Today: 18 November 2025
Subscribe
Browse Tag

FDA approval

Outlook Therapeutics (OTLK) Soars as FDA Accepts ONS‑5010 BLA and Sets December 31, 2025 Review Date

Outlook Therapeutics (OTLK) Soars as FDA Accepts ONS‑5010 BLA and Sets December 31, 2025 Review Date

Outlook Therapeutics (NASDAQ: OTLK) shares jumped today after the U.S. FDA accepted the company’s resubmitted Biologics License Application (BLA) for ONS‑5010/LYTENAVA, its bevacizumab-based eye drug for wet AMD, and set a PDUFA review date of December 31, 2025. Here’s what investors need to know. What Outlook Therapeutics announced today This morning, Outlook Therapeutics, Inc. (NASDAQ: OTLK) announced that the U.S. Food and Drug Administration has accepted the company’s resubmitted Biologics License Application for ONS‑5010 (bevacizumab‑vikg)/LYTENAVA, its investigational ophthalmic formulation of bevacizumab for the treatment of wet age‑related macular degeneration (wet AMD). GlobeNewswire+2Outlook Therapeutics+2 According to the company’s press release and
13 November 2025
 ·  ·  ·  ·  · 
Merck (MRK) Stock Could Skyrocket: Key Drug Approvals & Analyst Targets Unveiled

Merck (MRK) Rallies on Nov. 11, 2025: FDA Approves New Keytruda Companion Diagnostic; Fresh SITC Combo Data, and Dow Momentum

Published: November 11, 2025 At a glance (today) Market move: MRK helps lead the Dow’s advance By early afternoon Tuesday, Merck & Co. (NYSE: MRK) shares were up about 3.9%, helping lead the Dow Jones Industrial Average higher; Nike and Merck together contributed an estimated ~36 points to the index’s ~386‑point climb at that time. MarketWatch In a separate Data Talk update, MRK was up for a sixth straight session, putting it on pace for its longest winning streak since August and tracking toward its highest close since Oct. 1—contingent on late‑day trading. Morningstar Regulatory update: FDA okays Promega’s OncoMate®
11 November 2025
 ·  ·  ·  ·  · 
J&J Makes Bold Move: Orthopedics Spin-Off (“DePuy Synthes”) Announced – 2025 Forecast Raised

NJ Stock: What to Know Before the Bell on November 10, 2025 (Fresh FDA Wins, Dividend Date, and Legal Overhang)

Dateline: Monday, November 10, 2025 — pre‑market Johnson & Johnson (NYSE: JNJ) starts the new week with momentum from multiple drug approvals, a firm dividend timetable, and a still‑active litigation backdrop. Here’s a concise, investor‑focused briefing on the key developments likely to guide JNJ sentiment before the U.S. market opens today. Key takeaways• Q3 beat and higher 2025 sales outlook; adjusted EPS guidance reaffirmed. JNJ.com+1• Two fresh FDA wins in the past few weeks: Caplyta add‑on use in depression and Darzalex Faspro for high‑risk smoldering myeloma. Reuters+1• Inlexzo bladder‑cancer device approval broadens 2025 product catalysts. U.S. Food and Drug Administration•
9 November 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
 ·  ·  ·  · 
NeurAxis (NRXS) Stock Skyrockets on First-Ever FDA Approval for GI Pain Device

NeurAxis (NRXS) Stock Skyrockets on First-Ever FDA Approval for GI Pain Device

Recent FDA Approval and Market Reaction NeurAxis’s Oct. 24, 2025 announcement of FDA 510(k) clearance for its PENFS device immediately grabbed market attention. The clearance authorizes use in adults (8 years and up) for functional abdominal pain associated with FD and nausea, a segment previously lacking any approved device treatment investing.com. Investing.com and other outlets confirm this milestone — noting it’s “the first FDA clearance or approval” for an adult FD treatment investing.com. In pre-market trading on Oct. 24, NRXS shares jumped (around +4% in early quotes) on the news, reflecting relief that FDA evidence support (from pediatric studies) could
24 October 2025
 ·  ·  ·  ·  · 
Scienture Holdings (SCNX) Stock Skyrockets on FDA Drug Launch – Will the Rally Last?

Scienture Shares Skyrocket 350% on FDA-Approved Drug Launch – What’s Next?

Scienture’s unprecedented Oct. 23 rally was driven by the commercial rollout of Arbli, its first revenue-generating product. The company’s press release on Oct. 23 confirmed that it began sales and shipped first customer orders for Arbli (losartan suspension), immediately triggering the Nasdaq surge finviz.com. CEO/co-CEO Narasimhan Mani said the event “represents a major achievement for Scienture” in moving from development to execution finviz.com. Investors piled in on the news: as Benzinga reported, SCNX shares leapt over 140% on Thursday following word of the launch benzinga.com benzinga.com. The price pop was staggering for a penny stock. Finviz confirmed the stock hit
24 October 2025
 ·  ·  ·  ·  · 
Scienture Holdings (SCNX) Stock Skyrockets on FDA Drug Launch – Will the Rally Last?

Scienture Holdings (SCNX) Stock Skyrockets on FDA Drug Launch – Will the Rally Last?

