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: 

• Akebia Therapeutics (AKBA), 158% surge in interest
• Mannkind (MNKD), 131% surge in interest
• Ardelyx (ARDX), 95% surge in interest
• 89bio (ETNB), 81% surge in interest
• Capricor Therapeutics (CAPR), 73% surge in interest
• Mereo BioPharma (MREO), 61% surge in interest
• Cabaletta (CABA), 58% surge in interest
• BioLineRx (BLRX), 56% surge in interest
• FibroGen (FGEN), 51% surge in interest

Pipeline and key clinical candidates for these companies:

Akebia Therapeutics is a fully integrated biopharmaceutical company that says its purpose is “to better the lives of people impacted by kidney disease.”

MannKind Corporation focuses on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases.

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.

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.

Capricor Therapeutics is a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of muscular and other select diseases. Capricor’s lead candidate, CAP-1002, is an allogeneic cardiac-derived cell therapy that is currently in late-stage clinical development for treating Duchenne muscular dystrophy. Further, Capricor has entered into a partnership for the exclusive commercialization and distribution of CAP-1002 for DMD in the United States and Japan with Nippon Shinyaku Co., Ltd., subject to regulatory approval. Capricor is also developing its exosome technology as a next-generation therapeutic platform. 

Mereo BioPharma is a biopharmaceutical company focused on the development of innovative therapeutics for rare diseases. The company has two rare disease product candidates, setrusumab for the treatment of Osteogenesis Imperfecta (OI) and alvelestat for the treatment of severe alpha-1-antitrypsin deficiency-associated lung disease (AATD-LD) and Bronchiolitis Obliterans Syndrome (BOS).

Cabaletta Bio is focused on the discovery and development of engineered T cell therapies that have the potential to provide a deep and durable, perhaps curative, treatment for patients with autoimmune diseases. The CABA platform encompasses chimeric antigen receptor T cells for autoimmunity and Cabaletta Bio’s proprietary chimeric autoantibody receptor T cells.

BioLineRx is a pre-commercial-stage biopharmaceutical company focused on oncology. The company’s lead development program, motixafortide, a novel selective inhibitor of the CXCR4 chemokine receptor, may support diverse therapeutic approaches in oncology and other diseases. APHEXDA was successfully evaluated in a Phase 3 study in stem cell mobilization for autologous transplantation for multiple myeloma patients, has reported positive results from a pre-planned pharmacoeconomic study in the U.S., and has had its NDA submission accepted by the FDA with an assigned PDUFA date of September 9, 2023. Motixafortide was also successfully evaluated in a Phase 2a study for the treatment of metastatic pancreatic cancer, or mPDAC, in combination with the PD-1 inhibitor pembrolizumab and chemotherapy and is currently being studied in combination with the PD-1 inhibitor cemiplimab and chemotherapy as a first line mPDAC therapy.

FibroGen says it is “committed to leveraging its expertise in connective tissue growth factor biology and hypoxia-inducible factor to discovering, developing, and commercializing a pipeline of first-in-class therapeutics for the treatment of unmet needs.” Pamrevlumab, an anti-CTGF human monoclonal antibody, is in clinical development for the treatment of idiopathic pulmonary fibrosis, or IPF, locally advanced unresectable pancreatic cancer, metastatic pancreatic cancer, and Duchenne muscular dystrophy, or DMD. Roxadustat is currently approved in China, Europe, Japan, and numerous other countries for the treatment of anemia in CKD patients on dialysis and not on dialysis. Roxadustat is in Phase 3 clinical development in the U.S. and Europe for anemia associated with myelodysplastic syndromes, or MDS, and in Phase 3 clinical development in China for treatment of chemotherapy-induced anemia, or CIA.

Recent news on these stocks:

August 29

FibroGen announced topline data from the Phase 3 LELANTOS-2 trial of pamrevlumab for the treatment of ambulatory patients with Duchenne muscular dystrophy, or DMD, on background systemic corticosteroids. The study did not meet the primary endpoint of change in the North Star Ambulatory Assessment, or NSAA, total score from baseline to week 52. Secondary endpoints measured by change from baseline at week 52 in 4-stair climb velocity, 10-meter walk/run test, time to stand, time to loss of ambulation, and proportion of patients with greater than 10 seconds in the 10-meter walk/run test were also not met. Preliminary safety data showed that pamrevlumab was generally safe and well tolerated. The majority of treatment emergent adverse events were mild or moderate. Treatment-emergent serious adverse events were observed in 8.3% of patients in the pamrevlumab group and 2.8% of patients in the placebo group. FibroGen is in the process of evaluating the totality of the data, including other pre-specified endpoints, to determine the next steps for the program. The company plans to communicate the full results of the LELANTOS-2 study at an upcoming medical forum.

August 28

H.C. Wainwright upgraded Akebia Therapeutics to Buy from Neutral with a $3.75 price target. With meeting minutes confirmation, the analyst is now “highly confident” in the FDA approval of vadadustat early next year. The firm expects vadadustat’s FDA approval in March 2024, saying the meeting minutes “fully aligned” with an expedited approval path.

UBS initiated coverage of 89bio with a Buy rating and $36 price target. The firm sees non-alcoholic steatohepatitis, or NASH, as an “underappreciated market opportunity broadly” and thinks the FGF21 class “could lead the field longer-term.” In that context, the firm sees upside for 89bio into Akero Therapeutics’ (AKRO) Phase 2b NASH F4 data due in Q4 with 89bio’s PGZ “clearly active,” the analyst told investors.

August 25

Cantor Fitzgerald analyst Louise Chen upgraded Ardelyx to Overweight from Neutral with a price target of $10, up from $5. The analyst increased sales estimates for the company’s flagship drug, Xphozah, and thinks the Street is underappreciating its peak sales potential. Cantor increased its assumed probability of success for the U.S. approval and launch of Xphozah to treat hyperphosphatemia from 10% to 80% in its financial model. In addition, there may be a path towards resolution/ and adoption of the PATIENT act as early as end of year, delaying the inclusion of phosphate-lowering drugs into the Medicare dialysis bundle from 2025 to 2033, the analyst tells investors in a research note.

August 22

Cabaletta Bio has entered into certain work orders relating to Good Manufacturing Practice manufacturing under its existing master services agreement with WuXi Advanced Therapies. As part of the agreement, WuXi ATU will serve as a cell processing manufacturing partner for the planned global clinical development of CABA-201 in multiple indications, including potential late-stage clinical trials and commercial readiness activities for CABA-201. Under the terms of the agreement, WuXi ATU will provide GMP manufacturing of CABA-201, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy, to support any of Cabaletta’s planned clinical trials, including the previously announced separate Phase 1/2 clinical trials of CABA-201 for the treatment of patients with systemic lupus erythematosus and idiopathic inflammatory myopathies, or myositis. In addition, WuXi ATU will continue to serve as the Company’s cell processing manufacturing partner for the MusCAARTes Phase 1 clinical trial of MuSK-CAART.

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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.