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: 

• Galera Therapeutics (GRTX), 329% surge in interest
• Quanterix (QTRX), 308% surge in interest
• Mannkind (MNKD), 307% surge in interest
• Fibrogen (FGEN), 204% surge in interest

Pipeline and key clinical candidates for these companies:

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.

Quanterix is a company that’s digitizing biomarker analysis with the goal of advancing the science of precision health. The company’s digital health solution, Simoa, “has the potential to change the way in which healthcare is provided today by giving researchers the ability to closely examine the continuum from health to disease,” the company says. Quanterix’ technology is currently being used for research applications in several therapeutic areas, including oncology, neurology, cardiology, inflammation and infectious disease.

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

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 9

Galera Therapeutics announced that it has received a Complete Response Letter, or CRL, from the FDA regarding the company’s New Drug Application, or NDA, for avasopasem manganese for radiotherapy-induced severe oral mucositis in patients with head and neck cancer undergoing standard-of-care treatment. In the CRL, the FDA communicated that the results from the Phase 3 ROMAN trial together with the supporting data from the GT-201 trial are not sufficiently persuasive to establish substantial evidence of avasopasem’s effectiveness and safety for reducing severe oral mucositis in patients with head and neck cancer. FDA stated that results from an additional clinical trial will be required for resubmission. The company intends to request a Type A meeting with the FDA to understand the FDA’s rationale for its decision and discuss next steps to support an NDA resubmission seeking approval of avasopasem. The company will also explore strategic alternatives, including partnering, for the continued development of avasopasem and rucosopasem. “This response from the FDA is deeply disappointing for Galera and for patients who suffer from severe oral mucositis,” said CEO Mel Sorensen. “We continue to believe in avasopasem’s potential to bring a meaningful benefit to these patients, who currently have no FDA-approved drugs for this debilitating condition. As we explore a potential approval path for avasopasem, we are taking decisive actions to extend our cash runway. Unfortunately, this necessitates reducing our workforce by approximately 70%.”

Quanterix announced that it has appointed Vandana Sriram as CFO, effective August 21. Sriram replaces Michael Doyle, who has served as the company’s CFO since July 2021. As previously announced, Doyle will transition to the role of executive director, finance, focusing on strategic growth programs until his retirement in March 2024. Sriram is a global senior executive with more than 20 years of diversified experience supporting the growth of high-tech manufacturing industries through financial strategy and transformation. Most recently, Sriram served as Senior Vice President of Global Finance at Azenta Life Sciences.

August 8

BofA downgraded FibroGen to Underperform from Neutral with a price target of $2, down from $4, post the Q2 report. The analyst sees an “unfavorable catalyst pathway” for the company. The firm has seen “catalyst-light biotechs” trade at discounts to cash for extended periods and is cautious around the upcoming data for pamrev in Duchene muscular dystrophy.

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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.