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: 

• Evofem Biosciences (EVFM), 1,380% surge in interest
• Achieve Life Sciences (ACHV), 930% surge in interest
• Evelo Biosciences (EVLO), 595% surge in interest
• Acadia Pharmaceuticals (ACAD), 559% surge in interest
• Seagen (SGEN), 392% surge in interest
• Incyte (INCY), 328% surge in interest
• Connect Biopharma (CNTB), 248% surge in interest
• Vertex Pharmaceuticals (VRTX), 223% surge in interest
• Blueprint Medicines (BPMC), 201% surge in interest
• Edesa Biotech (EDSA), 185% surge in interest

Pipeline and key clinical candidates for these companies:

Evofem Biosciences is commercializing products to address unmet needs in women’s sexual and reproductive health. The company’s first FDA-approved product, Phexxi — lactic acid, citric acid and potassium bitartrate — is a hormone-free, on-demand prescription contraceptive vaginal gel.

Achieve’s focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline, a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. Cytisinicline is an investigational product candidate being developed for treatment of nicotine addiction and has not been approved by the FDA for any indication in the United States.

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.

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.

Seagen discovers, develops, manufactures and commercializes targeted cancer therapeutics, with antibody-drug conjugates at its core. As “an ADC technology trailblazer,” approximately one-third of FDA-approved and marketed ADCs use Seagen technology, the company has noted. Seagen is headquartered in Bothell, Washington and has locations in California, Canada, Switzerland and across Europe.

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

Connect Biopharma is a global, clinical-stage biopharmaceutical company that says it is “applying its expertise in T cell biology and deep knowledge of the drug discovery industry to develop innovative therapies to treat chronic inflammatory diseases.” Its lead product candidate, rademikibart, is an antibody designed to target interleukin-4 receptor alpha in development for the treatment of atopic dermatitis and asthma. The company’s second product candidate, icanbelimod, is a modulator of S1P1 T cell receptors and is in development for the treatment of ulcerative colitis. Connect’s third product candidate, CBP-174, is an investigational antagonist of histamine receptor 3 designed to act peripherally, in development for the treatment of pruritus associated with AD.

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has multiple approved medicines that treat the underlying cause of cystic fibrosis and has several ongoing clinical and research programs in CF. Beyond CF, Vertex has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including sickle cell disease, beta thalassemia, APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes and alpha-1 antitrypsin deficiency.

Blueprint Medicines is a global precision therapy company that says it “invents life-changing therapies for people with cancer and blood disorders” by “applying an approach that is both precise and agile.” Blueprint is globally advancing multiple programs for mast cell disorders, including systemic mastocytosis and chronic urticaria, breast cancer and other cancers vulnerable to CDK2 inhibition, as well as EGFR-mutant lung cancer.

Edesa Biotech is a clinical-stage biopharmaceutical company focused on developing treatments for inflammatory and immune-related diseases with clear unmet medical needs. The company’s two lead product candidates, EB05 and EB01, are in later stage clinical studies.

Recent news on these stocks:

December 15

Vertex Pharmaceuticals announced that the European Medicines Agency’s, or EMA’s, Committee for Medicinal Products for Human Use, or CHMP, has adopted an opinion for the conditional approval of Casdevy, a CRISPR/Cas9 gene-edited therapy, for the treatment of severe sickle cell disease, or SCD, and transfusion-dependent beta thalassemia, or TDT. If approved, exa-cel would be the only genetic therapy for patients in the European Union who are 12 years of age and older with either severe SCD with recurrent vaso-occlusive crises, or VOCs, or TDT, for whom hematopoietic stem cell, or HSC, transplantation is appropriate and a human leukocyte antigen matched related HSC donor is not available. An approval decision by the European Commission is expected in February 2024.

