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:

• ARCA biopharma (ABIO), 10,065% surge in interest
• Acorda Therapeutics (ACOR), 2,996% surge in interest
• Vanda Pharmaceuticals (VNDA), 1,054% surge in interest
• VBI Vaccines (VBIV), 497% surge in interest
• Crinetics Pharmaceuticals (CRNX), 472% surge in interest
• Aldeyra Therapeutics (ALDX), 433% surge in interest
• SIGA Technologies (SIGA), 395% surge in interest
• Arbutus Biopharma (ABUS), 358% surge in interest
• Galectin Therapeutics (GALT), 294% surge in interest
• Nektar Therapeutics (NKTR), 208% surge in interest

Pipeline and key clinical candidates for these companies:

ARCA biopharma is dedicated to developing genetically and other targeted therapies for cardiovascular diseases through a precision medicine approach to drug development.

Acorda Therapeutics develops therapies to restore function and improve the lives of people with neurological disorders. Inbrija is approved for intermittent treatment of OFF episodes in adults with Parkinson’s disease treated with carbidopa/levodopa and utilizes Acorda’s innovative ARCUS pulmonary delivery system, a technology platform designed to deliver medication through inhalation. Acorda also markets the branded Ampyra Extended Release Tablets, 10 mg.

Vanda Pharmaceuticals is focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients.

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.

Crinetics Pharmaceuticals is focused on the discovery, development, and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors. Paltusotine, an investigational, oral somatostatin receptor type 2 agonist, is in Phase 3 clinical development for acromegaly and Phase 2 clinical development for carcinoid syndrome associated with neuroendocrine tumors. Crinetics has demonstrated pharmacologic proof-of-concept in Phase 1 clinical studies for CRN04777, an investigational, oral somatostatin receptor type 5 agonist in development for congenital hyperinsulinism, and for CRN04894, an investigational, oral ACTH antagonist in development for the treatment of Cushing’s disease, congenital adrenal hyperplasia, and other diseases of excess ACTH.

Aldeyra is a clinical-stage biotechnology company whose pre-commercial product candidates are reproxalap, a potential treatment for dry eye disease and allergic conjunctivitis, and ADX-2191, a potential treatment for primary vitreoretinal lymphoma, proliferative vitreoretinopathy, and other rare sight-threatening retinal diseases. In addition, Aldeyra is developing other product candidates, including ADX-629 and chemically related molecules, for the potential treatment of systemic and retinal immune-mediated diseases.

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.

Arbutus Biopharma is a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to identify and develop novel therapeutics with distinct mechanisms of action, which can be combined to provide a functional cure for patients with chronic hepatitis B virus (cHBV). The company’s pipeline of internally developed, proprietary compounds includes an RNAi therapeutic, imdusiran (AB-729) and an oral PD-L1 inhibitor, AB-101. Imdusiran has generated meaningful clinical data demonstrating an impact on both surface antigen reduction and reawakening of the HBV-specific immune response. Imdusiran is currently in two Phase 2a combination clinical trials. AB-101 is currently being evaluated in a Phase 1a/1b clinical trial.

Galectin Therapeutics is dedicated to developing novel therapies to improve the lives of patients with chronic liver disease and cancer. Galectin’s lead drug belapectin is a carbohydrate-based drug that inhibits the galectin-3 protein, which is directly involved in multiple inflammatory, fibrotic, and malignant diseases, for which it has Fast Track designation by the FDA. The lead development program is in non-alcoholic steatohepatitis with cirrhosis, the most advanced form of NASH-related fibrosis. This is the most common liver disease and one of the largest drug development opportunities available today. Additional development programs are in treatment of combination immunotherapy for advanced melanoma and other malignancies. Advancement of these additional clinical programs is largely dependent on finding a suitable partner. Galectin seeks to leverage extensive scientific and development expertise as well as established relationships with external sources to achieve cost-effective and efficient development.

Nektar Therapeutics is a biopharmaceutical company that describes itself as having “a robust, wholly owned R&D pipeline of investigational medicines in immunology and oncology as well as a portfolio of approved partnered medicines.”

Recent news on these stocks:

April 4

Arbutus Biopharma issued the following statement regarding the claim construction ruling of the U.S. District Court for the District of Delaware in the lawsuit brought by Arbutus and its licensee Genevant Sciences against Moderna, (MRNA) and a Moderna affiliate seeking damages for infringement of U.S. Patent Nos. 8,058,069, 8,492,359, 8,822,668, 9,364,435, 9,504,651, and 11,141,378 in the manufacture and sale of MRNA-1273, Moderna’s vaccine for COVID-19. The following summarizes the Court’s Opinion: Composition of Total Lipid: The Court agreed with Plaintiffs’ position that the claimed molar percentage ranges can be met by any particle and is not limited to “finished” particles that are not subjected to further process steps. The Court agreed with Plaintiffs’ position that the claimed mol. % ranges include standard variation based on the number of significant figures recited in the claim. Cationic Lipid with Protonatable Tertiary Amine: The Court agreed with Plaintiffs’ position that there is no limitation as to the mol. % of the claimed cationic lipid. Encapsulation of mRNA: The Court held that “wherein at least 70% / at least 80% / about 90% of the mRNA in the formulation is fully encapsulated in the lipid vesicles” means “wherein at least 70% / at least 80% / about 90% of the mRNA is fully, as distinct from partially, contained inside the lipid vesicles”. “We are pleased with how the Court construed the disputed claim terms,” said Michael J. McElhaugh, Interim President and CEO of Arbutus Biopharma. “We remain committed to protecting and defending our intellectual property and look forward to the next steps in the litigation.”

