Sophiris’ shares $SPHS took a beat­ing two months ago when the biotech dis­closed that a pa­tient died on the same day of a sec­ond ad­min­is­tra­tion of their drug top­salysin in a Phase IIb prostate can­cer tri­al.

That death caused the biotech to put a brake on their dos­ing plans. Now, they’d like to wipe the slate clean of any nag­ging safe­ty is­sues.

Ran­dall Woods

In a new state­ment out this morn­ing, the San Diego-based biotech says the re­searchers in­volved have con­clud­ed that their pa­tient had like­ly died as a re­sult of “sud­den car­diac death prob­a­bly due to an ar­rhyth­mia…The in­ves­ti­ga­tor and the com­pa­ny con­cur that the event is un­like­ly re­lat­ed to top­salysin or the pro­ce­dure.”

Their stock quick­ly jumped more than 27% on the news.

I asked the com­pa­ny some fol­lowup ques­tions to the state­ment they sent out Wednes­day morn­ing. First, there’s no sign that the com­pa­ny plans to go ahead with the two oth­er planned sec­ond rounds for their drug. What’s hap­pen­ing on that score? And was the move to sus­pend dos­ing com­plete­ly vol­un­tary? If it was, why not just an­nounce you were re­turn­ing to com­plete the dos­ing?

In an email re­sponse from CFO Pe­ter Slover, Sophiris re­spond­ed that they won’t fin­ish the sec­ond round of dos­ing as “there were on­ly two pa­tients that would have been el­i­gi­ble for a sec­ond treat­ment.” And Slover em­pha­sized that the study halt was en­tire­ly vol­un­tary, with in­ves­ti­ga­tors re­port­ing the in­ci­dent to reg­u­la­tors.

“We con­tin­ue to plan and move for­ward with a po­ten­tial Phase 3 study de­sign based on the re­sponse rates and safe­ty pro­file we have ob­served to date,” said CEO Ran­dall Woods in a state­ment. “We look for­ward to re­port­ing the com­plete ef­fi­ca­cy and safe­ty da­ta from the Phase 2b study by the end of the year which will in­clude the biop­sy and safe­ty da­ta from the 10 pa­tients who re­ceived a sec­ond ad­min­is­tra­tion of top­salysin.” 

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine drugs for approval this week while also giving thumbs up for six expanded indications, including Novo Nordisk’s approved obesity medication Wegovy for younger people. Wegovy is already approved as an obesity treatment in the EU for adults, and the new indication would allow prescriptions for adolescents aged 12 and older.

RNA biotech GreenLight Biosciences has been handed an offer for potential acquisition.

GreenLight said in a release that it has received a non-binding “indication of interest” from Fall Line Endurance Fund to acquire GreenLight’s capital stock for $0.60 per share in cash. The release said any potential agreement between the two parties would depend on certain conditions.

Through a special committee, the biotech will evaluate the offer but added there’s no certainty a deal will go forward. GreenLight will also not make any more announcements until a deal comes through or “otherwise determines” a statement is necessary.

A public T cell biotech’s chief executive has decided to leave the company.

TScan Therapeutics said Friday morning that CEO David Southwell stepped down earlier this week, leaving both his chief executive and board member roles. Filling in is Gavin MacBeath, the company’s CSO and COO. He became the acting CEO on Tuesday, and will continue to remain CSO and COO, TScan’s announcement read.

The German life science group Sartorius will be picking up French contract manufacturer Polyplus for the price of €2.4 billion, or $2.6 billion.

On Friday, Sartorius announced the acquisition through its French subgroup, Sartorius Stedim Biotech, which will be acquiring Polyplus from private investors ARCHIMED and WP GG Holdings IV. Polyplus has 270 employees and produces materials and components that go into making viral vectors that are used in cell and gene therapies. This includes DNA/RNA reagents as well as plasmid DNA. Polyplus has locations in France, Belgium, China and the US.