December 14

Acadia Pharmaceuticals announced that the U.S. District Court for the District of Delaware has issued a Claim Construction Order in favor of Acadia regarding its ‘721 formulation patent for Nuplazid, Acadia’s drug for the treatment of Parkinson’s Disease Psychosis. In this order, the court ruled in favor of Acadia on all of the disputed claim construction points. In the order, the court adopted Acadia’s interpretation of key disputed terms of the patent. Acadia believes that the court’s interpretations affirm the strength of the patent. As a result of this order, a claims construction hearing, which had been scheduled for December 19, has been cancelled by the court. The case remains scheduled for trial in December 2024. This was the second ruling issued by the court pertaining to Acadia’s patents covering Nuplazid. Earlier, in a separate litigation, the court granted summary judgment to Acadia, confirming validity of Acadia’s ‘740 composition of matter patent.

Pfizer (PFE) announced the completion of its acquisition of Seagen. Pfizer completed its acquisition of all outstanding common stock of Seagen for $229 in cash per share, for a total enterprise value of approximately $43B. As previously disclosed, to address U.S. Federal Trade Commission concerns, Pfizer has chosen to irrevocably donate the rights of royalties from sales of Bavencio in the U.S. to the American Association for Cancer Research, or AACR.

December 12

Aditxt (ADTX) and Evofem announced the signing of a definitive agreement under which Aditxt is to acquire Evofem in consideration of the issuance of a combination of common stock and preferred stock, and the assumption of certain senior indebtedness, having an aggregate amount of approximately $100M. Pending a successful transaction, it will also mark the establishment of a women’s health mission within Aditxt’s platform, aligning with global healthcare needs. The boards of directors of both companies have unanimously approved the transaction. Aditxt has assumed Evofem’s senior secured debt that was issued to the investor under the securities purchase and security agreement dated April 2020, as amended, and shall pay $5M to Evofem’s senior secured debtholder by year-end 2023, $8M by September 2024, and up to an additional $5M thereafter. Aditxt has also agreed to provide a $3M loan to Evofem between the date of signing of the agreement and closing and to cover Evofem’s legal costs related to the transaction. At closing, the holders of Evofem’s common stock will exchange their shares for an aggregate of 610,000 shares of Aditxt common stock. In addition, Aditxt has agreed to issue up to an aggregate of 89,126 shares of preferred stock to the holders of Evofem’s currently outstanding unsecured notes, purchase rights, certain warrants, and preferred stock. Upon closing of the Transaction, which is currently anticipated to occur in the first half of 2024, Evofem will be a wholly owned subsidiary of Aditxt, with the Evofem management team to receive equity grants in the subsidiary of up to ten percent on a fully diluted basis after closing, and will continue to be led by Saundra Pelletier, CEO of Evofem, and the current management team. The boards of directors of Aditxt and Evofem have unanimously approved the proposed Transaction. The transaction is subject to, among other things, the approval of both Aditxt and Evofem stockholders and satisfaction or waiver of the conditions stated in the agreement.

Connect Biopharma announced positive topline results from the global Phase 2b trial evaluating rademikibart efficacy and safety in adult patients with moderate-to-severe persistent asthma. The trial met its primary endpoint of absolute change from baseline in pre-bronchodilator – BD – forced expiratory volume over one second showing that at Week 12, lung function significantly improved over placebo with both rademikibart doses. The significant improvements seen compared to placebo with both rademikibart 150 mg and 300 mg started as early as Week 1 and were sustained through 24 weeks of treatment. A predefined exploratory analysis showed further improvement in lung function was achieved in patients with eosinophil levels of greater than or equal to 300 cells/microl. Strong and significant improvement in asthma control was also observed. Improvement was evident as early as Week 1 and statistically significant starting at Week 2 through Week 24 for both doses of rademikibart. Treatment with rademikibart showed strong trends toward reduced exacerbations with more than half of all exacerbations during the 24-week study occurring in the placebo group. Treatment with 150 mg and 300 mg Q2W of rademikibart was generally well tolerated.

