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: 

• Akero Therapeutics (AKRO), 384% surge in interest
• 89Bio (ETNB), 253% surge in interest
• Nektar Therapeutics (NKTR), 233% surge in interest
• Jaguar Health (JAGX), 183% surge in interest
• Cara Therapeutics (CARA), 90% surge in interest
• BridgeBio Pharma (BBIO), 84% surge in interest
• BioCardia (BCDA), 72% surge in interest
• Biohaven Pharmaceutical (BHVN), 65% surge in interest

Pipeline and key clinical candidates for these companies:

Akero Therapeutics is developing “transformational treatments for patients with serious metabolic diseases marked by high unmet medical need,” including NASH, a disease without any approved therapies. Akero’s lead product candidate, EFX, is a differentiated Fc-FGF21 fusion protein that has been engineered to mimic the balanced biological activity profile of native FGF21, an endogenous hormone that alleviates cellular stress and regulates metabolism throughout the body. EFX is currently being evaluated in two Phase 2b clinical trials: the HARMONY study in patients with pre-cirrhotic NASH and the SYMMETRY study in patients with cirrhotic NASH. EFX is also being evaluated in an expansion cohort of the SYMMETRY study, comparing the safety and tolerability of EFX to placebo when added to an existing GLP-1 receptor agonist in patients with pre-cirrhotic NASH and Type 2 diabetes.

89bio is a clinical-stage biopharmaceutical company dedicated to the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases. The company’s lead product candidate, pegozafermin, is currently being developed for the treatment of NASH and SHTG.

Nektar Therapeutics is a biopharmaceutical company that describes itself as having “a robust, wholly owned R&D pipeline of investigational medicines in immunology and oncology as well as a portfolio of approved partnered medicines.”

Jaguar Health is a commercial stage pharmaceuticals company focused on developing novel, plant-based, sustainably derived prescription medicines for people and animals with GI distress, including chronic, debilitating diarrhea. Jaguar Health’s wholly owned subsidiary, Napo Pharmaceuticals, focuses on developing and commercializing proprietary plant-based human pharmaceuticals from plants harvested responsibly from rainforest areas. Their crofelemer drug product candidate is the subject of the OnTarget study, an ongoing pivotal Phase 3 clinical trial for prophylaxis of diarrhea in adult cancer patients receiving targeted therapy.

Cara Therapeutics is a commercial-stage biopharmaceutical company that notes that its Kapruvia injection is “the first and only” MHRA-approved treatment for moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis. The company is developing an oral formulation of difelikefalin and has Phase 3 programs ongoing for the treatment of pruritus in patients with non-dialysis dependent advanced chronic kidney disease and atopic dermatitis. In addition, the company has initiated a Phase 2/3 program of oral difelikefalin for the treatment of moderate-to-severe pruritus in patients with notalgia paresthetica.

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.

BioCardia is a developer of cell and cell-derived therapies for cardiovascular and pulmonary disease. The company has two biotherapeutic platforms, CardiAMP autologous bone marrow-derived mononuclear cell therapy for cardiovascular indications and the NK1R+ allogeneic bone marrow-derived mesenchymal stem cell therapies for cardiovascular and pulmonary diseases.

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:

March 6

A BridgeBio 8.6M share Secondary offering priced at $29.00. JPMorgan, Cantor Fitzgerald and Mizuho acted as joint book running managers for the offering.

March 5

Nektar initiated its Phase 2b clinical trial evaluating rezpegaldesleukin in patients with severe to very severe alopecia areata. Rezpegaldesleukin is a novel agonistic T regulatory cell biologic that is designed to both dampen the inflammatory response and simultaneously restore immune balance by directly expanding functional T reg cells and engaging multiple immunoregulatory pathways. Nektar expects topline data from this study expected in the first half of 2025. Initial results from the study are anticipated in the first half of 2025.

March 4

Akero Therapeutics released preliminary topline week 96 results from HARMONY, a Phase 2b study evaluating the efficacy and safety of its lead product candidate efruxifermin in patients with pre-cirrhotic metabolic dysfunction-associated steatohepatitis, fibrosis stage 2 or 3. The study previously met its primary endpoint of greater than or equal to1 stage improvement in fibrosis with no worsening of MASH after 24 weeks of treatment for both the 50mg EFX (41%) and 28mg EFX (39%) dose groups, compared to 20% for the placebo arm. At week 96, the response rates on this endpoint increased to 75% for 50mg EFX and 46% for 28mg EFX, compared to 24% for placebo. The study also met additional histology endpoints at week 96-notably 36% and 31% of patients treated with 50mg EFX and 28mg EFX experienced a 2-stage improvement in fibrosis without worsening of MASH-which is more than 10-fold the placebo rate of 3%. Results for all of the histological endpoints are summarized in the table below, based on either the primary analysis or intent-to-treat analysis. “Notwithstanding inherent limitations in making cross-trial comparisons, the statistically significant results for greater than or equal to1- and 2-stage fibrosis improvement and no worsening of MASH observed for 50mg EFX at week 96 are the largest response rates reported publicly to date for these endpoints in any MASH population,” said Stephen Harrison, M.D., medical director of Pinnacle Clinical Research and the HARMONY study’s principal investigator. “I believe the magnitude and general consistency of results observed across the Phase 2a BALANCED and Phase 2b HARMONY studies in patients with pre-cirrhotic MASH are reasons to be optimistic about results of the ongoing Phase 3 SYNCHRONY Histology study and the potential for EFX to be an important MASH medicine, if approved.”

