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: 

• Galmed Pharmaceuticals (GLMD), 6,660% surge in interest
• Titan Pharma (TTNP), 3,549% surge in interest
• Bio-Path (BPTH), 1,244% surge in interest
• Sol-Gel Technologies (SLGL), 304% surge in interest
• Eyenovia (EYEN), 281% surge in interest
• Ginkgo Bioworks (DNA), 114% surge in interest
• Redhill Biopharma (RDHL), 102% surge in interest
• Sarepta Therapeutics (SRPT), 98% surge in interest
• Lexicon Pharmaceuticals (LXRX), 86% surge in interest
• Viking Therapeutics (VKTX), 84% surge in interest

Pipeline and key clinical candidates for these companies:

Galmed is a clinical stage biopharmaceutical company focused on the development of Aramchol for liver and fibro-inflammatory diseases. The company has focused almost exclusively on developing Aramchol for the treatment of noncirrhotic nonalcoholic steatohepatitis, or NASH, and are currently developing Aramchol for Primary Sclerosing Cholangitis, or PSC, and exploring the feasibility of developing Aramchol for other fibro-inflammatory indications outside of liver disease.

Titan Pharmaceuticals is a development stage company previously focused on developing proprietary therapeutics utilizing ProNeura long-term, continuous drug delivery technology. In December 2021, Titan commenced a process to explore and evaluate strategic alternatives to enhance shareholder value.

Bio-Path is developing DNAbilize, a technology that has yielded a pipeline of RNAi nanoparticle drugs that can be administered with an intravenous transfusion. Bio-Path’s lead product candidate, prexigebersen , or BP1001, is in a Phase 2 study for blood cancers and BP1001-A, a drug product modification of prexigebersen, has been cleared by the FDA and Phase 1 studies in solid tumors will commence in 2022. The company’s second product, BP1002, is being evaluated for the treatment of blood cancers and solid tumors, including lymphoma and acute myeloid leukemia. In addition, an IND is expected to be filed for BP1003, a novel liposome-incorporated STAT3 antisense oligodeoxynucleotide developed by Bio-Path as a specific inhibitor of STAT3, in 2022 or Q1 of 2023.

Sol-Gel Technologies is a dermatology company focused on identifying, developing and commercializing or partnering drug products to treat skin diseases. Sol-Gel developed TWYNEO which is approved by the FDA for the treatment of acne vulgaris in adults and pediatric patients nine years of age and older; and EPSOLAY, which is approved by the FDA for the treatment of inflammatory lesions of rosacea in adults.

Eyenovia is an ophthalmic pharmaceutical technology company developing a pipeline of microdose array print therapeutics. Eyenovia is currently focused on the late-stage development of microdosed medications for mydriasis, presbyopia, and myopia progression.

Ginkgo Bioworks calls itself “the leading horizontal platform for cell programming, providing flexible, end-to-end services that solve challenges for organizations across diverse markets, from food and agriculture to pharmaceuticals to industrial and specialty chemicals.” Ginkgo Biosecurity is building and deploying the next-generation infrastructure and technologies that global leaders need to predict, detect, and respond to a wide variety of biological threats.

RedHill Biopharma is primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik for opioid-induced constipation in adults, Talicia for the treatment of Helicobacter pylori infection in adults, and Aemcolo for the treatment of travelers’ diarrhea in adults.

Sarepta Therapeutics engineers precision genetic medicine for rare diseases. The company holds leadership positions in Duchenne muscular dystrophy, or DMD, and limb-girdle muscular dystrophies, or LGMDs, and currently has more than 40 programs in various stages of development. Sarepta’s pipeline is driven by its multi-platform Precision Genetic Medicine Engine in gene therapy, RNA and gene editing.

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.

Viking Therapeutics is focused on the development of novel first-in-class or best-in-class therapies for the treatment of metabolic and endocrine disorders. The company’s clinical programs include VK2809, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the treatment of lipid and metabolic disorders, which is currently being evaluated in a Phase 2b study for the treatment of biopsy-confirmed non-alcoholic steatohepatitis, or NASH, and fibrosis.

Recent news on these stocks:

August 23

BTIG analyst Mark Massaro lowered the firm’s price target on Ginkgo Bioworks to $7 from $8 and kept a Sell rating on the shares. Ginkgo effected its 1-for-40 reverse stock split, which reduced the company’s share count from 2B to 51M, the analyst told investors in a research note. The firm looks to get more visibility on Ginkgo’s monetization success of its cell engineering programs across its business.

