Biotech Alert: Searches spiking for these stocks today

Stay ahead of biotech stocks seeing a surge in interest from retail and financial professional investors with this exclusive recap from The Fly

These names in the biotech sector are seeing a substantial increase in search activity today, as determined by InvestingChannel. They include:

• Minerva Neurosciences (NERV), 1,133% surge in interest
• Iveric Bio (ISEE), 636% surge in interest
• Urogen (URGN), 338% surge in interest
• Ascendis Pharma (ASND), 192% surge in interest
• TG Therapeutics (TGTX), 152% surge in interest

Pipeline and key clinical candidates for these companies:

Minerva Neurosciences is a clinical-stage biopharmaceutical company focused on developing product candidates to treat central nervous system, or CNS, diseases. Minerva’s portfolio of compounds includes roluperidone, or MIN-101, in clinical development for negative symptoms of schizophrenia, and MIN-301 for Parkinson’s disease.

Iveric Bio is focused on the discovery and development of novel treatments for retinal diseases with significant unmet medical needs. The company says it is "committed to having a positive impact on patients’ lives by delivering high-quality, safe and effective treatments designed to address debilitating retinal diseases including earlier stages of age-related macular degeneration."

UroGen is dedicated to developing and commercializing solutions that treat urothelial and specialty cancers. UroGen has developed RTGel reverse-thermal hydrogel, a proprietary sustained release, hydrogel-based platform technology that it says "has the potential to improve therapeutic profiles of existing drugs." UroGen’s first commercial product Jelmyto for pyelocalyceal solution, and investigational treatment UGN-102 for intravesical solution for patients with low-grade non-muscle invasive bladder cancer, are designed to ablate tumors by non-surgical means.

Ascendis Pharma says it is applying its "innovative platform technology to build a leading, fully integrated, global biopharmaceutical company focused on making a meaningful difference in patients’ lives." The company uses its TransCon technologies to "create new and potentially best-in-class therapies," Ascendis adds.

TG Therapeutics is focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG has received approval from the FDA for Briumvi, for the treatment of adult patients with relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Recent news on these stocks:

May 1

Minerva Neurosciences announced that the FDA filed the company’s New Drug Application, NDA, for roluperidone for the treatment of negative symptoms in patients with schizophrenia on April 27, 2023. The decision to file the NDA follows the company’s request for formal dispute resolution and appeal of FDA’s October 2022 refuse to file letter. The issues cited in the refuse-to-file decision included those discussed at the type C meeting in April 2022. In granting the appeal, the FDA deciding official agreed with the company that the issues cited in the refuse-to-file decision should be considered during FDA’s review of the NDA. "We thank the FDA for its thoughtful review and consideration of our materials submitted during the formal dispute resolution process. We look forward to continuing to work with the FDA with the ultimate goal of obtaining approval of roluperidone as the first approved treatment for negative symptoms of schizophrenia for the benefit of patients, their families, caregivers, and physicians," said Dr. Remy Luthringer, CEO of Minerva.

UroGen Pharma highlighted the results of a sub-analysis from the first and largest post-commercial utilization review of JELMYTO, or mitomycin, for pyelocalyceal solution at the American Urological Association Meeting 2023. Upper Tract Urothelial Cancer, or UTUC, patients in this retrospective study who underwent complete endoscopic ablation followed by JELMYTO were more likely to be disease-free at first endoscopic evaluation than those who underwent chemoablation alone — 69% vs. 40%, whereas in the Phase 3 OLYMPUS study of JELMYTO, LG-UTUC patients in the primary chemoablation setting achieved a 59% complete response rate at first endoscopic evaluation. Response at primary endoscopic evaluation was defined as no visual tumor or negative biopsy. The rate of ureteral stenosis for those in this study who underwent complete endoscopic ablation followed by JELMYTO treatment was 23%. Ureteral stenosis was defined as a condition requiring ureteral stent or nephrostomy, or that would typically warrant stent or nephrostomy. In their publication the authors noted that longer follow-up rate is needed to determine if JELMYTO after complete endoscopic ablation of UTUC will lead to durable disease-free interval. The limitations of this study include the retrospective design, lack of a control group, the lack of a centralized pathology review, and standardized clinicopathologic assessment. Other limitations include: the assumption that complete endoscopic ablation resulted in complete tumor destruction, though data from early second-look ureteroscopy after endoscopic ablation show in-field recurrences suggesting incomplete tumor ablation; follow-up was short and the interval between surveillance ureteroscopy after initial post-treatment evaluation of surveillance was not uniform amongst centers, which may lead to bias in survivorship data; and tumor size prior to endoscopic ablation was not accounted for in this study and may have biased patients with lower tumor volume to undergo complete endoscopic ablation. To further explore the full potential of JELMYTO for the treatment of patients with UTUC, investigators are in the process of enrolling the prospective and retrospective uTRACT Registry to capture data in a large-scale, standardized manner to report further on patient outcomes following JELMYTO treatment including longitudinal follow-up.

