseases and improve the lives of patients worldwide.” Assembly Bio is committed to improving outcomes for patients struggling with the serious, chronic impacts of herpesvirus, hepatitis B virus and hepatitis delta virus infections, the company states.

ESSA is focused on developing novel and proprietary therapies for the treatment of patients with prostate cancer. ESSA is developing the first generation of ANITen bAsed Chimera degraders targeting the AR NTD. In preclinical models, the orally bioavailable ANITAC degraders can eliminate forms of AR protein found in castration-resistant prostate cancer that can potentially drive disease progression including LBD mutants and LBD truncated splice variants.

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.

Mereo BioPharma is a biopharmaceutical company focused on the development of innovative therapeutics for rare diseases. The company has two rare disease product candidates, setrusumab for the treatment of Osteogenesis Imperfecta, or OI, and alvelestat for the treatment of severe alpha-1-antitrypsin deficiency-associated lung disease and Bronchiolitis Obliterans Syndrome.

Evelo Biosciences is a clinical stage biotechnology company developing a novel platform of orally delivered medicines acting on the small intestinal axis, SINTAX, with systemic therapeutic effects. The company’s product candidates are pharmaceutical preparations of single strains of microbes or their extracellular vesicles, or EVs. Evelo initially is developing EDP1815 in psoriasis and atopic dermatitis and EDP2939 in psoriasis. “If shown to be effective in inflammatory disease mediated by the Th1, Th2 or Th17 inflammatory pathways, these same investigational medicines could be effective in additional inflammatory diseases, such as psoriatic and other forms of arthritis, asthma, allergy, and inflammatory bowel disease,” the company says.

Prothena Corporation is a late-stage clinical biotechnology company with expertise in protein dysregulation and a pipeline of investigational therapeutics with the potential to change the course of devastating neurodegenerative and rare peripheral amyloid diseases. Prothena is advancing a pipeline of therapeutic candidates for a number of indications and novel targets. Prothena’s pipeline includes both wholly-owned and partnered programs being developed for the potential treatment of diseases including AL amyloidosis, ATTR amyloidosis, Alzheimer’s disease, Parkinson’s disease and a number of other neurodegenerative diseases.

Summit Therapeutics is initiating development activities for SMT112 and will do so first in NSCLC indications. Summit plans to start treating patients in clinical studies by the second quarter of 2023.

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.

Daré Bioscience is advancing products for women’s health, stating that the company’s mission is “to identify, develop and bring to market a diverse portfolio of differentiated therapies that prioritize women’s health and well-being, expand treatment options, and improve outcomes, primarily in the areas of contraception, fertility, and vaginal and sexual health.” Daré’s first FDA-approved product, XACIATO vaginal gel, is a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older, which is under a global license agreement with Organon. Daré’s portfolio also includes potential first-in-category candidates in clinical development: Ovaprene, a novel, hormone-free monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement with Bayer; Sildenafil Cream, 3.6%, a novel cream formulation of sildenafil to treat female sexual arousal disorder utilizing the active ingredient in Viagra; and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for hormone therapy following menopause.

Ultragenyx is a biopharmaceutical company committed to bringing novel products to patients for the treatment of serious rare and ultrarare genetic diseases. The company says it has “built a diverse portfolio of approved therapies and product candidates aimed at addressing diseases with high unmet medical need and clear biology for treatment, for which there are typically no approved therapies treating the underlying disease.” 

