RA-backed Pep­Gen sets terms for up­com­ing IPO; Sanofi com­mences dos­ing of De­nali can­di­date in ALS

Though the mar­ket has ex­pe­ri­enced a strong down­turn this year, a pre­car­i­ous few com­pa­nies are test­ing the IPO wa­ters. And Pep­Gen is the newest biotech to ap­proach Nas­daq.

The Phase I biotech said Mon­day that it plans to raise just over $100 mil­lion this week by of­fer­ing 7.2 mil­lion shares some­time this week. The price has not been set yet, but the cur­rent range would be be­tween $13 and 15 per share. At the mid­point of the range, it would give Pep­Gen a po­ten­tial mar­ket val­ue of around $300 mil­lion.

The biotech had filed with the SEC last month that it would at­tempt an IPO, and orig­i­nal­ly pen­ciled in $115 mil­lion. The Ox­ford spin­out had re­ceived $45 mil­lion in a 2020 Se­ries A backed by RA Cap­i­tal Man­age­ment, which his­tor­i­cal­ly has in­di­cat­ed a fu­ture ap­pear­ance on Nas­daq.

The biotech fo­cus­es on de­vel­op­ing “cell-pen­e­trat­ing” pep­tides for se­vere neu­ro­mus­cu­lar dis­eases, such as Duchenne mus­cu­lar dy­s­tro­phy. Its lead can­di­date, PGN-EDO51 for DMD, re­cent­ly en­tered a Phase I tri­al in healthy nor­mal vol­un­teers, with topline da­ta an­tic­i­pat­ed by the end of the year.

Pep­Gen plans to list on the Nas­daq un­der the tick­er $PEPG.

Sanofi start­ing to dose pa­tients in Phase II study us­ing De­nali’s drug can­di­date

While De­nali had been fac­ing a clin­i­cal hold for its Alzheimer’s drug can­di­date since Jan­u­ary, the biotech has shown no signs of slow­ing down and gave a new up­date on its deal with Sanofi Mon­day.

The biotech an­nounced that Sanofi has start­ed dos­ing pa­tients in an on­go­ing Phase II tri­al called Hi­malaya, us­ing SAR443820, an RIPK1 in­hibitor al­so known as DNL788, in pa­tients with ALS. There was no in­fo giv­en on when topline or in­ter­im da­ta would be ex­pect­ed. How­ev­er, De­nali will re­ceive $40 mil­lion as a mile­stone pay­ment.

De­nali’s CMO Ca­r­ole Ho said in a state­ment that “we are ex­cit­ed about the pro­gres­sion of De­nali’s port­fo­lio in ALS with this mile­stone.”

The deal from 2018, struck by Sanofi’s then-new R&D chief John Reed, in­clud­ed $125 mil­lion up­front and more than $1 bil­lion in po­ten­tial mile­stones.

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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Deborah Dunsire, Lundbeck CEO

Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti against Alzheimer's ag­i­ta­tion

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

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A Mer­ck part­ner is sucked in­to the fi­nan­cial quag­mire as key lender calls in a note

Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.

Members of the G7 from left to right: Prime Minister of Italy Mario Draghi, European Commission President Ursula von der Leyen, President Joe Biden, German Chancellor Olaf Scholz, British Prime Minister Boris Johnson, Canadian Prime Minister Justin Trudeau, Prime Minister of Japan Fumio Kishida, French President Emmanuel Macron and European Council President Charles Michel (AP Photo/Susan Walsh)

Biden and G7 na­tions of­fer funds for vac­cine and med­ical prod­uct man­u­fac­tur­ing project in Sene­gal

Amidst recently broader vaccine manufacturing initiatives from the EU and European companies, the G7 summit in the mountains of Bavaria has brought about some positive news for closing vaccine and medical product manufacturing gaps around the globe.

According to a statement from the White House, the G7 leaders have formally launched the partnership for global infrastructure, PGII. The effort will aim to mobilize hundreds of billions of dollars to deliver infrastructure projects in several sectors including the medical and pharmaceutical manufacturing space.

Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

Chris Anzalone, Arrowhead CEO

Take­da, Ar­row­head spot­light da­ta from small tri­al show­ing RNAi works in a rare liv­er con­di­tion

Almost two years after Takeda wagered $300 million cash to partner with Arrowhead on an RNAi therapy for a rare disease, the companies are spelling out Phase II data that they believe put them one step closer to their big dreams.

In a small, open label study involving only 16 patients who had liver disease associated with alpha-1 antitrypsin deficiency (AATD), Arrowhead’s candidate — fazirsiran, previously ARO-AAT — spurred substantial reductions in accumulated mutant AAT protein in the liver, a hallmark of the condition. Investigators also tracked improvements in symptoms, with seven out of 12 who received the high, 200 mg dose seeing regression of liver fibrosis.

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Mi­to­chon­dria biotech re­ceives Morn­ing­side buy­out of­fer af­ter PhII fail; On­col­o­gy mi­cro­cap with­draws IPO plans

Not even two months after reporting a Phase II fail for its lead drug candidate, Stealth BioTherapeutics is now being eyed for a potential acquisition, with one firm wanting to take it private.

Stealth reported Monday that Morningside Venture Investments sent Stealth’s board of directors a non-binding preliminary proposal to acquire all outstanding shares not yet owned by Morningside for 2.6 cents per share and 31.3 cents per ADS.