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: 

• GlycoMimetics (GLYC), 5,313% surge in interest
• NovaBay Pharmaceuticals (NBY), 1,492% surge in interest
• Hoth Therapeutics (HOTH), 492% surge in interest
• Regulus Therapeutics (RGLS), 457% surge in interest
• AnaptysBio (ANAB), 455% surge in interest
• Incyte (INCY), 454% surge in interest
• Intra-Cellular Therapies (ITCI), 355% surge in interest
• BioMarin Pharmaceutical (BMRN), 220% surge in interest
• Spero Therapeutics (SPRO), 197% surge in interest
• Exelixis (EXEL), 173% surge in interest

Pipeline and key clinical candidates for these companies:

GlycoMimetics is a late clinical-stage biotechnology company discovering and developing glycobiology-based therapies for cancers, including Acute Myeloid Leukemia, and for inflammatory diseases. The company’s specialized chemistry platform is being deployed to discover small molecule drugs–known as glycomimetics–that alter carbohydrate-mediated recognition in diverse disease states.

NovaBay Pharmaceuticals develops and sells eyecare and skincare products. NovaBay’s leading product, Avenova Antimicrobial Lid & Lash Solution, is often prescribed by eyecare professionals for blepharitis and dry-eye disease and is also available directly to eyecare consumers through online distribution channels such as Amazon.

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.

Regulus Therapeutics is a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs. Regulus has leveraged its oligonucleotide drug discovery and development expertise to develop a pipeline complemented by a rich intellectual property estate in the microRNA field.

AnaptysBio is a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics. It is developing immune cell modulators for autoimmune and inflammatory diseases, including two checkpoint agonists: ANB032, its BTLA agonist, in a Phase 2b trial for the treatment of atopic dermatitis and rosnilimab, its PD-1 agonist, in a Phase 2b trial for the treatment of rheumatoid arthritis and in a Phase 2 trial for the treatment of ulcerative colitis. It also has other immune cell modulator candidates in its portfolio, including ANB033, an anti-CD122 antagonist antibody, entering a Phase 1 trial and ANB101, a BDCA2 modulator antibody, in preclinical development. In addition, Anaptys has developed two cytokine antagonists available for out-licensing: imsidolimab, an anti-IL-36R antagonist, that has completed Phase 3 trials for the treatment of generalized pustular psoriasis, and etokimab, an anti-IL-33 antagonist that is Phase 2/3 ready. Anaptys has also discovered multiple therapeutic antibodies licensed to GSK in a financial collaboration for immuno-oncology, including an anti-PD-1 antagonist antibody and an anti-TIM-3 antagonist antibody.

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

Intra-Cellular Therapies is a biopharmaceutical company working to understand how therapies affect the inner-workings of cells in the body. The company leverages its intracellular approach to “develop innovative treatments for people living with complex psychiatric and neurologic diseases,” it states.

BioMarin is a biotechnology company “dedicated to transforming lives through genetic discovery.” The company develops and commercializes targeted therapies that address the root cause of genetic conditions. BioMarin’s robust research and development capabilities have resulted in multiple innovative commercial therapies for patients with rare genetic disorders, the company says.

Spero Therapeutics is a multi-asset clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and MDR bacterial infections with high unmet need.

Exelixis is an oncology company that says it is “innovating next-generation medicines and regimens at the forefront of cancer care.” The company says it is rapidly evolving its product portfolio to target an expanding range of tumor types and indications with its clinically differentiated pipeline of small molecules, antibody-drug conjugates and other biotherapeutics.

Recent news on these stocks:

October 30

After Eli Lilly (LLY) announced that it is discontinuing its Phase 2b study of peresolimab for treatment of rheumatoid arthritis, or RA, due to the overall risk/benefit profile of the drug, H.C. Wainwright noted that AnaptysBio’s rosnilimab is a PD-1 agonist similar to peresolimab that is also in development for RA in an ongoing Phase 2 trial expected to have a topline readout in Q1 of 2025. There is pressure on AnaptysBio shares after Lilly noted it did not observe the same results in Phase 2b as it did in the small Phase 2a study, which could lead to concerns for efficacy of rosnilimab in the Phase 2 data readout, but the firm believes that rosnilimab is potentially a best-in-class PD-1 agonist and remains “optimistic” about the upcoming data, said the analyst, who kept a Buy rating and $55 price target on AnaptysBio.

