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: 

• Intra-Cellular Therapies (ITCI), 3,244% surge in interest
• Galera Therapeutics (GRTX), 1,187% surge in interest
• Vanda Pharmaceuticals (VNDA), 1,004% surge in interest
• Jaguar Health (JAGX), 262% surge in interest
• Sage Therapeutics (SAGE), 230% surge in interest
• Daré Bioscience (DARE), 192% surge in interest
• Corcept Therapeutics (CORT), 137% surge in interest
• Corbus Pharmaceuticals (CRBP), 61% surge in interest

Pipeline and key clinical candidates for these companies:

Intra-Cellular Therapies is a biopharmaceutical company working to understand how therapies affect the inner-workings of cells in the body. The company leverages its intracellular approach to “develop innovative treatments for people living with complex psychiatric and neurologic diseases,” it states.

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.

Vanda Pharmaceuticals is focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients.

Jaguar Health is a commercial stage pharmaceuticals company focused on developing novel, plant-based, sustainably derived prescription medicines for people and animals with GI distress, including chronic, debilitating diarrhea. Jaguar Health’s wholly owned subsidiary, Napo Pharmaceuticals, focuses on developing and commercializing proprietary plant-based human pharmaceuticals from plants harvested responsibly from rainforest areas. Their crofelemer drug product candidate is the subject of the OnTarget study, an ongoing pivotal Phase 3 clinical trial for prophylaxis of diarrhea in adult cancer patients receiving targeted therapy.

Sage Therapeutics is a biopharmaceutical company “fearlessly leading the way to create a world with better brain health.” The company’s mission is to “pioneer solutions to deliver life-changing brain health medicines, so every person can thrive,” Sage has stated.

Daré Bioscience is advancing products for women’s health, stating that the company’s mission is “to identify, develop and bring to market a diverse portfolio of differentiated therapies that prioritize women’s health and well-being, expand treatment options, and improve outcomes, primarily in the areas of contraception, fertility, and vaginal and sexual health.” Daré’s first FDA-approved product, XACIATO vaginal gel, is a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older, which is under a global license agreement with Organon. Daré’s portfolio also includes potential first-in-category candidates in clinical development: Ovaprene, a novel, hormone-free monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement with Bayer; Sildenafil Cream, 3.6%, a novel cream formulation of sildenafil to treat female sexual arousal disorder utilizing the active ingredient in Viagra; and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for hormone therapy following menopause.

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 liver disease. In February 2012, the company introduced Korlym, the first medication approved by the FDA for the treatment of patients with Cushing’s syndrome.

Corbus Pharmaceuticals is an oncology company “committed to connecting innovation to our purpose of improving lives by developing new medicines that target the nexus between the immune system and cancer.” Corbus’ current pipeline includes anti-integrin monoclonal antibodies that block activation of TGF-beta and small molecules that activate or inhibit the endocannabinoid system.

Recent news on these stocks:

April 17

Vanda Pharmaceuticals confirmed that, since March, it received several unsolicited proposals from Future Pak, to acquire all of the outstanding shares of Vanda. The most recent proposal from April 1 offered $7.25 – $7.75 per share, subject to certain terms and conditions. The Vanda board in consultation with its independent financial and legal advisors, consistent with its fiduciary duties, carefully reviewed the Conditional Proposals and unanimously concluded that they are not in the best interests of the company and its shareholders, as they significantly undervalue the company. The board believes the Conditional Proposals are opportunistic attempts to purchase the company’s shares at a discount to Vanda’s intrinsic value and would transfer significant value to Future Pak at the expense of Vanda shareholders, including approximately $6.751 per share in cash and marketable securities. Future Pak’s latest unsolicited proposal provides a mere 7%-15% premium to such cash balance, ascribing therefore very little value to the company’s significant revenue stream and pipeline.

Sage Therapeutics announced topline results from PRECEDENT, a double-blind, placebo-controlled Phase 2 study of the investigational oral medicine dalzanemdor, or SAGE-718, in people with mild cognitive impairment or MCI, in Parkinson’s Disease, or PD. The PRECEDENT Study did not meet its primary endpoint of demonstrating statistically significant difference from baseline in participants treated with once-daily dalzanemdor versus placebo on the Wechsler Adult Intelligence Scale Fourth Edition-IV, or WAIS-IV, Coding Test score at Day 42. Dalzanemdor was generally well-tolerated, and there were no new safety signals observed. “We are disappointed by the results of the Phase 2 PRECEDENT study given the significant burden of mild cognitive impairment on people and families affected by Parkinson’s Disease,” said Barry Greene, CEO. The PRECEDENT Study was a double-blind, placebo-controlled Phase 2 study in people with MCI in PD. The study is designed to evaluate the safety and efficacy of dalzanemdor (SAGE-718) dosed over 6 weeks. A total of 86 participants were enrolled and randomized. The PRECEDENT Study did not meet its primary endpoint of demonstrating statistically significant difference from baseline in participants treated with once-daily dalzanemdor versus placebo on the Wechsler Adult Intelligence Scale Fourth Edition-IV Coding Test score at Day 42.

