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: 

• Madrigal Pharmaceuticals (MDGL), 327% surge in interest
• Aytu Bioscience (AYTU), 315% surge in interest
• Fortress Biotech (FBIO), 223% surge in interest
• Adaptive Biotechnologies (ADPT), 218% surge in interest
• Akero Therapeutics (AKRO), 120% surge in interest
• Sarepta Therapeutics (SRPT), 92% surge in interest
• Aravive (ARAV), 76% surge in interest
• Seagen (SGEN), 64% surge in interest
• Brainstorm Cell (BCLI), 62% surge in interest
• Viking Therapeutics  (VKTX), 61% surge in interest

Pipeline and key clinical candidates for these companies:

Madrigal Pharmaceuticals is a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis, or NASH, a liver disease with high unmet medical need. Madrigal’s lead candidate, resmetirom, is a once daily, oral, thyroid hormone receptor-beta selective agonist designed to target key underlying causes of NASH in the liver.

Aytu BioPharma is a pharmaceutical company commercializing a portfolio of commercial prescription therapeutics and consumer health products. The company’s prescription products include Adzenys XR-ODT extended-release orally disintegrating tablets and Cotempla XR-ODT extended-release orally disintegrating tablets for the treatment of attention deficit hyperactivity disorder, Karbinal ER, an extended-release antihistamine suspension indicated to treat numerous allergic conditions, and Poly-Vi-Flor and Tri-Vi-Flor, two complementary fluoride-based prescription vitamin product lines available in various formulations for infants and children with fluoride deficiency. Aytu’s consumer health segment markets a range of over-the-counter medicines and consumer health products addressing a range of common conditions including diabetes, allergy, hair regrowth, and gastrointestinal conditions.

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.

Adaptive Biotechnologies is a commercial-stage biotechnology company that applies its platform to partner with biopharmaceutical companies, inform drug development, and develop clinical diagnostics across its two business areas of Minimal Residual Disease and Immune Medicine. The company says its commercial products and clinical pipeline enable the diagnosis, monitoring, and treatment of diseases such as cancer, autoimmune disorders, and infectious diseases and states that its goal is “to develop and commercialize immune-driven clinical products tailored to each individual patient.”

Akero Therapeutics says it 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.

Sarepta Therapeutics engineers precision genetic medicine for rare diseases. The company holds leadership positions in Duchenne muscular dystrophy, or DMD, and limb-girdle muscular dystrophies, or LGMDs, and currently has more than 40 programs in various stages of development. Sarepta’s pipeline is driven by its multi-platform Precision Genetic Medicine Engine in gene therapy, RNA and gene editing.

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.

Seagen is a global biotechnology company that discovers, develops and commercializes transformative cancer medicines to make a meaningful difference in people’s lives. Seagen is headquartered in the Seattle, Washington area, and has locations in California, Canada, Switzerland and the European Union. On March 12, 2023, Seagen entered into an agreement and plan of merger that will see the company become a wholly owned subsidiary of Pfizer (PFE) when the deal is completed.

BrainStorm Cell Therapeutics is a developer of autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the FDA and the EMA for the treatment of amyotrophic lateral sclerosis, ALS. BrainStorm has completed a Phase 3 pivotal trial in ALS; this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine.

Viking Therapeutics is focused on the development of novel first-in-class or best-in-class therapies for the treatment of metabolic and endocrine disorders. The company’s clinical programs include VK2809, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the treatment of lipid and metabolic disorders, which is currently being evaluated in a Phase 2b study for the treatment of biopsy-confirmed non-alcoholic steatohepatitis, or NASH, and fibrosis.

Recent news on these stocks:

September 28

BrainStorm announced the outcome of the FDA’s Cellular, Tissue and Gene Therapies Advisory Committee meeting to review the biologics license application, or BLA, for NurOwn, an investigational mesenchymal stem cell therapy for the treatment of amyotrophic lateral sclerosis, or ALS. The Committee voted that NurOwn did not demonstrate substantial evidence of effectiveness for treatment of mild to moderate ALS. “The Committee’s vote was a sad outcome for the ALS community, who have too few options to help manage this merciless and deadly disease,” said Stacy Lindborg, PhD, co-CEO of BrainStorm. “We firmly believe that the totality of data presented for NurOwn today provide a compelling case for approval, with clinical evidence in those with less advanced disease supported by strong and consistent biomarker data that are predictive of clinical response. We truly did our best to make the NurOwn data clear to the FDA Advisory Committee. Unfortunately, had more time and opportunity been allowed, many remaining questions posed by Advisory Committee members could have been sufficiently addressed.”

September 26

Mizuho spoke to Sarepta Therapeutics about the selloff in the shares and was told the price decline is “nothing fundamental,” suggesting to the firm that it is not EMBARK-related. Sarepta continues to expect the readout for the confirmatory Phase 3 EMBARK trial in Q4, the analyst tells investors in a research note. Mizuho says investor feedback suggests the price decline may be driven by the unwinding of a poorly performing hedge fund. It sees the selloff as a buying opportunity and kept a Buy rating on the shares with a $160 price target.

September 25

In a regulatory filing, Madrigal Pharmaceuticals reported that Remy Sukhija, who has served as the company’s Chief Commercial Officer since April of 2020, is leaving the company to pursue other opportunities.

September 22

Seagen and Astellas Pharma (ALPMY) announced positive topline results from the Phase 3 EV-302 clinical trial for PADCEV in combination with KEYTRUDA versus chemotherapy in patients with previously untreated locally advanced or metastatic urothelial cancer, a form of bladder cancer that has spread to surrounding organs or muscles, or other parts of the body. The EV-302 trial enrolled patients with previously untreated la/mUC who were eligible for cisplatin- or carboplatin-containing chemotherapy regardless of PD-L1 status. The EV-302 study met its dual primary endpoints of overall survival and progression-free survival, compared to chemotherapy. An Independent Data Monitoring Committee determined that OS crossed the pre-specified efficacy boundary at interim analysis. The safety results of the combination are consistent with those of enfortumab vedotin in combination with pembrolizumab previously reported in cisplatin-ineligible patients with la/mUC.

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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.