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: 

• Adial Pharmaceuticals (ADIL), 2,010% surge in interest
• Alpine Immune Sciences (ALPN), 594% surge in interest
• Leap Therapeutics (LPTX), 445% surge in interest
• Rapt Therapeutics (RAPT), 240% surge in interest
• Altamira (CYTO), 212% surge in interest
• Syros Pharmaceuticals (SYRS), 204% surge in interest
• Entera Bio (ENTX), 203% surge in interest
• Eyenovia (EYEN), 177% surge in interest
• Jaguar Health (JAGX), 164% surge in interest
• Moderna (MRNA), 150% surge in interest

Pipeline and key clinical candidates for these companies:

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.

Alpine Immune Sciences says it is “committed to leading a new wave of immune therapeutics.” Alpine is seeking to create first- or best-in-class multifunctional immunotherapies via unique protein engineering technologies to improve patients’ lives, the company states. Alpine has entered into strategic collaborations with global biopharmaceutical companies and has a diverse pipeline of clinical and preclinical candidates in development, the company adds.

Leap Therapeutics is focused on developing targeted and immuno-oncology therapeutics. Leap’s most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 protein. DKN-01 is being developed in patients with esophagogastric, gynecologic, and colorectal cancers. Leap has entered into a strategic collaboration with BeiGene (BGNE) for the rights to develop DKN-01 in Asia excluding Japan, Australia, and New Zealand.

Rapt Therapeutics is focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in inflammatory diseases and oncology. Rapt has discovered and advanced two unique drug candidates, RPT193 and FLX475, each targeting C-C motif chemokine receptor 4, for the treatment of inflammation and cancer, respectively. The company is also pursuing a range of targets that are in the discovery stage of development.

Altamira Therapeutics is currently active in three areas: the development of RNA therapeutics for extrahepatic therapeutic targets via the OligoPhore/SemaPhore platforms; nasal sprays for protection against airborne allergens and, where approved, viruses or for the treatment of vertigo; and the development of therapeutics for intratympanic treatment of tinnitus or hearing loss.

Syros is committed to developing new standards of care for the frontline treatment of patients with hematologic malignancies. Driven by the motivation to help patients with blood disorders that have largely eluded other targeted approaches, Syros is developing tamibarotene, an oral selective RARalpha agonist in frontline patients with higher-risk myelodysplastic syndrome and acute myeloid leukemia with RARA gene overexpression.

Entera is a clinical stage company focused on developing oral peptide or protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The company leverages on a disruptive and proprietary technology platform and its pipeline includes five differentiated, first-in-class oral peptide programs, expected to enter into the clinic by 2025. The company’s most advanced product candidate, EB613, is being developed as the first oral, osteoanabolic once-daily tablet treatment for post-menopausal women with low BMD and high-risk osteoporosis, with no prior fracture.

Eyenovia is an ophthalmic pharmaceutical technology company developing a pipeline of microdose array print therapeutics. Eyenovia is currently focused on the late-stage development of microdosed medications for mydriasis, presbyopia, and myopia progression.

Jaguar Health is a commercial stage pharmaceuticals company focused on developing novel, plant-based, sustainably derived prescription medicines for people and animals with GI distress, including chronic, debilitating diarrhea. Jaguar Health’s wholly owned subsidiary, Napo Pharmaceuticals, focuses on developing and commercializing proprietary plant-based human pharmaceuticals from plants harvested responsibly from rainforest areas. Their crofelemer drug product candidate is the subject of the OnTarget study, an ongoing pivotal Phase 3 clinical trial for prophylaxis of diarrhea in adult cancer patients receiving targeted therapy.

Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA, or mRNA, to “an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio and integrated manufacturing facilities that allow for rapid clinical and commercial production at scale,” the company states. Most recently, Moderna’s capabilities have come together to allow the authorized use and approval of vaccines against the COVID pandemic. The company is pursuing the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases.

Recent news on these stocks:

April 11

Leap Therapeutics announced it has entered into a securities purchase agreement with a select group of institutional investors to issue and sell an aggregate of 12.66M shares of its common stock at a price of $2.82 per share and pre-funded warrants to purchase 1.52M shares of common stock at a price of $2.819 per share of common stock issuable upon exercise of the pre-funded warrants, in a private placement. Leap anticipates the gross proceeds from the private placement will be approximately $40M, before deducting any offering-related expenses. The financing is expected to close on April 15, subject to satisfaction of customary closing conditions. The private placement investors included new and existing investors, including Gilead Sciences, Samsara BioCapital, 683 Capital Partners, LP, Laurion Capital Management, and Rock Springs Capital. J.P. Morgan acted as the exclusive placement agent for the transaction.

