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: 

• Reata Pharma (RETA), 1,334% surge in interest
• Homology Medicines (FIXX), 1,223% surge in interest
• Siga Technologies (SIGA), 924% surge in interest
• Uniqure (QURE), 625% surge in interest
• Tonix Pharmaceuticals (TNXP), 371% surge in interest

Pipeline and key clinical candidates for these companies:

Reata Pharma is “committed to developing and commercializing novel therapeutics for patients with serious or life-threatening diseases with few or no approved therapies.” The company is focused on molecular pathways involved in the regulation of cellular metabolism and inflammation. Reata’s first product, Skyclarys, has been approved by the FDA for the treatment of Friedreich’s ataxia and is under review in Europe by the EMA. In addition, Reata is developing cemdomespib for the treatment of patients with diabetic neuropathic pain. Cemdomespib is an investigational drug, and its safety and efficacy have not been established by any regulatory agency.

Homology Medicines is a clinical-stage genetic medicines company focused on rare diseases. The company’s clinical programs include HMI-102, an investigational gene therapy for adults with phenylketonuria, or PKU; HMI-103, a gene editing candidate for PKU; and HMI-203, an investigational gene therapy for Hunter syndrome. Additional programs focus on metachromatic leukodystrophy, or MLD, paroxysmal nocturnal hemoglobinuria, or PNH, and other 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. TPOXX is a novel small-molecule drug and the US maintains a supply of TPOXX under Project BioShield. 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.

uniQure is focused on gene therapy with a goal of “single treatments with potentially curative results.” The company is advancing a pipeline of gene therapies to treat patients with hemophilia B, Huntington’s disease, refractory temporal lobe epilepsy, Fabry disease, and other diseases.

Tonix is focused on central nervous system, rare disease, immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL, is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022 and interim data expected in the second quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix initiated a Phase 2 study in Long COVID in the third quarter of 2022 and expects interim data in the second quarter of 2023. TNX-1300 is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA.

Recent news on these stocks:

July 31

Tonix Pharmaceuticals announced that the first participant was enrolled in the investigator-initiated Phase 2 Study of The Results of Oxytocin in Binge Eating ‘STROBE’ study of TNX-1900 for the treatment of binge-eating disorder at the Massachusetts General Hospital. The aim of the study is to investigate the efficacy and safety of TNX-1900 as a novel therapeutic agent to reduce binge eating frequency in adults with binge-eating disorder. Tonix is supporting the STROBE study through a clinical trial agreement with MGH. MGH is the sponsor of the trial, which is being conducted under an investigator-initiated investigational new drug application. The 8-week double-blind, placebo-controlled trial has a target enrollment of at least 60 participants 18-45 years old with binge-eating disorder.

July 28

Biogen (BIIB) and Reata Pharmaceuticals announced the companies have entered into a definitive agreement under which Biogen has agreed to acquire Reata for $172.50 per share in cash, reflecting an enterprise value of approximately $7.3B. Reata has made significant advancements developing therapeutics that regulate cellular metabolism and inflammation in serious neurologic diseases. Reata’s FDA-approved SKYCLARYS is the first and only approved treatment for Friedreich’s ataxia in the United States, with a commercial launch underway, and European regulatory review ongoing. In addition, Reata is developing a portfolio of innovative products for a range of neurological diseases. The transaction, which was approved by the boards of directors of both companies, is currently anticipated to close in the fourth quarter of 2023. Biogen expects this acquisition to be accounted for as a business combination. The acquisition of Reata is expected to be slightly dilutive to Biogen’s Non-GAAP diluted Earnings Per Share in 2023, roughly neutral in 2024, and significantly accretive beginning in 2025, inclusive of associated transaction costs. Biogen plans to update its Full Year 2023 Financial Guidance in conjunction with its third quarter 2023 earnings release. Biogen expects to finance the acquisition with cash on hand, supplemented by the issuance of term debt. The transaction is subject to customary closing conditions, including approval by Reata stockholders and the receipt of necessary regulatory approvals. Biogen has entered into voting and support agreements with certain stockholders of Reata representing approximately 36% of the voting power of Reata’s common stock.

July 27

Homology Medicines announced that it has completed a review of its business, and the board of directors has approved a plan to evaluate strategic alternatives to maximize shareholder value. Earlier , Homology reported initial data from the first dose level in the Phase 1, dose-escalation trial evaluating gene editing candidate HMI-103 in adults with classical phenylketonuria, which showed it was generally well-tolerated in all three participants and resulted in a meaningful reduction in plasma phenylalanine in two participants as of the data cut-off date of July 26. Despite these encouraging data, based on the current financing environment and Homology’s anticipated clinical development timelines, Homology will not be further developing its programs and will be instituting a related reduction in force while it explores options for the company and its assets, including HMI-103. Homology has retained TD Cowen as its strategic financial advisor. Homology is reducing its workforce by 87% and stopping further program development efforts outside of required actions, including continued collection of data from and monitoring of participants in its clinical trials, to significantly reduce the company’s ongoing operating costs. These measures are expected to extend Homology’s cash runway into 2026. As of March 31, Homology had approximately $150M in cash, cash equivalents and short-term investments, and the Company will provide an update in its second quarter 2023 financial results.

SIGA Technologies “announced that the U.S. Department of Health and Human Services exercised procurement options for the delivery of approximately $113 million worth of oral TPOXX treatment courses and approximately $25 million worth of IV TPOXX treatment courses. SIGA expects to fully deliver approximately $113M of oral TPOXX under this order in 2023 and expects to start delivering IV TPOXX under this order in 2024. Prior to delivery of IV TPOXX under this order, SIGA will be focused on fulfilling delivery obligations under a prior IV TPOXX order.”

July 26

uniQure announced the appointment of Walid Abi-Saab, M.D., as Chief Medical Officer, effective immediately. He will report to Matt Kapusta, CEO of uniQure, and will be based in the Company’s Basel, Switzerland office. Dr. Abi-Saab will be responsible for leading all clinical research and development, regulatory affairs, medical affairs, and program management at uniQure. With Dr. Abi-Saab’s appointment, Dr. Ricardo Dolmetsch becomes President and Chief Scientific Officer. He will continue to lead all research, non-clinical research, and vector and enabling technology. Dr. Abi-Saab joins uniQure from the Belgium-based biopharmaceutical company Galapagos (GLPG), where he served as Chief Medical Officer from 2017 through 2022.

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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.