Market Recap: Key Stock Movements in Biotechnology Sector – Tue, July 11, 2023
Uladzimir "Vlad" Ladziata
Senior Scientist II, Medicinal Chemistry at Flagship Labs // Experienced Medicinal and Organic Chemist
?? Today's key financial highlights from the biotech and pharmaceutical sector are as follows:
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?? ADC Therapeutics SA (NYSE: ADCT), after consulting with the Data Monitoring Committee, voluntarily paused new patient enrollment into its Phase 2 LOTIS-9 clinical trial evaluating ZYNLONTA and rituximab in unfit or frail patients with untreated diffuse large B-cell lymphoma (DLBCL). The decision was made due to a potentially excessive number of respiratory-related events signaled by recent aggregate data review of enrolled patients in the trial. ZYNLONTA is a CD19-directed antibody drug conjugate (ADC) that delivers the PBD dimer cytotoxin payload. The PBD dimer—an alkylating agent—binds to the DNA minor groove and forms highly cytotoxic DNA interstrand crosslinks. The company's shares closed down by 22% at $1.85.
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?? Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) observed an increase in share trading following the announcement of regulatory feedback from both FDA and EU regulators. This feedback confirmed the primary US endpoint in the AD04 trials and raised no concerns about safety data from the ONWARD trial. Adial Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development of therapeutics for the treatment or prevention of addiction and related disorders. Its lead product is AD04, a serotonin-3 antagonist, which is in Phase III clinical trial for the treatment of alcohol use disorder (AUD). Shares ended the day up 90% at $0.39.
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?? An analyst from Oppenheimer has retained an Outperform rating on Eloxx Pharmaceuticals (NASDAQ: ELOX) and increased the price target from $50 to $55. Eloxx Pharmaceuticals is engaged in the science of ribosome modulation, leveraging its innovative TURBO-ZM TM chemistry technology platform in an effort to develop novel Ribosome Modulating Agents (RMAs) and its library of Eukaryotic Ribosome Selective Glycosides (ERSGs). One of their therapeutic assets is ELX-02, which is currently in Phase 2 clinical trials for Cystic Fibrosis (CF) patients affected by nonsense mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. The shares of Eloxx Pharmaceuticals closed up by 94% at $7.58.
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?? Journey Medical Corporation (NASDAQ: DERM) shared data from two Phase 3 clinical trials, MVOR-1 and MVOR-2 of DFD-29 (Minocycline Modified Release Capsule 40 mg) for treating papulopustular rosacea. Both trials met their co-primary and all secondary endpoints, completing the 16-week treatment without any significant safety issues arising. However, shares closed down by 17% at $2.36.
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?? NanoViricides, Inc. (NYSE: NNVC) released animal model data suggesting NV-387 as a potential RSV (Respiratory Syncytial Virus) treatment. Animals treated with ribavirin injections survived for 16 days, while animals treated with injectable NV-387 lasted for 15 days. In preclinical studies, NV-387 demonstrated excellent safety levels. NV-387 is a first-in-class chemical nanomachine that acts by a novel mechanism of action called “Re-Infection Blocker”. It is a nanoviricide composed of covalently attached polyethylene glycol and alkyl pendants that are designed to bind free virion particles of multiple strains of coronaviruses in a broad-spectrum manner at multiple points. The binding interaction is like a nano-velcro-tape and may cause a lipid–lipid fusion between the nanoviricide micelle and the lipid envelope of the virus. The drug is designed to directly attack the virus particle with a multi-pronged attack and thereby disable the virus completely so that it cannot further infect human cells and the infection cannot progress. Shares concluded trading up 11% at $1.56.
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?? Salarius Pharmaceuticals, Inc. (NASDAQ: SLRX) received clearance from FDA to start a Phase 1 clinical trial with SP-3164 in patients suffering from relapsed/refractory non-Hodgkin lymphoma (NHL). SP-3164 is an oral, next-generation molecular glue that uses Salarius’ deuterium-enabled chiral switching platform to stabilize the preferred (S)-enantiomer of avadomide, an extensively studied clinical compound. SP-3164 interacts with the cereblon (CRBN) component of a CRL4 E3 ligase, inducing recruitment of select proteins, i.e., Ikaros (IKZF1) and Aiolos (IKZF3), leading to their ubiquitination and proteasomal degradation. Salarius anticipates starting patient treatment in the dose-escalation part of this trial during the latter half of 2023 to assess safety, clinical activity, pharmacokinetics and pharmacodynamics parameters of SP-3164 drug candidate . Despite this positive update, shares ended down by 12% at $1.27.
? This update is provided for informational purposes only and should not be construed as investment advice. It is recommended to seek professional advice before making any investment decisions.
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?? Data courtesy: FinViz