A week af­ter pre­sent­ing pos­i­tive da­ta on its drug for treat­ing the heart fail­ure con­di­tion called transthyretin-me­di­at­ed amy­loi­do­sis (AT­TR) with car­diomy­opa­thy, Al­ny­lam wants to get al­most $1 bil­lion in new mon­ey.

The com­pa­ny an­nounced that it was of­fer­ing a $900 mil­lion prin­ci­pal amount of con­vert­ible se­nior notes due 2027. Con­vert­ible notes are short-term debt that con­verts in­to eq­ui­ty.

“The of­fer­ing of the notes is sub­ject to mar­ket and oth­er con­di­tions and there can be no as­sur­ance as to whether or when the of­fer­ing may be com­plet­ed, or as to the ac­tu­al size or terms of the of­fer­ing,” the com­pa­ny said in a press state­ment.

Al­ny­lam plans to use ap­prox­i­mate­ly $762.0 mil­lion of the funds to pay off its loans and debt.

On Sept. 8, the com­pa­ny pre­sent­ed de­tailed re­sults of the Phase III Apol­lo-B study, show­ing that its drug On­pat­tro had a clear ad­van­tage over a place­bo in pre­vent­ing a rapid de­cline in a 6-minute walk test.

In the study, those on the drug arm had a me­di­an drop from base­line of 8.15 me­ters in the walk test while those on the place­bo arm had a drop of 21.34 me­ters — trans­lat­ing in­to an es­ti­mat­ed 14.7-me­ter ad­van­tage and a p-val­ue of 0.0162.

The study how­ev­er did not meet its sec­ondary end­points, which mea­sured all-cause hos­pi­tal­iza­tions, fre­quen­cy of all-cause hos­pi­tal­iza­tions and ur­gent heart fail­ure vis­its, rais­ing ques­tions about the drug’s help­ful­ness to pa­tients.

The com­pa­ny joins a grow­ing list of com­pa­nies that are rais­ing cap­i­tal at the be­hest of pos­i­tive da­ta, es­pe­cial­ly when the mar­ket is bear­ish and oth­er cash av­enues re­main large­ly shut.

For in­stance, Verona Phar­ma is­sued a pub­lic of­fer­ing of 10 mil­lion Amer­i­can de­posi­tary shares af­ter show­ing that its COPD drug had its pri­ma­ry end­point in a Phase III tri­al. An­oth­er ex­am­ple is Xenon Phar­ma­ceu­ti­cals which is­sued a $250 mil­lion pub­lic of­fer­ing straight af­ter an ex­pan­sion study for its dai­ly epilep­sy pill.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.