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: 

• Eloxx Pharmaceuticals (ELOX), 5,641% surge in interest
• Athenex (ATNX), 1,150% surge in interest
• Oramed Pharmaceuticals (ORMP), 831% surge in interest
• Xenetic Biosciences (XBIO), 750% surge in interest
• Sarepta Therapeutics (SRPT), 295% surge in interest

Pipeline and key clinical candidates for these companies:

Eloxx Pharmaceuticals’ lead investigational product candidate, ELX-02, is a small molecule drug candidate designed to restore production of full-length functional proteins. It is in clinical development, focusing on cystic fibrosis. The FDA has granted Fast Track designation for ELX-02 for the treatment of CF patients with nonsense mutations. In addition, ELX-02 has also been granted Orphan Drug Designation for the treatment of CF patients with nonsense mutations by the FDA and orphan medicinal product designation by the European Commission.

Athenex is a global clinical-stage biopharmaceutical company that says it is "dedicated to becoming a leader in the discovery, development, and commercialization of next generation cell therapy drugs for the treatment of cancer." The company’s current clinical pipeline is derived mainly from cell therapy, based on NKT cells and Orascovery, based on a P-glycoprotein inhibitor.

Oramed Pharmaceuticals calls itself "a platform technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection." The company’s novel Protein Oral Delivery technology is designed to protect drug integrity and increase absorption. Oramed has offices in the United States and Israel.

Xenetic Biosciences is a biopharmaceutical company focused on advancing innovative immune-oncology technologies addressing hard to treat cancers. The company’s DNase platform is designed to improve outcomes of existing treatments, including immunotherapies, by targeting neutrophil extracellular traps, which have been implicated in cancer progression and resistance to cancer treatments. Xenetic is currently focused on advancing its systemic DNase program into the clinic as an adjunctive therapy for pancreatic carcinoma and locally advanced or metastatic solid tumors.

Sarepta Therapeutics engineers precision genetic medicine for rare diseases. The company holds leadership positions in Duchenne muscular dystrophy, or DMD, and limb-girdle muscular dystrophies, or LGMDs, and currently has more than 40 programs in various stages of development. Sarepta’s pipeline is driven by its multi-platform Precision Genetic Medicine Engine in gene therapy, RNA and gene editing.

Recent news on these stocks:

May 16

H.C. Wainwright downgraded Xenetic Biosciences to Neutral from Buy without a price target post the Q1 results. The company’s second reverse-split in four years, combined with a lack of catalysts "to shore up the shares," could continue to erode the stock following the reverse, the analyst tells investors in a research note. The firm has no visibility as to the timing of entry of Xenetic’s lead DNAse candidate into the clinic and initial path forward.

May 15

Eloxx Pharmaceuticals reported Q1 EPS of ($2.88) vs. ($5.36) last year. The company stated: "As of March 31, 2023, we had unrestricted cash and cash equivalents of $4.9 million. In March 2023, we amended the terms of the Hercules Term Loan Agreement and repaid $7.5 million of the outstanding principal. The minimum qualified cash balance requirement was reduced to $2.25 million and the interest only payment period was extended to September 1, 2023, at which time the company will be required to begin making principal payments. Assuming that we initiate Phase 3 clinical trial activities in the third quarter of 2023, our expectation is that our current cash position and assuming maintaining compliance with our debt covenants, will be sufficient to fund our operations into the third quarter of 2023." "We are approaching a significant milestone for Eloxx, with topline data, including kidney biopsy results, expected for ELX-02 in Alport syndrome in the coming weeks," said Sumit Aggarwal, CEO. "In addition, ZKN-013, our lead TURBO-ZM(TM) based molecule, is the first program developed from hit to lead and our excitement for the program continues to grow. Eloxx has additional promising TURBO-ZM based discovery programs in cystic fibrosis and in certain cMYC-overexpressing cancers."

Oramed Pharmaceuticals announced that Hefei Tianhui Biotechnology Co. Ltd., a strategic partner of Oramed, has successfully completed its Phase 3 trials of oral insulin in type 2 diabetes in China under a differentiated study protocol. HTIT is now moving toward regulatory approval and has submitted the data to the National Medical Products Administration. Oramed has recently completed an analysis of the data from its U.S.-based, Phase 3 trial, ORA-D-013-1, for the treatment of type 2 diabetes. This analysis found that subpopulations of patients with pooled specific parameters, such as body mass index, baseline HbA1c, age, gender and body weight, responded well to oral insulin. These subsets exhibited an over 1% placebo adjusted, statistically significant, reduction in HbA1c. The significant impact of baseline BMI on the responder group within the U.S. Phase 3 trial aligns with the positive data from the HTIT trial in China. The U.S. subpopulation and the Chinese general trial population shared a very similar baseline BMI.

May 13

Sarepta Therapeutics announced that the Food and Drug Administration Cellular, Tissue and Gene Therapies Advisory Committee voted 8 to 6 in support of accelerated approval of SRP-9001 for the treatment of ambulatory patients with Duchenne muscular dystrophy with a confirmed mutation in the DMD gene. SRP-9001 is intended to treat the underlying cause of Duchenne, which is characterized by mutations in the dystrophin gene that results in the lack of dystrophin protein. In the absence of dystrophin, which is required to strengthen and protect muscles, muscles become weakened and damaged, the company said in a statement. "The committee’s positive vote is based on the evaluation of the totality of evidence including the SRP-9001 product design as well as biological and empirical data," it added. The Biologics License Application for SRP-9001 is currently under priority review by the FDA with a regulatory action date of May 29. "With the May 29 action date our top priority, we will work collaboratively with the FDA to complete the review of our BLA for SRP 9001," said Doug Ingram, CEO of Sarepta.

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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.