Will some pent-up deal pres­sure amp up a biotech ral­ly?

Over the last 6 weeks we’ve seen the Nas­daq biotech in­dex surge 21%, an ear­ly-stage com­pa­ny just up­sized its IPO and stuck to the range, sec­ondary of­fer­ings are do­ing bet­ter and a whole slate of big biotechs and phar­mas have made it plain that they’re hunt­ing for sig­nif­i­cant new deals be­fore the end of this year.

It’s the kind of en­vi­ron­ment that has peren­ni­al en­thu­si­asts cheer­ing a ral­ly that the in­dus­try hopes has legs need­ed to con­tin­ue past the dog days of sum­mer. And it has some big im­pli­ca­tions for the deal teams bar­ter­ing over biotech as­sets.

While Medi­va­tion $MD­VN is def­i­nite­ly in play, ru­mors abound that big out­fits like As­traZeneca $AZN and Bio­gen $BI­IB con­tin­ue to at­tract takeover in­ter­est. Most buy­ers these days, though, are look­ing to fol­low up on strate­gies adopt­ed by the likes of Al­ler­gan or Gilead. Al­ler­gan likes bit-sized deals – “step­ping stones,” if you ask CEO Brent Saun­ders — tar­get­ing late-stage as­sets that fit neat­ly in­to its core de­vel­op­ment ar­eas. Gilead has been stalk­ing li­cens­ing ef­forts that re­quire big up­front pay­ments. Ab­b­Vie $AB­BV may have set the stan­dard on over-ea­ger­ness when it paid $9.8 bil­lion for Stem­cen­trx in April. And Bio­gen ex­ecs have been talk­ing about deals for a sol­id year now.

But big game hunts have been sparse, more smoke than fire.

Val­u­a­tions, of course, are still well off the heights scaled a year ago, which may al­so help con­cen­trate ef­forts at the deal ta­ble. But they’re climb­ing, al­low­ing com­pa­nies like Bio­Marin (al­so reg­u­lar­ly fea­tured in the ru­mor mill) to raise more mon­ey. If sell­ers have more op­tions than tak­ing any­thing that’s put on the ta­ble, that can on­ly dri­ve deal val­ues fur­ther north.

For all the con­stant chat­ter about M&A, though, the re­al­i­ty is that plung­ing stocks have yet to trig­ger a much dis­cussed wave of ac­qui­si­tions.

Dealog­ic tracked $45 bil­lion in U.S. phar­ma and biotech M&A in the first half, a first-half low we haven’t seen since 2012, when the biotech boom was just start­ing to take off.

An­oth­er bit of food for thought: EP Van­tage just list­ed the most valu­able as­sets in the pipeline, based on sell-side analy­sis, top­ping it with Ax­o­vant’s $AX­ON late-stage drug for Alzheimer’s. In-li­censed from Glax­o­SmithK­line for $5 mil­lion in cash plus promis­es of more if it makes the grade, the bil­lions in val­ue at­trib­uted to such high-risk ef­forts un­der­scores that there may not be as many great deals avail­able as you might be­lieve.

UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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GSK, Vir's hopes for a Covid-19 an­ti­body fall flat in NIH 'mas­ter pro­to­col' with no ben­e­fit in hos­pi­tal­ized pa­tients

GlaxoSmithKline and Vir Biotechnology were hopeful that one of their partnered antibodies would carve out a win after getting the invite to a major NIH study in hospitalized Covid-19 patients. But just like Eli Lilly, the pair’s drug couldn’t hit the mark, and now they’ll be left to take a hard look at the game plan.

The NIH has shut down enrollment for GSK and Vir’s antibody VIR-7831 in its late-stage ACTIV-3 trial after the drug showed negligible effect in achieving sustained recovery in hospitalized Covid-19 patients, the partners said Wednesday.

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The 2021 top 100 bio­phar­ma in­vestors: As the pan­dem­ic hit and IPOs boomed, VCs swung in­to ac­tion like nev­er be­fore

The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights.

Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates.

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As Brain­Storm con­tin­ues to tout ‘clear sig­nal’ on ALS drug, the FDA of­fers a rare pub­lic slap­down on the da­ta

A little more than a week after BrainStorm acknowledged that regulators at the FDA had informed them that the biotech needed more data before it could expect to gain an approval for its ALS treatment NurOwn — while still touting a “clear signal” of efficacy and not ruling out an application — the agency has decided to clarify the record in a most unusual statement.

The FDA statement amounts to a straight slap own, offering a different set of efficacy numbers from the company’s public presentation last November and ruling out any chance of statistical significance.

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Eli Lil­ly claims suc­cess in a new JAK in­di­ca­tion: hair loss

Over the last decade, drugmakers have proven JAK inhibitors can treat a smattering of immune-related diseases ranging from rheumatoid arthritis to Covid-19. Now Eli Lilly has pulled out a new one.

Lilly and its biotech partner Incyte announced Wednesday that their JAK inhibitor baricitinib effectively regrew patients’ hair in a Phase III trial for alopecia areata, an autoimmune condition that can cause sudden, severe and patchy hair loss. Lilly didn’t break down the results from the 546-patient trial, but the primary endpoint was improvement on a standard score for alopecia symptoms.

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In­tro­duc­ing End­points FDA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.

Antoine Papiernik, Sofinnova managing director (Business Wire)

Sofinno­va Part­ners stays fo­cused on late-stage deals with a new, $540M crossover fund

One of Europe’s most high-profile biopharma investors is getting $540 million to invest in new crossover deals for late-stage companies.

The Paris-based VC says the fresh Sofinnova Crossover Fund raise positions them as the “largest crossover investor in Europe dedicated to late-stage biopharma and medtech investments.”

They got a leg up in France after winning a special “Tibi” designation from the French government, giving them access to a pool of €6 billion that helped them gain an edge with institutional investors. Since they were founded close to 50 years ago, the venture group has backed more than 500 companies and currently has more than €2 billion under management.

Presage teams with Mer­ck on its Phase 0 test­ing; Kem­Pharm AD­HD drug wins ap­proval in chil­dren aged 6 and up

Seattle-based Presage Biosciences, which approaches drug development through its microdosing platform, has some new partnerships and cash to come with them.

Presage closed a $13 million financing round Tuesday, aiming to expand its network of clinical trial sites and advance development of its microdosing injection devices. They also closed partnership deals with Merck and Maverick Therapeutics.

The financing included $7 million from new investors, including the LabCorp Venture Fund, Bristol Myers Squibb, and InHarv Partners. An additional $6 million convertible note from Takeda Ventures will convert to equity.

Thank you, next: Take­da hands Ovid $196M cash to rein back in Phase III-ready seizure drug, re­viv­ing bat­tered stock

Soticlestat made it.

Takeda is bringing the drug back into its fold more than four years after first entrusting the team at Ovid with the mid-stage clinical work. For all that — generating what they saw as positive Phase II data in Dravet syndrome and Lennox-Gastaut syndrome — the biotech has been rewarded with $196 million in upfront cash, with another $660 million reserved for regulatory and commercial milestones.

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