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: 

• Hoth Therapeutics (HOTH), 1,681% surge in interest
• Exicure (XCUR), 961% surge in interest
• Akari Therapeutics (AKTX), 643% surge in interest
• Tonix Pharmaceuticals (TNXP), 464% surge in interest
• Aclaris Therapeutics (ACRS), 460% surge in interest
• Incyte (INCY), 286% surge in interest
• Aptevo (APVO), 166% surge in interest
• Apellis Pharmaceuticals (APLS), 154% surge in interest
• Coherus (CHRS), 131% surge in interest

Pipeline and key clinical candidates for these companies:

Hoth Therapeutics refers to itself as “a catalyst in early-stage pharmaceutical research and development, elevating drugs from the bench to pre-clinical and clinical testing.” Hoth “collaborates and partners with a team of scientists, clinicians, and key opinion leaders to seek out and investigate therapeutics that hold immense potential to create breakthroughs and diversify treatment options,” the company stated.

Exicure is an early-stage biotechnology company historically focused on developing nucleic acid therapies targeting ribonucleic acid against validated targets. The company says it continues to actively pursue out-licensing opportunities for its clinical asset, cavrotolimod, as well as for its preclinical candidates, including the SCN9A program for neuropathic pain, and to pursue all strategic alternatives with the goal of maximizing stockholder value.

Akari Therapeutics is a biotechnology company developing advanced therapies for autoimmune, oncology and inflammatory diseases. Akari has two lead assets, investigational nomacopan and an antibody drug conjugate, or ADC, platform. Nomacopan is a bispecific recombinant inhibitor of complement C5 activation and leukotriene B4 activity. The company is conducting pre-clinical research of long-acting PAS-nomacopan in geographic atrophy, or GA. The company’s ADC platform includes novel toxins and linkers coupled with important cancer antibody targets.

Tonix is focused on central nervous system, rare disease, immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL, is in mid-Phase 3 development for the management of fibromyalgia.

Aclaris Therapeutics is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of drug candidates powered by a robust R&D engine exploring protein kinase regulation.

Incyte is a global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics.

Aptevo Therapeutics is focused on developing novel immunotherapies for the treatment of cancer. APVO436 is a bispecific CD3xCD123 ADAPTIR currently in Phase 1b development in a multi-center, multi-cohort trial designed to evaluate safety, tolerability and efficacy in combination therapy and monotherapy for patients with acute myeloid leukemia, or AML. The company plans to initiate a Phase 2 trial, evaluating APVO436 in combination with venetoclax and azacitidine in patients with AML who are venetoclax treatment naive, in 2H23.

Apellis Pharmaceuticals says the company “ushered in the first new class of complement medicine in 15 years” with the approval of the first and only targeted C3 therapy. Apellis is advancing this science to “continually develop transformative medicines for people living with rare, retinal, and neurological diseases,” it stated.

Coherus is a commercial-stage biopharmaceutical company focused on the research, development and commercialization of immunotherapies to treat cancer. Coherus’ immuno-oncology pipeline includes multiple antibody immunotherapy candidates focused on enhancing the innate and adaptive immune responses to enable a robust immunologic response and enhance outcomes for patients with cancer.

Recent news on these stocks:

