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:

• Eiger Biopharmaceuticals (EIGR), 1,763% surge in interest
• Galera Therapeutics (GRTX), 223% surge in interest
• 89bio (ETNB), 87% surge in interest
• Gritstone Oncology (GRTS), 46% surge in interest
• Voyager Therapeutics (VYGR), 31% surge in interest
• Vistagen (VTGN), 31% surge in interest

Pipeline and key clinical candidates for these companies:

Eiger is a commercial-stage biopharmaceutical company focused on the development of innovative therapies for rare metabolic diseases. Eiger’s lead product candidate, avexitide, is a well characterized, first-in-class GLP-1 antagonist for the treatment of post-bariatric hypoglycemia and congenital hyperinsulinism. Avexitide is the only drug in development for PBH with Breakthrough Therapy designation from the FDA.

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.

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.

Gritstone is “working to create the world’s most potent vaccines” by leveraging its “innovative vectors and payloads to train multiple arms of the immune system to attack critical disease targets,” the company says. Gritstone has programs in viral diseases and solid tumors.

Voyager Therapeutics says its TRACER AAV capsid discovery platform has “generated novel capsids with high target delivery and blood-brain barrier penetration at low doses, potentially addressing the narrow therapeutic window associated with conventional gene therapy delivery vectors.” The platform is fueling alliances with Pfizer (PFE), Novartis (NVS) and Neurocrine Biosciences (NBIX) as well as multiple programs in Voyager’s own pipeline, which includes wholly-owned and collaborative preclinical programs in Alzheimer’s disease, amyotrophic lateral sclerosis, Parkinson’s disease, and Friedreich’s Ataxia, the company has stated.

Vistagen is a late clinical-stage biopharmaceutical company whose clinical-stage candidates are targeting multiple types of anxiety and depression. PH94B and PH10 belong to a new class of drugs known as pherines, which are designed with a novel rapid-onset mechanism of action that activates chemosensory neurons in the nasal passages and can impact the olfactory-amygdala neural circuits without systemic uptake or direct activity on CNS neurons in the brain.

Recent news on these stocks:

April 1

Eiger BioPharmaceuticals announced that it and its direct subsidiaries have filed voluntary petitions for chapter 11 protection under the United States Bankruptcy Code in the United States Bankruptcy Court for the Northern District of Texas. The company also announced a “stalking horse” agreement for the sale of Zokinvy to Sentynl Therapeutics, Inc., a biopharmaceutical company focused on rare diseases. Under the terms of the “stalking horse” agreement, subject to court approval, Sentynl Therapeutics will pay up to $26.0 million, subject to certain purchase price adjustments, including per diem reductions if the sale closes after April 24, 2024, for the acquisition of Zokinvy. In accordance with Section 363 of the Bankruptcy Code, other potential bidders can submit competing bids for the company’s assets through a court-supervised process. Eiger filed customary “first day” motions with the court requesting relief designed to enable Eiger to transition into chapter 11 and uphold its commitments to stakeholders during the process without material disruption to its ordinary course of operations. The company intends to sell substantially all of its assets during the bankruptcy case and to facilitate an orderly wind down of its operations.

