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: 

• Intercept Pharmaceuticals (ICPT), 3,838% surge in interest
• Acasti Pharma (ACST), 1,320% surge in interest
• Adial Pharmaceuticals (ADIL), 678% surge in interest
• Morphic Holding (MORF), 599% surge in interest
• Madrigal Pharmaceuticals (MDGL), 478% surge in interest
• Vaccinex (VCNX), 465% surge in interest
• Adaptive Biotechnologies (ADPT), 280% surge in interest
• Ionis Pharmaceuticals (IONS), 267% surge in interest
• Brainstorm Cell (BCLI), 248% surge in interest
• MEI Pharma (MEIP), 183% surge in interest

Pipeline and key clinical candidates for these companies:

Intercept is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat rare and serious liver diseases, including primary biliary cholangitis and severe alcohol-associated hepatitis. On September 26, Alfasigma agreed to acquire Intercept for $19 per share in cash.

Acasti is a late-stage specialty pharma company with drug delivery technologies and drug candidates addressing rare and orphan diseases. Acasti’s three lead clinical assets have each been granted Orphan Drug Designation by the FDA, which provide the assets with seven years of marketing exclusivity post-launch in the United States, and additional intellectual property protection with over 40 granted and pending patents.

Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of treatments for addictions. The company’s lead investigational new drug product, AD04, is a genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder, or AUD, in heavy drinking patients and was recently investigated in the company’s ONWARD pivotal Phase 3 clinical trial for the potential treatment of AUD in subjects with certain target genotypes identified using the company’s proprietary companion diagnostic genetic test. The company is also developing adenosine analogs for the treatment of pain and other disorders.

Morphic Holding is developing a portfolio of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular, and metabolic diseases, fibrosis, and cancer. Morphic is also advancing its pipeline and discovery activities in collaboration with Schrodinger (SDGR) using its proprietary MInT technology platform which leverages the company’s unique understanding of integrin structure and biology.

Madrigal Pharmaceuticals is a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis, or NASH, a liver disease with high unmet medical need. Madrigal’s lead candidate, resmetirom, is a once daily, oral, thyroid hormone receptor-beta selective agonist designed to target key underlying causes of NASH in the liver.

Vaccinex is pioneering a differentiated approach to treating slowly progressive neurodegenerative diseases and cancer through the inhibition of semaphorin 4D. The company’s lead drug candidate, pepinemab, is designed to block SEMA4D, a potent biological effector that is believed to trigger damaging inflammation in chronic diseases of the brain and inhibit immune infiltration and activation in tumors. In neurodegenerative diseases, pepinemab is being studied as a monotherapy in the Phase 1/2a SIGNAL-AD study in Alzheimer’s Disease, with ongoing exploration of potential Phase 3 development in Huntington’s disease. In oncology, pepinemab is being evaluated in combination with KEYTRUDA in the Phase 1b/2 KEYNOTE-B84 study in recurrent or metastatic head and neck cancer and in combination with BAVENCIO in a Phase 1b/2 study in patients with metastatic pancreatic adenocarcinoma. The oncology clinical program also includes several investigator-sponsored studies in solid tumors including breast cancer and melanoma.

Adaptive Biotechnologies is a commercial-stage biotechnology company that applies its platform to partner with biopharmaceutical companies, inform drug development, and develop clinical diagnostics across its two business areas of Minimal Residual Disease and Immune Medicine. The company says its commercial products and clinical pipeline enable the diagnosis, monitoring, and treatment of diseases such as cancer, autoimmune disorders, and infectious diseases and states that its goal is “to develop and commercialize immune-driven clinical products tailored to each individual patient.”

Ionis has been a leader in RNA-targeted therapy, pioneering new markets and changing standards of care with its novel antisense technology. Ionis currently has three marketed medicines and a promising late-stage pipeline highlighted by cardiovascular and neurological franchises.

