These names in the biotech sector are seeing a substantial increase in search activity today, as determined by InvestingChannel. They include:
- Fibrogen (FGEN), 722% surge in interest
- Esperion (ESPR), 506% surge in interest
- NanoViricides (NNVC), 291% surge in interest
- AIM ImmunoTech (AIM), 286% surge in interest
- Corvus Pharma (CRVS), 257% surge in interest
- Ligand Pharmaceuticals (LGND), 220% surge in interest
- CEL-SCI (CVM), 211% surge in interest
- Siga Technologies (SIGA), 168% surge in interest
- Vanda Pharmaceuticals (VNDA), 161% surge in interest
- Adaptive Biotechnologies (ADPT), 123% surge in interest
Pipeline and key clinical candidates for these companies:
FibroGen is “committed to leveraging its expertise in connective tissue growth factor biology and hypoxia-inducible factor to discovering, developing, and commercializing a pipeline of first-in-class therapeutics for the treatment of unmet needs.” Pamrevlumab, an anti-CTGF human monoclonal antibody, is in clinical development for the treatment of idiopathic pulmonary fibrosis, or IPF, locally advanced unresectable pancreatic cancer, metastatic pancreatic cancer, and Duchenne muscular dystrophy, or DMD. Roxadustat is currently approved in China, Europe, Japan, and numerous other countries for the treatment of anemia in CKD patients on dialysis and not on dialysis. Roxadustat is in Phase 3 clinical development in the U.S. and Europe for anemia associated with myelodysplastic syndromes, or MDS, and in Phase 3 clinical development in China for treatment of chemotherapy-induced anemia, or CIA.
Esperion discovers, develops, and commercializes innovative medicines and combinations to lower cholesterol, especially for patients whose needs aren’t being met by the status quo.
NanoViricides is a development stage company that is creating special purpose nanomaterials for antiviral therapy. The company’s novel nanoviricide class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. The company’s lead drug candidate is NV-CoV-2 for the treatment of RSV, COVID-19, Long COVID, and other respiratory viral infections. Its other advanced candidate is NV-HHV-1 for the treatment of Shingles. The company is currently focused on advancing NV-CoV-2 into Phase I/II human clinical trials.
AIM ImmunoTech is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders and viral diseases, including COVID-19. The company’s lead product is a first-in-class investigational drug called Ampligen, a dsRNA and highly selective TLR3 agonist immuno-modulator with broad spectrum activity in clinical trials for globally important cancers, viral diseases and disorders of the immune system.
Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company that says it is “pioneering the development of ITK inhibition as a new approach to immunotherapy for a broad range of cancer and immune diseases.” The company’s lead product candidate is CPI-818, an investigational, oral, small molecule drug that selectively inhibits ITK and is in a mid-stage clinical trial for patients with T cell lymphoma. Its other clinical-stage candidates are being developed for a variety of cancer indications.
Ligand Pharmaceuticals is focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines. Ligand’s Captisol platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Ligand’s Pelican Expression Technology is a “validated and scalable” platform for recombinant protein production that is suited for complex, large-scale protein production “where traditional systems are not,” the company states.
CEL-SCI said it “believes that boosting a patient’s immune system while it is still intact should provide the greatest possible impact on survival. Therefore, in the Phase 3 study, CEL-SCI studied patients who were newly diagnosed with locally advanced primary squamous cell carcinoma of the head and neck with the investigational product Multikine first, before they received surgery and radiotherapy or surgery plus concurrent radiotherapy and chemotherapy.” This approach is called neo-adjuvant. Most other cancer immunotherapies are administered only after conventional therapies have been tried and/or failed. Multikine received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. Multikine is designed to help the immune system “target” the tumor at a time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor. CEL-SCI has completed a 928 patient Phase 3 clinical trial in locally advanced primary head and neck cancer patients.
SIGA Technologies is a commercial-stage pharmaceutical company focused on the health security market. Health security comprises countermeasures for biological, chemical, radiological and nuclear attacks, vaccines and therapies for emerging infectious diseases, and health preparedness. The company’s lead product is TPOXX, also known as tecovirimat and ST-246, an orally administered and IV formulation antiviral drug for the treatment of human smallpox disease caused by variola virus. The oral formulation of TPOXX was approved by the FDA for the treatment of smallpox in 2018, and the IV formulation was approved for the same indication in 2022.
