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:

• Milestone Pharmaceuticals (MIST), 1,327% surge in interest
• Coherus Bio (CHRS), 358% surge in interest
• Brainstorm Cell (BCLI), 276% surge in interest
• Lexicon Pharmaceuticals (LXRX), 159% surge in interest
• Verona Pharma (VRNA), 127% surge in interest
• Zymeworks (ZYME), 112% surge in interest
• Ocugen (OCGN), 54% surge in interest
• Palatin Technologies (PTN), 38% surge in interest

Pipeline and key clinical candidates for these companies:

Milestone Pharmaceuticals is a biopharmaceutical company developing and commercializing cardiovascular solutions for people living with complex and life-altering heart conditions. Milestone’s lead investigational product is etripamil, a novel calcium channel blocker nasal spray that is being studied for patients to self-administer without medical supervision to treat highly symptomatic episodic attacks associated with PSVT and AFib-RVR.

Coherus is a commercial-stage biopharmaceutical company focused on the research, development and commercialization of immunotherapies to treat cancer. Coherus’ immuno-oncology pipeline includes multiple antibody immunotherapy candidates focused on enhancing the innate and adaptive immune responses to enable a robust immunologic response and enhance outcomes for patients with cancer.

BrainStorm Cell Therapeutics is a developer of autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the FDA and the EMA for the treatment of amyotrophic lateral sclerosis, ALS. BrainStorm has completed a Phase 3 pivotal trial in ALS; this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine.

Lexicon says it is “pioneering the discovery and development of innovative medicines to safely and effectively treat disease.” Lexicon has advanced one of these medicines to market and has a “pipeline of promising drug candidates in discovery and clinical and preclinical development in heart failure, neuropathic pain, diabetes and metabolism and other indications,” the company states.

Verona Pharma is a clinical-stage biopharmaceutical company focused on developing and commercializing therapies for the treatment of chronic respiratory diseases with significant unmet medical needs. If successfully developed and approved, Verona’s product candidate, ensifentrine, has the potential to become the first non-steroidal therapy for the treatment of respiratory diseases that combines bronchodilator and anti-inflammatory activities in one molecule, the company says.

Zymeworks is committed to the discovery, development, and commercialization of novel, multifunctional biotherapeutics. “Zymeworks’ mission is to make a meaningful difference for people impacted by difficult-to-treat cancers and other serious diseases. Zymeworks’ complementary therapeutic platforms and fully integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly differentiated antibody-based therapeutic candidates,” the company states.

Ocugen is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. The company’s “breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product,” says Ocugen, which adds that it is advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs.

Palatin is a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor systems, with targeted, receptor-specific product candidates for the treatment of diseases with significant unmet medical need and commercial potential. “Palatin’s strategy is to develop products and then form marketing collaborations with industry leaders to maximize their commercial potential,” the company says.

Recent news on these stocks:

December 26

Milestone Pharmaceuticals received a Refusal to File letter from the FDA for the New Drug Application for self-administered etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia. Upon preliminary review, the FDA determined that the NDA, submitted in October 2023, was not sufficiently complete to permit substantive review. The FDA requested clarification about the time of data recorded for adverse events in Phase 3 clinical trials; FDA did not express concerns about the nature or severity of adverse events. Milestone will seek clarification and is in the process of planning a meeting with the FDA.

Coherus BioSciences announced that the FDA approved UDENYCA ONBODY, the company’s on-body injector presentation of UDENYCA, a pegfilgrastim biosimilar administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia. The approval of UDENYCA ONBODY was supported by a comprehensive analytical and clinical data package, including pharmacokinetic (PK) and pharmacodynamic bioequivalence data as well as adhesive performance and tolerability data. Commercial availability of UDENYCA ONBODY is planned for the first quarter of 2024.

Brainstorm Cell Therapeutics provided an update on the grant and allowance of three patent applications for NurOwn and NurOwn-Exosomes. The European Patent office granted patent No. 3105587 titled ‘Method of Qualifying of Cells’ for a method of qualifying whether a cell population is a suitable therapeutic for treating ALS. The patent also grants claims for an isolated population of mesenchymal stem cells for use in treating ALS. The Australian patent Office granted patent No. 2019252987 titled ‘Cell-Type Specific Exosomes and Use Thereof’ for an isolated Exosomes population derived from MSC-NTF cells as well as a pharmaceutical composition for the treatment of neurodegenerative diseases. The Israel Patent Office announced the allowance of the same claims for application No. 277447 with an Acceptance date on December 01, 2023.

December 21

Ocugen announced that the company received alignment from FDA on key aspects of the Phase 3 clinical trial design to assess the safety and efficacy of OCU400 in patients with RHO and other gene mutations associated with Retinitis Pigmentosa. “This news brings us even closer to fulfilling our mission to bring our first-in-class, gene-agnostic therapies to market and provide access to patients globally,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder of Ocugen. “We look forward to beginning the Phase 3 clinical trial, which we plan to initiate in early 2024.” During a multidisciplinary meeting with FDA, based on preliminary results from an ongoing Phase 1/2 study, Ocugen received alignment on key aspects of the Phase 3 study design-including the study endpoint, patient enrollment strategy, and study duration of one year. The Phase 3 clinical trial will enroll a broader group of RP patients, including patients with the most common RHO gene mutation, based on OCU400’s potentially gene-agnostic mechanism of action. With orphan drug and RMAT designations in place for OCU400, FDA’s alignment on key aspects of the Phase 3 study design positions Ocugen to confidently move forward in pursuing product development and licensure for OCU400.

December 20

Palatin Technologies announced the sale of Vyleesi to Cosette Pharmaceuticals for up to $171M, consisting of an upfront purchase price of $12M plus contingent, sales-based milestone payments of up to $159M. Vyleesi is the first and only as-needed treatment approved by the FDA for premenopausal women with acquired, generalized hypoactive sexual desire disorder.

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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.