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: 

• Krystal Biotech (KRYS), 2,238% surge in interest
• CytomX Therapeutics (CTMX), 1,010% surge in interest
• Galera Therapeutics (GRTX), 916% surge in interest
• Viking Therapeutics (VKTX), 810% surge in interest
• Ligand Pharmaceuticals (LGND), 810% surge in interest
• Milestone Pharmaceuticals (MIST), 741% surge in interest
• Minerva Neurosciences (NERV), 595% surge in interest
• Neu Base Therapeutics (NBSE), 549% surge in interest
• iBio (IBIO), 491% surge in interest
• Altimmune (ALT), 488% surge in interest

Pipeline and key clinical candidates for these companies:

Krystal Biotech is a biotechnology company focused on developing and commercializing genetic medicines for patients with rare diseases. The company’s pipeline is based on its proprietary redosable HSV vector. In May, Vyjuvek was approved by the FDA for the treatment of dystrophic epidermolysis bullosa. Vyjuvek is a non-invasive, topical, redosable gene therapy designed to treat DEB at the molecular level.

CytomX is a clinical-stage, oncology-focused biopharmaceutical company whose pipeline comprises seven therapeutic candidates across multiple treatment modalities including antibody-drug conjugates, or “ADCs,” T-cell engaging bispecific antibodies, or “TCBs,” and immune modulators such as cytokines and checkpoint inhibitors. CX-2029 is an investigational conditionally activated antibody-drug conjugate directed toward CD71, which has demonstrated encouraging antitumor activity in patients with squamous non-small cell lung cancer and is being developed in collaboration with AbbVie (ABBV). CytomX’s clinical pipeline also includes cancer immunotherapeutic candidates against validated targets such as the CTLA-4-targeting Probody therapeutics, BMS-986249 and BMS-986288, partnered with Bristol Myers Squibb (BMY), as well as CX-904, a conditionally activated T-cell-engaging bispecific antibody targeting the epidermal growth factor receptor on tumor cells and the CD3 receptor on T cells, which is partnered with Amgen (AMGN).

Galera Therapeutics is focused on developing and commercializing a pipeline of therapeutic candidates that have the potential to transform radiotherapy in cancer. Galera’s selective dismutase mimetic product candidate avasopasem manganese, avasopasem, or GC4419, is being evaluated for radiotherapy-induced toxicities. The company’s second product candidate, rucosopasem manganese, rucosopasem, or GC4711, is in clinical-stage development to augment the anti-cancer efficacy of stereotactic body radiation therapy in patients with non-small cell lung cancer and locally advanced pancreatic cancer.

Viking Therapeutics is focused on the development of novel first-in-class or best-in-class therapies for the treatment of metabolic and endocrine disorders. The company’s clinical programs include VK2809, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the treatment of lipid and metabolic disorders, which is currently being evaluated in a Phase 2b study for the treatment of biopsy-confirmed non-alcoholic steatohepatitis, or NASH, and fibrosis.

Ligand Pharmaceuticals is focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines. Ligand’s Captisol platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Ligand’s Pelican Expression Technology is a “validated and scalable” platform for recombinant protein production that is suited for complex, large-scale protein production “where traditional systems are not,” the company states.

Milestone Pharmaceuticals is a biopharmaceutical company developing and commercializing cardiovascular solutions for people living with complex and life-altering heart conditions. Milestone’s lead investigational product is etripamil, a novel calcium channel blocker nasal spray that is being studied for patients to self-administer without medical supervision to treat highly symptomatic episodic attacks associated with PSVT and AFib-RVR.

Minerva Neurosciences is a clinical-stage biopharmaceutical company focused on developing product candidates to treat central nervous system, or CNS, diseases. Minerva’s portfolio of compounds includes roluperidone, or MIN-101, in clinical development for negative symptoms of schizophrenia, and MIN-301 for Parkinson’s disease.

NeuBase Therapeutics is a biotechnology company developing Stealth Editors to perform in vivo gene editing without triggering the immune system.

iBio develops next-generation biopharmaceuticals using computational biology and 3D-modeling of subdominant and conformational epitopes, prospectively enabling the discovery of new antibody treatments for hard-to-target cancers and other diseases. iBio’s mission is to “decrease drug failures, shorten drug development timelines, and open up new frontiers against the most promising targets,” the company stated.

Altimmune is a clinical-stage biopharmaceutical company that says it is focused on developing “innovative next-generation therapeutics for the treatment of patients with liver diseases and obesity.” The company’s lead product candidate, pemvidutide, is a GLP-1/glucagon dual receptor agonist that is being developed for the treatment of obesity and NASH. In addition, Altimmune is developing HepTcell, an immunotherapeutic designed to achieve a functional cure for chronic hepatitis B.

Recent news on these stocks:

February 29

A Milestone Pharmaceuticals 16.667M share spot secondary stock offering priced at $1.50. Piper Sandler acted as sole book running manager for the offering. Milestone previously stated that it intended to use the net proceeds from the offering to continue the development of etripamil in its lead indication of paroxysmal supraventricular tachycardia and its subsequent indication of atrial fibrillation with rapid ventricular rate, as well as for working capital and other general corporate purposes.

