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:
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.
Hepion Pharmaceuticals is a clinical stage biopharmaceutical company that has been developing a treatment for non-alcoholic steatohepatitis, hepatocellular carcinoma, and other chronic liver diseases. Hepion's lead drug candidate, rencofilstat, is a potent inhibitor of cyclophilins, which are involved in many disease processes. Rencofilstat has been shown to reduce liver fibrosis and hepatocellular carcinoma tumor burden in experimental disease models and is currently in Phase 2 clinical development for the treatment of NASH.
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.
Kiniksa is a commercial-stage biopharmaceutical company focused on discovering, acquiring, developing, and commercializing therapeutic medicines for patients suffering from debilitating diseases with significant unmet medical need. Kiniksa's immune-modulating assets, ARCALYST, abiprubart, and mavrilimumab, are based on strong biologic rationale or validated mechanisms, target a spectrum of underserved cardiovascular and autoimmune conditions, and offer the potential for differentiation.
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.
Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on the discovery and development of proprietary drugs for the treatment of cancer, independently and through research and development collaborations. The company's core objective is to leverage its proprietary Phospholipid Drug Conjugate delivery platform to develop the next-generation of cancer cell-targeting treatments, delivering improved efficacy and better safety as a result of fewer off-target effects. The company's product pipeline includes lead asset iopofosine, a small-molecule PDC designed to provide targeted delivery of iodine-131, proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets.
Jaguar Health is a commercial stage pharmaceuticals company focused on developing novel, plant-based, sustainably derived prescription medicines for people and animals with GI distress, including chronic, debilitating diarrhea. Jaguar Health's wholly owned subsidiary, Napo Pharmaceuticals, focuses on developing and commercializing proprietary plant-based human pharmaceuticals from plants harvested responsibly from rainforest areas. Their crofelemer drug product candidate is the subject of the OnTarget study, an ongoing pivotal Phase 3 clinical trial for prophylaxis of diarrhea in adult cancer patients receiving targeted therapy.
Dynavax is a commercial-stage biopharmaceutical company that says it is "developing and commercializing innovative vaccines to help protect the world against infectious diseases." The company has two commercial products, HEPLISAV-B vaccine, which is approved in the U.S., the European Union and Great Britain for the prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older, and CpG 1018 adjuvant, currently used in multiple adjuvanted COVID-19 vaccines.
Fortress Biotech is focused on acquiring, developing and commercializing high-potential marketed and development-stage drugs and drug candidates. The company has nine marketed prescription pharmaceutical products and over 30 programs in development at Fortress, at its majority-owned and majority-controlled partners and subsidiaries and at partners and subsidiaries it founded and in which it holds significant minority ownership positions. Such product candidates span six large-market areas, including oncology, rare diseases and gene therapy.
Recent news on these stocks:
July 25
Actinium Pharmaceuticals announced the FDA clearance of an Investigational New Drug, IND, application to study Iomab-ACT for targeted conditioning prior to a bone marrow transplant, in patients with sickle cell disease. If successful, the trial is expected to inform a clinical trial to evaluate Iomab-ACT as a targeted conditioning agent prior to gene therapy for which there are two approved agents for patients with sickle cell disease, Casgevy and Lyfgenia. Iomab-ACT is an ARC that targets CD45, a marker expressed on blood cancer cells and immune cells that is intended to enable conditioning prior to cell and gene therapies replacing the non-targeted chemotherapy and total body irradiation that is currently used for conditioning. It is the only CD45 targeting conditioning agent in clinical development.
Fortress Biotech has entered into a new loan agreement for up to $50M with funds managed by Oaktree Capital Management. The company will receive an initial tranche of $35M and is eligible to draw an additional $15M at Oaktree's discretion to support future business development activities. In connection with the new loan agreement, the company repaid its prior $50M term loan with Oaktree.
July 24
Wells Fargo analyst raised the firm's price target on Kiniksa to $35 from $34 and kept an Overweight rating on the shares. Arcalyst revenues came out on top, and management upped its 2024 guidance range by +8% at the midpoint, the firm noted. Wells thought further commentary on treatment duration and growth of prescribers sounded positive.
July 23
Adial Pharmaceuticals announced the progression to the second cohort in the pharmacokinetics, PK, study of AD04, the company's lead investigational genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder, AUD, in heavy drinking patients, following the successful completion of the first cohort. Topline results from both cohorts are expected to be announced during the fourth quarter of 2024. Cary Claiborne, CEO of Adial commented, "We are pleased with the progress of our pharmacokinetics study of AD04. The successful completion of the first cohort allows us to advance to the second cohort as planned, staying on track with our projected timeline. The results from both cohorts will offer invaluable insights that are critical for the design of our upcoming Phase 3 Clinical Trial. We anticipate engaging with the FDA following receipt of the topline data from this study and seek their feedback on the overall design of our Phase 3 program."