Raymond James analyst Steven Seedhouse made no change to the firm’s Strong Buy rating on 89Bio after Akero reported a week 96 update for its Phase 2b HARMONY study evaluating the efficacy and safety of its lead product candidate efruxifermin in patients with pre-cirrhotic metabolic dysfunction-associated steatohepatitis, fibrosis stage 2 or 3. The firm views Akero’s update as positive for 89Bio, whose drug previously showed biomarker stabilization from weeks 24-48, the analyst told investors in a research note. 89Bio is running a pivotal compensated cirrhosis Nonalcoholic Steatohepatitis study with an interim 2-year histology assessment to form the basis for accelerated approval, the firm added.

Cara Therapeutics reported Q4 EPS of (59c) against a consensus of (41c), and reported Q4 revenue of $3M against a consensus of $9.42M.”Earlier this year, we announced the decision to focus all our resources on our late-stage notalgia paresthetica clinical program, which we believe puts us on the path to significant near-term value creation,” said Christopher Posner, President and Chief Executive Officer of Cara Therapeutics. “We completed enrollment in KOURAGE 1 Part A, the dose-finding portion of our pivotal program, earlier than anticipated and now expect to report topline efficacy and safety results in the third quarter of 2024. With a sizeable patient population and no approved or effective therapies on the market, we are excited about the commercial potential for oral difelikefalin in NP. Importantly, our cash runway into 2026 gives us the resources necessary to reach all potential key value-inflection milestones in our NP clinical program.”

BioCardia announced positive interim results from the Phase III randomized controlled trial of its CardiAMP autologous cell therapy in 110 randomized patients with advanced chronic heart failure at a mean 20-month follow-up. Results showed reductions in heart death equivalents and MACCE, with a magnified reduction among patients with elevated NTproBNP, a common marker of heart distress. Over a mean 20 months of follow-up, patients with advanced chronic heart failure who received a single endomyocardial dose of autologous CardiAMP cell therapy while on maximal medical therapy had a 37% relative risk reduction in all-cause heart death equivalents and a 9% relative risk reduction in non-fatal incidence of heart attacks, strokes, and hospitalization due to heart failure. Patients treated with CardiAMP cell therapy saw an almost 5% lower rate of heart death equivalents at up to two years compared to control patients treated with heart failure medication alone. In a subgroup analysis of patients with elevated NTproBNP at baseline – encompassing 59% of total enrolled randomized patients – patients treated with CardiAMP cell therapy experienced an 86.2% relative risk reduction in heart death equivalents and a 23.9% relative risk reduction in MACCE. These patients saw more than a 17% lower rate of heart death equivalents at up to two years compared to control patients treated with heart failure medication alone.

H.C. Wainwright raised the firm’s price target on Biohaven to $63 from $50 and kept a Buy rating on the shares post the Q4 results. The analyst said Biohaven’s diverse portfolio is progressing through multiple indications, but the firm is focused on its epilepsy, metabolic and IgG degrader platforms. It says near-term value-creating inflection catalysts for the company warrant investor attention.

February 23

Jaguar Health provided an update regarding the status of its listing with The Nasdaq Stock Market. “Jaguar requested a hearing to appeal a potential delisting of the company’s securities from Nasdaq, and I’m pleased to report that a hearing has been scheduled, ” said Lisa Conte, Jaguar’s president and CEO. “The company’s common stock will continue to trade on Nasdaq under the symbol ‘JAGX’ pending the ultimate decision of any appeal process, and Jaguar’s board remains committed to taking all required steps to remain in compliance with Nasdaq’s listing standards.” As previously reported, on May 10, 2023 Jaguar was notified by Nasdaq’s Listing Qualifications Staff that the bid price for the company’s common stock for the last 30 consecutive business days had closed below the minimum $1.00 per share required for continued listing on Nasdaq. The company was granted a grace period until May 6, 2024, to regain compliance. On February 15, 2024, the company received a letter from the Staff indicating that as of February 14, 2024, the company’s common stock had a closing bid price of $0.10 or less for 10 consecutive trading days, subjecting the company to the provisions of Nasdaq’s “Low Priced Stocks Rule,” and indicating Nasdaq’s intention to delist the company’s securities from Nasdaq on February 26, 2024, unless the company requests an appeal before the Nasdaq Hearings Panel.

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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.