GERN shares rise after FDA panel approves blood cancer therapy

Geron Inc. NASDAQ: WILLINGLY is a clinical-stage biotechnology in the medical sector focused on the development of cell therapies for the treatment of certain types of blood cancers and myeloid hematological cancers. Their lead drug is imetelstat, which blocks a protein called telomerase to treat specific blood cancers such as myelofibrosis and myelodysplastic syndromes. Its shares rose 92% after a Federal Drug Administration (FDA) advisory panel voted 12 to 2 in favor of FDA approval.

How is cell therapy different from gene therapy?

Gene therapy has received a lot of headlines in 2024, especially for CRISPR Therapeutics AG NASDAQ: CRSP AND Vertex Pharmaceuticals Inc. NASDAQ: VRTX FDA approval for its CRISPR/cas-9 gene-editing treatment for sickle cell disease (SCD). Gene therapy involves modifying the genetic material of a cell to prevent or treat an inherited disease. Cell therapy involves using whole cells that are introduced into the body to repair or replace damaged tissue and help the immune system fight diseases such as cancer. Both methods attempt to treat the disease at the cellular level but involve different mechanisms to achieve this goal.

Imetelstat Applications

Imetelstat can be used as last-line therapy for transfusion-dependent anemia, which occurs in a blood disorder called myelodysplastic syndrome (MDS). Imetelstat would be used in cases where other therapies have not been successful. In MDS, the bone marrow is unable to produce enough healthy blood cells. Therefore, abnormal blood cells overcrowd healthy blood cells, which can lead to anemia and fatigue. People who suffer from this condition require regular blood transfusions to help manage symptoms.

Imetelstat was developed to treat transfusion-dependent anemia in adult patients with low-risk MDS. It is a telomerase inhibitor, which blocks the activity of an enzyme called telomerase. Telomerase allows cancer cells to maintain their ability to divide indefinitely. Restricting telomerase can help slow or stop tumor growth by preventing it from duplicating. Check the heat map of the sector on MarketBeat.

First line treatments

First-line treatment in the anemia therapy segment can be performed using Reblozyl, which was approved by the FDA in 2023. It was developed as part of a collaboration between Bristol Myers-Squibb Co. NYSE:BMY AND Merck&Co. NYSE:MRK. The FDA has set the action date of June 16, 2024 for its Prescription Drug User Fee Act (PDUFA). The FDA Advisory Committee’s vote is not binding, but the FDA typically sides with the Approvals Advisory Committee when deciding on approval.

Stay afloat until final FDA approval

On February 28, 2024, Geron reported an EPS loss of 9 cents, one cent compared to consensus analyst estimates. Revenue fell 77% year-over-year to $0.02 million versus analyst estimates of $0.06 million. The company lost $194 million in the first quarter of 2024. Total operating expenses for 2024 are expected to range from $270 million to $280 million. The company had $378.1 million in cash and cash equivalents. Geron has raised cash through 2023 through secondary offerings of its common stock. Management plans to hire more workers, from 114 to 270, by the end of the calendar year.

Comments from the CEO

Geron, Executive Vice President and Chief Medical Officer Fay Feller, MD, commented: “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 lower-risk adult patients MDS: There are few treatment options, and significant unmet medical needs remain for these patients, particularly among those with difficult-to-treat subtypes of this blood cancer.

Feller continued, “We believe that imetelstat has the potential to become an important new medicine for patients, and we look forward to continuing our collaboration with the FDA as they complete their review of our New Drug Application.”

Needham raises price target

Needham already had a buy rating on GERN. After the successful FDA advisory committee vote, Needham raised his price target to $5, up from $4.

Geron analyst ratings and price targets I’m on MarketBeat. The titles of Geron’s contestants and competitors can be found with MarketBeat Stock Screener.

Descending triangle weekly breakout

The daily candlestick chart for GERN illustrates a descending triangle daily breakout pattern. The descending trendline formed at a high of $3.41 on July 17, 2023. GERN stock fell to flat-bottomed trendline support at $1.73. Bounce attempts from that area were limited to the descending trend line. The FDA advisory committee is a scheduled event and GERN stock was sold ahead of the decision. After receiving the panel’s decision, GERN shares rose to a high of $3.49 before stabilizing. The weekly relative strength index (RSI) has risen to test the 70 band. Pullback support levels are at $2.66, $2.21, $1.94, and $1.73.

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