April show­ers bring more biotechs to Nas­daq, as Rain and Im­pel bump 2021's to­tal raise above $6B

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What’s that in the sky — is it a bird? Is it a plane? No, it’s an­oth­er hand­ful of biotech IPOs.

Two more biotechs priced their pub­lic of­fer­ings late Thurs­day, com­ing just one day af­ter Zymer­gen blew folks away with its $500 mil­lion pric­ing. This week’s win­ners are Rain Ther­a­peu­tics and Im­pel Neu­rophar­ma, who raised $125 mil­lion and $80 mil­lion, re­spec­tive­ly. Rain priced at $17 and Im­pel’s shares de­buted at $15 apiece.

Com­bined, the sec­tor has now raised more than $6 bil­lion among near­ly three dozen de­buts, ac­cord­ing to the End­points News tal­ly. That’s on pace to top last year’s record raise of $16.5 bil­lion and 91 IPOs, per Nas­daq.

Al­so on Thurs­day came the F-1 fil­ing of Swiss biotech Mol­e­c­u­lar Part­ners, which is pen­cil­ing in $100 mil­lion for its leap to Nas­daq. The com­pa­ny is al­ready pub­licly trad­ed in its home coun­try.

Rain stock price could bring com­pa­ny’s val­u­a­tion to $427 mil­lion

Af­ter a 2020 that led to a sig­nif­i­cant ex­pan­sion of its pipeline, Rain Ther­a­peu­tics has priced its IPO.

The biotech that spe­cial­izes in on­col­o­gy has priced its 7,352,941 shares of its stock at $17 a share, and is ex­pect­ed to raise $125 mil­lion. In a re­lease Mon­day, the com­pa­ny stat­ed that price would com­mand a mar­ket cap of $457 mil­lion.

Rain’s pipeline tripled in a sin­gle week around La­bor Day last year, when it li­censed a re­search pro­gram from Drex­el Uni­ver­si­ty and grabbed a Phase II-ready drug from Dai­ichi Sankyo. That pro­gram has be­come RAIN-32. That is the com­pa­ny’s lead pro­gram now, and should see the ma­jor­i­ty of IPO funds fun­neled to­ward it. RAIN-32 is a small mol­e­cule in­hibitor of MDM2 tak­en oral­ly to re­duce tu­mors ac­tiv­i­ty in li­posar­co­ma and oth­er sol­id tu­mors.

In 2018, the com­pa­ny launched the ex­per­i­men­tal drug tar­lox­o­tinib with its $18 mil­lion in Se­ries A fundrais­ing. Last year, it raised $63 mil­lion. Rain will trade un­der the tick­er $RAIN. — Josh Sul­li­van

Im­pel an­nounces IPO to launch mi­graine treat­ment

Im­pel Neu­roPhar­ma is go­ing pub­lic a lit­tle more than two years af­ter its crossover raise, and Thurs­day, the com­pa­ny an­nounced that it would be priced at $15 a share.

Im­pel is ex­pect­ed to take home $80 mil­lion in pro­ceeds with the pub­lic of­fer­ing of 5,333,334 shares of its stock. The biotech from Seat­tle will use that mon­ey to com­mer­cial­ly launch its mi­graine treat­ment Trud­he­sa, de­liv­ered through an up­per nasal for­mu­la­tion of di­hy­droer­go­t­a­mine.

The pro­ceeds will al­so help its INP105 pro­gram, which is de­signed for treat­ment of ag­i­ta­tion and ag­gres­sion as­so­ci­at­ed with autism spec­trum dis­or­der. This can­di­date, like many of the com­pa­ny’s drugs, is de­liv­ered to the brain through the nose, as it’s a nasal re­for­mu­la­tion of olan­za­p­ine.

Shares of Im­pel’s stock — which will be list­ed as $IM­PL — will be­gin trad­ing to­day. — Josh Sul­li­van

Swiss biotech look­ing to hop across the pond with its pro­tein ther­a­pies

Mol­e­c­u­lar Part­ners is os­ten­si­bly seek­ing to cap­i­tal­ize on last month’s news that one of their an­tivi­ral pro­grams will par­tic­i­pate in an NIH-run Covid-19 tri­al. Mol­e­c­u­lar Part­ners teamed up with No­var­tis for the can­di­date, which is what they’re call­ing a “trispe­cif­ic” DARPin an­tivi­ral known as enso­vibep.

Re­searchers will eval­u­ate the an­tivi­ral as part of the NIH’s AC­TIV-3, the hos­pi­tal­ized mild-to-mod­er­ate pa­tient arm of their AC­TIV pro­to­col against Covid-19. If the med­i­cine hits all its mile­stones, No­var­tis will be on the hook for up to $231 mil­lion.

