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: 

• MacroGenics (MGNX), 814% surge in interest
• Matinas BioPharma (MTNB), 369% surge in interest
• Akebia Therapeutics (AKBA), 160% surge in interest
• Jazz Pharma (JAZZ), 153% surge in interest
• Ligand Pharma (LGND), 122% surge in interest
• Biomarin Pharmaceuticals (BMRN), 108% surge in interest
• Esperion (ESPR), 94% surge in interest
• Fibrogen (FGEN), 90% surge in interest
• Mannkind (MNKD), 88% surge in interest

Pipeline and key clinical candidates for these companies:

MacroGenics is a biopharmaceutical company focused on developing, manufacturing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. “The combination of MacroGenics’ technology platforms and protein engineering expertise has allowed the company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies,” MacroGenics states.

Matinas BioPharma is a biopharmaceutical company focused on delivering groundbreaking therapies using its lipid nanocrystal platform delivery technology. Matinas’ lead LNC-based therapy is MAT2203, an oral formulation of the broad-spectrum antifungal drug amphotericin B, which although highly potent, can be associated with significant toxicity. MAT2203 was successfully evaluated in the completed Phase 2 EnACT study in cryptococcal meningitis, meeting its primary endpoint and achieving robust survival. MAT2203 will be further evaluated as an oral step-down monotherapy treatment following IV amphotericin B in a single pivotal Phase 3 study in the treatment of aspergillosis in persons with limited treatment options who are unable to be treated with azoles for reasons related to drug-drug interactions, resistance or for whom these antifungal agents are unable to be used for other clinical reasons.

Akebia Therapeutics is a fully integrated biopharmaceutical company that says its purpose is “to better the lives of people impacted by kidney disease.”

Jazz Pharmaceuticals is a biopharmaceutical company who says its purpose is to “innovate to transform the lives of patients and their families.” The company has a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. Within these therapeutic areas, Jazz says it is “identifying new options for patients by actively exploring small molecules and biologics, and through innovative delivery technologies and cannabinoid science.”

Ligand Pharmaceuticals is focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines. Ligand’s Captisol platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Ligand’s Pelican Expression Technology is a “validated and scalable” platform for recombinant protein production that is suited for complex, large-scale protein production “where traditional systems are not,” the company states.

BioMarin is focused on therapies for people with serious and life-threatening genetic diseases and medical conditions. The company’s portfolio consists of eight commercial products and multiple clinical and preclinical product candidates for the treatment of various diseases.

Esperion discovers, develops, and commercializes innovative medicines and combinations to lower cholesterol, especially for patients whose needs aren’t being met by the status quo.

FibroGen 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.

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

Recent news on these stocks:

November 8

Jazz Pharmaceuticals reported Q3 adjusted EPS of $4.84, consensus $4.90, and Q3 revenue of $972M, consensus $966.26M. “We have once again delivered strong financial results from increasingly diversified revenue streams and remain well-positioned for long-term growth. Low-sodium Xywav grew 30% year-over-year despite additional competition, with continued compelling adoption across both narcolepsy and idiopathic hypersomnia. Epidiolex is well-positioned to deliver on its blockbuster potential as a differentiated treatment option with multiple ex-U.S. launches expected through 2024. Oncology net product sales grew 17% year-over-year and our Oncology therapeutic area remains on course to reach approximately $1B in annual revenue this year,” said CEO Bruce Cozadd. “We have raised our 2023 total revenue guidance yet again, as well as our Oncology revenue guidance, at the mid-points. We are increasing our investment in R&D based on our confidence in zanidatamab to raise the standard of care for patients and create long-term value for Jazz. Our disciplined capital deployment and strong execution has also enabled us to increase investment in our key commercial franchises, while delivering on our full year GAAP net income and non-GAAP adjusted net income guidance. We remain well-positioned to achieve Vision 2025.” “We now expect as many as five late-stage readouts from our robust R&D pipeline by the end of 2024 and continue to progress multiple early-stage programs in both neuroscience and oncology. We plan to initiate the zanidatamab rolling BLA submission this year for accelerated approval in 2L BTC and expect to complete it in the first half of 2024. Our pivotal, Phase 3 trial of Epidyolex in Japan is progressing well and we now anticipate top-line data in the second half of 2024. Nearer term catalysts include the anticipated readout of JZP150 Phase 2 top-line data in PTSD and initial proof-of-concept from JZP441 in healthy volunteers. The breadth and depth of our expanded R&D pipeline continues to add to the diversification and transformation of our company together with the ability to improve patients’ lives,” said executive VP Rob Iannone, global head of research and development.

