These names in the biotech sector are seeing a substantial increase in search activity today, as determined by InvestingChannel. They include:
- InflaRx (IFRX), 7,871% surge in interest
- Ascendis Pharma (ASND), 1,307% surge in interest
- Apellis Pharmaceuticals (APLS), 1,040% surge in interest
- Oncternal Therapeutics (ONCT), 467% surge in interest
- VBI Vaccines (VBIV), 428% surge in interest
Pipeline and key clinical candidates for these companies:
InflaRx is a clinical-stage biopharmaceutical company focused on applying its proprietary anti-C5a and C5aR technologies to discover and develop first-in-class or best-in-class, potent and specific inhibitors of the complement activation factor known as C5a and its receptor known as C5aR.
Ascendis Pharma is applying its innovative platform technology to build a leading, fully integrated, global biopharmaceutical company focused on making a meaningful difference in patients’ lives. Guided by its core values of patients, science and passion, the company uses its TransCon technologies to create new and potentially best-in-class therapies.
Apellis Pharmaceuticals says the company "ushered in the first new class of complement medicine in 15 years" with the approval of the first and only targeted C3 therapy. Apellis is advancing this science to "continually develop transformative medicines for people living with rare, retinal, and neurological diseases," it stated.
Oncternal Therapeutics is focused on the development of novel oncology therapies for the treatment of patients with cancers that have critical unmet medical need. The lead clinical program is zilovertamab, an investigational monoclonal antibody designed to inhibit the function of Receptor Tyrosine Kinase-Like Orphan Receptor 1, or ROR1. ZILO-301, a global Phase 3 Study to evaluate zilovertamab in combination with ibrutinib for the treatment of patients with relapsed/refractory mantle cell lymphoma has been initiated. Zilovertamab continues to be evaluated in an ongoing Phase 1/2 study in combination with ibrutinib for the treatment of patients with MCL and chronic lymphocytic leukemia, and this trial was recently amended to include patients with marginal zone lymphoma. Zilovertamab is also being evaluated in two investigator-initiated studies, including a Phase 2 clinical trial of zilovertamab in combination with venetoclax, a Bcl-2 inhibitor, in patients with relapsed/refractory CLL, and in a Phase 1b study of zilovertamab in combination with docetaxel in patients with metastatic castration-resistant prostate cancer.
VBI Vaccines is a biopharmaceutical company focused on virus-like particles, or VLPs, including a proprietary enveloped VLP, eVLP, platform technology. VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system. "VBI is committed to targeting and overcoming significant infectious diseases, including hepatitis B, coronaviruses, and cytomegalovirus, as well as aggressive cancers including glioblastoma," the company says.
Recent news on these stocks:
April 5
Oppenheimer downgraded Ascendis Pharma to Perform from Outperform. Following discussions held with consultants since Monday morning’s update on TransCon PTH’s NDA review, the firm believes the outcome will be a complete response letter, or CRL, on/around the April 30 PDUFA. Although Oppenheimer can only speculate as to what issues the FDA may raise, what Ascendis may need to do to address such, and to what extent these activities may delay a potential re-submission, the firm gives consideration to a scenario in which the agency would like more comfort that treatment with TransCon PTH over time does not increase fracture risk-a concern that its has touched on in its past work on Ascendis.
April 4
InflaRx N.V. announced that Gohibic, a first-in-class monoclonal anti-human complement factor C5a antibody, has been granted an Emergency Use Authorization by the U.S. Food and Drug Administration for the treatment of coronavirus disease 19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation or extracorporeal membrane oxygenation, or ECMO. "InflaRx continues discussions with FDA related to submission of a BLA for full approval of Gohibic in this COVID-19 indication. InflaRx has also completed encouraging meetings with the rapporteur and co-rapporteur teams of the European Committee for Medicinal Products for Human Use, CHMP, related to a planned Marketing Authorization Application with the European Medicines Agency, or EMA. In addition, InflaRx is continuing to develop vilobelimab in other indications, including pyoderma gangrenosum, for which the Company is currently initiating a Phase III trial," the company stated.
VBI Vaccines announced plans to focus the company’s efforts on the fight against hepatitis B, or HBV, concentrating on broadening access to VBI’s FDA-approved 3-antigen HBV vaccine for adults, PreHevbrio Hepatitis B Vaccine Recombinant, and advancing its HBV immunotherapeutic candidate, VBI-2601, which has the potential to be part of a functional cure regimen for chronic HBV patients. As part of this commitment, the company intends to reduce its internal workforce by 30%-35%, a reduction which is expected to begin in April and complete by the end of June. As a result of this and other reductions in spend, VBI also expects its operating expenses from normal business to be 30%-35% lower in the second half of 2023 as compared with the second half of 2022. Additionally, by mutual agreement, Christopher McNulty, VBI’s current CFO will resign from the company and the board of directors effective April 10. In his place, the company and its board of directors have appointed Nell Beattie, VBI’s current chief business officer, as the new CFO and head of corporate development. Beattie has also been elected to VBI’s board.
April 3
Apellis Pharmaceuticals is drawing takeover interest from larger drugmakers, Michelle Davis and Dinesh Nair of Bloomberg reported, citing people with knowledge of the matter. The company is speaking to advisors to consider its options. Apellis may also consider seeking partnership or licensing agreement for its ophthalmology product, people said, according to Bloomberg.
Oncternal Therapeutics announced a strategic reprioritization based on the rapidly changing commercial landscape for Bruton’s tyrosine kinase inhibitors. The Phase 3 study and the Phase 1/2 study of zilovertamab in combination with ibrutinib will be closed, and other project and indirect expenses will be reduced, resulting in extending the expected cash runway into 2025. The projected cash runway will support the clinical advancement of our two pipeline assets ONCT-808 and ONCT-534. The company said, "In addition, management will continue to drive operational efficiencies and prudent cost reduction and cost containment measures. We estimate that our cash, cash equivalents and short-term investments were $54.3 million, and we had 58.7 million shares of common stock outstanding, as of March 31, 2023, and we expect our cash, cash equivalents and short-term investments to support our planned operations into 2025." "It is an extremely difficult decision to halt the clinical development of zilovertamab in combination with ibrutinib for patients with hematologic malignancies," said James Breitmeyer, Oncternal’s president and CEO. "The dramatic adoption of recently approved Bruton’s tyrosine kinase inhibitors made the continued development of zilovertamab with ibrutinib an unviable commercial opportunity. The decision was not based on any concerns about the safety or efficacy of zilovertamab. Going forward we will focus on reaching clinical proof of concept and data catalysts from the clinical trials of ONCT-808 in patients with resistant aggressive lymphoma, and ONCT-534 in patients with prostate cancer resistant to standard of care androgen receptor inhibitors."
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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.
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