Recent news on these stocks:

October 17

Gilead Sciences (GILD) and Assembly Biosciences announced that the companies have entered into a 12-year partnership to advance the research and development of novel antiviral therapies, with an initial focus in Assembly Bio’s established areas of herpesviruses, hepatitis B virus HBV and hepatitis D virus HDV . Assembly Bio’s current portfolio of small molecule antiviral therapeutics includes both clinical and preclinical programs, including next-generation core inhibitor ABI-4334 for the treatment of HBV, long-acting helicase-primase inhibitor ABI-5366 for herpes simplex virus , an orally bioavailable HDV entry inhibitor ABI-6250, and a pan-herpes polymerase inhibitor program…Under the terms of the agreement, Assembly Bio will receive $100M, consisting of an $84.8M upfront payment and a $15.2M equity investment from Gilead. Gilead’s initial equity investment at a premium represents 19.9 percent of the outstanding voting stock of Assembly Bio as of the date of closing. In addition, subject to certain conditions, Gilead has agreed to purchase up to 29.9% of Assembly Bio’s outstanding voting stock at a premium. ..Following Gilead’s exercise of its option for an Assembly Bio program, Assembly Bio will have the right to opt-in to share profits and costs in the United States. For future new programs, Assembly Bio will also have an option to co-promote those products in the United States.

Evelo Biosciences announced top-line results from its Phase 2 clinical study with EDP2939 in moderate psoriasis. The study’s primary endpoint, the difference in the proportion of patients who achieved an outcome of a 50% improvement from baseline in Psoriasis Area and Severity Index score between EDP2939 and placebo after 16 weeks of daily treatment, was not achieved. The Company is continuing to gather and analyze the study data. Simba Gill, Ph.D., Chief Executive Officer of Evelo, commented, “Whilst we are disappointed with the results of the Phase 2 study with EDP2939, we continue to believe in the value of our Small Intestinal Axis platform and in our potential product, EDP1815. We previously reported positive efficacy and safety data in a Phase 2 study of mild to moderate psoriasis with EDP1815. We will cease development of EDP2939, given the results of this study, and are conducting a review of potential strategic alternatives, including seeking to partner EDP1815 and the SINTAX platform.” In the EDP2939-101 Phase 2 study, the primary endpoint was the difference in the proportion of patients who reached at least PASI-50 reductions between EDP2939 and placebo after 16 weeks of daily treatment. A PASI-50 response was chosen as this is clinically meaningful for patients with moderate psoriasis and had been positive in the previous study with EDP1815. Although there was no statistically significant difference between the proportion of patients who achieved a PASI-50 response on EDP2939 compared to placebo, it was notable that such numeric proportion went from being inferior to placebo at week 16 to being superior at the week 20 follow-up visit. Ongoing analysis of the secondary endpoints continues. Overall safety data was consistent with what was previously reported in the Phase 1 portion of this study: EDP2939 was well-tolerated with adverse events comparable to placebo. There were no related serious adverse events. Based on these results, Evelo has initiated a process to explore strategic alternatives.

October 16

In a regulatory filing, the company stated: “On October 16, 2023, Aldeyra Therapeutics announced that it received minutes from a late-cycle review meeting with the U.S. Food and Drug Administration relating to the new drug application for reproxalap for the treatment of the signs and symptoms of dry eye disease. The Minutes identified substantive review issues in connection with the NDA for reproxalap. The FDA stated that “(i)t does not appear that you have data to support the clinical relevance of the ocular signs to support your dry eye indication.” In subsequent communications between Aldeyra and the FDA, Aldeyra has submitted responses to the FDA that Aldeyra believes to be sufficient to mitigate the identified issues, but the FDA has not directly opined on the sufficiency of the information submitted, has no legal obligation to review the information submitted by Aldeyra, and has indicated that Aldeyra needs to conduct an additional clinical trial to satisfy efficacy requirements. As such, based on the time remaining in the NDA review cycle, the FDA may not be in the position to approve the NDA for reproxalap on or about the Prescription Drug User Fee Act target action date of November 23, 2023 or afterwards, and it may issue a Complete Response Letter and require that Aldeyra conduct additional clinical trials and submit the results of those clinical trials before the application will be reconsidered.”

Prothena is preparing for a potential sale ahead of key Alzheimer’s data expected in the coming months, Michelle Davis, Dinesh Nair and Manuel Baigorri of Bloomberg report, citing people with knowledge of the matter. The company has been speaking to advisers as it gets ready to explore strategic options that may include a sale or partnership, sources told Bloomberg. The people added that Prothena would likely attract interest from large drugmakers. Deliberations are at an early stage, and Prothena could opt to remain independent for longer, the sources added.

