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:

• Alnylam Pharmaceuticals (ALNY), 1,953% surge in interest
• Regulus Therapeutics (RGLS), 1,664% surge in interest
• GlycoMimetics (GLYC), 1,489% surge in interest
• Wave Life Sciences (WVE), 614% surge in interest
• BridgeBio Pharma (BBIO), 482% surge in interest
• Galera Therapeutics (GRTX), 379% surge in interest
• Arca Biopharma (ABIO), 332% surge in interest
• Altimmune (ALT), 310% surge in interest
• Gossamer Bio (GOSS), 283% surge in interest
• Argenx (ARGX), 282% surge in interest

Pipeline and key clinical candidates for these companies:

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.

Regulus Therapeutics is a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs. Regulus has leveraged its oligonucleotide drug discovery and development expertise to develop a pipeline complemented by a rich intellectual property estate in the microRNA field.

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.

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.

BridgeBio Pharma is a commercial-stage biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. BridgeBio’s pipeline of development programs ranges from early science to advanced clinical trials, the company has stated.

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.

Arca Biopharma is dedicated to developing genetically and other targeted therapies for cardiovascular diseases through a precision medicine approach to drug development.

Altimmune is a clinical-stage biopharmaceutical company that says it is 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.

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.

Argenx is an immunology company that says it is “committed to improving the lives of people suffering from severe autoimmune diseases” and “aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines.” Argenx developed and is commercializing what it calls “the first-and-only approved neonatal Fc receptor blocker in the U.S., the EU and UK, and Japan.” The company is evaluating efgartigimod in multiple autoimmune diseases and advancing several earlier stage experimental medicines within its therapeutic franchises.

Recent news on these stocks:

June 27

Tracy Swartz of the New York Post highlighted recent data for Altimmune’s weight loss drug pemvidutide. Researchers said pemvidutide helped more than 200 overweight adults shed an average of 15.6% of their body weight after 48 weeks, with less muscle lost, Swartz pointed out, citing data shared this week at the American Diabetes Association’s annual science conference. “These findings demonstrated that the use of pemvidutide may have important effects on the quality of weight loss and cardiometabolic-associated comorbidities of obesity,” said primary investigator Dr. Louis J. Aronne, professor of metabolic research at Weill-Cornell Medical College, the article highlighted.

June 26

Altimmune announced that Richard Eisenstadt, the company’s CFO, passed away unexpectedly on Monday, June 24. Eisenstadt’s duties have been assumed and are being performed by Altimmune’s finance and accounting team until his replacement is named. The company has initiated a search for his replacement.

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.”

BofA lowered the firm’s price target on BridgeBio to $42 from $50 and kept a Buy rating on the shares after competitor Alnylam announced positive data from HELIOS-B, its pivotal trial of vutrisiran in ATTR-cardiomyopathy, or ATTR-CM. The results approaching a “best-case” scenario are “a win for BridgeBio’s rival” and shares were pressured, likely given concerns over the opportunity. While the firm recognizes the competitive threat and worries silencers might take some first-line share, it “wouldn’t be quick to dismiss acoramidis” would be buyers on the weakness, the analyst told investors.

Argenx announced that new data from across the company’s autoimmune pipeline were presented at the 2024 Peripheral Nerve Society PNS Annual Meeting in Montreal, Quebec. “argenx is on a mission to transform the treatment of severe autoimmunity,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer, argenx. “We have established MMN and CIDP as autoantibody-mediated diseases, and by developing novel medicines that precisely target disease biology, we are fulfilling our mission to create truly transformative outcomes for patients. We are excited to present data for our novel therapies that may offer benefits beyond symptom management – to safely help patients regain control of their lives without harsh side effects, residual impairments, or treatments dependent on high frequency infusions. argenx continues to build scientific and clinical evidence that supports the advancement of our innovative pipeline and shows the potential to expand therapeutic choices while reducing the risk of relapse and accumulating disability.”

June 24

Alnylam Pharmaceuticals announced positive topline results from its HELIOS-B Phase 3 study of vutrisiran, an investigational RNAi therapeutic in development for the treatment of ATTR amyloidosis with cardiomyopathy, ATTR-CM. The study met the primary endpoint, demonstrating a statistically significant reduction in the composite of all-cause mortality and recurrent cardiovascular events during the double-blind period in both the overall population and in the monotherapy population. The study also demonstrated statistically significant improvements across all secondary endpoints in both the overall and monotherapy populations. This includes key measures of disease progression: 6-minute walk test, Kansas City Cardiomyopathy Questionnaire and New York Heart Association Class at Month 30. Importantly, treatment with vutrisiran also reduced all-cause mortality in the overall population and in the monotherapy population up to Month 42. This was a pre-specified, intent-to-treat analysis that included up to six months of data from the open-label extension.

Regulus Therapeutics announced positive topline results from the third cohort of patients in its Phase 1b MAD study of RGLS8429 for the treatment of ADPKD. In the third cohort, 16 subjects were randomized 3:1 to receive either 3 mg/kg of RGLS8429 or placebo every other week for three months. RGLS8429 was well tolerated with no safety concerns. Continued evidence of a mechanistic dose response was observed following completion of 3 mg/kg dose level based on urinary PC1 and PC2. 3 mg/kg demonstrated more consistent increases in PC1 and PC2 across patients compared to earlier cohorts Percent change from baseline in PC1 and PC2 demonstrated a dose response across all doses tested, with statistical significance seen at 3 mg/kg compared to placebo. Exploratory MRI imaging analysis suggested RGLS8429 reduced htTKV at 3 mg/kg after 3 months of dosing 70% of subjects demonstrated reductions in htTKV following completion of 3 mg/kg dose level. “We are pleased to see the consistent mechanistic response and reduction in htTKV at the 3mg/kg dose level of RGLS8429 along with an appropriate safety and tolerability profile,” said Preston Klassen, M.D., President and Head of Research & Development. “These data support our ongoing and final 300 mg fixed dose cohort in this Phase 1b trial. We believe the data from this study will form the basis for a potentially pivotal Phase 2/3 study of RGLS8429 under an Accelerated Approval regulatory pathway to be discussed with the FDA.” “Building on the positive results from our first two cohorts, these cohort 3 data, particularly the reduction in htTKV seen in the majority of patients, further strengthen our conviction in RGLS8429’s ability to potentially address the underlying, genetic cause of ADPKD,” said Jay Hagan, CEO of Regulus Therapeutics. “We anticipate requesting an End-of-Phase 1 meeting with the FDA in the fourth quarter of this year and look forward to providing a data update from the open-label fourth and final cohort of the Phase 1b MAD study by year-end.”

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.

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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.