Ligand reported Q3 EPS of (74c) vs. 2c last year. Reported Q3 revenue of $32.9M, consensus $27.2M. “We’re pleased to report another quarter of strong financial results and we are now actively executing on our investment strategy as evidenced by the recent Tolerance, Ovid, Novan and Primrose transactions, in which we collectively invested over $75M in Q3 and early Q4 2023,” said Todd Davis, CEO of Ligand. “We have a strong balance sheet and are generating positive cash flow which positions us advantageously in this market to further build a robust portfolio of assets that are expected to drive future revenue growth. We look forward to sharing our long term financial forecast at our upcoming Investor and Analyst Day scheduled for December 12th in New York City.”

November 7

Guggenheim upgraded MacroGenics to Buy from Neutral with a $12 price target following the company’s Q3 earnings report. The company’s Phase 2 TAMARACK study has completed enrollment ahead of schedule and the company now heads into “a nearer-term potential catalyst” in the first half of 2024, the analyst tells investors. In context of all this upcoming catalyst, as well as other developments and the company’s roughly $5.40 per share in cash and 2026 cash runway, the firm sees the risk-reward as “skewed to the upside from current levels.”

Matinas BioPharma announces positive results from an in vivo animal study of an oral LNC formulation of docetaxel, a well-known chemotherapeutic agent used in the management of multiple metastatic and unresectable tumors. Currently, docetaxel is administered intravenously and can be associated with significant side effects and toxicities. “We are excited to report new in vivo data demonstrating the therapeutic efficacy of an oral LNC formulation of docetaxel,” said Dr. James Ferguson, Chief Medical Officer of Matinas. “We believe this is a step forward for Matinas’ unique drug delivery platform, taking us beyond our successes in infectious disease by providing convincing proof-of-principle that orally administered LNCs can effectively target tumors and successfully deliver small molecule therapeutics to those tumors.” Key Findings: Efficacy: Anti-tumor effect of daily oral LNC docetaxel in both the high-dose and low-dose arms were comparable to IV docetaxel with statistically significant reductions in tumor volume compared with untreated controls at Day 14, and similar reductions in tumor weight at Day 14. Safety: No systemic toxicities were noted. Body weight was stable over treatment duration and hematologic parameters were similar to untreated controls.

Activist investor Elliott Investment Management has built a stake in BioMarin Pharmaceutical and has been in discussions with the company for months about its future, Svea Herbst-Bayliss of Reuters reported, citing two people familiar with the matter. Elliott has spent over $1B on the stake in BioMarin, sources told Reuters, which noted that the nature of the conversations and any demands the hedge fund may have made could not be learned.

Esperion reported Q3 EPS of (37c), consensus (43c), and Q3 revenue of $34.0M, consensus $29.58M. “We continued to deliver on our commitments during Q3 of 2023, posting strong revenue growth, prudently managing expenses, and executing on our strategic plan to maximize the blockbuster potential of NEXLETOL and NEXLIZET,” said CEO Sheldon Koenig. “We built upon the momentum we generated in the first half of the year, continuing to deliver prescription growth even with our narrow indication and promotional footprint. We made progress toward label expansion, receiving FDA acceptance of our cardiovascular risk reduction indication submissions in the U.S. and with the EMA review process on track in Europe. We anticipate approval in the U.S. by March 31 and in Europe in the first half of 2024.”

MannKind reported Q3 EPS of 1c, consensus (2c), and Q3 revenue of $51.3M, consensus $50.72M. “We had another strong quarter of revenue growth with total revenues exceeding $51M,” said CEO Michael Castagna. “With the continued success of Tyvaso DPI, we believe we will continue to have the ability to execute our commercial operating plan and fund our pipeline development efforts.”

November 6

FibroGen reported Q3 EPS of (65c), consensus (68c), and Q3 revenue of $40.13M, consensus $36.84M. “Today, we reported another quarter of strong roxadustat volume growth in China, achieving the highest ever value share, at 42%, in the anemia of CKD category,” said Thane Wettig, Chief Executive Officer, FibroGen. “The continued strength of our China business, sooner than expected realization of our corporate cost reduction efforts and our strong balance sheet provide us a cash runway into 2026. Over the next 12 months, we will obtain data read-outs from our two late-stage pancreatic cancer trials, start a Phase 2 metastatic castrate-resistant prostate cancer trial, and file two immuno-oncology INDs. These unique and exciting programs, combined with the quality of our talented colleagues, provide a strong foundation to create significant value for shareholders relative to our current valuation.”

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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.