FDA, Alnylam and BridgeBio

FDA Begins Review of Alnylam's sNDA for Expanded Amvuttra Use
Alnylam Pharmaceuticals ALNY announced that the FDA has accepted its supplemental new drug application (sNDA) seeking the label expansion of Amvuttra (vutrisiran) for review to treat ATTR amyloidosis with cardiomyopathy (ATTR-CM).
Days After BridgeBio Approval, FDA Agrees to Review Alnylam’s Amvuttra in ATTR-CM
The FDA has accepted Alnylam’s supplemental New Drug Application for Amvuttra on the heels of BridgeBio’s Attruby nod, potentially giving Pfizer’s tafamidis franchise another competitor.
US FDA approves BridgeBio's drug for rare heart condition (Nov 22)
The U.S. Food and Drug Administration has approved BridgeBio's drug for a rare and deadly heart condition, the company said on Friday, making it the first new treatment in a market dominated by Pfizer's blockbuster Vyndaqel.
BridgeBio Catapults After Snagging Approval For Its Rival To Pfizer's Heart Drug
BridgeBio Pharma snagged FDA approval for its rival to Pfizer's heart disease treatment, Vyndaqel. BridgeBio stock catapulted.
FDA accepts Alnylam’s sNDA for vutrisiran for ATTR-CM treatment
Pharmaceuticals announced that the U.S. Food and Drug Administration or FDA, has accepted for review the Company’s supplemental
BridgeBio Pharma Gets FDA Approval for Heart Disease Drug Attruby
The Palo Alto, California-based biopharmaceutical company said the Food and Drug Administration approved Attruby for adults with transthyretin amyloid cardiomyopathy, or ATTR-CM, to reduce cardiovascular death and cardiovascular-related hospitalization.
FDA approves BridgeBio’s Attruby for ATTR-CM treatment
Attruby is the first approved product with a label that specifies near-complete TTR stabilisation. The approval triggers a $500m payment to BridgeBio under a royalty funding agreement. The ATTRibute-CM Phase III trial,
Alnylam Pharmaceuticals: Strategic Positioning and Growth Opportunities Reinforce Buy Rating Amidst Competitive ATTR-CM Market
Canaccord Genuity analyst Whitney Ijem maintained a Buy rating on Alnylam Pharma (ALNY – Research Report) yesterday and set a price target of ...
Check Out What Whales Are Doing With ALNY
Delving into the details, we found 5% of traders were bullish, while 84% showed bearish tendencies. Out of all the trades we spotted, 14 were puts, with a value of $931,387, and 5 were calls, valued ...
FierceBiotech8d
Intellia's CRISPR and Alnylam's RNAi data drops present contrasting visions for cardiomyopathy care
But the incumbents look set to fight to hold on to the market, with Alnylam Pharmaceuticals sharing early-phase data on its ...
Scotiabank Reaffirms Their Buy Rating on Alnylam Pharma (ALNY)
Scotiabank analyst Greg Harrison maintained a Buy rating on Alnylam Pharma (ALNY – Research Report) today and set a price target of $310.00.
STAT1d
What to make of Trump’s health care nominees
The presumptive new CDC director, Dave Weldon, is a known vaccine safety skeptic. In contrast, the FDA choice — Johns Hopkins ...
GlobalData on MSN8d
Alnylam reveals trial outcomes of nucresiran for ATTR amyloidosis treatment
The study showed significant reductions in serum TTR levels in subjects after a single dose, with sustained effects over time ...
Business Wire9d
Alnylam Announces Interim Phase 1 Data of Nucresiran (ALN-TTRsc04) Showing Rapid Knockdown of TTR that is Sustained at Six Months Following a Single Dose
--(BUSINESS WIRE)--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced the presentation of new results from its Phase 1 study of nucresiran ...
Alnylam Pharma: Strong Buy Rating Backed by Regulatory Success and Diverse RNAi Portfolio
Alnylam Pharma (ALNY – Research Report), the Healthcare sector company, was revisited by a Wall Street analyst today. Analyst Kostas Biliouris ...