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:

• Coherus Bio (CHRS), 434% surge in interest
• Galera Therapeutics (GRTX), 308% surge in interest
• BioXcel (BTAI), 216% surge in interest
• Fortress Biotech (FBIO), 197% surge in interest
• Aravive (ARAV), 171% surge in interest
• Acadia Pharmaceuticals (ACAD), 154% surge in interest
• Apellis Pharmaceuticals (APLS), 148%
• Lexicon (LXRX), 142% surge in interest
• Ardelyx (ARDX), 131% surge in interest
• Biohaven Pharmaceutical (BHVN), 113% surge in interest

Pipeline and key clinical candidates for these companies:

Coherus is a commercial-stage biopharmaceutical company focused on the research, development and commercialization of innovative immunotherapies to treat cancer and the commercialization of our portfolio of FDA-approved therapeutics. Coherus’ strategy is to build a leading immuno-oncology franchise funded with cash generated through net sales of its diversified portfolio of FDA-approved therapeutics.

Galera Therapeutics is focused on developing and commercializing a pipeline of therapeutic candidates that have the potential to transform radiotherapy in cancer. Galera’s selective dismutase mimetic product candidate avasopasem manganese, avasopasem, or GC4419, is being evaluated for radiotherapy-induced toxicities. The company’s second product candidate, rucosopasem manganese, rucosopasem, or GC4711, is in clinical-stage development to augment the anti-cancer efficacy of stereotactic body radiation therapy in patients with non-small cell lung cancer and locally advanced pancreatic cancer.

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.

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.

Aravive is developing targeted therapeutics to treat metastatic disease. The company’s lead product candidate, batiraxcept, formerly AVB-500, is an ultra-high affinity decoy protein that binds to GAS6, the sole ligand that activates AXL, inhibiting metastasis, tumor growth, and restoring sensitivity to anti-cancer agents. Batiraxcept has been granted Fast Track Designation by the FDA and Orphan Drug Designation by European Commission in PROC. Batiraxcept is in an active registrational Phase 3 trial in platinum resistant ovarian cancer, a Phase 1b/2 trial in clear cell renal cell carcinoma, and a Phase 1b/2 trial in pancreatic adenocarcinoma.

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.

Apellis Pharmaceuticals says the company “ushered in the first new class of complement medicine in 15 years” with the approval of the first and only targeted C3 therapy. Apellis is advancing this science to “continually develop transformative medicines for people living with rare, retinal, and neurological diseases,” it stated.

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.

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.

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.

Recent news on these stocks:

October 10

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.

October 5

Coherus BioSciences announced the company has resubmitted the Biologics License Application, BLA, Supplement for UDENYCA ONBODY, the company’s on-body injector presentation of UDENYCA, to the U.S. Food and Drug Administration, FDA, for review. The resubmission of the UDENYCA ONBODY BLA Supplement follows the completion and satisfactory resolution of the FDA’s review of inspection findings at a third-party filler, which was the only issue identified in the Complete Response Letter the FDA issued on September 21, 2023. The CRL did not identify any issues with the UDENYCA ONBODY clinical efficacy or safety, trial design, labeling, drug substance manufacturing, or device design or manufacturing, and no additional data or trials have been requested. “We are pleased that resolution of the FDA’s inspection findings has enabled our rapid resubmission of the UDENYCA ONBODY BLA supplement. As the CRL identified no other issues with the BLA supplement, we look forward to working closely with the agency to complete the review of the UDENYCA ONBODY application in a timely manner and anticipate potential approval later this year,” said Theresa LaVallee, Chief Development Officer of Coherus.

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.