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:

• DiaMedica Therapeutics (DMAC), 2,400% surge in interest
• Wave Life Sciences (WVE), 1,092% surge in interest
• Oramed Pharmaceuticals (ORMP), 955% surge in interest
• CNS Pharmaceuticals (CNSP), 826% surge in interest
• Savara (SVRA), 804% surge in interest
• GlycoMimetics (GLYC), 632% surge in interest
• CASI Pharmaceuticals (CASI), 484% surge in interest
• Gossamer Bio (GOSS), 238% surge in interest
• Rigel Pharmaceuticals (RIGL), 218% surge in interest
• Seres Therapeutics (MCRB), 153% surge in interest

Pipeline and key clinical candidates for these companies:

DiaMedica Therapeutics is a clinical stage biopharmaceutical company committed to improving the lives of people suffering from serious diseases with a focus on acute ischemic stroke. DiaMedica’s lead candidate DM199 is the first pharmaceutically active recombinant form of the KLK1 protein, an established therapeutic modality in Asia for the treatment of acute ischemic stroke and other vascular diseases.

Wave Life Sciences is a biotechnology company “focused on unlocking the broad potential of RNA medicines to transform human health” whose RNA medicines platform, PRISM, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and prevalent disorders, the company says. Wave’s pipeline includes clinical programs in Duchenne muscular dystrophy, Alpha-1 antitrypsin deficiency and Huntington’s disease, as well as a preclinical program in obesity.

Oramed Pharmaceuticals calls itself “a platform technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection.” The company’s novel Protein Oral Delivery technology is designed to protect drug integrity and increase absorption. Oramed has offices in the United States and Israel.

CNS Pharmaceuticals is a clinical-stage pharmaceutical company developing a pipeline of anti-cancer drug candidates for the treatment of primary and metastatic cancers of the brain and central nervous system. The company’s lead drug candidate, Berubicin, is a novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier. Berubicin is currently in development for the treatment of a number of serious brain and CNS oncology indications including glioblastoma multiforme, or GBM, an aggressive and incurable form of brain cancer.

Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. Its lead program, molgramostim nebulizer solution, is an inhaled granulocyte-macrophage colony-stimulating factor in Phase 3 development for autoimmune pulmonary alveolar proteinosis.

GlycoMimetics is a late clinical-stage biotechnology company discovering and developing glycobiology-based therapies for cancers, including Acute Myeloid Leukemia, and for inflammatory diseases. The company’s specialized chemistry platform is being deployed to discover small molecule drugs–known as glycomimetics–that alter carbohydrate-mediated recognition in diverse disease states.

CASI Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products in China, the United States, and throughout the world. The company is focused on acquiring, developing, and commercializing products that augment its hematology oncology therapeutic focus as well as other areas of unmet medical need. The company intends to execute its plan to become a leader by launching medicines in the greater China market, leveraging the company’s China-based regulatory and commercial competencies and its global drug development expertise.

Gossamer Bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary hypertension. Its goal is to be an industry leader in, and to enhance the lives of patients living with, pulmonary hypertension.

Rigel Pharmaceuticals is dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with hematologic disorders, cancer, and rare immune diseases. Rezlidhia is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia, or AML, with a susceptible isocitrate dehydrogenase-1 mutation as detected by an FDA-approved test.

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.

Recent news on these stocks:

June 26

DiaMedica Therapeutics announced that it plans to expand its DM199, or rhKLK1, clinical development program into preeclampsia. Preeclampsia is a life-threatening pregnancy-associated vascular disorder characterized by new onset hypertension with proteinuria, and/or end organ dysfunction, and poses significant risks to both mother and baby. DM199 has the potential to lower blood pressure, enhance endothelial health, and improve perfusion to maternal organs and the placenta. This mode of action is believed to occur through the increased production of endothelial nitric oxide, prostacyclin, and endothelial-derived hyperpolarizing factors, or EDHFs. These pathways are typically depressed or impaired in preeclampsia. DM199 holds the potential to be disease modifying for preeclampsia patients if it can effectively increase placental perfusion and reduce placental hypoxia, a significant contributor to the pathophysiology of preeclampsia. DM199 has demonstrated blood pressure reductions in multiple prior studies. New results from analysis of overall participants with elevated blood pressure from the DM199 Phase 2 REDUX clinical trial in three types of chronic kidney disease, or CKD, which demonstrated a statistically significant reduction in systolic blood pressure, or SBP, at day 95. DiaMedica has also completed studies on fertility, embryofetal development and pre- and post-natal development in animal models, which support the potential safety in pregnant humans. DiaMedica recently completed a placental transfer study in pregnant rats in which DM199 did not cross the placental barrier. Specifically, DM199 was detectable in the maternal blood, but undetectable in the fetal blood. Up to 90 women with preeclampsia, and potentially 30 subjects with fetal growth restriction, will be evaluated with the first subject anticipated to be enrolled in the fourth quarter of 2024, pending regulatory approval. Part 1A topline study results are anticipated in the first half of 2025, which will demonstrate whether DM199 is safe, lowers blood pressure, and dilates intrauterine arteries to increase placental blood flow. This Phase 2 open-label, single center, single-arm, safety and pharmacodynamic, proof-of-concept, investigator-sponsored study of DM199 in treating preeclampsia will be conducted at the Tygerberg Hospital, Cape Town, South Africa in collaboration with DiaMedica. More details on DM199 for preeclampsia and fetal growth restriction will be presented at a key opinion leader event to be held on July 29. Instructions for participating in this event will be provided in the coming weeks.

