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: 

• TG Therapeutics (TGTX), 277% surge in interest
• Ascendis Pharma (ASND), 268% surge in interest
• Cabaletta Bio (CABA), 164% surge in interest
• Incyte (INCY), 152% surge in interest
• Eyenovia (EYEN), 113% surge in interest

Pipeline and key clinical candidates for these companies:

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.

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

Cabaletta Bio is focused on the discovery and development of engineered T cell therapies that have the potential to provide a deep and durable, perhaps curative, treatment for patients with autoimmune diseases. The CABA platform encompasses chimeric antigen receptor T cells for autoimmunity and Cabaletta Bio’s proprietary chimeric autoantibody receptor T cells.

Incyte is a global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics.

Eyenovia is an ophthalmic pharmaceutical technology company developing a pipeline of microdose array print therapeutics. Eyenovia is currently focused on the late-stage development of microdosed medications for mydriasis, presbyopia, and myopia progression.

Recent news on these stocks:

May 2

Incyte reported Q1 EPS of 37c against a consensus of 75c, and Q1 revenue of $808.7M against a consensus of $857.52M ."Our first quarter results demonstrate continued year-over-year double-digit revenue growth driven by Jakafi, which grew across all indications, and Opzelura, which is on track to become one of the most successful dermatology launches in recent years. In addition, we further expanded our commercial portfolio with several regulatory approvals including Opzelura for vitiligo in Europe." said Herve Hoppenot, Chief Executive Officer, Incyte. "Furthermore, in Q1 we made a decision to focus our development efforts on eight programs that have high potential value for us and discontinued six other programs. This allows us to optimize our allocation of resources on programs that can have a high impact for patients and for Incyte."

May 1

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."

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."

Cabaletta Bio announced that the FDA has granted Fast Track Designation for CABA-201, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy, designed to deplete CD19-positive B cells and improve disease activity in patients with systemic lupus erythematosus and lupus nephritis. "Despite advances over the last few decades, treatment options for SLE remain inadequate. There are currently no curative options available that achieve durable disease remission. Existing therapies typically result in general immunosuppression, require chronic administration, and are often administered in conjunction with steroids and other immunosuppressive medications to reduce disease burden, which can leave patients with continued disease activity, treatment-associated side effects, and impaired quality of life," said David J. Chang, M.D., Chief Medical Officer of Cabaletta. "We believe the FDA’s decision to grant Fast Track Designation for CABA-201 underscores the unmet need for a treatment that has the potential to provide deep and durable responses for people living with lupus and potentially other autoimmune diseases where B cells contribute to disease. We look forward to initiating the Phase 1/2 trial for CABA-201 and further evaluating its therapeutic potential for patients in need."

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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