These names in the biotech sector are seeing a substantial increase in search activity today, as determined by InvestingChannel. They include:
- Merus (MRUS), 912% surge in interest
- Tenax Therapeutics (TENX), 743% surge in interest
- Regenxbio (RGNX), 681% surge in interest
- Affimed (AFMD), 543% surge in interest
- Veracyte (VCYT), 437% surge in interest
Pipeline and key clinical candidates for these companies:
Merus is developing full-length human bispecific and trispecific antibody therapeutics, referred to as Multiclonics. Multiclonics are manufactured using industry standard processes and have been observed in preclinical and clinical studies to have several of the same features of conventional human monoclonal antibodies, such as long half-life and low immunogenicity, the company has said.
Tenax Therapeutics is focused on identifying, developing, and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need. The company owns North American rights to develop and commercialize subcutaneous and oral formulations of levosimendan. Tenax Therapeutics is also developing a unique oral formulation of imatinib designed to minimize the gastric irritation observed in a previous Phase 3 trial of the marketed version of the therapy while assuring that the dose achieved is at the level proven to be effective. Tenax Therapeutics expects to conduct a single pivotal trial pursuant to the 505(b)(2) pathway for regulatory approval.
Regenxbio is exploring the curative potential of gene therapy. Regenxbio’s NAV Technology Platform, a proprietary adeno-associated virus gene delivery platform, consists of exclusive rights to more than 100 novel AAV vectors, including AAV7, AAV8, AAV9 and AAVrh10. Regenxbio and its third-party NAV Technology Platform Licensees are applying the NAV Technology Platform in the development of a broad pipeline of candidates, including late-stage and commercial programs, in multiple therapeutic areas.
Affimed is a clinical-stage immuno-oncology company whose proprietary ROCK platform enables a tumor-targeted approach to recognize and kill a range of hematologic and solid tumors. The ROCK platform "predictably generates customized innate cell engager molecules, which use patients’ immune cells to destroy tumor cells," the company has said.
Veracyte is a global diagnostics company with a menu of advanced diagnostic tests. In addition to making its tests available in the United States through its central laboratories, its exclusive license to its diagnostics instrument, the nCounter Analysis System, "positions the company to deliver its tests to patients worldwide through laboratories that can perform them locally," Veracyte says.
Recent news on these stocks:
Affimed announced data updates from two phase 1/2a trials with AFM24, the company’s tetravalent, bispecific innate cell engager, in patients with solid tumors. AFM24 binds both EGFR on tumor cells and CD16A on natural killer cells and macrophages, thereby facilitating the killing of EGFR-positive tumor cells. Abstracts for the upcoming data presentations at the 37th Annual Meeting of the Society for Immunotherapy of Cancer were published today.
H.C. Wainwright analyst Andrew Fein lowered the firm’s price target on Merus to $39 from $45 and kept a Buy rating on the shares. The analyst views the stock selloff as overreaction to the FDA recommending the company to enroll additional patients in the eNRGy trial prior to a regulatory submission. "All pathways lead to approval," Fein told investors in a research note.
Needham analyst Ami Fadia lowered the firm’s price target on Merus to $28 from $40 and kept a Buy rating on the shares. The analyst stated that the most notable update from the company’s Q3 earnings is that more data will be needed for a Zeno BLA filing. Fadia is updating her model while pushing out her assumed launch timing for Zeno to 2025.
Chardan analyst Daniil Gataulin lowered the firm’s price target on Regenxbio to $61 from $70 and kept a Buy rating on the shares based on a probability-adjusted modeling of key franchises after the company reported Q3 results and discussed interim data from the phase II ALTITUDE dose escalation study of its anti-VEGF gene therapy, RGX-314, for diabetic retinopathy using suprachoroidal delivery. The analyst believes that a relatively high rate of non-responders to anti-VEGFs in DR patients may potentially mask efficacy of RGX-314 and that the trial design for a pivotal trial could potentially benefit from inclusion criteria that specifically require participants in the RGX-314 treatment arms to have demonstrated a clinical response to previous anti-VEGF treatments.
Shares of clinical-stage oncology company Merus were down 34% on Thursday after indicating that the FDA recommended additional enrollment in eNRGy trial to support potential BLA filing for Zenocutuzumab, or Zeno, in NRG1 fusion cancer. "Based on the FDA feedback, Merus believes that a potential registrational path remains viable in a NRG1+ cancer tumor agnostic indication or separate applications for NRG1+ lung and NRG1+ pancreatic cancer, which could then be followed by a potential tumor agnostic filing. The majority of the eNRGy trial and Early Access Program enrollment to date has been NRG1+ non-small cell lung cancer and NRG1+ pancreatic cancer. The FDA recommended that Merus enroll additional patients under either approach, to obtain further supportive data for a potential registrational data set, consistent with the recent FDA draft guidance on Tissue Agnostic Drug Development in Oncology. The amount of data needed for a potential filing under either approach will depend upon the magnitude and durability of responses and the overall risk benefit assessment," said the company in a statement.
Veracyte reported a Q3 loss per share of (12c) against a consensus of (25c), and Q3 revenue of $75.6M against a consensus of $66.4M. "Our third quarter results were robust given test adoption growth across our key products, new reimbursement contracts and expanded clinical evidence for our tests," said Marc Stapley, Veracyte’s chief executive officer. "We continue to invest in our long-term growth drivers, while maintaining our firm focus on financial discipline. I’m delighted with our team’s progress as we pursue our global vision of improving outcomes for patients all over the world through our exceptional diagnostic tests."
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 15-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.
Published first on TheFly
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