Stay ahead of biotech stocks seeing a surge in interest from retail and financial professional investors with this exclusive recap from The Fly 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:
Fennec Pharmaceuticals is a specialty pharmaceutical company focused on the development and commercialization of Pedmark to reduce the risk of platinum-induced ototoxicity in pediatric patients. Further, Pedmark received FDA approval in September 2022 and European Commission approval in June 2023 and U.K. approval in October 2023. Pedmark has received Orphan Drug Exclusivity in the U.S.
Arca Biopharma is dedicated to developing genetically and other targeted therapies for cardiovascular diseases through a precision medicine approach to drug development.
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.
Actinium develops targeted radiotherapies to meaningfully improve survival for people who have failed existing oncology therapies. Advanced pipeline candidates Iomab-B, an induction and conditioning agent prior to bone marrow transplant, and Actimab-A, a therapeutic agent, have demonstrated potential to extend survival outcomes for people with relapsed and refractory acute myeloid leukemia. Actinium plans to advance Iomab-B for other blood cancers and next generation conditioning candidate Iomab-ACT to improve cell and gene therapy outcomes.
Daré Bioscience is advancing products for women's health, stating that the company's mission is "to identify, develop and bring to market a diverse portfolio of differentiated therapies that prioritize women's health and well-being, expand treatment options, and improve outcomes, primarily in the areas of contraception, fertility, and vaginal and sexual health." Daré's first FDA-approved product, XACIATO vaginal gel, is a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older, which is under a global license agreement with Organon. Daré's portfolio also includes potential first-in-category candidates in clinical development: Ovaprene, a novel, hormone-free monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement with Bayer; Sildenafil Cream, 3.6%, a novel cream formulation of sildenafil to treat female sexual arousal disorder utilizing the active ingredient in Viagra; and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for hormone therapy following menopause.
Seelos Therapeutics is focused on the development and advancement of novel therapeutics to address unmet medical needs for the benefit of patients with central nervous system, or CNS, disorders and other rare diseases. The company's portfolio includes several late-stage clinical assets targeting indications including Acute Suicidal Ideation and Behavior in Major Depressive Disorder, amyotrophic lateral sclerosis, or ALS, and spinocerebellar ataxia, or SCA, as well as early-stage programs in Huntington's disease, Alzheimer's disease, and Parkinson's disease.
Allogene Therapeutics is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of "off-the-shelf" CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients.
Curis is a biotechnology company focused on the development of emavusertib, an orally available, small molecule IRAK4 inhibitor for the treatment of hematologic malignancies. Emavusertib is currently undergoing testing in the Phase 1/2 TakeAim Lymphoma study in patients with hematologic malignancies, such as non-Hodgkin's lymphoma and other B cell malignancies in combination with the BTK inhibitor, ibrutinib, and as a monotherapy in the Phase 1/2 TakeAim Leukemia study in patients with acute myeloid leukemia and myelodysplastic syndrome, for which it has received Orphan Drug Designation from the U.S. Food and Drug Administration. Curis, through its 2015 collaboration with Aurigene, has the exclusive license to emavusertib. Curis licensed its rights to Erivedge to Genentech, a member of the Roche Group, under which they are commercializing Erivedge for the treatment of advanced basal cell carcinoma.
Avidity Bioscience's proprietary AOCs - Antibody Oligonucleotide Conjugates - are designed to combine the specificity of monoclonal antibodies with the precision of oligonucleotide therapies to target the root cause of diseases previously untreatable with RNA therapeutics, the company says. Avidity's advancing and expanding pipeline has three programs in clinical development. AOC 1001 is designed to treat people with myotonic dystrophy type 1 and is currently in Phase 1/2 development with the ongoing MARINA and MARINA-OLE trials. AOC 1020 is designed to treat people living with facioscapulohumeral muscular dystrophy and is currently in Phase 1/2 development with the FORTITUDE trial. AOC 1044 is designed for people with Duchenne muscular dystrophy mutations amenable to exon 44 skipping and is currently in Phase 1/2 development with the EXPLORE44 trial.
Verrica is a dermatology therapeutics company developing medications for skin diseases requiring medical interventions. On July 21, 2023, Verrica's lead product, Ycanth, became the first treatment approved by the FDA to treat pediatric and adult patients with molluscum contagiosum, a highly contagious viral skin infection affecting approximately 6 million people in the United States, primarily children. VP-102 is also in development to treat common warts and external genital warts, two of the largest unmet needs in medical dermatology. Verrica is developing VP-103, its second cantharidin-based product candidate, for the treatment of plantar warts. Verrica has also entered a worldwide license agreement with Lytix Biopharma AS to develop and commercialize VP-315 for dermatologic oncology conditions.
Recent news on these stocks:
May 15
Verrica Pharmaceuticals announced that it has entered into an amendment to its existing licensing agreement with Torii Pharmaceutical to jointly conduct a global pivotal Phase 3 clinical trial of YCANTH for the treatment of common warts. "We are pleased to announce this significant amendment to our license agreement with Torii Pharmaceutical to advance YCANTH into a global pivotal Phase 3 clinical trial for the treatment of common warts," said Ted White, CEO of Verrica Pharmaceuticals. "Torii has been an outstanding partner in the development of YCANTH for molluscum contagiosum, and we look forward to our continued collaboration to progress YCANTH through a pivotal global Phase 3 clinical trial for common warts, which represents the single largest and most underserved patient population in all of dermatology. If positive, the data from this global Phase 3 clinical trial would not only potentially allow Verrica to submit a sNDA in the U.S. seeking FDA approval for the use of YCANTH for the treatment of common warts, but may also be utilized by Verrica to seek future marketing authorizations in territories outside the U.S. and Japan, including potentially within the European Union."