April 10

Adial Pharmaceuticals announced the publication of a peer-reviewed article highlighting the promising clinical results, strong safety profile and high compliance among patients administered AD04 , the Company’s lead investigational new drug product being developed for the treatment of Alcohol Use Disorder, AUD. The publication also reported the results of a new study analyzing the liver safety profile of AD04 compared with placebo in subjects with AUD in the Company’s prior Phase 3 clinical trial. The published study provides a comprehensive analysis of the liver safety profile of AD04 compared to a placebo in individuals with AUD and a specific 5-marker genetic profile. AUD, characterized by compulsive alcohol consumption and loss of control over intake, poses significant health risks and is a major contributor to alcohol-associated liver disease, a leading cause of liver transplantation and global mortality. According to the publication, low-dose AD04 did not significantly change biochemical markers of liver injury, such as ALT, AST, and Serum Bilirubin. Additionally, while patients with AUD displayed elevated GGT levels, typically associated with increased alcohol consumption, this parameter remained unaffected by low-dose AD04. Additionally, no significant adverse effects were observed due to oral low-dose AD04 treatment. The publication also highlighted that low-dose AD04 demonstrated an outstanding safety and tolerability profile compared to placebo, featuring a low occurrence of adverse events, high medication compliance, and a minimal dropout rate. The authors further noted that there is no existing study in alcohol literature where an effective medication exhibits a similar AE profile to a placebo.

Vertex Pharmaceutials (VRTX) and Alpine Immune Sciences announced that the companies have entered into a definitive agreement under which Vertex will acquire Alpine for $65 per share or approximately $4.9B in cash. The transaction was unanimously approved by both the Vertex and Alpine Boards of Directors and is anticipated to close later this quarter. “Alpine is a compelling strategic fit for Vertex and furthers our ambition of using scientific innovation to create transformative medicines targeting serious diseases with high unmet need in specialty markets,” said Reshma Kewalramani, M.D., FASN, CEO and President of Vertex. “We look forward to welcoming the talented Alpine team to Vertex and believe that together we can bring povetacicept, a potential best-in-class treatment for IgAN to patients faster. We also look forward to fully exploring povetacicept’s potential as a ‘pipeline-in-a-product’ and adding Alpine’s protein engineering and immunotherapy capabilities to Vertex’s toolbox.” Under the terms of the merger agreement, Vertex will acquire Alpine for $65 per share in cash, for a total equity value of approximately $4.9B, or approximately $4.6B net of estimated cash acquired. A subsidiary of Vertex will commence a cash tender offer to purchase all outstanding shares of Alpine common stock. The transaction is expected to close in Q2 of 2024, subject to certain conditions, including the tender of a majority of the outstanding shares of Alpine common stock and the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions.

Altamira Therapeutics reported FY23 EPS (CHF 14.80) vs. (CHF 409.60) last year. “Altamira emerged from the 2023 business year as a stronger and more focused company,” commented Thomas Meyer, Altamira Therapeutics’ founder, chairman, and CEO. “We keep progressing with our RNA delivery business, concluding recently our second collaboration agreement with another exciting biotech company. With the recent partial spin-off of our Bentrio legacy business we took a significant first step on our journey towards becoming a fully focused RNA delivery company. We expect to complete the strategic repositioning of the Company through partnering the remaining legacy assets in 2024. At the same time, we managed to streamline our cost structure and strengthen our balance sheet by eliminating all financial debt and rebuilding shareholders’ equity. We look forward to moving to our next milestones in 2024.”

April 9

RAPT Therapeutics announced safety and efficacy data from its ongoing Phase 2 trial of tivumecirnon in combination with the anti-PD-1 checkpoint inhibitor pembrolizumab in the cohort of patients with advanced head and neck squamous cell carcinoma whose disease progressed despite previous treatment with CPI therapy. The results were presented at the American Association for Cancer Research Annual Meeting in San Diego, CA. The AACR poster highlighted data from the 32-patient CPI-experienced HNSCC cohort in the trial evaluating tivumecirnon, an oral small molecule CCR4 antagonist designed to block the migration of regulatory T cells, in combination with pembrolizumab. Patients in this cohort had heavily pretreated disease, with 69% of patients having received three or more prior lines of treatment. In the entire cohort, confirmed responses were observed in 5/32 patients regardless of PD-L1 or HPV status. In the 23 patients known to have PD-L1+ disease, an ORR of 17.4% was observed, and in the 18 patients known to have HPV+ disease, an ORR of 22.2% was observed. These findings compare favorably to the expected ORR of anti-PD-1 monotherapy in patients with recurrent or metastatic HNSCC who have progressed on, or relapsed after, previous anti-PD-1 therapy, which is believed to be less than5-10%. These data complement previously reported clinical data for tivumecirnon, which has now been dosed in more than 350 patients with various advanced cancers either as monotherapy or in combination with pembrolizumab. Findings to date have shown the combination treatment to be well tolerated with no signal of increased immune-related toxicity over that expected with pembrolizumab alone.