November 22

Aptevo Therapeutics provided additional details about its oncology pipeline which is poised to potentially address some of the most challenging and aggressive forms of cancer in both blood and solid tumors. As bispecific antibodies gain prominence for their revolutionary therapeutic potential and expanding market opportunities, Aptevo’s differentiated platforms and promising clinical results across two clinical programs, together with preclinical assets are demonstrating how bispecifics rationally differentiated for safety and targeted efficacy may impact the future of cancer care. The company plans to add another targeted asset to the pipeline in the near-term and looks forward to providing more detail about the new compound at that time. Aptevo’s commitment to transforming cancer therapeutics is exemplified by its development pipeline, which features five bispecific antibodies, two clinical and three preclinical, targeting hematological malignancies and solid tumors. The company’s focus on developing highly potent, safe, and versatile therapeutics positions it as a significant player in the expanding field of bispecific antibody based therapies. Lead Candidate Mipletamig for Acute Myeloid Leukemia: Mipletamig, Aptevo’s lead bispecific antibody, is currently in a frontline Phase 1b/2 combination trial, RAINIER, following positive results from earlier studies. The Company announced an initial efficacy response earlier this week where the first patient dosed experienced a 90% reduction in leukemic blasts within 30 days of treatment initiation, continuing the efficacy trend seen in prior mipletamig clinical studies. Mipletamig is designed to engage the immune system and directly target AML cells, offering new hope for a patient population with historically poor outcomes. Mipletamig’s encouraging clinical performance underscores the potential to transform AML treatment standards, reinforcing Aptevo’s innovative approach to tackling blood cancers. Clinical Candidate: ALG.APV-527: ALG.APV-527 is being evaluated in a Phase 1 trial for solid tumors likely to express the tumor antigen 5T4. Tumor types treated to date include breast, colon, pancreatic and non-small cell lung cancer. Positive preliminary data from the study were presented at the European Society of Medical Oncology Congress in September and at the Society for Immunotherapy of Cancer conference earlier in November. These results showed that ALG.APV-527 demonstrated safety and tolerability across all cohorts, nine of 16 evaluable patients achieved stable disease, and biomarker analysis confirmed immune activation in the tumor microenvironment. This drug has the potential to advance treatment in hard-to-treat solid tumors, demonstrating the versatility of Aptevo’s technology across a wide range of cancer types. The Company’s preclinical candidates represent diverse but complementary approaches to cancer treatment and were designed, like the clinical candidates, with safety, targeted efficacy and combinability in mind. APVO711: Dual immune mechanisms that act as an immune checkpoint blockade plus immune activator where CD40 only functions when both binding domains are engaged APVO603: Broad solid tumor targeting that simultaneously engages two co-stimulatory molecules in the tumor and only functions when both binding domains are engaged APVO442: Precision targeting of prostate cancer antigens with immune engagement driven by CD3 engagement on T cells which are intended to directly kill PSMA-expressing prostate tumor cells.

November 20

Hoth Therapeutics announced that the company’s board of directors approved the purchase of up to $1M in Bitcoin as a treasury reserve asset.

November 19

Akari Therapeutics announces receipt of written notice from the Listing Qualifications Staff of The Nasdaq Stock Market informing the company that its deficiency under Listing Rule 5550(b) has been cured. The company is now in full compliance with all Nasdaq continued listing requirements. Based on the foregoing, the previously scheduled Nasdaq hearing before the Hearings Panel on November 21, has been canceled. The company will continue to be traded on The Nasdaq Capital Market.

Astellas Pharma (ALPMY) announced the FDA issued a Complete Response Letter regarding the supplemental new drug application for Izervay for the treatment of geographic atrophy secondary to age-related macular degeneration. The drug application sought to include positive two-year data in the U.S. Prescribing Information for Izervay based on results from the GATHER2 Phase 3 clinical trial, which evaluated the efficacy and safety of monthly and every other month dosing through year two. The FDA stated the agency cannot approve the application in its present form by the action date of November 19. “The FDA comments outlined in the CRL are unrelated to the safety and benefit/risk of the use of IZERVAY; rather, the comments focus on a statistical matter related to labelling language proposed by Astellas. Astellas is seeking further clarification from the FDA and looks forward to working with the agency to quickly address the agency’s feedback,” the company said in a statement. Shares of Apellis, whose Syfovre competes with Izervay, rose 3% to $26.99 in premarket trading.

