These names in the biotech sector are seeing a substantial increase in search activity today, as determined by InvestingChannel. They include:
- Fibrogen (FGEN), 1,096% surge in interest
- NanoViricides (NNVC), 809% surge in interest
- Plus Therapeutics (PSTV), 722% surge in interest
- Eyepoint Pharmaceuticals (EYPT), 692% surge in interest
- Glycomimetics (GLYC), 629% surge in interest
- Esperion (ESPR), 486% surge in interest
- Corvus Pharma (CRVS), 413% surge in interest
- BioCryst Pharma (BCRX), 400% surge in interest
- AIM ImmunoTech (AIM), 339% surge in interest
- Lineage Cell Therapeutics (LCTX), 257% 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.
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.
Plus Therapeutics is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma and leptomeningeal metastases.
EyePoint Pharmaceuticals is committed to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders. The company’s pipeline leverages its proprietary Durasert technology for sustained intraocular drug delivery including EYP-1901, an investigational sustained delivery intravitreal treatment currently in Phase 2 clinical trials. The proven Durasert drug delivery platform has been “safely administered to thousands of patients’ eyes” across four U.S. FDA approved products, including Yutiq for the treatment of posterior segment uveitis, EyePoint said.
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.
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.
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.
BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. Oral, once-daily Orladeyo is approved in the United States and many global markets. BioCryst has active programs to develop oral medicines for multiple targets across the complement system, including BCX10013, an oral Factor D inhibitor in clinical development. Rapivab is approved in the U.S. and multiple global markets, with post-marketing commitments ongoing.
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.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials.
Recent news on these stocks:
May 8
EyePoint reported Q1 EPS of (55c) against a consensus of (42c), reported Q1 revenue of $11.684M against a consensus of $9.99M. “We have continued advancing our pipeline through significant milestones including the announcement of topline data from our Phase 2 PAVIA clinical trial of DURAVYU in non-proliferative diabetic retinopathy,” said Jay Duker, M.D., CEO of EyePoint Pharmaceuticals. “Although the PAVIA trial did not meet the pre-specified primary endpoint, we were encouraged that DURAVYU demonstrated a biologic effect in patients with NPDR and continues to show a favorable safety and tolerability profile. As such, we plan to assess the full twelve-month study results once they are available to evaluate the path forward for DURAVYU as a potential treatment for NPDR. Looking ahead, we remain on track to initiate the first pivotal Phase 3 LUGANO non-inferiority clinical trial of DURAVYU in wet AMD in the second half of 2024 and for topline data for the Phase 2 VERONA trial in diabetic macular edema in the first quarter of 2025.”
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.
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.
Plus Therapeutics has entered into a securities purchase agreement with new institutional investors and company insiders to raise up to approximately $18M in gross proceeds, including initial upfront funding of approximately $6.5M, and up to an additional approximately $11.5M upon cash exercise of accompanying warrants at the election of the investors. The financing includes participation from AIGH Capital Management with additional participation from new healthcare-focused institutional investors as well as certain company insiders. Pursuant to terms of the securities purchase agreement, the company will issue up to an aggregate of 3.24M shares of its common stock and accompanying warrants to purchase up to an aggregate of 6.48M shares of its common stock at a combined purchase price of $2.022 per share and accompanying warrants.
GlycoMimetics announced topline results from its Phase 3 global pivotal study of uproleselan in 388 patients with R/R AML. In the study, uproleselan combined with chemotherapy did not achieve a statistically significant improvement in overall survival in the intent to treat population versus chemotherapy alone. Patients treated with uproleselan had a median overall survival of 13 months, compared to 12.3 months in the placebo arm. Adverse events were consistent with known side effect profiles of chemotherapy used in the study. The randomized, double-blind, placebo-controlled Phase 3 clinical study evaluated uproleselan in combination with MEC or FAI in patients with R/R AML. The primary endpoint of the study was overall survival without censoring for transplant. Secondary endpoints included incidence of severe oral mucositis, complete remission rate and remission rate. A total of 388 patients across 70 sites in nine countries were randomized 1:1 between treatment and placebo arms.
BioCryst reported Q1 EPS of (17c) against a consensus of (21c), and reported Q1 revenue of $92.8M against a consensus of $85.6M. “We are off to a fantastic start to the year with outstanding ORLADEYO revenue growth and our prioritized pipeline programs advancing on schedule. We are focused on continuing this momentum as we see strong patient demand for ORLADEYO and more pipeline programs advancing into the clinic, starting later this year,” said Jon Stonehouse, CEO of BioCryst.
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.”
Lineage Cell Therapeutics announced that 24 month visual acuity results from patients enrolled in a Phase 1/2a clinical study in patients with geographic atrophy GA secondary to age-related macular degeneration AMD , were presented at the 2024 Retinal Cell & Gene Therapy Innovation Summit. The meeting was jointly organized by the Foundation Fighting Blindness and the Oregon Health & Science University Casey Eye Institute. The presentation, “OpRegen Retinal Pigment Epithelium RPE Cell Therapy for Patients with Geographic Atrophy : Month 24 Results from the Phase 1/2a Trial,” was presented by David Telander, MD, PhD, Retinal Consultants Medical Group, on behalf of Roche and Genentech, a member of the Roche Group. RG6501 OpRegen is a suspension of human allogeneic retinal pigment epithelial RPE cells currently in development for the treatment of GA secondary to AMD. OpRegen subretinal delivery has the potential to counteract RPE cell loss in areas of GA lesions by supporting retinal cell health and improving retinal structure and function. It is being developed under an exclusive worldwide collaboration between Lineage, Roche, and Genentech, a member of the Roche Group, and is currently being evaluated in a Phase 2a clinical study in patients with GA secondary to AMD. “The products approved recently for the treatment of GA secondary to AMD have not demonstrated a compelling functional benefit, so there remains a need for treatments that can positively affect patient vision,” stated Brian M. Culley, Lineage CEO. “We are encouraged by the apparent durability of visual performance being achieved by patients in this study, notably in the 5 patients who received a thorough coverage of OpRegen cells across the majority of their atrophic areas and who had experienced a cessation or reversal of their areas of atrophy, evidenced by outer retinal structural improvements on optical coherence tomography OCT . Dry AMD has traditionally been considered to be an irreversible and progressively degenerative disease leading to vision loss. However, these data suggest that OpRegen RPE cells may provide a one-time treatment which could slow or even reverse this damage by way of direct support to the patients’ remaining retinal cells, including those near or within atrophic areas. We look forward to additional, future clinical data updates on the OpRegen program from our partners, Roche and Genentech.”
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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.
