Outlook Therapeutics Faces a Second FDA Rejection for ONS-5010
A second Complete Response Letter puts renewed focus on the uncertainty of binary FDA decisions for small-cap biotechnology companies.
Moderna-Merck Cancer Vaccine Trial Success Gives Investors a New Oncology Catalyst
Moderna and Merck cleared a major Phase 3 hurdle, strengthening the case for individualized cancer vaccines and renewed pipeline attention.
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Merck’s Oncology Approval Fuels Debate Over a Potential 37% Valuation Discount
Merck’s Welireg-Lenvima approval adds an oncology catalyst as investors weigh a DCF-based 37% undervaluation claim and K…
Mirum Shares Gain as FDA Approval Validates Rare-Disease Drug Strategy
Mirum shares rose 1.0% to $90.23 as FDA approval transformed a key regulatory question into a confirmed catalyst for Nas…
Eli Lilly Expands Olumiant Reach With FDA Approval for Adolescent Alopecia
FDA approval for adolescent alopecia broadens Olumiant’s reach and reinforces Eli Lilly’s immunology strategy beyond GLP…
Merck Wins FDA Approval for Welireg-Lenvima Combination in Advanced Kidney Cancer
Merck’s Welireg-Lenvima approval expands its oncology portfolio and may influence long-term revenue models as patent-cli…
Grail Stock Jumps 55% After FDA Panel Supports Multi-Cancer Detection Test
Grail shares surged 55% through Friday morning after a favorable FDA advisory vote on its multi-cancer early detection t…
Iovance Shares Rally as Survey Points to Strong Amtagvi Demand in Melanoma
A proprietary analyst survey is lifting sentiment around IOVA, but its demand signal is not the same as confirmed sales …
Abeona Shares Draw Buy Rating After FDA Approval of FAYUVI Gene Therapy
H.C. Wainwright reiterated a Buy rating on Abeona after FDA approval of partner Ultragenyx’s FAYUVI gene therapy for ped…
Eli Lilly Shares Rise 3.7% After FDA Clears Once-Weekly Onswik Insulin
FDA approval of once-weekly Onswik lifted LLY shares 3.73%, adding another pillar to Eli Lilly’s diabetes and metabolic-…
GoDaddy Stock Jumps 6% as Reported Gen Digital Takeover Interest Sparks Fresh M&A Focus
GoDaddy shares jumped about 6% after a report of takeover interest from Gen Digital, putting deal confirmation and terms…