iHub News
1月前
MoonLake (MLTX) Shares Gain After Positive FDA Meeting on Sonelokimab FilingMay 11, 2026 10:16 AM
IH Market News MoonLake Immunotherapeutics (NASDAQ:MLTX) shares rose more than 4% in premarket trading on Monday after the biotechnology company announced positive progress in discussions with the U.S. Food and Drug Administration regarding its planned biologics license application for sonelokimab.The company also reported a first-quarter loss of $0.98 per share, slightly wider than analyst expectations for a loss of $0.89 per share. FDA Aligns With Company on Submission Strategy MoonLake said it completed its final pre-BLA meeting with the FDA on April 1, reaching agreement on plans for the submission of sonelokimab for the treatment of hidradenitis suppurativa.According to the company, the FDA confirmed the acceptability of data from the MIRA trial and also agreed to include results from the VELA-TEEN adolescent study in the proposed product label.This would allow MoonLake to seek approval for patients aged 12 years and older.The proposed label is expected to feature the MIRA trial’s approximately 43% HiSCR75 response rate as well as an approximately 29 percentage point improvement over placebo at week 12.MoonLake said it plans to submit its biologics license application by the end of September 2026, with formal acceptance anticipated before the end of November.“With no remaining gaps identified, the pre-BLA process for HS is complete,” the company stated.Subject to regulatory approval, MoonLake expects a first commercial launch in the United States during the second half of 2027. Cash Position Supports Development Plans At the end of the quarter, MoonLake held $357.9 million in cash, cash equivalents and short-term marketable debt securities.The company said its existing capital resources are expected to fund operations through the end of 2027.MoonLake also noted that up to $400 million in additional non-dilutive financing remains available under its debt agreement with Hercules Capital. Operating Expenses Reflect Commercial Preparation Research and development expenses totaled $54.5 million for the three months ended March 31, 2026, compared with $56.0 million in the previous quarter.General and administrative expenses increased to $15.5 million from $9.2 million, primarily due to $4.8 million in accelerated expense recognition related to the voluntary cancellation of unvested stock option awards.MoonLake Immunotherapeutics stock price Original: MoonLake (MLTX) Shares Gain After Positive FDA Meeting on Sonelokimab Filing
iHub News
4月前
MoonLake Shares Climb on Encouraging axSpA Trial ResultsFebruary 23, 2026 11:14 AM
IH Market News
MoonLake Immunotherapeutics (NASDAQ:MLTX) shares advanced 6.6% in premarket trading Monday after the company reported positive topline findings from its Phase 2 S-OLARIS study evaluating sonelokimab for axial spondyloarthritis (axSpA).According to the company, 81% of patients receiving sonelokimab achieved an ASAS40 response at Week 12, indicating at least a 40% improvement across key disease measures. More than 80% of participants also recorded clinically meaningful improvement based on ASDAS-CRP scores over the same period.Imaging data further supported the clinical outcomes. PET scans demonstrated a notable reduction in inflammation and osteoblast activity within affected sacroiliac joints, a process associated with irreversible bone formation in axSpA. Improvements were also confirmed through SPARCC MRI scoring by Week 12.MoonLake said the safety profile observed in the S-OLARIS trial aligned with prior studies, with no new safety concerns identified.The company ended the fourth quarter with $394 million in cash, cash equivalents, and short-term marketable debt securities. Combined with $75 million in gross proceeds from a recent equity raise, MoonLake expects its cash runway to extend into the second half of 2027.MoonLake also disclosed an amendment to its debt agreement with Hercules Capital, including an immediate $25 million drawdown while retaining access to as much as $400 million in additional non-dilutive funding.Research and development expenses totaled $56.0 million for the quarter ended December 31, 2025, down from $60.6 million in the previous quarter, while general and administrative costs declined to $9.2 million from $10.8 million.Looking ahead, the company anticipates reporting 52-week results from its VELA-1 and VELA-2 hidradenitis suppurativa trials in the second quarter of 2026, with primary endpoint data from Phase 3 studies in psoriatic arthritis expected around mid-2026.MoonLake Immunotherapeutics stock price
Original: MoonLake Shares Climb on Encouraging axSpA Trial Results
iHub News
4月前
MoonLake shares jump after FDA Fast Track nod for PPP therapyFebruary 2, 2026 11:14 AM