BrainStorm Cell Therapeutics is a developer of autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the FDA and the EMA for the treatment of amyotrophic lateral sclerosis, ALS. BrainStorm has completed a Phase 3 pivotal trial in ALS; this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine.

MEI Pharma is a clinical-stage pharmaceutical company focused on developing potential new therapies for cancer. MEI Pharma’s portfolio of drug candidates includes clinical stage candidates with differentiated or novel mechanisms of action intended to address unmet medical needs and deliver improved benefit to patients, either as standalone treatments or in combination with other therapeutic options.

Recent news on these stocks:

September 28

Vaccinex announced a new publication in the journal mAbs describing a novel way in which its proprietary ActivMAb poxvirus platform can enable the presentation of high complexity, hard-to-drug proteins as targets for antibody discovery. The article, titled “Use of poxvirus display to select antibodies specific for complex membrane antigens” provides an overview of how Vaccinex created an elegant, poxvirus system modified for safety that can readily express high levels of hard-to-drug protein targets, such as G-protein coupled receptors and ion channels, on the natural external membrane of virus in a “native”, properly-oriented conformation. “We believe this new “Antigen Virus” application is a powerful complement to Vaccinex’ ActivMAb platform and we are pleased for this work to be published in mAbs. After rigorous evaluation, using a variety of different, complex protein targets including the SARS-CoV-2 Spike protein and a number of GPCRs, we believe that the ActivMAb system can readily generate functional and properly folded complex proteins that can be used for selection of novel, high-value, antibody therapeutics,” said Ernest Smith, Ph.D., Senior Vice President of Research and Chief Scientific Officer of Vaccinex. This novel application of Vaccinex’s ActivMAb technology was successfully used with OmniAb, Inc.’s high-throughput B cell screening and proprietary in vivo immunization platform. OmniAb was able to select antibodies against challenging multipass membrane targets, that were displayed on ActivMAb antigen viruses.

September 27

BrainStorm Cell Therapeutics announced that Nasdaq has halted trading of the company’s common stock. The FDA’s Cellular, Tissue and Gene Therapies Advisory Committee is meeting September 27 to review BrainStorm’s Biologics License Application for NurOwn for the treatment of amyotrophic lateral sclerosis. The ADCOM meeting is scheduled to take place 10:00 am to 6:00 pm ET.

Ionis Pharmaceuticals announced that it has entered an agreement with Roche (RHHBY) for two undisclosed early-stage programs for RNA-targeting investigational medicines for the treatment of Alzheimer’s disease, or AD, and Huntington’s disease, or HD. Roche gains exclusive worldwide rights and will be responsible for clinical development, manufacturing, and commercialization of the medicines if they receive regulatory approval. The companies will leverage Ionis’ expertise discovering medicines that target the root cause of central nervous system diseases and Roche’s global experience developing and commercializing therapies for nervous system disorders. nder terms of the agreement, Ionis will have responsibility to advance the two programs through pre-clinical studies; Roche will have sole responsibility for clinical development and, if approved, commercialization worldwide. Ionis will receive a $60M upfront payment from Roche and is eligible to receive development, regulatory and commercial milestone payments, and tiered royalties.

Stifel lowered the firm’s price target on MEI Pharma to $9 from $10 and kept a Hold rating on the shares. Following management’s Q4 earnings announcement and corporate update, the firm see MEI being positioned to yield preliminary data disclosures for two recently-initiated proof-of-concept trials for voruciclib and ME-344 in early 2024 and the first half, respectively. Stifel’s “slightly-reduced” target reflects its estimation of year-end FY24 cash on-hand, the analyst noted.

