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FDA Approval News 26 September 2025 - 30 October 2025

Apellis’ $458M Shocker: FDA Win, Analyst Buzz & 20% Stock Whiplash

Apellis’ $458M Shocker: FDA Win, Analyst Buzz & 20% Stock Whiplash

Blockbuster Quarter Meets Stock Turbulence Apellis Pharmaceuticals, a biotech focused on complement-mediated diseases gurufocus.com, delivered standout financial results for the third quarter of 2025 – yet its stock took a beating. The company reported Q3 revenue of $458.6 million, more than doubling from $196.8 M in the same quarter last year investing.com. This record top-line was boosted by a one-time $275 M licensing deal with partner Sobi investing.com, which paid Apellis upfront for future ex-U.S. royalties on Aspaveli (Empaveli’s overseas brand). Thanks largely to this deal, Apellis swung to a net profit of $215.7 M (versus a $57.4 M loss a year ago) markets.businessinsider.com. However,
30 October 2025
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Psychedelic Biotech Rally: Atai Life Sciences Stock Soars 18% on FDA Breakthrough and $130M Fundraise

Psychedelic Biotech Rally: Atai Life Sciences Stock Soars 18% on FDA Breakthrough and $130M Fundraise

Stock Surge & Analyst Reaction Atai shares exploded higher on Oct. 17, 2025. Investors bid the stock up ~17.7%, closing at roughly $6.45 ts2.tech (versus ~$5.48 offering price). In after-hours trading it briefly touched ~$6.86 ts2.tech. This rally follows a week of good news: BPL-003’s FDA breakthrough, plus well-received capital raise plans. Volume on Oct. 17 was very high (tens of millions of shares), reflecting heavy trading. Over 2025 the stock has skyrocketed ~348% ts2.tech, making ATAI one of the year’s top biotech performers. Its market cap now hovers around $1.2 billion ts2.tech. Analysts have taken notice. Needham Research just initiated
18 October 2025
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Achieve Life Sciences Skyrockets on FDA Boost – Is This Nicotine Addiction Breakthrough a Game Changer?

Achieve Life Sciences Skyrockets on FDA Boost – Is This Nicotine Addiction Breakthrough a Game Changer?

Stock Price Surge & Recent Performance Achieve Life Sciences stock exploded higher on the FDA news, reflecting growing optimism around cytisinicline’s prospects. In pre-market trading on Oct. 17, ACHV jumped about 22.7% after the company revealed it received a rare FDA Commissioner’s National Priority Voucher (CNPV) for cytisinicline’s vaping cessation indication investing.com. This rally propelled the shares to multi-month highs in the mid-$3 range. Earlier in the week, ACHV had already begun gaining momentum – on Oct. 15 the stock broke above its 200-day moving average (~$2.81) and hit $3.19 marketbeat.com, a bullish technical signal. As of Thursday’s close (Oct.
17 October 2025
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Spruce Biosciences Skyrockets on FDA Breakthrough – Will SPRB’s Rally Last or Fade?

Spruce Biosciences (SPRB) Skyrockets 1,300% on FDA Breakthrough – Inside the Stock Surge, Pipeline & Outlook (Oct 2025)

Stock Performance & Financial Metrics (as of Oct 7, 2025) Spruce Biosciences’ stock chart for 2025 looks like a hockey stick – mostly flat/down all year and then vertical in October. On Monday, Oct 6, SPRB opened around $8.60 and skyrocketed to $130.40 by the close (+1,378%) after the FDA news. The 52-week high was shattered in the process (previously the stock had been languishing below $2 pre-split, equivalent to <$150 post-split). Volume surged into the tens of millions of shares, far exceeding the tiny float, as investors clamored for a piece of the action. The rally continued after hours
7 October 2025
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Crinetics (CRNX) Stock Skyrockets on FDA Approval – Full 2025 Investor Update

Crinetics (CRNX) Stock Skyrockets on FDA Approval – Full 2025 Investor Update

Stock Price Performance (YTD & Recent) Crinetics stock has been volatile but trending upward in 2025, with the recent FDA catalyst propelling it sharply higher. On September 26, 2025, CRNX closed around $45–$46, up roughly +28% in a single day reuters.com. This spike followed the Palsonify approval news and likely a short squeeze, given the high short interest (~14 million shares short, ~15.5% of float) prior to the decision marketbeat.com marketbeat.com. The one-year trading range spans $24.10 – $62.53 marketbeat.com, meaning the stock is now nearly double its 52-week low and about 26% below its 2023 high. In other words,
26 September 2025
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