Blueprint Medicines announced the European Commission has approved AYVAKYT for thetreatment of adult patients with indolent systemic mastocytosis with moderate to severe symptoms inadequately controlled on symptomatic treatment. AYVAKYTis the first and only approved therapy for people living with ISM in Europe.

December 11

In a regulatory filing, Achieve Life Sciences stated: “As previously reported, Achieve Life Sciences recently conducted a pre-New Drug Application, or ‘NDA,’ meeting with the U.S. Food and Drug Administration for the company’s drug product candidate, cytisinicline, during which agreement was reached on many of the submission requirements for an NDA. During that meeting, the FDA expressed support for an NDA submission based on adequate data to assess efficacy from the two randomized and controlled Phase 3 trials. In addition, the FDA advised that long-term exposure data beyond 12 weeks would be needed to adequately assess safety risk given that it views smoking cessation drugs as products for chronic, intermittent use because patients may relapse and require subsequent courses of treatment over a lifetime. The FDA advised that long-term safety data could be collected on a patient’s cumulative treatment over time and could also be collected in the vaping cessation program. The company is participating in ongoing discussions with the FDA to clarify the requirements and timing for the long-term exposure safety data to support an NDA submission and the company’s NDA filing timing may be delayed to address this FDA feedback. Following receipt of additional input from the FDA, anticipated in the first quarter of 2024, the company will provide an update on its projected NDA submission timing.”

December 10

Incyte and Syndax Pharmaceuticals (SNDX) announced the full results from the pivotal Phase 2 AGAVE-201 trial of axatilimab, an anti-CSF-1R antibody, in adult and pediatric patients with refractory chronic graft-versus-host disease who had received at least two prior lines of systemic therapy. These data are featured today in the Plenary Scientific Session at the 65th American Society of Hematology Annual Meeting 2023. The results, which build on previously announced topline data, show that the trial met the primary endpoint across all cohorts receiving axatilimab, at doses of 0.3 mg/kg every two weeks, 1.0 mg/kg every two weeks and 3.0 mg/kg every four weeks. Patients who received axatilimab at 0.3 mg/kg every two weeks achieved the highest overall response rate of 74% within the first six months of treatment. Patients in this cohort experienced a median time to response to axatilimab of 1.7 months, and 60% of patients maintained a response at 12 months. The recommended dose of axatilimab for future trials in chronic GVHD is 0.3 mg/kg every two weeks. The AGAVE-201 trial also met key secondary endpoints in the 0.3 mg/kg dose, with 55% of patients achieving a greater than or equal to 7-point improvement in the modified Lee Symptom Scale score. Organ-specific responses, including complete responses, were seen across all organs involved at baseline, including lower gastrointestinal, upper GI, esophagus, joints/fascia, mouth, lungs, liver, eyes and skin. Additionally, responses were notable in fibrosis-dominated organs, including the esophagus, joints and fascia, lungs and skin. The AGAVE-201 pivotal trial enrolled 241 patients with relapsed and refractory cGVHD who had received two or more prior systemic therapies, with 74% having previously received ruxolitinib, 31% having previously received ibrutinib and 23% having previously received belumosudil. Patients were enrolled across 121 sites in 16 countries. The most common treatment-emergent adverse events were consistent with the on-target effects of CSF-1R inhibition and with what was previously observed with axatilimab treatment. In the overall trial population, 33% of patients experienced at least one grade greater than or equal to 3 TEAE, with 15.5% experiencing adverse events leading to discontinuation of treatment. For patients who received axatilimab at 0.3 mg/kg, grade greater than or equal to3 TEAEs occurred in 17.7% of patients, with 6.3% experiencing TEAEs leading to discontinuation of treatment. Based on these results and pending agreement from the U.S. Food and Drug Administration, Syndax and Incyte expect to submit a Biologics License Application to the FDA by year-end 2023.

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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.