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: 

• Exicure (XCUR), 2,348% surge in interest
• Precision BioSciences (DTIL), 1,214% surge in interest
• Seres Therapeutics (MCRB), 1,173% surge in interest
• Galera Therapeutics (GRTX), 1,068% surge in interest
• NovaBay Pharmaceuticals (NBY), 486% surge in interest
• Amarin (AMRN), 432% surge in interest
• Mediwound (MDWD), 423% surge in interest
• SOHM (SHMN), 395% surge in interest
• Mersana Therapeutics (MRSN), 381% surge in interest

Pipeline and key clinical candidates for these companies:

Exicure is an early-stage biotechnology company historically focused on developing nucleic acid therapies targeting ribonucleic acid against validated targets. The company says it continues to actively pursue out-licensing opportunities for its clinical asset, cavrotolimod, as well as for its preclinical candidates, including the SCN9A program for neuropathic pain, and to pursue all strategic alternatives with the goal of maximizing stockholder value.

Precision BioSciences is an advanced gene editing company dedicated to improving life with its novel and proprietary ARCUS genome editing platform that differs from other technologies in the way it cuts, its smaller size, and its simpler structure. Key capabilities and differentiating characteristics may enable ARCUS nucleases to drive more intended, defined therapeutic outcomes. Using ARCUS, the company’s pipeline is comprised of in vivo gene editing candidates designed to deliver lasting cures for the broadest range of genetic and infectious diseases where no adequate treatments exist.

Seres Therapeutics is a microbiome therapeutics company developing a novel class of multifunctional bacterial consortia that are designed to functionally interact with host cells and tissues to treat disease. Seres’ SER-109 program achieved “the first-ever positive pivotal clinical results for a targeted microbiome drug candidate,” according to the company, and has obtained Breakthrough Therapy and Orphan Drug designations from the FDA. The SER-109 program is being advanced to prevent further recurrences of C. difficile infection. Seres is evaluating SER-155 in a Phase 1b study in patients receiving allogeneic hematopoietic stem cell transplantation to reduce incidences of gastrointestinal infections, bloodstream infections and graft-versus-host disease as well as additional preclinical stage programs targeting Infection Protection in medically compromised patients.

Galera Therapeutics is focused on developing and commercializing a pipeline of therapeutic candidates that have the potential to transform radiotherapy in cancer. Galera’s selective dismutase mimetic product candidate avasopasem manganese, avasopasem, or GC4419, is being evaluated for radiotherapy-induced toxicities. The company’s second product candidate, rucosopasem manganese, rucosopasem, or GC4711, is in clinical-stage development to augment the anti-cancer efficacy of stereotactic body radiation therapy in patients with non-small cell lung cancer and locally advanced pancreatic cancer.

NovaBay Pharmaceuticals develops and sells eyecare and skincare products. NovaBay’s leading product, Avenova Antimicrobial Lid & Lash Solution, is often prescribed by eyecare professionals for blepharitis and dry-eye disease and is also available directly to eyecare consumers through online distribution channels such as Amazon.

Amarin is an “innovative pharmaceutical company leading a new paradigm in cardiovascular disease management” and is “committed to increasing the scientific understanding of the cardiovascular risk that persists beyond traditional therapies and advancing the treatment of that risk for patients worldwide.”

MediWound is the global leader in next-generation enzymatic therapeutics focused on non-surgical tissue repair. Specializing in the development, production and commercialization of solutions that seek to replace existing standards of care, the Company is committed to providing rapid and effective biologics that improve patient experiences and outcomes, while reducing costs and unnecessary surgeries.

SOHM is a growing generic pharmaceutical manufacturing and marketing company with a vision of “Globalè Prospèro” that aims to build continuous growth. SOHM manufacturing and marketing targets rapidly growing healthcare segments such as nutraceuticals, cosmeceuticals and other major therapeutic segments. SOHM is headquartered in North America with manufacturing alliances in India and strategic alliances with U.S. manufacturing facilities. Although SOHM’s generic pharmaceuticals are exported globally and were introduced to the USA in early 2013, SOHM continues its focus on distribution to emerging markets in Africa, Latin America and Southeast Asia.

Mersana Therapeutics is a clinical-stage biopharmaceutical company focused on the development of novel antibody-drug conjugates and driven by the knowledge that patients are waiting for new treatment options. The company has developed proprietary cytotoxic and immunostimulatory ADC platforms that are generating a pipeline of wholly-owned and partnered product candidates with the potential to treat a range of cancers. Its pipeline includes XMT-1660, a Dolasynthen ADC targeting B7-H4, and XMT-2056, an Immunosynthen ADC targeting a novel epitope of human epidermal growth factor receptor 2 (HER2).

Recent news on these stocks:

January 10

Amarin reported Q4 revenue outlook of $72M-$74M, against a consensus of $62.03M. For FY23, Amarin estimates total revenue between $304M-$306M. Amarin ended 2023 with approximately $321M in cash and investments, with positive cash flow of approximately $10M for the full year. Additionally, Amarin entered into a conditional share repurchase agreement with Cantor Fitzgerald & Co. to purchase up to $50M of Amarin’s ordinary shares held in the form of American depository shares, ADSs. Amarin added that it continues to make progress on reducing operating expenses and managing its cash position and is on-track to deliver $40M of annual savings based on the reduction in force announced in July 2023. With the recent cash preservation initiatives, Amarin reiterates its belief that current cash and investments and other assets are adequate to support continued operations including the share repurchase program.

