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: 

• Redhill Biopharma (RDHL), 2,477% surge in interest
• Orchard Therapeutics (ORTX), 627% surge in interest
• Applied Therapeutics (APLT), 530% surge in interest
• Revance Therapeutics (RVNC), 388% surge in interest
• Incyte Corp (INCY), 360% surge in interest
• Fate Therapeutics (FATE), 320% surge in interest
• Galera Therapeutics (GRTX), 302% surge in interest
• Biocryst Pharma (BCRX), 300% surge in interest
• Apellis Pharmaceuticals (APLS), 182% surge in interest
• Vir Biotechnology (VIR), 164% surge in interest

Pipeline and key clinical candidates for these companies:

RedHill Biopharma is primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik for opioid-induced constipation in adults, Talicia for the treatment of Helicobacter pylori infection in adults, and Aemcolo for the treatment of travelers’ diarrhea in adults. 

Orchard Therapeutics discovers, develops and commercializes new treatments that tap into the curative potential of hematopoietic stem cell, or HSC, gene therapy. In this approach, a patient’s own blood stem cells are genetically modified outside of the body and then reinserted, with the goal of correcting the underlying cause of disease in a single treatment. In 2018, the company acquired GlaxoSmithKline’s (GSK) rare disease gene therapy portfolio, which originated from a collaboration between GSK and the San Raffaele Telethon Institute for Gene Therapy in Milan, Italy. Today, Orchard has a pipeline spanning pre-clinical, clinical and commercial stage HSC gene therapies.

Applied Therapeutics says it is “developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need.” The company’s lead drug candidate, AT-007, is a novel central nervous system penetrant Aldose Reductase Inhibitor for the treatment of CNS rare metabolic diseases, including Galactosemia, SORD Deficiency, and PMM2-CDG. The company is also developing AT-001, a novel potent ARI, for the treatment of Diabetic Cardiomyopathy, or DbCM, a fatal fibrosis of the heart.

Revance is a biotechnology company whose aesthetics portfolio includes Daxxify for injection, the RHA Collection of dermal fillers, and OPUL, the “first-of-its-kind Relational Commerce platform for aesthetic practices.” Revance has also partnered with Viatris to develop a biosimilar to Botox, which will compete in the existing short-acting neuromodulator marketplace. Revance’s therapeutics pipeline is currently focused on muscle movement disorders including evaluating Daxxify in two debilitating conditions, cervical dystonia and upper limb spasticity.

Incyte is a global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics.

Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell-derived cellular immunotherapies to patients with cancer and autoimmune disorders. Using its proprietary iPSC product platform, “the company has established a leadership position in creating multiplexed-engineered iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products,” the company states.

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.

BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. Oral, once-daily Orladeyo is approved in the United States and many global markets. BioCryst has active programs to develop oral medicines for multiple targets across the complement system, including BCX10013, an oral Factor D inhibitor in clinical development. Rapivab is approved in the U.S. and multiple global markets, with post-marketing commitments ongoing.

Apellis Pharmaceuticals says the company “ushered in the first new class of complement medicine in 15 years” with the approval of the first and only targeted C3 therapy. Apellis is advancing this science to “continually develop transformative medicines for people living with rare, retinal, and neurological diseases,” it stated.

Vir Biotechnology is an immunology company focused on combining cutting-edge technologies to treat and prevent infectious diseases and other serious conditions. Vir has assembled two technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current clinical development pipeline consists of product candidates targeting hepatitis B and hepatitis delta viruses, influenza A and B, human immunodeficiency virus and COVID-19. Vir has several preclinical candidates in its pipeline, including RSV/MPV and HPV.

Recent news on these stocks:

September 20

Needham lowered the firm’s price target on Revance to $35 from $40 but kept a Buy rating on the shares. The company’ is well-funded and expected to generate positive adjusted EBITDA in 2025, and the stock’s downward move – including the 17% decline on the discontinuation of the Opul business – is likely “overdone”, the analyst told investors in a research note. The new pricing strategy also removes a key barrier for Daxxify uptake, the firm added.

Goldman Sachs lowered the firm’s price target on Revance to $33 from $38 but keeps a Buy rating on the shares. The company delivered a “sustainable” Investor Day presentation, outlining several noteworthy strategic adjustments which have the potential to ultimately strengthen its longer-term outlook, the analyst tells investors in a research note. The decision to back away from their premium-pricing approach is likely triggering a net negative impact on revenues with accompanying market dynamic uncertainties, but it is net positives for Daxxify and Revance’s outlook in the longer-term as it directly addresses product cost/practice economics factors which have been the key concern, the firm added.

