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:

• vTv Therapeutics (VTVT), 1,369% surge in interest
• Outlook Therapeutics (OTLK), 727% surge in interest
• Coherus Bio (CHRS), 338% surge in interest
• Lexicon Pharmaceuticals (LXRX), 336% surge in interest
• Syros Pharmaceuticals (SYRS), 181% surge in interest
• Biohaven Pharmaceuticals (BHVN), 170% surge in interest
• Axsome Therapeutics (AXSM), 110% surge in interest
• Adma Biologics (ADMA), 107% surge in interest
• Heron Therapeutics (HRTX), 94% surge in interest

Pipeline and key clinical candidates for these companies:

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.

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.

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.

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.

Syros is committed to developing new standards of care for the frontline treatment of patients with hematologic malignancies. Driven by the motivation to help patients with blood disorders that have largely eluded other targeted approaches, Syros is developing tamibarotene, an oral selective RARα agonist in frontline patients with higher-risk myelodysplastic syndrome and acute myeloid leukemia with RARA gene overexpression.

Biohaven is focused on the discovery, development and commercialization of therapies for people with neurological and neuropsychiatric diseases, including rare disorders. Biohaven’s portfolio of early- and late-stage product candidates also includes discovery research programs focused on TRPM3 channel activation for neuropathic pain and CD-38 antibody recruiting, bispecific molecules for multiple myeloma.

Axsome Therapeutics is developing and delivering novel therapies for central nervous system, or CNS, conditions that have limited treatment options. AXS-05 is a novel, oral, patent protected, investigational N-methyl-D-aspartate receptor antagonist with multimodal activity under development for the treatment of Alzheimer’s disease agitation and other central nervous system disorders.

ADMA Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases. ADMA currently manufactures and markets three FDA-approved plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases: BIVIGAM for the treatment of primary humoral immunodeficiency; ASCENIV for the treatment of PI; and NABI-HB to provide enhanced immunity against the hepatitis B virus.

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.”

Recent news on these stocks:

January 25

RBC Capital initiated coverage of Axsome Therapeutics with an Outperform rating and $126 price target. The company’s lead value driver Auvelity is showing good Rx growth, and sales can reach $296M in 2024, ahead of $272M consensus thanks to the earlier than expected adoption of the drug, the analyst tells investors in a research note. Auvelity use as the rapid acting profile resonates with patients and prescribers, the firm states, adding that the company’s successful launch of Auvelity, stable cash flows from Sunosi, and underappreciated pipeline optionality make for an “attractive mid-cap biotech”.

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.

January 22

Sandoz (SDZNY) has signed an agreement to acquire the U.S. biosimilar ranibizumab Cimerli from Coherus BioSciences for an upfront cash purchase payment of $170M. This is inclusive of a biologics license application, product inventory, ophthalmology sales and field reimbursement talent, as well as access to proprietary commercial software. “Sandoz looks forward to providing even more treatment options for US patients with vision impairment and loss. The agreement to acquire the Cimerli business from Coherus allows us to build a more robust ophthalmic platform that would support future product launches. Closing is anticipated in 1H 2024, subject to standard conditions and approvals,” the company stated.

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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.