Intra-Cellular reported Q3 EPS of (25c) against a consensus of (20c), and reported Q3 revenue of $175.4M against a consensus of $172.35M. “We are encouraged by CAPLYTA’s strong growth trajectory in the third quarter and look forward to further growth in the remainder of 2024 and beyond. We are on track to submit our sNDA for the adjunctive treatment of MDD later this year and our commercial team is actively preparing for a potential launch in 2025,” said Dr. Sharon Mates, CEO of Intra-Cellular Therapies.

October 29

GlycoMimetics announced it has entered into an acquisition agreement with Crescent Biopharma, a privately held biotechnology company. Upon completion of the transaction, the company plans to operate under the name Crescent Biopharma. In support of the acquisition, a syndicate of investors led by Fairmount, Venrock Healthcare Capital Partners, BVF Partners, and a large investment management firm, with participation from Paradigm BioCapital, RTW Investments, Blackstone Multi-Asset Investing, Frazier Life Sciences, Commodore Capital, Perceptive Advisers, Deep Track Capital, Boxer Capital Management, Soleus, Logos Capital, Driehaus Capital Management, Braidwell LP, and Wellington Management, has committed $200M to purchase GlycoMimetics common stock and GlycoMimetics pre-funded warrants to purchase its common stock. The transaction is expected to close in the second quarter of 2025. The financing is expected to close immediately following the completion of the transaction. The company’s cash balance at closing is anticipated to fund operations through 2027, including advancement of the company’s lead program CR-001, a tetravalent PD-1 x VEGF bispecific antibody, through preliminary proof of concept clinical data in solid tumor patients expected in the second half of 2026. Crescent is the fifth company to launch with assets discovered and developed by Paragon Therapeutics. CR-001, a tetravalent PD-1 x VEGF bispecific antibody, matches the format and pharmacology of ivonescimab, which delivered efficacy compared to the current market leader pembrolizumab in a large third party Phase 3 trial. In addition to CR-001, Crescent is developing CR-002 and CR-003, antibody-drug conjugates (ADCs) against undisclosed targets using topoisomerase inhibitor payloads; ADCs with topoisomerase inhibitor payloads have shown improved efficacy and safety compared to ADCs with alternative payloads. The Company anticipates that the IND for CR-001 will be filed in 4Q25 or 1Q26, and interim Phase 1 data from patients is expected in 2H26. CR-002, Crescent’s first ADC program is expected to initiate Phase 1 in 2026; the company plans to disclose the target for CR-002 as the program approaches the clinic. The company intends to determine potential paths forward for its late-stage clinical candidate, Uproleselan, including by supporting continued data analyses of Uproleselan from NCI, its corporate partner for China, Apollomics, and investigator-initiated studies. Under the terms of the acquisition agreement, the pre-acquisition GlycoMimetics stockholders are expected to own approximately 3.1% of the combined company and the pre-acquisition Crescent stockholders are expected to own approximately 96.9% of the company. The percentage of the company that GlycoMimetics’s stockholders will own as of the closing of the acquisition is subject to adjustment based on the amount of GlycoMimetics’s net cash at the closing date. The transaction has received approval by the board of directors of both companies and is expected to close in the second quarter of 2025, subject to certain closing conditions, including, among other things, approval by the stockholders of each company and the satisfaction of customary closing conditions. The company will be named Crescent Biopharma and be led by Jonathan Violin, Crescent’s interim CEO who will be joined on Crescent’s board by Peter Harwin, Managing Member of Fairmount.

NovaBay announced that the company’s board of directors has determined that an unsolicited and non-binding offer from Refresh Acquisitions BidCo for an affiliate of Refresh to acquire the company’s Avenova brand and related assets is a “Superior Proposal” to the company’s asset purchase agreement with PRN Physician Recommended Nutriceuticals, or PRN. Refresh’s unsolicited offer provides for terms that are substantially similar to the contemplated transaction with PRN, except that the company would receive a purchase price of up to $11.5M, subject to a downside net working capital adjustment. Refresh’s unsolicited offer also includes Refresh providing a secured term loan to the company in the principal amount of $2M, which is expected to be repaid upon closing and deducted from the purchase price. The company has notified PRN of the board of directors’ determination and that the company intends to terminate its asset purchase agreement with PRN unless the company receives a revised proposal from PRN by 11:59 p.m. Pacific time on November 4, such that the company’s board of directors determines that Refresh’s unsolicited offer is no longer a superior proposal, in accordance with the process provided in the asset purchase agreement with PRN. The company’s asset purchase agreement with PRN, in accordance with such agreement, remains in full force and effect, and the company’s board of directors has not withdrawn or modified its recommendation regarding stockholders approving the pending transaction with PRN. The company’s transaction with PRN remains subject to certain closing conditions, including receiving stockholder approval. Consistent with its fiduciary duties, the company’s board of directors conducted an evaluation of the Refresh unsolicited offer with assistance from independent financial and legal advisors, before making its determination.

