After undergoing correction and consolidation, these ASX stocks appear to be ripe to move higher. Having good potential, long term investors can add to their portfolio as the timing is ideal.
PYC Therapeutics Limited (ASX: PYC)
PYC Therapeutics is focused on developing treatments for genetic diseases, and has several ongoing clinical programs. The company is advancing its lead drug candidate, VP-001, designed to treat Retinitis Pigmentosa type 11, a childhood blinding eye disease with no existing treatments. Clinical trials for VP-001 have shown promising results, including statistically significant improvements in vision and clinically meaningful gains in visual acuity, along with a favorable safety profile. These findings will be presented at upcoming international scientific conferences in May. In light of these positive outcomes, PYC Therapeutics is scheduled to meet with the FDA on June 6, 2025, to discuss the regulatory pathway for VP-001. The company's proprietary platform technology is proving to be effective in addressing these types of diseases.
In addition to the progress with VP-001, PYC Therapeutics is also making strides in its other drug development programs. The company has successfully extended its cash runway to over $200 million through a $146 million Entitlement Offer, securing funding into CY2027. This financial stability supports the advancement of its pipeline, which includes a drug candidate (PYC-003) for polycystic kidney disease. The first participant has received a dose of PYC-003 as PYC Therapeutics starts its Phase 1a clinical Trial. The company's focus remains on developing precision medicines for genetic diseases with unmet medical needs, and it anticipates several near-term human efficacy read-outs for its drug candidates.
Orthocell Limited (ASX: OCC)
Orthocell has achieved significant regulatory and commercial milestones, marking a period of substantial growth. The company received US FDA 510(k) clearance for its flagship Remplir nerve repair product, a pivotal step towards commercial distribution in the substantial US$1.6B US nerve repair market. This is expected to drive the company towards breakeven and profitability. Orthocell also secured regulatory approval from the Brazilian Health Regulatory Agency (ANVISA) for its Striate+ dental guided bone regeneration product, opening access to the US$65M Brazilian market. Furthermore, Orthocell has also been granted a license by the Food and Drug Administration of Thailand to commence sales of Remplir into the growing US$84M Thai nerve repair market. These regulatory approvals highlight Orthocell's success in expanding its commercial footprint across key global markets.
Building on these achievements, Orthocell is actively preparing for increased sales and broader market penetration. In the US, the company has established logistics and sales pathways for Remplir, including the strategic appointment of experienced US-based marketing, sales, and medical education executives, and the appointment of initial US distributors. Orthocell's manufacturing facility is prepared to supply the US market, with a capacity of over 100,000 units. The company plans to partner with an exclusive distributor in Thailand and expects first sales from that region in the second half of 2025. Orthocell's strong financial position, with approximately $31.7M in cash reserves, supports the ongoing commercial rollout of Remplir and Striate+ and enables further regulatory applications in markets including Canada and Thailand.
(Source: Company Announcements)
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