August 21

Bio-Path Holdings provided an update from the company’s ongoing Phase 1/1b clinical trial of BP1001-A in solid tumor patients and reports continued patient progress from the company’s ongoing Phase 2 triple combination study of prexigebersen in Acute Myeloid Leukemia, AML. Bio-Path’s first patient in the second dose cohort in its Phase 1/1b advanced solid tumor clinical trial experiencing a positive response may signal that this analog of prexigebersen has potential as a new treatment for advanced solid tumors. The patient appears to be doing well on study after failing extensive chemotherapy and surgical treatment for gynecologic cancer, demonstrating a 15% reduction in her primary tumor through six cycles of treatment. During the company’s recent pause for an interim analysis of results for Bio-Path’s Phase 2 clinical trial treating AML patients, attention focused on two elderly patients who demonstrated continued treatment durability. The first patient is an elderly female who has received 16 cycles of treatment over 21 months and continues in complete remission. The second patient is an elderly male who is completing his twelfth cycle of treatment over fourteen months and continues in complete remission. The clinical trial investigator treating these two patients indicated that they are both doing very well on treatment.

Eyenovia has agreed to sell 12.85M shares of common stock at a price per share of 40c. The closing of the offering is expected to occur on or about August 22, subject to the satisfaction of customary closing conditions. All of the securities in the offering are being sold by Eyenovia. Dawson James Securities is acting as the placement agent for the offering. The gross proceeds to Eyenovia from this offering are expected to be approximately $5.1M, before deducting the placement agent’s fees and other offering expenses payable by Eyenovia. Eyenovia intends to use the net proceeds from this offering to fund commercialization activities for Mydcombi and clobetasol propionate, complete the CHAPERONE pediatric myopia clinical study, and for working capital and general corporate purposes, which may include the repayment of a portion of existing indebtedness.

Lexicon Pharmaceuticals announced that the FDA expects to convene a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee for Zynquista as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease on October 31, with no change to the PDUFA goal date of December 20. According to the notice provided, the FDA intends to make the background materials available to the public no later than two business days before the meeting.

August 19

Titan Pharmaceuticals announced that it has entered into a merger and contribution and share exchange agreement regarding a business combination with KE. The merger agreement was approved by Titan’s board. If the merger agreement is approved by the stockholders of Titan and KE, and upon consummation of the transactions contemplated by the merger agreement, Titan will be combined with KE in a “reverse merger” transaction consisting of two steps: TTNP Merger Sub, a wholly owned subsidiary of BSKE, will merge with and into Titan; the separate existence of merger sub will cease; and Titan will be the surviving corporation of the merger and a direct wholly owned subsidiary of BSKE. Within five business days of the filing by Titan and BSKE of a proxy statement/prospectus relating to the proposed transaction, shareholders of KE may elect to enter into a share exchange agreement with Titan and BSKE, pursuant to which, immediately following the merger, each KE shareholder entering into the share exchange agreement will contribute and exchange all of his KE shares in exchange for ordinary shares of BSKE. Titan may terminate the merger agreement if fewer than all KE shareholders enter into the share exchange agreement within the specified period. Dato’ Seow Gim Shen, chairman of the board and CEO of Titan, is the holder of 47.4% of the outstanding shares of KE. In addition, Seow is the sole stockholder of The Sire Group, which is the holder of Series AA Preferred Stock currently convertible into 150,087 shares of Titan common stock. Upon completion of the merger, the existing security holders of KE and Titan expect to own approximately 86.7% and 13.3%, respectively, of the outstanding shares of the combined company. It is expected that Seow will own 48.9% of the outstanding shares of the combined company following the merger. Such ownership percentages could be subject to proportional dilution for any required financing in connection with the closing. Completion of the merger is subject to the approval of the merger by Titan’s stockholders and issuance of shares related to the merger, approval of the listing by Nasdaq of BSKE on the Nasdaq Capital Market, post-merger, and satisfaction or waiver of other customary conditions set forth in the merger agreement. Accordingly, there can be no assurance that the proposed merger will be consummated.

Raymond James downgraded Sol-Gel Technologies to Outperform from Strong Buy with a price target of $4, down from $6.

RedHill Biopharma announced positive results from multiple in vivo studies, undertaken by RedHill’s partner, Apogee Biotechnology Corporation, showing the impact of opaganib on weight gain and glucose tolerance in a high fat diet,or HFD model, supporting the potential clinical use of opaganib for the prevention and therapy of Type 2 diabetes and other obesity-related disorders. The studies were designed to examine some of the most fundamental aspects of diabetes and obesity-related disease. The encouraging outcomes showed the benefit of opaganib therapy in suppression of HFD-induced body weight gain, loss of glucose tolerance and fat deposition. Additionally, opaganib treatment reduced weight gain and restored glucose tolerance in an already obese HFD model, suggesting its potential for treating, not just preventing, obesity-related disorders. The global obesity-diabetes drugs market is projected to be worth around $100B by 2034 – largely driven by Glucagon-like peptide-1 inhibitors like Novo Nordisk’s Ozempic and Wegovy and Eli Lilly’s (LLY) Trulicity and Mounjaro and sodium glucose cotransporter-2 inhibitors such as Boehringer Ingelheim’s Jardiance. Opaganib has also shown positive preclinical results in renal fibrosis, and has the potential to target multiple oncology, radioprotection, viral, inflammatory, and gastrointestinal indications.

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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.