Cellectar Biosciences announced positive results from its CLOVER WaM pivotal study evaluating iopofosine I 131, a potential first-in-class, targeted radiotherapeutic candidate for the treatment of relapsed/refractory Waldenstrom's macroglobulinemia patients that received at least two prior lines of therapy, including Bruton tyrosine kinase inhibitors. CLOVER WaM is the first and largest WM study to date in a highly refractory patient population, including patients who are refractory to all available treatment categories. As of May 31, 2024, results in the CLOVER WaM study (NCT02952508) had an overall response rate of 80% and a major response rate of 56.4%, which exceeded the agreed-upon primary endpoint of a 20% MRR. Median age was 70 years in the modified intent to treat population. The median number of prior lines of therapy was 4, with approximately 27% of patients refractory to all available therapies, and 40% of patients dual-class refractory. Notably, comparable ORRs were observed across all clinically challenging disease subgroups, including: MYD88-wt, P53-mutated, and clinical patient cohorts including post-BTKi, as well as dual-class, and triple-class refractory patients. Secondary endpoints of disease control rate and duration of response presented evidence that iopofosine provided durable clinical benefit across all response categories. The median DoR in patients achieving major response and overall response were not reached as of the data cutoff, with 78% and 72% of patients remaining free from disease progression at 18 months, respectively.
July 22
Hepion Pharmaceuticals has entered into a definitive merger agreement with Pharma Two B Ltd., a late-clinical stage private Israeli company that is developing P2B001, an innovative combination product candidate in development for the treatment of Parkinson's Disease. Under the merger agreement, Hepion will merge into and become an indirectly wholly-owned subsidiary of Pharma Two B. The combined company will continue to operate under the "Pharma Two B" name and Pharma Two B has agreed to file a registration statement on Form F-4 with the SEC to register the ordinary shares proposed to be issued to Hepion's equity-holders in the acquisition, and will also apply to list its ordinary shares on Nasdaq under the ticker symbol "PHTB". Hepion has also announced a private placement of $2.9M non-convertible senior notes to qualified institutional investors. The notes are unsecured, interest-free, and were issued with an aggregate $400.0 thousand original issue discount, and mature at the earlier of December 31, 2024; the closing of merger; or the termination of merger pursuant to terms of merger Agreement. Hepion also loaned $600.0 thousand of the proceeds to Pharma Two B through a non-convertible unsecured note that bears nominal interest and matures on the same terms as the $2.9M notes, but which will be forgiven and canceled upon consummation of the merger. In connection with the purchase of the notes, the investors received 1,159,245 shares of Hepion common stock, or approximately 19.99% of Hepion's outstanding common stock immediately prior to the issuance. In support of the merger, Pharma Two B has entered into a securities purchase agreement for an $11.5M private placement of ordinary shares and accompanying Series A warrants and Series B warrants with a syndicate of new and existing institutional life science investors. The private placement is expected to close immediately after the closing of the merger. The Series A warrants will have a 5-year term, and an exercise price of $6.00 per ordinary share. The Series B warrants will have a 2.5-year term, and an exercise price of $6.00 per ordinary share. The warrants will have customary anti-dilution adjustments as well as anti-dilution price protection and share adjustment features, subject to a floor price of 20% of the initial exercise price per share, as well as a cash true up feature, in each case subject to certain limitations. Pharma Two B has agreed to register for resale the shares to be issued in the concurrent private financing. Under the terms of the merger agreement, the merger is valued at an estimated pro-forma implied equity value of approximately $58.M. At close, Pharma Two B expects up to $11.5M of gross cash proceeds, and intends to use net proceeds to fund continuing growth and expansion of its lead product candidate P2B001 and repay up to $2.9M of Hepion's senior unsecured notes to the extent outstanding at closing of the merger. Following the merger, the combined company will continue to be led by Pharma Two B's management, a highly experienced team in PD, supported by top-tier scientific and clinical key opinion leaders and backed by a dedicated group of investors. The merger is expected to close in Q4 of 2024 and is subject to approval by Hepion's stockholders, regulatory approval, and other customary closing conditions.
MEI Pharma announced that its board has determined unanimously to begin evaluation of the company's strategic alternatives, including potential transactions as well as an orderly wind down of the company, if appropriate, in order to maximize the value of its assets for its stockholders. The company intends to evaluate and engage a financial advisor to assist in this process. In order to best preserve the company's existing cash, the company will commence a reduction-in-force beginning as soon as practicable and continuing in stages as the company's operational and strategic direction evolves. The company intends to promptly discontinue the clinical development of voruciclib, while certain non-clinical activities related to MEI's drug candidate assets will continue to be conducted by the company. Consistent with the company's intention to preserve the cash, David Urso, the company's president and CEO, and Richard Ghalie, the company's chief medical officer, have agreed in principle with the company to step down, effective as of August 1. Urso will also leave the company's board of directors at that time. The company expects to enter into consulting agreements with both Urso and Ghalie under which they will remain available to assist the company in its strategic efforts. Charles Baltic III, the current chairperson of the company's board of directors, will also step down from the board contemporaneous with this announcement. As part of the review of strategic alternatives, the company will consider options such as out-licensing opportunities for existing programs and merger and acquisition opportunities. The Company's Board of Directors has appointed Justin "Jay" File, currently the company's CFO, to assume the position of acting CEO upon Urso's departure to lead the company through this period of transition. The board has also appointed Frederick Driscoll chairperson of the company to lead the board during this period.
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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.