November 18

Tonix Pharmaceuticals presented data in a poster presentation at the ACR Convergence 2024 Annual Meeting, held November 14-19, 2024, in Washington, D.C. A copy of the Company’s presentation, titled “Randomized, Double-Blind, Placebo-Controlled Confirmatory Phase 3 Trial of Bedtime Sublingual Cyclobenzaprine in Fibromyalgia” is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com. In the Phase 3 RESILIENT study, TNX-102 SL met the pre-specified primary endpoint of significantly reducing daily pain compared to placebo in participants with fibromyalgia. In the RESILIENT study, TNX-102 SL demonstrated a broad spectrum of benefits with statistically significant improvement in all six pre-specified key secondary endpoints including those related to improved sleep quality, reduced fatigue, and improved patient global ratings and overall fibromyalgia symptoms and function. TNX-102 SL was generally well tolerated with an adverse event profile comparable to prior studies and no new safety signals observed. Tonix submitted a new drug application to the U.S. Food and Drug Administration in October 2024 for TNX-102 SL for the management of fibromyalgia. The FDA typically has a 60-day filing review period to determine whether the submitted NDA is complete and accepted for review. If the FDA accepts the NDA for review, the Company expects a 2025 date for a FDA decision on approval, based on the Prescription Drug User Fee Act.

Aclaris Therapeutics has entered into an exclusive license agreement with Biosion for worldwide rights to BSI-045B, a potential best-in-class, clinical-stage, novel anti-TSLP monoclonal antibody, and BSI-502, a potential best-in-class, pre-clinical stage, novel bispecific antibody that is directed against both TSLP and IL4R. In a completed Phase 2a, single-arm, proof-of-concept trial in the United States in 22 patients with moderate to severe atopic dermatitis, BSI-045B was observed to have a pharmacodynamic, safety and efficacy profile that could position it as a potential best-in-class therapy. BSI-045B is also being advanced in multiple Phase 2 studies in China by Biosion’s regional partner, Chia Tai Tianqing Pharmaceutical Group, targeting both severe asthma and chronic rhinosinusitis with nasal polyps, accelerating the potential to show proof-of-concept across additional indications. Biosion is a global biotechnology company that has built a pipeline of innovative biologics through its internally derived proprietary technologies. Concurrent with the Biosion transaction, Aclaris has made two key additions to its leadership team: Hugh Davis, Ph.D., joins as President and COO, bringing over 35 years of experience in biologics development, clinical pharmacology, and business development from leadership roles at Biosion, Frontage, GSK, and Johnson & Johnson. Steven Knapp, PharmD, joins as Executive Vice President, Head of Regulatory & Quality, with over 35 years of regulatory and quality experience from senior positions at Biosion, Antares, Valeant, and BMS.

Incyte announced that it will pause enrollment in the ongoing Phase 2 study of MRGPRX2 in chronic spontaneous urticaria, CSU. The decision was made following the observation of certain in vivo preclinical toxicology findings. These data have been shared with the FDA and Incyte will work closely with the FDA to determine next steps. Enrollment in the other INCB000262 proof-of-concept studies is complete and data from all clinical studies will help inform its future development and guide the potential development of back-up molecules. In addition, data from the Phase 2 study evaluating MRGPRX4 in cholestatic pruritus, CP, does not support further development.

November 14

Exicure entered into two share purchase agreements, stating,”Exicure has historically been an early-stage biotechnology company focused on developing nucleic acid therapies targeting ribonucleic acid against validated targets. In September 2022, the company announced a significant reduction in force, suspension of preclinical activities and halting of all research and development, and that the company was exploring strategic alternatives to maximize stockholder value. In an agreement dated November 6, and executed on November 12, the company agreed to sell and issue to HiTron Systems 433K shares of common stock for $1.3M, at a purchase price of $3.00 per share. The closing of this transaction is expected to occur within 10 days from its execution. On November 13, in a subsequent agreement, the company agreed to sell and issue to HiTron 2.9M additional shares of common stock for $8.7M, at a purchase price of $3.00 per share. The closing of the investment pursuant to this subsequent agreement is conditioned on stockholder approval, among other customary conditions.”

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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.