Vanda Pharmaceuticals is focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients.
Adaptive Biotechnologies is a commercial-stage biotechnology company that applies its platform to partner with biopharmaceutical companies, inform drug development, and develop clinical diagnostics across its two business areas of Minimal Residual Disease and Immune Medicine. The company says its commercial products and clinical pipeline enable the diagnosis, monitoring, and treatment of diseases such as cancer, autoimmune disorders, and infectious diseases and states that its goal is “to develop and commercialize immune-driven clinical products tailored to each individual patient.”
Recent news on these stocks:
May 8
CEL-SCI announced an outcome from its recent meeting with the FDA regarding the path to approval for its first-line investigational cancer immunotherapy Multikine. Based on strong safety and efficacy data from CEL-SCI’s completed Phase 3 head and neck cancer study, the FDA indicated CEL-SCI may move forward with a confirmatory Registration Study of Multikine in newly diagnosed advanced primary head and neck cancer patients with no lymph node involvement and with low PD-L1 tumor expression.
Vanda Pharmaceuticals reported Q1 EPS of (7c) against one estimate of 5c. Reported Q1 revenue of $47.5M against one estimate of $48.5M. Cash, cash equivalents and marketable securities was $394.1M as of March 31, representing an increase to cash of $5.9M compared to December 31, 2023. “We are very proud of our accomplishments in the first quarter of 2024, which were achieved with a small but efficient organization that is enthusiastic to continue developing and commercializing treatments for people who need them,” said Mihael Polymeropoulos, M.D., Vanda’s CEO. “We expect several significant milestones in the coming months, including the launch of Fanapt in acute bipolar I disorder, the launch of Ponvory in multiple sclerosis, the potential approval of tradipitant in gastroparesis, the phase III results of tradipitant in motion sickness, the upcoming NDA filings of milsaperidone in psychiatric disorders and of tradipitant in motion sickness and the initiation of clinical programs in depression, psoriasis, ulcerative colitis and pediatric insomnia. We are confident that our robust revenue, strong cash position and efficient operations position us well for significant growth and value creation in the years to come.” The company added, “Given continuing uncertainties surrounding the U.S. market for HETLIOZ for the treatment of Non-24 as a result of continued generic competition in the U.S. and the upcoming commercial launches for Fanapt in acute bipolar I disorder and PONVORY in multiple sclerosis, Vanda is unable to provide 2024 financial guidance at this time.”
May 7
Esperion reported Q1 EPS of 34c against a consensus of 5c, and reported Q1 revenue of $137.7M against a consensus of $84.51M. We are proud of our strong start to 2024 and the continued momentum and growth we again delivered in the first quarter,” said Sheldon Koenig, CEO. “We posted retail prescription equivalent growth of 43% year-over-year, generated our highest level of revenue yet, and ended the quarter with a cash balance that positions us to capitalize on our new label and deliver long term value growth.”
Oppenheimer raised the firm’s price target on Corvus Pharmaceuticals to $8 from $7 and kept an Outperform rating on the shares after the company reported Q1 results and following the $30M financing announced last week to bolster the balance sheet. In a positive surprise, two new responses were announced from the Phase 1b soquelitinib trial, bringing the ORR to 39%, at the target dose, the firm notes. The pivotal study in rPTCL remains on track to begin next quarter.
Ligand reported Q1 EPS $1.20 against a consensus of 78c, reported Q1 revenue $31.0M against a consensus of $27.9M. “We are pleased to report another quarter of strong financial results driven by the performance of our commercial royalty portfolio. Simultaneously, we continue to build our portfolio of development stage royalty assets to deliver future growth,” said Todd Davis, CEO of Ligand. “We continue to originate a robust pipeline of royalty opportunities with our proactive business development efforts. This is evidenced by our most recent royalty financing agreement with Agenus which will add several new late stage oncology assets to our portfolio. As we look ahead to the near term, we have several important catalysts in our existing portfolio in 2024. This includes Verona Pharma’s ensifentrine and Merck’s V116, both of which have been assigned PDUFA dates in June, top-line Phase 3 data on Takeda’s soticlestat, expected in the third quarter, and the commercial launch of ZELSUVMI, a much-needed treatment for molluscum contagiosum, in late 2024.” Ligand also reaffirmed its 2024 financial guidance. The company expects 2024 royalties ranging from $90M-$95M, sales of Captisol to range from $25M-$27M, and contract revenue ranging from $15M-$20M.