Oramed Pharmaceuticals announced that its board has authorized a common stock repurchase plan allowing for the buy-back of up to $20M in maximum value of its common stock through open market purchases, privately-negotiated transactions, or otherwise in compliance with Rule 10b-18 under the Securities Exchange Act of 1934, as amended, over the next 12 months.

CNS Pharmaceuticals has entered into securities purchase agreements with health-care focused institutional investors for the purchase and sale of 568,000 shares of common stock in a registered direct offering and warrants to purchase up to 568,000 shares of common stock in a concurrent private placement at a combined purchase price of $2.45 per share. The warrants issued pursuant to the concurrent private placement will have an exercise price of $2.32 per share, will be exercisable immediately following the date of issuance and will expire 5 years from the initial exercise date. The closing of the offering is expected to occur on or about June 27, subject to the satisfaction of customary closing conditions. The gross proceeds from the offering are expected to be approximately $1.39M before deducting financial advisory fees and other offering expenses payable by the company. The company intends to use the net proceeds from the Offering for working capital and general corporate purposes.

Savara announced positive results from the pivotal, Phase 3 IMPALA-2 clinical trial. IMPALA-2 is a 48-week, randomized, double-blind, placebo-controlled trial assessing the efficacy and safety of molgramostim 300 mcg administered once daily by inhalation with matching placebo in adult patients with aPAP. Molgramostim is an inhaled form of recombinant human granulocyte-macrophage colony-stimulating factor. The trial met its primary endpoint. The treatment difference between molgramostim and placebo for mean change from baseline to Week 24 in hemoglobin-adjusted percent predicted DLCO achieved statistical significance. This statistically significant treatment difference was sustained at Week 48, a secondary endpoint, which demonstrated durability of effect. The treatment difference between molgramostim and placebo for mean change from baseline to Week 24 in SGRQ Total Score achieved statistical significance. Two additional secondary endpoints reached nominal significance: SGRQ Activity Score at Week 24 and exercise capacity using a treadmill test at Week 48. Molgramostim was well tolerated. The frequency of adverse events was generally similar between treatment groups. Two patients discontinued molgramostim treatment due to adverse events, both of which were considered unrelated to trial drug. The most commonly reported adverse events in the molgramostim group were COVID-19, cough, and pyrexia, with COVID-19 occurring more frequently with molgramostim than with placebo.

Casi Pharmaceuticals’ board received a preliminary non-binding proposal letter from CEO and chairman Wei-Wu He, to acquire the entire business operations of the company in China and all license-in, distribution and related rights in Asia – excluding Japan – related to all of the company’s pipeline products for an aggregate purchase price of $40.0M, which shall include assumption of up to $20.0M of indebtedness of the company. The board has formed a special committee comprised solely of incumbent independent directors to evaluate the transaction and other strategic and business alternatives available to the company in respect of the company’s business operations in China. No decisions have been made with respect to the proposed transaction or any alternative strategic option that the company may pursue.

CASI Pharmaceuticals is planning to submit an Investigational New Drug, or IND, application to the FDA for CID-103 for the treatment of antibody-mediated rejection in kidney transplant recipients by the end of 2024. CID-103 is an antibody recognizing a unique epitope that has demonstrated preclinical efficacy and safety profile compared to other anti-CD38 monoclonal antibodies. The company believes that with the proceeds from the private placement financing, together with its existing cash and cash equivalents, it will have sufficient capital to complete the Phase II clinical trial for AMR.

June 25

Wave Life Sciences announced positive results from its Phase 1b/2a SELECT-HD clinical trial of WVE-003, which is being developed as a potential disease modifying therapeutic for Huntington’s disease HD . WVE-003 is a first-in-class, allele-selective antisense oligonucleotide ASO designed to lower mutant huntingtin mHTT protein and preserve healthy, wild-type huntingtin wtHTT protein. “We are very proud to have demonstrated mHTT lowering of 46%, with preservation of wtHTT, and are encouraged to see these reductions in mHTT significantly correlating with a slowing in caudate atrophy after just 28 weeks. These results represent a significant achievement for Wave, for the oligonucleotide field, and most importantly, for the HD community,” said Anne-Marie Li-Kwai-Cheung, MChem, MTOPRA, RAPS, Chief Development Officer at Wave Life Sciences. “Alongside the HD community, we have been working diligently to establish caudate volume as a biomarker for clinical development due to its association with clinical outcomes. We believe these strong data compel a case for accelerated approval for WVE-003, which we plan to discuss with regulators. We would like to express our immense gratitude to the HD community, the study participants, their families, and study site staff for their trust, support, and engagement that have helped us reach this important milestone.”

Rigel Pharmaceuticals announced that it will effect a reverse stock split of its issued and outstanding shares of common stock at a ratio of 1-for-10, effective at on Thursday, June 27. The company’s common stock will begin trading on a post-split basis on The Nasdaq Global Select Market under the same symbol when the market opens on Thursday, June 27, with the new CUSIP number 766559702.

June 24

Oppenheimer initiated coverage of Gossamer Bio with an Outperform rating and $9 price target. Gossamer’s lead asset seralutinib is an inhaled tyrosine kinase inhibitor in Phase 3 development for the treatment of pulmonary arterial hypertension, or PAH, as well as pulmonary hypertension associated with interstitial lung disease, or PH-ILD, notes the analyst, who sees seralutinib emerging as a preferred choice among severe PAH patients who are not adequately served by currently available therapies given the drug’s “unique safety and efficacy profile.” With shares trading below cash, the firm sees “an attractive entry point at current levels,” the analyst told investors.

Hear more from InvestingChannel by signing up for The Spill.

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.