April 16

Intra-Cellular Therapies announced positive topline results from Study 501 evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of major depressive disorder. Topline results from our second Phase 3 study, Study 502, are anticipated late in the second quarter of this year. “The positive Phase 3 results in MDD represent a significant step towards our goal of further establishing CAPLYTA as a first-choice treatment across mood disorders,” said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies. “We believe that these robust efficacy results coupled with its favorable safety and tolerability profile and convenient dosing make CAPLYTA a compelling option as an adjunctive treatment for MDD, if approved. At ITCI, we are committed to bringing improved treatment options to patients with major neuropsychiatric conditions through our efforts to expand CAPLYTA’s label and advance our pipeline.” Lumateperone 42 mg given once daily as adjunctive therapy to antidepressants met the primary endpoint in Study 501 by demonstrating a statistically significant and clinically meaningful reduction in the MADRS total score compared to placebo at Week 6. In the modified intent-to-treat study population, the least squares mean reduction from baseline for lumateperone 42 mg was 14.7 points, versus 9.8 points for placebo. Lumateperone 42 mg also met the key secondary endpoint in the study by demonstrating a statistically significant and clinically meaningful reduction in the CGI-S score compared to placebo at Week 6. Statistically significant efficacy was seen at the earliest time point tested and maintained throughout the study in both the primary and the key secondary endpoints.

Jaguar Health signed an exclusive five-year in-license agreement with United Kingdom-based Venture Life Group for Venture Life’s FDA-approved oral mucositis prescription product, Gelclair, for the U.S. market. Gelclair is a clinically proven, convenient, and easy to use gel that provides rapid and long-lasting pain relief and improves the ability of oral mucositis patients to eat, drink, swallow, speak and sleep. Gelclair also reduces the need to use parenteral feeding or opiate analgesics.

April 15

Corcept Therapeutics announced completion of enrollment in DAZALS, a randomized, double-blind, placebo-controlled Phase 2 trial of its proprietary selective cortisol modulator dazucorilant in patients with amyotrophic lateral sclerosis. DAZALS enrolled 249 patients, randomized 1:1:1 to receive either 150 mg of dazucorilant, 300 mg of dazucorilant or placebo daily for 24 weeks. The study’s primary endpoint is change from baseline in the ALS Functional Rating Scale-Revised, which measures motor impairment and functional deterioration in patients with ALS. Key secondary endpoints include overall survival and quality of life. DAZALS was conducted at sites in Europe, United States and Canada.

April 11

Dare Bioscience announced the publication of data from the postcoital test clinical study of Ovaprene in two original research articles in the journal Contraception. “We are very pleased to have the postcoital test study results for our investigational, hormone-free intravaginal contraceptive Ovaprene published in a leading reproductive health journal,” said Sabrina Martucci Johnson, President and CEO of Dare Bioscience. “Our published results show Ovaprene was safe and prevented essentially all sperm from entering the cervical canal across all women and cycles evaluated without disrupting the vaginal microbiome. PCT studies have been used as surrogate markers for contraceptive effectiveness and, based on comparable PCT studies, Ovaprene is expected to deliver efficacy approaching hormonal methods. The published results were seminal in enabling us to commence the pivotal Phase 3 clinical study of Ovaprene, which is now enrolling across the United States as we continue to advance this innovative candidate for women who want or need a hormone-free contraceptive.” The pivotal study is a single arm, open-label contraceptive efficacy study of Ovaprene(R) which aims to enroll sufficient participants across approximately 20 study sites in the U.S. to have approximately 250 participants complete approximately 12 months of use. Dare plans to provide updates on anticipated timing for study completion as enrollment progresses. If successful, Dare expects the pivotal study to support marketing approvals of Ovaprene in the U.S. and other countries. In July 2021, Dare entered into a Cooperative Research and Development Agreement with the U.S. Department of Health and Human Services, as represented by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, part of the National Institutes of Health to collaborate on the pivotal Phase 3 study of Ovaprene. The agreement gives Dare access to the contraceptive clinical trial expertise of NICHD’s Contraceptive Clinical Trial Network while also sharing the costs of the Phase 3 pivotal study with NICHD. In January 2020, Dare and Bayer announced an exclusive licensing agreement for U.S. commercial rights to Ovaprene. Under the agreement, Dare received an upfront payment and access to Bayer’s extensive clinical and market capabilities while retaining control over Ovaprene’s development and regulatory approval process. Bayer received the right to obtain exclusive rights to commercialize the product in the U.S. following completion of the pivotal clinical trial being undertaken by Dare if Bayer, in its sole discretion, pays Dare $20 million. In addition, Dare may receive from Bayer up to $310 million in commercial milestone payments, plus double-digit, tiered royalties on net sales. If Ovaprene is approved by the FDA, it could be the first monthly hormone-free contraceptive product for women and a first-in-category option for women seeking a hormone-free, self-administered and monthly birth control method.

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.