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: 

• Exicure (XCUR), 798% surge in interest
• Rigel Pharmaceuticals (RIGL), 226% surge in interest
• CRISPR Therapeutics (CRSP), 90% surge in interest
• Avid Bioservices (CDMO), 55% surge in interest
• Applied Therapeutics (APLT), 47% surge in interest
• Cassava Sciences (SAVA), 40% surge in interest

Pipeline and key clinical candidates for these companies:

Exicure is an early-stage biotechnology company historically focused on developing nucleic acid therapies targeting ribonucleic acid against validated targets. The company says it continues to actively pursue out-licensing opportunities for its clinical asset, cavrotolimod, as well as for its preclinical candidates, including the SCN9A program for neuropathic pain, and to pursue all strategic alternatives with the goal of maximizing stockholder value.

Rigel Pharmaceuticals is dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with hematologic disorders, cancer, and rare immune diseases. Rezlidhia is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia, or AML, with a susceptible isocitrate dehydrogenase-1 mutation as detected by an FDA-approved test.

CRISPR Therapeutics is a gene editing company focused on developing gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform. “CRISPR/Cas9 is a revolutionary gene editing technology that allows for precise, directed changes to genomic DNA. CRISPR Therapeutics has established a portfolio of therapeutic programs across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine and rare diseases. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Bayer, Vertex Pharmaceuticals and ViaCyte,” the company states.

Avid Bioservices is a dedicated contract development and manufacturing organization, or CDMO, focused on development and CGMP manufacturing of biologics. Avid’s services include CGMP clinical and commercial drug substance manufacturing, bulk packaging, release and stability testing and regulatory submissions support. For early-stage programs, the company provides a variety of process development activities, including upstream and downstream development and optimization, analytical methods development, testing and characterization.

Applied Therapeutics is “developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need.” The company’s lead drug candidate, AT-007, is a novel central nervous system penetrant Aldose Reductase Inhibitor for the treatment of CNS rare metabolic diseases, including Galactosemia, SORD Deficiency, and PMM2-CDG. The company is also developing AT-001, a novel potent ARI, for the treatment of Diabetic Cardiomyopathy, or DbCM, a fatal fibrosis of the heart.

Cassava Sciences is a clinical-stage biotechnology company that says its mission is to detect and treat neurodegenerative diseases, such as Alzheimer’s disease. “Its novel science is based on stabilizing-but not removing-a critical protein in the brain. The company’s product candidates have not been approved by any regulatory authority, and their safety, efficacy or other desirable attributes have not been established,” Cassava has stated.

Recent news on these stocks:

December 8

Rigel Pharmaceuticals and The University of Texas MD Anderson Cancer Center announced a multi-year strategic development collaboration to expand the evaluation of REZLIDHIA in acute myeloid leukemia and other hematologic cancers. The alliance brings together MD Anderson’s clinical research expertise with Rigel’s differentiated targeted molecule. Under the strategic collaboration, Rigel and MD Anderson will evaluate the potential of olutasidenib to treat newly diagnosed and relapsed or refractory patients with AML, higher-risk myelodysplastic syndromes, and advanced myeloproliferative neoplasms, in combination with other agents. The collaboration will also support the evaluation of olutasidenib as monotherapy in lower-risk MDS and as maintenance therapy in post-hematopoietic stem cell transplant patients.

Vertex Pharmaceuticals (VRTX) and CRISPR Therapeutics announced that the FDA has approved Casgevy, a CRISPR/Cas9 genome-edited cell therapy, for the treatment of sickle cell disease, or SCD, in patients 12 years and older with recurrent vaso-occlusive crises, or VOCs. “This approval means that for the first time, approximately 16,000 patients with SCD may be eligible for a durable one-time therapy that offers the potential of a functional cure for their disease by eliminating severe VOCs and hospitalizations caused by severe VOCs,” the companies stated. The administration of Casgevy requires specialized experience in stem cell transplantation; therefore, Vertex is engaging with experienced hospitals to establish a network of independently operated, authorized treatment centers, or ATCs, throughout the U.S. to offer Casgevy to patients. Additional ATCs will be activated in the coming weeks, the company noted. The use of Casgevy for the treatment of transfusion-dependent beta thalassemia, or TDT, in the U.S. remains investigational. Vertex has submitted a BLA to the U.S. FDA for the potential use of Casgevy for patients 12 years and older with TDT and has been assigned a Prescription Drug User Fee Act, or PDUFA, target action date of March 30, 2024. The press release contains no mention of a boxed warning for Casgevy; Bluebird Bio (BLUE), which also received FDA approval for a gene therapy for SCD, says the safety information for Lyfgenia included a boxed warning for hematologic malignancy.

December 7

Avid Bioservices reported Q2 EPS of (15c) against a consensus of (6c), and Q2 revenue of $25.4M against a consensus of $33.21M. “Second quarter revenues were impacted by a number of factors, requiring us to decrease our revenue guidance for the 2024 full fiscal year. With these factors now behind us, we are looking ahead to the second half of the year with some optimism. This outlook is driven in part by the fact that we expect revenue growth during the second half of the fiscal year, aided by our new business bookings of $35 million during the period. While we continue to see an increase in our late-stage project portfolio, which we view as critical to our medium and longer-term growth, we were also pleased to see some encouraging signs of early-stage programs advancing during the quarter despite the challenging macro environment,” stated Nick Green, CEO of Avid Bioservices. “We are pleased to have closed the quarter with a higher cash balance as compared to the end of the prior quarter, and while we have seen no requirement to utilize the credit revolver put in place earlier this year, during the quarter we agreed to extend the term through calendar Q3 2024. We were also pleased to complete construction of the cell and gene therapy (CGT) facility as planned, which also coincided with the signing of our second customer for the business. The CGT business also received further industry validation through our acceptance into the California Institute for Regenerative Medicine Industry Resource Partner Program. With the achievement of our CGT construction milestone, Avid has completed all phases of a broad multi-year expansion, and we are now well-positioned to meet the manufacturing needs of current and future clients advancing both mammalian and CGT products. As we stand today the business has revenue generating capacity of up to approximately $400M supported by a record high $199M backlog, which includes late phase programs that we anticipate will utilize a portion of this new capacity. “Despite the challenges of the first half of fiscal 2024, our current backlog and pipeline position us well to generate cash from operations in the near term, and significant growth in the medium-term and beyond. For these reasons, we believe the second half of the year holds great promise and opportunity for Avid.”

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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.