IH Market News
Shares of MoonLake Immunotherapeutics (NASDAQ:MLTX) climbed about 6.5% in premarket trading on Monday after the company said the U.S. Food and Drug Administration has granted Fast Track designation to sonelokimab (SLK) for the treatment of moderate-to-severe palmoplantar pustulosis (PPP).The Fast Track decision follows encouraging data from the Phase 2 LEDA study and comes alongside recent FDA guidance that supports MoonLake’s clinical evidence strategy ahead of a planned Biologics License Application submission for SLK in hidradenitis suppurativa (HS) in the second half of 2026.Fast Track status is intended to speed the development and review of medicines targeting serious conditions with significant unmet needs. For MoonLake, the designation enables more frequent engagement with the FDA, potential access to Accelerated Approval and Priority Review, and the option to submit sections of a future BLA on a rolling basis.“This FDA decision marks an important milestone for MoonLake and for patients living with PPP,” said Dr. Jorge Santos da Silva, Founder and CEO of MoonLake Immunotherapeutics. “It underscores the significant unmet need in this debilitating disease and SLK’s potential to address it.”The inflammation-focused biotech also announced it will host an Investor Day webcast on February 23, 2026. During the event, MoonLake plans to share the Phase 2 S-OLARIS data readout in axial spondyloarthritis (axSpA), provide updates on FDA feedback for HS, and outline key milestones expected in 2026.Near-term catalysts include the primary endpoint readout from the Phase 2 S-OLARIS trial in axSpA in February 2026, 52-week data from the VELA trials in HS in the second quarter of 2026, and primary endpoint results from Phase 3 studies in psoriatic arthritis and adolescent HS slated for mid-2026.MoonLake Immunotherapeutics stock price
Original: MoonLake shares jump after FDA Fast Track nod for PPP therapy
dinogreeves
5月前
So what I found out that Merck offered $42 in June of last year, of course they raised their offer to 92 dollars in September, they have or have not been back on the negotiating table as of late, who knows, if other suitors will come to table, nevertheless, I am buying more next week.
dinogreeves
5月前
I don't know, probably insiders keep buying to help push it up slowly for the inevitable Nasdaq listing end of the year, who knows bud. But that other ticker I mentioned to you supposedly going to hit 40 dollars by February 21st, who knows if that is true, if I really knew it would hit that number, I would buy at least 30,000 shares, I did buy 4000 shares of HYOR today too, had I know it would go up like it did today, would have bought easily another 100,000 shares just yesterday, besides what I already bought 50,000 shares just yesterday. It's a slow methodical buying.
dinogreeves
5月前
No, sold everything between 0.03-0.035 and won't get back, once out, never to get back in, those are my rules in the OTC. Rode 3.5 million shares from 0.0068, you know, when I am done posting past 3 days I been out of the game. Especially my last few comments, you should have known. The only reason I am not posting on HYOR because I was loading and might still load if the opportunity is there, penny stock exempt is what was intriguing for me, QB status coming soon plus hopefully more contracts and it will be the ride of our lives, I think it will play out like $HGRAF. Good luck.
Hosai
8月前
Moonlake HS drug comparison with two FDA/EMA approved HS drugs:
Primary endpoint (POOLED, Week 16)
MoonLake (sonelokimab): HiSCR75 34–35% vs 21–22% placebo +13 pp, p < 0.001
Cosentyx (secukinumab): HiSCR50 42–45% vs 26–29% placebo +16–17 pp, p ˜ 0.001–0.003
Bimzelx (bimekizumab): HiSCR50 52–59% vs 37–41% placebo +14–18 pp, p ˜ 0.001–0.003
MoonLake chose the stricter HiSCR75 endpoint (75 % lesion reduction) instead of the easier HiSCR50 used by peers, therefore its +13 pp delta understates relative efficacy. In both VELA trials, the HiSCR50 delta was about 4 points higher than HiSCR75, implying that had the same “HiSCR50” bar been used, MoonLake’s pooled delta would be roughly +17 pp vs placebo (p < 0.001) — essentially matching Cosentyx and Bimzelx.
Individual trial primary endpoint “misses”
MoonLake: 1 of 2 trials narrowly missed (p = 0.053) under the composite estimand; significant under pre-specified treatment-policy (p = 0.033).
Cosentyx: One dose arm failed in each Phase 3.
Bimzelx: One dose arm failed hierarchy in each Phase 3.
Secondary Endpoints
Pain (NRS =3 responders)
MoonLake: +15 pp vs placebo (p ˜ 0.002)
Cosentyx: +10–12 pp vs placebo (p ˜ 0.01–0.02)
Bimzelx: +11–12 pp vs placebo (p ˜ 0.01–0.03)
MoonLake shows the largest and most significant pain improvement, a key clinical driver.
