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: 

• Geron (GERN), 174% surge in interest
• AgeX Therapeutics (AGE), 105% surge in interest
• Outlook Therapeutics (OTLK), 104% surge in interest
• Akebia Therapeutics (AKBA), 76% surge in interest
• Madrigal Pharmaceuticals (MDGL), 62% surge in interest

Pipeline and key clinical candidates for these companies:

Geron is a late-stage biopharmaceutical company pursuing therapies with the potential to extend and enrich the lives of patients living with hematologic malignancies. Its investigational first-in-class telomerase inhibitor, imetelstat, “harnesses Nobel Prize winning science in a treatment that may alter the underlying course of these diseases,” the company says.

AgeX Therapeutics is focused on developing and commercializing innovative therapeutics to treat human diseases to increase healthspan and combat the effects of aging.

Outlook Therapeutics is working to develop and launch ONS-5010, or Lytenava, as the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD, DME and BRVO. 

Akebia Therapeutics is a fully integrated biopharmaceutical company that says its purpose is “to better the lives of people impacted by kidney disease.”

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.

Recent news on these stocks:

March 14

Geron announced that the FDA Oncologic Drugs Advisory Committee, or ODAC, voted 12 to 2 in favor of the clinical benefit/risk profile of imetelstat for the treatment of transfusion-dependent anemia in adult patients with low-to-intermediate-1 risk myelodysplastic syndromes who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents. “We are pleased with the Committee’s decision to recognize the positive clinical benefit/risk profile of imetelstat for the treatment of transfusion-dependent anemia in adult patients with lower-risk MDS. There are few treatment options and significant unmet medical need remains for these patients, particularly among those with difficult-to-treat subtypes of this blood cancer. We believe that imetelstat has the potential to be an important new medicine for patients and look forward to continuing our collaboration with the FDA as they complete their review of our New Drug Application,” said Faye Feller, M.D., Geron’s Executive Vice President, Chief Medical Officer. The FDA assigned a Prescription Drug User Fee Act, or PDUFA, target action date of June 16 for Geron’s New Drug Application for imetelstat for the treatment of TD anemia in adult patients with low- to intermediate-1 risk myelodysplastic syndromes, who have failed to respond, or have lost response to, or are ineligible for ESAs. “The ODAC provides the FDA with independent opinions and recommendations from outside medical experts, patients and caregivers, though the recommendations are not binding. Geron plans to commercially launch imetelstat in the U.S. upon potential FDA approval,” the company stated.

AgeX’s stockholders approved an amendment to AgeX’s Certificate of Incorporation to effect a reverse stock split of issued and outstanding shares of common stock of AgeX. The board of directors of AgeX approved the reverse stock split at a ratio of 1-for-35.17.

Akebia reported Q4 EPS of 0c, consensus (4c), and reported Q4 revenue of $56.2M, consensus $55.39M. “We are eagerly awaiting the PDUFA date for vadadustat, now within weeks, and we believe the progress we have made over the past 12 months has positioned our team to successfully launch vadadustat in the U.S., if approved,” said CEO John Butler. “A U.S. approval for vadadustat will be transformational for Akebia and a significant step toward our goal of bettering the lives of people impacted by kidney disease. Our team remains dedicated to delivering an innovative oral therapeutic treatment for anemia due to chronic kidney disease for patients on dialysis. We are approaching a potential U.S. launch of vadadustat from an extremely strong financial position. We expect Auryxia net product revenue growth in 2024, with a quarterly revenue cadence that is similar to 2023, we executed a term loan with BlackRock and implemented other financial strategies that together we believe will support our business operations for at least two years if vadadustat is approved. As we move forward, we will continue to carefully manage expenses, while investing appropriately for a successful potential launch of vadadustat.”

Madrigal Pharmaceuticals announced that the FDA has granted accelerated approval for Rezdiffra, or resmetirom, in conjunction with diet and exercise for the treatment of adults with noncirrhotic nonalcoholic steatohepatitis, or NASH, with moderate to advanced liver fibrosis consistent with stages F2 to F3 fibrosis. Continued approval for this indication may be contingent upon verification and description of clinical benefit in ongoing confirmatory trials. Bill Sibold, Chief Executive Officer of Madrigal, stated, “NASH with moderate to advanced liver fibrosis is a serious and progressive liver disease that, until now, has not had an FDA-approved therapy. The accelerated approval of Rezdiffra is a culmination of more than 15 years of research from our founder Dr. Becky Taub and a small R&D team that took on one of the biggest challenges in drug development. This is a historic moment for the NASH field and represents the best of what our industry is capable of. We’re excited to deliver Rezdiffra to patients in need.” MAESTRO-NASH remains ongoing as an outcomes study designed to generate confirmatory data that, if positive, will help verify clinical benefit and may support full approval. A second ongoing outcomes trial is evaluating progression to liver decompensation events in patients with well-compensated NASH cirrhosis treated with Rezdiffra versus placebo. Rezdiffra is expected to be available to patients in the U.S. in April and will be distributed through a limited specialty pharmacy network. “Madrigal is committed to helping appropriate patients who may benefit from Rezdiffra access the medication through the Madrigal Patient Support program. This program is designed to help patients navigate insurance and affordability challenges and provide co-pay support for eligible patients. Madrigal has also established a patient assistance program to help patients with no insurance access Rezdiffra,” the company stated.

March 12

Outlook Therapeutics announced that a 1-for-20 reverse stock split of its outstanding shares of common stock will be effective on March 14. The company’s common stock will begin trading on a reverse stock split-adjusted basis at the opening of the market on March 14. Following the reverse stock split, the company’s common stock will continue to trade on The Nasdaq Capital Market under the symbol “OTLK”. The reverse stock split is part of the company’s plan to regain compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market.

Hear more from InvestingChannel by signing up for The Spill.

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.