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: 

• AC Immune (ACIU), 5,009% surge in interest
• Fulcrum Therapeutics (FULC), 343% surge in interest
• Verrica Pharmaceuticals (VRCA), 198% surge in interest
• Incyte (INCY), 87% surge in interest
• Vaxart (VXRT), 67% surge in interest
• Novavax (NVAX), 26% surge in interest

Pipeline and key clinical candidates for these companies:

AC Immune is a clinical-stage biopharmaceutical company and a global leader in precision prevention for neurodegenerative diseases, including Alzheimer’s disease, Parkinson’s disease, and NeuroOrphan indications driven by misfolded proteins. The company’s two clinically validated technology platforms, SupraAntigen and Morphomer, fuel its broad and diversified pipeline of first- and best-in-class assets, which currently features sixteen therapeutic and diagnostic programs, including five in Phase 2 development and one in Phase 3. AC Immune has a strong track record of securing strategic partnerships with leading global pharmaceutical companies, resulting in substantial non-dilutive funding to advance its proprietary programs and >$4.5B in potential milestone payments plus royalties.

Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases in areas of high unmet medical need. Fulcrum’s two lead programs in clinical development are losmapimod, a small molecule in development for the treatment of facioscapulohumeral muscular dystrophy, and pociredir, a small molecule designed to increase expression of fetal hemoglobin and in development for the treatment of sickle cell disease.

Verrica is a dermatology therapeutics company developing medications for skin diseases requiring medical interventions. On July 21, 2023, Verrica’s lead product, Ycanth, became the first treatment approved by the FDA to treat pediatric and adult patients with molluscum contagiosum, a highly contagious viral skin infection affecting approximately 6 million people in the United States, primarily children. VP-102 is also in development to treat common warts and external genital warts, two of the largest unmet needs in medical dermatology. Verrica is developing VP-103, its second cantharidin-based product candidate, for the treatment of plantar warts. Verrica has also entered a worldwide license agreement with Lytix Biopharma AS to develop and commercialize VP-315 for dermatologic oncology conditions.

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

Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart believes that its proprietary pill vaccine delivery platform is “suitable to deliver recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications,” the company has stated. Vaxart’s development programs currently include pill vaccines designed to protect against norovirus, coronavirus, seasonal influenza, and respiratory syncytial virus, or RSV, as well as a therapeutic vaccine for human papillomavirus, or HPV, Vaxart’s first immune-oncology indication.

Novavax says it promotes improved health by discovering, developing and commercializing innovative vaccines to protect against serious infectious diseases. Novavax offers a differentiated vaccine platform that combines a recombinant protein approach, innovative nanoparticle technology and Novavax’s patented Matrix-M adjuvant to enhance the immune response.

Recent news on these stocks:

May 15

Verrica Pharmaceuticals announced that it has entered into an amendment to its existing licensing agreement with Torii Pharmaceutical to jointly conduct a global pivotal Phase 3 clinical trial of YCANTH for the treatment of common warts. “We are pleased to announce this significant amendment to our license agreement with Torii Pharmaceutical to advance YCANTH into a global pivotal Phase 3 clinical trial for the treatment of common warts,” said Ted White, CEO of Verrica Pharmaceuticals. “Torii has been an outstanding partner in the development of YCANTH for molluscum contagiosum, and we look forward to our continued collaboration to progress YCANTH through a pivotal global Phase 3 clinical trial for common warts, which represents the single largest and most underserved patient population in all of dermatology. If positive, the data from this global Phase 3 clinical trial would not only potentially allow Verrica to submit a sNDA in the U.S. seeking FDA approval for the use of YCANTH for the treatment of common warts, but may also be utilized by Verrica to seek future marketing authorizations in territories outside the U.S. and Japan, including potentially within the European Union.”

May 13

AC Immune reported Q1 EPS of (18c) against a consensus of (15c). The company’s cash balance provides sufficient capital resources for at least three years, when including the upfront payment of $100M from Takeda, and assuming the potential milestone payment of CHF24.6M related to achieving an undisclosed enrolment target for our ACI-35.030, and no other milestones. CEO Andrea Pfeifer commented: “We are thrilled to have announced today our agreement with Takeda to advance ACI-24.060 anti-Abeta active immunotherapy in Alzheimer’s disease…We remain on track to report the first Phase 2 data this quarter on amyloid plaque reduction…This is a potentially de-risking event for ACI-24.060 that could enable advancement into a registrational study. We continue to make strong progress elsewhere in our pipeline. Our partner Janssen continues to push ahead with the launch of the Phase 2b trial, ReTain, evaluating ACI-35.030, our anti-phospho-Tau active immunotherapy, in patients with pre-symptomatic AD. At the same time, our wholly-owned anti-alpha-synuclein active immunotherapy, ACI-7104.056, is advancing through Phase 2 testing to treat Parkinson’s disease, with safety and immunogenicity updates expected in the second half of 2024. Any of these three studies could be transformational for treatment of patients with neurodegenerative disease. With our significantly strengthened financial position, we are well-positioned to achieve our clinical development milestones across our pipeline through 2024 and beyond.” Additionally, Takeda (TAK) and AC Immune announced an exclusive, worldwide option and license agreement for AC Immune’s active immunotherapies targeting toxic forms of amyloid beta, including ACI-24.060 for the treatment of Alzheimer’s disease. AC Immune will be responsible for completing the ABATE trial. Following option exercise, Takeda would conduct and fund all further clinical development and be responsible for all global regulatory activities as well as worldwide commercialization. Under the terms of the agreement, AC Immune will receive an upfront payment of $100M and be eligible to receive an option exercise fee and additional potential development, commercial and sales-based milestones of up to approximately $2.1B if all related milestones are achieved over the course of the agreement. Upon commercialization, AC Immune will be entitled to receive tiered double-digit royalties on worldwide net sales.

