My­ovan­t's Myfem­bree sN­DA gets new PDU­FA af­ter CRL spec­u­la­tion; In­xMed bags more funds for piv­otal stud­ies

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.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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David Loew (Ipsen)

Ipsen snags an ap­proved can­cer drug in $247M M&A deal as an­oth­er bat­tered biotech sells cheap

You can add Paris-based Ipsen to the list of discount buyers patrolling the penny stock pack for a cheap M&A deal.

The French biotech, which has had plenty of its own problems to grapple with, has swooped in to buy Epizyme $EPZM for $247 million in cash and a CVR with milestones attached to it. Epizyme shareholders, who had to suffer through a painfully soft launch of their EZH2a inhibitor cancer drug Tazverik, will get $1.45 per share along with a $1 CVR tied to achieving $250 million in sales from the drug over four consecutive quarters as well as an OK for second-line follicular lymphoma by 1 Jan. 2028.

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AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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GSK says its drug for chron­ic hep B could ‘lead to a func­tion­al cure’ — but will it be alone or in com­bi­na­tion?

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 a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

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.

Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

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.”

Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

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.

Sen. Thom Tillis (R-NC) (J. Scott Applewhite/AP Images)

Phar­ma-friend­ly sen­a­tor calls on FDA for a third time to show patent pro­tec­tions should­n't be blamed for high drug prices

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.”