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: 

• NKGen Biotech (blue‘>NKGN), 634% surge in interest
• BlueBird Bio (BLUE), 605% surge in interest
• Acelyrin (SLRN), 468% surge in interest
• Invivyd (IVVD), 137% surge in interest

Pipeline and key clinical candidates for these companies:

NKGen is a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic NK cell therapeutics. 

BlueBird Bio is pursuing curative gene therapies to give patients and their families more bluebird days. With a dedicated focus on severe genetic diseases, the company says it has the largest and deepest ex-vivo gene therapy data set in the field, with industry-leading programs for sickle cell disease, β-thalassemia and cerebral adrenoleukodystrophy. BlueBird Bio custom design each of its therapies to address the underlying cause of disease and have developed in-depth and effective analytical methods to understand the safety of our lentiviral vector technologies and drive the field of gene therapy forward.

Acelyrin is focused on providing patients life-changing new treatment options by identifying, acquiring, and accelerating the development and commercialization of transformative medicines. Acelyrin’s lead program, lonigutamab, is a subcutaneously delivered monoclonal antibody targeting IGF-1R being investigated for the treatment of thyroid eye disease.

Invivyd is a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2. Invivyd deploys a proprietary integrated technology platform unique in the industry designed to assess, monitor, develop, and adapt to create best in class antibodies. In March 2024, Invivyd received emergency use authorization from the U.S. FDA for a monoclonal antibody in its pipeline of innovative antibody candidates.

Recent news on these stocks:

February 24

Invivyd announced that Invivyd’s request to expand the existing emergency use authorization for pre-exposure prophylaxis of COVID-19 EUA for PEMGARDA to provide a treatment option for mild-to-moderate COVID-19 in adults and adolescents who have moderate-to-severe immune compromise due to certain medical conditions such as cancer and organ transplant, and for whom alternative COVID-19 treatment options are not accessible or clinically appropriate, was declined by the U.S. Food and Drug Administration. Existing PEMGARDA EUA for pre-exposure prophylaxis of COVID-19 in certain immunocompromised patients remains in effect. 

“This is a sad day for patients in need. Immunocompromised people who cannot access standard of care are once again left with no option for COVID-19 treatment. Pemivibart, in contrast to all other COVID-19 antibodies ever made, is active and in clinical use today in the U.S. as authorized. Pemivibart is safe enough for certain immunocompromised patients who are not currently sick with COVID-19, but it is now being withheld from those same immunocompromised patients fighting active COVID-19 infection purportedly because its measured antiviral activity is in-line with, but does not clearly exceed, the activity of its key comparator antibody adintrevimab, as well as other comparative mAbs,” commented Mark Wingertzahn, Invivyd’s Senior Vice President of Clinical Development. Invivyd plans in the near term to share detailed data and regulatory correspondence regarding pemivibart, VYD2311 and immunobridging of COVID-19 antibodies, so Americans can better appreciate the historic and recent governmental handling of these assets in contrast to COVID-19 vaccines and small molecule treatment.

H.C. Wainwright maintains a Buy rating on Invivyd with a $10 price target after the FDA rejected its submission to expand Pemgarda’s Emergency Use Authorization to include COVID-19 treatment for certain immunocompromised patients who have no other therapeutic options. While the news is disappointing, H.C. Wainwright had not factored treatment revenues into Invivyd’s model. The firm says its valuation for the shares remains anchored solely on Pemgarda’s “robust potential” as a pre-exposure prophylactic for immunocompromised patients, where it believes the clinical data have already supported its efficacy.

February 21

Bluebird Bio announced that it has entered into a definitive agreement to be acquired by funds managed by Carlyle and SK Capital Partners. David Meek, former CEO of Mirati Therapeutics and Ipsen, is expected to become CEO of Bluebird upon closing. Under the terms of the agreement, Bluebird stockholders will receive $3.00 per share in cash and a contingent value right per share, entitling the holder to a payment of $6.84 in cash per contingent value right if Bluebird’s current product portfolio achieves $600M in net sales in any trailing 12-month period prior to or ending on December 31, 2027, for a potential total value of up to $9.84 per share in cash, subject to the tender of a majority of the outstanding shares of bluebird, receipt of applicable regulatory approvals, and other customary closing conditions. Bluebird determined that, absent a significant infusion of capital, bluebird is at risk of defaulting on its loan covenants. The bluebird Board has decided that this transaction is the only viable solution to generate value for stockholders. The transaction is expected to close in the first half of 2025, subject to the tender of a majority of the outstanding shares of bluebird, receipt of applicable regulatory approvals, and other customary closing conditions. Bluebird has also entered into amendments to its loan agreement with Hercules Capital to facilitate adequate liquidity to position it to maintain operations through the closing. Upon completion of the transaction, bluebird will become a privately held company, and shares of bluebird common stock will no longer be listed on any public market.

Baird downgraded Bluebird Bio to Neutral from Outperform with a price target of $5, down from $54, after the company entered into an agreement to be acquired by funds managed by Carlyle and SK Capital Partners for $3.00 per share in cash and a contingent value right per share, entitling the holder to a payment of $6.84 in cash per contingent value right if Bluebird’s current product portfolio achieves $600M in net sales in any trailing 12-month period prior to or ending on December 31, 2027, for a potential total value of up to $9.84 per share in cash.

NKGen Biotech announced the administration of troculeucel, an expanded autologous NK cell therapy, in an FTD patient under a single compassionate use, Investigational New Drug cleared by the U.S. Food and Drug Administration NKGen has begun to explore the potential therapeutic role of troculeucel for the treatment of FTD in collaboration with Mario Mendez, Director of the Behavioral Neurology Program at the David Geffen School of Medicine at UCLA and Jessica Rexach, Director of the Rexach Lab at UCLA Department of Neurology. This single, FDA-cleared, IND compassionate use will be the initial step towards a future full IND application as the dosing of the first FTD patient is part of NKGen’s ongoing effort to explore the potential of its NK cell therapy for those suffering from neurodegenerative diseases, especially when existing therapies have not been effective.

February 20

Acelyrin “confirmed receipt of an unsolicited indication of interest from Concentra Biosciences, of which Tang Capital Partners is the controlling shareholder, to acquire all of the outstanding shares of Acelyrin for $3.00 per share in cash, plus a contingent value right that represents the right to receive 80% of the net proceeds from any out-license or disposition of Acelyrin’s development programs or intellectual property. On February 6, 2025, Acelyrin announced an agreement to merge with Alumis (ALMS) in an all-stock transaction. The transaction is expected to close in the second quarter of 2025, subject to approval by the stockholders of both companies and satisfaction of other customary closing conditions. The Acelyrin board is committed to acting in the best interests of all stockholders, consistent with its fiduciary duties, and to its obligations under the merger agreement with Alumis. A further announcement will be made in due course. Acelyrin stockholders do not need to take any action at this time.”

February 19

NKGen Biotech announced that Anita Fletcher, M.D. has been appointed as the National Principal Investigator for its Phase 2a clinical trial of troculeucel, expanded enhanced autologous NK cell therapy, for the treatment of moderate Alzheimer’s disease. In addition to Dr. Fletcher’s appointment as National PI, NKGen is pleased to announce AdventHealth Research Institute, Neuroscience Research in Orlando will be the first clinical site on the East Coast with the intent of enrolling moderate stage Alzheimer’s Disease patients in the very near term.

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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.