These names in the biotech sector are seeing a substantial increase in search activity today, as determined by InvestingChannel. They include:
Pipeline and key clinical candidates for these companies:
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).
Agios is a biopharmaceutical company that markets a "first-in-class" pyruvate kinase activator for adults with PK deficiency in the U.S., Pyrukynd, which it calls "the first disease-modifying therapy for this rare, lifelong, debilitating hemolytic anemia." Agios is advancing a clinical pipeline of investigational medicines with programs in alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency and MDS-associated anemia.
Lineage Cell Therapeutics is developing novel cell therapies for unmet medical needs, including five allogeneic, or “off-the-shelf,” product candidates: OpRegen, a retinal pigment epithelial cell therapy in development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche (RHHBY); OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage.
Editas Medicine is a clinical stage genome editing company focused on CRISPR/Cas9 and CRISPR/Cas12a genome editing systems with an aim to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for a broad class of diseases. Editas Medicine is the exclusive licensee of Broad Institute’s and Harvard University’s Cas9 patent estates and Broad Institute’s Cas12a patent estate for human medicines.
Immunic has a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases. The company is developing three small molecule products. Its lead development program, vidofludimus calcium, is a selective immune modulator that is currently being developed as a treatment option for multiple sclerosis, and primary sclerosing cholangitis. IMU-935 is targeted for development in psoriasis and castration-resistant prostate cancer. IMU-856, which targets the restoration of the intestinal barrier function, is targeted for development in diseases involving bowel barrier dysfunction.
Recent news on these stocks:
November 18
Morgan Stanley analyst Matthew Harrison lowered the firm's price target on Editas Medicine to $8 from $10 and kept an Underweight rating on the shares after removing Leber congenital amaurosis 10, or LCA10, from his model given management is no longer pursuing development based on the BRILLIANCE trial results. In addition, given the emerging competitive landscape in sickle cell disease, he has moved his anticipated launch date for EDIT-301 to 2026 from 2025, increased his view on the odds of success to 65% from 40% given competitive success, and lowered his 2031 sales estimate in SCD to about $450M from $1.2B in 2030 given the product could be third to market, Harrison tells investors.
BofA analyst Greg Harrison lowered the firm's price target on Editas Medicine to $15 from $18 and keeps a Neutral rating on the shares, stating that deprioritization of the EDIT-101 program in LCA10 was "not a completely unanticipated setback," while adding that it only impacts "a small portion" of his valuation. Though the data are not sufficient for program continuation, it has still demonstrated Editas' ability to apply its gene editing technology to an ocular indication, according to Harrison, who views the EDIT-301 data in sickle cell disease expected in December as "significantly more important given the larger patient population and derisked treatment strategy." The analyst, who removed the EDIT-101 program from his model as a result of the data, added that the 101 setback is "not the end of the story."
Truist analyst Joon Lee lowered the firm's price target on Editas Medicine to $35 from $80 but keeps a Buy rating on the shares. The analyst cites the company pausing its Phase 1/2 BRILLIANCE trial for LCA-10 due to limited efficacy signal, also removing EDIT-101 and lowering probability of success for its EDIT-102 in his model. Lee maintains a positive stance on the stock however because of the "scarcity value of an unencumbered CRISPR-Cas platform company" that offers a broad array of genome editing tools at its disposal. The upcoming update on EDIT-101 topline data in LCA10 also serves as one of the value drivers for Editas, the analyst tells investors in a research note.
November 17
Editas Medicine announced clinical data from the Phase 1/2 BRILLIANCE trial of EDIT-101, an in vivo CRISPR/Cas9 genome editing medicine in a Company-sponsored webinar. EDIT-101 is under development for the treatment of blindness due to Leber congenital amaurosis 10 and is designed to repair the IVS26 CEP290 mutant allele that impacts approximately 1,500 LCA10 patients in the U.S. Three out of 14 treated subjects met a responder threshold having experienced clinically meaningful improvements in best corrected visual acuity and demonstrated consistent improvements in two of the following three additional endpoints: full field sensitivity test, visual function navigation course, or the visual function quality of life. An examination of baseline characteristics of the treatment responder patients revealed that two of the three responders were homozygous for IVS26 mutation. No other baseline characteristics that could pre-select a responder patient population were identified in the BRILLIANCE dataset. Since LCA10 patients homozygous for CEP290 IVS26 mutation represent an estimated population of approximately 300 in the U.S., the Company will not progress this program independently, and will seek to identify a collaboration partner to continue the development of EDIT-101. As a result, Editas Medicine is pausing further enrollment in the BRILLIANCE trial and will continue long term follow-up of all patients who have been treated to date.
