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: 

• Athersys (ATHX), 270% surge in interest
• Acadia (ACAD), 265% surge in interest
• Fortress Biotech (FBIO), 248% surge in interest
• Lexicon (LXRX), 220% surge in interest
• Crispr Therapeutics (CRSP), 176% surge in interest
• BioXcel (BTAI), 163% surge in interest
• Alnylam Pharmaceuticals (ALNY), 119% surge in interest
• Miratai Therapeutics (MRTX), 63% surge in interest
• Altimmune (ALT), 60% surge in interest
• Ardelyx (ARDX), 49% surge in interest

Pipeline and key clinical candidates for these companies:

Athersys is a biotechnology company engaged in the discovery and development of therapeutic product candidates designed to extend and enhance the quality of human life. Athersys is developing its MultiStem cell therapy product, a patented, adult-derived “off-the-shelf” stem cell product, initially for disease indications in the neurological, inflammatory and immune, and other critical care indications and has several ongoing clinical trials evaluating this potential regenerative medicine product.

Acadia says it is advancing “breakthroughs in neuroscience to elevate life.” The company developed and commercialized what it identifies as “the first and only approved therapies” for hallucinations and delusions associated with Parkinson’s disease psychosis and for the treatment of Rett syndrome. Acadia’s clinical-stage development efforts are focused on treating the negative symptoms of schizophrenia, Alzheimer’s disease psychosis and neuropsychiatric symptoms in central nervous system disorders.

Fortress Biotech is focused on acquiring, developing and commercializing high-potential marketed and development-stage drugs and drug candidates. The company has nine marketed prescription pharmaceutical products and over 30 programs in development at Fortress, at its majority-owned and majority-controlled partners and subsidiaries and at partners and subsidiaries it founded and in which it holds significant minority ownership positions. Such product candidates span six large-market areas, including oncology, rare diseases and gene therapy.

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.

CRISPR Therapeutics is a gene editing company focused on developing gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform. “CRISPR/Cas9 is a revolutionary gene editing technology that allows for precise, directed changes to genomic DNA. CRISPR Therapeutics has established a portfolio of therapeutic programs across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine and rare diseases. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Bayer, Vertex Pharmaceuticals and ViaCyte,” the company states.

BioXcel Therapeutics is utilizing artificial intelligence approaches to develop medicines in neuroscience and immuno-oncology. The company’s drug re-innovation approach “leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indices,” BioXcel states. The company’s commercial product, IGALMI, developed as BXCL501, is a proprietary, sublingual film formulation of dexmedetomidine approved for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.

Alnylam markets commercial RNAi therapeutic products Onpattro, Givlaari, Oxlumo, Amvuttra and Leqvio, which is being developed and commercialized by Alnylam’s partner, Novartis (NVS). Alnylam has a pipeline of investigational medicines, including multiple product candidates that are in late-stage development.

Mirati Therapeutics is focused on bringing forward therapies that address areas of high unmet medical need, including lung cancer, and advancing a pipeline of novel therapeutics targeting the genetic and immunological drivers of cancer. Bristol Myers Squibb (BMY) has announced a deal to acquire Mirati for $58 per share plus a contingent value right potentially worth $12 per share.

Altimmune is a clinical-stage biopharmaceutical company focused on developing innovative next-generation therapeutics for the treatment of patients with liver diseases and obesity. The company’s lead product candidate, pemvidutide, is a GLP-1/glucagon dual receptor agonist that is being developed for the treatment of obesity and NASH. In addition, Altimmune is developing HepTcell, an immunotherapeutic designed to achieve a functional cure for chronic hepatitis B.

Ardelyx says it was founded with “a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs.” Ardelyx’s first approved product, Ibsrela is available in the United States and Canada. Ardelyx is developing Xphozah, a novel product candidate to control serum phosphorus in adult patients with chronic kidney disease on dialysis, which has completed three successful Phase 3 trials. Ardelyx has a Phase 2 potassium lowering compound, RDX013, for the potential treatment of elevated serum potassium, or hyperkalemia, a problem among certain patients with kidney and/or heart disease and an early-stage program in metabolic acidosis, a serious electrolyte disorder in patients with CKD.

Recent news on these stocks:

October 10

Athersys announced that it intends to continue exploring available strategic options. However, in the event Athersys is unable in the near-term to enter into a strategic transaction or obtain adequate financing, it expects to have to file for protection under the bankruptcy laws to allow the company to conduct an orderly wind down of operations. In the interim, the company is streamlining its operations to preserve its capital and cash resources.

JPMorgan upgraded Acadia Pharmaceuticals to Overweight from Neutral with a price target of $32, up from $29. The shares have underperformed the broader biotech markets over the recent months and is down 35% from its summer highs due to concerns related to Nuplazid’s composition of matter patents, the analyst tells investors in a research note. Even in a worst-case scenario, Acadia confirmed that the loss of exclusivity would only ever be pulled forward to early-2028 for Nuplazid, says the firm. In that case, its discounted cash flow model would only decrease by $6 per share and still reflect some upside to the current valuation. In time, and perhaps as soon as the coming weeks, the focus of the stock to return to launch execution, particularly around Daybue’s Q3 print, contended JPMorgan.