Adaptive Biotechnologies reported Q1 EPS of (33c) against a consensus of (34c). Reported Q1 revenue of $41.87M against a consensus of $38.78M. “This quarter, we implemented important decisions to maximize the value of our MRD and Immune Medicine businesses. I am confident in the steps we are taking to execute on their respective priorities with separate segment reporting,” said Chad Robins, CEO of Adaptive Biotechnologies. “Our cash position is strong and will enable us to bridge the MRD business to profitability while advancing key programs in Immune Medicine through gated investments.”
May 6
FibroGen reported Q1 EPS of (33c) against a consensus of (42c), and reported Q1 revenue of $55.9M against a consensus of $36.67M. “We are off to a strong start in 2024 marked by the recent release of compelling Phase 1 data on FG-3246, our CD46 targeted antibody drug conjugate, in metastatic castration-resistant prostate cancer and continued robust growth of our roxadustat business in China,” said Thane Wettig, CEO. “Looking ahead, we expect to report topline data from our two late-stage clinical trials of pamrevlumab in pancreatic cancer in the coming months. In addition, we have a strong balance sheet and reaffirm our cash runway into 2026.”
NanoViricide said that the ultra-broad antiviral activity spectrum of NV-387 includes Influenza A viruses, possibly including Bird Flu H5N1 virus as well. NanoViricides reports that in a lethal animal model of lung infection by Influenza A /H3N2 virus, NV-387 was found to have substantially superior antiviral effects compared to three approved anti-influenza drugs. The company recently performed a lethal lung infection study of mice infected with Influenza A/H3N2 that were treated with NV-387 or one of the three approved drugs for direct comparison: Oseltamivir, Peramivir and Baloxivir. In this study, NV-387 Oral treatment led to a survival lifespan of 15 days, compared to 10 days with Oseltamivir Oral treatment, 11 days with Peramivir I.V. treatment, and 11 days with Baloxivir Oral treatment, while the vehicle-treated and untreated animals survived only 8 days. Thus the anti-Influenza activity of NV-387 given orally was substantially superior to all three of the approved anti-influenza drugs, namely Tamiflu, Rapivab, and Xofluza. Given the broad-spectrum of antiviral activity of NV-387 against viruses in many different virus families, the company believes that its effectiveness against Influenza A/H3N2 is indicative of potential antiviral activity against most if not all Influenza A viruses. In particular, the company believes, based on structural information, that the H5 hemagglutinin of H5N1 bird flu virus may be even more susceptible to NV-387 attack than the H3 hemagglutinin of the H3N2 virus. This is because H5 contains a long polybasic site sequence, which has biochemical affinity from electrostatic interactions with the antiviral ligand used in NV-387. This antiviral ligand is a sulfated proteoglycan mimetic. Thus it is very likely that NV-387 may have strong antiviral activity against the bird flu H5N1 virus, although further work is needed in this regard.
AIM ImmunoTech announced the successful completion of cGMP manufacturing of 9,042 clinical vials of Ampligen, AIM’s dsRNA product candidate being developed for globally important cancers, viral diseases and disorders of the immune system. AIM Chief Executive Officer Thomas Equels commented, “We remain focused on operational execution and the successful continued production of our commercial-sized manufacturing process for Ampligen represents a critical component of our overall development, commercial and business development strategies. This is an important milestone as we look to advance our pipeline and work toward clinical and commercial success. Our record of successful manufacturing is both important as we seek commercial partners, as well as for establishing Ampligen reserves for ongoing and upcoming clinical trials.”
Hear more from InvestingChannel by signing up for The Spill.
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.
