Applied Therapeutics Inc. (NASDAQ: APLT) is back on traders’ radar today, with its penny stock surging on enormous volume despite intense regulatory uncertainty and a stretched balance sheet.
On November 17, 2025, APLT is trading like a biotech rollercoaster: pre‑market gains, intraday spikes of 30–70%, and tens of millions of shares changing hands as investors reassess the company’s prospects after last week’s Q3 update and fresh analyst commentary. [1]
Below is a detailed look at everything that matters about Applied Therapeutics today, plus the context behind the move.
Key Takeaways
- APLT is one of today’s most active healthcare stocks, with pre‑market and intraday gains of 20–70% and trading volume many times its daily average. [2]
- The spike follows last week’s Q3 2025 results, which showed a sharply narrower net loss but a major drop in cash, down to $11.9 million as of September 30, 2025. [3]
- Regulatory uncertainty around lead drug govorestat remains the central overhang, with the FDA still questioning key aspects of the CMT‑SORD program and a Phase 3 trial not yet recruiting. [4]
- Analysts are split between long‑term upside and near‑term survival risk: some see multi‑bagger potential from current levels, while others doubt the company can fund pivotal trials without a partner or fresh capital. [5]
- Ongoing legal and governance issues, including a securities class action settlement and law‑firm investigations into past disclosures, continue to weigh on sentiment. [6]
1. What Happened to APLT Today?
Pre‑market and intraday action
Early on Monday, November 17, APLT appeared on multiple “most active” and “top movers” lists:
- Pre‑market: Benzinga’s automated movers feed flagged Applied Therapeutics among the top gaining healthcare names, with shares up about 16–22% around $0.26 and a market cap near $31 million, explicitly linking the move to Q3 earnings from two days prior. [7]
- Midday session: In a separate intraday movers report, Benzinga again listed APLT as a major gainer, noting the stock up roughly 30% around $0.28–0.29 in regular trading, still citing the fresh earnings release as the main catalyst. [8]
- Most‑active lists: A ChartMill scan of heavily traded stocks shows APLT changing hands at $0.356 around 2:00 p.m. ET, up over 60% on the day and ranked among the session’s most active tickers. [9]
European retail platforms tell the same story. A German market dashboard tracked APLT at €0.28, up nearly 49%, in late evening trading, while another real‑time feed showed the stock up double digits on the L&S exchange earlier in the day. [10]
Massive volume
A feature of today’s move is sheer volume:
- A Sete News article published today notes that about 42.6 million APLT shares had already traded, compared with an average volume of roughly 5.6 million shares. [11]
- Yahoo Finance data later in the session shows volume above 74 million shares, versus an average of about 6.3 million. [12]
Put simply, APLT is trading 7–12× its normal volume, signaling intense speculative interest and likely heavy participation from day traders and short‑term momentum players.
From collapse to spike
Today’s rebound comes after a brutal stretch:
- APLT fell about 19% on Friday, November 14, closing at $0.218, and had dropped in 8 of the last 10 sessions, down roughly 81% over that period, according to technical site StockInvest.us. [13]
- Sete News calculates that the stock is down around 98% year‑to‑date, with a 52‑week range of $0.27 to $10.48. [14]
That backdrop helps explain why a modest positive catalyst—or simple bargain hunting and short‑covering—can produce such outsized percentage moves in a low‑priced, heavily beaten‑down biotech stock.
2. Today’s Fresh Coverage: What Are Outlets Saying?
Sete News: “Investors in cash trouble should check out APLT”
In a piece published today, Sete News highlights Applied Therapeutics as a risky but potentially high‑upside idea for investors willing to tolerate extreme volatility. Key points from the article include: [15]
- Intraday range: So far today, APLT has traded between about $0.218 and $0.313, underscoring intraday swings of over 40%.
- Analyst targets: The article cites a 12‑month average price target near $1.67, with a high of $2.00 and low of $1.00, implying many‑hundred‑percent upside from current levels if the company survives and executes.
- Volatility & beta: With a reported beta above 2, APLT is more than twice as volatile as the broader market—what Sete basically frames as “not for the faint of heart.”
- Share structure & short interest: The piece notes about 144.3 million shares outstanding, a float of roughly 127 million, and over 10 million shares sold short as of October 31, 2025, suggesting that short‑covering could be contributing to today’s surge.
The tone is speculative and data‑driven rather than overtly promotional, but the message is clear: this is a distressed, high‑beta name where small fundamental shifts can trigger enormous price swings.
Biotech Snap & Fierce Biotech: Rising skepticism around govorestat
In its “Daily Snap – 17 November 2025,” biotech newsletter Biotech Snap singles out Applied Therapeutics under the heading “FDA doubt.” The note summarizes growing concern among analysts that the company may struggle to ever bring its lead drug, govorestat, to market for CMT‑SORD, even after last week’s regulatory update. [16]
That skepticism traces back to a November 14 article in Fierce Biotech, which reports that: [17]
- Applied has received the official minutes from an FDA “Type C” meeting on govorestat for Charcot‑Marie‑Tooth sorbitol dehydrogenase deficiency (CMT‑SORD).