Quality of Life (DLQI)
MoonLake: -5 vs placebo, p < 0.001 (clinically meaningful & survives multiplicity)
Cosentyx: -1.2 vs placebo, p ˜ 0.08 (not significant, small effect)
Bimzelx: -1.2 vs placebo, p ˜ 0.09 (not significant, small effect)
MoonLake’s QoL improvement (~5 pts) is ~4× larger and statistically significant, unlike the others.
IHS4 =55% responders (lesion control)
MoonLake: 47–50% vs 28–30% placebo +17–22 pp, p < 0.001
Cosentyx: 45–50% vs ~35% placebo +10–15 pp, p < 0.01
Bimzelx: mid-40s% vs mid-30s% placebo +10–12 pp, p < 0.01
MoonLake’s effect size is the largest and most significant.
Phase 2 (HS)
MoonLake (MIRA): HiSCR75 +29 pp vs placebo (p = 0.0002)
Cosentyx: No published Phase 2 with quantitative HS outcomes.
Bimzelx: Phase 2 HiSCR50 significant; smaller deltas, no detailed p-values.
Safety (serious adverse events, % of patients)
MoonLake: ~3–4% (no pattern of concern; no systemic fungal infections or new signals)
Cosentyx: ~4–5% (generally mild infections; no new safety issues)
Bimzelx: ~5–6% (fungal infections slightly higher but manageable)
All have favorable safety, but MoonLake’s looks cleanest so far, without class-related fungal issues.
Regulatory outcome
MoonLake: TBD
Cosentyx: ✅ Approved (FDA + EMA, 2023–24)
Bimzelx: ✅ Approved (FDA + EMA, 2024)
Hosai
8月前
Moonlake HS drug comparison with two FDA/EMA approved HS drugs:
Primary endpoint (POOLED, Week 16)
MoonLake (sonelokimab): HiSCR75 34–35% vs 21–22% placebo +13 pp, p < 0.001
Cosentyx (secukinumab): HiSCR50 42–45% vs 26–29% placebo +16–17 pp, p ˜ 0.001–0.003
Bimzelx (bimekizumab): HiSCR50 52–59% vs 37–41% placebo +14–18 pp, p ˜ 0.001–0.003
All relied on pooled significance; MoonLake’s bar (HiSCR75) is tougher but equally or more significant statistically.
Individual trial primary endpoint “misses”
MoonLake: 1 of 2 trials narrowly missed (p = 0.053), significant under pre-specified treatment-policy (p = 0.033).
Cosentyx: One dose arm failed in each Phase 3.
Bimzelx: One dose arm failed hierarchy in each Phase 3.
Secondary Endpoints
Pain (NRS =3 responders)
MoonLake: +15 pp vs placebo (p ˜ 0.002)
Cosentyx: +5 pp vs placebo (p ˜ 0.05)
Bimzelx: +11–12 pp vs placebo (p ˜ 0.01–0.03)
MoonLake shows the largest and most significant pain improvement, a key clinical driver.
Quality of Life (DLQI)
MoonLake: -5 vs placebo p < 0.001 (clinically meaningful & survives multiplicity)
Cosentyx: -1.2 vs placebo p ˜ 0.08 (not significant, small effect)
Bimzelx: -1.2 vs placebo p ˜ 0.09 (not significant, small effect)
MoonLake’s QoL improvement (~5 pts) is ~4× larger and statistically significant, unlike the others.
IHS4 =55% responders (lesion control)
MoonLake: 47–50% vs 28–30% placebo +17–22 pp, p < 0.001
Cosentyx: 45–50% vs 35% placebo +10–15 pp, p < 0.01
Bimzelx: mid-40s vs mid-30s placebo +10–12 pp, p < 0.01
MoonLake’s effect size is the largest and most significant.
Phase 2 (HS)
MoonLake (MIRA): HiSCR75 +29 pp vs placebo (p = 0.0002)
Cosentyx: No published Phase 2 with quantitative HS outcomes.
Bimzelx: Phase 2 HiSCR50 significant; smaller deltas, no detailed p-values.
Safety (serious adverse events, % of patients)
MoonLake: ~3–4% (no pattern of concern; no systemic fungal infections or new signals).
Cosentyx: ~4–5% (generally mild infections; no new safety issues).
Bimzelx: ~5–6% (fungal infections slightly higher but manageable).
All have favorable safety, but MoonLake’s looks cleanest so far, without class-related fungal issues.
Regulatory outcome
MoonLake: TBD
Cosentyx: ✅ Approved (FDA + EMA, 2023–24)
Bimzelx: ✅ Approved (FDA + EMA, 2024)
Summary:
MoonLake’s pooled efficacy is at least as strong as both approved drugs despite a stricter HiSCR75 endpoint and shows superior pain, QoL, and lesion-control improvements, all with a clean safety profile.
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