May 14
Fennec reported Q1 EPS of 41c against a consensus of 26c, and reported Q1 revenue of $25.4M against a consensus of $18.88M. "We made significant progress with our strategic plans to refocus our organizational efforts in the outpatient oncology community where Pedmark use has been endorsed by the NCCN in the adolescent and young adult population. Effective April 1, CMS has amended our permanent J-code to specify the non-interchangeability of Pedmark with other formulations of sodium thiosulfate. With the successful execution of the Norgine EU licensing agreement, we are well funded and confident in the significant market opportunity in front of us," said Rosty Raykov, CEO of Fennec Pharmaceuticals.
Actinium Pharmaceuticals announced that results from the Phase 3 SIERRA trial of Iomab-B have been accepted for an oral presentation and poster presentation at the 2024 European Hematology Association Hybrid Congress being held June 13 - 16, 2024, in Madrid, Spain. The Phase 3 SIERRA trial enrolled 153 patients ages 55 and above with active relapsed or refractory acute myeloid leukemia and compared outcomes of patients receiving an Iomab-B led bone marrow transplant to those of patients receiving physician's choice of care in the control arm. Across all patients in SIERRA study, only patients receiving an Iomab-B led BMT achieved the trial's primary endpoint of durable complete remission with these patients having 92% 1-year survival and 69% 2-year survival with statistically significant higher event free survival. The SIERRA trial enrolled high-risk patients including those with one or more of the following: a TP53 mutation, advanced age up to 77 years old, complex cytogenetics and prior therapy including venetoclax and other targeted agents.
Brookline upgraded Dare Bioscience to Buy from Hold with a $3 price target. Dare recently secured $22M in non-dilutive funding from a royalty monetization transaction with Xoma (XOMA), the analyst told investors in a research note. The company's Q1 update highlighted management's plan to focus on late-stage assets that can create value with current funding, says Brookline. The firm believes that while the Xoma transaction does not fully fund both Dare's Phase 3 programs, it increases the probability of getting to the Ovaprene readout while giving management flexibility to obtain funding for the Sildenafil trial.
Seelos Therapeutics announced that its board approved a 1-for-8 reverse stock split of its outstanding shares of common stock, to be effective on Thursday, May 16. The company's common stock will begin trading on a reverse stock split-adjusted basis at the opening of the market on Thursday, May 16. Following the reverse stock split, the company's common stock will continue to trade on the Nasdaq Capital Market under the symbol "SEEL" with the new CUSIP number, 81577F307. The reverse stock split is intended for the company to regain compliance with the minimum bid price requirement of $1.00 per share of common stock for continued listing on the Nasdaq Capital Market.
Curi announced updated data from the ongoing TakeAim Leukemia study, or CA-4948-102, in relapsed/refractory, or R/R, AML to be presented at the ASCO and EHA conferences. This update includes data for 25 new patients in the FLT3 mutation, or FLT3m, and U2AF1/SF3B1 Splicing Factor mutation, or SFm, cohorts who had received fewer than 3 lines of prior therapy and were treated with emavusertib as monotherapy at the Recommended Phase 2 Dose, or RP2D, of 300 mg BID. 12 R/R AML patients with FLT3m were treated with emavusertib. Prior therapies included venetoclax, hypomethylating agents or HMA, and FLT3 inhibitors. Preliminary data show 6 objective responses in 11 response-evaluable patients: 3 complete remission, or CR, 1 CR with partial hematologic recovery, or CRh, and 2 morphologic leukemia-free state, or MLFS, with on-treatment duration range of 46-324 days. 4 patients are ongoing at the data-cutoff, including 1 CRh and 1 MLFS. 3 of 3 patients who were naive to FLT3i treatment achieved objective response, 3 of 8 patients who progressed on, or following, prior FLT3i treatment achieved objective response, 1 patient is not response-evaluable. All responders demonstrated complete normalization of blast counts in the bone marrow. One of these patients proceeded to allogenic stem cell transplantation. Responses were achieved rapidly in this population, with 5 of 6 responses occurring within one cycle of treatment.
May 13
BioCryst Pharmaceuticals announced that the Federal Commission for Protection against Health Risks, COFEPRIS, in Mexico has granted approval for oral, once-daily ORLADEYO for the prophylaxis of hereditary angioedema, HAE, attacks in adults and pediatric patients 12 years of age or older. "With this decision by COFEPRIS, ORLADEYO is now approved in four countries in the pan-Latin America region. We are proud to work with our partner, Pint Pharma, to bring our oral, once-daily prophylactic therapy to people living with HAE who are in need of new treatment options in Mexico and throughout LATAM," said Charlie Gayer, chief commercial officer of BioCryst. BioCryst has an exclusive collaboration with Pint Pharma GmbH to register and promote ORLADEYO in the pan-Latin America region. Under the terms of the agreement, Pint is responsible for obtaining and maintaining all marketing authorizations and for commercializing ORLADEYO in LATAM. ORLADEYO has previously been approved in this region by regulatory agencies in Chile, Argentina and Brazil.
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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.