Gritstone announced preliminary data from the ongoing, signal seeking Phase 2 portion of the Phase 2/3 study evaluating GRANITE, its personalized neoantigen cancer vaccine, in front-line metastatic microsatellite stable colorectal cancer, mor MSS-CRC. The randomized, controlled, open-label study is designed to quantify the clinical benefit of maintenance therapy with GRANITE in combination with immune checkpoint blockade in addition to fluoropyrimidine/bevacizumab versus fluoropyrimidine/bevacizumab alone. Overall progression free survival, or PFS, data show an early trend in benefit for GRANITE patients and extended PFS benefit in high-risk patients, in whom progression occurs faster. Circulating tumor DNA analysis over several months of treatment shows the expected relationship with disease progression and favors GRANITE, while short-term ctDNA response analysis did not demonstrate a difference between study arms. Gritstone bio successfully manufactured GRANITE product candidate for every eligible patient. Early trend in PFS benefit was observed for GRANITE recipients. Hazard ratio of 0.82 in all patients. Hazard ratio of 0.52 in high-risk patients. Median PFS of 12 months vs. seven months. High-risk subgroup defined as baseline ctDNA above the median value for the control group. This analysis was performed on 44 patients who received study treatment and have available baseline ctDNA data. GRANITE and control arms begin separating one to two months after initiation of GRANITE treatment, consistent with expected kinetics of GRANITE-induced immune response. Short-term molecular response is uninformative due to unanticipated continuation of ctDNA drop beyond induction chemotherapy. Molecular response, similar in both arms. Long-term ctDNA responses align with PFS trends and favor GRANITE vs. control patients. Analysis in the high-risk group shows that between first blood draw and last blood draw, ctDNA shifted from high to low in 56% of GRANITE patients vs 22% of control patients. Progressive disease was observed in 44% vs 78%, respectively, within this group. Analysis in patients whose ctDNA was negative after induction chemotherapy, a low-risk group, favors GRANITE. Sustained ctDNA negativity was observed in 67% of GRANITE recipients vs 38% control patients. Progressive disease was observed in 11% and 38% of these patients, respectively. GRANITE demonstrated a favorable safety and tolerability profile. Vast majority of adverse events were Grade 1/2. Common AEs were mild systemic and local effects typically associated with any potent vaccine. No patients discontinued study treatment due to an AE.

Vistagen announced that it has enrolled the first patient in its PALISADE-3 Phase 3 trial of fasedienol, an investigational pherine candidate in development for the acute treatment of social anxiety disorder SAD . “Initiating Study of Fasedienol for the is another major milestone in our plan to develop and commercialize fasedienol as the first treatment of its kind for social anxiety disorder,” said Shawn Singh, Chief Executive Officer. “We look forward to initiating PALISADE-4 in the second half of this year and advancing our innovative pherine pipeline to deliver pioneering neuroscience to patients affected by mental health disorders and unsatisfied with current treatments.” PALISADE-3, similar to PALISADE-2, is a randomized, double-blind, placebo-controlled Phase 3 study designed to evaluate the efficacy, safety, and tolerability of the acute administration of fasedienol to relieve anxiety symptoms in patients with SAD induced by a public speaking challenge conducted in a clinical setting. …The U.S. FDA has granted Fast Track designation for the investigation of fasedienol for the acute treatment of SAD.

March 28

Galera Therapeutics reported Q4 EPS (10c) vs. (58c) last year. “As a result of last year’s FDA request for a second Phase 3 trial to support the avasopasem NDA, we have implemented key measures to extend our cash runway and assess strategic alternatives,” said Mel Sorensen, M.D., Galera’s CEO. “Among these measures, we recognize that the decision to discontinue our GRECO trials was challenging for our team and our clinical investigators, but we believe it was the appropriate decision, following the negative futility analysis in the pancreatic trial. We are continuing to explore strategic options to maximize value to our shareholders, including a potential development path for avasopasem. This process could ultimately result in the dissolution of the company.”

March 27

89bio announced that the European Medicines Agency has granted Priority Medicines status to pegozafermin in patients with MASH. The PRIME status was supported by positive data from the Phase 2b ENLIVEN trial of pegozafermin in patients with non-cirrhotic MASH with fibrosis and MASH with compensated cirrhosis. “The EMA PRIME status further supports pegozafermin’s positioning as a leading FGF21 analog for the treatment of MASH, which has demonstrated robust anti-fibrotic and metabolic benefits as seen in our Phase 2b ENLIVEN trial,” said Rohan Palekar, Chief Executive Officer of 89bio. “This status recognizes the urgent need for effective treatment options for MASH patients with advanced fibrosis and underscores pegozafermin’s potential to address the targeted unmet medical need. We look forward to working closely with regulatory agencies as we continue to advance our Phase 3 clinical development program, ENLIGHTEN, aimed at potentially benefiting advanced MASH patients and MASH patients with compensated cirrhosis.”

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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.