Omeros provided an update regarding the interim analysis outcome in ARTEMIS-IGAN, the company’s Phase 3 trial evaluating narsoplimab for the treatment of immunoglobulin A, or IgA nephropathy. The primary endpoint is reduction in proteinuria assessed by 24-hour urine protein excretion at 36 weeks compared to placebo in the intent-to-treat population of 180 IgA nephropathy patients with high baseline proteinuria. Topline results show that narsoplimab did not achieve statistically significant improvement over placebo. The UPE reduction in the placebo group was markedly greater than that reported in trials of other agents in IgA nephropathy. Based on the absence of statistical significance and as previously agreed with FDA, Omeros will not submit an application for approval of narsoplimab in this indication and will discontinue the ARTEMIS-IGAN clinical trial.

Dare Bioscience announced the first shipment of XACIATOTM vaginal gel, 2% in connection with the first commercial sale of the product in the United States, triggering a $1.8M milestone payment to Dare under its global license agreement with Organon (OGN). “This is a major achievement for Dare Bioscience, proving our ability to accelerate the development of much-needed, innovative medicines for women,” said Sabrina Martucci Johnson, President and CEO of Dare Bioscience. “In less than five years since licensing the technology, we advanced a pivotal clinical trial, gained U.S. Food and Drug Administration approval, and ensured supply to support the launch of XACIATO. We look forward to our continued collaboration with Organon and its established sales force to offer this important treatment for bacterial vaginosis in females 12 years or older.” The New Drug Application for XACIATO was supported by positive results from the DARE-BVFREE Phase 3 randomized, multi-center, double-blinded, placebo-controlled clinical trial evaluating XACIATO for the treatment of bacterial vaginosis.

October 15

Ultragenyx Pharmaceutical and Mereo BioPharma announced interim data from the Phase 2 portion of the Phase 2/3 Orbit study demonstrating that treatment with setrusumab significantly reduced incidence of fractures in patients with OI with at least 6 months of follow-up and continues to demonstrate ongoing and meaningful improvements in lumbar spine bone mineral density. The data were presented in a late-breaker presentation at the American Society for Bone and Mineral Research 2023 Annual Meeting. As of the cut-off date and following at least 6 months of treatment with setrusumab, the annualized fracture rate across all 24 patients in the Phase 2 portion of the study was reduced by 67%. In the 2 years prior to treatment with setrusumab all patients experienced at least 1 fracture. The median annualized fracture rate of 0.72 in the 2 years prior to treatment was reduced to 0.00 during the mean treatment duration period of 9 months. Following initiation of treatment with setrusumab, 20 patients experienced no radiographic-confirmed fractures, and 4 patients experienced 7 radiographic-confirmed fractures in 5 separate events. These fractures exclude fractures of the fingers, toes, skull, and face consistent with the Phase 3 study design. The reduction in annualized fracture rates was associated with a clinically meaningful increase in BMD. At the 6-month timepoint, treatment with setrusumab resulted in a mean increase in lumbar spine BMD from baseline of 13% at 20 mg/kg and 16% at 40 mg/kg, which represents the same substantial mean improvement in Z-score of +0.85 for both dose groups at 6 months compared to a combined mean baseline Z-score of -1.68. The small apparent difference in BMD change from baseline is likely related to differences in patients assigned to the two treated groups. There was no statistically significant difference in BMD percent change or Z-score change from baseline between the 20 and 40 mg/kg dosing cohorts. As of the data cut-off, there were no treatment-related serious adverse events observed in the study. Reported adverse events were generally consistent with those observed in the ASTEROID study with infusion-related events and headache determined to be the most common adverse events related to the study drug. There have been no reported hypersensitivity reactions related to setrusumab. There were no notable safety-related differences observed between dosing groups or age groups.

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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.