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: 

• Applied Therapeutics (APLT), 1,181% surge in interest
• Atara Biotherapeutics (ATRA), 1,117% surge in interest
• Spero Therapeutics (SPRO), 910% surge in interest
• Revance Therapeutics (RVNC), 353% surge in interest
• Immunogen (IMGN), 169% surge in interest

Pipeline and key clinical candidates for these companies:

Applied Therapeutics says it 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.

Atara is “harnessing the natural power of the immune system to develop off-the-shelf cell therapies for difficult-to-treat cancers and autoimmune conditions, including multiple sclerosis, that can be rapidly delivered to patients within days. With cutting-edge science and differentiated approach, Atara is the first company in the world to receive regulatory approval of an allogeneic T-cell immunotherapy.”

Spero Therapeutics is focused on identifying, developing, and commercializing novel treatments for serious bacterial infections, including MDR bacterial infections and rare diseases. Spero is developing SPR720 as a novel investigational oral candidate antimicrobial for the treatment of a rare, orphan pulmonary disease caused by non-tuberculous mycobacterial infections. Tebipenem HBr is an investigational oral carbapenem candidate antimicrobial in development for the treatment of cUTI, including pyelonephritis, including infections caused by MDR pathogens in adult patients who have limited oral treatment options; tebipenem HBr is not FDA-approved. Spero is developing SPR206 as an investigational intravenous-administered next-generation polymyxin product candidate developed from its potentiator platform, which is in development to treat MDR Gram-negative infections in the hospital setting.

Revance is a biotechnology company whose aesthetics portfolio includes Daxxify for injection, the RHA Collection of dermal fillers, and OPUL, the “first-of-its-kind Relational Commerce platform for aesthetic practices.” Revance has also partnered with Viatris to develop a biosimilar to Botox, which will compete in the existing short-acting neuromodulator marketplace. Revance’s therapeutics pipeline is currently focused on muscle movement disorders including evaluating Daxxify in two debilitating conditions, cervical dystonia and upper limb spasticity.

ImmunoGen says it is “developing the next generation of antibody-drug conjugates to improve outcomes for cancer patients.” By generating targeted therapies with enhanced anti-tumor activity and favorable tolerability profiles, the company “aims to disrupt the progression of cancer and offer patients more good days,” ImmunoGen states.

Recent news on these stocks:

July 31

Spero Therapeutics received a written agreement from the U.S. Food and Drug Administration, under a Special Protocol Assessment, on the design and size of PIVOT-PO, a pivotal Phase 3 clinical trial of tebipenem HBr in patients with complicated urinary tract infection, including acute pyelonephritis. PIVOT-PO is a global, randomized, double-blind, pivotal Phase 3 clinical trial of oral tebipenem HBr vs. IV imipenem cilastatin, in hospitalized adult patients with cUTI/AP. The primary efficacy endpoint will be overall response at the test-of-cure visit. The primary analysis for the trial will be an assessment of non-inferiority in the microbiological intention-to-treat population, based on a 10% NI margin, which is consistent with FDA guidance for non-inferiority studies in cUTI/AP. The FDA has indicated that positive and persuasive results from PIVOT-PO, along with previously completed studies, could be sufficient to support approval of tebipenem HBr as a treatment for cUTI, including pyelonephritis, for a limited use indication. Spero is also eligible to receive the following milestone/royalty payments under the terms of its license agreement with GSK, conditional upon achievement of certain progression of milestones: up to an additional $120 million in development milestones as the Phase 3 clinical trial progresses; up to $150 million in potential commercial milestones based on first commercial sales; up to $225 million in potential sales-based milestones; and low-single digit to low- double digit tiered royalties on net product sales of tebipenem HBr in all territories, except Japan and certain other Asian countries.

Canaccord raised the firm’s price target on ImmunoGen to $25 from $23 and kept a Buy rating on the shares following the company’s Q2 earnings report. The firm noted the company’s ELAHERE posted excellent net sales of $77.4M versus a $38.7M consensus, indicating a very rapid uptake. Avastin combination use is a promising driver, which should expand. Also, the firm believes that PICCOLO data YE23 should pave the way for usage in platinum sensitive patients.

July 25

Applied Therapeutics provided a regulatory update on the Galactosemia program, including updates on the regulatory paths for govorestat in both the U.S. and Europe. The United States FDA has granted a Pre-New Drug Application meeting to be held this summer to discuss a potential NDA submission for govorestat for the treatment of Galactosemia. The company believes that the clinical efficacy demonstrated to date, combined with galactitol biomarker data and a favorable safety profile, may support an NDA submission, and is seeking feedback from the FDA and alignment on the details of the submission. If the FDA is in agreement on the potential path forward to approval, the company will plan to submit an NDA in the fall. The company expects to provide a further update following the meeting. Regarding regulatory submission plans in Europe, Applied Therapeutics and its European commercial partner, Advanz Pharma, met with the European Medicines Agency rapporteurs earlier this summer, and plan to proceed with an EMA Marketing Authorization Application submission as expeditiously as possible. The EMA submission is anticipated in the fall in order to provide sufficient time for approval of the Pediatric Investigational Plan, as well as incorporation of rapporteur comments and suggestions from the meeting.

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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.