When PolyPid re­vealed its lead pro­gram had flunked the main goal of the first Phase III tri­al, it un­der­scored pos­i­tive re­sults from a sub­group analy­sis. The Is­raeli biotech, which al­ready had an­oth­er Phase III un­der­way, said it would talk to the FDA be­fore de­cid­ing what to do with the sec­ond tri­al.

Al­most five months lat­er, the com­pa­ny says the FDA is keep­ing the doors open for an ap­proval.

PolyPid’s lead can­di­date, D-PLEX100, is a for­mu­la­tion of the an­tibi­ot­ic doxy­cy­cline. On the mol­e­c­u­lar lev­el, it com­pris­es al­ter­nat­ing lay­ers of poly­mers and lipids that en­trap the drug, there­by al­low­ing for a pro­longed and sus­tained re­lease; prac­ti­cal­ly, it’s a paste that can be ap­plied di­rect­ly dur­ing surgery to sur­gi­cal sites to pre­vent in­fec­tions.

In SHIELD I, the failed tri­al, PolyPid looked at the com­bi­na­tion of in­ci­sion­al sur­gi­cal site in­fec­tions and mor­tal­i­ty. It found that while D-PLEX100 de­creased both in­fec­tions and deaths com­pared to stan­dard of care, the dif­fer­ence wasn’t sta­tis­ti­cal­ly sig­nif­i­cant (23% re­duc­tion, p=0.1520).

But zoom­ing in­to a pre-spec­i­fied sub­group — an analy­sis that PolyPid said the FDA re­quest­ed — in­ves­ti­ga­tors found that pa­tients with large in­ci­sions (i.e. those larg­er than 20 cm) who re­ceived PolyPid’s treat­ment did see a 54% re­duc­tion in in­fec­tions and deaths (p=0.0032).

Ac­cord­ing to PolyPid, the agency said in a re­cent meet­ing that the sub­group da­ta “may pro­vide sup­port­ive ev­i­dence” for use in this pa­tient pop­u­la­tion — and “rec­om­mend­ed that the Com­pa­ny con­duct an ad­di­tion­al study to sup­port a po­ten­tial NDA sub­mis­sion.”

Reg­u­la­tors al­so con­firmed that SHIELD II, a study for which PolyPid has al­ready en­rolled more than 200 pa­tients, could po­ten­tial­ly be that ad­di­tion­al study, the com­pa­ny said.

PolyPid is work­ing “ex­pe­di­tious­ly” to re­vise and fi­nal­ize the de­sign of that tri­al, with plans to re­sume pa­tient re­cruit­ment over the next few months. Ex­ecs are al­so in talks with reg­u­la­tors in Eu­rope.

How ex­pe­di­tious­ly the com­pa­ny can go will be crit­i­cal. News of the SHIELD I dis­ap­point­ment had dec­i­mat­ed PolyPid’s shares on Nas­daq, push­ing it off a cliff from more than $6 to the dol­lar-range. The com­pa­ny laid off 20% of its em­ploy­ees in an ef­fort to re­duce cost and ex­tend its cash run­way in­to the third quar­ter of 2023.

The stock is trad­ing at $1.05 Tues­day morn­ing.

New York City is investing $20 million in biotech this year in the form of a 50,000-square-foot “innovation space” at the Brooklyn Navy Yard, complete with offices, research laboratories and events and programming space to grow biotech startups and companies.

Mayor Eric Adams said during his State of The City Address last Thursday that there will be an “emphasis” on making more opportunities for women and people of color to further diversify the industry. The City first reported the news.

Boehringer Ingelheim uncorked some positive results suggesting that Spevigo can help prevent flare-ups in patients with a severe form of psoriasis, months after the drug was approved to treat existing flares.

Spevigo, an IL-36R antibody also known as spesolimab, met its primary and a key secondary endpoint in the Phase IIb EFFISAYIL 2 trial in patients with generalized pustular psoriasis (GPP), Boehringer announced on Monday. While the company is keeping the hard numbers under wraps until later this year, it said in a news release that it anticipates sharing the results with regulators.

AstraZeneca, Novo Nordisk, and Sanofi won an appeals court win on Monday, as the US Court of Appeals for the Third Circuit found that the companies cannot be forced to provide 340B-discounted drugs purchased by hospitals from an unlimited number of community and specialty pharmacies.

“Legal duties do not spring from silence,” the decision says as the court makes clear that the federal government’s interpretation of the “supposed requirement” that the 340B program compels drugmakers to supply their discounted drugs to an unlimited number of contract pharmacies is not correct, noting:

A US appeals court has ruled against Johnson & Johnson’s use of bankruptcy to deal with mounting talc lawsuits, deciding that doing so would “create a legal blind spot.”

The Third Circuit Court of Appeals reversed a previous bankruptcy court decision on Monday, calling for the dismissal of a Chapter 11 filing by J&J’s subsidiary LTL Management.

Faced with more than 38,000 lawsuits alleging its talc-based products caused cancer, J&J spun its talc liabilities into a separate company called LTL Management back in October 2021 and filed for bankruptcy, a controversial move colloquially referred to as a “Texas two-step” bankruptcy. Claimants argued that the strategy is a misuse of the US bankruptcy code — and on Monday, a panel of judges agreed.