September 26

Alfasigma S.p.A and Intercept Pharmaceuticals have entered into a definitive merger agreement under which Alfasigma has agreed to acquire Intercept for $19.00 per share in cash. The anticipated transaction will materially expand Alfasigma’s gastrointestinal and hepatology portfolio and its presence in the U.S. market. Intercept’s lead medicine is Ocaliva, a farnesoid X receptor agonist approved in the United States and several other jurisdictions for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA. Ocaliva is the only approved second-line therapy for PBC and has experienced double-digit year-over-year growth supported by an experienced specialty sales force and strong prescriber base. Intercept also benefits from a broader clinical development pipeline anchored by a novel fixed-dose combination of obeticholic acid and bezafibrate in phase 2 trials for PBC. Under the terms of the merger agreement, Alfasigma has agreed to commence a cash tender offer to acquire all issued and outstanding shares of Intercept common stock for $19.00 per share in cash. The purchase price represents a premium of 82% to Intercept’s closing stock price on September 25, 2023. The transaction will be fully financed by Alfasigma’s existing cash on hand and existing corporate credit facilities. The members of the Board of Directors of Intercept participating in the decision have unanimously approved the transaction. Upon successful completion of the tender offer, Alfasigma would acquire all shares not acquired in the tender offer through a second-step merger for the same consideration that the tendering stockholders will receive in the tender offer. It is anticipated the transaction will close by the end of 2023.

Acasti Pharma announced that it has closed a private placement of the company’s securities pursuant to the terms of a securities purchase agreement, dated September 24, by and between the company and certain institutional and accredited investors. Pursuant to the terms of the agreement, the company issued and sold an aggregate of 1.95M common shares, pre-funded warrants to purchase up to an aggregate of 2.11M common shares, each at a purchase price of $1.8481 per common share or pre-funded warrant and accompanying common warrants to purchase up to an aggregate of 2.54M common shares, in a private placement priced at-the-market under Nasdaq rules. The private placement closed on September 25.

September 25

In a regulatory filing, Madrigal Pharmaceuticals reported that Remy Sukhija, who has served as the company’s Chief Commercial Officer since April of 2020, is leaving the company to pursue other opportunities.

September 22

An abstract posted to the site of UEG Week, the United European Gastroenterology Week meeting in Copenhagen, is being attributed as the reason for weakness in shares of Morphic, which are down $18.24, or 35%, to $33.16. The abstract states in part: “MORF-057 is an orally dosed small molecule designed to selectively inhibit the alpha4beta7 integrin, avoiding the need for parenteral administration. This Phase 2a open label study aimed to assess the safety, tolerability, pharmacokinetics, and efficacy of MORF-057 dosed 100 mg twice daily for induction treatment in adults with moderately to severely active ulcerative colitis, UC… Of the 35 patients in the Full Analysis Set, 31/35 (89%) completed the 12-week induction Period. The mean baseline modified Mayo score was 6.7 and the mean RHI score was 22.7. At Week 12, the primary endpoint of the study was met with a mean reduction in the RHI score of – 6.4. For the secondary endpoint of change from baseline in the modified Mayo Clinic score, a change of -2.3 points was observed. 25.7% of patients achieved mMCS clinical remission. The proportion of patients achieving a mMCS clinical response was 45.7% and endoscopic improvement was achieved in 25.7% of patients.”

Wells Fargo thinks the negative reaction being seen in Morphic shares after the UEG abstract for the Phase 2a trial of MORF-057 was posted to the event’s site is “likely overblown.” The new info was the endoscopic improvement, or EI, rate of 25.7% at 12 weeks which “matched exactly” the clinical remission rate from MORF-057 in the trial and was “considerably lower” than vedo’s 41% at 6 weeks from its Phase 3 trial, says the analyst. However, past ulcerative colitis, or UC, trials shows variability across endoscopic improvement rates as it relates to clinical remission rate, the analyst contends. The firm, which would “chalk up the rates being the same to the small trial size,” believes the idea that MORF-057’s data is worse than vedo is driving the weakness, but “we don’t think this is conclusive at all.” Wells has an Overweight rating and $80 price target on Morphic shares and would be “buyers here.”

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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.