Per­cep­tive fields SPAC #3 as an­oth­er group of biotechs scoops up $364M in lat­est Nas­daq romp

There’s no sign that the wind­fall of cash drop­ping biotech’s way on Wall Street is abat­ing. Three more bio­phar­mas priced IPOs on Thurs­day and Fri­day morn­ing, rid­ing a his­toric boom with a $364 mil­lion pay­off.

Lon­don-based biotech Free­line Ther­a­peu­tics took home the li­on’s share of the cash with $159 mil­lion af­ter pric­ing 8,823,529 shares at $18 a pop. Check­mate Phar­ma­ceu­ti­cals, of Cam­bridge, MA, raised $75 mil­lion with an of­fer of 5 mil­lion shares at $15 — right at the mid­point of its range. And Arya Sci­ences Ac­qui­si­tion Corp III, the third in a se­ries from Per­cep­tive, priced 13,000,000 shares at $10 per share.

Drug­mak­ers are se­cur­ing big sums amid the pan­dem­ic boom, in­clud­ing AlloVir, which bagged $276 mil­lion from 16.3 mil­lion shares last week. Ini­tial­ly, the com­pa­ny had filed for a $100 mil­lion IPO. By June, all 23 new­ly pub­lic com­pa­nies had priced above their mid­point or up­sized their of­fer­ing.

And there’s more com­ing: Kymera Ther­a­peu­tics an­nounced plans to go pub­lic on Mon­day, when it filed for a $100 mil­lion IPO.

Check­mate ini­tial­ly filed for an IPO on Ju­ly 17, then raised its max­i­mum of­fer­ing price to $92 mil­lion in an amend­ed S-1 fil­ing. The im­muno-on­col­o­gy biotech is in­ves­ti­gat­ing its drug CMP-001 across mul­ti­ple can­cers, in­clud­ing melanoma and head and neck squa­mous cell car­ci­no­ma (HN­SCC), and says it will use the funds to ad­vance clin­i­cal tri­als. Bo­fA Se­cu­ri­ties, Jef­feries Group and BMO Cap­i­tal Mar­kets are man­ag­ing the deal.

CMP-001 us­es the im­mune sys­tem to its ad­van­tage, di­rect­ing ac­ti­vat­ed an­ti-tu­mor T cells to at­tack both the in­ject­ed tu­mor and tu­mors through­out the body. It’s been test­ed on more than 200 melanoma pa­tients to date, and based on clin­i­cal da­ta, the com­pa­ny be­lieves “there is an op­por­tu­ni­ty for CMP-001 to be de­vel­oped as a dif­fer­en­ti­at­ed im­muno-on­col­o­gy ther­a­py,” ac­cord­ing to the S-1 fil­ing.

Free­line ini­tial­ly filed for a $100 mil­lion IPO, with JP Mor­gan Se­cu­ri­ties LLC, Mor­gan Stan­ley & Co. and Ever­core Group as joint bookrun­ners. Its AAV gene-ther­a­py treat­ments tar­get he­mo­phil­ia A and B, Fab­ry dis­ease, and Type 1 Gauch­er dis­ease.

The biotech’s lead can­di­date, FLT180a, is cur­rent­ly in a Phase I/II tri­al for he­mo­phil­ia B. IPO funds will pro­pel the com­pa­ny’s pipeline, in­clud­ing Phase I/II tri­als for FLT180a and FLT190, a po­ten­tial drug to treat Fab­ry dis­ease.

SPACs (spe­cial pur­pose ac­qui­si­tion com­pa­nies) are ben­e­fit­ing from the boom, too. Once rare in the biotech world, they now rep­re­sent near­ly 35% of list­ings, Nas­daq’s Jay Heller told End­points last month.

Per­cep­tive Ad­vi­sors’ blank check com­pa­ny Arya III filed for a $143.7 mil­lion IPO on Ju­ly 21, and in­vestors are bet­ting on a prof­itable merg­er. In March, Arya I merged with biotech Im­mat­ics in a $252 mil­lion deal. Cerev­el Ther­a­peu­tics merged with Arya II in Ju­ly, ex­pect­ing to raise about $445 mil­lion to de­vel­op its pipeline.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

Just 5 months after Gilead gutted its rich partnership with Galapagos following a bitter setback at the FDA, the Belgian biotech is hunkering down and chopping the pipeline in an effort to conserve cash while their BD team pursues a mission to find a “transformative” deal for the company.

The filgotinib disaster didn’t warrant a mention as Galapagos laid out its Darwinian restructuring plans. Forced to make choices, the company is ditching its IPF molecule ’1205, while moving ahead with a Phase II IPF study for its chitinase inhibitor ’4617.

