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: 

• Kura Oncology (KURA), 1,934 surge in interest
• Outlook Therapeutics (OTLK), 861% surge in interest
• Altamira Therapeutics (CYTO), 759% surge in interest
• Lexicon Pharmaceuticals (LXRX), 540% surge in interest
• Redhill Biopharma (RDHL), 466% surge in interest
• Rhythm Pharmaceuticals (RYTM), 370% surge in interest
• vTv Therapeutics (VTVT), 367% surge in interest
• Heron Therapeutics (HRTX), 94% surge in interest
• GlycoMimetics (GLYC), 192% surge in interest
• Savara (SVRA), 175% surge in interest

Pipeline and key clinical candidates for these companies:

Kura Oncology is a clinical-stage biopharmaceutical company whose pipeline consists of small molecule drug candidates that target cancer signaling pathways. Ziftomenib is a once-daily, oral drug candidate targeting the menin-KMT2A protein-protein interaction for the treatment of genetically defined AML patients with high unmet need. The company is currently enrolling patients in a Phase 2 registration-directed trial of ziftomenib in NPM1-mutant relapsed or refractory AML and is preparing to initiate multiple Phase 1 trials to evaluate ziftomenib in combination with current standards of care in earlier lines of therapy and across multiple patient populations. Tipifarnib, a potent and selective FTI, is currently in a Phase 1/2 trial in combination with alpelisib for patients with PIK3CA-dependent HNSCC. Kura intends to evaluate KO-2806, a next-generation FTI, in a Phase 1 dose-escalation trial as a monotherapy and in combination with other targeted therapies in adult patients with advanced solid tumors.

Outlook Therapeutics is working to develop and launch ONS-5010, or Lytenava, as the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD, DME and BRVO. The FDA accepted Outlook Therapeutics’ BLA submission for ONS-5010 to treat wet AMD with a PDUFA goal date of August 29, 2023. If ONS-5010 ophthalmic bevacizumab is approved, Outlook Therapeutics expects to commercialize it as the first and only FDA-approved ophthalmic formulation of bevacizumab for use in treating retinal diseases in the United States, United Kingdom, Europe, Japan, and other markets.

Altamira Therapeutics is currently active in three areas: the development of RNA therapeutics for extrahepatic therapeutic targets via the OligoPhore/SemaPhore platforms; nasal sprays for protection against airborne allergens and, where approved, viruses or for the treatment of vertigo; and the development of therapeutics for intratympanic treatment of tinnitus or hearing loss.

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.

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.

Rhythm is a commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. Rhythm’s lead asset, IMCIVREE, an MC4R agonist designed to treat hyperphagia and severe obesity, is approved by the FDA for chronic weight management in adult and pediatric patients 6 years of age and older with monogenic or syndromic obesity due to pro-opiomelanocortin, proprotein convertase subtilisin/kexin type 1 or leptin receptor deficiency confirmed by genetic testing, or patients with a clinical diagnosis of Bardet-Biedl syndrome. Both the European Commission and the UK’s Medicines & Healthcare Products Regulatory Agency have authorized setmelanotide for the treatment of obesity and the control of hunger associated with genetically confirmed BBS or genetically confirmed loss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR deficiency in adults and children 6 years of age and above. Additionally, Rhythm is advancing a broad clinical development program for setmelanotide in other rare diseases, as well as RM-718 and a preclinical suite of small molecules for the treatment of congenital hyperinsulinism.

vTv Therapeutics is focused on developing oral, small molecule drug candidates. vTv has a pipeline of clinical drug candidates led by programs for the treatment of type 1 diabetes. vTv’s development partners are pursuing additional indications in type 2 diabetes, chronic obstructive pulmonary disease, renal disease, primary mitochondrial myopathy, and pancreatic cancer.

Heron Therapeutics is a commercial-stage biotechnology company that says its “advanced science, patented technologies, and innovative approach to drug discovery and development have allowed it to create and commercialize a portfolio of products that aim to advance the standard-of-care for acute care and oncology patients.”

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. 

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, or aPAP.

Recent news on these stocks:

January 25

RedHill Biopharma announced that it has entered into definitive agreements with institutional investors for the purchase and sale of 10M of the company’s American Depositary Shares, each ADS representing 400 ordinary shares, at a purchase price of 80c per ADS, in a registered direct offering. In addition, in a concurrent private placement, the company will issue unregistered warrants to purchase up to 10M ADSs. The closing of the offering is expected to occur on or about January 29, subject to the satisfaction of customary closing conditions. H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering. The gross proceeds to the company from the offering are expected to be $8M, before deducting the placement agent’s fees and other offering expenses payable by the company. The company intends to use the net proceeds from the offering for general working capital, acquisitions, research and development, and general corporate purposes.