Syros Pharmaceuticals announced that the FDA has granted Fast Track Designation, FTD, to tamibarotene in combination with azacitidine and venetoclax for the treatment of newly diagnosed acute myeloid leukemia with RARA overexpression as detected by an FDA approved test in adults who are over age 75 years or who have comorbidities that preclude the use of intensive induction chemotherapy. “We are pleased to receive Fast Track designation for tamibarotene for the treatment of AML. This designation reflects the tremendous need for a safe and effective therapy, which can improve the clinical outcomes and prognosis among people diagnosed with AML, many of whom cannot tolerate intensive treatment,” said David Roth, M.D., Chief Medical Officer of Syros Pharmaceuticals. “We are particularly encouraged to secure Fast Track designation following initial randomized data from a prespecified interim analysis of our ongoing SELECT-AML-1 clinical trial, in which treatment with our RARalpha agonist, tamibarotene, in combination with venetoclax and azacitidine resulted in a 100% CR/CRi rate compared with a 70% CR/CRi rate for the comparator of venetoclax and azacitidine. Additionally, tamibarotene in combination with venetoclax and azacitidine demonstrated no added toxicity relative to venetoclax and azacitidine alone. We look forward to sharing additional data from SELECT-AML-1 later this year, and to potentially accelerate the delivery of tamibarotene as a new frontline option for the approximately 30% of AML patients who are positive for RARA overexpression.”

Jaguar Health announced the voting results of the company’s Special Meeting of Stockholders held on April 9: Four proposals were submitted to and approved by the stockholders of the company at the Special Meeting. “As we announced last week, the company received formal notice that the Listing Qualifications Staff of The Nasdaq Stock Market has granted Jaguar an additional grace period, through August 13, to regain compliance with the $1.00 bid price requirement for continued listing on The Nasdaq Capital Market. Although we do not intend to effect a reverse split of the company’s issued and outstanding voting common stock at present, seeking the discretion to implement actions, if necessary to maintain Jaguar’s Nasdaq listing, is an important responsibility of the board, and we are grateful to our shareholders for voting to approve the related proposal,” said Lisa Conte, Jaguar’s president, and CEO. Jaguar’s paramount near-term clinical activity is the company’s Phase 3 pivotal OnTarget trial of crofelemer for the follow-on indication of the preventative treatment of cancer therapy-related diarrhea. Top line results from this pivotal study are forthcoming

April 8

Entera Bio announced that data from the Phase 2 Trial of its lead clinical compound, EB613 Oral PTH Tablets for the Treatment of Post-Menopausal Women with Low BMD or Osteoporosis compared to placebo were published in the Journal of Bone and Mineral Research JBMR .Miranda Toledano, CEO of Entera, commented, “We are excited to share that data from our successful Phase 2 study of EB613 has been accepted and now published in the prestigious JBMR. We believe EB613 addresses the current treatment gap in osteoporosis as the first oral, osteoanabolic bone building once-daily tablet treatment due to its unique format and potential dual mode of action. We remain highly committed to moving EB613 forward to meet the needs of patients.”We conclude that this PTH tablet might be the first effective orally administered bone building medication and should be studied further in treatment of women with osteoporosis.

Eyenovia announced its plans for accelerating development of its potential multi-billion dollar product for pediatric progressive myopia, MicroPine, and initiated a process to explore strategic alternatives to maximize shareholder value. As part of this process, the company plans to consider a wide range of options, including potential sale of assets of the Company, a sale of the Company, a merger, or other strategic action. In conjunction with the strategic process and focus on its late stage MicroPine asset, Eyenovia reiterated its immediate commercialization opportunities and corporate savings intended to reduce operating expenses while continuing to support meaningful value generation from the company’s two FDA-approved products. …”In the meantime, we will be evaluating strategic opportunities for MicroPine with organizations that have existing capabilities and infrastructure necessary to fully capitalize on this large opportunity. Additionally, we continue to make significant progress advancing our commercialization strategy, with Mydcombi and Avenova currently being sold through our targeted sales force, and clobetasol to be commercially launched as soon as this summer.”…”However, we believe this progress, and the broader potential of MicroPine, which will be back in our hands in a matter of weeks, has been underrecognized and underappreciated by the financial markets. As a result, while we remain intently focused on laying a foundation for accelerating sales growth in 2025, we are in parallel reducing costs in areas that do not impact our ability to deliver on our core strategy and exploring a possible transaction or transactions that could generate capital or otherwise enhance value for our shareholders, who remain very supportive. I look forward to evaluating a comprehensive variety of alternatives with my fellow Board members in the coming weeks.” …Eyenovia is in the process of engaging with investment banks to assist with the evaluation. There can be no assurance that this process will result in the company entering or completing any transaction. Eyenovia does not intend to make any further disclosures regarding the strategic review process unless and until a specific course of action is approved.

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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.