Ascendis Pharma announced that the FDA has issued a complete response letter for the TransCon PTH New Drug Application, NDA, for the treatment of adults with hypoparathyroidism. In the letter, the FDA cited concerns related to the manufacturing control strategy for variability of delivered dose in the TransCon PTH drug/device combination product. The FDA did not express concern about the clinical data submitted as part of the NDA package and no new preclinical studies, or Phase 3 clinical trials to evaluate safety or efficacy, were requested in the letter. Ascendis will request a Type A meeting with the FDA as soon as possible to agree on the best path forward. The company said, "As recently announced, 145 of 154 clinical trial participants continue treatment with TransCon PTH for up to 3 years, and the U.S. Expanded Access Program continues to enroll new patients. In the clinical trials, TransCon PTH has been generally well tolerated, with no discontinuations related to study drug. We anticipate a European Commission decision on our MAA during the fourth quarter of 2023. If approved, we are planning our first EU launch in Germany in early 2024. In addition, we expect to enroll the first patient in a German early access program, if approved, during the second quarter of 2023."

TG Therapeutics reported Q1 EPS of (28c) against a consensus of (37c), and reported Q1 revenue of $7.803M against a consensus of $3.38M. Michael Weiss, the company’s CEO, stated, "2023 is off to an exciting start for us at TG. With the U.S. approval and commercial launch of BRIUMVI, we are excited to be able to offer patients the first and only anti-CD20 monoclonal antibody approved for relapsing forms of multiple sclerosis that can be administered in a one-hour infusion, twice a year, following the starting dose, which are some of the attributes that support our belief in BRIUMVI’s best-in-class potential in multiple sclerosis. It’s gratifying to see that the pre-launch enthusiasm for BRIUMVI is translating into the commercial setting and the feedback we have heard from both healthcare providers and patients has been highly encouraging." Weiss continued, "Overall, I believe our team is doing a fantastic job and I am pleased to share that in our first partial quarter, essentially two months of commercial availability, we generated approximately $8M in net sales. The early launch of BRIUMVI has exceeded our internal expectations, and we believe the momentum will continue to build throughout the year."

April 30

Astellas Pharma and Iveric Bio announced that on April 29, the companies entered into a definitive agreement under which Astellas through Berry Merger Sub, a wholly-owned subsidiary of Astellas US Holding, has agreed to acquire 100% of the outstanding shares of Iveric Bio for $40 per share in cash for a total equity value of approximately $5.9B. In the acquisition, Iveric Bio will become an indirectly wholly-owned subsidiary of Astellas. The total equity value of Iveric Bio in the acquisition assumes that there are approximately 148.2M outstanding shares of Iveric Bio common stock on a fully diluted basis. The purchase price represents a premium of 64% to Iveric Bio’s unaffected closing share price of $24.33 on March 31, and a premium of 75% to Iveric Bio’s 30 trading day volume weighted average price as of March 31. The boards of both companies have unanimously approved the transaction. Astellas expects that the acquisition of Iveric Bio will not only contribute to Astellas’ fiscal 2025 revenue targets set in its Corporate Strategic Plan 2021, but also, that ACP in conjunction with fezolinetant and PADCEV, is anticipated to be a revenue-generating pillar to help compensate for the decline in sales of XTANDI due to anticipated patent expiration later this decade. The completion of the acquisition is not subject to a financing condition. Astellas does not anticipate making any change in its dividend policy following the acquisition. The closing of the proposed acquisition is subject to approval by Iveric Bio’s stockholders and other customary closing conditions, including receipt of required regulatory approvals. The companies expect to complete the acquisition in Q2 of Astellas’ fiscal year.

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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.

Keywords: biotech, biotech sector, biotech alert, investingchannel, XBI, SPDR S&P Biotech ETF