January 24

Kura Oncology has agreed to sell 1.38M shares of its common stock at a price of $17.25 per share, representing a premium of approximately 29% to Kura’s closing price on January 23, 2024, and pre-funded warrants to purchase 7.32M shares of its common stock at price per pre-funded warrant of $17.2499 to a select group of institutional and accredited healthcare specialist investors in an oversubscribed private placement. The private placement is expected to close on or about January 26, subject to customary closing conditions. The proceeds from this financing, combined with current cash, cash equivalents and investments, are expected to fund current operations into 2027.

Altamira Therapeutics has filed a second provisional patent application with the United States Patent and Trade Office to provide broad coverage of different KRAS mutations in human cancer treatment with nanoparticles comprising the Company’s OligoPhore platform and a single siRNA sequence, polyKRASmut. The nanoparticles are developed by Altamira as AM-401. The second provisional application contains in vitro data confirming the ability of polyKRASmut siRNA to knock down a broad range of KRAS mutations in cancer cell lines. These mutations include G12C, G12V, G12D, G12R, G12A, and A146T, which account for 90.9% of KRAS mutations reported in pancreatic ductal adenocarcinoma, 65.3% in colorectal cancer and 80.0% in non-small cell lung cancer. In comparison, currently approved small molecule inhibitors target just one KRAS mutation, which represents 1.7%, 7.1% and 41.0% of total KRAS mutations in PDAC, CRC and NSCLC, respectively. Since polyKRASmut was tested against only a limited number of mutations, it may potentially knock down other, yet untested mutations. Altamira expects the second provisional patent application to further strengthen its intellectual property around the AM-401 program, under which the Company is aiming to develop a treatment for KRAS-driven cancers. Previous in vitro and in vivo work demonstrated efficient uptake of OligoPhore nanoparticles with KRAS-targeted siRNA in CRC and PDAC cells, strong inhibition of KRAS expression, reduced viability of tumor cells, and significant reduction in tumor growth and volume.2 Importantly, a murine model demonstrated the capacity of the OligoPhore platform to drive targeted delivery of the nanoparticles specifically to tumor cells. Altamira intends to file for an Investigational New Drug application with the FDA in 2025 and to partner the program upon an IND grant or following a phase 1 clinical trial.

January 23

Outlook Therapeutics has received written agreement from the FDA under an SPA for the NORSE EIGHT clinical trial protocol evaluating ONS-5010 in neovascular age-related macular degeneration subjects. Additionally, Outlook Therapeutics entered into securities purchase agreements with certain institutional and accredited investors for up to $172 million in gross proceeds to fund the advancement of ONS-5010. The FDA has reviewed and agreed upon the NORSE EIGHT trial protocol pursuant to the SPA. If the NORSE EIGHT trial is successful, it would satisfy the FDA’s requirement for a second adequate and well-controlled clinical trial to address fully the clinical deficiency identified in the Complete Response Letter. NORSE EIGHT will be a randomized, controlled, parallel-group, masked, non-inferiority study of approximately 400 newly diagnosed, wet AMD subjects randomized in a 1:1 ratio to receive 1.25 mg ONS-5010 or 0.5 mg ranibizumab intravitreal injections. Subjects will receive injections at Day 0, Week 4, and Week 8 visits. The primary endpoint will be mean change in BCVA from baseline to week 8. Outlook Therapeutics expects NORSE EIGHT topline results and resubmission of the ONS-5010 BLA by the end of calendar year 2024. In addition, through a Type A meeting and additional interactions, Outlook Therapeutics has identified the approaches needed to resolve the chemistry, manufacturing and controls comments in the CRL. Outlook Therapeutics is working to address the open items and expects to resolve these comments prior to the expected completion of NORSE EIGHT.

Heron Therapeutics announced that the FDA has approved its supplemental New Drug Application for ZYNRELEF extended-release solution to expand the indication for soft tissue and orthopedic surgical procedures including foot and ankle, and other procedures in which direct exposure to articular cartilage is avoided. ZYNRELEF was previously approved for foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures in adults. This expanded indication for ZYNRELEF will now cover an estimated 13 million procedures annually, an estimated increase of 86% over prior indicated procedures. To obtain this labeling expansion, Heron successfully conducted studies for cesarean section, spinal surgery, augmentation mammoplasty, and total shoulder arthroplasty. No unique safety issues were identified from the new clinical trials, and the bupivacaine and meloxicam blood concentrations were consistent with previous experience following ZYNRELEF administration. ZYNRELEF is the first and only therapy for postoperative pain management to be rigorously tested in Phase 3 studies and demonstrate superiority to bupivacaine solution, the current standard-of-care. ZYNRELEF demonstrated superiority compared to bupivacaine with lower pain scores, fewer patients experiencing severe pain, and lower opioid consumption. ZYNRELEF was initially approved by the FDA in May 2021 and received approval of the first supplemental NDA for an expanded label in December 2021.

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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.