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:

• Acorda Therapeutics (ACOR), 5,645% surge in interest
• Eiger Biopharmaceuticals (EIGR), 2,294% surge in interest
• SIGA Technologies (SIGA), 312% surge in interest
• Gritstone Oncology (GRTS), 297% surge in interest
• Galera Therapeutics (GRTX), 277% surge in interest
• VBI Vaccines (VBIV), 267% surge in interest
• 89bio (ETNB), 180% surge in interest
• Affimed (AFMD), 177% surge in interest
• Citius Pharmaceuticals (CTXR), 151% surge in interest

Pipeline and key clinical candidates for these companies:

Acorda Therapeutics develops therapies to restore function and improve the lives of people with neurological disorders. Inbrija is approved for intermittent treatment of OFF episodes in adults with Parkinson’s disease treated with carbidopa/levodopa and utilizes Acorda’s innovative ARCUS pulmonary delivery system, a technology platform designed to deliver medication through inhalation. Acorda also markets the branded Ampyra Extended Release Tablets, 10 mg.

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.

SIGA Technologies is a commercial-stage pharmaceutical company focused on the health security market. Health security comprises countermeasures for biological, chemical, radiological and nuclear attacks, vaccines and therapies for emerging infectious diseases, and health preparedness. The company’s lead product is TPOXX, also known as tecovirimat and ST-246, an orally administered and IV formulation antiviral drug for the treatment of human smallpox disease caused by variola virus. The oral formulation of TPOXX was approved by the FDA for the treatment of smallpox in 2018, and the IV formulation was approved for the same indication in 2022.

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.

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.

VBI Vaccines is a biopharmaceutical company focused on virus-like particles, or VLPs, including a proprietary enveloped VLP, eVLP, platform technology. VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system. “VBI is committed to targeting and overcoming significant infectious diseases, including hepatitis B, coronaviruses, and cytomegalovirus, as well as aggressive cancers including glioblastoma,” the company says.

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.

Affimed is a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer by actualizing the untapped potential of the innate immune system. The company’s innate cell engagers, ICE, enable a tumor-targeted approach to recognize and kill a range of hematologic and solid tumors. ICE are generated on the company’s proprietary ROCK platform which predictably generates customized molecules that leverage the power of innate immune cells to destroy tumor cells. A number of ICE molecules are in clinical development, being studied as mono- or combination therapy.

Citius Pharmaceuticals is a late-stage biopharmaceutical company focused on the development and commercialization of first-in-class critical care products, with a pipeline of anti-infectives in oncology, adjunct cancer care, stem cell therapy and unique prescription products. Its diversified pipeline of therapies targeting unmet medical needs includes three potential first-and-only prescription treatments in their indications, and a next-generation single-donor, allogeneic, clonal and scalable stem cell therapy program.

Recent news on these stocks:

April 3

Acorda Therapeutics announced that Nasdaq notified the company that it will suspend trading in and delist the company’s common stock, effective with the opening of business on April 12. The notice follows the company’s April 1 announcement that it has reached an agreement with Merz Therapeutics to acquire substantially all of the assets of the company. In connection with that announcement, Acorda and certain of its affiliates filed voluntary petitions to commence Chapter 11 proceedings. Nasdaq commenced proceedings to delist the company’s common stock, based on the company’s noncompliance with Nasdaq Listing Rules as a result of the company’s commencement of Chapter 11 proceedings and also because the company was not in compliance with stockholders’ equity of at least $10M. Once the delisting takes effect, Acorda expects its common stock to begin trading on the Pink Open Market.

VBI Vaccines announced that David E. Anderson, Ph.D., VBI’s Chief Scientific Officer, will present early tumor response data from the ongoing Phase 2b study of VBI-1901, VBI’s cancer vaccine immunotherapeutic candidate, in recurrent glioblastoma at the World Vaccine Congress Washington on April 3, 2024. The multi-center, randomized, controlled, open-label study has been designed to evaluate overall survival, tumor response rates, and safety and tolerability of VBI-1901 as a monotherapy in rGBM patients. Dr. Anderson commented: “In recurrent GBM, tumors typically double or triple in size within six weeks, with no effective treatments available to improve survival. Early indications from this ongoing study suggest tumor growth behavior in-line with expectations for both the standard-of-care arm and the VBI-1901 arm, based on positive data seen from the Phase 1/2a study. While early, I am very excited by these results and hope to see the trends continue to confirm the results seen in earlier studies, where VBI-1901 improved median overall survival by ~5 months compared to historical controls – ~13 months vs. ~8 months1 – and achieved a 44% DCR.”

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.

SIGA Technologies announced that it entered into an amendment to its international promotion agreement with Meridian Medical Technologies. Effective June 1, SIGA will drive international promotion activities for oral TPOXX while maintaining its contractual relationship with Meridian to maintain continuity for key customer relationships. “We are excited about the long-term growth opportunities for oral TPOXX and believe this amendment to the Meridian promotion agreement will be instrumental in driving our expansion efforts for TPOXX outside the U.S.,” said Diem Nguyen, Chief Executive Officer. “This strategic move, which gives SIGA greater control, will enable us to meet our global customers’ needs more effectively during these uncertain times of orthopox threats. The ability to forge direct relationships with key international stakeholders is essential to our plans to expand access to TPOXX and maximize value creation.” This amendment, which extends the term of the promotion agreement by two years with respect to specific territories including the European Union, gives SIGA primary responsibility for promoting oral TPOXX. Certain existing contracts under the promotion agreement, including Meridian’s contract with the European Commission’s DG Health Emergency Preparedness and Response Authority HERA , will remain in effect.

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.

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.”

Hear more from InvestingChannel by signing up for The Spill.

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.