Credit Suisse analyst Tiago Fauth downgraded Editas Medicine to Neutral from Outperform with a price target of $13, down from $25, after removing the contribution from EDIT-101 and other ocular indications from his model following the company's update from the BRILLIANCE trial. Fauth also lowered his estimate of the pipeline value and reduced his M&A weight to 33% from 50% following the news on EDIT-101.
Oppenheimer analyst Jay Olson downgraded Editas Medicine to Perform from Outperform with a price target of $12, down from $28. The downgrade follows the announcement that the Phase 1/2 BRILLIANCE trial of EDIT-101 for Leber congenital amaurosis 10 is pausing enrollment following preliminary efficacy data that showed only three of the 14 patients met the responder threshold of clinically meaningful improvement in best corrected visual acuity, Olson tells investors in a research note. The analyst consequently lowered his estimated probability of success for EDIT-101 but views Editas as "financially well-positioned."
Regeneron Pharmaceuticals (REGN) and CytomX Therapeutics announced a collaboration and licensing agreement to create conditionally-activated investigational bispecific cancer therapies utilizing CytomX's Probody therapeutic platform and Regeneron's Veloci-Bi bispecific antibody development platform. The collaboration is strategically focused on applying CytomX's biologic masking strategies to develop investigational Regeneron bispecifics that remain inactive until activated by proteases in the tumor microenvironment. This technology has the potential to widen the therapeutic window and help minimize off-target effects for these next-generation T-cell engaging therapies, potentially addressing tumor types that have historically been unresponsive to immunotherapy. Under the agreement, Regeneron and CytomX will collaborate on the discovery activities to identify and validate conditionally active bispecific antibodies. Regeneron will be responsible for funding preclinical and clinical development and commercialization activities. CytomX will receive an upfront payment of $30M and will be eligible to receive future target nomination payments and preclinical, clinical, and commercial milestones of up to $2B. CytomX is also eligible to receive tiered global net sales royalties.
Immunic reported newly available data from its phase 2 EMPhASIS trial of lead asset, vidofludimus calcium, in relapsing-remitting multiple sclerosis, or RRMS. Long-term open-label treatment with vidofludimus calcium was associated with a low rate of confirmed disability worsening over time, and compares favorably to historical trial data for currently available multiple sclerosis, or MS, medications. EMPhASIS is an international, multicenter, double-blind, placebo-controlled, randomized, parallel-group trial, designed to assess the efficacy and safety of vidofludimus calcium in patients with RRMS. The trial included a 24-week blinded main treatment period testing 10, 30 and 45 mg of vidofludimus calcium and placebo. In the third quarter of 2020, Immunic reported that the trial achieved both primary and key secondary endpoints with high statistical significance, with a safety and tolerability profile similar to placebo. The trial also includes an optional long-term open-label extension, or OLE, phase running up to 9.5 years. An interim analysis was performed with data extraction in October, when 209 patients remained on treatment in the OLE phase, some of whom have already received more than 180 continuous weeks of active treatment with vidofludimus calcium. During the 24-week double-blind main treatment period, 12-week and 24-week Confirmed Disability Worsening events occurred in 1.6% of subjects in the combined vidofludimus calcium treatment arms as compared to 3.7% in the placebo group. In the OLE phase, the proportion of patients free from 12wCDW was 97.6% after 48 weeks and 94.5% after 96 weeks of vidofludimus calcium treatment as compared to the start of the OLE phase. Similar results were observed for 24wCDW and sustained CDW. The OLE phase also showed low relapse activity.
Goldman Sachs analyst Salveen Richter upgraded Agios Pharmaceuticals to Neutral from Sell with a price target of $32, up from $17. The analyst is "constructive" on the company's updated research and development strategy following the recent CEO transition, saying it is supported by its cash position. Richter continue to have a cautious view of Pyrukynd's launch in pyruvate kinase deficiency.
November 14
BMO Capital analyst Etzer Darout downgraded CytomX Therapeutics (CTMX) to Market Perform from Outperform with a price target of $2.60, down from $3. The analyst has become more cautious on CX-2029's opportunity after revisiting antibody-drug conjugates non-small lung cancer responses. In addition, he lacks "visibility and strong conviction" on Bristol-Myers' (BMY) CTLA-4 Probody programs and says CytomX's internal pipeline is "far away from meaningful data."
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 15-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.
CytomX Therapeutics
+ (+0.00%)
Agios Pharmaceuticals
+0.59 (+2.09%)
Lineage Cell Therapeutics
+0.02 (+1.40%)
Editas Medicine
-0.335 (-3.06%)
Immunic
-0.015 (-1.07%)
AbbVie
+1.5 (+0.97%)
Bristol Myers
+0.64 (+0.83%)
Amgen
+2.63 (+0.92%)
Roche
-0.03 (-0.07%)
Regeneron
-8.72 (-1.18%)