Selected stock price target news of the day - December 30th, 2024

By: Matthew Otto

Axsome Announces Completion of Phase 3 Trials for AXS-05 in Alzheimer’s Disease Agitation

Axsome Therapeutics has announced the completion of its Phase 3 clinical program for AXS-05, an investigational treatment for Alzheimer’s disease agitation, a condition affecting up to 70% of the 7 million Americans diagnosed with Alzheimer’s disease.

The ACCORD-2 Phase 3 trial achieved its primary endpoint. Showing AXS-05 delaying agitation relapse by a significant 3.6-fold compared to placebo (hazard ratio: 0.276, p=0.001). The trial also met secondary endpoints. Reporting only 8.4% of patients on AXS-05 relapsing compared to 28.6% on placebo (p=0.001). Additionally, the drug reduced the worsening of overall Alzheimer’s disease severity. Reporting 13.3% of patients showing deterioration versus 39.3% on placebo (p<0.001).

AXS-05 demonstrated a favorable safety profile across all trials. Among 456 participants in the long-term safety study, adverse events occurred in 39.9% of patients, with no deaths reported. Notably, the rate of serious adverse events was only 2.6%, none attributed to the study drug.

Analyst Reiterates Rating and Target, Highlighting Positive Results for AXS-05

Needham analyst Ami Fadia kept with a Buy rating and a $130 price target.

Which Analyst has the best track record to show on AXSM?

Analyst Charles Duncan (CANTOR FITZGERALD) currently has the highest performing score on AXSM with 7/21 (33.33%) price target fulfillment ratio. His price targets carry an average of $26.34 (27.83%) potential upside. Axsome Therapeutics stock price reaches these price targets on average within 49 days.

Citius Reports Transformative Year with FDA Approval and Significant Clinical Advances

Citius Pharmaceuticals announced its financial and operational results for fiscal year 2024, ending September 30. Reported the FDA approval of LYMPHIR™ (denileukin diftitox-cxdl) for adults with relapsed or refractory cutaneous T-cell lymphoma (CTCL), a condition affecting approximately 16,000 individuals in the United States annually.

Citius also progressed with the Phase 3 trial for Mino-Lok®, targeting catheter-related bloodstream infections that affect over 500,000 patients annually in the U.S. LYMPHIR’s approval. It is expected to open opportunities for broader application, with investigator-led trials exploring its potential as a combination therapy in immuno-oncology. In total, over 1,000 patients are expected to benefit from ongoing clinical studies across these programs.

Financially, Citius reported a net loss of $39.4 million, or $5.97 per share, for 2024, compared to $32.5 million, or $5.57 per share, in 2023. R&D expenses decreased to $11.9 million from $14.8 million in the prior year, attributed to the completion of the Halo-Lido trial and regulatory activities for LYMPHIR. However, general and administrative expenses rose to $18.2 million due to pre-launch activities. Citius closed the year with $3.3 million in cash and cash equivalents and raised $13.8 million through equity issuance.

Analyst Upgrades Rating, Reflecting Confidence in LYMPHIR’s Market Potential

D. Boral Capital analyst Jason Kolbert upgraded Citius Pharma from Hold to Buy and announced a $9 price target.

Which Analyst has the best track record to show on CTXR?

Analyst Vernon Bernardino (HC WAINWRIGHT) currently has the highest performing score on CTXR with 5/6 (83.33%) price target fulfillment ratio. His price targets carry an average of $3.5 (700.00%) potential upside. Citius Pharmaceuticals stock price reaches these price targets on average within 339 days.

Halozyme’s HYQVIA® Approved in Japan for Agammaglobulinemia and Hypogammaglobulinemia

Halozyme Therapeutics announced that Takeda has received regulatory approval for HYQVIA® from Japan’s Ministry of Health, Labour and Welfare (MHLW). The approval is for treating agammaglobulinemia and hypogammaglobulinemia, which are rare disorders caused by primary or secondary immunodeficiency (PID/SID). It is estimated that agammaglobulinemia affects around 1 in 200,000 individuals. Additionally, hypogammaglobulinemia is more common, affecting about 1 in 10,000 people worldwide.

HYQVIA® combines Immunoglobulin 10% with Halozyme’s ENHANZE® technology, which uses Recombinant Human Hyaluronidase PH20 (rHuPH20) to improve the dispersion and absorption of immunoglobulin, allowing larger volumes to be infused subcutaneously. This enables a reduced dosing frequency of every 3 to 4 weeks, compared to the typical weekly or bi-weekly schedules for other subcutaneous treatments.

The approval is based on two Phase 3 studies in Japan (NCT05150340, NCT05513586) involving 16 patients aged 2 years or older. These studies demonstrated that the Geo Mean of IgG trough levels at the final visits was 9.494g/L, which is comparable to treatments with intravenous or other subcutaneous immunoglobulin products (9.624g/L).

This data supports the potential benefit for a significant portion of the estimated 1,000 to 2,000 people with PID in Japan. Adverse reactions were reported in 31.3% of patients, with the most common being pyrexia and infusion site reactions (12.5%).

Analyst Reiterates Rating, Highlights HYQVIA® Approval

HC Wainwright & Co. analyst Mitchell Kapoor maintained a Buy rating and a $68 price target.

Which Analyst has the best track record to show on HALO?

Analyst Joseph Catanzaro (PIPER SANDLER) currently has the highest performing score on HALO with 14/14 (100%) price target fulfillment ratio. His price targets carry an average of $-6.47 (-11.07%) potential downside. Halozyme Therapeutics stock price reaches these price targets on average within 140 days.