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An­oth­er failed tri­al for Or­p­hazyme's 'pipeline-in-a-pro­duc­t' leaves shad­ow on drug's fu­ture

The tumultuous ride for Orphazyme continued on Friday as the company announced that a pivotal trial for its lead drug arimoclomol failed yet again, this time in the treatment of ALS, seeding doubt in a drug that had recently been cleared by the FDA for priority review. The latest failure casts a darker shadow on the upcoming decision despite Orphazyme’s upbeat outlook.

In a statement, the Danish biotech announced that the drug did not meet its primary or secondary endpoints evaluating function and survival. But the company has not announced any data surrounding the failure, instead saying that it will publish the complete results later this year.

As­traZeneca caps PD-L1/CT­LA-4/chemo com­bo come­back with OS win. Is treme­li­mum­ab fi­nal­ly ready for ap­proval?

AstraZeneca’s closely-watched POSEIDON study continues to be the rare bright spot in its push for an in-house PD-L1/CTLA-4 combo.

Combining Imfinzi and tremelimumab with physicians’ choice of chemotherapy helped patients with stage IV non-small cell lung cancer live longer, the company reported — marking the first time the still-experimental tremelimumab has demonstrated an OS benefit.

For AstraZeneca and CEO Pascal Soriot, the positive readout — which is devoid of numbers — offers much-needed validation for the big bet they made on Imfinzi plus tremelimumab, after the PD-L1/CTLA-4 regimen failed multiple trials in head and neck cancer as well as lung cancer.

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Angela Merkel (AP Photo/Michael Sohn)

Covid-19 roundup: Pfiz­er sub­mits vac­cine for full ap­proval; Merkel op­pos­es Biden pro­pos­al to sus­pend IP for vac­cines

Pfizer and BioNTech said Friday that they’ve submitted a biologics license application to the FDA for full approval of their mRNA vaccine for those over the age of 16.

How long it will take the FDA to decide on the BLA will be set once it’s been formally accepted by the agency.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, previously told Endpoints News that the review of the BLA should take between three and four months, but it may be even faster than that.

Stéphane Bancel, Getty

Mod­er­na CEO brush­es off US sup­port for IP waiv­er, eyes more than $19B in Covid-19 vac­cine sales in 2021

Moderna is definitively more concerned with keeping pace with Pfizer in the race to vaccinate the world against Covid-19 than it is with Wednesday’s decision from the Biden administration to back an intellectual property waiver that aims to increase vaccine supplies worldwide.

In its first quarter earnings call on Thursday, Moderna CEO Stéphane Bancel shrugged off any suggestion that the newly US-backed intellectual property waiver would impact his company’s vaccine or bottom line. Still, the company’s stock price fell by about 9% in early morning trading.

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In­cyte ponies up $12M to set­tle char­i­ty foun­da­tion kick­back claims; US ex­er­cis­es op­tion for more dos­es of mon­key­pox vac­cine

One in a string of lawsuits targeting copay charity foundations, the DOJ has been hunting drugmaker Incyte for what prosecutors alleged was a kickback scheme to court patients. Now, Incyte is clearing its name.

Incyte will shell out $12.6 million to settle claims it funneled funds through a charity foundation to cover federal copays for patients taking its JAK inhibitor Jakafi, the DOJ said this week.

CEO Khurem Farooq (Gyroscope)

Hours be­fore ex­pect­ed de­but, Gy­ro­scope post­pones its IPO as 2 oth­er biotechs hold the line on their march to Nas­daq

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In a surprising turn of events, UK-based Gyroscope Therapeutics has postponed its IPO mere hours before it was set to debut on Nasdaq.

Working on a gene therapy for wet AMD, Gyroscope was all set and ready to go public earlier this week, setting terms for a $142 million raise with a price range of $20 to $22. But in the wee hours of Friday morning, the company put out a press release saying they would delay their debut “in light of market conditions,” CEO Khurem Farooq said in a statement.

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EMA safe­ty com­mit­tee seeks more in­fo on heart in­flam­ma­tion fol­low­ing Pfiz­er Covid-19 vac­cine

The European Medicines Agency’s safety committee said Friday that it’s aware of cases of inflammation of the heart muscle and inflammation of the membrane around the heart, mainly reported following vaccination with Pfizer’s Covid-19 vaccine, known in Europe as Comirnaty.

“There is no indication that these cases are due to the vaccine,” the EMA’s Pharmacovigilance Risk Assessment Committee said.

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