Turn out the lights, the par­ty is over at Mil­len­do Ther­a­peu­tics.

Nine months af­ter pulling the plug on a piv­otal study of their lead drug, the Ann Ar­bor, MI-based biotech is shut­ter­ing its sole re­main­ing ear­ly-stage study for their NK3R an­tag­o­nist MLE-301. And they’re sound­ing a bleak note, plan­ning some deep cuts for the re­main­ing staff while the board goes about the busi­ness of find­ing a way to gain some val­ue out of this for share­hold­ers.

At the top of the al­ter­na­tive strate­gies on the ta­ble: A sale or merg­er of the com­pa­ny, or what’s left of it.

The biotech is wash­ing its hands of a drug aimed at treat­ing menopausal va­so­mo­tor symp­toms. Af­ter look­ing over the re­sults from their dose-as­cend­ing Phase I, re­searchers found lit­tle rea­son to re­main op­ti­mistic — es­pe­cial­ly giv­en the com­pet­i­tive land­scape of NK3R drugs.

This is the drug Mil­len­do — long helmed by Ju­lia Owens — turned to af­ter its Phase IIb tri­al for liv­o­le­tide went bel­ly up last spring.

The stock $ML­ND, which has erased vir­tu­al­ly all of its once high-fly­ing val­ue, dropped 14% Tues­day morn­ing,

Com­pa­ny chair­man Car­ol Gal­lagher summed it up in a state­ment:

The board has con­tin­ued to sup­port the com­pa­ny’s on­go­ing plans and ex­e­cu­tion ef­forts; how­ev­er, at this time the board be­lieves that it is in the best in­ter­est of the com­pa­ny and its share­hold­ers to ac­tive­ly seek a broad range of strate­gic al­ter­na­tives, in­clud­ing a sale or merg­er of the com­pa­ny in or­der to max­i­mize share­hold­er val­ue.

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

As the global biologics market is expected to hit nearly the half-trillion-dollar mark this year, new JAMA research points to the importance of timely biosimilar entry, particularly as fewer biosimilars are entering the US than in Europe, and as monthly treatment costs for biosimilars were “substantially higher” in the US compared with Germany and Switzerland.

Among the three countries, biosimilar market share at launch was highest in Germany, but increased at the fastest rate in the US, the authors from the University of Zurich’s Institute of Law wrote in JAMA Network Open today.

The European Medicines Agency said Friday that it’s pulling from all European markets pholcodine-containing medicines, which are an opioid used in adults and children for the treatment of dry cough and in combo with other drugs as a treatment for cold and flu.

The decision to pull the medicines comes as the EMA points to the results from the recent ALPHO study, which show that use of pholcodine during the 12 months preceding anesthesia is linked to a risk of an anaphylactic reaction related to the neuromuscular blocking agents (NMBAs) used (with an adjusted OR of 4.2, and a 95% confidence interval of 2.5 to 6.9).

Immunocore, which became the first company to win approval for a TCR therapy earlier this year, has penned a deal with gamma delta T cell specialist Gadeta to develop treatments for solid tumors, starting with colorectal cancer.

Immunocore R&D head David Berman told Endpoints News the deal is part of the company’s efforts to develop a “universal T cell engager.” TCR therapies made from typical T cells, like Immunocore’s TCR therapy Kimmtrak, are restricted to patients with certain HLA types, a kind of marker that helps the body separate friend and foe. Kimmtrak, for instance, is indicated only for patients with unresectable or metastatic uveal melanoma, a rare form of cancer that happens in the eye, who have the tissue type HLA-A*02:01, one of the more common HLA types which by Berman’s estimate includes around 40-50% of the population.