February 28

A Viking Therapeutics 6.47M share secondary stock offering priced at $85.00. The deal size was increased to $550M from $350M and it priced below the last closing price of $94.50. Morgan Stanley, Leerink, William Blair, Raymond James, Stifel and Truist acted as joint book running managers for the offering. Viking previously said it intended to use the net proceeds from the offering for continued development of its VK2809, VK2735 and VK0214 programs and for general research and development, working capital and general corporate purposes.

February 27

Ligand reported Q4 EPS $1.38 against a consensus of 66c, and reported Q4 revenue of $28.10M against a consensus of $25.72M. “2023 was a transformative year for Ligand, both operationally and financially. We refocused the company to be a lean-infrastructure, high-margin business,” said Todd Davis, CEO of Ligand. “We enhanced our deal making capabilities with the strengthening of our senior team and opening of a Boston office. These initiatives will help us execute on a larger scale and continue to expand our portfolio through a focus on life science royalty opportunities. We are now well positioned and resourced to close on multiple new investments. We also saw important clinical and regulatory events across our existing partnered assets and expect this momentum will continue in 2024 and beyond.”

Minerva Neurosciences announced that the FDA has issued a Complete Response Letter, or CRL, to the company’s New Drug Application, or NDA, for roluperidone for the treatment of negative symptoms in patients with schizophrenia. In the CRL, the FDA cited the following clinical deficiencies: Although one study demonstrated statistical significance on the primary efficacy endpoint, it is insufficient on its own to establish substantial evidence of effectiveness. The NDA submission lacks data on concomitant antipsychotic administration. The NDA submission lacks data needed to establish that the change in negative symptoms of schizophrenia with roluperidone treatment was clinically meaningful. The submitted safety database included an inadequate number of subjects exposed to roluperidone at the proposed dose for at least 12 months. To address these deficiencies, the FDA stated that Minerva must submit at least one additional positive, adequate, and well-controlled study to support the safety and effectiveness of roluperidone for the treatment of negative symptoms. Minerva must also provide additional data to demonstrate the safety and efficacy of roluperidone co-administered with antipsychotic medications, to support that observed effect on negative symptoms with roluperidone treatment corresponds to a clinically meaningful change, and to demonstrate the long-term safety of the proposed dose.

February 26

Krystal Biotech reported Q4 EPS 30c against a consensus of (38c), and reported Q4 revenue $42.1M against a consensus of $28.61M. “2023 was an inflection point for Krystal with the approval and launch of VYJUVEK, the first-ever FDA approved therapy for dystrophic epidermolysis bullosa and only medicine that delivers the corrective power of gene therapy in an easy-to-apply, redosable, topical gel formulation that can be administered at home,” said Krish Krishnan, chairman and CEO of Krystal Biotech. “Our U.S. commercial launch trajectory is tracking closely to that of the best recent rare disease launches with $50.7 million in net product revenue only six months since approval, supported by high patient and physician demand, broad access, and high compliance. We look forward to expanding VYJUVEK access in the U.S. and globally in the years to come, while advancing our clinical pipeline and reinforcing our leadership in redosable gene therapy.”

Milestone announced plans to resubmit the New Drug Application for etripamil to the FDA for paroxysmal supraventricular tachycardia. Following the previously announced receipt of a Refusal to File letter, Milestone held a Type A Meeting with FDA. FDA indicated that the timing of adverse events in question had minimal impact on the overall characterization of the etripamil safety profile. To align with FDA’s guidance, the company will restructure the data sets that capture timing of reported AEs, reformat certain data files to facilitate FDA’s analyses, and resubmit the NDA. Based on the guidance received during the Type A Meeting, the company expects that this approach will address the Refusal to File letter from FDA. FDA has not requested that the company complete additional clinical efficacy or safety trials prior to resubmitting the NDA. The company expects a standard NDA review period following resubmission of the NDA for etripamil for PSVT, which is planned for 2Q2024. Considering the revised timeline for NDA submission, the company has undertaken certain cash conservation measures to reduce spend through program deferrals and team restructuring and expects that the company’s existing cash resources will fund operations into mid-2025, including the expected Prescription Drug User Fee Act date for the NDA resubmission. If FDA approval is granted, the company expects to receive a $75M payment under an existing royalty agreement, which is intended to fund the potential commercial launch of etripamil for PSVT.

iBio entered into an asset purchase agreement with Otsuka Pharmaceutical (OTSKY), pursuant to which Otsuka acquired iBio’s assets related to its early-stage programmed cell death protein 1 agonist program. The transaction closed on February 25, 2024. Under the terms of the Agreement, iBio will receive an upfront payment of $1M in cash at closing. iBio will also be eligible to receive additional contingent cash payments totaling up to $52.5M upon the achievement of certain pre-specified clinical development and commercial milestones.

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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.