- The FDA raised key questions, including:
- Whether the proposed biological mechanism is sufficiently supported.
- Whether sorbitol levels can truly serve as a surrogate endpoint.
- How to choose a primary endpoint for a potential Phase 3 trial.
- The need for additional carcinogenicity testing.
- Applied’s current plan is to request another Type C meeting, and the company has not yet decided what regulatory path to pursue, including whether an accelerated approval route is feasible.
- A Phase 3 study for CMT‑SORD was listed on ClinicalTrials.gov in September, but its status is still “not yet recruiting”, despite an expected October start date, signaling delays.
Analysts at William Blair, quoted in the Fierce piece, specifically question whether Applied has enough cash to fund the necessary Phase 3 study and move govorestat all the way to commercial launch. Given that cash stood at just $11.9 million at the end of Q3, they argue additional funding will be required and that the company is “not in the position” to bring the drug to market alone right now. [18]
3. Q3 2025 Results: Narrower Loss, Thinner Cushion
The Q3 2025 earnings release, issued on November 13, is the fundamental backdrop for all of today’s trading and commentary. [19]
Financial highlights
According to the company’s official GlobeNewswire release:
- Cash & cash equivalents:
- $11.9 million as of September 30, 2025, down sharply from $79.4 million at December 31, 2024.
- Revenue:
- $1.0 million in license revenue this quarter, versus minimal revenue in prior periods.
- Operating expenses (Q3 2025 vs Q3 2024):
- R&D: $9.6M vs $14.8M.
- G&A: $8.2M vs $15.0M.
- Net loss:
- $19.0M, or $0.13 per share, significantly narrower than the $68.6M, or $0.48 per share loss a year earlier, largely due to reduced operating expenses and smaller fair‑value adjustments on warrants.
In other words, Applied is burning less, but from a much smaller cash pile, and its balance sheet now shows a shareholders’ deficit, reflecting cumulative losses outpacing capital raised. [20]
Corporate & leadership changes
The Q3 release also confirms an important board‑level change:
- Executive Chairman John Johnson resigned from the board in November 2025 for personal reasons, with the company stating that his departure was not related to any disagreement over operations or policies. [21]
This follows a turbulent governance period:
- In December 2024, founder and then‑CEO Shoshana Shendelman left the company after concerns about data handling and misrepresentation around govorestat’s clinical program were raised; she has since been the subject of ongoing securities litigation and efforts to dismiss related claims. [22]
- Les Funtleyder, previously CFO, now serves as interim CEO and CFO, a dual role noted in today’s Sete News article as well. [23]
Leadership stability—and how quickly Applied can install a permanent CEO and strengthen the board—remains a key question for institutional investors.
4. Regulatory Overhang: Govorestat’s Complicated Path
Applied Therapeutics is essentially a single‑asset story centered on govorestat, an aldose reductase inhibitor being developed for several rare metabolic conditions:
- CMT‑SORD (a subtype of Charcot‑Marie‑Tooth disease).
- Classic galactosemia.
- PMM2‑CDG (phosphomannomutase 2 congenital disorder of glycosylation). [24]
CMT‑SORD: FDA wants more answers
From the Q3 release and subsequent analysis: [25]
- The FDA has not given a clear green light for a near‑term New Drug Application (NDA).
- It has asked for:
- Stronger evidence linking sorbitol reduction to clinical benefit.
- Agreement on a primary endpoint suitable for Phase 3.
- Additional carcinogenicity data.
- Applied plans another Type C meeting to refine its Phase 3 strategy, but no timeline is set for filing an NDA.
Compounding this, the company previously reported that a Phase 2/3 trial in CMT‑SORD failed its primary endpoint at 12 months on a 10‑meter walk‑run test, and is instead leaning heavily on secondary endpoints such as patient‑reported outcomes and sorbitol lowering—a strategy regulators are clearly scrutinizing. [26]
Classic galactosemia: Recovering from a 2024 rejection
Govorestat has already suffered a major setback in classic galactosemia:
- In late November 2024, the FDA issued a Complete Response Letter (CRL) rejecting Applied’s NDA for govorestat in pediatric patients with galactosemia due to deficiencies in the clinical application. [27]
- Days later, the FDA publicly posted a warning letter, citing data handling issues—including deletion of electronic records and mishandling a dosing error—further damaging investor confidence. [28]
The Q3 2025 update notes that Applied has now secured a meeting with the FDA in Q4 2025 to revisit the regulatory path for galactosemia post‑CRL and warning letter, but there is no guarantee of a quick path back to filing. [29]
PMM2‑CDG: Encouraging but very early
On a more positive note, the Q3 release highlights new single‑patient data in PMM2‑CDG, published in the Journal of Inherited Metabolic Disease and presented at the 2025 ASHG meeting. Key observations include: [30]
- Govorestat appeared well‑tolerated with no treatment‑related adverse events reported.
