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: 

• Galmed Pharmaceuticals (GLMD), 7,518% surge in interest
• Applied Therapeutics (APLT), 1,909% surge in interest
• Capricor Therapeutics (CAPR), 845% surge in interest
• IGM Biosciences (IGMS), 395% surge in interest
• Corcept Therapeutics (CORT), 318% surge in interest
• Immunic (IMUX), 300% surge in interest
• Rhythm Pharmaceuticals (RYTM), 282% surge in interest
• Rocket Pharmaceuticals (RCKT), 248% surge in interest
• BioCardia (BCDA), 200% surge in interest

Pipeline and key clinical candidates for these companies:

Galmed is a clinical stage biopharmaceutical company focused on the development of Aramchol for liver and fibro-inflammatory diseases. The company has focused almost exclusively on developing Aramchol for the treatment of noncirrhotic nonalcoholic steatohepatitis, or NASH, and are currently developing Aramchol for Primary Sclerosing Cholangitis, or PSC, and exploring the feasibility of developing Aramchol for other fibro-inflammatory indications outside of liver disease.

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.

Capricor Therapeutics is a biotechnology company that says it is “dedicated to advancing transformative cell and exosome-based therapeutics to redefine the treatment landscape for rare diseases.” Lead product candidate, deramiocel, is an allogeneic cardiac-derived cell therapy that is currently advancing through Phase 3 clinical development for the treatment of Duchenne muscular dystrophy. 

IGM Biosciences is a clinical-stage biotechnology company committed to developing and delivering a new class of medicines to treat patients with cancer, autoimmune and inflammatory diseases and infectious diseases. IGM’s pipeline of clinical and preclinical assets is based on the IgM antibody, which has 10 binding sites compared to conventional IgG antibodies with only 2 binding sites. IGM also has an exclusive worldwide collaboration agreement with Sanofi to create, develop, manufacture, and commercialize IgM antibody agonists against oncology and immunology and inflammation targets.

Corcept’s focus on cortisol modulation and its potential to treat patients across a wide variety of serious disorders has led to the discovery of more than 1,000 proprietary selective cortisol modulators. Corcept’s advanced clinical trials are being conducted in patients with hypercortisolism, solid tumors, amyotrophic lateral sclerosis and non-alcoholic steatohepatitis. In February 2012, the company introduced Korlym, the first medication approved by the FDA for the treatment of patients with Cushing’s syndrome.

Immunic has a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases. The company is developing three small molecule products. Its lead development program, vidofludimus calcium, is a selective immune modulator that is currently being developed as a treatment option for multiple sclerosis, and primary sclerosing cholangitis. IMU-935 is targeted for development in psoriasis and castration-resistant prostate cancer. IMU-856, which targets the restoration of the intestinal barrier function, is targeted for development in diseases involving bowel barrier dysfunction.

Rhythm is a commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. Rhythm’s lead asset, IMCIVREE, an MC4R agonist designed to treat hyperphagia and severe obesity, is approved by the FDA for chronic weight management in adult and pediatric patients 6 years of age and older with monogenic or syndromic obesity due to pro-opiomelanocortin, proprotein convertase subtilisin/kexin type 1 or leptin receptor deficiency confirmed by genetic testing, or patients with a clinical diagnosis of Bardet-Biedl syndrome. Both the European Commission and the UK’s Medicines & Healthcare Products Regulatory Agency have authorized setmelanotide for the treatment of obesity and the control of hunger associated with genetically confirmed BBS or genetically confirmed loss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR deficiency in adults and children 6 years of age and above.

Rocket Pharmaceuticals is a fully integrated, late-stage biotechnology company focused on advancing a sustainable pipeline of investigational genetic therapies designed to correct the root cause of complex and rare disorders. Rocket’s multi-platform approach allows the company to design the optimal gene therapy for each indication, creating potentially transformative options that enable people living with devastating rare diseases to experience long and full lives.

BioCardia is a developer of cell and cell-derived therapies for cardiovascular and pulmonary disease. The company has two biotherapeutic platforms, CardiAMP autologous bone marrow-derived mononuclear cell therapy for cardiovascular indications and the NK1R+ allogeneic bone marrow-derived mesenchymal stem cell therapies for cardiovascular and pulmonary diseases.

Recent news on these stocks:

September 19

Galmed Pharmaceuticals announced that based on the recently published results from the Open-Label part of its Phase 3 NASH study, new scientific publications on the role of SCD1 as a critical metabolic signaling hub as well as an extended cash runway, it plans to broaden its drug development activities. The planned expansion consists of two additional programs over the next two years. One program aims to identify novel Aramchol-based drug combinations to overcome resistance to standard-of-care oncological treatments for patients with advanced colorectal and hepatic cancers. Another program aims to unravel new mechanisms of action that will allow the development of a novel Aramchol-based drug combination targeting cardiac fibrosis, or scarring of the heart, which occurs in many cardiovascular diseases that can lead to heart dysfunction and failure. The company plans on releasing new data from in-vitro and ex-vivo studies in these programs during the fourth quarter of 2024.

