Shares of Plus Therapeutics, Inc. PSTV were up a whopping 311.4% on March 6 after the company announced that the FDA has granted an Orphan Drug Designation (“ODD”) to its lead radiotherapeutic candidate, rhenium (186Re) obisbemeda, for treating leptomeningeal metastases (“LM”) in patients with lung cancer. The stock continued to gain another 51.4% in after-hours trading following the news announcement.

The FDA grants ODD to support the development of medicines for rare disorders that affect fewer than 200,000 people in the United States. The ODD 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, including the Prescription Drug User Fee Act (PDUFA) charge of $4.3 million in 2025.

LM is a rare cancer complication in which the primary cancer spreads to the cerebrospinal fluid and leptomeninges that cover the brain and spinal cord.

In the past year, shares of Plus Therapeutics have declined 14.8% compared with the industry’s decrease of 9.9%.

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More Updates on PSTV's Radiotherapeutic Candidate

A novel injectable radiotherapy, rhenium (186Re) obisbemeda is specifically developed to deliver highly targeted high-dose radiation in central nervous system (“CNS”) tumors, with the potential to reduce risks and improve patient outcomes.

Last month, PSTV announced that it has completed enrollment in the ReSPECT-LM phase I single-dose escalation study, which evaluated the safety, tolerability and potential efficacy of intrathecally administered rhenium (186Re) obisbemeda in patients with LM.

The company is now advancing a phase II single-dose expansion study and a phase I multiple-dose study on rhenium (186Re) obisbemeda for patients with LM.

The company is evaluating rhenium (186Re) obisbemeda in the phase I/II ReSPECT-GBM study for the treatment of recurrent glioblastoma.

The company is also planning to develop rhenium (186Re) obisbemeda for treating pediatric brain cancers.

PSTV's Zacks Rank & Stocks to Consider

Plus Therapeutics currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the drug/biotech sector are Xencor, Inc. XNCR, Amylyx Pharmaceuticals, Inc. AMLX and BioMarin Pharmaceutical Inc. BMRN, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

In the past 60 days, estimates for Xencor’s loss per share have narrowed from $3.70 to $2.87 for 2025. In the past year, shares of XNCR have lost 42.9%.

XNCR’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average negative surprise being 4.77%.

In the past 60 days, estimates for Amylyx’s loss per share have narrowed from $1.50 to $1.36 for 2025. In the past year, shares of AMLX have increased 7.4%.

AMLX’s earnings missed estimates in each of the trailing four quarters, the average negative surprise being 102.20%.

In the past 60 days, estimates for BioMarin’s earnings per share have increased from $4.04 to $4.24 for 2025. In the past year, shares of BMRN have declined 17.1%.

BMRN’s earnings beat estimates in each of the trailing four quarters, the average surprise being 32.36%.

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This article originally published on Zacks Investment Research (zacks.com).

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