SCNX Stock Soars on Arbli Launch News Scienture’s stock has been on a rollercoaster in late October amid excitement over Arbli’s rollout. The initial catalyst came on October 16, 2025, when the company announced Arbli™ was available through major wholesalers – making it the first FDA-approved liquid losartan on the market ts2.tech. That morning, SCNX shares surged over 30% from the prior day’s $0.72 close, even hitting an intraday high around $1.12 before profit-taking set in ts2.tech. By mid-day Oct. 16, Reuters reported the stock had pulled back near $0.71 ts2.tech, indicating traders sold into the early pop. Still, the
23 October 2025
 ·  ·  ·  · 
Beam Therapeutics Stock Soars on FDA Backing – Analysts Forecast ~70% Upside

Beam Therapeutics Stock Soars on FDA Backing – Analysts Forecast ~70% Upside

Ticker: Beam Therapeutics (NASDAQ: BEAM) globenewswire.com. – Price (Oct 21, 2025): ~$30 per share (about +17% recently) ts2.tech. – Sector: Biotechnology (precision gene editing) globenewswire.com. – Recent News: FDA granted Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug designations to Beam’s lead programs (BEAM-101 for sickle cell disease and BEAM-302 for alpha-1 antitrypsin deficiency) globenewswire.com stocktitan.net. Early trial data for these programs have been promising. – Analyst Outlook: Consensus is “Moderate Buy” with average 1-year target ~$45–46 marketbeat.com nasdaq.com, implying roughly 70–80% upside. Beam’s stock jumped sharply after the FDA awarded priority designations to its gene-editing therapies. On Oct 20,
21 October 2025
 ·  ·  ·  ·  · 
Replimune Stock Rockets 100% on FDA Nod – Analysts Eye Upside

Replimune Stock Rockets 100% on FDA Nod – Analysts Eye Upside

Stock Performance and Recent Rally Replimune’s stock has been extremely volatile in 2025. It soared on Oct. 20 after the FDA acceptance news: shares nearly doubled from about $4.50 to $8.94 that day marketbeat.com. (On Oct 21, REPL was trading around $8.95 reuters.com.) This reversed a mid-year collapse – in July 2025 a disappointing FDA Complete Response Letter caused the stock to collapse ~73% in one day globenewswire.com. Over the past year the 52-week trading range is roughly $2.68 (low) to $17.00 (high) marketbeat.com, reflecting that roller-coaster. Institutional interest remains high: recently hedge funds like TD Asset Management increased their
21 October 2025
 ·  ·  ·  ·  · 
Intuitive Surgical Stock Primed for Rally on FDA Approvals and Congressional Buying

Intuitive Surgical Stock Primed for Rally on FDA Approvals and Congressional Buying

Stock Performance & Analyst Consensus Intuitive’s stock has been volatile in 2025. It gained ground last week on optimism (e.g. up ~2.7% on Oct. 17) and now sits around $446 investing.com marketbeat.com. Over the past year, the price swung between about $425 and $616 investing.com. At ~$446, ISRG trades at a high single-digit P/E (~60x) compared to the medtech sector, but analysts argue much of Intuitive’s growth is already priced in. Institutional sentiment is upbeat: 22 of 32 surveyed analysts rate ISRG a Buy, with an average 12-month target of roughly $576 investing.com (implying ~29% upside). For example, RBC Capital
19 October 2025
 ·  ·  ·  ·  · 
ATAI Life Sciences Skyrockets on FDA Breakthrough and $130M Cash Infusion

ATAI Life Sciences Skyrockets on FDA Breakthrough and $130M Cash Infusion

Key Facts – October 18, 2025 Stock Soars on Breakthrough News and Funding Boost ATAI’s stock price surged in the last few days amid a flurry of good news. Shares jumped 17.7% on Friday (Oct 17) alone, finishing at $6.45 marketbeat.com, after trading around the mid-$5 range earlier in the week. In fact, as of early Friday, ATAI was already up about 8% for the week on anticipation of the announcements nasdaq.com. The strong finish came as investors digested multiple catalysts: a coveted FDA designation for a key drug, a fresh capital raise, and bullish commentary from analysts. Notably, after-hours
18 October 2025
 ·  ·  ·  ·  · 
Disc Medicine (IRON) Stock Soars on FDA Fast-Track News as Analysts Boost Targets

Disc Medicine (IRON) Stock Soars on FDA Fast-Track News as Analysts Boost Targets

FDA Voucher Ignites IRON Stock Rally Disc Medicine’s stock price (NASDAQ: IRON) spiked dramatically in mid-October 2025 after news of the FDA voucher, vaulting from the mid-$70s to the low-$90s in a single day gurufocus.com. On Friday (Oct. 17), IRON opened around $85 and surged to an intraday high of $92.50 before closing at $93.00, marking a ~25% jump on the day stockanalysis.com. This leap capped a steady uptrend over the past month – the shares were trading near $60 in early September and gradually climbed into the $70s as anticipation built around bitopertin’s NDA filing and review stockanalysis.com stockanalysis.com.
17 October 2025
 ·  ·  ·  · 
1 2
Go toTop