September 18

Applied Therapeutics announced an update on the ongoing New Drug Application, or NDA, review of govorestat for the treatment of Classic Galactosemia. The company recently completed its late-cycle review meeting with the FDA. The FDA communicated that an Advisory Committee meeting would no longer be required, which was previously tentatively scheduled for October 9, 2024. The FDA informed the company that the Priority Review of the NDA is continuing as planned with alignment on post-marketing requirements expected in October 2024. The previously announced Prescription Drug User Fee Act, PDUFA, target action date remains on track for November 28, 2024.

Piper Sandler raised the firm’s price target on Corcept Therapeutics to $67 from $38 and kept an Overweight rating on the shares. Following a survey of endocrinologists, the firm believes the Cushing’s syndrome space is poised to continue its expansion post Corcept’s presentation of prevalence data from the Phase IV CATALYST study. Endocrinologists envision a fairly wide patient footprint for relacorilant in the wake of the presentation of data from the Phase III GRACE study, the analyst told investors in a research note. Piper upped estimates for Corcept’s Cushing’s syndrome franchise and continues to expect relacorilant will drive much of the company’s sales growth over time.

H.C. Wainwright analyst Raghuram Selvaraju initiated coverage of Rhythm Pharmaceuticals with a Buy rating and $64 price target. Rhythm is commercial stage international biotech company with a marketed product targeting lucrative niches in both the U.S. and Europe, the analyst told investors in a research note. The firm noted that the company’s sole approved drug, Imcivree, which is a novel melanocortin-4 receptor agonist designed to treat hyperphagia and severe obesity, provides a “pipeline-in-a-product solution for a range of genetically driven, rare obesity-linked disorders.”

BioCardia has regained full compliance with the Nasdaq Capital Market’s Listing Requirements as required by the Hearing Panel’s decision on May 13, 2024. On September 17, 2024, BioCardia received notice from Nasdaq confirming that the Company has demonstrated compliance with Listing Rule 5550(b)(1) of The Nasdaq Stock Market. Accordingly, the Panel has determined to continue the listing of the Company’s securities on the Nasdaq Stock Market and is closing this matter.

September 17

Capricor Therapeutics announced it has entered into a binding term sheet with Nippon Shinyaku, a Japanese pharmaceutical company listed on the TYO, for the commercialization and distribution in Europe of Capricor’s lead asset, deramiocel, for the treatment of Duchenne muscular dystrophy, or DMD, a rare neuromuscular disease with limited treatment options. The potential transaction covered by the term sheet is similar to the existing commercialization and distribution agreements with Nippon Shinyaku in the United States and Japan with an opportunity for further product reach globally. In addition, Nippon Shinyaku has agreed to purchase approximately $15M of Capricor common stock at a 20% premium to the 60-day VWAP. Under the terms of the binding term sheet and further subject to finalization of a definitive agreement, which is expected to occur in the fourth quarter of 2024, Capricor will be responsible for the development and manufacturing of deramiocel for potential approval in all countries in the European Union, United Kingdom and several other countries in the region. Nippon Shinyaku will be responsible for the sales and distribution of deramiocel in those territories. Capricor will also receive an upfront payment of $20M subject to execution of the definitive agreement and there are potential additional development and sales-based milestone payments to Capricor of up to $715M and Capricor will receive a double-digit share of product revenue. Contemporaneously with the term sheet, Nippon Shinyaku has also agreed to purchase 2,798,507 shares of common stock at a price of $5.36 per share, which price represents a 20% premium to the 60-day volume-weighted average price of Capricor’s common stock, for an aggregate purchase price of approximately $15M. The closing of the offering is expected to take place on or about September 20. The company expects to use the proceeds from the transaction primarily to support product development as well as general, administrative and corporate purposes.

Rocket Pharmaceuticals announced that all patients have been enrolled in the global, pivotal Phase 2 clinical trial evaluating RP-A501 to treat male patients with Danon disease. After the two-patient safety run-in, followed by harmonized global site activations, the remaining 10 patients were enrolled across the United States and European Union within three months. Given the prevalence of Danon disease across regions, the Company plans to pursue regulatory filings concomitantly in the U.S. and ex-U.S. “From a clinical perspective, the important thing is that we are moving closer to the goal of having a treatment for patients with Danon disease,” said Barry H. Greenberg, MD, FHFSA, Director of the Advanced Heart Failure Treatment Program and Distinguished Professor of Medicine at UC San Diego Health. “I can attest to the excitement and anticipation within the Danon patient community for this novel, one-time treatment designed to improve cardiac abnormalities associated with Danon disease and help preserve normal cardiac function by delivering functional LAMP2B genes to the heart tissue. The rapid recruitment of the Phase 2 trial signifies the positive views of the study clinicians regarding this investigational therapy.”

September 16

EF Hutton analyst Jason Kolbert initiated coverage of Immunic with a Buy rating and $17 price target. Immunic is a pivotal Phase 3 biotechnology company developing a “potent” oral small molecule, IMU-838, for multiple sclerosis, the analyst tells investors in a research note. The firm believes IMU-838 can potentially introduce a new treatment paradigm in the multiple sclerosis space.

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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.