January 9

TG Therapeutics (TGTX) announced that it has entered into an agreement with Precision BioSciences to acquire a worldwide license to Precision’s Azercabtagene Zapreleucel, an allogeneic CD19 CAR T cell therapy program for autoimmune diseases and all other non-oncology indications. Azer-cel is an allogeneic CAR T program and the company has near-term plans to evaluate the program in multiple autoimmune indications, with an investigational new drug filing targeted for mid-2024. Michael Weiss, CEO of TG Therapeutics stated, “We are excited to expand our autoimmune portfolio and leverage our robust drug development and commercialization expertise in partnering with Precision on this CAR T program. We look forward to exploring azer-cel’s potential to be a meaningful therapy for patients with various autoimmune disorders with a target IND filing mid-2024.” Under the terms of the agreement, TG Therapeutics will receive exclusive worldwide rights to develop and commercialize azer-cel in non-oncology indications, and in exchange, Precision will receive upfront and potential near-term economics valued at $17.M. The upfront payment of $7.5M will consist of cash and the purchase of Precision common stock by TG Therapeutics at a 100% premium to the 30-day VWAP prior to purchase. Precision will also receive $2.5M in deferred consideration due within 12 months as an equity investment in Precision’s common stock at a 100% premium to the then 30-day VWAP prior to purchase. Upon the achievement of certain near-term clinical milestones, Precision will receive an additional $7.5M payment, consisting of cash and the purchase of Precision common stock by TG at a 100% premium to the then current 30-day VWAP. Precision is also eligible to receive up to $288M in additional payments based on the achievement of certain clinical, regulatory, and commercial milestones, in addition to high-single-digit to low double-digit royalties on net sales.

NovaBay Pharmaceuticals and Sonoma Pharmaceuticals (SNOA) announced an agreement for the sale and marketing of Avenova-branded products by Sonoma in the European Union. The new products will combine Sonoma’s existing eye product Ocudox, which has already received a Class IIB CE mark for sale in the European Union, with Avenova branding, and are expected to be marketed through Sonoma’s established European distribution network. This agreement brings together NovaBay’s deep knowledge of eye care reflected in its Avenova brand with Sonoma’s expertise in distributing hypochlorous acid products overseas. Sonoma will manufacture Ocudox by Avenova with packaging similar to NovaBay’s Avenova products, which are the leading hypochlorous acid-based eye care products in the U.S. Sonoma will pay NovaBay a royalty fee based on net product sales of Ocudox by Avenova, and Sonoma will continue to market its Ocudox product in the European Union.

MediWound announced that the FDA has completed their filing review and accepted a supplement to the NexoBrid biologics license application, sBLA, for the removal of eschar in pediatric patients with deep partial- and/or full-thickness thermal burns. The sBLA seeks to expand the label for NexoBrid to include both adult and pediatric burn patients of all ages. It is based on the results of a global Phase 3 clinical trial, Children Innovation Debridement Study, which evaluated the safety and efficacy of NexoBrid in hospitalized pediatric patients, as well as additional pediatric data available from Phase 3 and Phase 2 studies conducted during the clinical development of NexoBrid. “The acceptance of the NexoBrid sBLA filing by the FDA marks an important milestone for MediWound and reinforces our commitment to redefine the standard of care for the treatment of severe burns across all age groups,” said Ofer Gonen, CEO of MediWound. “NexoBrid is already approved for the adult and pediatric populations in Europe and Japan, and we look forward to working with the FDA, alongside our partner Vericel, throughout the sBLA review process.”

January 5

Mersana Therapeutics announced business updates, its expected 2024 milestones and its upcoming presentation at the 42nd Annual J.P. Morgan Healthcare Conference. Mersana continues to advance its Phase 1 clinical trial of XMT-1660, the company’s lead Dolasynthen ADC candidate targeting B7-H4. Mersana plans to initiate tumor-specific expansion cohorts in the second quarter of 2024 and share initial dose escalation and backfill cohort data in mid-2024. XMT-2056: Mersana is restarting its Phase 1 clinical trial of XMT-2056, the company’s lead Immunosynthen ADC candidate targeting a novel HER2 epitope. The company plans to advance dose escalation in 2024. In the first half of 2024, Mersana expects to present data at multiple scientific meetings demonstrating Dolasynthen’s differentiation from first-generation cytotoxic ADC platforms. The presentations will include clinical data from two discontinued ADC candidates, XMT-1592 and XMT-1536. Mersana continues to advance its collaborations with Janssen Biotech (JNJ) and Merck KGaA, (MKKGY) Darmstadt, Germany. Financial Resources: Mersana’s cash, cash equivalents and marketable securities as of September 30, 2023 were $241M. The company continues to expect that its available funds will be sufficient to support its current operating plan commitments into 2026.

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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.