Hoth Therapeutics announced early data from a preclinical study of its latest cancer treatment. The preliminary results demonstrate that the treatment successfully stabilizes tumor growth with remarkable consistency across subjects, showing potential as an effective therapeutic option in oncology. This study was performed and took place under a sponsored scientific research agreement with NC State University. The study measured tumor volumes in treated and untreated subjects over the course of the experiment. Key observations from the initial data include: Tumor volumes in treated subjects remained remarkably stable over the course of the study, suggesting that the treatment may significantly inhibit tumor growth. Tumor sizes were highly consistent across all treated animals, as demonstrated by the minimal error bars on the graph. This uniform response highlights the treatment’s potential reproducibility and reliability. In contrast, untreated subjects showed greater variability and an increase in tumor volume, underscoring the potential efficacy of the treatment in slowing or halting tumor growth. As Hoth Therapeutics advances this research, the company will continue analyzing additional tissue data to further validate these results. The company is committed to moving forward with the development of this promising treatment and exploring its full potential for patients in need of effective cancer therapies.

BofA upgraded Incyte to Buy from Neutral with a price target of $90, up from $68, following “another strong quarter.” The firm had been cautious on competitive pressure to Jakafi in myelofibrosis, or MF, but thinks the strong continued demand indicates less risk at this point, adding that it is also encouraged by continued growth for Opzelura with potential to expand into pediatric AD.

BioMarin reported Q3 non-GAAP EPS of 91c against a consensus of 52c, and reported Q3 revenue of $746M against a consensus of $700.14M. “The strategic and operational decisions we have made over the last nine months are driving strong performance, reflected in year-over-year revenue growth in the third quarter of 28% and accelerated profitability,” said Alexander Hardy, CEO of BioMarin. “We are executing on our new corporate strategy, focused on Innovation, Growth, and Value Commitment, as demonstrated by another quarter of strong financial performance and clinical progress as we advance potential new medicines for the patients we serve.” Additionally, BioMarin raised its FY24 non-GAAP EPS view to $3.25-$3.35 from $3.10-$3.25, and raised its FY24 revenue view to $2.790B-$2.825B from $2.750B-$2.825B.

Spero Therapeutics announced that a planned interim analysis of the Phase 2a proof-of-concept study of SPR720 for the treatment of NTM-PD demonstrated that the program did not meet its primary endpoint. While the data showed antimicrobial activity associated with SPR720, the interim analysis did not show sufficient separation from placebo and highlighted potential dose limiting safety issues in subjects dosed at 1,000 mg orally once daily, including three cases of reversible grade 3 hepatotoxicity. In evaluating the totality of both the efficacy and safety data, the company has elected to suspend its current development program for SPR720 and will evaluate other potential paths forward as the remaining data are collected and analyzed. As a result of the suspension of the current SPR720 development program, Spero will undergo a restructuring and reduction in force of approximately 39%, which will extend cash runway and support operations into mid-2026, to further support the development of tebipenem HBr, SPR206, and potential strategic activities. Following the reduction in force and restructuring, Spero estimates that its existing cash and cash equivalents, together with earned and non-contingent development milestone payments from GSK, as well as other non-dilutive funding commitments, will be sufficient to fund its operating expenses and capital expenditures into mid-2026. During this period, the company remains focused on advancing tebipenem HBr in the ongoing global PIVOT-PO Phase 3 clinical trial and preparing for a Phase 2 clinical trial for SPR206 contingent on continued non-dilutive funding.

Exelixis reported Q3 EPS of 47c against a consensus of 35c, and reported Q3 revenue of $539.5M against a consensus of $490.02M. The company said, “The favorable ruling on our cabozantinib intellectual property estate and recently announced zanzalintinib development collaboration with Merck have generated important momentum to drive future growth across all components of our business. We are increasing 2024 full year guidance for total and net product U.S. revenues based on the strong commercial performance of the cabozantinib franchise in the third quarter. We continue to execute on our plans for potential cabozantinib label expansions in neuroendocrine tumors and prostate cancer, with the final results from CABINET published in The New England Journal of Medicine in September and our partner Ipsen’s regulatory submission in Europe. Importantly, the zanzalintinib development program, which is now the subject of six ongoing or planned phase 3 pivotal trials, including two new renal cell carcinoma studies as part of our collaboration with Merck, headlines our emerging pipeline of novel agents with the potential to improve standards of care for patients with cancer. At the same time, we are accelerating our early-stage clinical pipeline with XL309, XB010 and XL495 in phase 1 development.”

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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.