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: 

• Inozyme Pharma (INZY), 1,125% surge in interest
• Affimed (AFMD), 866% surge in interest
• Acadia Pharmaceuticals (ACAD), 494% surge in interest
• UroGen Pharma (URGN), 214% surge in interest
• Cabaletta Bio (CABA), 144% surge in interest

Pipeline and key clinical candidates for these companies:

Inozyme Pharma is a clinical-stage biopharmaceutical company that says it is “dedicated to developing innovative therapeutics that target the PPi-Adenosine Pathway, a key regulator of bone health and blood vessel function”. Its lead investigational therapy, INZ-701, is an ENPP1 Fc fusion protein enzyme replacement therapy designed to restore pyrophosphate and adenosine levels. INZ-701 is currently in late-stage clinical development in ENPP1 Deficiency, with the potential to expand into additional indications where deficiencies in the Pyrophosphate-Adenosine Pathway contribute to disease pathology, including ABCC6 Deficiency and calciphylaxis.

Affimed is a clinical-stage immuno-oncology company that says it is “committed to giving patients back their innate ability to fight cancer by actualizing the untapped potential of the innate immune system.” The company’s innate cell engagers, ICE, enable a tumor-targeted approach to recognize and kill a range of hematologic and solid tumors. ICE are generated on the company’s proprietary ROCK platform, notes the company, which says a number of ICE molecules are in clinical development, being studied as mono- or combination therapy.

Acadia Pharmaceuticals says it is advancing “breakthroughs in neuroscience to elevate life.” The company developed and commercialized what it identifies as “the first and only approved therapies” for hallucinations and delusions associated with Parkinson’s disease psychosis and for the treatment of Rett syndrome. Acadia’s clinical-stage development efforts are focused on treating the negative symptoms of schizophrenia, Alzheimer’s disease psychosis and neuropsychiatric symptoms in central nervous system disorders.

UroGen is a biotech company 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 has the potential to improve the therapeutic profiles of existing drugs. UroGen’s sustained release technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option. The company’s first product to treat LG-UTUC 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.

Caballeta 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.

Recent news on these stocks:

May 16

BioMarin Pharmaceutical (BMRN) and Inozyme Pharma announced that BioMarin has entered into a definitive agreement to acquire Inozyme for $4.00 per share in an all-cash transaction for a total consideration of approximately $270M. The transaction has been unanimously approved by the boards of directors of both companies and is expected to close in Q3 of 2025, subject to regulatory approval, successful completion of a tender offer and other customary closing conditions.

Acadia Pharmaceuticals announced that the U.S. District Court for the District of Delaware ruled in favor of Acadia regarding its ‘721 formulation patent for Nuplazid, the company’s drug for the treatment of Parkinson’s disease psychosis. The court ruled in favor of Acadia on both infringement and validity arguments in its formulation patent litigation against Aurobindo Pharma Limited and other abbreviated new drug application filers, Acadia said in a statement “We are very pleased with today’s decisive ruling in our favor, which provides patent protection for NUPLAZID 34 mg capsule formulation into 2038 This result highlights Acadia’s dedication to safeguarding our advancements in therapies for conditions with significant unmet medical needs,” said CEO Catherine Owen Adams.

The FDA confirmed an ODAC meeting for UroGen’s UGN-102 will occur on May 21 and posted the associated briefing documents. The FDA acknowledged that complete response rates reflect true drug activity as lesions “would not be expected to resolve spontaneously in the absence of treatment,” but the agency “does not agree” with the statement that the CR rate for UGN-102 was higher or more durable than that for TURBT as ATLAS and “the FDA does not consider ATLAS appropriately designed to compare efficacy in the recurrent-only population given the loss of randomization when considering this exploratory subgroup as well as the issues regarding the non-inferiority design and primary endpoint definition,” the document stated. The discussion question prior to voting is, “Given uncertainty regarding interpretation of duration of response in low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC), discuss whether randomized trials should be required in the future to assess the effectiveness of therapies in this disease setting.”

May 15

Cabaletta Bio announced plans for an anticipated 2027 rese-cel BLA submission following a recent U.S. Food and Drug Administration meeting on a proposed registrational cohort design for the RESET-Myositis trial of rese-cel. Following a Type C meeting with the FDA and receipt of meeting minutes in April 2025, Cabaletta is planning to implement the following design for two single-arm, disease-specific registrational cohorts in the ongoing RESET-Myositis trial, either of which, if successful, enable a future Biologics License Application submission for rese-cel in myositis. The FDA also granted Regenerative Medicine Advanced Therapy designation to rese-cel for the treatment of myositis.

May 14

Affimed announced that it has received a written notice from the staff of the Nasdaq Listing Qualifications Department notifying the company that, in accordance with Nasdaq Listing Rule 5101, 5110(b) and IM-5101-1, the trading of the company’s common shares will be suspended at the opening of business on May 20, and a Form 25 Notification of Delisting will be filed with the U.S. SEC to delist the company’s securities from The Nasdaq Stock Market. The company does not expect to appeal this determination.

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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.