Fulcrum Therapeutics reported Q1 EPS of (43c) against a consensus of (44c), and reported Q1 revenue of $0 against a consensus of $360,000. “It’s a very exciting time for Fulcrum as we remain on track to report topline data for the Phase 3 REACH trial in the fourth quarter of 2024. As we prepare for the potential NDA filing and commercial launch of losmapimod in the U.S., we are extremely pleased to announce a collaboration with our new partner, Sanofi, to leverage their global reach and rare disease expertise for the benefit of patients outside the U.S.” said Alex C. Sapir, Fulcrum’s president and chief executive officer. “In our Phase 1b PIONEER trial of pociredir, a highly differentiated oral treatment option for sickle cell disease, we have activated additional clinical trial sites and are building key relationships with leading physicians in the SCD community. We also recently strengthened our leadership team with the addition of Pat Horn as our chief medical officer. Pat brings extensive late-stage rare disease development experience and strategic insight to help us bring potentially transformative therapies to patients.” Additionally, Fulcrum Therapeutics announced that it has entered into a collaboration and license agreement with Sanofi (SNY) for the development and commercialization of losmapimod, an oral small molecule being investigated for the treatment of facioscapulohumeral muscular dystrophy. Under the collaboration and license agreement, Sanofi obtains exclusive commercialization rights for losmapimod outside of the U.S. Fulcrum will receive an upfront payment of $80M, and is eligible to receive $975M in potential milestones, plus royalties on ex-U.S. product sales; parties will share future global development costs 50:50. In addition, Fulcrum and Sanofi will equally share future global development costs.

Incyte announced that its board approved a share repurchase authorization of $2B. The company has commenced a modified Dutch Auction tender offer to repurchase shares of its common stock for an aggregate purchase price of up to $1.672B. In addition, on May 12, Incyte entered into a separate stock purchase agreement with Julian Baker, Felix Baker, and entities affiliated with Julian and Felix Baker, including funds advised by Baker Bros. Advisors, to repurchase up to $328M of the company’s common stock. This would enable the Baker Entities to maintain their current ownership level of approximately 16.4% of Incyte’s outstanding common stock. The Baker Entities purchase will be at the same price per share as is determined and paid in the tender offer. Incyte is offering to purchase up to $1.67B in value of its common stock at a price not greater than $60.00 per share nor less than $52.00 per share, net to the seller in cash, less any applicable withholding taxes and without interest, upon the terms and subject to the conditions set forth in the tender offer documents that are being distributed to stockholders.

Vaxart reported Q1 EPS of (14c) against a consensus of (14c), and reported Q1 revenue of $2.18M against a consensus of $800,000. “We are pleased that we achieved an important milestone in our norovirus clinical program, delivering positive topline results from the Phase 1 trial of our oral pill bivalent norovirus candidate focused on lactating mothers,” said Steven Lo, Vaxart’s CEO. “We look forward to additional data from this study that will further inform future pediatric studies for this indication. We have also made significant progress and remain on track to initiate a Phase 2b study evaluating our XBB COVID-19 vaccine candidate as early as this quarter.”

May 10

Novavax reported Q1 EPS of ($1.05), consensus ($1.06), and reported Q1 revenue of $93.86M, consensus $101.16M. Additionally, Novavax cut its FY24 revenue view to $400M-$600M from $800M-$1B and said it was prepared to initiate an additional cost reduction program to reduce 2025 R&D plus SG&A expenses to below $500M, a portion of which it expects to be reimbursed by Sanofi under the agreement, which reflects a greater than $225M reduction beyond prior stated targets. “Today we announce the beginning of an exciting new chapter for Novavax with the launch of a strategically important partnership with one of the world’s leading vaccine companies. We believe the combined strength of Novavax and Sanofi will enable us to better fulfill our mission of developing and improving access to life-saving vaccines,” said John Jacobs, CEO. “I am proud of the progress our company has made this quarter as we continue to advance our COVID-19 vaccine for the upcoming 2024-2025 vaccination season and plan for the launch of our Phase 3 CIC and standalone influenza program in the second half of this 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.