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MindMed's (MNMD) Anxiety Drug Gets FDA Breakthrough Therapy Tag
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Mind Medicine (MindMed) Inc. (MNMD - Free Report) announced that the FDA granted a breakthrough therapy designation to its lead candidate, MM120 (lysergide D-tartrate) for treating generalized anxiety disorder (GAD).
The FDA grants breakthrough therapy designation to expedite the development and review of therapies for severe or life-threatening diseases where preliminary clinical evidence shows that therapy may provide substantial improvements over available treatments.
Simultaneously, the company announced that the phase IIb MMED008 study, which evaluated a single oral dose of MM120 (100 µg) in GAD, met its key secondary endpoint by demonstrating clinically and statistically significant durability of activity seen through week 12 of treatment.
MNMD stock surged 51.5% on Mar 7 following the announcement of the news.
MindMed previously announced that treatment with a single dose of MM120 demonstrated rapid, clinically meaningful, and statistically significant improvements on the Hamilton Anxiety rating scale (HAM-A) versus placebo at week four of treatment—the primary endpoint of the MMED008 study.
The latest secondary endpoint data showed that MM12 maintained a clinically and statistically significant HAM-A reduction compared with a placebo at 12 weeks with a 65% clinical response rate and 48% clinical remission rate-
Shares of MindMed have skyrocketed 183% in the past year against the industry’s decline of 1.6%.
Image Source: Zacks Investment Research
Following an end-of-phase II meeting with the FDA, which is expected to be held during the first half of 2024, the company plans to initiate a phase III study on MM120 in the second half of 2024, underlying its potential in the treatment of anxiety.
If successfully developed and upon potential approval, MM120 should be able to serve an area of high unmet medical need and generate significant revenues for the company.
MindMed is also exploring the potential of MM120 in other serious brain health disorders.
This apart, during the fourth quarter of 2023, the company initiated a phase I study evaluating another candidate, MM-402, in adult healthy volunteers for treating autism spectrum disorder.
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share have improved from 18 cents to 30 cents. In the past year, shares of ADMA have risen 87.8%.
ADMA Biologics’ earnings beat estimates in three of the trailing four quarters and met the same once. ADMA delivered an average earnings surprise of 85.00%.
In the past 60 days, the Zacks Consensus Estimate for Vanda Pharmaceuticals’ 2024 bottom line has improved from a loss of 46 cents per share to earnings of 1 cent. In the past year, shares of VNDA have plunged 38.2%.
Vanda Pharmaceuticals’ earnings beat estimates in each of the trailing three quarters. VNDA delivered an average earnings surprise of 92.88%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have improved from $4.06 to $4.40. In the past year, shares of ANIP have increased 54.5%.
Earnings of ANI Pharmaceuticals beat estimates in each of the trailing four quarters. ANIP delivered a four-quarter average earnings surprise of 109.60%.
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MindMed's (MNMD) Anxiety Drug Gets FDA Breakthrough Therapy Tag
Mind Medicine (MindMed) Inc. (MNMD - Free Report) announced that the FDA granted a breakthrough therapy designation to its lead candidate, MM120 (lysergide D-tartrate) for treating generalized anxiety disorder (GAD).
The FDA grants breakthrough therapy designation to expedite the development and review of therapies for severe or life-threatening diseases where preliminary clinical evidence shows that therapy may provide substantial improvements over available treatments.
Simultaneously, the company announced that the phase IIb MMED008 study, which evaluated a single oral dose of MM120 (100 µg) in GAD, met its key secondary endpoint by demonstrating clinically and statistically significant durability of activity seen through week 12 of treatment.
MNMD stock surged 51.5% on Mar 7 following the announcement of the news.
MindMed previously announced that treatment with a single dose of MM120 demonstrated rapid, clinically meaningful, and statistically significant improvements on the Hamilton Anxiety rating scale (HAM-A) versus placebo at week four of treatment—the primary endpoint of the MMED008 study.
The latest secondary endpoint data showed that MM12 maintained a clinically and statistically significant HAM-A reduction compared with a placebo at 12 weeks with a 65% clinical response rate and 48% clinical remission rate-
Shares of MindMed have skyrocketed 183% in the past year against the industry’s decline of 1.6%.
Image Source: Zacks Investment Research
Following an end-of-phase II meeting with the FDA, which is expected to be held during the first half of 2024, the company plans to initiate a phase III study on MM120 in the second half of 2024, underlying its potential in the treatment of anxiety.
If successfully developed and upon potential approval, MM120 should be able to serve an area of high unmet medical need and generate significant revenues for the company.
MindMed is also exploring the potential of MM120 in other serious brain health disorders.
This apart, during the fourth quarter of 2023, the company initiated a phase I study evaluating another candidate, MM-402, in adult healthy volunteers for treating autism spectrum disorder.
Zacks Rank & Stocks to Consider
MindMed currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector are ADMA Biologics, Inc. (ADMA - Free Report) , Vanda Pharmaceuticals Inc. (VNDA - Free Report) and ANI Pharmaceuticals, Inc. (ANIP - Free Report) , 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 ADMA Biologics’ 2024 earnings per share have improved from 18 cents to 30 cents. In the past year, shares of ADMA have risen 87.8%.
ADMA Biologics’ earnings beat estimates in three of the trailing four quarters and met the same once. ADMA delivered an average earnings surprise of 85.00%.
In the past 60 days, the Zacks Consensus Estimate for Vanda Pharmaceuticals’ 2024 bottom line has improved from a loss of 46 cents per share to earnings of 1 cent. In the past year, shares of VNDA have plunged 38.2%.
Vanda Pharmaceuticals’ earnings beat estimates in each of the trailing three quarters. VNDA delivered an average earnings surprise of 92.88%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have improved from $4.06 to $4.40. In the past year, shares of ANIP have increased 54.5%.
Earnings of ANI Pharmaceuticals beat estimates in each of the trailing four quarters. ANIP delivered a four-quarter average earnings surprise of 109.60%.