BioXcel Therapeutics announced positive overall survival data from its Phase 2 trial of BXCL701, the company’s investigational oral innate immune activator, in combination with KEYTRUDA in patients with small cell neuroendocrine prostate cancer, SCNC. As of a data cutoff of September 6, 2023, evaluable patients with SCNC showed a median OS of 13.6 months, and a 12-month survival rate of 56.5%. “OS is the most meaningful measure by which the effectiveness of an oncology treatment is evaluated. Though these results are based on a non-randomized cohort of patients, observing a median OS of this duration including patients with long-term survival at 12 months and beyond shows exceptional promise, bearing in mind historic data with checkpoint inhibitor monotherapy in this high-risk subset of prostate cancer,” said Rahul Aggarwal, M.D., Principal Investigator, Associate Director for Clinical Sciences, Helen Diller Family Comprehensive Cancer Center, and Professor of Medicine at the University of California San Francisco. “SCNC represents a major unmet medical need, with the majority of patients unfortunately succumbing to their disease in less than one year following chemotherapy. The results of this trial suggest that BXCL701 has the potential to extend the lives of patients, and I look forward to its continued clinical development.”

October 9

Fortress Biotech announced that it will effect a 1-for-15 reverse stock split of its issued and outstanding common stock. Fortress expects its common stock to begin trading on a split-adjusted basis on the Nasdaq Capital Market as of the commencement of trading on October 10. The reverse stock split was approved on August 10 by Fortress’ board of directors and by Fortress’ stockholders at a special meeting held on October 9, with the authorization to determine the final ratio within a specified range having been granted to the company’s board. The reverse stock split is intended to bring the company into compliance with Nasdaq’s $1.00 per share minimum bid price requirement for continued listing, the company noted.

Alnylam announced that the FDA has issued a complete response letter, or CRL, in response to the company’s supplemental new drug application, or sNDA, for patisiran for the treatment of the cardiomyopathy of transthyretin-mediated, or ATTR, amyloidosis. Patisiran is the established name for Onpattro, which is approved by the FDA for the treatment of the polyneuropathy of hereditary ATTR amyloidosis in adults. The CRL does not pertain to, nor does it impact commercial availability of, Onpattro for this existing indication. The CRL indicated that the clinical meaningfulness of patisiran’s treatment effects for the cardiomyopathy of ATTR amyloidosis had not been established, and therefore, the sNDA for patisiran could not be approved in its present form. The CRL did not identify any issues with respect to clinical safety, study conduct, drug quality or manufacturing. As a result of the CRL, the company will no longer pursue an expanded indication for patisiran in the U.S. The company remains dedicated to the ATTR amyloidosis community and will continue to focus on the HELIOS-B Phase 3 study of vutrisiran, an investigational RNAi therapeutic subcutaneously administered once every three months in development for the treatment of the cardiomyopathy of ATTR amyloidosis, and ALN-TTRsc04, which utilizes the company’s Ikaria technology, with the potential for greater than 90% TTR knockdown with once annual dosing.

October 8

Bristol Myers Squibb (BMY) and Mirati Therapeutics announced that they have entered into a definitive merger agreement under which Bristol Myers Squibb has agreed to acquire Mirati for $58.00 per share in cash, for a total equity value of $4.8B. Mirati stockholders will also receive one non-tradeable Contingent Value Right for each Mirati share held, potentially worth $12.00 per share in cash, representing an additional $1B of value opportunity. The transaction was unanimously approved by both the Bristol Myers Squibb and the Mirati Boards of Directors. Through this acquisition, Bristol Myers Squibb will add KRAZATI, a lung cancer medicine, to its commercial portfolio. The company gains access to other clinical assets that complement its oncology pipeline and are candidates for single agent development and combination strategies. The transaction is expected to be treated as a business combination and to be dilutive to Bristol Myers Squibb’s non-GAAP earnings per share by approximately 35c per share in the first 12 months after the transaction closes. The transaction is anticipated to close by the first half of 2024, subject to fulfillment of customary closing conditions, including approval of Mirati’s stockholders and receipt of required regulatory approvals. Bristol Myers Squibb expects to finance the acquisition with a combination of cash and debt.

October 4

Ardelyx shared data on the investigational use of IBSRELA in pediatric patients via two poster presentations presented at the 2023 North American Society for Pediatric Gastroenterology, Hepatology and Nutrition Annual Meeting, currently being held in San Diego, California. IBSRELA, discovered and developed by Ardelyx, is a first-in-class treatment with a differentiated mechanism of action that is currently approved by the U.S. Food and Drug Administration to treat irritable bowel syndrome with constipation in adults. The first poster presented, Trial In Progress: R-Ally, A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Tenapanor in Pediatric Patients with IBS-C, details the design and methods of the ongoing R-Ally Phase 3 Trial aimed at assessing the safety, tolerability and efficacy, of tenapanor in patients ages 12 to 17 with IBS-C. Patients enrolled in the study will be administered either tenapanor or placebo for 12 consecutive weeks. The primary endpoint for the study is an increase in spontaneous bowel movements of greater than or equal to 2 and a greater than or equal to 30% reduction in abdominal pain from baseline, both during the same week, for greater than or equal to 6 out of 12 weeks. The study was launched in November 2022. The second poster shown at NASPGHAN, Preliminary Blinded Safety Data from R-Ally, A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Tenapanor in Pediatric Patients with IBS-C, shared preliminary blinded safety data from an ongoing investigational study designed to assess the safety, tolerability and efficacy of tenapanor compared to placebo in pediatric patients between the ages of 12 and 17 with IBS-C. The study expects to enroll approximately 180 pediatric patients with IBS-C who meet the entry criteria during a two-week screening period at up to 60 US sites. The poster presentation detailed that as of May 2023, 42 pediatric patients had been screened, 23 had been included in the randomized trial and begun treatment and three have completed the study. Among these, there were no serious treatment-emergent adverse events, and all that were reported were resolved and considered unrelated to the study drug, except for diarrhea.

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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.