Turn­ing Point un­veils $166M IPO; Aque­s­tive's rilu­zole film prod­uct is ac­cept­ed for FDA re­view

San Diego-based Turn­ing Point Ther­a­peu­tics has hit the high end of the range it set for their IPO, pric­ing an up­sized set of 9.3 mil­lion shares at $18 a pop. They end­ed up with $166 mil­lion raise, which will go a long way to in­spir­ing more in­dus­try IPOs among drug de­vel­op­ers.

The biotech $TP­TX has been de­vel­op­ing what they call oral, sec­ond-gen­er­a­tion TKIs, re­port­ing some ear­ly snap­shots of ef­fi­ca­cy and at least one death of a pa­tient that may have been drug re­lat­ed. Part of a grow­ing wave of Q2 biotech IPOs, the com­pa­ny plans to push ahead in­to the Phase II por­tion of an on­go­ing study of re­potrec­tinib with an eye to hunt­ing an ear­ly ap­proval for ROS1+ ad­vanced NSCLC or NTRK+ sol­id tu­mors.

Their suc­cess to­day in break­ing out well ahead of the $100 mil­lion fig­ure they had pen­cilled in on the S-1 spot­lights an open sea­son for biotech IPOs. Just a few days ago we saw 5 new IPOs hit, 4 on Nas­daq and one in Hong Kong. And this wave looks like it will con­tin­ue to gath­er force in the weeks ahead. 

The FDA has ac­cept­ed Aque­s­tive Ther­a­peu­tics’ $AQST ap­pli­ca­tion to mar­ket a film ver­sion of gener­ic rilu­zole, a decades-old treat­ment used to help pa­tients with amy­otroph­ic lat­er­al scle­ro­sis (ALS), an in­cur­able and al­ways fa­tal dis­ease that af­fects con­trol of the mus­cles need­ed to move, speak, eat and breathe. The agency will make its de­ci­sion by No­vem­ber 30 on the prod­uct, which has been en­gi­neered to help pa­tients who face dif­fi­cul­ty swal­low­ing or tak­ing tra­di­tion­al forms of med­ica­tion.

→ Still re­cov­er­ing from a stock bash­ing in the wake of dis­ap­point­ing Phase IIb da­ta, On­coSec $ONCS has inked a new col­lab­o­ra­tion with Duke Uni­ver­si­ty to test Ta­vo in a new in­di­ca­tion: breast can­cer. This time around, the drug will be paired with a HER2-plas­mid vac­cine ad­min­is­tered with its own in­tra­tu­moral de­liv­ery sys­tem.

Rex­ahn has picked up a $3 mil­lion up­front li­cens­ing Chi­na and Sin­ga­pore rights of its pan­cre­at­ic can­cer drug to BioSense, which plans to con­duct a Phase II tri­al of RX-3117 in Chi­na in up to three oth­er in­di­ca­tions.

Fangliang Zhang, AP Images

Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom

Amid a flurry of splashy pandemic IPOs, a J&J-partnered Chinese biotech has emerged with one of the largest public raises in biotech history.

Legend Biotech, the Nanjing-based CAR-T developer, has raised $424 million on NASDAQ. The biotech had originally filed for a still-hefty $350 million, based on a range of $18-$20, but managed to fetch $23 per share, allowing them to well-eclipse the massive raises from companies like Allogene, Juno, Galapagos, though they’ll still fall a few dollars short of Moderna’s record-setting $600 million raise from 2018.

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Mer­ck wins a third FDA nod for an­tibi­ot­ic; Mereo tack­les TIG­IT with $70M raise in hand

Merck — one of the last big pharma bastions in the beleaguered field of antibiotic drug development — on Friday said the FDA had signed off on using its combination drug, Recarbrio, with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. The drug could come handy for use in hospitalized patients who are afflicted with Covid-19, who carry a higher risk of contracting secondary bacterial infections. Once SARS-CoV-2, the virus behind Covid-19, infects the airways, it engages the immune system, giving other pathogens free rein to pillage and plunder as they please — the issue is particularly pertinent in patients on ventilators, which in any case are breeding grounds for infectious bacteria.

As it hap­pened: A bid­ding war for an an­tibi­ot­ic mak­er in a mar­ket that has rav­aged its peers

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

RA Cap­i­tal, Hill­house join $310M rush to back Ever­est's climb to com­mer­cial heights in Chi­na

Money has never been an issue for Everest Medicines. With an essentially open tab from their founders at C-Bridge Capital, the biotech has gone two and a half years racking up drug after drug, bringing in top exec after top exec, and issuing clinical update after update.

But now other investors want in — and they’re betting big.

Everest is closing its Series C at $310 million. The first $50 million comes from the Jiashan National Economic and Technological Development Zone; the remaining C-2 tranche was led by Janchor Partners, with RA Capital Management and Hillhouse Capital as co-leaders. Decheng Capital, GT Fund, Janus Henderson Investors, Rock Springs Capital, Octagon Investments all joined.

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Covid-19 roundup: Ab­b­Vie jumps in­to Covid-19 an­ti­body hunt; As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.

David Meline (file photo)

Mod­er­na’s new CFO took a cut in salary to jump to the mR­NA rev­o­lu­tion­ary. But then there’s the rest of the com­pen­sa­tion pack­age

David Meline took a little off the top of his salary when he jumped from the CFO post at giant Amgen to become the numbers czar at the upstart vaccines revolutionary Moderna. But the SEC filing that goes with a major hire also illustrates how it puts him in line for a fortune — provided the biotech player makes good as a promising game changer.

To be sure, there’s nothing wrong with the base salary: $600,000. Or the up-to 50% annual cash bonus — an industry standard — that comes with it. True, the 62-year-old earned $999,000 at Amgen in 2019, but it’s the stock options that really count in the current market bliss for all things biopharma. And there Meline did well.

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Por­tion of Neil Wood­ford’s re­main­ing in­vest­ments, in­clud­ing Nanopore, sold off for $284 mil­lion

It’s been precisely one year and one day since Neil Woodford froze his once-vaunted fund, and while a global pandemic has recently shielded him from the torrent of headlines, the fallout continues.

Today, the California-based patent licensing firm Acacia Research acquired the fund’s shares for 19 healthcare and biotech companies for $284 million.  Those companies include shares for public and private companies and count some of Woodford’s most prominent bio-bets, such as Theravance Biopharma, Oxford Nanopore and Mereo Biopharma, according to Sky News, which first reported the sale. It won’t include shares for BenevelontAI, the machine learning biotech once valued at $2 billion.