The FDA has issued a complete response letter for Aquestive Therapeutics' sublingual epinephrine film Anaphylm, citing concerns over packaging and user instructions. The company aims to address the issues and resubmit its application by the third quarter of this year.
The U.S. Food and Drug Administration has issued a complete response letter for Aquestive Therapeutics' oral film drug designed to treat severe allergic reactions, the company announced Monday, delaying a potential new option for millions at risk.
Analyst Piper Sandler has lowered its price target on Black Diamond Therapeutics (BDTX) while maintaining an Overweight rating, following a broad review of its biotech coverage. The adjustment comes even as the company recently reported encouraging Phase 2 data for its lead oncology drug candidate.
H.C. Wainwright maintains a Buy rating on Lexeo Therapeutics but slashes its price target, citing persistent market doubts over the company's PKP2 cardiomyopathy program despite encouraging early clinical results.
Barclays initiates coverage of 4D Molecular Therapeutics with an Overweight rating and a $33 price target, citing a favorable industry backdrop with potential M&A tailwinds and shifting focus away from drug pricing pressures. The gene therapy developer also outlined key clinical milestones expected through 2026.
Piper Sandler and Barclays have raised price targets for CytomX Therapeutics (CTMX), citing promising early-phase data for its experimental colorectal cancer therapy. Updated results from a larger patient cohort are expected this quarter.
Clear Street downgrades Janux Therapeutics (JANX) to Hold, slashing its price target amid concerns over a lack of durability data for its lead candidate JANX007 and rising competitive pressures, despite a recent major collaboration deal with Bristol Myers Squibb.
Analysts at Stifel have raised their price target for Nurix Therapeutics (NRIX) to $35, maintaining a Buy rating ahead of anticipated 2026 clinical milestones for its lead asset, bexobrutinib. The move comes as Wells Fargo also adjusted its target, highlighting divergent near-term views but shared long-term optimism for the biotech firm.
Quince Therapeutics' lead candidate, eDSP, has failed to meet primary and secondary endpoints in its pivotal Phase III NEAT trial for the rare neurological disorder Ataxia-Telangiectasia (A-T), triggering a catastrophic drop in the company's share price.
Travere Therapeutics faces a securities fraud investigation by Robbins Geller Rudman & Dowd LLP, raising questions about the accuracy of its past disclosures. The probe casts a shadow over the company's critical transition, as it banks on its kidney drug FILSPARI to drive growth amid mounting legal and commercial pressures.
Shares of Perspective Therapeutics (CATX) have rallied sharply following encouraging interim results from its lead cancer therapy trial and a strategic business update. While the data fuels optimism, a deep dive into the numbers reveals a stark disconnect between its current market price and analyst targets, highlighting both opportunity and significant risk.
Biotech firm Definium Therapeutics appoints seasoned commercial executive Roger Adsett to its board, signaling a strategic shift towards commercialization as key late-stage trial data approaches.
Ovid Therapeutics (NASDAQ: OVID) has garnered analyst optimism following positive Phase 1 trial results for its novel neurological drug candidate and a recent 'Outperform' initiation. The biotech firm is now shifting focus to a more potent oral therapy, with key regulatory milestones ahead.
Piper Sandler raises its price target for Century Therapeutics (IPSC), highlighting the biotech firm's robust financial position extending into 2029 and an upcoming Investigational New Drug application for its lead cell therapy candidate, CNTY-813.
A mixed third-quarter earnings season for therapeutics stocks reveals divergent paths, with United Therapeutics missing estimates while peers like Halozyme and Biogen post strong beats. Sector-wide revenue growth and positive stock reactions suggest underlying investor confidence despite regulatory and pricing headwinds.
Barclays' upgrade of PTC Therapeutics to Overweight has spotlighted the biotech firm's valuation, with shares showing strong momentum but questions lingering over its path to profitability and reliance on a narrow drug portfolio.
Shares of Corcept Therapeutics plunged 16% after a corrected FDA letter disclosed the agency had repeatedly cautioned the company against filing its application for a Cushing's syndrome drug, which was later rejected over efficacy and safety concerns.
Summit Therapeutics (SMMT) finds itself at a crossroads, with its stock down over 30% in the past year. Conflicting signals from valuation models paint a complex picture: is the biotech firm dramatically overvalued on traditional metrics, or deeply undervalued based on future cash flows?
Vera Therapeutics (VERA) is drawing bullish attention from Wall Street, with multiple analysts significantly raising price targets following a key competitor's FDA approval and revised revenue forecasts for its lead drug candidate.
Clinical-stage biopharma Mineralys Therapeutics has filed its New Drug Application for lorundrostat, a potential treatment for resistant hypertension, following positive results from multiple trials. The move positions the company for a potential 2026 market entry and has drawn upgraded price targets from analysts.
