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Weekly FDA Drug Pipeline Calendar (Nov 21 - Nov 26)

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BioPharm Insight US wrote a column · Nov 21, 2022 09:50
Hello mooers, welcome to another week of the FDA calendar. Here are what happened last week and what's coming up this week.
Top Medical News of the Week
A variant of the flu that hits kids and seniors worse than other strains of the virus is dominant in the U.S. right now, setting the country up for a potentially bad flu season. The flu hospitalization rate has surged to a decade high this season.
$Pfizer(PFE.US)$ said its omicron booster triggers a stronger immune response against a number of emerging covid subvariants circulating in the U.S. The booster triggered more antibodies against omicron sublineages BQ.1.1, BA.4.6, BA.2.75.2 and XBB.1 in adults older than 55 compared with a fourth dose of the original vaccines, according to new data released by the company on Friday. Antibodies are a key part of the immune system that block the virus from invading cells.
$PaxMedica(PXMD.US)$ shares traded up this week after it announced that it entered into a purchase agreement with Lincoln Park Capital Fund, LLC for the right to sell up to $20 million of its shares over a 30-month period. Shares closed the week up 51% at $2.12.
$Opiant Pharmaceuticals(OPNT.US)$ soared this week after $INDIVIOR PLC SPON ADR EACH REP 1 ORD SHS(INVVY.US)$ announced that it would acquire the company for $20 per share. The total deal value was $145 million and included contingent value rights (CVRs) for Opiant shareholders. Shares closed the week up 115% at $20.08.
$Satsuma Pharmaceuticals(STSA.US)$ released Phase 3 data from the SUMMIT trial of STS101 as a treatment for migraine. The trial did not meet its primary endpoint, however the company will continue to pursue a New Drug Application (NDA) filing with the ASCEND trial data. Shares closed the week down 84% at $0.65.
$4D Molecular Therapeutics(FDMT.US)$ released interim data from its Phase 1/2 clinical trial of intravitreal 4D-150 for wet AMD. Data reported that annualized anti-VEGF injection rate was reduced by 96.7% and 80% of patients have remained anti-VEGF injection-free. Goldman Sachs also upgraded the company from a Neutral rating to a Buy and announced a $68 price target. Shares closed the week up 128% at $22.20.
Weekly FDA Drug Pipeline Calendar (Nov 21 - Nov 26)
Happy Thanksgiving! Enjoy the holiday.
Source: CNBC, BioPharmCatalyst, Benzinga
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