- Biomarkers such as sorbitol and liver enzymes improved, and a standardized pediatric rating scale score improved meaningfully over the course of treatment.
While intriguing, this is still single‑patient expanded‑access data, far from the scale or robustness needed for registration. For now, it mainly supports the biological plausibility of govorestat across multiple indications.
5. Legal Clouds and Shareholder Actions
Today’s trading is also occurring against a backdrop of ongoing legal and shareholder actions, many of which stem from the 2024 galactosemia debacle and earlier clinical data issues.
- A securities fraud class action against Applied Therapeutics and certain officers has reached a settlement, according to a September 17, 2025 notice from Grabar Law Office, which continues to solicit long‑term shareholders who bought before January 3, 2024. [31]
- Multiple securities law firms—including Faruqi & Faruqi and The Gross Law Firm—have public campaigns describing allegations that Applied made overly positive statements while allegedly concealing problems in the Phase III INSPIRE trial and the govorestat NDA process. [32]
- As recently as late October 2025, Halper Sadeh LLC launched a fresh investigation into whether Applied’s officers and directors breached fiduciary duties, encouraging current long‑term shareholders to contact the firm. [33]
For potential investors, these actions don’t automatically imply wrongdoing, but they increase headline risk and can complicate future capital raises or strategic deals.
6. Why Is the Stock Up If the Story Is So Messy?
Given the regulatory setbacks, thin cash cushion, and legal baggage, today’s sharp rally might look puzzling at first glance. Several dynamics likely intersect:
- Short‑covering & technical bounce
- Re‑rating after Q3 results
- Q3 numbers showed a much narrower net loss, progress on cost‑cutting, and at least some revenue, which may have reassured traders that the company is still operationally active despite its cash burn. [36]
- Speculation on regulatory “second chances”
- The Q3 release presented the FDA interactions as “constructive” and emphasized upcoming meetings in both CMT‑SORD and galactosemia, language that can be read—optimistically—as leaving a path open to eventual approval. [37]
- Some investors appear willing to bet that a path forward exists and that the current valuation already discounts a lot of bad news.
- Analyst targets vs. current price
- Sete News highlights that the average 12‑month price target near $1.67 implies 500–700% upside from current trading levels, even after today’s spike. [38]
- For speculative traders, that kind of potential upside—however uncertain—can be irresistible.
At the same time, more conservative voices, like the William Blair analysts quoted in Fierce Biotech, stress that without new funding or a partner, govorestat may never reach the market, regardless of theoretical upside. [39]
7. What To Watch Next
For readers following Applied Therapeutics after today’s fireworks, several upcoming developments are critical:
- FDA meetings in Q4 2025
- The scheduled FDA meeting on classic galactosemia and the planned additional Type C meeting for CMT‑SORD will be key to clarifying whether govorestat has a realistic path to approval in either indication. [40]
- Funding and strategic options
- With just $11.9 million in cash at the end of September and quarterly net losses still near $19 million, Applied likely needs new capital or a partnership in the near term. [41]
- Investors will be watching for:
- Equity offerings or PIPE deals.
- Debt or royalty financing.
- Out‑licensing or co‑development deals for govorestat.
- Trial status updates for CMT‑SORD Phase 3
- If the “not yet recruiting” status on ClinicalTrials.gov changes and a clear Phase 3 design is agreed with the FDA, that could be a powerful derisking event. [42]
- Resolution of legal matters
- Further details on the class action settlement, and whether additional investigations lead to governance changes or settlements, may influence institutional willingness to re‑engage with the name. [43]
Bottom Line
On November 17, 2025, Applied Therapeutics looks like a classic high‑risk biotech trade:
- Today’s rally is real—driven by massive volume, short‑covering, and traders reacting to Q3 headlines.
- The fundamental picture remains fragile, with significant regulatory uncertainty around govorestat, limited cash, and ongoing legal overhang.
- Long‑term outcomes hinge on a handful of binary events: FDA feedback, financing, and whether the company can design and execute a registrational‑quality trial in CMT‑SORD or successfully re‑engage regulators in galactosemia.
For investors, APLT is not a “steady compounder” story; it is an option‑like bet on a distressed rare‑disease pipeline. Anyone considering the stock should closely follow upcoming FDA and financing updates—and be prepared for continued extreme volatility.
This article is for information and news purposes only and does not constitute investment, legal, or medical advice. Always do your own research or consult a professional before making financial decisions.
References
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