Neurocrine: Success Continues To Roll In With Positive MDD Treatment Data

seekingalpha04-26

Neurocrine Biosciences, Inc. achieved positive results achieved from phase 2 SAVITRI study using NBI-1065845 for the treatment of patients with Major Depressive Disorder.NBI-1065845 may offer some ...

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Treatment Data\n</h2>\n\n<h4 class=\"meta\">\n\n\n2024-04-26 06:28 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://seekingalpha.com/article/4686417-neurocrine-success-continues-to-roll-in-with-positive-mdd-treatment-data><strong>seekingalpha</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Neurocrine Biosciences, Inc. achieved positive results achieved from phase 2 SAVITRI study using NBI-1065845 for the treatment of patients with Major Depressive Disorder.NBI-1065845 may offer some ...</p>\n\n<a href=\"https://seekingalpha.com/article/4686417-neurocrine-success-continues-to-roll-in-with-positive-mdd-treatment-data\">Source Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"LU2065171402.SGD","symbol_name":"M&G (LUX) GLOBAL MAXIMA \"A\" (SGD) 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reach $14.96 billion by 2032.NBI-1070770 is another drug being advanced in the pipeline, which holds potential to target 1st-line Major Depressive Disorder patients.   andresr/E+ via Getty Images Neurocrine Biosciences, Inc. (NASDAQ:NBIX) was able to report positive results from its phase 2 SAVITRI study, which used a drug known as NBI-1065845 for the treatment of patients with major depressive disorder [MDD]. This drug is being advanced for the treatment of this patient population in collaboration with Takeda Pharmaceuticals (TAK). The thing is that that is not another \"me too\" type of drug. The reason why I say that is because it may offer several advantages over existing treatment options that are currently approved by the FDA. The positive data leads to the ability for it to advance the use of this MDD drug towards a phase 3 study. The company, along with its partner, intends to meet with the FDA in an end-of-phase 2 meeting to be able to eventually initiate such a late-stage study. The company is a good long-term name to own, in my opinion, because it has already received FDA approval of Ingrezza for the treatment of tardive dyskinesia and chorea due to Huntington's Disease [HD]. Matter of fact, it expects to earn between $2.1 to $2.2 billion in net product sales for this drug in 2024. Lastly, there are actually a few catalysts on the regulatory front. This would be regarding the expected NDA filing of crinecerfont for the treatment of pediatric and adult patients with congenital adrenal hyperplasia [CAH]. Such a regulatory filing to the FDA of this drug for the treatment of this patient population is expected to happen in Q2 of 2024. I believe that this biotech has several milestones to look forward to and, thus, why it is a good name to look into. With positive MDD data that may hold several competitive advantages over current market leaders, plus several catalysts along the way this year, I believe that investors could benefit with any potential gains made. NBI-1065845 For The Treatment Of Patients With Major Depressive Disorder As I stated above, Neurocrine Biosciences was able to achieve positive results from the phase 2 SAVITRI study. This mid-stage study used NBI-1065845 for the treatment of this patient population. Major Depressive Disorder [MDD] is a type of disorder characterized as someone who has a low or depressed mood. In other words, they no longer have pleasure in doing daily activities. Other problems that these patients might experience are a disturbance of sleep patterns and/or suicidal thoughts. Some other symptoms that these patients with MDD might experience are as follows:  Feeling sad Having angry outbursts  Lack of energy/motivation Having thoughts of worthlessness.  Plus, many other symptoms that such patients experience who have this disorder. The thing is that this is a considerable market opportunity, which is why the positive data released from the ongoing phase 2 SAVITRI study is a good thing. The global Major Depressive Disorder treatment market is expected to reach $14.96 billion by 2032. As I will explain a bit below with the newly released data, it will not be easy, though. That's because there are a few drugs already approved by the FDA that may give it some competition. On the flip side, NBI-1065845 may hold some competitive advantages over them so that Neurocrine Biosciences and partner Takeda Pharmaceuticals can compete well, should the drug ultimately be approved by the FDA. The phase 2 SAVITRI study was to use NBI-1065845 for the treatment of MDD patients who had an inadequate response. Thus, these are patients for late-line treatment with this disorder who have failed on prior therapies. There were a total of 183 patients who were enrolled into this study and were randomized into either receiving low-dose drug, high-dose drug or placebo. The primary endpoint of the study was to establish a change from baseline in a scale known as Montgomery Asberg Depression Rating Scale [MADRS] total score at Day 28. The secondary endpoint used this same measure, but was to see if such a change was still significant at Day 56. It was noted that one of the doses in this study achieved statistical significance at Day 28 [p-value of p=0.0159 and at Day 56 [p-value of p=0.0016]. This positive data brings about several catalysts on the way that investors might be able to look forward to during this year. The first of which is that full data from this phase 2 SAVITRI study will be released at an upcoming medical conference. A second catalyst would be a positive outcome from an end-of-phase 2 meeting with the FDA, gaining guidance on what the design for a phase 3 study should look like. The final catalyst being the actual initiation of a late-stage study using NBI-1065845 for the treatment of patients with MDD. The thing is that this appears to be a good drug to help late-line MDD patients who don't respond to currently available therapies. However, there are two pharmaceutical companies in particular that might provide some competition, even if this drug is ultimately approved by the FDA. The first competitor that it may have to deal with would be Johnson & Johnson (JNJ) with its drug Spravato. Spravato has been approved as a nasal spray with an oral anti-depressant for treatment-resistant depression. Again, patients who had failed to achieve an adequate response to currently available depression therapies. The problem with this approved therapy is that it can possibly cause serious adverse events [SAEs] and thus the only way to be given this treatment is through a Risk Evaluation and Mitigation Strategy [REMS]. Thus, NBI-1065845 can possibly do better against this in terms of safety. As far as the other competitor, Axsome Therapeutics (AXSM), it received FDA approval of Auvelity for the treatment of patients with MDD back in August 2022. The thing is that NBI-1065845 isn't the only drug that Neurocrine Biosciences licensed from Takeda Pharmaceuticals. I believe that there is an expansion opportunity here. How so? That's because regarding the licensing agreement that was made, it also was able to license another depression drug into its pipeline. This drug is known as NBI-1070770, and it is being developed to treat adults with MDD in an ongoing phase 2 study. The difference between this and the other drug, for starters, is that this is a NMDA NR2B NAM agonist. Whereas, the other one uses a different mode of action, which is being an alpha-amino-3-hydroxy-5-methyl-4-isoxazole propionic acid [AMPA] positive allosteric modulator [PAM]. The primary endpoint is going to evaluate a change of Total Montgomery-Asberg Depression Rating Scale [MADRS] score from baseline to Day 5. The secondary outcome, again, will also use this MADRS total score, but will evaluate this endpoint up to Day 49. Hopefully, all of these drugs end up working out, especially since Neurocrine Biosciences made a deal with Takeda to in-license several early-stage to mid-stage drugs from its psychiatry pipeline. Financials According to the 10-K SEC Filing, Neurocrine Biosciences had cash, cash equivalents and marketable securities of $1.7 billion as of December 31st of 2023. This biotech is highly differentiated than most others, because it has already received FDA approval. It received regulatory approval of Ingrezza, both for the treatment of tardive dyskinesia and chorea due to Huntington's Disease. It has been able to continue to build revenue growth just based on this product alone. In reported Q4 of 2023 and full-year 2023 net product sales of $500 million and $1.8 billion respectively. One example of growth would be to see a year-over-year comparison. From Q2 of 2022 to Q3 of 2023, sales of Ingrezza grew by 25% year-over-year. If such a double-digit growth trend continues moving forward, then this bodes well for the future of this company. On the flip side, despite substantial net product revenue growth, it has an extensive pipeline that must be funded. Its cash burn is roughly $356.4 million per quarter. Its cash runway is expected to fund its operations for at least the next 12 months. Risks To Business There are several risks that investors should be aware of before investing in Neurocrine Biosciences. The first risk to consider would be regarding the release of the most recent positive results from the phase 2 SAVITRI study, which used NBI-1065845 for the treatment of patients with Major Depressive Disorder [MDD]. That's because even though this drug was able to achieve the primary endpoint of change from baseline in MADRS compared to placebo at Day 28, there is no assurance that it will receive a \"green light\" from the FDA to initiate a phase 3 study. Not only that, but even if a late-stage study is initiated for this program, there is no assurance that the primary endpoint will eventually be met for it with statistical significance. Lastly, the goal is to release the full data set from the phase 2 SAVITRI study. There is no way of knowing whether such results will be seen positively by the market. A second risk to consider would be regarding the other MDD drug that is being advanced in a phase 2 study, which is the use of NBI-1070770 for the treatment of this patient population. The goal is to target other adult MDD patients who have not yet received any type of therapy. Again, totally different from the use of NBI-1065845, which was targeting MDD patients who had an inadequate response to prior therapies. Even though the phase 2 SAVITRI study had the primary endpoint met with statistical significance, there is no assurance that this other mid-stage study will achieve a similar outcome. A third risk to consider for the advancement of both NBI-1070770 and NBI-1065845, would be in terms of competition in the MDD space. As I noted above, Johnson & Johnson has Spravato and Axsome Therapeutics has Auvelity. There is no assurance that upon completion of phase 3 studies, using either of Neurocrine Biosciences' drugs, will ultimately end up establishing competitive advantages over them. Not only that, but the basis of advancing these psychiatry drugs is because of the license agreement established by it and Takeda. If Neurocrine decides to back out of this license agreement, then it would no longer have access to being able to advance either of these MDD candidates. A fourth risk to consider would be regarding the advancement of crinecerfont, which is being advanced for the treatment of patients with congenital adrenal hyperplasia [CAH]. An NDA filing of this drug for the treatment of this patient population is expected to happen during this quarter. There is no guarantee that the FDA will accept this regulatory application, nor that crinecerfont will ultimately be approved, even if the application is accepted by the agency. The fifth and final risk to consider would be in terms of the financial position that it is in. It believes that it only has enough cash to fund its operations for at least the next 12 months. This means that there is a risk of a cash raising event that could occur at any moment, which investors must know when looking into this name. Conclusion Neurocrine Biosciences was able to report positive results from its phase 2 SAVITRI study, which used NBI-10655845 for the treatment of patients with MDD. Matter of fact, one of the doses in this trial met the primary endpoint of statistically significant reduction in MADRS total score at Day 28. The global Major Depressive Disorder treatment market is expected to reach $14.96 billion by 2032. The hope is that it can achieve success in MDD either with this therapy or the other one I described above, known as NBI-1070770. The downside, though, is that in order for it to license these, plus several other psychiatric candidates, it had to make a specific deal. Even if either of these candidates or any other in-licensed drug is successful, it will be responsible for paying Takeda up to $1.9 billion in milestone payments. Still, I believe that this is still a good biotech to look into because of the several other candidates in its pipeline. I noted that an NDA filing of crinecerfont for CAH is expected to happen in Q2 of 2024, which sets up another major catalyst for investors to keep an eye on. The thing is that Neurocrine Biosciences, Inc. has a quite extensive pipeline it is working on. I haven't even tapped into the potential it has advancing the use of NBI-1117568, which is being advanced in a phase 2 study for the treatment of patients with Schizophrenia.  Editor's Note: This article discusses one or more securities that do not trade on a major U.S. exchange. 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