Immuneering Corporation IMRX announced that the FDA has granted orphan drug designation to its lead product candidate, IMM-1-104, for the treatment of pancreatic cancer. Shares of the company were up 15.5% on Oct. 15 following the announcement of the news.

The FDA grants Orphan Drug Designation to support the development of medicines for rare disorders that affect fewer than 200,000 patients in the United States. The Orphan Drug Designation makes the sponsor eligible to receive seven years of market exclusivity following a potential approval and tax credit for qualified clinical studies as well as exemptions from certain FDA application fees.

IMM-1-104 was earlier granted the FDA’s Fast Track designation in the United States for the treatment of first- and second-line pancreatic cancer.

Year to date, shares of Immuneering have plunged 68.6% compared with the industry’s decrease of 1.8%.

Image Source: Zacks Investment Research

Recent Developments Related to IMRX's IMM-1-104

Last month, the company announced positive early response data from the first five patients of an ongoing early to mid-stage study evaluating IMM-1-104 combined with chemotherapy (modified gemcitabine/nab-paclitaxel) in first-line pancreatic cancer.

IMM-1-104, an investigational RAS medication, is being evaluated in the phase I/IIa study in patients with advanced solid tumors harboring RAS mutations.

A phase IIa study is evaluating the 320mg dose of IMM-1-104 as a monotherapy and in combination with two different chemotherapy regimens to treat pancreatic cancer. The phase IIa portion is also evaluating IMM-1-104 as monotherapy for non-small cell lung cancer and melanoma in different treatment arms.

The combination regimen of IMM-1-104 and modified gemcitabine/nab-paclitaxel was also overall well tolerated by the pancreatic cancer patients in the phase IIa portion of the study with a consistent safety profile for both therapeutics.

Initial data from at least one additional arm of the phase IIa portion of the early to mid-stage study is expected by the end of 2024.

Besides IMM-1-104, Immuneering has another pipeline candidate, IMM-6-415, which is being evaluated in a separate phase I/IIa study in patients with advanced solid tumors harboring RAS or RAF mutations.

In the absence of an approved product, pipeline development remains in key focus for the company.

IMRX's Zack Rank & Stocks to Consider

Immuneering currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are ANI Pharmaceuticals, Inc. ANIP, Voyager Therapeutics, Inc. VYGR and Alnylam Pharmaceuticals, Inc. ALNY, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have moved up from $4.69 to $4.81. Earnings per share estimates for 2025 have improved from $5.37 to $5.86. Year to date, shares of ANIP have increased 6.2%.

ANIP’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 31.32%.

In the past 60 days, estimates for Voyager Therapeutics’ 2024 loss per share have narrowed from $1.47 to $1.44. Loss per share estimates for 2025 have narrowed from $1.95 to $1.94. Year to date, shares of VYGR have declined 18.8%.

VYGR’s earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 104.33%.

In the past 60 days, estimates for Alnylam’s 2024 loss per share have narrowed from $1.20 to 63 cents. Loss per share estimates for 2025 have narrowed from 34 cents to 26 cents. Year to date, shares of ALNY have rallied 50.2%.

ALNY’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 108.53%.

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

Alnylam Pharmaceuticals, Inc. (ALNY) : Free Stock Analysis Report

ANI Pharmaceuticals, Inc. (ANIP) : Free Stock Analysis Report

Voyager Therapeutics, Inc. (VYGR) : Free Stock Analysis Report

Immuneering Corporation (IMRX) : Free Stock Analysis Report

To read this article on Zacks.com click here.

Zacks Investment Research