Piper Sandler lowered the firm’s price target on Revance to $44 from $50 and keeps an Overweight rating on the shares. The firm attended Revance’s investor day at the company’s hub in Nashville, where management notably outlined revised pricing for Daxxify. Though the optics of the “reset” are admittedly messy, Piper nonetheless would view what is essentially the removal of premium pricing as the elimination of a hurdle to wider adoption in the context of a highly competitive neuromodulator space, but one that is vast in terms of the addressable patient population. Put differently, there is strong practitioner receptivity to Daxxify, but in the context of a more measured pricing structure. That is not a bad thing, and does not change the firm’s view that Revance is well-positioned to drive a $1B-plus sales footprint, Piper added.

Vir Biotechnology announced that the first participant has been dosed in a Phase 1 trial evaluating the safety, reactogenicity and immunogenicity of VIR-1388, an investigational novel T cell vaccine for the prevention of human immunodeficiency virus. The Company expects initial data from the Phase 1 trial in the second half of 2024. “HIV continues to be a major global public health challenge with no approved vaccines despite decades of research efforts,” said Carey Hwang, M.D., Ph.D., Vir’s Senior Vice President, Clinical Research, Head of Chronic Infection. “The initiation of our first clinical trial evaluating VIR-1388 is an important clinical milestone in our pursuit of developing an HIV vaccine and we are grateful to all our partners for their support of this Phase 1 trial. We are hopeful that our unique approach will help close the longstanding public health gap in HIV prevention.” The trial is supported by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, and the Bill & Melinda Gates Foundation.

September 19

Citi kept a Buy rating on Incyte with an $82 price target after the FDA approved GSK’s (GSK) Ojjaara for intermediate to high-risk myelofibrosis in adults with anemia, irrespective of prior treatment. The analyst expects some impact on Incyte’s Jakafi penetration, but sees the therapy remaining the frontline in the overall myelofibrosis population. While the Phase 3 SIMPLIFY studies failed to establish Ojjaara non-inferiority to Jakafi overall, the FDA label recognizes Ojjaara’s frontline splenic benefit in the subset of anemic myelofibrosis patients, the analyst tells investors in a research note.

September 18

RedHill Biopharma announced FDA approval of its supplemental new drug application for Talicia, allowing a change to a more flexible three times daily, taken at least 4 hours apart with food, dosing regimen for H. pylori eradication. This differs from the previously approved dosing regimen, which required dosing every eight hours with food, by enabling patients to follow a convenient “breakfast, lunch and dinner” dosing routine, which may support increased patient adherence and optimize the potential for successful H. pylori eradication.

Orchard Therapeutics announced the FDA has accepted the filing of its Biologics License Application, BLA, for OTL-200 in metachromatic leukodystrophy, MLD, under Priority Review. The agency has set a Prescription Drug User Fee Act, PDUFA, goal date of March 18, 2024. “Today is another significant step forward for patients and families in the U.S. impacted by this devastating and cruel disease who for too long have dealt with the unimaginable burden of going through the diagnostic odyssey, being told there were no treatments beyond supportive care, and then having to watch their child slip away,” said Bobby Gaspar, M.D., Ph.D., co-founder and chief executive officer of Orchard Therapeutics. “We look forward to collaborating with the FDA throughout the review and evaluation of our application. Due to the nature of the disease and the urgency to treat children affected by MLD, we are working diligently in parallel to prepare for a potential launch in 2024 and ensure OTL-200 will be available to patients in the U.S. as quickly as possible.”

BioCryst Pharmaceuticals announced that the Institut national d’excellence en sante et services sociaux, INESSS, has issued a positive recommendation for ORLADEYO to be reimbursed for the prevention of hereditary angioedema, HAE, attacks in adults and pediatric patients 12 years of age and older in Quebec. “We are committed to bringing ORLADEYO to as many Canadians living with HAE as possible. This announcement from INESSS, which follows the positive recommendation from CADTH earlier this year, takes us one step closer to making our oral, once-daily therapy available to Canadians who are in need of a new option to help improve control of their HAE attacks,” said Anand Janack, VP and general manager of BioCryst Canada.

Galera Therapeutics announced that a Type A Meeting has been scheduled for September 28, 2023 with the FDA regarding the Complete Response Letter received for the company’s New Drug Application for avasopasem manganese. The FDA is expected to issue written meeting minutes approximately 30 days following the meeting. The Company intends to gain an understanding from the FDA of its evaluation of avasopasem for radiotherapy-induced severe oral mucositis in patients with head and neck cancer undergoing standard-of-care treatment and next steps to support an NDA resubmission. The Type A Meeting is the highest priority classification of meeting that the FDA grants to NDA sponsors.

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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.