Last month, an­a­lysts spec­u­lat­ed the sN­DA for My­ovant Sci­ences and Pfiz­er’s Myfem­bree could be hit by a CRL af­ter the FDA iden­ti­fied “de­fi­cien­cies.” Now, the com­pa­nies are say­ing the drug de­ci­sion da­ta has been pushed back.

The Swiss biotech said Fri­day that the PDU­FA date was pushed from May 6 to Aug. 6, and Cowen an­a­lysts re­act­ed pos­i­tive­ly.

“This is an en­cour­ag­ing de­vel­op­ment. Fol­low­ing the dis­clo­sure of de­fi­cien­cies, we had ex­pect­ed a CRL to­day, but the ex­ten­sion sug­gests a path to ap­proval this sum­mer. We con­tin­ue to be­lieve MY­OV is un­der­val­ued for the re­l­u­golix fran­chise,” Cowen an­a­lysts wrote in a note.

SVB Se­cu­ri­ties an­a­lysts were a lit­tle more cau­tious in their as­sess­ment, not­ing: “While this news is hope­ful, we are still con­cerned that My­ovant is not out of the woods yet.”

My­ovant said last month the FDA had “iden­ti­fied de­fi­cien­cies that pre­clude dis­cus­sion of la­bel­ing and/or post-mar­ket­ing re­quire­ments and com­mit­ment at this time.”

Juan Cami­lo Ar­jona Fer­reira

The three-in-one pill is un­der re­view for an ex­ten­sion to treat mod­er­ate to se­vere pain as­so­ci­at­ed with en­dometrio­sis. An FDA nod would trig­ger a $100 mil­lion reg­u­la­to­ry mile­stone from part­ner Pfiz­er.

“We re­main con­fi­dent in the clin­i­cal pro­file of MYFEM­BREE and its po­ten­tial to be­come a ther­a­peu­tic op­tion for the man­age­ment of en­dometrio­sis-as­so­ci­at­ed pain,” My­ovant med­ical chief Juan Cami­lo Ar­jona Fer­reira said in a press re­lease. “We will con­tin­ue to work close­ly with the FDA to sup­port the on­go­ing re­view of the sN­DA.”

My­ovant’s shares $MY­OV have slid since the ini­tial de­fi­cien­cies dis­clo­sure last month, falling from about $14 apiece to $8.68 at the clos­ing bell on Fri­day.

In­xMed snags more mon­ey to bankroll piv­otal stud­ies of its fast track can­cer drug

In­xMed said it has picked up an ad­di­tion­al $15 mil­lion in Se­ries B funds af­ter ini­tial­ly dis­clos­ing a $50 mil­lion round in March. The pro­ceeds will bankroll the Nan­jing, Chi­na-based biotech’s stud­ies of IN10018, a fo­cal ad­he­sion ki­nase (FAK) small mol­e­cule in­hibitor pro­gram.

That in­cludes piv­otal stud­ies on tap for the sec­ond half of this year, In­xMed said in a press re­lease. The FDA gave the drug fast track des­ig­na­tion last Au­gust and Chi­na’s reg­u­la­tor re­cent­ly gave it break­through des­ig­na­tion for the treat­ment of pa­tients with plat­inum-re­sis­tant ovar­i­an can­cer. More da­ta on the drug will be re­vealed next month at AS­CO.

IN10018 is in mul­ti­ple stud­ies in the US and Chi­na across var­i­ous can­cers, in­clud­ing uveal melanoma and NRAS mu­tant metasta­t­ic melanoma; ovar­i­an and gas­tric can­cer; and pan­cre­at­ic can­cer and non-small cell lung can­cer.

Found­ed in late-2018, the Mer­ck, Roche and Boehringer In­gel­heim-part­nered biotech has work­ers in Shang­hai, Bei­jing, Nan­jing, the US, Cana­da and Aus­tralia. The com­pa­ny pre­vi­ous­ly raised $19 mil­lion in a Sep­tem­ber 2020 Se­ries A. Back­ers in­clude Hyfin­i­ty In­vest­ments, En­no­va­tion Ven­tures, Chi­na Growth Cap­i­tal, In­noMed Cap­i­tal, Grand Yangtze Cap­i­tal, CS Cap­i­tal, AI­HC Fund, Growth Fund and Ho­sen­care Fund.

GSK, newly branded and soon-to-be demerged, shared interim results from its Phase II trial on its chronic hepatitis B treatment, one that it says has the “potential to lead to a functional cure.”

At a presentation at the EASL International Liver Congress, GSK shared that in around 450 patients who received its hep B drug bepirovirsen for 24 weeks, just under 30% had hepatitis B surface antigen and viral DNA levels that were too low to detect.

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”