With Biotech sector unraveling its potential, a few ASX Listed Companies are showing a turnaround from temporary retracements. Two of the most promising stocks are
Neuren Pharmaceuticals Limited (ASX: NEU)
Neuren Pharmaceuticals Limited, is considered among good Fundamental Stocks. announced on 27 May 2024, the top-line results from its Phase 2 clinical trial of NNZ-2591 in children with Pitt Hopkins syndrome (PTHS). Both clinicians and caregivers observed a statistically significant improvement from baseline due to treatment, across all 4 efficacy measures specifically designed to assess the core characteristics of PTHS.
Previously, the company reported its quarterly results for the period ended 31 March 2024 (Q1 2024).
Neuren’s partner Acadia Pharmaceuticals (NASDAQ: ACAD) introduced DAYBUE (trofinetide) in the United States in April 2023 as the first and only approved treatment for Rett syndrome. Net sales rapidly grew to reach US$177 million for 2023, resulting in royalties of $27 million to Neuren.
During the recent American Academy of Neurology meeting, Acadia presented extended efficacy and tolerability findings from the Daffodil study, focusing on Rett syndrome patients aged 2-4 years.
Data was collected for up to 78 weeks of treatment with DAYBUE Since DAYBUE was approved in March 2023, the study was concluded early, so only 9 of the 12, who had completed were having data at week 78, while all 12 had data at week 52).
Efficacy data showed sustained improvements, which increased with time on therapy. The mean Clinical Global Impression of Improvement (CGI-I) score improved to 2.2 at 78 weeks.
As a result of recently improved sales activity, particularly from DAYUBE, the company has reiterated its full-year FY24 guidance for net sales, projecting a range of US$370 million to US$420 million. Notably, DAYUBE is expected to contribute full-year royalties in the range of $61 million to $70 million.
Net cash from operating activities for Q1 2024 were $8.0 million, including receipt of $13.4 million royalties for Q4 2023.
The company is achieving significant financial growth upon commercialization, leading to a breakthrough in shareholder earnings. Neuren displays promising long-term growth prospects through efforts in product expansion and geographical expansion outside North America, with its products addressing critical unmet clinical needs.
Botanix Pharmaceuticals Limited (ASX: BOT)
Botanix Pharmaceuticals Limited has achieved a significant milestone with the FDA's approval of its New Drug Application for Sofdra™ (sofpironium) topical gel at 12.45%. This approval marks Sofdra™ as the first and only new chemical entity sanctioned for treating primary axillary hyperhidrosis in both adults and children aged 9 years and older.
The company has recently achieved a significant expansion of its balance sheet and book value through the expansion of additional fixed assets. Its liquidity has also markedly improved, evidenced by an increase in the current ratio from 3.08x at the end of 2H FY23 to 9.5x by the end of 1H FY24. Additionally, the company's cash position remained robust at $17.32 million as of 31 March 2024.
The company continues to make significant strides in its commercialization strategy. After recently receiving FDA approval for its primary treatment candidate for hyperhidrosis, Sofdra, and establishing manufacturing supplies and processes, the company is advancing its sales activities for the product. Initially, the company will target a small proportion of the overall market, focusing on high-priority patients who actively seek treatment and visit dermatologists. Following this, the company will expand its focus to include other priority patients who can be treated from home.
The Long Term Growth is evident from its substantial scalability potential. To capitalize on this, the company will allocate marketing and PR efforts to increase doctors' reach for prescribing Sofdra to their patients, while also strengthening its market position among the overall population suffering from hyperhidrosis. Additionally, the company's efforts to expand into treatment of other underserved common skin diseases are poised to be significant in the long term, complementing its primary product.
Source: Company's Report
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