But Mol­e­c­u­lar Part­ners is al­so fo­cus­ing on eye dis­eases, on­col­o­gy and AML. The com­pa­ny has a Phase III pro­gram for wet AMD where they’ve part­nered with Al­ler­gan/Ab­b­Vie and a lead can­cer pro­gram for FAP-pos­i­tive can­cers in col­lab­o­ra­tion with Am­gen.

The biotech has three pro­grams it ex­pects to fund with its IPO: a Phase I tri­al for its sec­ond on­col­o­gy pro­gram seek­ing to bind FAP and CD40, to com­plete a Phase I study for the sec­ond No­var­tis-part­nered Covid-19 pro­gram known as MP0423, and to ad­vance their liq­uid tu­mor port­fo­lio in AML through Phase I as well.

Once the IPO is closed, Mol­e­c­u­lar Part­ners will trade on the tick­er $MOLN, which is al­so their Swiss tick­er. — Max Gel­man

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

UP­DAT­ED: Boehringer nabs FDA's first in­ter­change­abil­i­ty des­ig­na­tion for its Hu­mi­ra com­peti­tor — but will it mat­ter?

The FDA late Friday awarded Boehringer Ingelheim the first interchangeability designation for its Humira biosimilar Cyltezo, meaning that when it launches in July 2023, pharmacists will be able to automatically substitute the Boehringer’s version for AbbVie’s mega-blockbuster without a doctor’s input.

The designation will likely give Boehringer, which first won approval for Cyltezo in 2017, the leg up on a crowded field of Humira competitors.

Bio­gen hit by ALS set­back with PhI­II fail­ure for tofersen — but fol­lows a fa­mil­iar strat­e­gy high­light­ing the pos­i­tive

Patients and analysts waiting to hear Sunday how Biogen’s SOD1-ALS drug tofersen fared in Phase III didn’t have to wait long for the top-line result they were all waiting for. The drug failed the primary endpoint on significantly improving the functional and neurologic decline of patients over 28 weeks as well as the extension period for continued observation.

In fact, there was very little difference in response.

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Scott Struthers, Crinetics CEO

Cri­net­ics spins out ra­dio­phar­ma ef­forts in­to a new com­pa­ny, high­light­ing the grow­ing field­'s al­lure

Largely known for its nonpeptide small molecule research, Crinetics has been keeping its radiopharma work comparatively under wraps. But that changed Monday afternoon as the California biotech spun out a new company focused solely on the burgeoning field.

Crinetics launched Radionetics after the closing bell Monday, the company announced, seeding the new entity with $30 million raised from 5AM Ventures and Frazier Healthcare Partners. Radionetics will start with its own radiopharma-centric platform and a pipeline of 10 programs aimed at solid tumors.

Two drug­mak­ers hit with PDU­FA date de­lays from FDA amid back­log of in­spec­tions

As the FDA is weighed down with more and more pandemic responsibilities, the agency is beginning to miss PDUFA dates with more frequency too. Two different companies on Monday said they received notices that the FDA has not completed their drug reviews on time.

The review of an NDA for Avadel Pharmaceuticals’ candidate treatment for narcolepsy is not coming this month, the company said, and the review of UCB’s BLA for bimekizumab, used to treat moderate to severe plaque psoriasis, will miss its target date as well.

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Reshma Kewalramani, Vertex CEO (YouTube)

Ver­tex gets much-need­ed win with ‘ex­tra­or­di­nary’ first pa­tient re­sults on po­ten­tial di­a­betes cure

Vertex said Monday that the first patient dosed with its cell therapy for type 1 diabetes saw their need for insulin injections vanish almost entirely, a key early step in the decades-long effort to develop a curative treatment for the chronic disease.

The patient, who had suffered five potentially life-threatening hypoglycemic — or low blood sugar — episodes in the year before the therapy, was injected with synthetic insulin-producing cells. After 90 days, the patient’s new cells produced insulin steadily and ramped up their insulin production after a meal like normal cells do, as measured by a standard biomarker for insulin production.

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Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; 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.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Jeffrey Nau, Oyster Point Pharma CEO

FDA OKs an in­haled ver­sion of smok­ing ces­sa­tion drug Chan­tix — for a com­mon eye dis­ease

Oyster Point Pharma now has its first FDA-approved product — Tyrvaya. And the biotech has taken a unique route to get there by using an old drug with a storied past.

The New Jersey biotech announced this morning that the FDA has approved their nasal spray product for dry eye disease on Friday — the first nasal spray to be approved for the disease. The product’s active ingredient is 0.03 mg of varenicline, also known as smoking cessation aid Chantix.