April 3

ARCA biopharma and Oruka Therapeutics have entered into a definitive agreement to combine the companies in an all-stock transaction. The resulting entity will focus on advancing Oruka’s pipeline of potentially best-in-class biologics, including ORKA-001 and ORKA-002. Upon completion of the merger, the combined company plans to operate under the name Oruka Therapeutics, and trade on Nasdaq under the ticker symbol “ORKA”. In support of the merger, Oruka has secured commitments for a $275M private investment in its common stock and pre-funded warrants to purchase its common stock from a syndicate of healthcare investors, as well as other investors, including multiple large investment management firms. The financing is expected to close immediately prior to completion of the merger. The combined company’s cash balance at closing is anticipated to fund Oruka’s operations through 2027 and support the advancement of ORKA-001 and ORKA-002 through initial clinical proof-of-concept. In addition, prior to closing of the merger, ARCA expects to declare a cash dividend to the pre-merger ARCA stockholders equal to the amount by which ARCA’s net cash exceeds $5M. The transaction has received approval by the boards of both companies and is expected to close in Q3 of 2024, subject to certain closing conditions, including, among other things, approval by the stockholders of each company, the effectiveness of a registration statement to be filed with the SEC to register the securities to be issued in connection with the merger, and the satisfaction of customary closing conditions.

Acorda Therapeutics announced that Nasdaq notified the company that it will suspend trading in and delist the company’s common stock, effective with the opening of business on April 12. The notice follows the company’s April 1 announcement that it has reached an agreement with Merz Therapeutics to acquire substantially all of the assets of the company. In connection with that announcement, Acorda and certain of its affiliates filed voluntary petitions to commence Chapter 11 proceedings. Nasdaq commenced proceedings to delist the company’s common stock, based on the company’s noncompliance with Nasdaq Listing Rules as a result of the company’s commencement of Chapter 11 proceedings and also because the company was not in compliance with stockholders’ equity of at least $10M. Once the delisting takes effect, Acorda expects its common stock to begin trading on the Pink Open Market.

VBI Vaccines announced that David E. Anderson, Ph.D., VBI’s Chief Scientific Officer, will present early tumor response data from the ongoing Phase 2b study of VBI-1901, VBI’s cancer vaccine immunotherapeutic candidate, in recurrent glioblastoma at the World Vaccine Congress Washington on April 3, 2024. The multi-center, randomized, controlled, open-label study has been designed to evaluate overall survival, tumor response rates, and safety and tolerability of VBI-1901 as a monotherapy in rGBM patients. Dr. Anderson commented: “In recurrent GBM, tumors typically double or triple in size within six weeks, with no effective treatments available to improve survival. Early indications from this ongoing study suggest tumor growth behavior in-line with expectations for both the standard-of-care arm and the VBI-1901 arm, based on positive data seen from the Phase 1/2a study. While early, I am very excited by these results and hope to see the trends continue to confirm the results seen in earlier studies, where VBI-1901 improved median overall survival by ~5 months compared to historical controls – ~13 months vs. ~8 months1 – and achieved a 44% DCR.”

Oppenheimer upgraded Aldeyra to Outperform from Perform with a $10 price target. Following the CRL in November 2023 requiring symptom trial, management disclosed its dry eye chamber design of Reproxalap, with ocular discomfort as the primary endpoint. Additionally, the firm considers the company’s plans to simultaneously conduct two backup trials as prudent. Oppenheimer views the upcoming chamber trial as derisked, considering the statistically significant difference in previous ocular discomfort data. Given Reproxalap’s already differentiated product profile, the revised clinical development plan, and Aldeyra’s strong balance sheet, the firm’s confidence in Reproxalap’s regulatory approval potential is renewed, Oppenheimer to change its rating to Outperform without even accounting for the AbbVie (ABBV) option agreement.

April 2

Vanda Pharmaceuticals announced that the FDA has approved Fanapt tablets for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. Fanapt is an atypical antipsychotic agent that has been used for the acute treatment of patients with schizophrenia since its FDA approval in 2009. “Manic or mixed episodes associated with bipolar I disorder are highly complex conditions, which require a host of trusted options to meet individual patient needs. With over 100,000 patient years of experience, Fanapt is a familiar therapeutic agent that offers flexible dosing with a well-known safety profile. This FDA approval gives patients and service providers a new treatment option for managing bipolar I disorder,” said Mihael HPolymeropoulos M.D., Vanda’s CEO.

April 1

SIGA Technologies announced that it entered into an amendment to its international promotion agreement with Meridian Medical Technologies. Effective June 1, SIGA will drive international promotion activities for oral TPOXX while maintaining its contractual relationship with Meridian to maintain continuity for key customer relationships. “We are excited about the long-term growth opportunities for oral TPOXX and believe this amendment to the Meridian promotion agreement will be instrumental in driving our expansion efforts for TPOXX outside the U.S.,” said Diem Nguyen, Chief Executive Officer. “This strategic move, which gives SIGA greater control, will enable us to meet our global customers’ needs more effectively during these uncertain times of orthopox threats. The ability to forge direct relationships with key international stakeholders is essential to our plans to expand access to TPOXX and maximize value creation.” This amendment, which extends the term of the promotion agreement by two years with respect to specific territories including the European Union, gives SIGA primary responsibility for promoting oral TPOXX. Certain existing contracts under the promotion agreement, including Meridian’s contract with the European Commission’s DG Health Emergency Preparedness and Response Authority HERA , will remain in effect.

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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.